cyrilzakka/clinical-trials huggingface dataset:
Use of "iSuite" During CMR-guided Electrophysiological Procedures

The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "iSuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-guided electrophysiological procedure (CMR-EP).


Eligibility Criteria:
Inclusion Criteria:

* Already scheduled by the treating electrophysiologist for CMR-EP as standard care for the treatment of a cardiac arrhythmia.
* Minimum age of 18 years old.
* Written informed consent

Exclusion Criteria:

* Participation in another investigational study that has not reached its primary endpoint.
* Contraindication for MRI such as: metallic implant, body weight \> 130 kg, pregnancy, breast feeding women, known severe allergy to gadolineum contrast agents, renal failure with eGFR ≤ 30 mL/min/1,73m2.
Towards Worldwide Comparability of Visual Acuity Assessment

Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.

Assessment of distant visual acuity is the most frequently used procedure for estimation of visual performance. However, there exist a vast number of markedly differing visual acuity tests worldwide; furthermore there are differing report formats to express acuity. This variety may critically interfere with standardization and comparability of this basic visual test method.

Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, i.e., the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts, a conventional projected distant visual acuity test according to DIN 58220 part 3, and the Freiburg visual acuity test (FrACT), to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of:

* normal ophthalmological status,
* opacity of the refractive media,
* maculopathy,
* optic neuropathy
* chiasmal and postchiasmal visual pathway pathologies,
* amblyopia (deprivation),
* amblyopia (strabism)

Exclusion Criteria:

* underage person
* concomitance of different eye-diseases
Influence of Temporo-occipital Transcranial Magnetic Brain Stimulation on Aversive Episodic Memory Performance

A pilot study, examining the effect of repeated transcranial magnetic brain stimulation (rTMS) on the formation of memories with negative valence. The investigators hypothesize that an effective rTMS protocol to reduce memory performance for adverse events can be found.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Generally healthy
* Normotensive (BP 90/60mmHg - 140/90mmHg)
* BMI: 19 - 30 kg/m2
* Age: 18 - 30 years
* Fluent German-speaking

Exclusion Criteria:

* Metal in the brain, skull or elsewhere in the body (e.g., splinters, fragments, clips, etc.)
* Implanted neurostimulator (e.g., DBS, epidural/subdural, VNS)
* Cardiac pacemaker or intracardiac lines
* Medication infusion device
* Nonremovable Piercings in the head area, pivot teeth (retainers are no exclusion criterion)
* Tattoos (head area) less than 3 months old or older than 20 years
* Condition after neurosurgery
* Hearing problems or tinnitus
* Not able to sit still due to tremor, tics, itching
* History of repeated syncope
* Head trauma diagnosed as concussion or associated with loss of consciousness
* diagnosis of epilepsy, or a convulsion or a seizure in the past of the participant or his/her close family
* TMS in the past showing problems
* Surgical procedures to spinal cord
* Spinal or ventricular derivations
* Alcohol or drug intake 48 hours before start of visits
* Regular intake of any medication or CNS-active medication 48h before visit
* rMT above the limits of rTMS device.
Rezafungin Prophylaxis in Liver Transplant

This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of IFIs.

This is a single arm interventional study of consecutive liver transplant recipients who have consented to this rezafungin prophylaxis study. The outcome will be compared with that of similar group of patients not enrolled in the study and those who underwent liver transplant in the preceding two years (historical controls). Propensity score matching will be used to select retrospective cohort.

There will be 3 groups:

1. Study group (prospective intervention cohort): Rezafungin (180 patients)
2. Prospective control group (prospective control cohort): Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's tiered antifungal prophylaxis standard of care (20 patients: 10 who receive fluconazole/voriconazole and 10 who do not receive fluconazole/voriconazole)
3. Historical control group (retrospective control cohort): Patients at risk for IFI who received fluconazole/voriconazole (tier approach) in the two years preceding this study (180 patients)

Eligibility Criteria:
Inclusion Criteria:

* Liver transplant recipient
* 18 years of age or older
* ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy anastomosis, or peri-operative Candida colonization, recent Candida infection, renal replacement therapy post-transplant, and reoperation within the first 90 days of transplant.

Exclusion Criteria:

* Participants who are perceived not to survive past 7 days after transplant
* Participants who elect not to participate in the prospective trial
* Participants who had active candidiasis at the time of transplant
* Participants with a history of allergy to an echinocandin
* Participants who are pregnant.
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support

Exclusion Criteria:

* Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Radical Cystectomy, Nutrition and Convalescence

The purpose of this study is to determine whether a goal directed nutritional intervention can reduce the convalescence period for patients undergoing radical cystectomy (RC).

The aim is to examine the effect on quality of life of a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery versus a goal-directed nutritional intervention combining oral intake and parenteral nutrition, in patients undergoing RC.

The study is a randomized controlled trial. Inclusion criteria: Bladder cancer, ability to give an informed consent. Exclusion criteria: Previous radiation therapy at the pelvic area, ureterocutaneostomy or robot-assisted surgery. The intervention aims to secure that 75% of the patient's total energy and protein needs are met during hospitalization.

Primary outcome: Quality of Life, using the EORTC QLQ-C30 and BLM30 questionnaire. Secondary outcomes: Body-weight, Hand Grip strength, biochemical measures, length of hospital stay, time to bowel recovery. The follow-up period is 12 weeks. Statistical analysis is performed in collaboration with a statistician.

Eligibility Criteria:
Inclusion Criteria:

* Bladder cancer
* Ability to give an informed consent

Exclusion Criteria:

* Previous radiation therapy at the pelvic area
* Ureterocutaneostomy
* Robot-assisted surgery
The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

This study wishes to understand:

1. whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects;
2. whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.

Influenza infection may become complicated in patients with chronic conditions, including coronary artery disease (CAD) \[1\]. Influenza vaccination is now recommended as part of comprehensive secondary prevention in individuals with coronary and other atherosclerotic vascular disease (evidence level: Class I, Level B) \[2\]. Although there is controversial evidence pro \[3,4\] and against \[5\] the efficacy of influenza vaccination in protecting CAD population against cardiovascular events, the efficacy of vaccine in actual reduction in episodes of influenza infection and its fatal complications in CAD patients has not been, to our knowledge, well studied before. Furthermore, we found no report comparing serologic response to the influenza vaccine antigens between CAD patients and healthy controls.

This study aims to identify the efficacy of influenza vaccination in CAD individuals in terms of both serologic response (as compared with healthy individuals) and clinical outcomes (as compared with CAD patients not vaccinated).

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease (CAD) group (CAD-Exp and CAD-Control):
* Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:

  1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
* Ischemic symptoms
* Development of pathologic Qwaves on the ECG
* ECG changes indicative of ischemia (ST segment elevation or depression); OR
* Coronary artery intervention (e.g., coronary angioplasty). 2. Pathologic findings of an acute MI \[1\]:
* Patients with stable angina pectoris (SA) and documented coronary artery stenosis (angiography).
* Healthy Control group: healthy controls, proportionally matched by gender and age with the patient group (separate control groups for MI and SA patients).

Exclusion Criteria:

* Any acute disease
* Chronic liver or kidney diseases
* Conditions accompanied by immunosuppression (like organ transplantation, HIV)
* Diagnosed malignancy
* Incubation with influenza vaccine within the past 5 years
* Any psychological disease that interferes with regular follow-up
* Congestive heart failure (Killip class IV)
* Unstable angina; AND
* Contradictions of vaccine incubation (like egg allergy).
Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care

The aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed PRO (HM-PRO) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy.

Design: A two-arm prospective randomized controlled trial.

Population: Patients diagnosed with chronic myeloid leukemia (CML), clonal cytopenia of unknown significance (CCUS), myelodysplastic syndrome (MDS) or myeloproliferative neoplasia (MPN).

Patients will be recruited from the outpatient clinic at the Dept. of Hematology at Rigshospitalet in Denmark. Patients will be identified and screened by their physician. Patients who are eligible for study inclusion will hereafter be approached, informed and recruited by the primary research investigator. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.

The intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients.

The control group will receive standard care in the outpatient clinic. The patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control.

Data Collection: The questionnaires will be distributed and completed by patients electronically via REDCap consisting of clinical data, PRO data (HM-PRO) and endpoint measures (see below).

* Primary outcome: Change in QoL measured by EORTC-QLQ-C30, global health domain, at 12 months.
* Secondary outcomes: Change in symptoms of depression and anxiety measured by HADS, change in symptom burden measured by MDASI symptom scale and clinical data outcomes at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* adults \> 18 years
* diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, Rigshospitalet
* The patients can be included approximately six months after initial diagnosis if in stable condition.
* able to manage an e-mail account

Exclusion Criteria:

* Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Histologically confirmed esophageal squamous cell carcinoma (ESCC).
* Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition).
* Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent.
* Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose.

Key Exclusion Criteria:

* Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy.
* Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways.
* History of fistula due to primary tumor invasion.
* Participants with high risk of fistula or sign of perforation evaluated by investigator.
* Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.

  \* Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted.
* Active autoimmune diseases or history of autoimmune diseases that may relapse.

  \* Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
* With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection.

  * Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  * Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects

Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.

In this study we want to address the sensitivity and specificity of breath analysis by MCC-IMS in the context of SARS-CoV-2 detection from PCR- proven infected and non-infected subjects.

Therefore nasal breath will be aspirated for 10 seconds during normal respiration by a foam cuffed oxygen catheter connected via a 0.22μm filter and a line into the MCC-IMS and directly analyzed without any pre-analytic procedures.

The during the proof-of-concept study derived significant peaks for volatile organic compounds will be used for discrimination in a point-of-care approach.

Eligibility Criteria:
Inclusion Criteria:

hospital admission staff members

Exclusion Criteria:

too sick to comply with study procedures
PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery

RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment.

PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.

OBJECTIVES:

* Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision.
* Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal CT scan and chest x-ray.

OUTLINE: This is a diagnostic study conducted concurrently with multimodality management.

Within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo baseline positron emission tomography (PET) imaging of the thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (FDG) IV followed 45 minutes later by PET imaging. Patients also undergo baseline CT imaging of the abdomen and pelvis. A CT scan of the chest is obtained if the prestudy chest x-ray is abnormal.

Patients receive preoperative radiotherapy/chemotherapy. Within 4-6 weeks of completion of radiotherapy/chemotherapy, patients undergo repeat FDG-PET imaging and CT scan. Patients undergo surgical resection 1-2 weeks later.

PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Primary resectable rectal cancer as determined by currently accepted diagnostic work-up, including CT scan and endorectal ultrasound (EUS)
* Must meet criteria for preoperative radiotherapy and chemotherapy:

  * Bulky tumors and/or EUS evidence of T3-4 and/or N1 disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* No uncontrolled diabetes mellitus (i.e., greater than 175 mg/dL)
* No intolerance of being inside PET scanner for duration of study
* No vulnerable patients (e.g., mentally retarded or prisoners)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants greater than 18 years of age
* Single organ (heart) transplant recipients
* At risk for post-transplant renal dysfunction

Exclusion Criteria:

* Previous organ transplant
* Previous treatment with mycophenolate mofetil, daclizumab or sirolimus
* Positive for human immunodeficiency virus (HIV) infection
* History of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse
Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet

To Evaluate the Efficacy and Safety of CKD-333

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period
2. Lipid levels measured after run-in period were:

   * Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
   * Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL
   * Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL

Exclusion Criteria:

1. Patients whose blood pressures measured at Visit 2 were:

   * Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg
2. Patients who had lipid levels measured at Visit 2

   * Patients with fasting LDL-C \<100 mg / dL or fasting LDL-C\> 250 mg / dL and / or TG ≥ 500 mg / dL