cyrilzakka/clinical-trials huggingface dataset:
Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression

Research has demonstrated that psychedelic compounds possess significant therapeutic potential for a variety of disorders, including depression. Despite these findings, the underlying mechanisms driving the therapeutic efficacy of psychedelics remain elusive. Furthermore, there exists a debate over the contribution of the subjective psychedelic experience to their therapeutic benefits. In this study, virtual reality (VR) is utilized as a tool to replicate the subjective experiences induced by psychedelics, aiming to explore their impact on depressive symptoms within a clinical sample.

The primary objective of this research is to examine the influence of psychedelic-like phenomenology, as simulated through VR, on depressive symptoms. The study is structured into two distinct arms: the experimental condition features 'Psyrreal,' a VR experience designed to emulate psychedelic effects and the control condition which includes 'Routine Realms,' an analogous VR experience devoid of psychedelic elements. A third waiting list condition may be included, dependent on the availability of sufficient participants and resources. Additionally, the study seeks to identify and analyze various potential mediators that might underpin the therapeutic outcomes observed.


Eligibility Criteria:
Inclusion Criteria:

* Persistent depressive symptoms observed during the initial screening and confirmed at baseline, as determined through a comprehensive psychiatric evaluation.
* Provision of written informed consent by the participant.
* Fluent in Estonian as a native language.

Exclusion Criteria:

* Presence of significant impairments in vision, hearing, or balance.
* Active suicidal ideation or current engagement in self-harm behaviors. Note: Individuals meeting this criterion will be directed to suitable crisis intervention services.
* Established diagnosis of bipolar disorder.
* Manifestation of psychotic symptoms.
* History of schizophrenia, either personally or within two generations of the family lineage.
* Ongoing diagnosis of epilepsy, dementia, or any other neurological condition that could interfere with the effective utilization of virtual reality (VR) technology.
* Susceptibility to motion sickness.
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices

This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.

The study will be conducted over a 40 day time period inclusive of screening and follow up time periods. Eligible subjects will receive oral CRD-102 for 14 days.

Eligibility Criteria:
Inclusion Criteria:

Patients are enrolled only if they met the following criteria.

1. Males and females aged 18-85 years inclusive
2. Have received a LVAD (HeartWare HVAD, HeartMate II) at least 30 days prior to screening.
3. Stable LVAD patients with evidence of ongoing right heart failure as evidenced by raised right atrial pressure indicated by JVP \>6cm OR measured right atrial pressure ≥12mmHg within the 3 months prior to or at Baseline OR dilated IVC on echocardiography PLUS all of the following;

   1. ongoing diuretic therapy;
   2. echocardiography in the 3 months prior to or at Baseline showing at least mild impairment in overall RV systolic function by visual assessment together with a TAPSE \< 14mm.
4. Able to give written informed consent and agree to adhere to all protocol requirements.
5. All patients will be required to have an implanted cardiaoverter defibrillator. (ICD)

Exclusion Criteria:

1. Hemodynamically unstable patients.
2. Hypotension (MAP\<60 or systolic BP \<90 mmHg) at Screening or Baseline
3. Hypertension (MAP\>95 or systolic BP \>130 mmHg) at Screening or Baseline
4. Ventricular tachycardia or ventricular fibrillation in the past 30 days or poorly controlled atrial fibrillation (ventricular rate \>120 bpm)
5. Concurrent participation in another investigational device study or prior participation in which a device was implanted and remains in place
6. Receipt of any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to Baseline.
7. Current treatment with intravenous inotropes or levosimendan, or treatment within the 2 weeks prior to Screening
8. Significant renal (eGFR\<25 ml/min/1.73 sq m) or hepatic (bilirubin \>3mg/dL) impairment or anemia (Hb \<90g/dL) at Screening or Baseline.
9. Expected heart transplantation within the study period.
10. Pregnancy
11. History of allergic reaction to milrinone or any excipients in the study drug.
A Comprehensive Evaluation of a the Talaris Demonstrator

The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.

A within study design will be conducted in order to evaluate four different prosthetic devices (current, non-propulsive TDF, propulsive TDF and Cyberlegs) with ten participants.

Prior to the baseline test, a familiarization trial aimed to accustom participants to the experimental protocol, to get used to the measurements and interface of the measurement devices. The baseline experimental trial is implemented to evaluate the current prosthesis during the different tests. The same tests will be performed during the evaluation of the other devices. Participants are asked to perform the following consecutive tasks with ten minutes of rest in between each task. The first task is a stair climbing test where participants' will be asked to ascend and descend a staircase. Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg. The second task is the L-test, where participants are asked to rise from a chair, walk through an office door, turn 90 degrees, walk down a hallway, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter will be covered. The slope walking test assesses the participants' ability to ascend and descend an inclined ramp as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position. During a two-minute walk test, participants are asked to respond as fast as possible to a stimulus visualized on a computer screen one meter in front of the treadmill. Finally, a hallway six-minute walk test will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.

In between each test with a novel device, participants need accustom to the novel device to ensure a good alignment and fitting. Participants will be fitted and aligned to the novel device by a physiotherapist and prosthetist.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25 - 75 years
* Gender: men and women
* Level of amputation: unilateral transfemoral
* Vascular, traumatic, congenital or other cause of amputation
* Completed the rehabilitation program, meaning that participants possess their final prosthesis
* Medicare Functional Classification Level: K2-4
* Participants wear their prosthesis for at least 8 hours/day

Exclusion Criteria:

* Any neurological disease
* No upper limb or bilateral amputation
* Stump pain or bad fit of the socket
Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced esophageal cancer.

By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced esophageal cancer.

The safety will be evaluated by statistics of adverse reactions.The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions

Synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (Surguchov et al., 2001). Gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. It is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (Liu et al., 2018). Smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the Gamma-synuclein expression in cancer cells (Hsu et al., 2020a).

Gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (Liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (Liu et al., 2012). It is present in blood, serum, cerebrospinal fluid and saliva. The detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (Surguchov, 2016).

This study aims to identify the diagnostic accuracy of Gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.


Eligibility Criteria:
Inclusion Criteria:

Group 1: patients with malignant lesions will be diagnosed through clinical and histopathological examination of tissue biopsy.

Group 2: patients with oral potentially malignant lesions will be diagnosed clinically and histopathological examination of tissue biopsy.

Group 3: healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history

Exclusion Criteria:

-
Adults Nutrition as a Protective or Health-risk Factor

To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the consumption of foods and enabling the assessment of energy and macronutrient intakes. Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination, in which thyroid size will be aslo measured, to investigated thyroid epidemiology in Slovenia.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Republic of Slovenia (included to the register of residents)
* Finished EU MENU Slovenia Study

Exclusion Criteria:

* Not willing to give blood\&urine sample
* Long-term disease
* Living in institutions with controled diet, such as such as in elderly care, hospital, prison, etc.
Effect of Lumacaftor/Ivacaftor in Children With Cystic Fibrosis Homozygote for F508del on Small Airway Function

To obtain prospective real world data of the effect of lumacaftor/ivacaftor or tezacaftor/ ivacaftor on small airway disease in children aged 6-18 years with cystic fibrosis (CF) homozygous for F508del. The effect of the medication on small airway disease is evaluated by measurement of multiple breath washout (MBW) with its outcome parameter lung clearance index (LCI) and the Perth-Rotterdam Annotated Grid Morphometric Analysis for CF (PRAGMA-CF) cpmputed tomography (CT) score. In addition the relation between changes in LCI and PRAGMA-CF score is evaluated.

Multi-center observational study. Duration 12 months after the start of lumacaftor/ ivacaftor or tezacaftor/ ivacaftor .

To collect these data and to assist in clinical decisions regarding initiation and continuation of lumacaftor/ivacaftor or tezacaftor/ ivacaftor, the investigators of the CF center (Beatrix Children's Hospital, University Medical Center Groningen (UMCG), the Netherlands) developed an extensive protocol of testing before children aged 6-18 years start therapy and during the first year after start.

The protocol includes the following tests: growth parameters, sweat test, lung function testing (spirometry, MBW, body plethysmography), blood test panel (AST, ALT, alkalic phosphatase (AF), total and direct bilirubin, LDH), fecal elastase, high resolution (HR)CT and CF quality of life questionnaires. These tests are repeated at regular intervals.

Multi-center observational study. Duration 12 months after the start of lumacaftor/ ivacaftor or tezacaftor/ ivacaftor .

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-18 years
* CF, Homozygote F508del confirmed by DNA analysis
* Considered for start of lumacaftor/ ivacaftor or tezacaftor/ivacaftor

Exclusion Criteria:

* - Unable to perform acceptable, repeatable lung function tests
Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions

The purpose of this study is to determine if closure of deep neck infection incisions at the time of extraoral drain removal has any impact on rates of reinfection and to determine if this treatment will have any impact on scar formation and qualitative measures of pain or impact on quality of life during the post-operative healing period.


Eligibility Criteria:
Inclusion Criteria:

* deep neck space infection
* who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces

Exclusion Criteria:

* pregnant females
* cognitively impaired individuals
* deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.
Venous Leg Ulcer and Lymphedema Registry

This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National bench marking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.

Eligibility Criteria:
Inclusion Criteria:

* All patients with venous leg ulcers seen by the practitioner.

Exclusion Criteria:

* None
BM Characterization Pilot

This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged 0-12 months

Exclusion Criteria:

* Formula Fed
* Use of topical or oral antibiotics or antifungals within the past 4 weeks
First-in-Man, Dose-escalation Trial of c-Met Kinase Inhibitor EMD 1204831 in Subjects With Advanced Solid Tumors

EMD Serono has closed enrollment into this trial prior to determination of maximum tolerated dose (MTD). EMD Serono has decided not to pursue the development of EMD 1204831 in patients with advanced solid tumors for reasons other than safety.

This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore the safety, tolerability, pharmacokinetics, and clinical activity of an investigational drug, EMD 1204831, in patients with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will receive EMD 1204831 twice a day (BID) during each 21-day cycle until disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria

1. Histologically or cytologically confirmed solid tumor, either refractory standard therapy or for which no effective standard therapy is available
2. Measurable or evaluable disease, as defined by RECIST 1.0
3. Men or women aged ≥ 18 years
4. ECOG performance status of 0 to 2
5. Adequate hematological function: Hemoglobin ≥ 9.0 g/dL; Neutrophils \> 1.5 x 109/L; Platelets ≥ 100 x 109/L
6. Adequate liver function: Total bilirubin ≤ 1.5 x ULN; AST/ ALT ≤ 2.5 x ULN
7. For subjects with liver metastases: Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 5 ULN
8. Adequate renal function: Serum creatinine \< 1.5 x ULN, and/or Calculated creatinine clearance \> 60 mL/min
9. Resolution of all acute chemotherapy, radiotherapy or surgery-related AEs to Grade ≤1, except for alopecia
10. Recovery from any surgical intervention
11. Subjects enrolling after the MTD has been determined must present specific c-Met alterations (overexpression, amplification, mutation)

Exclusion Criteria:

Main Exclusion Criteria

1. Received chemotherapy, immunotherapy, hormonal therapy (except subjects with prostate cancer), biologic therapy, or any other investigational agent or anticancer therapy within 28 days (or five half-lives for non-cytotoxics, whichever is shorter), of Day 1 of trial treatment (six weeks for nitrosureas or mitomycin C)
2. Received extensive prior radiotherapy on more than 30% of bone marrow
3. Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptics and requiring high doses of steroids
4. Medical history of liver fibrosis/ cirrhosis
5. Medical history of surgery within six weeks prior to enrollment
6. Neuropathy Grade ≥ 2
7. Requires concurrent treatment with a non-permitted drug
8. Absence or abnormal pupillary reflex
Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease

This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.

Patients who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study.

A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm dilatation catheters for pre-dilatation and will complete the study within the U.S. This equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age;
* Willing and able to provide informed consent;
* Willing and able to meet all study requirements;
* Patients with symptomatic ischemic heart disease due to stenotic lesions or occlusions in coronary arteries that are amenable to percutaneous coronary interventions;
* Patients who tolerate DAPT

Exclusion Criteria:

* A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated;
* LVEF \< 30%;
* Evidence of an acute myocardial infarction within 72 hours of the intended index procedure;
* Planned treatment of unprotected left main disease;
* History of cerebral vascular accident (CVA) within 6 months prior to consideration for this study;
* Transient ischemic attack (TIA) within 6 months prior to consideration for this study;
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months prior to consideration for this study;
* History of bleeding diathesis or coagulopathy;
* Refuses blood transfusions;
* Any general contraindication to revascularization procedures;
* Pregnant or lactating;
* In the judgement of the investigator, patient is not a suitable candidate for this study.
Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer

Informal caregivers to patients with head and neck cancer report that they are unprepared for caregiving, that they experience a high caregiver burden and a deteriorated health. The aim is to develop an internet based intervention for informal caregivers of individuals with head and neck cancer and evaluate the feasibility and acceptability of the intervention. The internet based intervention (Carer eSupport) will be based on scientific evidence, established theoretical frameworks and focus groups with caregivers and health care professionals. The feasibility and acceptability of Carer eSupport will be evaluated by 30 caregivers who will have access to Carer eSupport during one months. The feasibility and acceptability of Carer eSupport will be evaluated with quantitative and qualitative data.


Eligibility Criteria:
Inclusion Criteria:

* Informal caregivers (defined by the patients) to patients with head and neck cancer who are about to start treatment, undergoing treatment or have completed treatment within the past month.

Exclusion Criteria:

* Confusion or dementia, inability to understand, speak or read Swedish.
Efficacy of Erector Spinae Plane Block Analgesia After Off Pump Cardiac Surgery

In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.

General anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of Atracurium. After induction, bilateral erector spinae plane block will be performed in the block group. Intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. Postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.

Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years
* ejection fraction of \> 45%
* undergoing elective off-pump cardiopulmonary bypass surgery

Exclusion Criteria:

* vertebral anomalies
* intra-aortic balloon pump in the preoperative period
* acute myocardial infarction
* local infection at the site of block
* allergy to the local anesthetic used
* morbid obesity, psychiatric disorders, neurologic deficits, alcohol and chronic opioid abuse, and patients with bleeding diathesis.