cyrilzakka/clinical-trials huggingface dataset:
CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair

Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.

This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.

Subjects with indications for M-TEER and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms: 1) intervention: cerebral protection device with M-TEER or 2) Control: Unprotected M-TEER.

Enrolled subjects will undergo a diffusion weighted magnetic resonance imaging (DW-MRI) at baseline and at 72 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days.

The study aims to address:

* To determine whether the total amounts of new brain lesion assessed by diffusion weighted magnetic resonance images at 72 hours is comparable between the experimental group and the control group.
* To assess the effectiveness and safety of cerebral protection device in the prevention of perioperative cerebrovascular events after M-TEER
* To explore the correlation between the volume/number/location of new brain lesions and changes in neurocognitive function
* To evaluate the histopathological features of the captured fragments and their relevance to clinical features

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet ALL of the following criteria:

General Inclusion Criteria

* Age ≥18 years
* Severe Mitral Regurgitation (3+ to 4+)
* Symptom status: NYHA functional class ≥ II
* Subjects scheduled to receive the M-TEER per the current approved indications for use
* Subjects agreed to join the study and complete follow-up

Exclusion Criteria:

Potential Subjects will be excluded if ANY of the following criteria apply:

General Exclusion Criteria

* Contraindication to MRI
* CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
* Cerebrovascular accident within prior 30 days
* Severe symptomatic carotid stenosis (\>70% by ultrasound)
* Carotid surgery or stenting within prior 30 days
* Hemodynamic instability requiring inotropic support or mechanical heart assistance
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
* Contraindication for transesophageal echocardiography
* Life expectancy \< 1 year
* Pregnant or planning pregnancy within next 12 months
* Participation in another interventional Trial
* Patients who are not able to give consent or complete the follow-up
Biofilm Composition as a Predictive Biomarker for Prosthetic Joint Infection

Prosthetic joint infection (PJI) represents one of the most common reasons for failure among hip and knee prostheses, with an incidence of around 1-2%. Infection can occur early (within days of surgery) or late (over a year after surgery), and no specific early markers for infection onset exist. Given the significant costs to the NHS for corrective revision surgery, the added suffering and risk to patients from surgery, and the risk of enhancing antimicrobial resistance through the use of broad-spectrum antibiotics, a more specific predictive test for early onset of infection is required.

Over 80% of human infection is estimated to be a result of biofilm formation. Biofilms are an accumulation of microorganisms (predominantly bacteria) on a surface, resulting in a functional community which provides antibiotic resistance and a beneficial environment for the growth of pathogenic species that would otherwise be removed by the body's defences.

The use of medical implants in modern medicine has become an increasingly common occurrence, with hip and knee arthroplasty accounting for a large number of medical implant surgeries. Unfortunately, infections frequently result in failure of the implanted device (around 1-2% for knee and hip arthroplasty), requiring extensive revision surgery. Currently, no predictive biomarkers for PJI exist, and diagnostic tests require infection to have already taken hold and may often be highly invasive. Research conducted by the NIH suggests that accumulation of bacteria (known as biofilms) may account for over 80% of microbial infections in the human body and have been shown to develop on medical implants, such as those used in hip and knee arthroplasty. Bacterial biofilms on medical implants are poorly understood, making treatment very complex.

The investigators aim to identify early predictive biomarkers for PJI based on assessment of the biofilm structure on implants removed in revision surgery, either as a result of PJI or due to aseptic causes such as mechanical failure. The investigators will explore biofilm formation on hip joint prostheses using next generation sequencing (NGS) and 3D phase-contrast X-ray microscopy, and will compare bacterial diversity and biofilm structure between infected and non-infected samples to answer three main questions:

1. Can The investigators accurately describe the characteristic microbiome of hip joint prosthetic biofilms?
2. Is there a distinct characteristic microbiome or biofilm structure associated with PJI?
3. Can The investigators detect such characteristic biofilm members as biomarkers in simple blood tests?

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 years or above.
* Due to undergo prosthetic revision surgery for any reason identified by the clinical team Willing to provide informed consent

Exclusion Criteria:

* Participant lacking capacity to give informed consent
* Any other clinical reason the participant should not be included in the study- at the discretion of the clinical team
RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM

The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. If recommended mobile cardiac telemetry (MCT) by the care provider
3. If instructed, be willing to record information such as daily activities and symptoms
4. Able to speak, read, and write English.

Exclusion Criteria:

1. Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
2. Have a known allergy to medical adhesives;
3. Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study.
Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy.

This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission.

Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 14 to 50 years old at screening visit
* History of IgE mediated allergy to peanut protein
* ImmunoCAP IgE level \> 50 kU/L for peanut;
* Total IgE level \< 5000 kU/L
* Willing to comply to all study requirements during participation in the study;

Exclusion Criteria:

* Previous adverse reactions to abatacept;
* Known hypersensitivity to abatacept or any of its components;
* Patients at risk of sepsis, such as immunocompromised or HIV positive;
* Patient undergoing a treatment with any other biologic agent;
* Uncontrolled asthma;
* Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease);
* Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker
* Concurrent/prior use of immunomodulatory therapy (within 6 months);
* A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis;
* Pregnant or breastfeeding women;
Adjunctive Clindamycin for Cellulitis: C4C Trial.

The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin, results in less tissue damage and a more rapid resolution of both systemic and local features, in a cost-effective manner. This study is a randomised controlled trial comparing Clindamycin with placebo.

Criteria to be used to assess tissue damage and clinical response:

1. Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin
2. Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected)
3. Document the duration between initial systemic features and the development of local signs
4. Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis
5. Examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis
6. Identify and quantify possible side effects of clindamycin

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb
* Who are able to understand the study and give consent
* Who are able to take oral medication

Exclusion Criteria:

* Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy
* Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year
* Patients unable to take oral medication
* Previous history of Clostridium difficile colitis
* Clindamycin taken within the last 30 days
* Clinically unstable
* Unable to understand the study or give consent
* Any doubt over the certainty of the diagnosis of cellulitis
* Patients taking any drug that is incompatible with either flucloxacillin or clindamycin
* Pre-existing diarrhoea
Naloxone Auto-injection in Healthy Volunteers

This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male/female volunteers
* \>18 years
* No allergy to naloxone or ingredients in its formulation
* Ability to read and understand English
* Written informed consent obtained from subject
* Ability to comply with study requirements

Exclusion Criteria:

* History of alcohol or substance abuse
* History of unusual pain sensitivity, lack of sensitivity
* History of chronic myofascial, inflammatory, neuropathic pain
* Chronic use of medication known to interfere with naloxone
* Pregnant women and nursing mothers
* Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise subject safety or the quality of the data (e.g., persons with liver disease, renal insufficiency/failure)
* Alcohol on the breath
Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery

General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative Antithrombin (AT).


Eligibility Criteria:
Inclusion Criteria:

* All patients were candidates for cardiac surgery intervention in extracorporeal circulation

Exclusion Criteria:

* positive history for allergic reactions to AT III
* cardiac surgery "Off-Pump"
* administration of AT during surgery or within 48 h
* treatment with drugs and non-steroidal steroids within 48 h prior
* disorders of coagulation
* platelets \<30,000
* pre-existing IRC in dialysis treatment
* severe liver failure
* enlistment in another trial in the last 30 days
* hypothermia
* emergency
* reopening
* length of CEC\> 180 minutes
* subjects incapable of giving legal consent
Effects of Transcranial Direct Current Electrical Stimulation on the Recovery of Ideomotor Apraxia of the Upper Limbs

Limbs apraxia is a motor disorder whose characteristic is the inability or difficulty to perform intentional movements of the limbs (gestures), most frequently involving the upper limbs. Recent literature indicated promising effects of transcranial direct current stimulation (tDCS) in the recovery of limbs apraxia, showing that, in stroke patients, excitatory anodal tDCS over left inferior parietal lobe (IPL) may improve limb apraxia. Despite this encouraging evidence, the need for larger well powered and sham-controlled clinical trials has also been identified. For these reasons, the objective of this study is to investigate the effects of tDCS application on the left posterior parietal cortex, associated with the treatment for apraxia made by Smania et al. in 2000, on the recovery of the upper limbs ideomotor apraxia in patients with left brain lesion of vascular origin.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of both gender, with ischaemic stroke;
* Left hemispheric injury documented by neuroimaging examination;
* Cerebrovascular disease onset within the first 30 days;
* Presence of ideomotor apraxia as documented by a score \< 53 in the De Renzi's test;
* Intact semantic skills as documented by normal performance on the Auditory or Visual Word Comprehension subtest of the Neuropsychological Examination for Aphasia (E. N. P. A.);
* Full comprehension skills as documented by normal performance in the sub-test of oral or orthographic comprehension (Auditory or Visual Words Comprehension) of the Neuropsychological Examination for Aphasia (E. N. P. A.);
* Age between 20 and 80 years;
* Any schooling;
* Patient's informed consent signature.

Exclusion Criteria:

* Comprehension and/or semantics deficit as documented by E. N. P. A.;
* Pre-existing psychiatric and/or neurological pathology;
* Failure to sign the patient's and/or caregiver's informed consent.
Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.

This protocol identifies a standard-of-care method for unrelated stem cell transplantation in adults. Performing this service in a consistent and documented fashion allows investigators to obtain informed consent from recipients. Data is tabulated locally for quality-control comparisons with nationally-reported standards. As a condition of maintaining transplant center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome data to the NMDP. As a result, UCSF is contributing to the resolution of remaining uncertainties regarding particular transplantation practices.

Eligibility Criteria:
Inclusion Criteria:

* Age \>15 and \<55
* Adequate renal function with serum creatinine \<2.0 mg/dl
* Pulmonary diffusing capacity\>50% of predicted
* Cardiac ejection fraction \>40% as measured by radionuclide wall motion study or echocardiography
* Total bilirubin must be \<2.5 mg/dl.
* Alkaline phosphatase and AST must be less than three times the upper limit of normal
* Negative serology for the human immunodeficiency virus
* Available HLA-matched donor
* Signed informed consent

Exclusion Criteria:

* No fully or single-antigen-mismatched sibling donor is available to donate stem cells
* No active liver disease.
The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. In this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with Parkinson's disease (PD), essential tremor (ET), and dystonia.

This study is to evaluate the feasibility, reliability, and clinical effects of Non-invasive vibrotactile stimulation (VTS) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. VTS Settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation.

The investigators will recruit 30 patients with PD who are between the ages of 18-80 years old and independently living in the community. The investigators will additionally recruit up to 5 patients with ET and up to 5 patients with dystonia.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 and able to provide informed consent.
* Have a diagnosis of Parkinson's disease, essential tremor, or cervical dystonia made by a movement disorders specialist.
* Medically optimized without planned medication changes for the duration of the study.
* For patients with ET, they will have a score of at least 2 on items 5 and 6 of the Fahn-Tolosa-Marin (FTM) Tremor Rating Scale.
* For patients with dystonia, they will have abnormal dystonic postures of the head and not isolated head tremor

Exclusion Criteria:

* The presence of additional neurologic diseases, that might confound testing or the coexistence of PD and ET together (action tremor that was present prior to the development of parkinsonism).
* Symptoms of peripheral neuropathy at the wrist (reduced vibratory, pinprick, or temperature sensation)
* Montreal cognitive assessment (MoCA) score \< 20 or previously documented dementia
* Unable to walk without a walking aid (e.g. cane, stick, walker)
Delusion Ideation in the Context of Everyday Life

The project aims to investigate the feasibility and acceptability of a blended face-to-face and smartphone intervention for distressing thoughts and experiences in people with schizophrenia spectrum disorders. A secondary aim is to assess the outcomes of the intervention at baseline (T0) and post-intervention (T1) (single-arm feasibility design). The study design is primarily based on Bell et al.'s (2018, 2020) blended face-to-face and smartphone intervention for hallucinations. The participants receive four face-to-face therapy sessions, using a smartphone between sessions employing elements of Ecological Momentary Assessment (EMA) and Intervention (EMI).

The investigators will identify eligible participants at different outpatient departments, suitable support groups, and online platforms. An eligibility screening conducted in person or by telephone to ensure the inclusion criteria and to introduce the study is held by the study assistant. All participants must sign an informed consent after written and verbal study clarification. Participants will carry out self-reported measurements at baseline (T0) and after the intervention phase of 4-6 weeks (T1). The group of participants receives four therapy sessions, using a smartphone between sessions.

The intervention begins with a session of psychoeducation, assessment and training, followed by a week of EMA monitoring using the participant's own smartphone or one provided by the research team. In the second session, EMA data will be discussed between therapist and participants to identify patterns in experiences, including effective and ineffective coping strategies. In the weeks between the remaining sessions, participants are reminded of these strategies via the app using EMI.

The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. Besides, the participants have the right to access their data, and the right to claim an annihilation. The data is being saved in an online database, only allowing researchers involved in the study to access the data.

Eligibility Criteria:
Inclusion Criteria:

1. be between 18 and 65 years old
2. fulfill the diagnostic criteria for schizophrenia as determined by the Mini-International Neuropsychiatric Interview (M.I.N.I.) (Sheehan et al., 1998)
3. suffer from residual delusions and significant self-reported distress as assessed by the PSYRATS Delusions (Haddock et al., 1999), Green Paranoid Thoughts, and Subjective Experiences of Psychosis Scales (Freeman et al., 2021).
4. sufficient knowledge of German
5. have not undergone a recent (\<6 weeks) or planned change in antipsychotic and other psychopharmacological medication
6. know how to use a smartphone or be willing to learn how to use it
7. Time availability to attend 4 therapy appointments with two additional rating appointments

   Exclusion Criteria:
8. Severe visual impairment
9. Acute suicidal tendencies
10. Excessive delusional symptoms (Reference: 25+; Persecution: 28+ in the Green Paranoid Thoughts and Subjective Experiences of Psychosis Scales (Freeman et al., 2021)
Health First-Study 2

The current study was designed to investigate the influence of choice of exercise program on exercise adherence. The two exercise programs included 1) traditional exercise at a fitness centre or 2) lifestyle exercise-walking using a pedometer to track steps. Biological and psychological indicators were examined to investigate the effect of choice in a sample of sedentary adults.


Eligibility Criteria:
Inclusion Criteria:

* 25-65 year old adults
* sedentary (exercise less than twice per month in the last 4 months)

Exclusion Criteria:

* physician non-consent
* too active (exercise more than twice per month in the last 4 months)
* participated in previous studies from this lab