cyrilzakka/clinical-trials huggingface dataset:
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer

A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.

This is a single-centre, prospective, non-randomised feasibility study. This study will assess whether SABR can safely be given immediately prior to Whipple's resection by assessing the rate of post-operative complications.

Eligibility Criteria:
Inclusion Criteria Stage 1:

* Have given written informed consent to participate in stage 1
* Be aged 16 years or over at the time of signing the informed consent form
* Presence of a hypodense pancreatic mass on contrast enhanced CT scan highly suspicious of operable primary pancreatic cancer as assessed by a pancreatic multi-disciplinary team (MDT)
* Have not had pre-operative systemic therapy or radiotherapy

Inclusion Criteria Stage 2:

* Have participated in stage 1 of the study
* Have confirmed histological or cytological diagnosis of primary pancreatic adenocarcinoma OR radiological evidence of pancreatic head mass with supportive cytological or histological findings.
* Be scheduled to undergo pancreatico-duodenectomy (Whipple's) resection.
* Written informed consent to participate in stage 2
* Aged 16 years or over at the time of signing informed consent
* Have not had pre-operative systemic therapy or radiotherapy
* ECOG Performance status 0-1
* Adequate renal function: GFR ≥ 60

Exclusion Criteria:

* Any condition or abnormalities that in the judgement of the investigator/surgeon/clinical oncologist would place the patient at undue risk
* Women who are known to be pregnant
* Previous abdominal radiotherapy
* Women of child-bearing potential who are unwilling to use 2 highly effective forms of contraception during the study treatment period
Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain

This randomized controlled trial will evaluate the effectiveness of an interdisciplinary treatment approach combining medical management with an online Mindfulness-Based Stress Reduction (MBSR) program in reducing disability and improving quality of life among cancer survivors living with moderate to severe chronic neuropathic pain.

Chronic neuropathic pain (CNP) affects close to 50% of cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. In our recent survey with cancer survivors, we found that the capacity to be aware of different aspects of one's day-to-day experiences, without judgment or reactivity (i.e., being mindful) predicted decreased pain intensity, pain related disability, and increased health-related quality of life among cancer survivors with CNP. Building on these findings, the present randomized controlled trial will evaluate the effectiveness of an online Mindfulness-Based Stress Reduction (MBSR) program for cancer survivors with moderate to severe CNP. The program will benefit patients in rural and remote regions and patients with mobility issues.

We will recruit 100 cancer survivors. All will have their medical treatment optimized by a pain specialist. Additionally, they will complete an 8-week online MBSR program. We hypothesize that the online MBSR program will result in less pain perception, better function and increased health-related quality of life. We will also examine the effects of the MBSR training on biomarkers of stress and immune function.

Eligibility Criteria:
Inclusion Criteria:

* cancer survivors
* experiencing cancer-related neuropathic pain symptoms for at least 3 months
* pain severity ≥4/10 (moderate to severe)
* ability to attend 7 out of 9 MBSR sessions
* ability to complete questionnaires and attend sessions conducted in English or French
* access to the internet and use of an electronic device capable of joining a video conference (i.e., computer or mobile device with a camera and microphone)

Exclusion Criteria:

* expected survival of less than 12 months
* cognitive impairment
* severe psychiatric disorder impacting ability to participate (e.g., schizophrenia, severe depression)
* prior experience with MBSR
ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

The purpose of this study is to determine the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the treatment of upper gastrointestinal submucosal tumors.

Most upper gastrointestinal submucosal tumors (SMTs), especially the gastrointestinal stromal tumors (GISTs) and leiomyoma, are regarded as benign if they are less than 3cm in size. Thus, it has been suggested that patients should receive periodic endoscopic follow-up in case of gradual changes in size; however this can be stressful and troublesome for patients. Nevertheless, some of these tumors do have a malignant potential, and management by periodic endoscopic surveillance may lead to delayed diagnosis of malignancy. Therefore, it is necessary to remove the SMTs.

To date, several approaches have been used for the treatment of upper gastrointestinal SMTs, including open, thoracoscopic and laparoscopic surgery, and endoscopic approaches such as band ligation, endoscopic submucosal dissection (ESD), and endoscopic full-thickness resection (EFR). However, the surgical approaches are invasive with a longer hospital stay and greater cost, while the endoscopic approaches were limited by technical difficulty, incomplete resections and risk of perforation.

Recently, the technique of peroral endoscopic myotomy (POEM) for esophageal achalasia was introduced, a procedure in which a submucosal tunnel is created to expose and dissect the circular muscle of the esophagus. Inspired by the POEM approach, we have successfully used a similar method, endoscopic submucosal tunnel dissection (ESTD), to resect SMTs in upper gastrointestinal.

However, the long-term efficacy and safety of ESTD were not determined, and there was no prospective study compared the ESTD with other conventional approaches. Therefore, we plan to conduct this prospective randomized controlled trial, aim to determine the efficacy and safety of ESTD, compared with the pneumatic dilation, in the treatment of upper gastrointestinal SMTs originating from the muscularis propria layer .

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 75 years of age
* Patient with upper gastrointestinal submucosal tumor
* Signed informed consent

Exclusion Criteria:

* Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
* Endoscopic ultrasound (EUS) or CT signs of metastasis
* Mega-oesophagus (greater than 7 cm) or Oesophageal diverticula in the distal oesophagus
* Previous oesophageal or gastric surgery
* Pregnancy or lactation women, or ready to pregnant women
* Not capable of filling out questionnaires
Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients

The study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-65 years old.
2. Completely spinal cord injury at the cervical and thoracic level (C4-T12).
3. Classification ASIA A, occurring within past 21 days.
4. Patients signed informed consent.
5. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

1. A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
2. Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
3. History of life threatening allergic or immune-mediated reaction.
4. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
5. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
6. Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
7. Lactating and pregnant woman.
8. Alcohol drug abuse /dependence.
9. Participated in any other clinical trials within 3 months before the enrollment.
10. A drug or treatment known to cause effect on the central nervous system during the past four weeks.
11. A drug or treatment known to cause major organ system toxicity during the past four weeks.
12. Poor compliance, difficult to complete the study.
13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study

A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).

This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System
* Subject willing to comply with study requirements and give informed consent.

Exclusion Criteria:

* In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU).
* Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor.
* Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)
A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults

The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.

The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics. The site will screen and enroll 12 HIV-infected subjects who will receive 150 mg ABX464 orally once daily for 28 days (Cohort 1). Following completion of this cohort a further 24 subjects will be enrolled: 12 HIV-uninfected subjects will receive 50 mg ABX464 orally once daily for 28 days (Cohort 2) and 12 HIV-infected subjects (Cohort 3) who will 50 mg ABX464 orally once daily for 84 days.

Eligibility Criteria:
Inclusion criteria:

* Males aged 18-65 years;
* Subjects with adequate hematological and biochemical laboratory parameters
* Subjects should be able and willing to comply with study visits and procedures as per protocol;
* Subjects should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;
* Subjects must agree to use in addition to the condom, a second highly effective method (one for the subject and one for the partner) of contraception (defined as per the Clinical Trials Facilitation and Coordination Group (CTFG) Guidance).

For HIV positive Subjects

* Subjects with a positive HIV-1 serology at any time before the study entry.
* Subjects treated for at least 12 months prior to screening with Dolutegravir or Raltegravir combined with either Tenofovir + Emtricitabine (TDF/FTC) or Abacavir + Lamivudine (ABC/3TC);
* Subjects with HIV plasma viral load ≤ 50 copies/mL during the 6 months prior to screening with a maximum of 2 blips ≤ 1000 copies during this period;
* Subjects' HIV-1 plasma viral load to be ≤ 100,000 copies/mL at any time beyond 6 months after the estimated date of primary infection;

Exclusion Criteria:

* History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of investigational products;
* Acute or chronic infectious disease other than HIV infection (include but not limited to viral hepatitis such as hepatitis B, hepatitis C, active tuberculosis, active syphilis \[i.e. currently treated\].
* Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (CNS) pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
* Severe hepatic impairment;
* Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
Chronic Insomnia and CSF Markers of Dementia

The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years.The purpose of this study is to examine the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-50
* Men and women
* To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance

Exclusion Criteria:

* Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history
* Women who have been pregnant or lactating within the past six months
* Non-fluency in spoken or written English
* Current or past month shiftwork defined as working during the evening or night shift
* Current use of medications or OTC products that impact sleep
* Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).
Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia

This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

A participant will be eligible for entry into the study if all of the following criteria are met:

1. Has a primary diagnosis of schizophrenia.
2. Is on a stable dose of antipsychotic medication(s).
3. Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational).

Exclusion Criteria:

A participant will not be eligible for study entry if any of the following criteria are met:

1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
2. Meets DSM-5, for diagnoses not under investigation.
3. Has participated in a CT-155 clinical study.
Autoreactive B Cells in Membranous Nephropathy

Membranous nephropathy (MN) is the most frequent cause of nephrotic syndrome (NS) in adults. The majority of MN patients show detectable circulating antibodies against the M-type phospholipase A2 receptor (PLA2R). Infusion of anti-CD20 monoclonal antibodies results in a profound depletion of B-cells, which are thought to be responsible for anti-PLA2R production. B-cell depletion is followed by NS remission in 70% of cases. Limited evidence highlighted that differences in the B- and T-cell compartments may exist between responders and non-responders. Owing to the non-homogenous efficacy of anti-CD20 treatment, investigators hypothesize that in MN patients who experience NS remission after B-cell depleting therapy, autoreactive B-cells may be mostly circulating, whereas in patients who do not respond to the same treatment, autoreactive B-cells may chiefly reside into secondary lymphoid organs - and thus be more resistant to the drug action. Researchers will therefore extensively analyze the circulating immune repertoire of MN patients before and after the infusion of B-cell lineage depleting agents, assessing the presence of circulating PLA2R autoreactive B cells from appropriately stratified responder and non-responder patients. Patients and healthy controls will be enrolled in this study. Patients will be stratified according to gender, anti-PLA2R status, type of B-cell lineage depleting agent received and response to treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients inclusion criteria

* Males and females.
* Adults (\> 18 years old).
* Patients with biopsy-proven idiopathic MN, who are candidate to receive (prospective cohort) or who already received (retrospective cohort) a B-cell depleting treatment as per center clinical practice.
* Mental state is such that they are able to understand and give valid consent to the study;
* Written informed consent according to the guidelines of the Declaration of Helsinki.

Healthy volunteers inclusion criteria

* Male and female (\>18 years) not known to suffer of any significant illness;
* Not assuming any medication or drug on a regular basis;
* Negative urine analysis (urine dipstick, multistick);
* Written informed consent according to the guidelines of the Declaration of Helsinki

Exclusion Criteria:

Patients exclusion criteria

* Reasonable possibility of a secondary cause of MN (e.g.systemic lupus erythematosus, active hepatitis B, malignancy, drugs such as gold salts and penicillamine).
* Legal incapacity, intellectual disability/mental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.

Healthy volunteers exclusion criteria

- Legal incapacity, intellectual disability/mental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.
SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.


Eligibility Criteria:
Major Inclusion Criteria:

* Age ≥18
* Currently receiving standard of care wound treatment (\>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment.
* Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and \<25 cm2. Index wounds on the heel must be \<10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis.
* Post revascularization intervention inclusion criteria include an attempt at open bypass grafting or endovascular intervention of a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in TBI post intervention. The following will be accepted as demonstrating a lack of post intervention toe brachial index (TBI) improvement:

  * TBI ≤ 0.51or;
  * Toe pressure ≤50 mmHg with flat or dampened wave forms or;
  * Skin Perfusion pressure ≤40 mmHg at mid foot level or;
  * TcPO2 ≤40 mmHg
* Subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced PAD from time of consent to 6 months following the initial injection of study drug

Major Exclusion Criteria:

* Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.
* Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease
* Staged or planned intervention in the index leg within 30 days after the index procedure
* Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
* Non-salvageable limb defined as major tissue loss and an unsalvageable foot;
* Wounds that have decreased in size by \>50% between the Screening visit and Day 0.
* If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled.
* Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.
* Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial