cyrilzakka/clinical-trials huggingface dataset:
Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair

With more and more people developing hypertension and atherosclerosis, the morbidity rate of Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment for Acute Aortic Dissection. However the secondary injury caused by reperfusion of spinal cord could lead to Catastrophic complications,such as paraplegia, hemiplegia or even death. So spinal protection is always the hot topic in clinical research.

Xenon is an ideal anesthetic gases with the following features,fast onset of action, stable hemodynamics, clean and non-toxic.The animal researches have showed the protective effects of xenon to alleviate the ischemia-reperfusion injury of the nervous system.Those clues suggest that Xenon may have the potential protection of spinal cord in patients undergoing aortic dissection repair.In order to clarify this hypothesis, the investigators designed this randomized, controlled clinic trial to evaluate the protection of Xenon against spinal cord ischemia-reperfusion injury and the potential mechanisms


Eligibility Criteria:
Inclusion Criteria:

* Patients doing selective operation of Bentall and Sun's or partial aortic arch replacement
* Patients doing selective operation of the full chest and abdominal aorta replacement

Exclusion Criteria:

* Emergency patient
* Patients with severe mental and neurological dysfunction
* Patients with severe hearing and visual impairment
* Illiteracy or patients can't cooperate with doing the cognitive function score
* Patients with severe cardiac insufficiency
* critically ill or dying patients
* Patients refuse to sign the informed consent
Outcomes Comparison of Robotic, Retropubic, and Perineal Prostatectomy

Compare peri-operative and postoperative outcomes of the three different surgical approaches to prostatectomy

Existing data collected from Prostatectomy Database study and Urology Database study will be analyzed. Compare peri-operative and postoperative outcomes of the three different surgical approaches to prostatectomy

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Radical Prostatectomy at William Beaumont Hospital

Exclusion Criteria:

* Dementia
Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control

To determine if coating miniscrews with K21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation.

The study design is a split mouth study where 2 miniscrews, one pretreated with K21 the other pretreated (experimental) with ethanol (placebo) are placed in the mouth for orthodontic therapy. All participants will receive 2 or more orthodontic miniscrews with equal numbers of experimental and control pretreatment solutions. Mobility will be assessed at the 4 and 8 week follow up appointments by gentle manipulation with cotton pliers. Clinical success will be defined as maintenance of stability for a period of 8 weeks. Peri-implant inflammation will be assessed at follow up appointments by looking for signs of soft-tissue inflammation (redness, swelling) where possible.

Eligibility Criteria:
Inclusion Criteria:

1. Good general health, with no significant medical findings
2. Requiring at least two miniscrews in their treatment plans (i.e., most participants will have two miniscrews, but some may receive four or six as indicated by their individual treatment plan)
3. Miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage).

Exclusion Criteria:

1. Recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews
2. Less than 12 years of age
3. Heavy tobacco use (\>10 cigarettes/day)
4. Peri-implant tissues must be observable at follow-up appointments
5. Being unable or unwilling to consent to the study
Plegridy Observational Program

The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.


Eligibility Criteria:
Key Inclusion Criteria:

* Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002).
* Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance.

Key Exclusion Criteria:

* Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Inhaled Ondansetron & Dyspnea

"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will improve the perception of dyspnea during strenuous exercise in health, young men. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy, men aged 20-40 years.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 20-40 years
* FEV1 ≥80% predicted
* FEV1/FVC \>70%

Exclusion Criteria:

* Current or ex-smoker
* Body Mass Index \<18.5 or \>30 kg/m2
* History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction.
* Taking doctor prescribed medications
* Allergy to latex
* Allergy to lidocaine or its "caine" derivatives
Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing

CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. "Lifebeam" developed a new non invasive sensor for body core temperature detection. The research purpose is to evaluate the "Lifebeam" sensor during heat tolerance test while wearing CB protective clothing.


Eligibility Criteria:
Inclusion Criteria:

* age 21-30
* healthy
* after medical checkup
* after signing concent form

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* sleep disorders
* diabetes
* anhydrosis
* skin disease
* acute illness in last 3 days prior to the examination
Effects of Expiratory Pressure on Arterial Oxygenation During Hypoxia

Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia.

Two types of procedures will be tested in a random order, interspaced by resting periods : threshold PEEP set at 5,10 and 15 cm of water and pursed leap breathing.

Subjects will be tested at rest, and during light exercise (30% of sea level predicted VO2max).

FiO2 will be set at 12.5% (4000 m). fc, VE, PETCO2, TA, ECG, cardiac output, and tissular oxygenation will be monitored.

Eligibility Criteria:
Inclusion Criteria :

* active (\> 2 hrs/week physical activity)
* adult
* non smoking volunteers

Exclusion Criteria :

* cardiac, respiratory, neuromuscular, metabolic pathology
Nucleus Basalis Deep Brain Stimulation for Thinking & Memory Problems in Parkinson's.

We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving cognitive deficits in PD patients referred and eligible for conventional DBS treatment for coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive impairments (including but not restricted to deficits in attention and working memory) will have bilateral electrodes implanted to ensure that superficial contacts lie in the conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see figure 1). We will place electrodes using our conventional image guided, stereotactic frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2 groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or switched off separated by a 1 month washout period, following which the patient will cross over to have the opposite condition for a further 3 months- see timeline. At the end of the crossover period, all patients will be invited for continued follow up with stimulation switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients will be given the option of receiving additional conventional stimulation to the motor GPi, through the higher contacts of each electrode, at the end of the crossover period.


Eligibility Criteria:
Inclusion Criteria:

* All patients will meet Queen Square brain bank criteria for the diagnosis of PD and will have motor fluctuations (off periods and/or L-dopa induced dyskinesias) in response to medications that are known to improve with GPi DBS, and will be appropriate candidates for GPi DBS aside from the coexistence of cognitive impairment.

Patients will be aged between 35 and 80 years.

Patients will be able to give informed consent.

Patients will meet criteria for PD dementia. Patients will have a MMSE score between 26 and lower cutoff of 21 to restrict the sample to those with mild dementia and cognitive impairment. This will be equivalent to an age and education adjusted scaled score of greater than 5 and lower than 9 (mildly impaired range) on the Mattis Dementia Rating Scale-2.

Patients will have only minimal atrophy on pre-operative brain MRI scans.

Patients will be living at home and will have a carer living with them e.g. their spouse

Able to comply with trial protocol and willing to attend clinic necessary visits

Exclusion Criteria:

* Diagnosis or suspicion of other cause for parkinsonism or dementia.

Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.

Prior intra-cerebral surgical intervention for Parkinson's disease including Deep Brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplant.
Prefrontal iTBS on Working Memory

The investigators previous pilot study showed that the brain remained activated after 3 minutes of intermittent theta burst stimulation (iTBS). Therefore, an open question remains that how long the effects will last and when the maximum effects will be achieved. In addition, many pioneering works showed the positive effects of repetitive transcranial magnetic stimulation (rTMS) on working memory. Intermittent theta burst stimulation (iTBS) is a patterned form of rTMS, it has shown a non-inferior efficacy in depression but with a much shorter time (approximately 3 mins) than traditional rTMS (approximately 40 mins).

As discussed above, this study aims to investigate the effects of prefrontal iTBS on working memory using concurrent iTBS/fNIRS and to explore the duration of the effects.


Eligibility Criteria:
Inclusion Criteria:

* right-handed participants
* normal or corrected-to-normal vision

Exclusion Criteria:

* a current or past diagnosis of any neurological or psychiatric disorder
* any severe medical conditions, seizure, and pregnancy
* contraindication to TMS (e.g., with mental implants)
Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval

This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

This EAP is available for indications where there is reasonable scientific basis for use. Availability will depend on territory eligibility.

Eligibility Criteria:
Key Inclusion Criteria:

* The patient's disease is serious or life-threatening.
* The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated.
* Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment.
* Sufficient clinical data are available to identify an appropriate dose and treatment duration.
* The patient's treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks.
* The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations.
* Expanded Access will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.
* The request must be made by the patient's treating physician.

Note: Other defined Inclusion/Exclusion criteria may apply.
Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking

This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy.

This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy. Healthy participants will wear this insole device in their own athletic/tennis shoes over the course of one week. There are two key purposes of this study: 1. To determine how using this insole device for 1 week may effect a healthy individual's balance and postural sway while standing; and 2. To determine how using this insole device for 1 week may effect how an individual walks (gait), how hard they hit the ground as they walk, and foot pressure patterns with each step. Each individual's balance, postural sway, and walking gait (how you walk) will be analyzed before and after wearing the shoe insole device for the one-week time period.

Eligibility Criteria:
Inclusion Criteria:

● Willing to maintain current level of physical activity during the study period of a week (no increase or decrease of activity level).

Exclusion Criteria:

* Moderate or severe obesity (body mass index \>35kg/m2)
* Known diagnosis of cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that impacts normal walking ability
* Any current ankle, knee, hip or low back pain
* Currently using any knee or ankle brace on a regular basis for joint pains
* Severe back pain, prior spinal fusion or spinal deformity that would affect gait
* Major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer
* Any major orthopedic injury within the prior 12 months
TaVNS Reduces Postoperative Pain and Complications in Patients with Gastric and Intestinal Tumors

Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes, postoperative recovery, hospital stay, and even perioperative mortality. The application of taVNS during the perioperative period can enhance or preserve vagal nerve function, which may protect important organ functions through multiple pathways such as alleviating pain and inflammatory responses caused by surgical trauma, improving gastrointestinal function, enhancing cardiovascular regulation, reducing postoperative nausea and vomiting, and accelerating postoperative recovery, thereby reducing postoperative complications and mortality.

Subjects who met the inclusion criteria were enrolled in the clinical trial and received 2 interventions at the following times: the day before surgery, and the afternoon of the 1st day postoperatively (15:00-17:00), a total of 2 times. The intervention implementers used vagus nerve stimulation equipment to place electrodes in the tragus area of the outer ear of the subjects in the experimental group (taVNS group). The control group (sham stimulation group) was set to have a pulse width of 200 μs, a frequency of 1 Hz, and an initial current of 10 mA, which was gradually increased to the pain tolerance threshold of the subject, capped at 50 mA，last for one hour. The VAS scores before and after stimulation for 10 minutes were recorded.

2) ECG monitoring: Both groups were monitored with a dynamic ECG monitor during the intervention period, starting 10 minutes before stimulation and ending 10 minutes after stimulation. The SDNN (Standard Deviation of NN intervals) of the sinus rhythm was measured before and after stimulation for 10 minutes. A uniform standard was used for anesthesia induction and maintenance during surgery, and all patients used the same patient-controlled intravenous analgesia (PCIA) plan.

Eligibility Criteria:
Inclusion Criteria:

Age 18-80 years, BMI 18-30 kg/m², ASA Ⅱ-Ⅲ, elective laparoscopic gastric or intestinal tumor surgery, expected surgical duration ≥2 hours, patient understands study content and signs informed consent form.

Exclusion Criteria:

Kidney replacement therapy, treatment for arrhythmias requiring treatment, dementia, severe bradycardia, orthostatic tachycardia syndrome, neuro-muscular disorders, auricular dermatitis, planned post-operative transfer to ICU
Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort

To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.

The Investigators propose a pilot study which utilizes bpMRI in conjunction with PSA in the early detection of clinically significant prostate cancer in a high-risk group. Our study would focus on these high-risk subjects between the ages of 40-55 with a normal PSA ranging from ≥1.0 to \<2.5 ng/mL. bpMRI would be obtained in this group of subjects. If any suspicious lesions are found, the recommendation is to undergo MRI/US fusion biopsy. Subjects with negative bpMRI will be followed every year with serum PSA. Subjects with a positive bpMRI will have a prostate fusion and systematic biopsy performed. Those with a benign biopsy will be followed every year with serum PSA. Those who have a biopsy positive for cancer will be managed and followed according to the standard of care. All subjects will be followed for 5 years. Our hypothesis is that bpMRI in conjunction with above average PSA in a high-risk group will increase detection of clinically relevant prostate cancer and provide a useful addition to PSA screening.

Eligibility Criteria:
Inclusion Criteria:

1. PSA between 1.0 and 2.5 ng/dL
2. High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2
3. Patient is willing to participated in prostate cancer screening
4. Patient is capable of giving informed consent

Exclusion Criteria:

1. Nodularity or firmness of prostate on exam
2. Patient has undergone a prior biopsy or prostate surgery
3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.
4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.
5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies
6. Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
7. The participant cannot tolerate lying flat for the study duration