cyrilzakka/clinical-trials huggingface dataset:
High-intensity Training and Its Effects on Neuroplasticity

Regular physical activity is known to reduce the risk for some neurodegenerative disorders and their symptoms. Several studies have shown positive effects of therapeutic exercise interventions on motor- and cognitive function as well as psychosocial benefits in persons with multiple sclerosis (MS). To improve exercise recommendations, it is necessary to learn more about the underlying biological mechanisms. A reduction of inflammatory stress through physical exercise has been suspected as one key mechanism, mediating the positive effects of exercise in the context of MS (being a "classical" neuro-inflammatory disease). This randomized controlled trial aims to investigate the influence of two different rehabilitative endurance exercise programs (3x/week moderate vs. vigorous endurance exercise) on (1) (anti-)inflammatory immune signalling and (2) various aspects of participation.


Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of MS (according to the revised McDonald criteria 2010)
* Expanded Disability Status Scale 3.0 - 6.0
* Age \> 21
* Relapsing remitting or secondary progressive MS
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Define drugs not allowed during the study or for specific periods of time prior to the administration of the test dose,
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer

The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.


Eligibility Criteria:
Inclusion Criteria:

\* Adenocarcinoma of the prostate.

Exclusion Criteria:

* Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
* Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
* History of hip replacement.
* Prior intrapelvic surgery. This includes the following:
* Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
* Transabdominal pelvic surgery
* Bladder surgery
* Prior myocardial infarction (MI) or congestive heart failure (CHF).
* Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
The Impact of Long COVID on People Living With Pre-existing LTC

The goal of this observational study is to learn about the impact of long COVID on people who have multiple (two or more) pre-existing long-term conditions (such as diabetes and asthma). The main question it aims to answer is:

• How does long COVID impact the lives of adults living with multiple pre-existing long-term conditions and what are their rehabilitation needs?

Participants will be asked to:

* Take photos of things they feel represent the impact of long COVID on their day-to-day lives across seven days and,
* Take part in an interview to discuss the impact of long COVID.

This qualitative study will involve participants taking photographs (during their usual day-to-day activities), followed by 1:1 semi-structured interviews. Participants will be adults living with multiple pre-existing long-term conditions (LTC) and long COVID or their carers/supporters.

Stage 1: Photographs Participants will be asked to take photographs of things they feel represent or symbolise the impact of long COVID on their day-to-day lives across seven days in advance of the interview.

Stage 2: Interviews Semi-structured 1:1 interviews will be held face-to-face, online or telephone (in accordance with participant preference to optimise inclusivity). The iterative interview topic guide will continue to be informed by patient and public involvement and engagement, evidence (including preceding projects of the PhD), and the participants' photographs. Photographs will be viewed during the interview with participants.

The findings of this qualitative study will be used to inform the adaptation of exercise-based rehabilitation programmes to improve health and well-being which meets the needs of individuals living with multiple pre-existing LTC and long COVID.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) living with long COVID (or 'post-COVID-19 condition' in accordance with the World Health Organisation definition) and ≥2 pre-existing long-term conditions or carer/supporter for someone who is
* Living in Leicester (UK)
* Able to take photographs or carer/supporter who is able and willing
* Able and willing to provide informed consent

Exclusion Criteria:

* Child (\<18 years)
* Unable to participate in a face-to-face, online or telephone interview
* Unable to access interpreter for first language
Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity

Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. We plan to conduct a single-center, randomized controlled trial in patients undergoing bariatric surgery to test the hypothesis that driving pressure guided PEEP could reduce the postoperative atelectasis.

Positive end-expiratory pressure (PEEP) is a strategy that helps to keep alveoli open during surgery and to prevent postoperative atelectasis. A fixed PEEP without considering the respiratory mechanics in individual patients, however, is not optimal. Individualized PEEP therefore has been increasingly studied, and has been shown to improve oxygenation in both nonobese and obese patients. Studies have shown that the occurrence and prognosis of PPCs are significantly associated with high driving pressure (DP), but not with VT and PEEP. Driving pressure-guided individualized PEEP is expected to be a novel perioperative lung protection strategy. Consequently, the main aim of this study is to investigate the effect of a driving pressure-guided individualized PEEP ventilation strategy on postoperative pulmonary atelectasis in morbidly obese patients undergoing bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years old;
* Body mass index (BMI) ≥ 40 kg/m2;
* ASA classification I to III;
* Signing the informed consent form for this clinical study;

Exclusion Criteria:

* Respiratory infection within 4 weeks; severe respiratory system diseases; history of pulmonary and/or thoracic surgery; neuromuscular dysfunction;
* Serious cardiac, renal or haematopoietic diseases;
* Contraindications to PEEP；
Study of Total Hip Arthroplasty Using Radlink Surgical Positioning Software

This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on visual inspection of fluoroscopic images.


Eligibility Criteria:
Inclusion Criteria:

* Total hip arthroplasty

Exclusion Criteria:

-
Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study

B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So our aim is to compare the detection rate of early stage HCC and false referral rate of HCC between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%) than that of B-mode US (3%).


Eligibility Criteria:
Inclusion Criteria:

1. Patient 20 years old or older,
2. Patient at high risk of HCC and is supposed to take ultrasonography,
3. Patient who has no suspicious HCC on previous examinations or patient who undergoes the first surveillance,
4. Patient who has liver cirrhosis proven by one of the following methods-liver biopsy (METAVIR score 4), identification of esophageal or gastric varix by endoscopically or radiologically, surface nodularity on ultrasonography, CT or MRI, platelet count less than 100,000/mm3, serum albumin less than 3.5 g/dl, or prothrombin time higher than 1.3 INR,
5. Patient without contraindication for sonazoid,
6. Patient willing to sign the informed consent

Exclusion Criteria:

1. Patient on pregnancy or breast feeding,
2. Patient with allergy to egg,
3. Patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary hypertension,
4. Patient with history of HCC,
5. Patient with history of malignancy other than HCC -
Group-based Metacognitive Therapy for Burns and Plastics Patients

Serious burns and other traumatic or disfiguring injuries represent a significant public health burden. Survivors often need intense medical or surgical treatment, including plastic surgery. As well as devastating physical injuries, up to 45% of people develop significant mental health difficulties following a traumatic injury. These difficulties include depression, anxiety and post-traumatic stress disorder (PTSD).

Cognitive Behavioural Therapy (CBT) is the most widely offered treatment within the National Health Service (NHS) and the most common treatment provided for burns and plastics patients. However, CBT is limited in efficacy, time-consuming, and focuses on treating the most distressing problem first.

One way to overcome these limitations is to evaluate a group therapy that can treat multiple mental health problems at once. One such treatment is called Metacognitive Therapy (MCT; Wells 2009). MCT targets metacognitive beliefs (beliefs people hold about their thinking) rather than the content of patients' thoughts (i.e. reality testing), which is advantageous over cognitive therapies as often following a burns or plastics injury patients experience realistic negative thoughts (e.g. thoughts about disfigurement). MCT has been shown to be more effective at treating anxiety and depression in mental health settings than CBT, however, more research is needed to evaluate MCT in physical health settings.

The aim of this study is to examine the acceptability and feasibility of group-MCT within the Department of Burns, Plastics and Reconstructive Surgery at Wythenshawe Hospital. We aim to recruit 20 patients to receive six weekly sessions of group-MCT. Sessions will last approximately 90 minutes. Indicators of feasibility and acceptability will be described including rates of referrals, recruitment, and dropout. Data on symptom outcomes (as measured by the PHQ-9 and GAD-7) at pre and post treatment will be assessed and benchmarked against usual treatment delivered. The data will be used to inform a future large-scale trial on the effectiveness of MCT.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients at the Adult Burns Centre in Wythenshawe Hospital;
* Age 18 or older;
* At least one month since the occurrence of the injury;
* A competent level of English language skills (able to read, understand and complete questionnaires in English).
* In the event that sessions will be conducted remotely, participants will require adequate internet connection and access to Microsoft Teams/Zoom.

Exclusion Criteria:

* Cognitive impairment which precludes informed consent or ability to participate;
* Acute suicidality;
* Active psychotic disorders;
* Current drug or alcohol abuse;
* Individuals engaging in active deliberate self-harm;
* Dementia or learning difficulties;
* Antidepressant or anxiolytic medications initiated in the previous 8 weeks;
* Individuals who intentionally set themselves on fire.
Bacterial Decolonization Plus Intraoperative Angiography for Soft Tissue Sarcomas Receiving Preoperative Radiotherapy (CONCERTO)

This trial will investigate the combination of two low-cost, non-toxic strategies to assess whether they can reduce the risk of acute major wound complications in soft tissue sarcoma of the lower extremity. Intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to radiation therapy and repeated for 5 days every 2 weeks during radiation therapy may significantly reduce the risk of acute radiation dermatitis. That, along with use of indocyanine green (ICG) angiography at the time of wound closure.

Strategies to reduce the risk of acute wound complications have historically been mostly unsuccessful. In soft tissue sarcomas, a prior study showed that the use of indocyanine green (ICG) angiography at the time of wound closure was associated with a reduction in wound dehiscence and infection when compared to historical controls. Cutaneous colonization of S. aureus has been implicated in severe cases of radiation dermatitis. Some known risk factors for acute major wound complications for patients with sarcomas are anatomic location in the lower extremity, preoperative radiation therapy, larger tumors, comorbidities (e.g., diabetes mellitus, tobacco usage, vascular disease, and obesity), tumors \<3mm from skin surface, and the development of grade ≥ 2 acute radiation dermatitis. Both large tumors and lower extremity location can increase the likelihood of seroma formation, which can act as a nidus for infection and subsequent wound complication. Rationale for this trial includes prior studies of treating patients with a bacterial decolonization (BD) protocol of intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to RT and repeated for 5 days every 2 weeks during radiation therapy that show significantly reduced risk of acute radiation dermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
2. Newly diagnosed soft tissue sarcoma arising from the lower extremity (defined as the tumor center arising at the level of the iliac crest or below)
3. Eligible for wide local excision
4. Eligible for external beam radiation therapy
5. Negative serum pregnancy test for women of childbearing potential \< 28 days prior to RT.
6. Informed consent signed and dated to participate in the study.
7. Willingness and ability to comply

Exclusion Criteria:

1. Allergy to mupirocin and/or chlorhexidine
2. Active dermatologic condition in RT field
3. Tumor size \> 32cm
4. Prior RT overlapping with fields
5. Concurrent/prior invasive malignancy that could potentially interfere with proposed treatment. Individual cases can be discussed with PI prior to registration
Prediction of Cervical Radiculopathy Success With PNF and Mobilization

The goal of this predictive interventional study is todetrmine clinical predictors for success with combined proprioceptive neuromusclualr faciitaion (PNF) and passive mobilization ain patients with cervical radiculopathy (CR).

This study will answer the question, what are the factors affecting success with PNF and mobilization for patients with CR? No control group. The goal of this new study is to see the effect of age, duration of symptoms, forward posture angle and neck disability index response to passive mobilization combined with the PNF technique

Eligibility Criteria:
Inclusion Criteria:

* Participants with cervical radiculopathy.
* Age ranges between 40 and 60 years old.
* Minimum score (3 out of 10-point) on a visual analog scale (VAS)
* Orthopedic clinical confirmation reveals a history of neck pain.

Exclusion Criteria:

* Whiplash injury.
* Previous Cervical surgery.
* Pain less than three months.
* Mechanical and non-specific neck pain.
* Pregnancy.
* Bilateral arm pain.
* Inflammatory arthritides.
* Osteoporosis.
* Symptoms of vertebrobasilar insufficiency.
Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder

Background and Objectives: Schema therapy has been shown to be of benefit in treating borderline personality disorder. However, it is still unclear what the most suitable treatment implementation format is and to what extent therapeutic gains may be generalizable to regular healthcare settings with limited resources.

Methods: A pragmatic randomized controlled trial was conducted ona representative Spanish sample of outpatients with a DSM-5 main diagnosis of borderline personality disorder. Patients were allocated either to a combined (group plus individual) schema therapy format (n=40) or to a group-only schema therapy format (n=40). Borderline personality disorder severity was the primary outcome, with other clinical variables considered as secondary outcomes (e.g., early maladaptive schemas, functioning). The assessment protocol included baseline, post-treatment (after 12months of treatment), and six-month follow-up evaluations. Data was analyzed through a two-way repeated measures ANOVA. Limitations were a limited follow-up assessment and the absence of multi-center data that detracted from the long-term stability and generalizability of the findings.


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 criteria for borderline personality disorder
* Aged 18 to 65 years

Exclusion Criteria:

* Psychotic disorders (except short, reactive psychotic episodes)
* Bipolar disorder (current hypo-manic or mixed episode)
* Antisocial personality disorder
* Substance intoxication
* Mental retardation
Preventing Anxiety and Depression in Older Hispanics

The purpose of this study is to look at the best ways to prevent anxiety and depression in older Latino adults who are at risk for developing anxiety and depression. Participants will be randomized to either a health promotion intervention or a healthy lifestyles education program.

Given the prevalence and morbidity of depression in later life, the inadequacies of current treatment approaches for averting years living with disability, the inequities in access to the mental health care delivery system, and the workforce shortages to meet the mental health needs of older Latinos, development and testing of innovative strategies to prevent depression and anxiety are of great public health significance and have the potential to change practice.

Eligibility Criteria:
Inclusion Criteria:

* Latino (self-identified);
* Age 60+;
* Subthreshold depression defined as a score ≥ 5 on the Patient Health Questionnaire (PHQ-9), OR subthreshold anxiety as defined as a score ≥ 5 on the GAD-7;
* Do not meet criteria for current MDD or GAD as indicated by the Mini International Neuropsychiatric Inventory (MINI);
* Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator;
* Medical clearance for participation in a health promotion intervention by a physician, physician's assistant, or nurse practitioner;
* Not taking steroidal or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization;
* Expect to be resident in Miami for the subsequent 2 years.

Exclusion Criteria:

* Have met criteria for major depressive disorder or generalized anxiety disorder within the past 12 months;
* Have met criteria for alcohol or other substance abuse disorders within the past 12 months;
* Are currently receiving antidepressant medication or participating in other mental health treatment;
* Have a lifetime history of bipolar disorder or other psychotic disorder including major depression with psychotic features;
* Have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam (MMSE) score \<24;
* Are current tobacco smokers since smoking influences systemic inflammation;
* Have contraindications to physical activity outlined in the American College of Sports Medicine standards;
* Have high suicide risk, i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire;
* Are unable to complete 10 m walk test;
* Currently residing in a nursing or group home;
* Have a terminal physical illness expected to result in the death within one year;
* Any evidence of current infection; and
* Have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention (further defined in the protocol).
Pilot Study of the TearCare System

The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of the TearCare™ System compared to standardized warm compress therapy for the application of controlled, localized heat therapy in adult patients with dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Dry eye symptoms within 30 months of the screening exam with a SPEED score \>=6
* Schirmer 1 value of \<010 mm in at least one eye or a Tear Breakup time \<10 seconds in at least one eye

Exclusion Criteria:

* Any active ocular or peri-ocular infection or inflammation
* Recurrent eye inflammation within the past 3 months
* Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
* Ocular surface abnormalities that may affect tear film distribution or treatment
* Abnormal eyelid function in either eye
* Diminished or abnormal facial, periocular, ocular or corneal sensation
* Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
* Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
* Allergies to silicone tissue adhesives
* An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
* Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
* Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
* Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
* Participation in another ophthalmic clinical trial within the past 30 days
* Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)