cyrilzakka/clinical-trials huggingface dataset:
Increased Physical Activity Through Mindfulness

In a pilot study, 90 physically inactive patients will be opportunistically and consecutively recruited and randomized to three intervention groups: mindfulness training, Physical Activity on Prescription (PAP) or only PAP. Follow-up will be done at baseline, three and six months with questionnaires, accelerometers and analysis of traditional risk factors to evaluate whether mindfulness may increase physical activity and decrease physical inactivity.

All patients between 40 and 65 years of age who fulfil the inclusion criteria will be asked to participate in the study. Posters with information about the study will be put in the waiting room and in other strategic places. Patients who accept to participate will get written and oral information; they will sign an informed consent after the information. The patients will estimate their level of physical activity in minutes per week to control inclusion criteria. The patients will return in the morning for fasting blood samples and get an accelerometer attached to them to wear for 7 days. During this time, randomization will be performed. They will also get to answer a couple of different surveys. The results from the surveys and blood samples will be the study baseline.

All patients with abnormal test results will follow a specific flow diagram for the usual care.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between 40-65 years of age, with insufficient physical activity ( \<150 minutes of moderate-intensity physical activity throughout the week, or \< 75 minutes of vigorous-intensity physical activity throughout the week, or an equivalent combination of moderate- and vigorous-intensity activity.)

Exclusion Criteria:

* Dementia, severe mental disorder,newly diagnosed untreated unstable angina pectoris,myocardial infarction within 6 weeks prior to study entry. Individuals who do not master the Swedish language in speech and writing will be excluded.The patients who have abnormal values according to guidelines that require contact with a physician on the same day or week will also be excluded
Ozurdex for Macular Edema Post Membrane Peeling

An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision.

In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.


Eligibility Criteria:
Inclusion Criteria

* Patients with macular edema who have had previous epi-retinal membrane peeling surgery for macular edema associated with epi-retinal membranes.
* All patients must have clear ocular media/lenses determined visually by the investigator in order to permit good quality stereoscopic fundus photography, fluorescein angiography and ocular coherence tomography.

Exclusion Criteria:

* Best corrected visual acuity 20/50 or better in the study eye
* Sub-macular hemorrhage in the study eye
* Sub-retinal fibrosis in the study eye
* Macular hole in the study eye
* Active inflammatory disease of the study eye
* Choroidal neovascularization in the study eye
* History of other ophthalmic disorders with the exception of cataract or previous cataract extraction in the study eye
* Active ocular infection in the study eye
* Previous subfoveal laser treatment in the study eye
* Previous verteporfin photodynamic therapy in the study eye
* Any systemic medical condition that would preclude them from undergoing surgery with monitored sedation.
Gut Permeability and Bariatric-metabolic Surgery

Increased intestinal permeability and dysbiosis have been causally associated with NAFLD and NASH progression. However, to date, there are no systematic studies, on the effect of bariatric-metabolic surgery on intestinal permeability and dysbiosis in the context of NAFLD development.

Morbid obesity is associated with non-alcoholic fatty liver disease (NAFLD) in 80-90% of patients, and non-alcoholic steatohepatitis (NASH) occurs in up to 60% of patients. If left untreated, the disease can progress to liver fibrosis, cirrhosis, or hepatocellular carcinoma. Weight loss of \>10% of body weight is the most effective treatment for NAFLD, and bariatric metabolic surgery plays an effective role in achieving long-term weight loss. About 80% of patients achieve improvement or reversal of NAFLD after bariatric-metabolic surgery. However, clinical and histological progression of liver disease may occur in about 20% of patients, despite weight the loss. Increased intestinal permeability and dysbiosis have been causally associated with NAFLD and NASH progression. However, to date, there are no systematic studies, on intestinal permeability and dysbiosis after bariatric-metabolic surgery.

Research questions

* To investigate the changes in intestinal permeability after bariatric-metabolic surgery.
* To investigate the differences in intestinal permeability at the time of surgery and 1 year after surgery between patients with liver fibrosis grades F≤1 and F≥2 (low-grade fibrosis vs advanced fibrosis).
* To investigate differences between patients with and without liver fibrosis progression using parameters for metabolic endotoxemia, intestinal permeability, and dysbiosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with morbid obesity undergoing bariatric metabolic surgery according to the IFSO criteria,
* Willingness to attend all follow-up visits
* Written consent

Exclusion Criteria:

* other liver disease than NAFLD
* presence of IBD, acute pancreatitis, amyotrophic lateral sclerosis, pregnancy
National Egyptian Network Pediatric Stroke and Hemiplegia Registry

Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.

Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with cerebrovascular stroke and hemiplegia .

Participants: Eligible infants and children with stroke and hemiplegia.

DESIGN: This study is a prospective cohort study.

Primary outcome measure: Initial acute stroke clinical and radiological presentation, recurrent stroke, mortality, and neurologic deficits in the acute stage, participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Eligibility Criteria:
Inclusion Criteria:

* Focal neurological deficit of acute onset lasting greater than 20 minutes. And CT or MRI showing infarct in location consistent with neurological signs and symptoms
* Hemiplegia

Exclusion Criteria:

1. Cerebral haemorrhage not associated with ischemic infarct.
2. Hypoxic ischemic event with diffuse or bilateral infarction alone.
Effects of Ghrelin Administration on Motivation

Everyday humans are confronted with a plethora of rewards competing for their attention. Nevertheless, to obtain a goal or reward, humans often need to invest effort. When humans are confronted with the challenge to integrate costs of action such as the effort of walking to one's favorite lunch place with its anticipated benefits (i.e., eating one's favorite meal), accumulating evidence suggest that humans might "go with the gut". Ghrelin is a stomach-derived hormone and the only known circulating peptide that stimulates appetite. At the same time, patients with major depressive disorder report deficits in motivated behavior which are oftentimes accompanied by changes in appetite and weight. Based on a wealth of accruing evidence from animal studies, the investigators suggest that the gut acts as an important arbitrator in effort allocation by signaling the energy level of the body. Within this physiological framework, ghrelin is thought to signal a short-term energy deficit to increase reward responsivity and willingness to work for reward as compensatory (allostatic) means. Here, the investigators propose to conduct a follow-up study (to NCT05318924) with subcutaneous administration of ghrelin vs. saline in patients with major depressive disorder and healthy control participants. During each visit, participants will receive a subcutaneous administration of either ghrelin or saline and perform an effort allocation task where they have to exert physical effort to obtain food and monetary rewards. The investigators hypothesize that ghrelin will increase the motivation to exert effort for rewards. The goal of this follow-up study is to test that the motivational effects of ghrelin are similar in patients with depression and healthy control participants. Furthermore, participants resting energy expenditure will be estimated before and after the administration. In line with a role of ghrelin as an energy deficit signal, the investigators expect ghrelin to decrease energy expenditure. During each visit, participants will answer questions about their current mood and physiological state. The investigators hypothesize that ghrelin increases mood state and hunger while decreasing satiety.


Eligibility Criteria:
Inclusion Criteria:

\* Must have participated in the behavioral study arm of NCT05120336

Exclusion Criteria:

* participation in the neuroimaging part of NCT05120336
* breastfeeding
* pregnancy
Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. In addition, we aim to investigate which outcome measures are the most relevant for assessing the severity of complaints and treatment outcomes. Also, we will define the Patients Acceptable Symptomatic State (PASS) and the Minimal Important Difference (MID) of the individual outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Orthopedic outpatient visit at the Helsinki University Hospital
* Signed informed consent
* Age over 18 years
* Finnish as language of communication

Exclusion Criteria:

* Recent surgery (within 2 months)
* Insufficient compliance
The Efficacy of Alcohol After Betadine and Combination of Alcohol and Betadine on Inflammation Vascular Access

The purpose of this study was to compare the efficacy of combination of alcohol and povidone iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to vascular access area in hemodialysis patients.

These cases were identified from patient that lack of specific diseases; Non-use of antibiotics or immunosuppressive drugs. That the participants will be selected using convenience sampling method and randomly divided into three groups: combination of alcohol and povidone iodine 10%, Alcohol after and control groups. In the Intervention in one group the vascular access site disinfected with Alcohol(group1) and in group 2, Alcohol and povidone iodine 10% was used to separate were disinfected. Then the patient in a month of inflammation and infection of the vascular access will be monitor. Exclusion criteria: inflammation or fistula failure during the study for any reason other than infection. Sample size determination: Through the pilot study. Date: 02.10.2014 till 02.11.2014 Outcome: Washing with both solution affected on reduce the inflammation and infection of the patient.

the efficacy of Alcohol after Betadine and combination of alcohol and Betadine on inflammation and infection related to Vascular access hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* absence of inflammatory vascular access site
* three dialysis sessions per week

Exclusion Criteria:

* patient dies
* patient withdrew from the partnership
Individualized Volume of Oral Contrast Agent in CT Enterography

Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics.

CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory for the assessment of the bowel wall. So, it is important to find clinical risk factors for inadequate small bowel distension and prescribe personalized regimen according to patient's personal characteristics to reduce patient acceptance.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing CT enterography

Exclusion Criteria:

* patients with a history of GI surgery
* patients with known or suspected bowel obstruction or perforation
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with acute upper GI bleeding
* patients with severe inflammatory bowel disease or megacolon
* patients with documented allergy to intravascular contrast agent
* patients with pregnancy or lactation
* patients hemodynamically unstable
* patients unable to give informed consent.
Gene Modified Allogeneic Neuroblastoma Cells For Treatment of Relapsed/Refractory Neuroblastoma

Neuroblastoma affects approximately 500 children a year in the United States. When the tumor occurs in infants, it is frequently localized and responds well to therapy. Even disseminated disease can be eradicated in about 75% of infants, and indeed may undergo spontaneous remission. In older children, the prognosis is far worse, and 80% or more of those with disseminated tumor can be expected to relapse within 3 years.

This study will utilize the concept of exploiting the immune system to eradicate neuroblastoma. In tumors in which there is consistent expression of tumor specific antigens as part of the malignant process, it may be possible to generate immune T-cells ex-vivo or in-vivo by using the specific protein or peptide(s) derived therefrom and eradicate the tumor. This study will evaluate the use of four to eight injections of IL-2 gene-transduced autologous neuroblastoma cells to induce a local, polyclonal T-cell infiltrate as well as an anti-tumor immune response.

Secondary objectives for this protocol included the following:

* To determine whether major histocompatibility complex (MHC) restricted or unrestricted antitumor immune responses are induced by injection of modified allogeneic neuroblasts and the cell doses required to produce these effects.
* To obtain preliminary data on the antitumor effects of this treatment regimen.

Eligibility Criteria:
* Diagnosis of recurrent advanced stage neuroblastoma.
* Must have a life expectancy of at least 8 weeks.
* Must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute neutrophil count of \>500/mm3.
* Not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six months.
* Bilirubin \<1.5 mg/dl.
* Creatinine \<1.5 mg/dl.
* ECOG performance status of 0-2 as below:
* Does not have rapidly progressive disease.
* Not pregnant or lactating.
Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol

The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis Factor alpha (TNFα) Certolizumab Pegol (CZP).

An open-label, prospective, and post-authorization observational study. This non-interventional study is designed to establish the importance of the measurement of HRQoL data and patient-reported outcomes in clinical practice in patients with RA, and to assess efficacy and safety use of CZP according to the summary of product characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female, aged 18 years or older
* Patient has active Rheumatoid Arthritis according to American College of Rheumatology (ACR) criteria with duration ≥ 3 months
* Patient has DAS28 (ESR) \> 4.5 and CRP \> 1.0 mg/dl at Baseline
* Patient has failed previous Disease Modifying Anti-Rheumatic Drugs (DMARDs) including Methotrexate treatment
* Patient has initiated treatment with subcutaneous anti-Tumour Necrosis Factor alpha (anti-TNFα) CZP, administered every 2 weeks
* Patient has no other prior anti-TNFα treatment (Naïve Patient) or CZP is administered after failure to the first anti-TNFα treatment (First Switch Patient)
* Patient is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the physician
* Patient has signed and dated a written informed consent form
* The patient's treatment must be within the terms of Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* Patient has a known hypersensitivity to the active substance or to any of the excipients
* Patient has active Tuberculosis or other severe infections such as Sepsis or Opportunistic Infections
* Patient has moderate to severe Heart Failure (New York Heart Association (NHYA) classes III/IV)
* Patient has any medical or psychiatric condition that, in the opinion of the physician, could jeopardize or would compromise the patient's ability to participate in this study or to complete the scheduled questionnaires
* Pregnant women or women of childbearing potential who are not using adequate contraception to prevent pregnancy
Real Life Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG

Evaluation of patient's proportion, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.

Primary objective of the study:

The primary objective is a clinical one and is to evaluate the proportion of patients, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with lung cancer at any diagnostic stage and histology.
2. Patient willing to use the follow-up setting with Moovcare® Lung apps.
3. Age ≥ 18 years.
4. Patient received anti-cancer treatment (surgery, chemotherapy, radiation (stereotaxy or not) or radio-chemotherapy association ended less than 12 weeks (Cohort 1 post-treatment); or during maintenance treatment or consolidation by chemotherapy or targeted therapy, or by immunotherapy initiated less than 12 weeks (Cohort 2 during treatment).
5. Imaging tumor evaluation less than 12 weeks showing disease control (response or stability according to RECIST 1.1 criteria).
6. Patient with symptomatic score on Moovcare® Lung apps less than 7.
7. Patient (or relatives) with internet access, a personnal e-mail box and a smartphone.
8. Patient with social security affiliation.
9. Signed informed consent form.

Exclusion Criteria:

1. Patient with progression after the first evaluation of initial treatment.
2. Pregnancy and breast-feeding.
3. Patient under tutorship or guardianship.
4. Dementia, mental alteration or psychiatric pathology influencing patient consent procedure and/or protocol observance and study follow-up.
5. Patient enable to protocol follow-up for psychological, social, familial or geographical reasons.
Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

The aim of this study is to determine the effect of epinephrine on systemic absorption of local anaesthetic mepivacaine administered for brachial plexus block in uremic patients scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patient acceptance of regional anaesthesia

Exclusion Criteria:

* peripheral arteriosclerosis
* diabetes mellitus
* bleeding disorder
* infection at the puncture site
* allergy to mepivacaine
* pregnancy
Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing

This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.

Objectives:

The overall goal of this protocol is to develop and refine an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance.

* Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with patients
* Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with care partners/caregivers
* Conduct expert reviews of a prototype decision aid with clinicians

Eligibility Criteria:
Patients

Inclusion Criteria:

1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. On active surveillance for 12 or more months
4. Fluent in English

Exclusion Criteria:

1. Receiving treatment for another cancer (primary or recurrence)

Caregivers

Inclusion Criteria:

1. Aged 18 or older
2. Fluent in English
3. Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)

   Exclusion Criteria:
4. None

Clinicians

Inclusion Criteria:

1. Aged 18 or older
2. Fluent in English
3. Provides clinical care for patients with prostate cancer (e.g. medical oncologists, urologists, radiation oncologists, nurse practitioners, physician assistants)

Exclusion Criteria:

1. None
Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)

Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF) to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective study to test the efficacy of NGF for CRN.


Eligibility Criteria:
Inclusion Criteria:

* The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

Exclusion Criteria:

* CRN combined with local or regional relapse, or with distant metastasis.
* CRN combined with other cerebrovascular disease.
* CRN combined with the second primary malignancy.
* CRN without neurologic symptoms or signs.
* CRN combined with diabetes.
* CRN patients that were supposed to live less than 6 months.