cyrilzakka/clinical-trials huggingface dataset:
Transcranial Pulse Stimulation on Motor Cortex

Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \&amp; Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer\&#39;s disease and depression. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, single-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* No physical, neurological or psychiatric disorder
* Right-handedness

Exclusion Criteria:

* Background with neuroscience
* TPS and TMS contraindications, including metal implants, pregnancy, coagulation disorders, thrombosis, brain tumor, cortisone therapy up to 6 weeks before first stimulation, pacemakers or cochlear implants.
Early Identification of Brain Insult in Chorioamnionitis

Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. The aim of this study is to identify, as early as, possible signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level were associated with the occurrence and size of stroke and brain trauma in adults and children. Moreover, S100B crosses the membrane and its level in women with preterm labor was associated with brain injury of preterm infant.

The study question is whether the levels of S100B in women with early amniotic fluids breakdown are associated with future brain injury of the infant, as assessed by head ultrasound and neurological examination.


Eligibility Criteria:
Inclusion Criteria:

* Rupture of the amniotic sac before 32 weeks
* Gestational age less than 32 weeks
* Singleton

Exclusion Criteria:

* Intrauterine growth restriction
* Positive TORCH
* Fetus' brain malformation
* Fetus' brain hemorrhage
* Maternal medication with teratogenic effect
A National Study of the Chronic Disease Self-Management Program

This survey will address important research, practice, and policy questions: How does Chronic Disease Self-Management Program (CDSMP) impact participants' general health, their health behaviors, and their need for health care utilization? Who benefits most from the CDSMP program? Are predicted gains maintained over a six and twelve month period? Can critical clinical changes be seen for those who are diabetic?

A national survey of participant outcomes is important for documenting how the CDSMP program is impacting people with chronic diseases and influencing health care outcomes. This study will help bridge the research to practice gap and further our knowledge about the outcomes of evidence?based programs that are widely disseminated.

Investigators hope to learn the answers to the following questions for English and Spanish-speaking populations:

1. How does the CDSMP impact a person's general health?
2. Does the CDSMP increase the use of healthful behaviors?
3. Does the CDSMP impact health care utilization?
4. What are the characteristics of those who benefit from the CDSMP?
5. Can these benefits be maintained over 6 and 12 month periods?
6. For people with type 2 diabetes, and hemoglobin A1c be impacted by the CDSMP?

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Has a chronic health condition
* Attending a Chronic Disease Self-Management Workshop at a designated host site in the United states
* Speaks English or Spanish
* For blood test portion of study: have type 2 diabetes

Exclusion Criteria:

* Do not meet inclusion criteria
Maternal Problem-Solving in Childhood Cancer

The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.

The purpose of this study is:

1. to develop a time-and-attention control condition to better assess the direct and mediational effect of PSST independent of social support (placebo);
2. to develop a personal digital assistant hand-held supplement to standard PSST to provide real-time training, reinforcement, and on-the-spot documentation of PSST usage;
3. to develop independent measures of the application of problem-solving strategies in everyday life; and
4. to measure utilization of and satisfaction with other resources accessed by mothers as independent indicators of the usefulness and cost-effectiveness of PSST.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact.

Exclusion Criteria:

* Mothers of children with cancer if they do not read or speak English or Spanish, if their child is in severe medical crisis, or if they live a prohibitive distance to complete the intervention.
Novel Methods for Management of Complicated Wounds

Difficult to heal wounds are a common and complex medical problem, causing suffer to the patients and challenging medical, social and economic burden on the health system. Based on data from the western world, it is estimated that in Israel, at any given time, 30 to 60 thousand patients with difficult to heal wounds. Among diabetics patients, it is estimated that 15% to 25% will develop a difficult to heal foot wounds during their live time.

The medical definition of a difficult to heal wounds is: a wound showing no signs of recovery after 4-6 weeks of treatment. Most of these wounds are caused by anaerobic bacteria inventions.

One of the methods for the treatment of difficult to heal wounds is - ROI-RNPT (Regulated Oxygen -Enriched \& Irrigation Negative Pressure -Assisted Wound Therapy).

This method creates in the wound a negative pressure in the presence of oxygen and irrigation applied directly into the wound bed.

As part of the wound closure process the investigators will use the "external tissue expansion". This method under clinical use is exercised by the - "Top Closure" "tension relief system" (TRS).

In this study, the investigators intend to investigate whether ROI-NPT system combined with TopClosure, is effective for the treatment of difficult to heal wounds, compared with methods currently in use.

1. The investigators will debride the wound if necessary. Wound biopsies will be taken to determine the existing pathogens and direct the antibiotic treatment.
2. Wound measurements will be taken (Width, length and depth).
3. Afterwards the wound will be closed with the TopClosure device and the patient will be connected to a Negative Wound pressure device Vcare Alpha.
4. the investigators will change dressings according to schedule. If the wound is clean the investigators will change dressings every 3-5 days. If the wound is infected the investigators will change dressings every 2-4 days. If the investigators encounter a severe infected wound with a lot of pus the investigators will change dressings every 1-3 days.
5. the investigators will determine the time to heal when the wound is clean and there is no further need for Negative Pressure Wound Treatment (ROI-NPR) up to 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

1.A patient in our in-patient rehabilitation ward that is willing to participate in our study and is willing to be constrained to his bed for the time of the study.

Exclusion Criteria:

1. Patient with cognitive impairments interfering with his or her ability to understand the instructions by our team.
2. Patient that is not willing to be constrained to his bed for the time of the study.
Vital Values at Circadian Markers in Postoperative Patients

To describe changes in various diurnal patterns in vital values after surgery. These will be analyzed based on whether the patients have complications or no complications.


Eligibility Criteria:
Inclusion Criteria:

* Admitted for surgery
* Expected time of surgery was more than 2 hours.
* Expected post-operative length of stay was more than 2 days.

Exclusion Criteria:

* Allergy to study materials
* Patients with a pacemaker
* Patients that were expected to be unable to cooperate with study procedures (for instance a Mini-Mental State Exam(MMSE \< 25)
Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD

The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral prefrontal cortex (LDLPFC) will induce long-lasting effects in improving motor function and reducing motor fatigue and fatigability in PD patients.

Parkinson's disease (PD) is the fastest growing and second most common neurodegenerative disease (after Alzheimer's disease) and affects approximately one million people in the United States. Impaired motor function is one of the cardinal features of PD. One of the diagnostic criteria for PD is bradykinesia (slowness of movement). In addition to bradykinesia, PD patients also suffer from increased motor fatigue and motor fatigability. In the body of fatigue research, the term "motor fatigue' usually refers to the general sensation of tiredness or of difficulty in initiating physical activity experienced over several days to weeks. This is often assessed by questionnaires completed by the subject. The term 'motor fatigability' refers to difficulty in maintaining physical activity at a desired level (Lou, 2009). This is often assessed quantitively in a laboratory setting. Motor impairments, motor fatigue, and motor fatigability affect quality of life in patients with Parkinson's disease.

Transcranial direct current stimulation (tDCS) is a noninvasive and safe brain stimulation technique that has been shown to be effective in improving motor function in subjects with Parkinson's disease. During tDCS, low-voltage, low amplitude current is passed through a pair of surface electrodes placed over the areas of brain of interest.

The specific aim of this study is to examine if atDCS to LDLPFC at 2 milliamps (mA) for 20 minutes daily for 5 days will improve motor function and reduce motor fatigue and fatigability in PD patients. The study will examine if the effects may last for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)
* Must be able to consent

Exclusion Criteria:

* Patients with dementia (MOCA \< 21)
* PD treatment using deep brain stimulation (DBS)
* Diagnosis of psychosis
* Diagnosis of multiple sclerosis
* Diagnosis of stroke
* Diagnosis of chronic obstructive pulmonary disease (COPD)
* Diagnosis of congestive heart failure (CHF)
The Effects of Yoga and Motor Control Exercises in Patients With Chronic Neck Pain

Identification of the effects of yoga and motor control exercises on pain intensity, pain sensitivity, function, and pain cognition in individuals with neck pain.

Patients participating in the study were divided into two parallel groups. The patients in the motor control exercise group were instructed to perform motor control exercises, which consist of strengthening of the deep cervical flexors, deep cervical extensors, and axioscapular muscles; stretching exercises; postural correction exercises, and patients in the yoga group were instructed to perform a yoga program, which consists of breathing, relaxation, and flexibility exercises.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific neck pain
* Must be pain at least 3 months

Exclusion Criteria:

* History of any cervical spine surgery
* Presence of neurological deficit
* Having been diagnosed with cardiovascular or systemic diseases that would prevent him/her from taking exercise training.
* Inflammatory, infectious, or tumoral disease of the vertebra
* Severe/progressive scoliosis, spinal stenosis, spondylolisthesis
* had been diagnosed with a neurological disease
* were currently pregnant.
Relationship Between Hyperventilation Syndrome and SARS-CoV-2 Infection

Following an acute COVID-19 infection, many patients suffer from long lasting physical symptoms that may greatly impair quality of life. Persisting dyspnea and other functional respiratory complaints could evoke Hyperventilation Syndrome (HVS) as a putative contributor of the long-COVID presentation in COVID-19 survivors. We aimed to assess the possible relationship between a HVS and previous acute SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Read and speak French
* Perform a pulmonary function test

Exclusion Criteria:

- incomplete questionnaire or inability to obtain an interpretable lung function assessment
Follow up of Stroke Patients by Neurologists and General Practitioners

From the region around Brussels there are currently few data on how the post-stroke process take place and how satisfied the care providers are with it. For this reason, this survey is set up with the aim of examining four pillars: the epidemiology of stroke, communication between neurologists and GPs and satisfaction with it, secondary prevention of cardiovascular disease and control/treatment of the most common sequelae after stroke. In the latter two, the emphasis is on detection and treatment, and explicitly on whose task this is (neurologist versus GP), with the aim of verifying the mutual consensus on treatment and the subsequent detection of treatment shortcomings. This study will mainly consist of interviewing general practitioners and neurologists in the periphery of Brussels. This will be done by means of partly structured questionnaires, that will be send out to the medical professionals by contact with the central umbrella organisations of neurology in the hospitals and contact with the various general practitioners' practices (directly or through the multidisciplinary meetings per region). The questionnaires will be made up in google forms, as this programme allows efficient data processing, is eas-ily understandable for every participant and as no individual patient data will be processed.


Eligibility Criteria:
Inclusion Criteria:

* Neurologist and/or general practitioner

Exclusion Criteria:

* Not actively treating stroke patients
Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan

Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis \[AS\]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. This study will assess how effective Rinvoq is in treating axSpA.

Rinvoq is an approved drug for treating axSpA. Approximately 100 adult participants who are prescribed Rinvoq by their physician in accordance with local label will be enrolled in Japan.

Participants will receive Rinvoq as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participant with clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York Criteria for AS.
* Participant who is administered the first dose of Rinvoq for AS.

Exclusion Criteria:

* Participant with prior treatment by JAK inhibitors.
* Participant currently participating in another clinical study except non-interventional study.
* Participant for whom upadacitinib is contraindicated.
* Participants who are not registered within 14 days after initiation of Rinvoq treatment for AS.
Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer

RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.

PURPOSE: This clinical trial is assessing how changes in genes affect disease progression in women with newly diagnosed or metastatic breast cancer.

OBJECTIVES:

Primary

* Correlate inherited and acquired variations in candidate genes with breast cancer progression and survival in women with newly diagnosed or metastatic breast cancer.

Secondary

* Establish a repository of blood and tumor samples from these patients, linked to a database of clinical, pathological, and treatment outcome data for future research studies.

OUTLINE: Patients complete epidemiological questionnaires and undergo blood sample collection. Tumor tissue specimens are requested from the pathology departments.

Blood samples are analyzed for single nucleotide polymorphisms and other polymorphic variants in candidate genes by polymerase chain reaction. Candidate genes include genes involved in the DNA damage response, programed cell death, inflammation, and angiogenesis. Tumor samples are analyzed by tissue microarrays using immunohistochemistry, denaturing high-performance liquid chromatography, and DNA sequencing to study genetic changes in the tumor.

PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Newly diagnosed or metastatic disease
* Resides within the North Trent Cancer Network (NTCRN) region
* Undergoing therapy at NTCRN centers
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* No concurrent participation in another genetic study
Stromal Gene Expression During Pulmonary Sarcoidosis

to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.

to collect small sample of lung tissue recovered from a clinical procedure such as bronchoscopy, or a mediastinoscopy (a procedure in which a lighted instrument (mediastinoscope) is inserted through a neck incision to visually examine the structures in the top of the chest cavity and to take a sample (biopsy) of tissue.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of sarcoidosis

Exclusion Criteria:

* inability to provide consent
Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer

This study is being conducted to investigate the effect of a more in-depth education plan for patients with breast cancer. Patients will be randomized to receive either the standard education plan during their breast cancer treatment or they will receive in-depth education about their breast cancer treatment. In order to see what kind of effect the different education plans have, patients will fill out three identical questionnaires during the course of treatment.

This study will be a prospective study of women receiving adjuvant radiation therapy for management of breast cancer at the University of California Davis. All patients will be staged according to the American Joint Committee on Cancer Seventh edition. Primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated.

All patients will have a validated quality of life assessment (FACIT-TS-PS) completed at three time points during their radiation therapy process. The patients will be randomized at the time of completion of radiation plan approval by the treating radiation oncologist in a one to one fashion to either proceed with standard education or more extensive plan review. The radiation oncology quality assurance (QA) process will be blinded to the randomization of the patient.

Eligibility Criteria:
Inclusion Criteria

1. Diagnosis of invasive breast cancer
2. AJCC stage 1, 2, 3 breast carcinoma
3. Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
4. Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
5. Patient must provide study specific informed consent prior to study entry
6. Breast implants allowed

Exclusion Criteria

1. Stage 4 breast cancer
2. Ductal carcinoma in situ
3. Patients treated with radiation for palliative intent
4. Prior treatment with radiation therapy to the ipsilateral breast or chest wall
5. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
6. Prior invasive or in-situ carcinoma of the breast (-prior LCIS is eligible)
7. Diagnosis of DCIS
Musculoskeletal Disorders in Mountain Runners

the study aims to estimate the prevalence of musculoskeletal disorders in a population of runners in the mountains; moreover it proposes to explore the relationship between distance traveled, the difference in height, the training frequency in the week, the shoes worn, the training method, the use of supports and experience of running with musculoskeletal disorders. The secondary objectives of this study are to investigate to which rehabilitative figures the sportsman turns and if the treatments have positive outcomes.

Running is one of the most popular forms of exercise in the world. The prevalence of musculoskeletal disorders in street runners has already been extensively studied and is about 55% of those affected. In recent years, more and more runners paid their attention to mountain running where, the different types of terrain and the important differences in height require a different musculoskeletal effort. In the literature there are few studies that have investigated the prevalence of disorders, risk factors and protective factors on these runners. The mountain running performed with regularity and method is certainly a healthy activity for individuals, but it is not free from injuries due to several factors, such as long distance, significant differences in level and uneven terrain. It is not clear whether these factors can influence the onset of skeletal muscle disorders. The study aims to estimate the prevalence of musculoskeletal disorders in this population of mountain runners; moreover it proposes to explore in this population the relationship between distance traveled, the difference in height, the training frequency in the week, the shoes worn, the training method, the use of supports and experience of running with musculoskeletal disorders. Moreover, the study wants to investigate to which rehabilitative figures the sportsman turns and if the treatments have positive outcomes. Inclusion criteria are: age over 18, be a participant of at least one trail, understand the Italian language, to have signed informed consent. Recruitment: all participants in mountain races will be invited to reply to the attached questionnaire anonymously when the race bib is picked up. The runners will be free to participate or not in the survey, without the choice can affect the results of the race in any way and can create situations of subjection to the organization.

Eligibility Criteria:
Inclusion Criteria:

* age over 18,
* be a participant of at least one mountain race
* understand the Italian language
* have signed an informed consent

Exclusion Criteria:

* under the age of 18
* do not understand Italian language
* not having given consent