cyrilzakka/clinical-trials huggingface dataset:
Motor Imagery Training in Children With Unilateral Cerebral Palsy

Motor imagery (MI) is a promising method to improve more cognitive aspects of motor behaviour, and may, thus, be effective for facilitating motor planning in children with Cerebral Palsy (CP). MI training facilitates the neural plasticity by enhancing the neuronal cortical pathways in brain. In children with CP, motor planning and MI capacity were found to be affected by studies. In the literature, there are studies about the evaluation of MI in Unilateral CP but there is insufficient number of studies included in MI in the rehabilitation program.

The aim of the study was to investigate the effect of motor imagery training for gait and lower extremity muscle activity (with EMG), functional capacity, quality of life, and time performance variables in Children with Unilateral CP.

The eligible participants will be allocated three groups, including motor imagery training group, traditional physiotherapy control group, and healthy control group. All the assessments will be performed before and after the training in the 8-week motor imagery training group and 6 weeks after the end of training. The participants in the control group will be evaluated with a 8-week interval and 6 weeks after the end of physiotherapy training. The healthy participants will be assessed only once. The motor imagery training will be designed for the individual basis with standard protocols. It will be applied two times a week for 8 weeks. All sessions will be performed in the clinic.

Unilateral CP and age matched healthy individuals will be participate the study between the ages of 7 and 18 years. Children's gross motor skills classified with GMFCS.

The control group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes). Motor imagery training group will receive a traditional physiotherapy and motor imagery training within a specific program, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes MI training) .

Within the scope of MI training, individual training program will be determined by taking into consideration the needs of the individuals and the expectations for gait. The basic case of PETTLEP (Physical, Environment, Task, Timing, Learning, Emotion, Perspective) will be followed. MI training will be given individually with the same physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cerebral Palsy voluntary participation
* Age between 7-18 years, Children with Unilateral Cerebral Palsy
* With suitable cognitive state for training
* To attend a formal school
* GMFCS Level I-II
* IQ\>70 Children with Unilateral Cerebral Palsy (from children's file)
* Mini-Mental State Exam For Children score above 24

Exclusion Criteria:

* Severe cognitive impairment and not able to follow task instructions
* IQ\<70 Children with Unilateral Cerebral Palsy (from children's file)
* Who received motor imagery training last 6 months
* Severe Vision and hearing problems
* Botox or surgeries in the last 6 months
Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.

Overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. Each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (PRVI) administration of the gemcitabine/Lipiodol® emulsion.

Complete enrollment in 12 months from date of enrollment of first study subject.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent
* Resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per NCCN guidelines
* The patient is deemed a candidate for the study by the Johns Hopkins Multidisciplinary Pancreatic Tumor Board
* Preserved liver function (Child-Pugh A-B class) without significant liver decompensation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry
* Measurable or evaluable disease that will be directly treated with intra-pancreatic therapy (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]
* Suitable for PRVI, based on blood parameters such as platelet count, LFTs including bilirubin and coagulation status including international normalized ratio (see "Exclusion Criteria" below)
* The patient is able to give informed consent
* The patient, if a woman of childbearing potential, has a negative pregnancy test
* The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans
* Life expectancy of at least 3 months

Exclusion Criteria:

* Serum total bilirubin \> 3.0 mg/dL
* Creatinine \> 2.0 mg/dL
* Platelets \< 75,000/μL
* Hgb \< 8.0 g/dl
* ANC ≤ 1,000/μL
* INR \> 2.0
* Complete portal vein thrombosis or significant cavernous transformation of the portal vein
* Ascites (trace ascites on imaging is OK)
* The patient is pregnant or breast-feeding
* The patient is allergic to contrast media that cannot be readily managed or prevented with premedication
* Patients with peripheral neuropathy \[\> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)\]
A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* Patients with inadequate response to statins or who have difficulty in treatment with statins as defined below \[Inadequate response to statins\] Patients with hyper-LDL cholesterolemia who are currently taking or have previously taken statins\[and other lipid-modifying therapies(LMTs) if needed\] and cannot achieve the lipid management goals of LDL-C \[Difficulty in treatment with statins\] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, or of those patients who have a history of statin administration and who are judged to have concerns of safety problems associated with the administration or dose increase of statins and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).
* Patients with fasting TG levels of \<400 mg/dL at screening
* Other protocol specific inclusion criteria may apply

Exclusion Criteria:

* Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
* Patients with homozygous familial hypercholesterolemia (HoFH)
* Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening
* Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening
* Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of \<10.0 g/dL at screening
* Patients with uncontrolled diabetes with HbA1c of ≥9% at screening
* Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of \>1.5 × ULN at screening
* Patients with liver disease or dysfunction, including:

  * Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening
  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screening
* Patients with creatine kinase (CK) of \>3 × ULN at screening
* Patients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73 m2 at screening
* Other protocol specific exclusion criteria may apply
PET Imaging of Giant Cell and Takayasu Arteritis

While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging is often included in the diagnostic work-up of patients with large-vessel vasculitis (LVV), 18F-FDG lacks specificity for inflammatory cells and has limited ability to track therapy response. Moreover, high background 18F-FDG uptake in the brain and myocardium largely precludes imaging temporal arteritis in giant-cell arteritis (GCA) and coronary artery involvement in Takayasu arteritis respectively. These limitations of 18F-FDG for imaging LVV highlight important unmet clinical needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.

Up-regulation of SST2 in activated macrophages represents a novel imaging target for measuring vascular inflammation, which has been previously examined in atherosclerosis using 68Ga-DOTATATE. To test the hypothesis that SST2 PET imaging can accurately identify LVV, patients with active GCA or Takayasu arteritis will undergo vascular 68Ga-DOTATATE or 18F-fluoroethyltriazole-(Tyr3)-octreotate (FETO) PET-MRI at baseline, with repeat imaging after 6 months of treatment. A group of individuals with LVV in clinical remission will also undergo SST2 PET imaging. Data from patients with clinically inactive disease will serve to confirm tracer specificity for active disease, as well as signal reproducibility. 18F-FETO is an alternative SST2 tracer to 68Ga-DOTATATE; the longer half-life and shorter positron range of 18F compared to 68Ga may offer several advantages, including wider tracer availability and improved spatial resolution when imaging small arteries. All patients will also undergo 18F-FDG imaging before treatment, where clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants \>18 years old
* Able to give written, informed consent and to lie flat
* Either:

  1. New clinical diagnosis or acute flare of LVV (Giant-cell arteritis or Takayasu's arteritis) within \~1 week of treatment initiation, and
  2. Clinical indication for 18F-FDG PET-CT scan determined by the referring physician, or
  3. Undergoing surgery for LVV, or
  4. Diagnosis of LVV in remission

Exclusion Criteria:

* Women of child bearing potential not using adequate contraception
* Contra-indication to MRI scanning
* Contrast allergy or contrast-nephropathy
* Chronic kidney disease (eGFR \<30 mL/min/1.73 m2)
* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
* History of recent malignancy deemed relevant to the study by the investigator
Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA

Prospective open label crossover self controlled study. The study population will randomly be divided into two groups.

The study will take place in Lot Spa Hotel at the Dead Sea in two cycles (one of 16 participants and one of 14 participants) and will be comprised of 3 main stages:

1. Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol)
2. 12-month washout period
3. Crossover of the two groups and second exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol).

The population in the study will be composed of patients diagnosed and treated for rheumatoid arthritis at the Soroka University Medical Center who are 18 and above of age.

The patients will be selected by the PI and his team and addressed regarding their willingness to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female ≥ 18
2. Patients with diagnosed rheumatoid arthritis
3. Patients with moderate disease activity (DAS28 \> 3.2)

Exclusion Criteria:

1. Patients who suffer from Photosensitivity
2. Patients with Suspected Lupus Erythematoides
3. Patients with tendency to sudden loss of consciousness and/or dizziness
4. Patients under chemotherapeutic treatment
5. Patients with Active Malignancy
6. Patients with lowest level of physical functioning (class 4)
7. Patients with serious uncontrolled concomitant chronic disease
8. Drug Abuser
9. Patients with severe peripheral venous insufficiency
10. Pregnant women
Antibiotics and Tissue Expanders in Breast Reconstruction

This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction. The investigators hypothesize that use of prophylactic antibiotics after breast reconstruction does not reduce surgical site infections.

Surgical site infections occur in up to one-third of patients who undergo implant-based breast reconstruction following mastectomy for cancer; most of such cases require subsequent prosthetic removal. This elevated risk relative to other surgical procedures and patient populations has been attributed to cancer-related immunocompromise, foreign body placement, postoperative drainage tube maintenance, and chemoradiotherapy administration. The use of extended postoperative prophylactic antibiotics is prevalent amongst plastic surgeons despite lack of evidence supporting efficacy of such practice. Further, the National Surgical Care Initiative Project (SCIP) as sponsored by the Centers for Medicare \& Medicaid Services (CMS) mandates discontinuation of antibiotics by 24 hours after surgery, as further extension not only fails to reduce infection risk in the general surgical population, but also may contribute to bacterial resistance. The primary objective of this study is to compare the risk of surgical site infection in implant-reconstruction patients who receive extended prophylactic antibiotics with those who do not. In this randomized-controlled trial, women at a single institution who undergo implant-based breast reconstruction will be assigned to receive either less than 24 hours or 7 days of prophylactic postoperative antibiotics. Primary outcome measures will include development of superficial incisional, deep incisional, and organ/space surgical site infections at one year as defined by the Centers for Disease Control (CDC). Following adjustment for patient age, body mass index, comorbid disease, reconstructive timing, disease stage, adjuvant therapy, implant volume, drain use, and other procedural variables, relative risk of postoperative infection with use of extended prophylactic antibiotics will be estimated. Secondary outcome measures will include prosthetic explantation and, in cases of infection, bacteriology and antibiotic susceptibilities.

Eligibility Criteria:
Inclusion Criteria:

* Patients in whom implant-based breast reconstruction is selected based on clinician recommendation, patient agreement, and mutual consensus.
* Ability to understand the purposes and risks of the study and willingly give standard written informed consent for treatment established by Emory University Hospital and affiliates.

Exclusion Criteria:

* Pregnancy
* Incarceration
* Non-implant based reconstructive plan
* Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy

In some patients, a few days or weeks after recovery from carbon monoxide poisoning, new symptoms develop. These can affect mood, ability to think or remember clearly, and movements. Some people develop movement problems that are similar to Parkinson's disease. This damage to brain tissue is called "encephalopathy," and this study will look at the effect of pressurized oxygen therapy on long term, or chronic, encephalopathy.

Carbon monoxide (CO) poisoning is a leading cause of unintentional poisoning deaths in the United States. After a period of apparent recovery, survivors of acute CO-poisoning can develop a potentially permanent neurologic deterioration (DNS). DNS is a rare, poorly known encephalopathy with a 25-50% prevalence among severely poisoned CO-poisoned patients. Its symptoms and signs range from subtle abnormalities to severe dementia, Parkinsonism, gait disturbances, mutism, and incontinence. Recovery from delayed neuropsychiatric syndrome occurs in 50-75% of patients within 1 year. However, this leaves 25-50% permanently impaired.

Hyperbaric oxygen therapy (HBO2) is useful after acute poisoning to reduce the chance of developing DNS. However, appropriate therapy for DNS is widely debated; particularly, the role of hyperbaric oxygen therapy (HBO2) after DNS has developed is controversial. This study proposes to ascertain whether hyperbaric oxygen is efficacious in the treatment of chronic DNS brain injury from carbon monoxide (CO) poisoning. Ten participants suffering from DNS for longer than one year will be recruited to the study, which will be prospective, blinded, sham-controlled and crossover in design. Participants will be divided into two groups of five. One group will receive 40 HBO2 treatments \[100% oxygen at twice normal air pressure (2 ATA)\] followed by 40 sham HBO2 treatments \[air at near normal pressure (1.2 ATA)\]. Treatments will be done once daily for 2 hours, Monday through Friday. Neurological and psychologic assessments will be done prior to starting treatments, after each group of 40 treatments. The second group will be treated similarly except that they will receive sham treatments in the first and oxygen treatments second. In this manner, all participants will act as both experimental and control subject and will receive treatment which we believe is therapeutic.

Eligibility Criteria:
Inclusion Criteria:

* CO induced neurological or cognitive sequelae assessed as at least mild (e.g. UPDRS part 3 (motor)\>15).
* chronicity- signs or symptoms present for greater than one year after exposure.

Exclusion Criteria:

* age \>90 or less than 10 years
* other morbidities which may contribute to chronic neurocognitive deficits (such as traumatic brain injury, poisoning by other toxins, other neurodegenerative diseases)
* pregnancy (if a subject becomes pregnant she will be removed from the study)
* routine contraindications to hyperbaric oxygen
Asthma Breath Biomarker Assessment

This study aims to assess the feasibility of capturing data on exhaled breath compounds during an acute asthma exacerbation. In addition to assessing the feasibility of such a study the investigators will collect data on exploratory outcomes including the ability of breath biomarkers to distinguish between controlled and exacerbated states and their ability to differentiate between triggers of exacerbation.

This will be a longitudinal observational study in which the investigators assess the ability to capture information on volatile organic compounds in exhaled breath during an acute asthma exacerbation using two different approaches:

A) Recruitment and assessment of patients in secondary care during an acute exacerbation of their asthma; patients to be re-assessed once their asthma is stable and controlled.

B) Recruitment of clinically stable outpatients who are at increased risk of exacerbation by virtue of having had an acute exacerbation within the previous 12 months. Participants to be followed for a period of up to 12 months; assessed in the event of an exacerbation; and re-assessed once controlled.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Aged 18 or above
3. Able to provide informed consent
4. A confirmed asthma diagnosis requiring treatment with inhaled bronchodilator therapy +/- inhaled corticosteroids.
5. Non-smoker (or ex-smoker of 6 months or more with a less than 10 pack year history).
6. Current exacerbation or exacerbation within the previous 12 months.
7. Within 24 hours of having presented to acute secondary care (applicable to current exacerbation only)

Exclusion Criteria:

1. Major chronic cardiorespiratory disease other than asthma
2. Significant comorbid condition
3. Receiving maintenance oral corticosteroid therapy or other immunosuppressant or immunomodulatory therapy (including biologics)
4. Pregnant
5. Participating in a clinical trial of an investigational medicinal product (CTIMP).
6. Unable to speak English.
TREg Activation in the Treatment of the PELADE (Alopecia Areata)

In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.

The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.


Eligibility Criteria:
Inclusion Criteria:

* Of more than 18 years old,
* Affiliated to the social security system,
* Clinical diagnosis of alopecia areata,
* 50 % of the surface of the scalp affected
* Last flaire started less than one year
* Alopecia areata resisting to at least 1 systematic treatment including phototherapy (UVB or PUVA), general corticosteroid therapy or methotrexate
* Signature of the informed consent

Exclusion Criteria:

* Pregnancy or refusal of contraception at the women old enough to procreate,
* Refusal of contraception at the men
* Local treatment (dermocorticoïdes, minoxidil) or systematism (oral corticosteroid therapy, méthotrexate or the other immunosuppresseur) since less than 2 less,
* Evolutionary autoimmune cancer or disease or in forgiveness
* Excessive grip(taking) of alcohol (upper to 3 glasses of wine a day or one pre-lunch drink a day)
* Seropositivity VHC, VHB, or HIV
* Patient presenting a severe renal and/or hepatic insufficiency,
* Presenting patient one zoned, the chicken pox, the herpes, the tuberculosis, an evolutionary infectious disease, a respiratory failure ...
* Vulnerable person (nobody under guardianship minor(miner), adults, deprived of freedom)
* IC in the treatment(processing) by IL-2R
* Presenting a contraindication to ProleukinR