cyrilzakka/clinical-trials huggingface dataset:
Physical Rehabilitation and Chronic Kidney Disease

Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* man or woman
* age over 70 years
* CKD stage 3B, 4 or 5 or a DFG \<45ml / min according to CKD-EPI formula
* an SPPB (Short Physical Performance Battery test )\<10
* having received a complete and loyal information and having given his written and informed consent.
* ability to rehabilitate

Exclusion Criteria:

* Subject not presenting previous inclusion criteria
* General condition not compatible for the realization of physical rehabilitation
* Patient protected under the terms of the law.
* Inability to respect the follow-up of the study for geographical, social or psychological reasons.
* depression or other psychiatric disorder
* Refusal to participate in the study
* Absence of affiliation to the social security system
* Subject in a exclusion period of an other study
Efficacy and Safety Assessment for a New UV-protected Pump Infusion Line in Intravenous Infusion Therapy

To verify the efficacy and safety of Original Perfusor Line (Art.No.8723017) in infusion therapy in Patients with light sensitive drug infusion.

Subjects who choose to use Original Perfusor Line for their planned infusion treatment (nimodipine injection) as per the study protocol will be enrolled. The 300 subjects will be 1:1 randomized into the experimental group or the control group, using Original Perfusor Line (Art.No. 8723017) connected with an injection pump for infusion treatment with nimodipine injection or Original Perfusor Line (Art.No.8723010) connected with an injection pump for infusion treatment with nimodipine injection, respectively.Use of both the test product and the control product will be in strict accordance with their package insert.

The primary endpoint is the percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications, visible catheter embolism, air embolism and micro embolism in the infusion system and the secondary endpoint is the quality assessment for the clinical application of the products,such as the percentage of products which are qualified for infusion administration including link and removal, transparence, and tenacity.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years, all genders;
* Patients who will be treated plan to use injection pump for infusion treatment with nimodipine injection by infusion pump.
* Participated in this study voluntarily and signed informed consent form.

Exclusion Criteria:

* Patients have contraindication on Nimodipine.
* Patients allergic to polyethylene (PE) material;
* Patients with aspartate transaminase(AST) and alanine transaminase(ALT) are 2 times higher than normal range, Serum creatinine(Scr) is 1.5 times higher than normal range.
* Patient with malignant tumor, pregnant or Lactation;
* Patients had participated in other clinical trials within 1 month and in parallel with other trials;
* Patients are unsuitable to participate in this study as judged by the investigator.
Development of Assessments for Later Stage HD

Later Stage HD Assessments (LSA) is an observational, multinational study aiming at developing two assessments that can be used to measure critical milestones and events during the later stages of Huntington's disease (HD). An important aspect of the evaluation will be to assess whether the assessments can be administered to a companion either in-person or remotely (i.e. by phone contact with the companion). Therefore, these assessments will be evaluated for their internal consistency, reliability and validity. Once established, these assessments may be incorporated into a large scale, global observational study of HD and/or other HD clinical studies as well as use them for planning clinical trials.

The primary objective of this study is to evaluate the internal consistency, reliability and validity of two assessments: (1) UHDRS Structured Interview of Function (SIF) that incorporates the UHDRS Total Functional Capacity, Functional Assessment Scale, and Independence Scale (UHDRS TFC, FAS and IS), and (2) the HD Clinical Status Questionnaire (HDCSQ). There will be two study parts: Part 1 will measure the performance of the UHDRS SIF assessment compared to the original UHDRS TFC, FAS and IS using a cross-over design by collecting data from the Manifest HD gene expansion carrier participants (Manifest HDGEC Participants) and their companions (Companion Participants) via an in-person baseline visit and a follow-up visit by phone. Part 2 will assess the UHDRS SIF and the HDCSQ using a cross-sectional design by collecting data from the Companion Participants via a follow-up visit by phone. Participants of Part 1 are eligible to participate in Part 2.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet all the following inclusion criteria to participate in this study:

All Participants

1. Individual of either gender
2. Fluent in English
3. Must be willing and able to provide informed consent or have a legal representative willing and able to provide assent

Manifest HDGEC Participants

1. Must be an active participant in the Enroll-HD study. An active participant is defined as a participant who has successfully enrolled in the Enroll-HD study and completed the Enroll-HD study baseline visit.
2. Age≥20 years
3. CAG repeat length≥36
4. DCL=4
5. Inclusion score of 16 at the time of the participant's most recent Enroll-HD study visit (for inclusion score calculation, see Appendix A - Inclusion Score Calculation) Companion Participants

1. Age≥18 years 2. A person who, in his/her opinion, has sufficient interface and knowledge of the Manifest HDGEC Participant's capabilities and daily activities 3. Acceptable to the Manifest HDGEC Participant and the Site Investigator or the Site Investigator's designees

Exclusion Criteria:

People who meet the following criteria will be excluded from participating in this study:

1. Individuals with choreic movement disorders in the context of a laboratory verified non-expansion mutation for the Huntingtin gene
2. Manifest HDGEC Participants with Juvenile-onset HD (rater estimate of age of onset \<20 years old)
Systemic Inflammation in Liver Cirrhosis

Investigate systemic inflammation in liver cirrhosis patients


Eligibility Criteria:
Inclusion Criteria:

1. Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices;
2. Adult patients aged 18-75 years;
3. Willing to anticipate and informed consent form obtained

Exclusion Criteria:

1. History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy;
2. Non-sinusoidal cirrhosis (e.g. vascular cirrhosis);
3. Coexistence with advanced hepatocellular carcinoma or other malignancies;
4. Coexistence with severe systemic diseases and less than 3 months of expected survival time;
5. Acute infection within 4 weeks before recruitment;
6. Antibiotic use within 4 weeks before recruitment;
7. Initial antiviral therapy for HBV or HCV within 4 weeks before recruitment;
8. Pregnant or lactating women;
9. Patients resistant to long-term follow-up
Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA

Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper airway training in the treatment of OSA and screening suitable population for upper airway training: Design: A randomized double-blind controlled trial. SAS 9.3 statistical software (SAS Institute, Cary, North Carolina, USA) was used to generate a random number table, and the selected patients were randomly divided into experimental group 1, experimental group 2, and control group according to the ratio of 1:1:1 with 100 cases each.

Unit: Shenyang, China Participants: Consecutive specific OSA patients, who are potential candidates for the treatment of upper airway training (n=300), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologists and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI\<40 kg/m2).

Interventions: The three groups of subjects completed 7-day functional training and control training of upper airway muscles in different modes, respectively completed polysomnography, neck circumference, Berlin questionnaire and Epworth sleepiness scale before and after training, The genioglossus myoelectric activity was measured after transcranial magnetic stimulation and the excitability of the genioglossus cortex motor center was used to determine the efficacy of different training. After regression analysis, the factors affecting the efficacy of upper airway muscle group training were analyzed to screen the OSA patient population suitable for upper airway muscle group training.


Eligibility Criteria:
Inclusion Criteria:

* Recent diagnosis of OSA (AHI\>15 events/h) announced by a sleep recording
* Mean oxygen saturation \>90%
* Must be able to complete the training

Exclusion Criteria:

* Inability to tolerate overnight polysomnography in sleep lab
* \>50% of observed sleep apneas being central
* Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome
CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease

The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.

The primary purpose of this clinical trial is to evaluate the safety of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy
* Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
* Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
* Donor must be CMV sero-positive.
* Karnofsky performance status ≥ 70%.
* Subject and donor must be one of the following HLA types: HLA A\*0201, HLA-A\*0101, HLA-A\*2402, HLA-B\*0702, HLA-B\*0801, HLA-B\*35, HLA-DR\*1, or HLA-DR\*4.
* Availability of the stem cell donor to provide multiple PBMC samples for T-cell culture if needed. These samples could be obtained via a 90cc peripheral blood draw or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis if this is necessary.
* Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
* Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
* In order to receive their T cell infusions, subjects should be:
* At least 2 weeks from the time of their allogeneic stem cell transplant.
* Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1 week; all non major organ toxicities must have resolved to grade-2 or less.

Exclusion Criteria:

* Pregnant women and nursing mothers.
* Current or prior history of brain metastases.
* More than 12 months since their allogeneic stem cell re-infusion.
* HIV+, Hepatitis BsAg+, Hepatitis C Ab+
Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients

Background: In this proposed study, we aim to investigate safety and efficacy of two synthetic retinoids - bexarotene (Targretin; LGD1069; 4-\[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl\] benzoic acid) and fenretinide (Dihydroceramide N-(4-Hydroxyphenyl retinamide) on severity of psychopathology and cognitive impairment in schizophrenia patients in an double-blind, placebo-controlled study. The rationale behind add-on these medications to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis: the growth factors deficiency and synaptic destabilization hypothesis of schizophrenia. Furthermore, in our preliminary open clinical trial, we found that a low dose of bexarotene (Targretin, 75 mg/day) was safe and led to significant improvement on total PANSS scores, general psychopathology, on the positive and the dysphoric mood factor scores. The aim of the present study was to provide further insight into the safety and efficacy of bexarotene in comparison to fenretinide (a medication with smaller potential of adverse effects) and placebo in patients suffered from schizophrenia.

In this clinical trial, a minimal dose of bexarotene (Targretin, 75 mg/day) or fenretinide 5 mg/day or placebo will be added for 8 weeks to the stable ongoing antipsychotic treatment of 90 schizophrenia patients. Participants will be assessed at baseline and after 2, 4 and 8 weeks of treatment. A battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years, male or female
2. DSM-IV criteria for schizophrenia
3. Ability and willingness to sign informed consent for participation in the study
4. Stable blood parameters
5. Only patients who had a normal baseline fasting triglyceride

Exclusion criteria:

1. Lipid abnormalities.
2. Leukopenia or neutropenia.
3. Evidence of organic brain damage, mental retardation, alcohol or drug abuse
4. Renal disease
5. Hepatic dysfunction.
6. A history of pancreatitis.
7. Thyroid axis alterations
8. Suicide attempt in past year.
9. Cataracts.
10. High dose of vitamin A daily treatment.
11. Patients with a known hypersensitivity to bexarotene or other components of the product.
12. Pregnant women or a woman who intends to become pregnant.
Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis

Exercise therapy and increased physical activity in persons with Multiple Sclerosis (MS) improves mobility, muscular strength, physical fitness and fatigue without increasing relapse rate. As such, physical activity and more particular exercise therapy have become an important part of MS rehabilitation. Despite the fact that the positive effects of exercise therapy in MS are obvious only 43 percent of the MS community reports to participate in an exercise program4. Therefore, new exercise therapy approaches that further optimize rehabilitation, improve exercise adherence and promote participation in physical exercise in MS are interesting to explore. Therefore, the randomized controlled trial investigates two types of exercise interventions (classic progressive vs periodized) with or without the addition of ergogenic supplements (beta-alanine vs placebo).

Following inclusion, baseline measurements (PRE) will be performed in MS patients (n=80). First, static(isometric) muscle strength (dynamometry), exercise capacity (maximal graded exercise test) and body composition (DEXA) will be evaluated. After 4 days of recovery, m. vastus lateralis muscle samples (Bergström procedure) will be taken. Hereafter, MS patients will be randomly allocated to one of four intervention groups following either 12 weeks of 'classical' moderate intensity cardiovascular exercise therapy (n=40) or periodized exercise therapy (n=40), with (MSβclassic, n=20; MSβperiod, n=20) or without (MSclassic, n=20; MSperiod, n=20) β-alanine supplementation. Groups not receiving β-alanine supplements, will receive placebo tablets that will be identical in taste and appearance. To evaluate post training fatigue, perceived exertion will be recorded following each training session (6-20 BORG scale). Following 12 weeks of classic or periodized training POST intervention measurements will be performed similar to baseline.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis Multiple Sclerosis.
* Healthy control.
* Aged \>18y.
* Written informed consent.

Exclusion criteria:

* Contraindications to perform moderate to high intensity exercise.
* Participation in another study.
* Experienced acute MS related exacerbation \<6 months prior to start of the study
* EDSS score \> 6
P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices

Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.

Hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in \~40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. Individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. Satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.

Eligibility Criteria:
Inclusion Criteria:

* 50 - 79 years old.
* Mild or moderate hearing difficulty.
* Normal cognition.
* No prior hearing aid experience.
* Ability and willingness to pay privately ($650.00) for hearing aids
* Ability to read and understand English
* Symmetric hearing loss, no greater than moderate in degree

Exclusion Criteria:

-
Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia

In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.

Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* ASA status 1 - 3
* Colorectal laparoscopic surgery with piece removal
* French speaking
* Written informed consent

Exclusion Criteria:

* laparoscopy without colorectal extraction
* chronic pain
* analgesic consumption during the 24 hours previous to the surgery
* morphine and LA intolerance
* drug addiction
* inflammatory bowel disease
* general inflammatory disease
* sepsis
* anemia \< 10 gr/dl
* liver or renal or cardiac insufficiency
* uncontrolled diabetes
* preoperative consumption of opiate/corticosteroid/beta-blockers, and anti-arrhythmic drugs, MAOIs, neuroleptics.
* preoperative consumption of NSAIDs excluding aspirin referred cardiology
18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) and Grading Glioma

Role of 18F-FET PET for grading gliomas according to 2016 WHO classification: value of quantitative and qualitative data obtained by 18F-FET PET for differentiating low grade glioma (WHO II) versus high grade gliomas (WHO III and IV)

The management and prognosis of patients with glioma is highly dependent on the tumour grade according to the new 2016 classification of the World Health Organization (WHO), which incorporates molecular characteristics. Standard magnetic resonance imaging (MRI) enhanced by contrast is the basis of imaging primary brain tumours including gliomas. Nevertheless MRI specificity to type glioma is limited. Recently, positron emission tomography (PET) molecular imaging using radiolabeled amino acids or their analogues has been recommended by the Neuro-Oncology Response Assessment (RANO) working group for differential diagnosis of brain lesions, non-invasive classification of glial tumours, prognostic value, tumour delineation, stereotactic biopsy radiotherapy planification and treatments follow-up, to provide additional informations beyond MRI on biological processes such as cell proliferation, membrane biosynthesis, glucose consumption and absorption of amino acid analogues. Among the radiotracers used in PET, radiolabeled amino acids or their analogues are increasingly used in clinical routine for glioma imaging. Although most previous PET studies focused on brain gliomas used L-\[methyl- 11 C\] -methionine (11C-MET), the fluorinated amino acid analogue O - (2-\[ 18 F\] fluoroethyl) -L-tyrosine (18F-FET) appeared to be a favorable marker for clinical routine due to his longer half-life than Carbone 11. Recent european guidelines attempt to provide some guidance on the performance and interpretation of molecular imaging. The authors recommend a static (20-40 mn after injection (Pi)) or dynamic PET acquisition (40-50 mn from injection). A visual analysis can be completed by a quantitative analysis which consists to measure mean and maximal tumour activity uptake values (SUVmean and SUVmax) and their respective tumour to background ratios (TBRmean and TBRmax). Although the mean physiological brain activity uptake is well defined, the measurement of mean glioma activity uptake is less clear. Indeed, TBRmean depends on the delineation of the tumour ROI and/or VOI. Most often previously, VOI was determined by a 3D contouring process using a tumour-to-brain ratio of at least 1.6 at the beginning of the scan, threshold defined on a brain gliomas biopsy-controlled study. Moreover, Albert et al. emphasized the interest of early TBRmax.To our knowledge, none study evaluated others parameters as SUVmax, SUVmean and TBRmean in early period. In this context, the aim of this study was to compare quantitative and qualitative PET parameters between Low Grade Glioma and High Grade Glioma.

Eligibility Criteria:
Inclusion Criteria:

* glial tumor
* patient underwent 18F-FET PET at Brest University Hospital
* no opposite to participate

Exclusion Criteria:

* patient Under 18 years old
* opposite to participate