cyrilzakka/clinical-trials huggingface dataset:
Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound

The test subjects were selected from patients with clinical manifestations in muscle tone and healthy volunteers. Elbow flexor is the main target muscle. Fifty patients and 50 healthy subjects were given three assessment methods to measure muscle tension: modified Ashworth rating scale, elastic ultrasound technology and surface electromyography, and the data obtained by these three methods will be statistically analyzed and discussed.


Eligibility Criteria:
Inclusion Criteria:

* There are clinical manifestations of changes in muscle tension of the elbow flexor group;
* Subject's diagnosis is clear;
* The degree of joint mobility meets the method of muscle tension assessment.

Exclusion Criteria:

* Has serious diseases such as heart, lung, liver, kidney, etc., cardiac function grade is greater than Grade I (NYHA), has symptoms and signs or examination results such as respiratory failure;
* History of muscle disorders;
* Recent (within 6 months) history of external injury, fracture or surgery of the limb;
* Are using drugs that affect muscle tone;
* Severe osteoporosis;
* Acute phase of inflammation
* Acute limb thrombosis of the subject;
* Pregnancy.
Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

Prospective randomized controlled study, primary objective: Pain reduction in patients with chronic Sacroiliac joint pain after therapy either with Peripheral Nerve Stimulation or with best medical treatment.

Randomization 4:3 to operative (PNS=Peripheral Nerve Stimulation) arm or conservative (BMT= Best Medical Treatment) arm with crossover possibility for the BMT group after 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old
* Subject with chronic sacroiliac joint pain refractory to conservative treatment
* Subject with NRS of at least 60/100
* Subject with temporary pain reduction of at least 50% (NRS) after fluoroscopy guided SIJ infiltration
* Subject received conservative treatment for at least three months including physiotherapy and pain medication
* Subject is able to understand the study and Impulse generator programming

Exclusion Criteria:

* Pregnancy
* Subject is under age
* Acute traumatic injury of the ISG
* Active inflammation or neoplastic infiltration of the SIJ
* Neoplastic diseases of the spine
* Spinal surgery within the last three months
* The SIJ pain is not the leading symptom
* Contraindication for Neuromodulation Device (severe psychiatric disease, severe coagulation disorder, acute infection, active autoimmune disease with immunosupression)
Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland

The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.

This is a post-market, multi-centre, prospective, interventional single arm study in Finland.

Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance.

HbA1c will be tested at the start and end of the study for primary endpoint analysis.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 to ≤ 75 years.
* Type 2 diabetes diagnosis ≥1 year prior to enrolment.
* Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment.
* Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment.
* Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.

Exclusion Criteria:

* Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
* Currently participating in another study that could affect glucose measurements or glucose management.
* Currently receiving dialysis treatment or receives dialysis during the study.
* A female participant who is pregnant.
* A breastfeeding female participant.
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.

REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.

In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.

Eligibility Criteria:
Inclusion Criteria:

* Women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains,
* Age between 40 and 70 years
* Adjuvant Radiotherapy is helical tomotherapy performed at Institut Claudius Regaud(Toulouse, France)

Exclusion Criteria:

* Indication of adjuvant chemotherapy
* Clinically or radiologically detectable metastasis
* Personal history of coronary artery or myocardial disease
* Personal history of breast cancer or other cancer requiring radiotherapy to the chest
* Contraindications to injection of iodinated contrast ( for CT ) : pregnancy , renal failure, allergy.
* Pregnancy, lactation
* Before radiotherapy, LVEF \<50%
* Before radiotherapy, longitudinal strain \> - 16 %
* Before radiotherapy,longitudinal strain rate \<1% / s
* Before radiotherapy, segmental wall motion abnormality
* Coronary CT before radiotherapy showing that a therapeutic treatment is required
Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer

* To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer
* The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level

-Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 proved effective and safe for the treatment of advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years.
* documented gastric adenocarcinoma via histological or cytological examinations;
* newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;
* no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -
* an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* an expected survival time of at least 3 months;
* and provision of informed consent by patients prior to commencement of the study.

Exclusion Criteria:

* a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;
* surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;
* severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy
* a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;
* women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 New York Heart Association (NYHA) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection
* epileptic patients requiring medical treatment (such as corticosteroids or antiepileptic drugs);
* patients who had received immunotherapy within 4 weeks prior to or throughout the study or had received mitomycin C or nitrourea drugs within 4 weeks previously;
* allergies or possible allergies to the study medications or other drugs administered during the study;
* any patient safety or compliance issues that might jeopardize their participation in the study;
* an inability to swallow oral drugs.
Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control

The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. The main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.


Eligibility Criteria:
Inclusion Criteria:

written informed consent prior to participation

for participants with intact CNS:

• no previous neurological or musculoskeletal disorders

for participants with spinal cord injury:

* Spinal cord injury due to trauma
* ≥ 12 months post-spinal cord injury
* complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)
* neurological level of spinal cord injury: C3-T10
* preserved tendon and cutaneo-muscular reflexes in the lower limbs

Exclusion Criteria:

* other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
* active implants (e.g., cardiac pacemaker, drug pump)
* passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)
* active infections or diseases, pressure sores
* dermatological issues at the stimulation site
* malignant diseases
* heart insufficiency (NYHA III-IV)
* potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)
Angiographic and Intravascular Ultrasound (IVUS) Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals

The purpose of this study is to investigate if there is any different follow-up results by angiography and IVUS between two different drug-eluting stents after implanted simultaneously in same individuals.


Eligibility Criteria:
Inclusion Criteria:

* These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.

Exclusion Criteria:

* Dual anti-platelet therapy less than 12 months.
Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11

The aims of the study are to investigate the physiological responses associated with deqi during stimulation of the LI11 and LI4 acupuncture points and the correlation between the intensity of the deqi sensation to such responses.


Eligibility Criteria:
Inclusion Criteria:

1. Normal healthy subjects who were naïve to acupuncture
2. Able to read Chinese and no communication barrier

Exclusion Criteria:

1. Subjects with medical disorders, including neurological and psychologic disorder
2. Use of medications that may affect the cardiovascular system within one week
3. Subjects with painful or uncomfortable sensations of upper and lower limbs
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus

This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus erythematosus for \> 16 weeks prior to screening and consistent histological findings on skin biopsy based on Gilliam classification who are candidates for systemic therapies (as determined by the Investigator)
* Must, in the opinion of the Investigator, have active skin lesions of sufficient severity at Screening and Baseline (a Cutaneous Lupus Area and Severity Index Activity Score of ≥ 10)
* All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of an ophthalmologic exam performed within 24 weeks of the Baseline Visit.
* Must meet the following laboratory criteria:

  * White blood cell count ≥3000/mm3 (≥ 3.0 x 109/L) and \< 14,000/mm3 (\< 14 x 109/L)
  * Absolute neutrophil count (ANC) \> 1500 cells/μL (1.5 x 109/L)
  * Platelet count ≥ 100,000/μL (≥ 100 x 109/L)
  * Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
  * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT)
  * ≤ 1.5 X upper limit of normal (ULN)
  * Total bilirubin \< 2mg/dL
  * Hemoglobin \> 11 g/dL Key Exclusion Criteria
* Participation in multiple CC-11050 cohorts or previous exposure to CC-11050
* Presence or history of SLE based on investigators' clinical evaluation where subject exhibits medically significant (as determined by the Investigator) LE-related pleuritis, pericarditis, neurologic, renal and/or other major SLE-related organ system involvement(SLE-related to SLE joint involvement is acceptable).
* Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
* Use of concomitant disease modifying anti-rheumatic drugs (DMARDs) with the exception of anti-malarials within 4 weeks of screening- Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
* Use of immunosuppressives (eg, azathioprine, mycophenolate mofetil, methotrexate, etc.) within 4 weeks of screening
68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer

The goal of this observational study is to learn whether 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. The main question it aims to answer is:

Could 68Ga-FAPI PET/CT effectively evaluate axillary lymph node after neoadjuvant treatment for breast cancer? Participants will have a 68Ga-FAPI PET/CT test between last neoadjuvant therapy and surgery.

Previous studies have shown that compared with conventional 18F-FDG PET/CT, 68Ga-FAPI PET/CT has the characteristics of not being affected by blood glucose, good tumor specificity, and high tumor-to-background ratio, and studies have shown that 68Ga- FAPI PET/CT can detect parts of breast cancer primary lesions and lymph node metastases with low 18F-FDG uptake, thereby increasing the lesion detection rate and improving the sensitivity of imaging examinations. Therefore, 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. Therefore, we plan to conduct this study to explore the ability of 68Ga-FAPI PET/CT to detect residual disease in axillary lymph nodes in patients with clinically positive axillary node (cN+) breast cancer after neoadjuvant treatment. By this way, we may explore an accurate and non-invasive assessment of axillary lymph node status after neoadjuvant therapy in breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18 and above
* ECOG score 0-2 points
* Pathological confirmation of malignant breast tumor
* Clinical axillary lymph node positivity (cN+)
* Completed at least 3 courses of neoadjuvant therapy and subjected to undergo surgical treatment
* Informed consent form signed

Exclusion Criteria:

* Distant metastasis
* Unable to complete the proposed neoadjuvant therapy plan
* Pregnancy
Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.

Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment.

The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnostic of idiopathic Parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa.
* At least 3 months of treatment continued of levodopa.
* Patients that give the their consent to participate in the study.

Exclusion Criteria:

* Patients with diagnostic of idiopathic Parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa.
* Patients with allergic predisposition to Plantago ovata husk or other contraindications for its use.
Early Detection of COVID-19 Using Breath Analysis

EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY

Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55 years at the time of consent
* Positive results for SARS-CoV-2
* Capable of understanding written and/or spoken language
* Able to provide informed consent

Exclusion Criteria:

* Age under 18 years old
* (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure, or claustrophobia when wearing the sampling mask
* Persons under guardianship or deprived of liberty
* Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
* Pregnant women
* Treated with antiviral drugs upon admission or during hospitalization
* Novices and soldiers in initial training
Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients

This is an open label study to evaluate the safety and efficacy of β-globin Restored Autologous Hematopoietic Stem Cells in ß-Thalassemia Major Patients

We will recruit ß-thalassaemia major patients and collect their autologous hematopoietic stem cells, which will be modified with the LentiHBBT87Q system to restore β-globin expression. After conditioning, the autologous hematopoietic stem cells with restored β-globin will be reinfused to the patients and followed up for two years to collect data.

Eligibility Criteria:
Inclusion Criteria:

* 8-16 years old. Subject and/or subject's legal guardian fully understand and voluntarily sign informed consent;
* Clinically diagnosed as transfusion-dependent β-thalassemia major;
* With sufficient RBC infusion, subjects must maintain hemoglobin ≥9g/dL, serum ferritin threshold ≤ 3000 ng/mL and the liver iron overload mild or absent for at least 3 months before mobilization of hematopoietic stem cell;
* Follow the arrangements for treatment and regular medical checks within two years post-transplantation

Exclusion Criteria:

* The physical condition does not meet the requirements for hematopoietic stem cell mobilization and transplantation myeloablation;
* Received gene therapy and allogeneic HSCT in the past.
* Have an available HLA matched donor.
* Enrolling in another clinical trial.
* Other unsuitable conditions identified by doctors.
Dead Space Evaluation in Pulmonary Hypertension

Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two components, alveolar and dead space ventilation.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 and ≤ 80 years
* ability to understand the research protocol and willing to sign the study informed consent
* diagnosis of pulmonary arterial hypertension belonging to Class I and IV
* stable haemodynamic status and optimized medical treatment since at least 2 months
* ability to perform maximal cardiopulmonary exercise test and pulmonary diffusing capacity for carbon monoxide evaluation

Exclusion Criteria:

* relevant comorbidities
* usual contraindications for cardiopulmonary exercise test
* pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.
Absorption and Muscle-stimulating Effect of Hydrolyzed and Minced Beef

To measure the absorption kinetics and postprandial amino acid availability after ingestion of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle protein synthesis and the postprandial muscle protein synthetic response to minced beef and hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein synthetic response is measured and compared during the early postprandial period (0-3 hours) after ingestion of the two meat products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-obese (BMI\<30)

Exclusion Criteria:

* Chronic medical disease
* \>5 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation