cyrilzakka/clinical-trials huggingface dataset:
Clinical Pilates Training for Persons With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic-progressive and neurodegenerative disease. Thus, exercise programs are needed to maintain and increase functional status of persons with MS (pwMS). Pilates exercises designed by physiotherapist can enhance participation and functionality in pwMS. The aim is to investigate the effects of a clinical Pilates training on balance, walking, fall risk, respiratory and cognitive functions in pwMS.

Forty-two pwMS will be included in this randomized controlled trial. Participants will be divided into two groups with stratified randomization. Pilates exercises group (n=21) will receive therapy once a week for 8 weeks plus home exercise programme. The home exercise program group (n = 21) will be given written exercises that matched the aims of the Pilates exercises and the program compliance will be monitored by telephone calls once a week. The assessments will be done twice at the beginning and at the end of the treatment. The outcome measures include the Timed 25-Foot Walk (T25FW), Six-Minute Walk Test (6MWT), Timed Up and Go (TUG), TUG cognitive and manual forms, 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Curl-Up Test (CUT), Falls Efficacy Scale-International (FES-I), Activities-specific Balance Confidence (ABC) Scale, respiratory muscle strength assessment, Brief International Cognitive Assessment for MS (BICAMS).


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of definite MS
* an age over than 18 years
* walking independently 100 meters
* willingness to participate in the study

Exclusion Criteria:

* any neurological disease other than multiple sclerosis
* relapse within 3 months
* having orthopaedic disorders that could negatively affect gait and balance
* having cardiopulmonary disorders
* diagnosed cognitive and psychiatric problems
* current and recent (within the last 6 months) participation in a core stability based exercise program
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas

Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study

Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks The patients will be observed and followed to determine whether there is regression of NHL after antiviral treatment. Conventional chemotherapy should be initiated shortly in cases without regression.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women
2. 18 to 70 years of age
3. Who had chronic HCV genotype 1b infection
4. An HCV RNA level of 105 IU per milliliter or higher
5. Being diagnosed to be low grade B cell non-Hodgkin lymphoma

Exclusion Criteria:

1. Patients with hepatitis B virus infection,
2. Other liver diseases
3. HIV infection,
4. Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N
5. Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.
Trichoscopy and Systemic Scleroderma

* Few data are available on scalp involvement in systemic scleroderma.
* Few data are available on the association between scalp abnormalities and features of systemic scleroderma
* Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice
* There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma

The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma


Eligibility Criteria:
Inclusion Criteria:

* Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria
* Signed informed consent
* Being social insured

Exclusion Criteria:

* Patients aged less than 18 years old
* patients under legal protection
* patients deprived of their liberty
* patients in emergency situations
* patients who refused or unable to give informed consent
* For the control group: sclap inflammatory disease active the day of the examination
The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study

Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are common in patients older than 65 years and cause a significant morbidity.

Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

Ulcers of the lower extremities, particularly in patients older than 65 years, are common among the population. Studies estimate the prevalence of current chronic leg ulcers at approximately 1%. The most common cause (approximately 80%) is thought to be chronic venous insufficiency disease. Recurrent cellulitis is an additional common cause. The ulcers cause a significant morbidity and negative impact on the patients' quality of life. The care of chronic vascular ulcers places a significant burden on the patient and the health care system. Additionally, these nonhealing ulcers place the patient at much higher risk for lower extremity amputation.

Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent obtained from the subject in accordance with the local regulations;
2. Male or female subjects, ≥18 to ≤90 years of age
3. Patient with venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8)
4. Chronic venous insufficiency or post-erysipelas ulcer
5. Ulcer size between 5 and 170 sq cm, inclusive
6. Ulcer present for at least one month
7. ankle-brachial index \>0.7

Exclusion Criteria:

1. Suffers from diabetes mellitus with HbA1c ≥ 8%
2. Albumin less than

2. 2. Patients with the following abnormal laboratory test levels hemoglobin \<10.5 g/dL platelet count \<100 x 109/L serum albumin level \< 2.5 g/dL 3. Suffers from clinically significant arterial disease 34. Has a known allergy to any of the compounds that are part of this protocol 45. Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone 56. Has used any investigational drug(s) within 30 days preceding randomization 67. Is unable to manage self-treatment 78. Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) 8. 9. Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data 9. 10. Unwilling or unable to comply with study requirements.
Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

The aim of this study is to evaluate the effect of adding Dexmedctomidinc as adjuvant to Bubivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy.

When compared to conventional surgery, laparoscopic cholecystectomy is less invasive and leads to less postoperative pain. However, the postoperative pain following laparoscopic cholecystectomy consists of both somatic and visceral components with pain originating from port entry' wounds, gallbladder resection and abdominal insufflation that leads to peritoneal distention and peritoneal damage.

Quadratus lamborum block (QLB) is abdominal truncal block that provides both somatic and visceral analgesia for both upper and lower abdominal surgical procedures, It was first introduced by Blanco.Currently There are 4 approaches described for QLB: lateral, posterior, anterior and intramuscular. Transmuscular (anterior) QLB Type 3 block involves injection in the plane between the psoas major (PM) and the QL muscles studies have reported spread of the injectate to the thoracic paravertebral space, as well as the spinal nerve which runs anterior to the QL muscle

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-65 years.
* Both genders.
* American society of Anesthesiology (ASA) class l, II undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patient refusal
* History of allergy to local anesthetic.
* Liver or renal pathology affecting drug elimination
* Menta!dysfunction or cognitive disorders.
* Patients on chronic pain medications.
* Body Mass Index \> 40 kg/m2.
* Coagulopathy
Retinal Biomarkers in Parkinson´s Disease

The goal of this observational study is to determine whether oxygen content of the retinal vessels of the eye may serve as a biomarker in Parkinson´s disease. The main questions it aims to answer are:

1. Is retinal vessel oxyhemoglobin saturation and vessel width altered in people with Parkinson´s disease?
2. Is the thickness of the retinal nerve fiber layer altered in people with Parkinson´s disease?
3. Is the response of ganglion cells of the inner retina and the visual cortex altered in people with Parkinson´s disease?

The study procedure is threefold. The participants will:

A. Sit in front of a screen and focus on a red dot of its middle. A simple recording electrodes are applied on the cornea, forehead and scalp for the electrophysiological measurements. Prior to this procedure a topical anesthetic gel is applied to numb the eye to prevent discomfort from placement of the corneal electrodes.

B. Undergo general eye examination and optical coherence tomography (OCT) to measure the retinal tissue thickness. Prior to eye examination,eye drops are applied into the eyes to enlarge the pupils C. Sit in front of a fundus camera for obtaining images of the retinal vessels to measure oxygen saturation and the vessel width

Researchers will compare the obtained measurements with age- and gender matching of healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Parkinson Disease

Exclusion Criteria:

* Eye disease
* Diabetic Mellitus
* Chronic Obstructive Pulmonary Disease (COPD)
* Other Neurological Disease
* Smoking on a daily basis
Movement Disorders Analysis Using a Deep Learning Approach

Bradykinesia is a key parkinsonian feature yet subjectively assessed by the MDS-UPDRS score, making reproducible measurements and follow-up challenging.

In a Movement Disorder Unit, the investigators acquired a large database of videos showing parkinsonian patients performing Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III protocols.

Using a Deep Learning approach on these videos, the investigators aimed to develop a tool to compute an objective score of bradykinesia from the three upper limb tests described in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Refusal of participation
Managing the Nutritional Needs of Older Filipino with Due Attention to Protein Nutrition and Functional Health Study

The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults.

The objective of the study is to determine the effects of nutrition supplementation and exercise intervention on the main indicators of sarcopenia in older adults such as body composition (fat mass and lean mass), muscle strength (leg and handgrip), and physical performance.

Eligibility Criteria:
Inclusion Criteria:

* Pre-sarcopenia/pre-frail
* Aged 60 years old and above, male or female
* Free-living in the community, ambulatory
* Able to respond to food recall/interview as self-declared
* Normal cardiac function as measured by resting ECG

Exclusion Criteria:

* Bed ridden, unable to perform exercise independently
* Presence of serious medical condition (i.e. cancer, existing fracture)
* Presence of unmanaged hypertension and/or type 2 diabetes or upon assessment of physician
* Renal Problem
* Under controlled or medically-supervised diet not flexible to include the intervention agent
* Allergic to any ingredients in the nutrition supplementation
In Vivo and in Vitro Anabolic Potential of Essential Amino Acids Following Resistance Exercise

This study seeks to investigate the anabolic potential of a dileucine-enriched essential amino acid (EAA) formulation compared with a branched chain amino acid (BCAA) alternative and a collagen beverage on muscle protein anabolism and catabolism following a bout of resistance exercise training. To do this, investigators will employ a novel 'breath test' method developed in our laboratory as well as blood and urine sampling. The results of this study will allow us to better understand the anabolic potential of dileucine which could have implications for people engaging in regular resistance training (such as athletes) as well as people that need to preserve muscle mass (older people who are susceptible to anabolic resistance and sarcopenia, or muscle wasting).


Eligibility Criteria:
Inclusion Criteria:

* Trained individuals currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months

Exclusion Criteria:

* Inability to perform physical activity as determined by the PAR-Q
* Inability to adhere to protocol guidelines (e.g., alcohol, habitual diet)
* Regular tobacco use
* Illicit drug use (e.g., growth hormone, testosterone, etc.)
* Diagnosed medical condition under the care of a physician (e.g. type 2 diabetes)
* Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc.) at least three weeks before the trial
* Individuals on any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
* Participants that are amenorrheic (females only)
* On medications that may interfere with protein metabolism (e.g. anti-inflammatory drugs, hormone therapy)
* Regular tobacco use (e.g. daily use of oral or inhaled tobacco)
* Illicit drug use (e.g. growth hormone, testosterone, etc.)
* Inability to comply with the study protocol as judged by the investigators
Mealtime Interactions and Risk of Toddler Obesity

The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Mother participated in clinical trial #NCT01545934
* Child 18-36 months old

Exclusion Criteria:

* Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).
A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Investigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.

Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (GA) secondary to macular degeneration. They will receive a single intravitreal injection of study drug (AVD-104) and will be followed for 3 months for safety observation. They will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations.

Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with geographic atrophy secondary to macular degeneration. Participants will be randomized to high dose AVD-104, low dose AVD-104, or active comparator (avacincaptad). The primary endpoint will be the difference in the rate of growth of the GA area as measured by fundus autofluorescence.

Eligibility Criteria:
Inclusion Criteria:

Part 1:

1. BCVA in the study eye using ETDRS Chart Visual Acuity Scale (VAS) of 5 to 55 letters (equivalent to Snellen VA of approximately 20/800 - 20/80)
2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA)
3. GA may be center involved.

Part 2:

1. BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better)
2. Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA in 50% of participants. Center involvement allowed in 50% of participants.
3. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Part 1 and 2

- Presence of the following ocular conditions - in the Study Eye:

1. Exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (SD-OCT) imaging and/or fluorescein angiography as assessed by the Reading Center.
2. Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
Radiomics-based Prediction Model of Tumor Spread Through Air Space in Lung Adenocarcinoma

Spread through air space (STAS) has been reported as a negative prognostic factor in patients with lung cancer undergone sublobar resection. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics has been recently proposed to predict STAS in patients with lung adenocarcinoma. However, all the studies have strictly selected both imaging and patients, leading to results hardly applicable to daily clinical practice. The aim of this study is to test a radiomics-based prediction model of STAS in practice-based dataset and verify its validity and translational potentials.

Radiological and clinical data from 100 consecutive patients with resected lung adenocarcinoma were retrospectively collected for the training section. As in common clinical practice, preoperative CT images were acquired independently by different physicians and from different hospitals. Therefore, our dataset presents high variance in model and manufacture of scanner, acquisition and reconstruction protocol, endovenous contrast phase and pixel size. To test the effect of normalization in highly varying data, preoperative CT images and tumor region of interest were preprocessed with four different pipelines. Features were extracted using pyradiomics and selected considering both separation power and robustness within pipelines. After that, a radiomics-based prediction model of STAS were created using the most significant associated features. This model were than validated in a group of 50 patients prospectively enrolled as external validation group to test its efficacy in STAS prediction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected or cito-histologically proven lung adenocarcinoma undergoing lung cancer surgery;
* Available preoperative CT images
* Age older than 18 years

Exclusion Criteria:

* Chest wall infiltration
* Induction radio or chemotherapy
* Incomplete surgical resection
Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer

Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131 administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is to perform intramuscular injection of recombinant human TSH, a hormone produced pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the metastases is similar after rhTSH administration or after thyroid hormone withdrawal.

Patients will undergo a rhTSH stimulation, staying on thyroid hormone treatment. Following 2 administration of rhTSH an injection of I-124 will be performed. Positron emission tomography with computed tomography scans (PET/CT), blood tests, and measurements of whole body radioactivity will occurred during the 4 to 96 hours following I-124 administration in order to perform dosimetry (i.e.) to estimate the radiation dose delivered to the metastases. After 4 weeks under thyroid hormones patients will undergo thyroid hormone withdrawal and a new administration of I-124 will be performed. The same dosimetry study will be realized with PET/CT, blood tests, and measurements of whole body radioactivity. A therapeutic activity of I-131will then be administered followed by whole body scan realized 24 to 72 hours after the administration of I-131. Dosimetry studies will be compared in order to determine whether rhTSH stimulation can replace thyroid hormone withdrawal for the treatment of distant metastases.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with thyroid cancer and known measurable (\>1cm) distant metastases demonstrating radioiodine uptake on a previous whole body scan
2. Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal
3. Age \>18 years
4. Previous treatment with radioiodine more than 6 months before inclusion.
5. Serum TSH level \<0.5 mU/L
6. Normal renal function with a creatinine clearance estimation using the Cockcroft-Gault formula \> 60 ml/ml
7. Effective means of contraception for female patient, at risk of pregnancy
8. Written informed consent

Exclusion Criteria:

1. Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake
2. Iodine excess (\< 50 μg/dl)
3. Large or diffuse bone or brain metastases
4. Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs
5. Patients already included in a therapeutic trial with an experimental medicine
6. Pregnancy and breast feeding patients
7. Subject with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
8. Treatment with antivitamin k