cyrilzakka/clinical-trials huggingface dataset:
The Effect of Feldenkrais Lessons on Walking and Balance

The purpose of this study is to investigate the effects of a series of Feldenkrais movement lessons on mobility and balance, particularly for older adults. The investigators hypothesise that mobility and balance will improve following the classes.

The Feldenkrais Method is an educational process which involves exploration of novel movement sequences that lead to expansion of the movement repertoire. This Method has been used with the aim of improving balance and mobility in several studies, and has been compared to the benefits of Tai Chi for improving balance in older adults. The current study investigates the effects of a 10 week series of Feldenkrais movement classes on gait parameters as measured on an instrumented gait mat, a balance test of stepping and turning (the Four Square Step Test) and a questionnaire about balance confidence (the Activites Specific Balance Confidence scale.

Eligibility Criteria:
Inclusion Criteria:

* community dwelling older adults (aged over 65)
* able to independently ambulate indoors and outdoors

Exclusion Criteria:

* currently undergoing physiotherapy treatment
* unable to comprehend written english
* unable to give informed consent
* walking with a walking frame indoors
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study

Although serum alpha-fetoprotein level and abdominal sonography are the main methods to screening hepatocellular carcinoma (HCC) in cirrhotic patients, the adequate time and methods used are not completely well-defined. This study aims to assess the better timing and methods for prospectively screening HCC in patients with cirrhosis

Well-diagnosed consecutive patients with cirrhosis were enrolled through a designed questionnaire to obtain basic information about gender, age, etiology of cirrhosis, conventional liver function tests, serum AFP level, education level, substance use including smoking, alcohol drinking, betel quid chewing, history of familial HCC, etc. Then the patients was followed by periodic abdominal sonography examination and determination of AFP and liver function. If AFP elevated or liver nodule appears, effort to diagnose HCC will be performed.If HCC was performed, the survival will be followed-up. As anti-viral therapy was found to decrease risk for HCC, patients with those therapy will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Image diagnosis or biochemical diagnosis or presence of portal hypertension

Exclusion Criteria:

* Presence of hepatocellular carcinoma
Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft

The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.


Eligibility Criteria:
Inclusion Criteria:

* single rooted tooth requiring extraction with future dental implant placement

Exclusion Criteria:

* smoking \> 10 cigarettes per day poorly controlled diabetes
Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears

This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the long-term safety and performance of EARFOLD® Implantable Clip System.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have ear prominence and/or have significant asymmetry

Exclusion Criteria:

* Subjects planning to use EARFOLD® in conjunction with other procedures (e.g. cartilage scoring, conchal reduction or concho-mastoid sutures) for correction of prominent ears are excluded
* Patients with impaired healing (e.g., current smokers, diabetic patients, patients with autoimmune disorders such as Ehlers-Danlos Syndrome or Scleroderma)
* Patients with an active infection, local or systemic
* Patients with known nickel or gold allergies.
Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study

Helen Keller International (HKI), the ministry of health and population, and ministry of agriculture and cooperatives, of Nepal and local non-governmental organizations (NGO) partners are currently implementing a USAID funded Action Against Malnutrition Through Agriculture (AAMA) project in Baitadi district located in far Western development region of Nepal. HKI is undertaking this study within the AAMA project to test whether providing micro-nutrient powders (MNPs) in a programmatic context along with homestead food production (HFP) and an intensive community level Infant and Young Child Feeding Behavior change communication (IYCF-BCC) intervention will have a greater impact on reducing anemia and improving growth in young children than only providing the HFP and IYCF-BCC intervention without MNPs or a control with no intervention.

The AAMA project uses the homestead food production (HFP) model that focuses on increasing households year round access to nutritious food as a platform to deliver a proven essential nutrition actions (ENA) related messages to household with children less than 2 years old. The AAMA project seeks to examine the effects of household level HFP on malnutrition. So the recipient and other partners wishes to undertake a study to explore a plausible delivery mechanism for MNPs along with HFP and intensive community level IYCF-BCC and their impact on infant/child growth and anemia.

The study is a cluster randomized controlled trial with a three arm factorial design. The trial involve 330 randomly selected children aged 6-9 months at the time of enrollment (n=110 per each of the three study arms). MNPs distributed through FCHVs to 110 children selected from communities that already have the HFP and IYCF-BCC intervention. This group of children will be compared on outcome parameters for anemia, growth (stunting, underweight and wasting) and infections (diarrhea, fever and cough) to a similar sub-set of children (n=110) who receive only the HFP and IYCF-BCC intervention and to a third sub-set of control children of similar age (n=110) who are not receiving either of these interventions. Children aged 6-9 months were chosen for the study because this age range captures the recommended age for introduction of complementary foods to children and our chosen age group also falls within the 0-24 month age range which is considered the period of rapid growth and development and therefore period of highest nutrient requirements in children.

Eligibility Criteria:
Inclusion Criteria:

* Children 6-9 months of age during enrollment time
* Mothers who want to enroll their children in study

Exclusion Criteria:

* Severe anemia
* Children age below six months and age over 23 months during study time
Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC

The purpose of this study is to observe and evaluate the efficacy and safety of A sintilimab plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Aged 18-75 years
3. Histologically confirmed esophageal squamous cell carcinoma
4. Clinical stages T3-4N0M0 or TxN1M0 or TxNxM1a or TxNxM1b (Only for cervical lymph nodes or celiac lymph nodes metastasis) based on the 6th UICC-TNM classification

7. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN

Exclusion Criteria:

1. Esophageal perforation or hematemesis
2. Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
3. Previously received or receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
4. Allergic to macromolecular protein preparations, or to any of the ingredients in sintilimab for injection.
5. Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
6. Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
7. Active infection or unexplained fever \>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
8. Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
9. According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.
Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI

This randomized clinical trial (RCT) is evaluating the usefulness of combining MyoMo robotic orthosis with visual and haptic feedback in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with acute SCI.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-80
* Be able to activate the muscles of my upper arm and forearm with enough strength as determined by the therapist.
* Be diagnosed with a spinal cord injury (iSCI (ASIA Impairment Scale (AIS) C and D) and be less than 3 months post initial injury at the start of the study
* Be medically stable
* Be able to follow study directions and communicate in English as determined by the study staff
* Continue to take all prescribed medication (example: baclofen: oral or via pump) without any major dosing changes
* Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue
* Have full passive range of motion at my elbow, as determined by study staff

Exclusion Criteria:

* Be younger than 18 years old or older than 80
* Have excessive pain in my arm or hand that would limit my participation in rehabilitation
* Have excessive spasticity in my elbow or wrist joints as determined by study staff
* Be participating in any experimental rehabilitation or drug studies
* Have a history of neurologic disorder other than spinal cord injury
* Have other conditions that would prevent safe and/or effective participation using the study device. Examples of these conditions include: severe sensory deficits, skin conditions, joint contractures, etc.
* Have difficulty following multiple step directions
* Have severe psychiatric problems or difficulty thinking clearly that would prevent me from participating in this study
* Have skin issues that would prevent wearing the Myo-Pro device
* Have had history of recurrent epilepsy, seizure or convulsion
* Have a past or current history of treated ringing in the ears known as tinnitus or severe hearing problems.
* Be taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. Study staff and physician will review my medications to see if I am taking any of these drugs. If I am taking one of these drugs, I will not be enrolled in this study.
* Because of potential risk to the fetus, women of child-bearing potential will be required to have a pregnancy test before they can enroll in this study. If I am female, and have a positive pregnancy test, I will not be enrolled.
Identification in Obese Patients of the Mechanism Involved in Intramuscular Lipid Accumulation

The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.

Obese insulin sensitive and obese insulin resistant patients undergo a glucose tolerance test, indirect calorimetry during exercise and muscular biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients with a Body Mass Index (BMI) between 30 and 40 kg/m2
* Patients who do not practice physical exercise (Voorips index \< 9)
* Age between 40 and 70 years- Male gender
* Fast blood glucose \<1,10 g/l and no hypoglycemic treatment
* Signed informed consent
* Social security affiliation
* Absence of anti VIH, anti hepatitis C antibodies, and HBS antigen
* Normal biological tests
* Non smoking persons

Exclusion Criteria:

* Patients who refuse the anti-VIH, anti-hepatitis C antibodies, and HBS antigens tests
* Patients treated by anticoagulant, b blockers, lipopenic, or anti-inflammatory.
* Patients with a contraindication to muscular exercise (retinopathy, coronaropathy, nephropathy) and to muscular biopsy
* Allergy to local anaesthetic
68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a heterogeneous group of neoplasms that arise from the endocrine cells of the gastroenteropancreatic tract.

The diagnostic work-up of these tumours include Computed Tomography (CT), Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI).

The majority of these tumours express somatostatin receptors on their surface. For this reason, in addition to traditional imaging exams, diagnostic work-up of GEP-NETs should include a Positron Emission Tomography/CT with 68Ga labeled somatostatin analogues targeting somatostatin receptors with high sensitivity and specificity. 68Ga-DOTATOC PET/CT scan is a corner stone to assess GEP- NET patients at different stage of disease and it is the standard functional imaging modality to study well-differentiated Pan-NETs, as reported in the being also included in the guidelines of the European Association of Nuclear Medicine (EANM). Moreover, quantitative parameters extracted from 68Ga- DOTA-peptides PET imaging have demonstrated their prognostic utility as markers for progression-free survival and disease specific mortality in patients affected by NET.

Additionally, 18F-FDG PET can be used for evaluating the possible presence ofa high-grade component within the tumour itself. The accurate morphofunctional characterization is of utmost importance in the field of GEP-NET.

the advent of new hybrid scanners, namely PET/MRI, opens the way to an innovative diagnostic work- up that can be applied to GEP-NETs. In fact, MRI plays a role as morphological imaging modalities for a better characterization of soft-tissue and liver parenchyma compared to CT; moreover, the low radiation exposure related to MRI, makes this imaging modality more suitable for patients requiring several imaging during follow-up.

Patients requiring 68Ga-DOTA peptides (68Ga-DOTATOC) PET scan and eventually MRI scan, can be studied in a single session examination, by using 68Ga-DOTATOC PET/MRI.

Considering the rarity of GEP_NETs, it is quite difficult to collect a sufficient number of patients in order to investigate the accuracy, predictive and prognostic value of the currently available imaging technique in this scenario. Based on these considerations, the possibility to analyze PET images deriving from both PET/CT and PET/MRI scans of patients affected by GEP-NET is of fundamental relevance in order to provide answers to the currently unmet clinical needs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with either histological diagnosis of GEP-NET at radiologic imaging and referred to 68Ga-DOTATOC PET;
* Age \> 18 years old;
* Willing to provide a signed informed consent.

Exclusion Criteria:

* Controindications to MR study (i.e. Pacemaker);
* Age\< 18 years old.
A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression

This study is a retrospective database study in Japan to evaluate the relative risk of serious intracranial hemorrhage requiring hospitalization between Vortioxetine tablet treatment and selective serotonin reuptake inhibitor (SSRI) treatment for patients with depression. This survey will conduct in use of medical database called JMDC claims database.


Eligibility Criteria:
Inclusion Criteria:

1. Has diagnosis of depression and prescription of Vortioxetine tablet or SSRI within the enrollment period (Index Date: first prescription date within the enrollment period).
2. Participants can be observed for the past 6 months (180 days) (Look back period) from the day before the Index Date.
3. Had not prescription of Vortioxetine tablet or SSRI in the Look back period.

Exclusion Criteria:

1. Has diagnosis of intracranial hemorrhage during the look back period.
2. Has been taken Vortioxetine tablet in combination with SSRI on the index date.
Impacts of Warning Labels on Ultra-Processed Foods

Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).

Participants: \~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.

Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned.

On the study platform (Qualtrics), participants will be randomly assigned to 1 of 3 arms with equal probability: a UPF health warning label, a UPF identity label, or a barcode control label. Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) displayed in random order, each with a label displayed on the front of package according to the participants' study arm. Participants will complete a 13-item online survey to assess each product as to a) whether the product is ultra-processed; b) perceptions of healthfulness; c) intentions to purchase the product.

Eligibility Criteria:
Inclusion Criteria:

* Identifying as Latino or Hispanic
* Ages 18-55 years old
* Currently resides in the United States

Exclusion Criteria:

* Not identifying as Latino or Hispanic
* Less than 18 or greater than 55 years old
* Not residing in the United States
Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma

The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate, lomustine, and procarbazine\] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\] in patients \> 65 years.


Eligibility Criteria:
Inclusion Criteria:

* first diagnosis of PCNSL, histologically confirmed
* age \> 65 years
* written signed and dated informed consent of the legal representative and - if possible - of the patient

Exclusion Criteria:

* manifestations of further lymphoma outside the CNS
* sero-positive for HIV
* severe pulmonary, cardiac, hepatic, renal impairment
* uncontrolled infection
* neutrophil count \< 1.500/µl, platelet count \< 100.000/µl
* pulmonary disease with IVC \< 55%, DLCO \< 40%
* cardiac ejection fraction \< 50%, uncontrolled malign arrhythmia
* creatinine \> 1,5 mg% or creatinine-clearance \< 50ml/min
* bilirubin \> 2mg/dl
* ascites or pleural effusion (\> 500ml)
* known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
* participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
* known or current drug or alcohol abuse
Microwave Coagulation Using CROMA Electrosurgical System

This is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK.

The study will recruit 30 patients undergoing endoscopic resection of complex colorectal polyps and be used to demonstrate safety and performance of the CROMA Electrosurgical System microwave coagulation modality. Study data will complement existing data to support a CE marking application for the CROMA Electrosurgical System (combined RF and microwave modalities).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age;
* After standard clinical work-up a benign appearing lower bowel lesion \>2cm in diameter;
* Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

* Aged \<18 years of age;
* Pregnant or lactating females;
* Lower bowel lesions \<2cm in diameter;
* Patients receiving regular systemic steroids;
* Patients who are immuno-compromised (either acquired or congenital);
* Patients with a known coagulopathy (either acquired or congenital);
* Patients on anti-platelet therapy at the time of the procedure, apart from low dose (75mg) aspirin alone;
* Concurrent participation in another experimental intervention or drug study;
* Unwilling or unable to provide informed consent.
Evaluate the Efficacy and Safety of DHA in the Adjuvant Treatment of Children With ASD.

In the etiopathogenesis of autistic spectrum disorder (ASD) several hypotheses have been described that include inflammation, metabolic alterations, activation of oxidative stress, changes in the intestinal microbiota and in the elimination capacity of heavy metals. Adjuvant therapies with omega-3 polyunsaturated fatty acids could modify these alterations.

Several hypotheses have been described in the etiopathogenesis and evolution of ASD, among which is that there is greater oxidative stress associated with a proinflammatory state, or even metabolic alterations after exposure to heavy metals, as well as differences in intestinal microbiota. This situation could negatively influence the correct establishment of neuronal synapses and their functioning, which have still been poorly investigated, especially in children. In this way, an early intervention with nutritional supplements with DHA, which could be deficient in autism, could decrease the proinflammatory and oxidative stress state, favoring the formation of neuronal synapses as well as their activity. This intervention could positively influence to prevent the clinical deterioration associated with ASD and it would be of special interest in early childhood since at this stage of neurodevelopment there is maximum neuronal plasticity.

Eligibility Criteria:
Inclusion Criteria:

* Children and girls aged between 2 and 5 years diagnosed with Autism Spectrum Disorder according to the DSM-V criteria and the Observation Scale for the Diagnosis of Autism (ADOS).
* Informed consent signed by one of the parents or legal representative.

Exclusion Criteria:

* Children under 2 years old.
* Children diagnosed with ASD over 4 years old.
* Coexistence of another diagnosis associated with autism.
* Patients who are receiving some type of supplement or concomitant medication that does not allow a period of washing.
* Patients diagnosed with other pathologies or with mediation that may affect the study variables (oxidative stress, inflammation, cell adhesion molecules, lipid profile or microbiota).