cyrilzakka/clinical-trials huggingface dataset:
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)

ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.


Eligibility Criteria:
Inclusion Criteria:

* Complete cervical (C7-8) or thoracic (T1-T12) spinal cord injury according to American Spinal Injury Association (ASIA) guidelines
* Male and non-pregnant non-lactating female Age 18-55
* At least 6 months after injury
* Regular use of RGO (Reciprocating Gait Orthosis) or KAFO's (Knee Ankle Foot Orthoses) or able to stand using a standing device (e.g., 'Easy stand')
* Patients must be capable of providing informed consent
* Height of 160 to 190 cm
* Weight of \<100 kg

Exclusion Criteria:

* History of severe neurological injuries other than SCI (Spinal Cord Injuries)(MS (Multiple Sclerosis), CP (Cerebral Palsy), ALS (Amyotrophic Lateral Sclerosis) , TBI (Traumatic Brain Injury) etc)
* Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
* Severe spasticity (Ashworth 4) or uncontrolled clonus
* Unstable spine or unhealed limbs or pelvic fractures
* Heterotopic ossification
* Significant contractures
* Psychiatric or cognitive situations that may interfere with the trial
A Study of a Multi-Modal Sensor Patch for Real-Time Physiological Monitoring and Inference

The purpose of this research is to validate the prototype AI-Flex device. Researchers at Mayo Clinic developed a new a flexible multi-modal bio-sensing device, AI-Flex, with integrated artificial intelligence (AI) capability. Integration of sensing and AI analysis on the same device removes the need for data storage on the cloud for later analysis. The goal of the device is to allow real-time monitoring of patient health and timely intervention based on patient health condition. It is hoped that the proposed flexible device will allow intimate skin contact using ultra-thin (\<10 µm) geometry to reduce or eliminate relative movement between the skin and flexible epidermal sensors even during rapid motion of the subject, which would significantly improve the sensor signal quality for AI analysis.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be referred for Cardiology Clinic Visit.
* Subject must have underlying cardiac structural disease or condition to increase yield of clinically significant transmission
* Subject must be 18 - 85 years of age.

Exclusion Criteria:

- \< 18 years of age or \> 85 years of age.
The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development

To investigate the efficacy of prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the second cesarean section.

120 patients who are admitted for the second cesarean delivery, not taking prophylactic medication after the first cesarean section, whose scar development and measurements are taken will be included in the study. First caesarean section scars will be removed surgically for all patients. 60 out of 120 patients (treatment group) will use prophylactic topical scar gel 2 times in a day, and remaining 60 patients (control group )won't use. The efficacy of the drug will be evaluated by taking strict measurements of the incision and POSAS (The Patient and Observer Scar Assessment Scale) and Vancouver Scales at 6.12 and 24 weeks.

Steps;

1. Observation of the primary cesarean scar by taking scar measurements and using Vancouver and POSAS scales.
2. Surgical removal of the primary cesarean scar in the second cesarean section.
3. 24 weeks topical application of gel containing extract of allium cepae, allantoin and heparin(only treatment group).
4. Observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with using Vancouver and POSAS scales.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted for the second cesarean delivery
* Not to use topical scar gel after the first c-section

Exclusion Criteria:

* chronic illness, immunosuppressive therapy or smoking
* development of wound infection during the second c- section
* allergies and hypersensitivities to components of the gel
Efficacy and Safety of DWC202404 and DWC202314 in Patients with Hypertension

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of DWC202404 and DWC202314 Combination Therapy in Patients with Essential Hypertension Inadequately Controlled on DWC202404 Monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Average systolic blood pressure (MSSBP) measured at the time of screening meet the following criteria (a) If anti-hypertensive drugs are not being administered: 140 mmHg ≤ MSSBP \< 180 mmHg (b) If anti-hypertensive drugs are being administered: 130 mmHg ≤ MSSBP \< 180 mmHg

Exclusion Criteria:

* If the blood pressure measured at the time of screening and randomization is MSDBP ≥ 110 mmHg
* Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
A Study of LY2584702 in Solid Tumors

The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists.
* Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria In Solid Tumors (RECIST). Japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and Lilly.
* Have adequate organ function including:

  * Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/liter (L), platelets greater than or equal to 100 x 10\^9/L, and hemoglobin greater than or equal to 9 gram/deciliter (g/dL) (transfusions are not allowed prior to enrollment within 2 weeks).
  * Hepatic: Bilirubin less than or equal to 1.5 times upper limit of normal (ULN), alkaline phosphatase (ALP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN, or 5 times ULN for patients with hepatic metastases. Patients with bone metastases may enter with alkaline phosphatase values less than 5 times ULN, as long as other hepatic parameters meet inclusion criteria.
  * Renal: Serum creatinine less than or equal to 1.5 times ULN.
* Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group scale
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy.
* Have an estimated life expectancy of 12 weeks or greater
* Are able to swallow capsules

Exclusion Criteria:

* Have received treatment within 4 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
* Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study.
* Prior clinical history of tuberculosis (patient doubt tuberculosis is screening required), and positive test results in hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening required).
* Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without history of CNS metastasis is not required.
* Have hematologic malignancies, or lymphoma.
Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to placebo, will significantly attenuate airway inflammation and hyperpnea-induced bronchoconstriction in asthmatic individuals.

Our research group has shown, on numerous occasions that fish oil has a markedly protective effect in suppressing airway inflammation and exercise-induced bronchoconstriction in elite athletes and asthmatic individuals. Purified fish oil and the marine lipid fraction PCSO-524™ (Lyprinol™) have both been used in supplementation studies in asthma \[2, 10, 11\]. While fish oil is a rich source of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), Lyprinol® is a patented extract of stabilized lipids from the New Zealand green-lipped mussel, Perna canaliculus, combined with olive oil and vitamin E. EPA and DHA are the main ingredients of fish oil, and thus there will be similarities between Lyprinol and fish oil in terms of mechanism of action. Thus, we are aiming to show that Lyprinol® can modulate these inflammatory eicosanoids to exert anti-inflammatory effects.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with asthma and EIB. Evidence of a diagnosis of asthma will include medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma. For the diagnosis of EIB, subjects must demonstrate a fall in FEV1 of ≥ 10% after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge; FEV1 is a measure of lung function
* Not currently be taking any fish oil supplements
* Limit their fish consumption to 1 fish meal per week during the course of the study

Exclusion Criteria:

* Severe asthma is indicated. These subjects will be identified by a post-EVH drop in FEV1 that is greater than 50% during their first lab testing session or will have a history of severe asthma-related events such as hospitalizations or emergency room visits. Only mild to moderate asthmatics (i.e. subjects whose FEV1 drops by 10-50%) will be included in this study.
* They taking currently taking asthma maintenance medications
* They are pregnant
* They have a history of hyperlipidemia (high cholesterol), hypertension, diabetes, bleeding disorder, delayed clotting time, or seizure disorder
* They are allergic to shellfish, fish, corn, or soy products
Tracking of Lipid Lowering Therapy in Jordan

The present study aims to examine the clinical practice of modifying the dose of lipid-lowering therapy in patients with atherosclerotic cardiovascular disease (ASCVD), who have LDL-C \> 70 mg/dl despite statin treatment.

ASCVD is the leading cause of morbidity and mortality worldwide, in the Middle East and in Jordan. One of the major risk factors that contribute to the development and progression of ASCAD is dyslipidemia. A large number of clinical trials have reported the benefits of lowering LDL-C, in reducing the mortality rate among ASCAD patients.

The 2019 ACC/AHA blood cholesterol treatment guideline to reduce atherosclerotic cardiovascular risk in adults has expanded the role of LDL-C targets and reiterated the importance of achieving an LDL-C level of 70 mg/dl or less for patients who have ASCVD.

Patients on statins and other lipid-lowering therapy in Jordan have not been tracked in the past for the potential of up escalating the lipid-lowering therapy to reach the LDL-C target.

The investigation will enroll patients with ASCVD who have LAL-C \>70 mg/dl on lipid-lowering therapy and follow them for 12 months to examine the treating physicians' action in up-titrating the lipid-lowering therapy dose(s) and the frequency of measuring serum lipids during the study period.

Eligibility Criteria:
Inclusion criteria

1. Adults aged 18 years or old.
2. Presence of atherosclerotic cardiovascular disease on lipid-lowering therapy.
3. LDL-C \> 70mg/dl.
4. Willingness to sign an informed consent.

Exclusion criteria

1. Life-threatening disease with limited survival.
2. Unwillingness to sign an informed consent.
Transcriptomic Study of Adult Population With Marfan Syndrome

This project is designed to discover circulating biomarkers for aortic aneurysms in adults affected by Marfan Syndrome (MFS). The first aim is to identify circulating transcripts, protein-coding (mRNA) and not (ncRNAs), which show differential expression between three groups of adult patients affected by MFS, based on: presence or absence of thoracic aortic aneurysms (TAA) and indication of TAA-surgery. This obtained TAA_MFS_signature will then be correlated to fundamental biological parameters, like cytokines and chemokines relevant during inflammation and transcriptomic as well as epigenetics changes in aortic aneurysm tissue. Furthermore, the association of TAA_MFS_signature to genetic, clinical and instrumental parameters at present used for diagnosis and treatment, will be evaluated.

The investigators will collect peripheral blood and aortic aneurysm tissues specimens from consenting subjects. For all three groups of MFS patients, total RNA will be isolated from peripheral whole blood, plasma and peripheral blood mononuclear cell (PBMC) and processed for transcriptomic analyses by RNAseq. Plasma will be used to determine cytokine and chemokine levels, using a luminex panel designed for inflammation biomarkers (serum proteomics). For all patients undergoing surgery, tissue specimens will be used for transcriptomic and epigenetic analysis, histological sections and serum proteomics.

Eligibility Criteria:
Inclusion Criteria:

General criteria:

* Clinically and genetically determined Marfan syndrome (according to the revised Ghent-criteria 2010)
* Signed informed consent
* Patient receiving regular pharmacological prophylaxis or newly diagnosed patients

Population without thoracic aortic aneurysms (TAA) Patients with clinically and genetically determined Marfan syndrome, presenting thoracic aortic diameters within established normal limits (mm and base Z-score).

Population with TAA "stable dimensions" Patients with clinically and genetically determined Marfan syndrome, presenting stable values for dimension / Z-score of the aortic root during the 12 months preceding the enrolment.

Population with TAA with surgery indication:

* Patients with clinically and genetically determined Marfan syndrome, presenting indication for surgical correctional according to the relevant International guidelines
* Trend of uncontrolled increase of aortic diameter compared to previous measurements
* Aortic ectasia associated to a clinically significant valve dysfunction
* Evaluation of cut-off for surgical intervention dependant also on familial dissection

Exclusion Criteria:

* Patients with chronic or acute inflammation states, like: chronic liver disease, chronic renal insufficiency (creatinine \> 1.5 mg/dl) and diseases affecting the thyroid apparatus.
* Pregnancy
Comparative Study Between Using WHO Labour Care Guide & Modified WHO Partograph

This randomized clinical trial is based on comparing the efficiency of modified WHO partographs vs. the new WHO labour care guide in monitoring and assessing the outcome of labour.

A group of primiparous women in first stage of labour will be randomized into two groups then monitored during first stage of labour. First group will be monitored by modified WHO partograph. The rest of participants will be monitored by WHO labour care Guide. The labour will be monitored regarding progress rate, mode of delivery.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous women.
* Term gestation between 37 and 40 weeks.
* Maternal age from 18 -35 years
* Body mass index BMI of 18.5 to 29.9 kg/m2
* Cephalic presentation. 6. Active first stage of labour

Exclusion Criteria:

* Women with any medical comorbidities, such as (hypertension, diabetes mellitus, renal disease, or pulmonary disease).
* Women with presence of any obstetrical complications, such as preterm birth, multiple gestation, breech presentation, postdated pregnancy, or bad obstetrical history.
* women who were given intrapartum epidural analgesia.
Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students

This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection \[LTBI\], defined as individuals infected with Mycobacterium tuberculosis with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.

Mycobacterium tuberculosis may develop symptoms and signs of disease or may have no clinical evidence of disease (latent tuberculosis infection \[LTBI\]). TB disease remains one of the major causes of morbidity and mortality in the world.

A survey to assess the prevalence of the individuals with a LTBI and evaluate the potential main risk-factors will be performed on both HCWs and students attending the hospital wards, trained at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.

This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection \[LTBI\], defined as individuals infected with Mycobacterium tuberculosis (MT) with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.

The study will involve all HCWs of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome - a tertiary reference hospital with over 1,500 beds - and all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS.

All enrolled participants, who will agree to participate to the study and answer the questionnaire, will respond a cross-sectional questionnaire survey through dedicated tablet. The survey will contain a brief explanation of the study aims and an invitation to respond to a 9 items multiple choice questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* all health-care workers of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome,
* all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS,
* written informed consent.

Exclusion Criteria:

* denied informed consent.
Pilot Study of an Intervention Involving Cognitive Training and tDCS in Morbidly Obese Subjects

The study aims to: 1) investigate the effects of cognitive training (CT) and combined CT and transcranial direct current stimulation (tDCS) on food intake and 2) to further understand its neuropsychological and neurophysiological basis (i.e. EEG) as well as its impact in endocannabinoids (EC) in a sample of morbidly obese patients seeking for a gastric bypass surgery

The study will explore the impact of a 4-day intervention with either CT (Active control condition) or CT+tDCS (Active condition) stimulation on food intake in a sample of morbidly obese patients, as measured by dietary assessments the week before, during and the week after the intervention. Additionally, to further understand the neuropsychological and neurophysiological basis of its impact, measures of executive function and attention performance and EEG recordings, respectively, will be collected. Furthermore, we will explore the effect of the intervention on endocannabinoids previously related to eating behaviour.

The Active Control condition will receive sham stimulation together with CT, through a computerized cognitive training platform (Guttmann NeuropersonalTrainer), including different tasks with designed to train executive functions and attention. Each session will last approximately 30-40 min.

The Active condition will receive tDCS stimulation (20 min, multichannel with an excitatory target over the r-dlPFC) together with CT (same as for the Active Control condition).

Participants will undergo a basal (the week before intervention) and a post treatment assessments (the day after finishing the intervention) that will include medical history, blood testing, anthropometric measures, a cognitive assessment battery and a 4-day dietary assessment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both gender, aged between 18 and 60 years-old
* Having a BMI \> 40 kg/m2 or having a BMI\>35 and suffering from diabetes mellitus, HBP or LDP.
* Obesity conventional treatment failure
* Wish of bariatric surgery
* Accepting the study and signing the Informed Consent

Exclusion Criteria:

* Do not meet inclusion criteria
* Being left-handed
* Using a pacemaker or deep cerebral stimulation device
* Having a psychiatric disease or serious disease
* Neurologic condition or learning issue or mental backwardness that could affect cognitive function
* Use of psycho-stimulating medicines and/or drugs, abuse or dependance to a psychoactive substance (or during the last 6 months)
* Dependance to alcohol or/and drugs (excepted from nicotina)
* In treatment with benzodiazepines, antipsychotics, tricyclic antidepressants or topiramate, started in the last month
* History of psychiatric disorders treated with lithio carbonate.
* Cutaneous lesion on the area of using of electrodes
* Contact allergy to material used in the used devices.