cyrilzakka/clinical-trials huggingface dataset:
Restoring Upright Mobility After Spinal Cord Injury

Up to 15 able-bodied individuals will participate in one testing session to evaluate the effectiveness of the A-FES system. Up to 20 individuals with SCI will participate in 12 sessions of A-FES therapy. At each session, participants will stand on a force plate (Accu Sway, AMTI, USA) with the A-FES system (Compex Motion II, Compex Motion, Switzerland) donned. The centre of pressure (COP) will be calculated in real time using the force plate data. The calculated COP will be presented to participants on a monitor and they will be instructed to shift their COP in the indicated directions as represented by a cursor (i.e. training with visual feedback). The intensity of electrical stimulation provided by the A-FES system will be regulated by the measured COP in a closed-loop manner. In this study we propose to develop and evaluate the clinically-feasible A-FES system for the training of standing balance.


Eligibility Criteria:
Inclusion Criteria:

1. A traumatic or non-traumatic, non-progressive (AIS) C or D SCI;
2. ≥18 years old;
3. Able to stand independently for 60s;
4. Moderate level of trunk control as evidenced by the ability to reach forward \>2 inches in standing (i.e. score of 2 on the BBS Reaching Forward task50,51); and
5. Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke).

Exclusion Criteria:

1. Severe spasticity in the legs;
2. Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
3. A prior lower extremity fragility fracture;
4. An injection of botulinum toxin to leg muscles in the past six months;
5. Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
6. A pressure sore (\>grade 2) on the pelvis or trunk where the safety harness is applied; o
7. Contraindications for FES52 (i.e. implanted electronic device, active cancer or radiation in past 6 months, epilepsy, skin rash/wound at a potential electrode site).

Participants will be withdrawn from the study if FES irritates their skin.
Treatment of Rotator Cuff Tears With Platelet Rich Plasma

The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.

Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification, will be enrolled in this study. They will receive dual platelet rich plasma (PRP) injections, one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion, in one treatment session. PRP will be prepared through a double spin technique to create two 4 cc doses for injection. Patients will evaluated at 6 months, 1 year and two years for improvement in symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Rotator cuff pathology established by exam
* Rotator cuff pathology confirmed with MRI.
* Failure to improve with activity modification and physical therapy
* Willingness to stop all NSAID medication

Exclusion Criteria:

* Additional significant shoulder pathology seen on xray or MRI including: severe arthritis, significant superior labrum anterior postierior (SLAP) Type II lesions and intra-articular loose bodies.
* Shoulder surgery within 6 months.
* Presence of full thickness rotator cuff tears in patients amenable to surgical repair.
Study on the Diagnosis and Management of CLL in Italy by GIMEMA

retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL.

retrospective cohort: all cases with a diagnosis between January 1st 2010 and August 31th 2021.

prospective cohort: all patients with a diagnosis between September 1st 2021 and September 1st 2025.

This is a retrospective and prospective multicenter observational study designed by the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA). The study consists of clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL (according to the WHO 2007 and 2018 diagnostic criteria). The retrospective part aims at including all cases followed at participating centers with a diagnosis between January 1st 2010 and August 31th 2021 (planned study initiation), while the prospective part will include all patients with a documented diagnosis of CLL, SLL or MBL between September 1st 2021 and September 1st 2025 by the first immunophenotypic/histological evaluation. The data is collected through electronic case report form accessible by the participating centers on a dedicated platform.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at diagnosis
2. One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017)

   1. Chronic lymphocytic leukemia (CLL)
   2. Small lymphocytic lymphoma (SLL)
   3. CLL-like monoclonal B-cell lymphocytosis (MBL)
3. Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th 2021.
4. Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st, 2025.
5. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable)

Exclusion Criteria:

* - -
Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing

For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal surgery and others, it is important that short time treatment with minimal side effect should be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing

The cornea is the specific anterior part of eye that is essential for normal vision. The corneal surface is comprised of a unique type of non-keratinized epithelial cell. Corneal epithelium contains transient amplifying cells and post mitotic cells. The limbal stem cells (LSC) are located between limbal cornea and conjunctiva which are main source of corneal epithelium healing in eye injuries. For some corneal disease such as chemical and thermal injuries, Corneal Dystrophies and corneal surgery, treatment in short time is important.

AM can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. This biological substrate maintain epithelial progenitor cells within the limbal stem cell niche and facilitate ocular surface epithelial renewal. It is well accepted that amniotic membrane Transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient.

Other studies have been reported that processed AM as a liquid has comparable effect to AMT in treatment of corneal epithelial healing.

This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with corneal epithelium injury
2. Without keratoconus
3. Without cornea scar
4. Without any other lesion of cornea

Exclusion Criteria:

1. Lack of timely referral of patients for examinations
2. Simultaneous use of other drugs that cause impairment of the data
3. Previous cornea surgery
4. Dry eye
5. Glaucoma
Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin

The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala response vary as a function of treatment dose and dose-test latency.

The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala vary as a function of dose and latency. In particular, the investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48 international units, IU) and three different dose-test latencies of IN-OXT administration (task starting at 15, 45 and 75min after administration) on established neural and behavioural correlates of emotion processing. As effects of OXT are particularly promising in autism, the investigators further want to investigate how autistic-like traits influence the OXT effects in exploratory post-hoc analyses

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Right-handed

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
* MRI contraindication (e.g. metal in body, claustrophobia)
National Lung Cancer Registry in Men and Women Based on Diagnosis in Algeria

National, prospective, multicentric, non-interventional registry-based study, conducted among oncologists, pulmonologists in community and university hospitals, from the public sector in Algeria.

The study will collect information on the characteristics, and lung carcinomas patterns of patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.

The study consists of:

* All patients meeting inclusion/exclusion criteria presenting to their oncologists/pulmonologists for a routine visit during recruitment period will be sequentially asked to participate to the study.
* The patients who do not consent will only be reported as new case of lung cancer for the incidence study.

The patients who consent to participate to the study will perform four in-hospital visits (Inclusion visit, visit at 3, 6 and 12 months). In addition to the 4 visits, a phone contact with the patients every 6 months at years 2,3, 4 and 5 will be done by the investigator or one of his/her authorised representative or the CRO or during a routine visit to the investigator, to check the patient's survival status.

THE STUDY DURATION 72 MONTHS

Eligibility Criteria:
Inclusion Criteria:

* Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist

  * Aged at least18 years at diagnosis
  * Patients who provide their informed consent form

Exclusion Criteria:

* Patients who did not provide the informed consent form
* Patients with a mental or psychological disorder according to their treating clinicians
The Impact of a Resilience-based Intervention on Emotional Regulation, Grit and Life Satisfaction: A Comparative Study Between Egyptian and Saudi Nursing Students

Nursing students may be perceived as having a stable college experience because they have a relatively clear career goal and a higher employment rate than students in other majors, but they consistently report that their heavy study loads, frequent exams, and clinical practice cause them to feel more stressed and depressed than students in other majors (Chernomas \& Shapiro 2013, Lee \& Jang 2021). Focusing on emotional events that have a direct impact on nursing students' learning and the college experience is crucial to their psychological wellbeing (Lee \& Jang 2021). In order to improve the emotional experiences and life satisfaction of nursing students, it is crucial to determine the factors that affect their emotions.

A constructivist and grounded theory design was recently used to create a model of resilience for nursing students (Reyes et al. 2015). Three steps represent how resilience is experienced, according to the "Pushing Through" model of resilience: first, "stepping into," or embracing, the adversity. The second is "staying the course," or understanding that they must keep working toward their objectives. Finally, "acknowledge" what they have learned from their difficulties and how they feel prepared to face new challenges. Additionally, students had brief obstacles, such as 'disengaging' from class because they felt overburdened. This paradigm serves as a lens to illustrate how, despite facing challenges, resilience can be developed over time. There is early support for encouraging resilience in nursing students before they begin their professions given the data linking resilience to burnout in nursing students

Eligibility Criteria:
Inclusion Criteria:

* nursing students who are willing to participate in the study and don't have any psychiatric illnesses

Exclusion Criteria:

* Those who refuse to participate in the study, nursing students with psychiatric illnesses
Clinical Performance of Bioactive Highly Filled Injectable Flowable Composite for Direct Posterior Occlusal Conservative Restorations Using FDI Criteria: Two Year Randomized Clinical Trial

The aim of this study is to evaluate Clinical Performance of bioactive highly filled injectable flowable composite for direct posterior occlusal conservative restorations using FDI Criteria


Eligibility Criteria:
Inclusion Criteria:The inclusion criteria: patient age range from 16-45 years, with a premolar indicated for extraction, patients required at least a couple of Class I restorations. The patient should have good general health.

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Exclusion Criteria:Where the exclusion criteria will be: poor oral hygiene, sever or chronic periodontal disease or bruxism, severe tooth sensitivity, non-vital or fracture or cracked teeth, defective restorations or bleaching procedures during the last 6 months, pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study.

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Brucella Serology and History of Brucellosis in Patients With Modic Changes Type 1

Objective: This study aims to examine Brucella serology and history of brucellosis in patients with lumbar Modic changes (MCs) type 1, considering results from cross-sectional and case-control comparisons.

Design: In comparative cross-sectional design, MCs type 1 patients (study group) and MCs type 2 patients (comparator group) were examined in terms of Brucella serology by using agglutination with Coombs test. In addition, in comparative case-control design, both of the MCs groups and age/sex-matched healthy controls were investigated for their medical history regarding brucellosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar Modic changes type 1
* Patients with lumbar Modic changes type 2
* Participant who given informed consent for the study

Exclusion Criteria:

* Patients aged\<18 years
* History of serious lumbar trauma
* Lumbar spinal surgery
* Scoliosis
* Cooperation disorder
Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation

For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. However, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. Therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy.

For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. However, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. Therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy. There is no consensus on postoperative adjuvant therapy, especially for the management of early-stage HCC. Most scholars believe that HCC in this period does not have high-risk factors for tumor recurrence, thus neglecting the role of adjuvant therapy. Early studies have found that microwave ablation can alter the tumor microenvironment, which is conducive to the action of immune checkpoint inhibitors such as PD-1 inhibitors and even has a synergistic anti-tumor effect. We therefore designed this prospective cohort study to explore the efficacy and safety of adjuvant PD-1 inhibitors after microwave surgery.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years
* Pathological type is HCC, BCLC stage 0-A
* No extrahepatic HCC
* No radiographic recurrence at 2-4 weeks after ablation
* Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
* Child-Pugh grade A or B and adequate hematologic and organ function

Exclusion Criteria:

* Any history of other malignant tumors or recurrent HCC
* Any preoperative treatment for HCC including local and systemic therapy
* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* Any persistent serious ablation-related complications
* Esophageal and/or gastric variceal bleeding within 6 months
* Inability or refusal to comply with the treatment and monitoring
* Participation in other clinical trials
Pain Neuroscience Education in Healthy Children

The primary objective of this study is to examine whether Pain Neuroscience Education for children is able to increase a child's knowledge on the neurophysiology of pain.

In addition, this study investigates the influence of PNE on several pain related outcomes; pain-related fear, pain catastrophizing and pain vigilance and awareness.

Pain is a common and daily experience among children that is usually short-term, causing little to moderate discomfort. Yet, a substantial number of children experience chronic pain. Persistent pain periods mainly affect the children's school attendance and participation in recreational activities, possibly leading to academic impairments and social exclusion. Even worse is the children's greater predisposition to develop chronic pain into adulthood. Considering these disadvantages, children suffering from chronic pain should be treated as fast as possible and in the most optimal way. The existing literature on management in children with chronic pain encourages a multidisciplinary approach involving physical therapy and psychological interventions (i.e. cognitive behavioural therapy).

Recently, the application of Pain Neuroscience Education (PNE) as an intervention on its own, as well as in combination with another form of therapy (such as physiotherapy or cognitive- behavioural therapy) is receiving growing interest in the pediatric field of chronic pain. PNE aims to make people understand how their pain is produced and enables them to integrate this understanding into their everyday lives and subsequent treatment components. This innovative education style has shown to be effective in various adult chronic pain populations, by improving the patients' pain coping strategies and health status, and changing their pain beliefs. Although, no study examined the effectiveness of PNE in the context of chronic pediatric pain.

The hypothetical efficacy of pediatric PNE is based on previous findings in adult research that a better understanding of the nature of the illness results in improved patient outcomes. When children do not understand the origin of their pain, they might develop irrational beliefs and fears (including catastrophizing) about their pain, sustaining the vicious circle of chronic pain. Indeed, the information and context in which children perceive their pain, has been shown to modulate pain expectations and emotional response to pain. Since research findings showed that even parental beliefs about the aetiology of the child's pain influences the child's pain outcomes, the role of parents as 'pain modulators' might not be underestimated. Therefore, parents should be involved during PNE.

Concrete, the present study will examine whether reconceptualization of pain, by PNE is able to influence both child and parent knowledge of pain, as well as some other pain-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children
2. Informed consent

Exclusion Criteria:

1. Previous pain education
2. Chronic pain
3. Insufficient knowledge of the Dutch language
4. Mental retardation
5. Parent with chronic pain
A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base

Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Arthritis in the thumb base.
* Radiological Eaton Littler class 1-3.
* Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.

Exclusion Criteria:

* Rheumatoid arthritis.
* Ongoing infection in the hand or wrist.
* History of gout or pseudo gout.
* Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
* Intra-articular injection in the affected joint within 6 months.
* Eaton Littler class 4 (STT joint involved).
Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the cerebral localization and in 60% of stroke interesting the territory of the posterior cerebral artery.


Eligibility Criteria:
Inclusion Criteria:

* Presence of an homonymous visual field amputation after vascular retrochiasmatic lesion of the occipital region (visual cortex alone or with optical radiations or with other associated occipital areas)
* inclusion 3 months to 36 months after stroke
* Patients aged 18 years and older

Exclusion criteria:

* Brain injury history
* Severe neuropsychological, psychiatric or behavioral disorder
* Severe eye disorder or visual impairment (visual acuity less than 3/10)
* Progressive eye disorder (cataracts or glaucoma)
* insufficient French language proficiency to understand the questionnaires and rehabilitation tasks
* patient under legal protection
* patient's opposition to participate in the study
* no medical insurance coverage
* pregnant pr breastfeeding patient