cyrilzakka/clinical-trials huggingface dataset:
National Registry for Egyptian Pediatric Neuromuscular Diseases

Our aim is to establish multi-center national Egyptian database of information for inherited and acquired neuromuscular diseases in infants and children from 0 to 18 years of age.

Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with Neuromuscular Diseases (NMD) inherited NMD (spinal muscular atrophy (SMA), Duchenne/Becker and congenital muscular dystrophies (DMD/BMD, CMD), congenital myopathies, and congenital myasthenic syndromes) and acquired NMD (neuropathies, myasthenia gravis and myositis).

Participants: Eligible infants and children with inherited and acquired neuromuscular diseases.

DESIGN: This study is a prospective cohort study.

Outcome measures: Motor development assessment, respiratory and cardiac examination.

Eligibility Criteria:
Inclusion Criteria:

* Weakness, hypotonia.
* Nerve conduction study and electromyographic confirmation of lower motor neuron affection.

Exclusion Criteria:

* Chromosomal diseases.
* Malformations and deformations.
Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.

This study aims to see if ultrasound can be used as a reliable and valid method to measure fatty infiltration, muscle thickness and muscle architecture to provide a quick, cheap and mobile alternative measure of muscle quality to MRI.

The MRS and MRI images will be used to validate the ultrasound images.

A key hallmark of the natural biology of ageing is a progressive loss of skeletal muscle mass, strength and aerobic capacity, termed 'sarcopenia' (Cruz-Jentoft et al. 2019a). The association between muscle loss (mass and quality) and increased incidence of falls, fractures, metabolic disease and other health complications is well established. Despite exercise and physiotherapy, recovery from these is often incomplete and studies have failed to identify fully effective countermeasures (Reeves et al, 2005). Ways to objectively measure the clinical effectiveness of the countermeasures are also limited.

Muscle quality can be measured in terms of muscle thickness, architecture (pennation angle and fascicle length) and fatty infiltration. At present ultrasound muscle thickness and architecture have been shown against MRI to be a reliable and valid but fatty infiltration can only be measured reliably using MRI. MRI is an expensive, time consuming and immobile technique limiting its use as a clinical tool in a rehabilitative setting. Finding a cheaper, quicker and mobile alternative, such as ultrasound, would enable clinicians to gather useful information on patient muscle quality in an objective manner and use this information to tailor treatment accordingly.

15 old (\>50y) and 15 young (\<40y) will be recruited. MRI, MRS and Ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame.

MRI and MRS will provide the validation to ultrasound fatty infiltration.

Eligibility Criteria:
Inclusion Criteria:

- Age \<40y or \>50yrs

Exclusion Criteria:

1. Significant cognitive deficits and the inability to follow directions during assessment.
2. Neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
3. Prosthesis with metalwork, eg. metal work from surgery
4. Aneurysm clip in situ
5. No metal work anywhere, history of metal fragments in eyes, spinal cord or brain.
6. Previous exposure to metal flakes and metallic injury.
7. No external implants; cochlear implant, spinal cord simulator, pacemaker or other implanted electronic devices.
8. Non-removal hearing aids
9. FEMALE ONLY Not pregnant
10. Not claustrophobic
Public Messaging to Increase Treatment Seeking for Veterans at Risk for Suicide

The risk for suicide increases by nearly 50% in the first year that service members transition from the military to civilian life underscoring the need for effective strategies to facilitate help seeking among Veterans vulnerable to self-directed violence. Yet despite a great need for treatment, more than half of returning Veterans at risk for suicide do not initiate mental health services. VA has embarked on the regular use of communication campaigns as part of a public health approach designed to reach the larger Veteran population with messages promoting help seeking. However, what types of messages effectively change beliefs and behaviors for at-risk Veterans resistant to seek treatment is unclear. The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. This represents the first study to systematically develop public messaging strategies for populations at risk for suicide.

The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. A four-year mixed methods study that uses a sequential embedded design will be used to collect data from nationwide samples of Veterans at risk for suicide not in mental health treatment who separated from the DoD in the past year. Informed by the Theory of Planned Behavior, individual interviews will first be conducted to guide the design of effective public messages that will be subsequently tested in a two-arm RCT to determine exposure effects among targeted audience vs. control group. Messages will be disseminated to study participants during the trial by a smartphone app. Research staff will collect assessments by telephone at baseline, 1- and 3-months post-randomization. Potential participants (for all study aims) will be identified using data available from the VA/DOD Identity Repository (VADIR) and recruited by invitational mailing and follow-up telephone calls. If the intervention is found effective, the investigators will work with the VA operational partner to include messages in future outreach approaches to prevent Veteran suicide and use findings to improve current communication performance measures.

Eligibility Criteria:
Inclusion Criteria:

* U.S. Veteran that separated from military service in the past 12 months (any discharge type);
* \>18 years old;
* experiencing suicidal ideation;
* low intent to seek help;
* capable of understanding the goals of the study;
* willing and able to provide verbal consent; and 7) smartphone ownership and willing to download/use study mobile app

Exclusion Criteria:

* currently (or in the past 12 months) in formal mental health treatment services;
* deemed impaired during eligibility screening; and 3) currently institutionalized
Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose

The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).

The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age 18 years-old or older
* Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
* Initiating or continuing buprenorphine for treatment of opioid use disorder
* History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)

Exclusion Criteria:

* Previous enrollment in the trial
* Incarcerated or in police custody\*
* Pregnant
* Live outside of Rhode Island (RI)
* Unable to provide informed consent
* Allergy to Buprenorphine
* Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \*Participants that become incarcerated/or in police custody during the study will be withdrawn.
Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC

single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of microvascular invasion (MVI) positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Focusing on the current status of clinical treatment of microvascular invasion (MVI) positive postoperative hepatocellular carcinoma (HCC) , single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of MVI-positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was HCC after surgery, and MVI was positive
* Child-Pugh score ≤9 points (Child-Pugh A-B), PS score 0-2 points, BCLC stage A-B
* The main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent
* With sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements
* Physical fitness score ECOG 0～2
* Expected survival\> 3 months
* No other systemic malignancies
* Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period
* Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents

Exclusion Criteria:

* Histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
* Severe liver dysfunction (Child-Pugh C), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation
* The main portal vein is completely blocked, and the formation of collateral vessels is small
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter

The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.

The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.

Study Design:

1. Prospective, international multi-center clinical study;
2. It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
3. In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis.
4. Register and collect data using the EDC system;
5. Enrollment method: competitive enrollment;
6. Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm;
* Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol.

Exclusion Criteria:

* Pregnant or lactating females;
* Patients with cardiogenic shock;
* Patients with severe congestive heart failure or severe heart failure with NYHA class IV;
* Patients with severe valvular heart disease;
* Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult;
* Patients who are considered unsuitable for inclusion by the investigator for other reasons.
* Those who are known to be allergic to melcrolimus and contrast media.
Application of MR-PET in Colorectal Cancer

This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.

This research expect that the image techniques and experience in this cancer group may be valuable and helpful for others. With advantage of MR-PET in better soft tissue delineation/functional information and less radiation dose than PET-CT, the ultimate goal in both research and clinical application is to establish new diagnostic standard and management guideline by MR-PET, which can further improve clinical outcome and disease prognosis in patients colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Group 1: Patients with newly diagnosed colorectal cancers
2. Group 2: Patients with suspicious recurrent colorectal cancers

Exclusion Criteria:

1. Age \<20 or \>90 years old
2. Contraindication for MRI: claustrophobia or MR non-compatible devices
3. Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre \> 2.0)
4. History of other malignancy
5. Prior arthroplasty of hip (may cause artifacts on MRI)
6. Pregnancy
The Effect of Affirmation and Massage on Babies

The research was designed as a randomized controlled trial model to examine the effects of affirmation and infant massage taught to the parents of 0-6 month-old infants registered in a Family Health Center and a Private Medical Center in Istanbul, on the sleep quality of their infants and mother-father-infant attachment. The research will be carried out between August and October 2022 by including the parents of the babies in the scope of the study. The Mother-Father and Infant Information Form and the Extended Infant Short Sleep Questionnaire, the Maternal Attachment Scale, and the Father-Infant Attachment Scale will be used to collect the data.

This study was designed as a randomized controlled experimental study with the aim of examining the effect of affirmation and massage applied by mothers and fathers to their infants on their infants' sleep quality and maternal-paternal attachment. Infants aged 0-6 months will be included in the study. In the study, 15 babies (d=0.80, G=0.80, p=0.05) will be randomly selected for each group, Experimental Group 1: The Group To which the Mother Applies Affirmation and Massage (A), Experimental Group 2: The Group To which the Father Applies Affirmation and Massage (B) and Control Group (C) will be determined as three groups. Some criteria will be considered in infants selected and not selected into groups.

Experimental Group 1: Mothers in Group (A) Affirmation and Massage, Experimental Group 2: Fathers in Group (B) Affirmation and Massage, 3 days a week for 15 minutes, will be taught to apply affirmation and massage. Affirmation and massage applications will be shown once in the practice hall of the center as an example for the mother and father to be applied to their baby. Afterwards, affirmation and massage applications will be applied by the mother and father at the baby's home. After 5 weeks, the experimental and control groups will be invited to the center and the results will be compared by measuring with the data collection tools again.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants
* Non-pregnant mothers
* Mothers and fathers who agree to participate in the study
* Who do not have communication problems
* Who does not have a chronic and mental disease

Exclusion Criteria:

* Babies with any disease
* Diagnosed with sleep a disorder
Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Sitravatinib (MGCD516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, TAM (Tyro3, AXL, MERTK) family, VEGFR family, PDGFR family, KIT, FLT3, TRK family, RET, DDR2, and selected EPH family members. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
* Receipt of at least one but not more than two prior treatment regimens in the advanced setting
* Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
* Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
* Candidate to receive docetaxel as second or third line therapy

Exclusion Criteria:

* Uncontrolled brain metastases
* Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
* Unacceptable toxicity with prior checkpoint inhibitor therapy
* Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
* Impaired heart function
An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy

The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren \[PTC124-GD-020-DMD {NCT01826487}\]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study.

This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued.


Eligibility Criteria:
Inclusion Criteria:

* Completion of study treatment in the previous Phase 3, double-blind study (PTC124-GD-020-DMD).
* Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. Note: If the study candidate is considered a child under local regulation, a parent or legal guardian must provide written consent prior to initiation of study screening procedures and the study candidate may be required to provide written assent. The rules of the responsible Institutional Review Board/Independent Ethic Committee (IRB/IEC) regarding whether 1 or both parents must provide consent and the appropriate ages for obtaining consent and assent from the participant should be followed.
* In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the period of study drug administration and 6-week follow-up period.
* Willingness and ability to comply with scheduled visits, ataluren administration plan, study procedures, laboratory tests, and study restrictions.

Exclusion Criteria:

* Known hypersensitivity to any of the ingredients or excipients of the study drug (Litesse® UltraTM \[refined polydextrose\], polyethylene glycol 3350, Lutrol® micro F127 \[poloxamer 407\], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla, Cab-O-Sil® M5P \[colloidal silica\], and magnesium stearate).
* Ongoing participation in any other therapeutic clinical trial.
* Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.