cyrilzakka/clinical-trials huggingface dataset:
Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease

The purpose of this research study is to determine optimum dose of vibration delivered by an experimental device called PDVibe2 required to treat freezing of gait in persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with PD while wearing the device.

Participation will require up to 8 treatment sessions within 5 days (no more than 2 sessions in one day) plus an additional day for screening and another for follow-up (7 days total). All visits will occur at the Virginia Commonwealth University Parkinson's Movement and Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. Participants will be asked to provide feedback on the device, the therapy session and how they are feeling.

Eligibility Criteria:
Inclusion criteria:

* age 21 years or older
* PD diagnosed by a movement disorder specialist for 3 months or longer prior to recruitment
* PD medication regimen is stable over the last 3 months with no changes
* Hoehn \& Yahr stage 2 (N = 13) and H\&Y stage 3 (N=13),
* able to walk independently or with a simple assistive device (e.g., cane, walker)
* observed by the research team to have PD related gait disturbance such as FOG, shortened or irregular stride lengths, irregular step cadence, slowed speed while on their regular treatment regimen.

Exclusion Criteria:

* diagnosed with a known Parkinson plus syndrome
* were previously exposed to vibration treatment for gait and balance
* presence of dementia (Montreal Cognitive Assessment \< 21)
* additional disorders (not related to PD)impairing gait, stance, balance or coordination (e.g. stroke, leg amputations, or multiple sclerosis)
* history of implantable cardiac device or any other implanted electronic device except a deep brain stimulator (DBS)
* use of braces/orthotics that assist with walking
* are currently in physical therapy (PT) treatment for balance or gait
* peripheral neuropathy by exam
* any condition that, in the opinion of the PIs, would compromise participant safety, data integrity, or data interpretation.
* Children under the age of 18
* Prisoners
* Women who are pregnant or may become pregnant during the course of this study since the safety of this device for an unborn child is unknown.
Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

The purpose of this randomized trial is to investigate the efficacy and toxicity of percutaneous high-dose radiotherapy in patients with oligometastases of hormone refractory prostate cancer. The effectiveness will be tested in comparison to an observation group, in which no further therapy is initially given. Treatment can be stereotactically hypofractionated or conventionally fractionated.

This is a monocentric, randomized, prospective Phase II intervention trial. Efficacy is measured as the rate in patients with PSA progression one year after randomization (defined as PSA nadir after randomization +2 ng/ml). There is a 2:1 randomization between intervention and observation group. Patients with PSA progression in the observation group are offered a new diagnosis. This should preferably correspond to the initial diagnosis.

Therapy is performed for all patients in the intervention arm using high dose radiation therapy, either as conventional fractional irradiation with 2 Gy/fraction up to a total dose of 50 Gy or as hypofractional irradiation with a single dose of 10 Gy up to a total dose of 30 Gy.

The decision as to which regimen the patient is to be treated according to is made by the treating physician, taking into account in particular the location of the volume to be irradiated in relation to the organs at risk and any previous irradiation.

Eligibility Criteria:
Indication:

Oligometastases (1-5) in castration-resistant prostate carcinoma

Inclusion Criteria:

* Patient with good general condition (WHO 0-1)
* Histologically confirmed prostate carcinoma
* After definitive local therapy, e.g. radical prostatectomy or definitive radiotherapy (also after neo-adjuvant hormone therapy, after postoperative radiotherapy).
* PSA progression under ongoing androgen deprivation (defined as three consecutive increasing PSA values at intervals of \> 4 weeks and testosterone in the castration area \<50ng/dl or \<1.73nmol/)
* Minimum duration of androgen deprivation 6 months before inclusion in study
* Present complete staging (max. 6 weeks old), preferably by means of PET hybrid imaging with prostate-specific PET tracer
* Imaging detection of individual active or progressive metastases (max. 5, depending on location) that are accessible to local ablative radiotherapy (histological confirmation of the metastases is not required)
* No parallel participation to further clinical therapy trials up to 4 weeks before and after radiation therapy
* Individual case discussion in an interdisciplinary tumor board
* Patient's ability to consent and written consent

Exclusion Criteria:

* Severe concomitant disease that limits further life expectancy to \< 5 years according to the physician's assessment.
* PSA \> 20ng/ml, testosterone \>50 dl or \>1,73nmol/l
* visceral metastasis (e.g. lung, liver, brain)
* lack of compliance
* previous taxane-containing chemotherapy
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband

The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the Quattro® X Suture Anchor with BroadBand™ Tape and Instruments when used in rotator cuff repair.

The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient. The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Constant \& Murley and EQ-5D-5L) at 1 year post-operative.

The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.

The Quattro® X Suture Anchor with BroadBand™ Tape is intended for use in rotator cuff repairs. It is intended for for the reattachment of soft tissue to bone.

Up to three sites will be involved in this study. The aim is to include a total of 109 consecutive series cases who received the Quattro® X Suture Anchor with BroadBand™ Tape. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Subject treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair;
2. Older than 18 years and skeletally mature;
3. Willing and able to comply with the study procedures;
4. Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
5. Subject is able to read and understand the ICF and has voluntarily provided written informed consent.

Exclusion Criteria:

1. Presence of infection;
2. Insufficient or immature bone;
3. Insufficient blood supply or previous infections which may hinder the healing process;
4. Foreign body sensitivity;
5. Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
6. The subject is unwilling or unable to give consent or to comply with the follow-up program;
7. Subject meets any contraindications of the appropriate Instruction for Use.
Guidewire Use in Nasotracheal Intubation

During nasotracheal intubation, nasopharyngeal trauma and associated bleeding may occur. The investigators think that some of this bleeding is due to trauma to the posterior wall of the nasopharynx. The investigators designed this study, thinking that if nasopharyngeal posterior wall trauma can be prevented, some of these bleedings can be prevented.

Nasotracheal intubation (NTI) is a frequently used airway management method in pedodontic dental treatments performed under general anesthesia. However, nasopharyngeal trauma and associated bleeding are common during conventional NTI. In this study, the investigators aimed to examine the effect of angling the end of the endotracheal tube (ETT) by placing a guide wire inside the ETT on nasopharyngeal bleeding.

The patients included in the study were randomized into two groups. In the control group (Group C), NTI will be done conventionally. In the study group (Group S), a guide wire will be inserted into the ETT before intubation and angled 100-120 degrees to the distal end (in the shape of a hockey stick). The angulation will not be sharp but slightly curved and the apex of the angulation will be 2.5-3 cm proximal from the distal end. The ETT will be positioned perpendicular to the face and inserted into the nostril. After the angled part of the ETT passes through the nostrils, it will be directed to caudally according to the angle given to the tip of the ETT. Meanwhile, the ETT will be moved as a whole to prevent the ETT tip from contacting the posterior wall of the nasopharynx. When the ETT tip reaches the oropharynx, the guidewire will be removed and the rest of the intubation will be completed as in the conventional method.

Eligibility Criteria:
Inclusion Criteria:

* 2-12 years old
* American Society of Anesthesiologists I-III
* Patients with elective dental surgery
* Patients whose parents have accepted informed consent forms
* Patients without previous nasopharyngeal anomalies
* Patients without previous nasopharyngeal surgeries
* Patients without upper airway infections

Exclusion Criteria:

* Under 2 or over 12 years old
* Emergency surgeries
* Patients whose parents have not accepted informed consent forms
* Patients with previous nasopharyngeal anomalies
* Patients with previous nasopharyngeal surgeries
* Patients with upper airway infections
Open Versus Endoscopic Surgical Management Of Posterior Calcaneal Deformity.

Patients with posterior calcaneal deformity may presented by many clinical data associated with retrocalcaneal bursitis which occurs due to the deformity this clinical complaining include pain and swelling in the back of the heel.

Many treatment choices available of this deformity with low level of response to conservative treatment which includes medical treatment , physiotherapy and corticosteroids injection. surgical treatment in cases of HAGLUND deformity is the treatment of choice including either endoscopic or open surgical approach for this deformity .


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients.
* Continued refractory pain despite use of extensive conservative management.

Exclusion Criteria:

* Asymptomatic patients
* Patients which are unfit for surgery.
Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease

The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* Angiographically confirmed multivessel CAD with involved LAD and critical (\>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG
* Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia
* Patient is willing to comply with all follow-up visits
* Patient signed an Informed Consent

Exclusion Criteria:

* Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment
* Prior surgery with the opening of pericardium or pleura
* Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects
* Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation
* One or more chronic total occlusions in major coronary territories
* Left main stenosis (at least 50% diameter stenosis)
* Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization
* Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
* Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition
* Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
* Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
* Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease
* Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age
* Concurrent enrollment in another clinical trial
* Patient inaccessible for follow-up visits required by protocol
The Use of Competition in a School-based Intervention for Increasing Cardiorespiratory Fitness in Adolescents

Regular physical activity offers numerous physical, psychological, and cognitive health benefits. However, physical inactivity among adolescents remains a global concern, with 81% of 11- to 17-year-olds failing to meet WHO's recommendation of at least one hour of moderate- to vigorous-intensity activity daily. This inactivity contributes to immediate and long-term health risks, as many non-communicable diseases (NCDs) in adulthood are linked to behaviors established during adolescence. Promoting healthy lifestyles early is crucial for lifelong health and disease prevention.

One significant barrier to effective school-based physical activity programs, such as High-Intensity Interval Training (HIIT), is maintaining student motivation. Low engagement often results in poor adherence. Integrating competition-focused on effort rather than performance-may enhance student participation and make HIIT interventions more effective and easier to implement.

This study will evaluate the impact of competition on the Burn 2 Learn - Mallorca (B2L-M) program, targeting adolescents aged 15-18. The intervention aims to determine whether competition improves engagement and outcomes compared to non-competitive groups. The primary outcome is cardiorespiratory fitness (CRF), while secondary outcomes include muscular strength, physical activity levels, body composition, mental health (stress and sleep quality), behavior change mediators (self-efficacy, motivation), on-task behavior, blood pressure, and sitting posture.

The B2L-M intervention will involve a 16-week, three-arm cluster randomized controlled trial in Mallorca, Spain, recruiting approximately 360 students from six schools. The program includes teacher-led HIIT sessions twice weekly during physical education, supported by information seminars, a dedicated website, and parental e-newsletters. Outcomes will be assessed at baseline and after 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Students who belong from "3º ESO" to "1º bachillerato" levels

Exclusion Criteria:

* Students with a health or medical condition that would preclude participation in vigorous physical activity will be excluded from the study but will still participate in normal lessons adapted by the PE teacher
Examine the Prognostic Role of FLT PET/CT for Patients With LR-NPC Treated by Carbon Ion Therapy

We aim, in this study, to examine whether reduction of FLT PET derived SUV before and after carbon ion radiotherapy can predict the treatment response and survivals for patients with locoregionally recurrent nasopharyngeal carcinoma.

This is a single-arm phase II clinical trial evaluating the prognostic value of FLT PET/CT for patients with locoregionally recurrent nasopharyngeal carcinoma. All patients will receive FLT PET/CT scans before and after carbon ion radiotherapy (CIRT). The sensitivity and specificity of reduction of FLT uptake reduction in terms of predicting the treatment outcome evaluated by MRI at 3 months after completion of CIRT according to RECIST 1.1. Its predictive value of OS, LPFS, RPFS and DMFS will be examined as well.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed as primary nasopharyngeal carcinoma;
* With recurrence at nasopharynx and/or recurrent retropharyngeal lymph node, recurrence was diagnosed by imaging or pathology studies;
* Already received one course of definitive radiation therapy, at least 6 months ago;
* Able to receive contrast MRI scan and PET/CT scan;
* ECOG: 0-2;
* Anticipated survival time \>= 12 months;
* With sufficient major organ functions;
* Willing to sign informed consent.

Exclusion Criteria:

* Metal implants that might significantly influence the radiation dose distribution;
* Dose constrains for organs-at-risk are beyond acceptable limit;
* With comorbidities/conditions that might influence the effectiveness of carbon-ion therapy;
* Pregnant or within lactation period;
* Drug/alcohol addiction;
* With mental disorder that might impede the completion of therapy.
AI-assisted cEEG Diagnosis of Neonatal Seizures in Neonatal Intensive Care Unit

A diagnostic accuracy study on Artificial intelligence assisted continue EEG diagnostic tool is to carried out comparing with manually EEG interpretation as the golden standard for neonatal seizure.

The occurrence of neonatal seizures may be the first, and perhaps the only, clinical sign of a central nervous system disorder in the newborn infant. The incidence of neonatal seizures is variable based on gestational age. The etiology of seizures may indicate the presence of a potentially treatable etiology and should prompt an immediate evaluation to determine the cause and to initiate etiology-specific therapy. Importantly, the earlier treatment of seizures positively affects the infant's long-term neurological development. However, even when continue electroencephalogram (cEEG) monitoring is available, the availability of on-site expertise to interpret cEEG signals is limited and in practice, the diagnosis is still based only on clinical signs. The previous study indicated that the reliable seizure detection was as little as 10% of seizure events. Therefore, an early automated seizure detection tool has been developed based on machine learning. The lack of an automated seizure detection tool has been validated in the external neonatal seizures cohort. The evidence on the utility of the automated seizure detection tool remains uncertain. This is a prospective, continuous double-blind designed diagnostic accuracy study. The study aims to validate the accuracy of the artificial intelligence (AI)-assisted cEEG diagnostic tool comparing the manually cEEG interpretation as the golden standard of neonatal seizure in neonatal intensive care units. Analysis of sensitivity and specificity is to evaluate the accuracy of AI-assisted cEEG diagnostic tool.

Eligibility Criteria:
Inclusion Criteria:

* Postnatal age \< or = 28 days;
* cEEG monitoring at least 12hours monitoring;
* Suspected seizures;
* Risk of Intracranial hemorrhage;
* Abnormality of MRI or ultrasound before cEEG;
* Neonates diagnosed with encephalopathy or suspected of encephalopathy;
* Hypoxic-ischemic encephalopathy or suspected hypoxic-ischemic encephalopathy;
* Metabolic disturbances (Hypoglycemia, Hypocalcemia, Hypomagnesemia, Inborn errors of metabolism);
* Central nervous system (CNS) or systemic infections;
* Postsurgical neonatal within 3 days;
* Suspected genetic disease or Positive genetic diagnoses;

Exclusion Criteria:

* The neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for cEEG monitoring during hospitalization.
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy

In the first part of the the study two new outcome measurements (force reproducibility and subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be assessed.

In a second part of the study 60 patients will be randomly allocated to two groups. Group A (n=30) will perform a traditional training program and group B (n=30) will perform an eccentric training program.

Before the onset of the training programs, pain, function, maximal force, range of motion, subacromial space and force reproducibility will be assessed. Both training programs will be accomplished at home. The first six weeks there will be an appointment with the therapist once a week to explain, correct and when necessary, aggravate the exercises. The next six weeks these appointments will be diminished to once every two weeks.

After 6 and after 12 weeks of training the patients will be reassessed for all the parameters.


Eligibility Criteria:
Inclusion Criteria:

* global tendon thinning
* inhomogeneous echo partitioning
* calcifications at the insertion
* symptoms present for at least 3 months: painful resisted isometric abduction, painful palpation of the supraspinatus tendon, impingement tests positive

Exclusion Criteria:

* documented full thickness rotator cuff rupture
* other lesions than CRCT at the moment of the study
* echographic criteria for ruptures (focal thinning, fluid-filled gap,compressibility)