cyrilzakka/clinical-trials huggingface dataset:
Effect of Joint Mobilization on Alpha Motoneuron Reflex Excitability

Objective: To determine the effect of ankle joint mobilization on the alpha motoneuron reflex excitability of the soleus muscle in people with spasticity.

Subjects and Methods: A controlled clinical trial with crossover design and simple masking was conducted in 24 randomized subjects to initiate the control or experimental group. Traction and rhythmic oscillation were applied for five minutes to the ankle joint. Alpha motoneuron reflex excitability was assessed by measuring H wave amplitude (Hoffmann reflex - H reflex), stimulating the tibial nerve at the level of the popliteal fossa and recording in the soleus muscle. In each subject 12 measurements were taken: basal rate, during and after mobilization. Changes in alpha motoneuron reflex excitability were calculated in relation to basal measurement. For each measurement a hypothesis test was performed (Student t test).

Results: In groups of patients with brain injury (BI) and incomplete spinal cord injury (ISCI), a significant difference was found between measurements of both studies, concerning variation in alpha motoneuron reflex excitability during the application of joint mobilization techniques, with a decrease in the experimental group and an increase in the control group. In contrast, no significant differences were found after mobilization therapy. Patients with complete spinal cord injury (CSCI) showed no significant differences in any measurements.

Conclusion: We demonstrate the effectiveness of passive movement in the decrease of muscle tone during the mobilization maneuver in patients with BI or ISCI, but no residual effect after completion of the trial. This research project showed no evidence regarding spasticity reduction in complete spinal cord injuries. This suggests that therapeutic interventions to decrease muscle tone, based on the passive exercise and stimulation of proprioceptors should be reconsidered.


Eligibility Criteria:
Inclusion criteria:

* people over 18 years old
* spasticity acquired after five years of age
* any etiology
* any location of the injury

Patients were instructed not to consume coffee, cigarettes or energy drinks 24 hours prior to the study nor participate in excessive physical exercise during the day.
A Trial to Reduce Delirium in Aged Post Acute Patients

The purpose of this study is to develop a comprehensive Delirium Abatement Program of care of delirious patients in the post acute care setting and to evaluate its impact on persistence and severity of delirium and on functional recovery.

Common, morbid, and costly, delirium affects one third of hospitalized elders, and plays a central role in the cascade of adverse events that leads to functional decline and loss of independence. Moreover, as acute care stays continue to shorten and evidence mounts that delirium may persist for many weeks, concern about delirium can no longer be confined to the hospital. It is believed that a Delirium Abatement Program may significantly reduce the persistence of delirium in post-acute settings, and thereby improve functional recovery both during the post-acute stay and after discharge.

The Delirium Abatement Program (DAP) will be designed to assist facility staff to 1) detect delirium among new admissions, 2) evaluate common underlying causes of delirium, 3) prevent complications commonly associated with delirium, and 4) restore delirious patients' cognitive, behavioral, social and self care functioning to baseline status.

This three year trial will enroll 500 delirious patients admitted to eight Boston area post-acute skilled nursing facilities. The DAP intervention will be carried out in four facilities. Four other facilities, matched to the intervention by demographic, facility, and clinical characteristics, will serve as controls. Patients will be recruited within 72 hours (maximum 120 hrs) of admission, assessed weekly while in the facility, and at one, three, and six months following admission.

Eligibility Criteria:
Inclusion Criteria:

* Admission to study site following acute care medical/surgical hospitalization
* Aged 65 or older
* English-speaking
* Communicative prior to acute illness
* Not admitted for terminal care (life expectancy greater than 6 months)
* Residence within 25 miles of research site

Exclusion Criteria:

* Significant hearing impairment which precludes interviews
* End stage dementia (complete ADL dependence)
* Previous study enrollment
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.

This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second baseline measurement, all subjects will be randomized to upper-extremity rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP) followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance training (Power) followed by FTP. Re-evaluation will occur following each block of treatment,and retention effects will be evaluated after 6 and 12 months with no additional treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical Neurology and Rehabilitation, a battery of biomechanical performance measures including: strength, muscle activation, reflex modulation, and motor coordination, and with kinematics of free reaching movements. The researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cerebrovascular accident
* Single event
* Unilateral hemiplegia
* Between 6 months and 18 months post-event
* Impairment of upper-extremity function
* Ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist
* At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers
* Cognitive ability to follow 3-step commands

Exclusion Criteria:

* Unstable or uncontrolled blood pressure
* Uncontrolled seizures
* Flaccid hemiplegia
* Severe cognitive impairment
New Procedure to Reduce Mother-newborn Separation

The goal of this single-centre interventional study without medication neither device (for procedure) is to limit the separation between mother and newborn by implementing a new procedure for the management of the newborn with respiratory distress in the delivery room.

The main questions it aims to answer are:

* Is it possible to reduce Neonatal Intensive Care Unit admissions within 24 hours of life by applying this new procedure, thus limiting separation between mother and newborn?
* Does the implementation of this procedure, reducing mother-newborn separation, improves the rate of exclusive breastfeeding?

Newborns with respiratory distress at birth will be evaluated in the delivery room in a dedicated pre-heated incubator, providing additional oxygen if necessary. In case of improvement they will be reunited with the mother, in case of worsening a thoracic ultrasound will be performed to assess the severity and possible hospitalization in Neonatal Intensive Care Unit

This procedure provides that newborn infants, who at 15 minutes of life manifest tachypnea or respiratory distress (that responds to supplementary oxygen with FiO2 \<30% and without the need for mechanical ventilation) they are placed in a preheated incubator with the required oxygen concentration (if necessary) and carefully monitored by medical and nursing clinicians. A clinical evaluation will be carried out every 15 minutes, with the detection of vital parameters, such as heart rate, oxygen saturation and respiratory rate. In case of clinical improvement and suspension of oxygen therapy, the newborn will be transferred to the Neonatal Observation Ward to perform multiparameter monitoring of vital signs up to 6 hours of life and then be reunited with the mother. In case of clinical worsening, a bedside thoracic ultrasound will be carried out and depending on the result and the Lung Ultrasonography score, it will be evaluated whether to continue the observation in the delivery room or hospitalize the newborn in the Neonatal Care, Neonatal Sub-Intensive Care or Neonatal Intensive care Units.

Eligibility Criteria:
Inclusion Criteria:

* Infants born by elective cesarean section, with gestational age ≥34 weeks, weight at birth ≥2000 grams, manifesting mild respiratory distress with need for oxygen at FiO2 ≤30%
* Signature by both parents of an informed consent

Exclusion Criteria:

* Multiple pregnancy
* Need for invasive respiratory assistance
* Need for resuscitation at birth
* Criteria for perinatal asphyxiation
* Fetal pathology
* Failure by both parents to sign up for informed consent
Effects of a Scapular-focused Exercise Protocol

Background: Current clinical practice still lacks consistent evidence in the physiotherapy management of Rotator cuff related pain syndrome (RCS). The purpose of this trial was to compare the effectiveness of a scapular-focused treatment with and without real-time electromyographic biofeedback (EMGBF) to a control therapy in patients with RCS.

Methods: 60 patients with RCS were divided into three groups: scapular-focused exercise protocol group (P_G n=20), scapular-focused exercise protocol with EMGBF group (P+EMGBF_G n=20) and control therapy group (CT_G n=20). Values of pain and function \[Shoulder Pain and Disability Index (SPADI) questionnaire, complemented by the Numeric Pain Rating Scale (NPRS) and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire\], scapular stabilizer neuromuscular control (SSNC), scapular stabilizer activation onset (SSAO), dynamic scapular alignment, range of motion (ROM) and glenohumeral flexor and abductor muscle strength (GMS) were assessed at baseline and after 6-weeks and compared within and between groups.

In order to advance the understanding of the value of scapular-focused exercise for rotator cuff related syndrome, a new trial was designed with the main objective of comparing pain and function outcomes between three different treatment protocols for patients with RCS:

P_G - Scapular-focused exercise protocol without electromyographic biofeedback (EMGBF) P+EMGBF_G - Scapular-focused exercise protocol supported by real-time EMGBF CT_G - Control therapy group with manual therapy (glenohumeral joint physiologic and accessory mobilization) , massage to reduce upper trapezius (UT) stiffness, and shoulder rotation strengthening into external rotation Every outcomes was assessed at the beginning of treatment, and then, weekly until completed 6 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1- age between 18 and 60 years; 2 - primary complaint of shoulder pain 3 - RCS clinical diagnosis

Exclusion Criteria:

1. - neurological symptoms;
2. - positive thoracic outlet syndrome (screened with Allen's and Adson's tests);
3. - history of shoulder surgery or fracture;
4. - structural injuries confirmed by imaging (e.g. ligaments and labrum);
5. - symptoms reproduced by cervical examination;
6. - unable to commit to scheduled treatments;
7. - Anti-inflammatory drug use
Covid-Intervention-Study

The goal of this invention study is test and compare short-term manual-based psychosocial group interventions in die Austrian population suffering from stresses and strains due to the Covid-19 Pandemic and other crises.

The main question it aims to answer: Does short-term manual-based psychosocial group interventions improve the mental well-being of the participants?

Participants will attend weekly a manual-based group (8 weeks) and answer online-questionnaires and surveys (pseudonymized).


Eligibility Criteria:
Inclusion Criteria:

* above 18 years with psychosocial stresses and strains due to covid-19 pandemic and other crises

Exclusion Criteria:

* suicidal tendency
* insufficient knowledge of the German language
* psychotic episode
* no internet-access
Eosinophilic Cationic Protein as a Biomarker in Diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow. It is changed to acute exacerbation of Chronic obstructive pulmonary disease when respiratory symptoms worsen, beyond normal day-to-day variations, severely enough that changes in medication are required.

Inflammation is a core feature of acute exacerbation of Chronic obstructive pulmonary disease since it gives insight into the pathological changes causing an exacerbation. Eosinophils may play a significant role in airway inflammation in some patients with Chronic obstructive pulmonary disease.

Previous studies have indicated that eosinophilic airway inflammation is also associated with the development of severe acute exacerbation of Chronic obstructive pulmonary disease. Eosinophilic Cationic Protein has various biological activities, including antibacterial, antiviral, antiparasitic and neurotoxic functions, and it contributes to the regulation of fibroblast activity. Eosinophilic Cationic Protein also induces airway mucus secretion and interacts with the coagulation and complement systems. Eosinophilic Cationic Protein has been developed as a marker for eosinophilic disease and quantified in biological fluids including serum, bronchoalveolar lavage and nasal secretions. It is found in diseases such as allergic asthma and allergic rhinitis but also occasionally in other diseases. Only activated eosinophil granulocytes release the granule content and therefore the determination of Eosinophilic Cationic Protein concentration is a considerably more specific indicator of eosinophil inflammation than eosinophil granulocyte count in peripheral blood as serum Eosinophilic Cationic Protein levels increase during acute exacerbation of Chronic obstructive pulmonary disease


Eligibility Criteria:
Inclusion Criteria:

* clinical features of Chronic obstructive pulmonary disease
* spirometry compatible with the GOLD criteria (Forced expiratory volume 1/ Forced vital capacity \<70%) post bronchodilator.

Exclusion Criteria:

* Patients with bronchial asthma
* Asthma -Chronic obstructive pulmonary disease overlap syndrome
* Atopic patients
* Pneumothorax
* Congestive heart failure
* Cancer of any kind
* A history of major surgery in the preceding 4 weeks.
* Patients undergoing mechanical ventilation or presenting with azotaemia (serum creatinine \>1.5 mg/dl).
Short and Medium Term Postoperative Complications After Hallux Valgus Surgery

The aim of this study is to make a precise inventory of the complications that may occur postoperatively in the more or less long term in a cohort of patients who should benefit from surgical management of Hallux Valgus.

Hallux Valgus surgery is one of the most common foot surgeries. The surgical procedure itself has evolved a lot and is now, in almost all cases, on an outpatient basis with greatly improved pain management.

However, various postoperative complications, more or less severe and more or less long term, can worsen the final result. The literature describing these complications comes mainly from meta-analysis, retrospective studies or studies targeting a particular type of complications.

As a result, there are few complete and objective descriptions of these complications.

In addition, studies reporting postoperative consequences always assess the "serious" long-term complications responsible for a poor functional outcome, primarily the recurrence of the initial deformity, defined as surgical failure. It seemed relevant to try to assess early complications, "less serious", not necessarily worsening the final result but directly impacting the postoperative recovery period.

The evaluation of this recovery period and the length of time off work based on these "less severe" complications could improve the quality of surgical management of hallux valgus.

This is why it seemed interesting to carry out a precise inventory of the complications that may occur postoperatively in the more or less long term in a cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with medical insurance.
* Patient who recieved information about study and signes a consent to participate in the study.
* Major patient requiring surgical management of a Hallux Valgus.

Exclusion Criteria:

* Minor patient.
* Patient participating in another interventional study.
* Patient with one of the following pathologies: Rheumatoid arthritis, haemophilia, inflammatory rheumatism or neurological spasticity.
* Patient to undergo a one-step bilateral Hallux Valgus surgical treatment (surgery of both feet on the same day).
* Patient refusing to sign the consent form.
* Patient for whom it is impossible to give informed information.
* Patient under the protection of justice, under curatorship ou under tutorship.
Pediatric Helmet CPAP Pilot Study

This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.

Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in infants, and no major safety concerns were identified with the use of helmet CPAP. This is a prospective pilot study to (1) determine if infants and pediatric patients requiring CPAP in the PICU will tolerate helmet CPAP for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. If helmet CPAP is found to be well tolerated in this small cohort, a larger study comparing it directly to other CPAP interfaces will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.

Exclusion Criteria:

* Age less than 1 month or greater than 5 years
* Positive for COVID-19
* Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
* Unresponsiveness (GCS 8 or less)
* Hypotension as defined as a systolic blood pressure less than 5th percentile for age
* Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure
* Non-English speaking parent
SimuVersity Medical Center: Pain and Opioid Management Training in Diverse Patient Populations

This study aims to compare the effectiveness of the new educational activity/game (a novel, engaging digital-training plus interaction with virtual patients to practice skills) in meeting clinical learning objectives and outcomes compared to traditional didactic (powerpoint slide-based training and text-base case scenarios) approaches to provider and student education and satisfaction.

Management of chronic pain and opioid use/misuse is challenging for clinicians and students, especially when working with diverse and underserved patient populations, and very few low-cost, flexible, highly-engaging, and effective learning resources are available to help the healthcare workforce best learn to manage these unique health concerns. Gamification holds promise as a user-friendly, fun, engaging and effective teaching strategy, especially for healthcare applications. SimuVersity Medical Center is an immersive 3D gaming platform that will engage students and practicing clinicians in a unique and captivating learning experience focused on pain and opioid management in diverse patient groups.

SimuVersity Medical Center is an innovative platform solution to education and training in specialty topics in healthcare. This novel learning platform will permit learners to explore a 3D virtual hospital space and can interact with objects, virtual colleagues/trainers and virtual patients (imbued with artificial intelligence) to learn and practice new clinical skills. The platform is built for ease-of-use with simple character controls that non-game-savvy learners find intuitive and easy. The graphical interface is clean and clear and the software runs on all modern computing platforms. The control intervention consists of traditional powerpoint slide-based training and text-base case studies for review.

This study aims to compare the effectiveness of the new educational activity/game (a novel, engaging digital-training plus interaction with virtual patients to practice skills) in meeting clinical learning objectives and outcomes compared to traditional didactic (powerpoint slide-based training and text-base case scenarios) approaches to provider and student education and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-80 years
2. English-speaking
3. Graduate-level health professional students and faculty at the Medical University of South Carolina
4. Willingness to volunteer to play the new educational game and complete questionnaires regarding satisfaction, knowledge acquisition, value, ease of use and ability to meet learning objectives

Exclusion Criteria:

1. Age outside the predefined range
2. Not a student or faculty at MUSC
3. Not willing or able to participate in the learning activity or complete study related questionnaires.