cyrilzakka/clinical-trials huggingface dataset:
Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting

Occupational therapy services will be integrated into an interactive vaulting program which is an equine assisted activity. Children with disabilities ages 5-17 will participate. The objectives of this study are to determine the influence of a collaborative occupational therapy interactive vaulting program on the executive function and social participation in children with disabilities.

Investment by researchers has been made, however, little research exists that systematically evaluates the effectiveness of occupational therapy (OT) interventions in equine assisted activities, and none have included interactive vaulting. Research that has been conducted has supported the use of equines in OT treatment sessions (hippotherapy) in increasing length of time engaged in activities, compared to conventional therapy as well as improvements in postural sway, adaptive behaviors, and participation. In addition, it has been found that children with visual impairments who participated in a 6-week EAT program demonstrated clinically significant changes in occupational performance and qualitative themes of peer interaction, taking on challenges and overall satisfaction with the program.

The gaps in research warrant investigation into the efficacy of this intervention in the development of executive functioning and social skills in children with disabilities. Further research needs to be conducted to determine the effectiveness of occupational therapy in this context. Occupational therapy interventions will be integrated into the existing program. Group interventions will target the emotional awareness and regulation, social skills, and use cognitive strategies to improve social interactions with peers and adults.

Eligibility Criteria:
Inclusion criteria

Children must:

* have a documented developmental disability
* be eligible only to participate in equine assisted activities.
* be ambulatory with or without an assistive device
* be able to follow 2-3 step directions
* not be aggressive toward animals, peers, or staff

Exclusion criteria:

Children who:

* do not have a documented developmental disability
* are ONLY eligible for equine assisted therapy because of significant physical and/ or medical limitations (i.e.: occupational, physical, or speech therapy).
* are non-ambulatory
* are unable to follow 2-3 step directions
* are aggressive towards animals, peers, or staff
* does not have a developmental disorder (i.e.: has only mental health disorder)
Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy

The purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling.

The investigators will investigate the tastes (umami, bitter, salty, sweet and sour) that the patients prefers in order to increase the energy intake and reduce the risk of weight loss and loss of fat-free mass for patients with hematological cancer.

The study will be conducted as a single blinded randomized controlled trial. 40 patients will be recruited, and will be divided into two groups; the intervention group and the control group. The patients will not know which group they belong to.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to understand the "Participant Information" paper
* Diagnosed with hematological cancer
* Must be undergoing chemotherapy (at least one treatment during the study)
* Outpatient
* Be able to take pictures of meals (and send to the sub-investigators)
* Be able to speak and read the danish language

Exclusion Criteria:

* Pacemaker
The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

This multi-center, open-label, randomized controlled trial aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients.

In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition to the treatments in the control arm, hemoperfusion will be conducted at least once every two weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram, echocardiography, heart function rating (based on New York Heart Association grading). Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be assessed according to the international conference on harmonization guidelines. The primary outcomes will include 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life (Kidney Disease Quality of Life Short Form).

Eligibility Criteria:
Patients must meet all of the following criteria are eligible:

1. Age ≥ 18 years old
2. Regular blood purification treatment at least 3 months before enrolled in this study

3) Standard Kt/V ≥ 1.2

Subjects with one of more of the following conditions will be excluded:

1. White blood cell count \< 4×10\^9/L and / or platelet count \< 100×10\^9/L
2. Cerebral hemorrhage in the past 12 weeks
3. MACEs in the past 8 weeks
4. Severe heart failure (New York Heart Association \[NYHA\] class IV)
5. Active gastrointestinal bleeding, or coagulation dysfunction
6. Malignant tumor
7. Active infection
8. Pregnancy or lactation 9) Mental disabilities
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2

Compared to U.S. urban counterparts, rural residents face major barriers to using health care services. Challenges include shortages of services, long distances to existing services, and stigma regarding mental illness in isolated communities. These difficulties hold true for Montana, but especially for adolescents. The objective of A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana is to improve stress-related mental and physical health outcomes for adolescents and educators in rural Montana through school-based, trauma-informed yoga exercises. This project builds on investigators' previous research (including a two-year CAIRHE pilot study, 2019-21) to promote positive youth development by simultaneously intervening with students and teachers with a trauma-informed yoga intervention. Geographic isolation and resulting lack of resources for many Montanan schools indicates a need for novel, school-centered interventions to address the needs of rural adolescents; yoga can benefit youth and teacher wellbeing.

In Year 2, investigators will expand the study to pilot test a remote delivery for students and teachers in rural schools through virtual delivery (in addition to an in-person high school student intervention at the school district of Aim 1. Primary outcomes for teachers will assess career satisfaction/self-efficacy; primary outcomes for students will assess depression/anxiety symptomology. Effects on secondary mental/physical health outcomes will be drawn from survey results, cortisol levels, and heart rate variability measures (collected pre/post).

Investigators will then determine which intervention design was more effective with students (in-person vs. remote) between the two years of this feasibility study through an outcome evaluation. Comparisons of mental and physical health outcomes will be examined by the research team using cohort data drawn from participants' physiological data and survey results.

The short-term public health impact of this study is to improve the mental and physical health of rural Montana youth and teachers through a novel, school-based intervention. If successful, this study's long-term public health impact will reduce rates of anxiety and depression and improve physical health in geographically isolated settings.

Eligibility Criteria:
Inclusion Criteria:

* Any teacher currently employed by the Livingston or Gardiner school district who wishes to participate in the intervention (up to 45 participants)
* Any freshmen student enrolled in pre-selected PE classes at Park High School in Livingston Montana
* Any PE student enrolled in pre-selected PE classes at Gardiner High School in Gardiner Montana

Exclusion Criteria:

* Any students that are not enrolled in pre-selected PE classes at Park or Gardiner High Schools in Southwest Montana
Less Invasive Beractant Administration in Preterm Infants

The aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants \<32 weeks of gestation and compare short and long term outcomes with the intubation, administration of surfactant and extubation method (INSURE).

This was a single-center, prospective, open-label, non-randomized, controlled study with an experimental cohort of 30 patients treated with LISA and a retrospective control group comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was administered as exogenous surfactant in both groups if patients on nasal continuous positive airway pressure (nCPAP) during the first three days of life were needed of more than 30% of fraction of inspired oxygen inspired oxygen fraction (FiO2).


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants of less than 32 weeks of gestation (WG)breathing spontaneously on nCPAP during the first three days of life that met exogenous surfactant administration criteria (Table l) were eligible to enroll in the study

Exclusion Criteria:

* Infants who met intubation criteria (Table 1) at the moment of the surfactant administration were excluded in both groups.
Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial

The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.

This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.

Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Furthermore, the procedure times are often longer than recommended by international guidelines, and repeated intubation attempts are associated with adverse events in unstable neonates.

Objectives: To compare success and time of intubation through intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.

Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure was the intubation success rate at the first attempt. Secondary outcome measures were the total time needed for the endotracheal tube positioning (calculated as the sum of the time of device positioning in all attempts), and the participant's opinion on using the device (evaluated using a Likert scale).

Eligibility Criteria:
Inclusion Criteria:

* Level III NICU consultants and residents will be eligible to participate in the study

Exclusion Criteria:

* None
Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments

This is a real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIgraine Disability Assessment (MIDAS), Headache Impact Test short-form (HIT-6), Patient Global Impression of Change (PGIC), Hospital Anxiety and Depression (HAD) scale and Work and Personal Activities Impairment (WPAI) questionnaires at each visit.

Data describing their care will be extracted from computerized patient records.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Migraine \[International Headache Society (IHS) criteria 2013, revised 2018\] with or without aura
* Monthly number of attacks ≥ 8 for at least 3 months
* Indication for prophylactic treatment
* For eptinezumab: resistance to at least 2 conventional disease-modifying therapies
* Agrees to use data for research purposes

Exclusion Criteria:

* Vascular history: myocardial infarction (MI), unstable angina or coronary bypass surgery, stroke or transient ischemic attack (TIA), Peripheral Arterial Disease of the Lower Limbs (PAD), uncontrolled hypertension

  * Need for analgesics for a cause other than migraine
  * Difficulty in understanding French language or cognitive impairment that compromises completion of self-questionnaires.
Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis

Evaluation of the effectiveness and safety of transbronchoscopic local precision infusion of amphotericin B + transoral nebulized inhalation of amphotericin B + transbronchoscopic interventional debridement + liposomal amphotericin B + posaconazole or Isavuconazole multimodal treatment of pulmonary mucormycosis

Key rationale for the treatment of mucormycosis is early surgical intervention, including local debridement and removal of infected tissues or organs if possible. Systemic antifungal therapy is also necessary for mucormycosis, including amphotericin B liposomes and deoxycholates, Isavuconazole, posaconazole, and so on. Antifungal drug therapy has a mortality rate of up to 40%, which can be reduced to 23% when combined with surgical treatment. However, some patients who are unable to tolerate surgical procedures on the chest when in bad condition, especially patients with hematological malignancies undergoing hematopoietic stem cell transplantation, are susceptible to multiple mucormycosis of the lungs, and the mortality rate of untreated systemically disseminated mucormycosis infections is high at 80%. Isavuconazole, so we aim to explore the multimodal treatment of liposomal amphotericin B + posaconazole or esaconazole + transbronchoscopic localized precise instillation of amphotericin B + oral nebulized inhalation of amphotericin B + transbronchoscopic interventional debridement to alleviate the pulmonary mucormycosis in chest imaging and reduce the mortality rate of patients with mucormycosis infection.

Eligibility Criteria:
Inclusion Criteria:

* Subjects suspected of pulmonary mucormycosis by clinical radiology will be enrolled in the study if the pathologic or microbiological diagnosis of mucormycosis (smear showing sterile mycelium, culture or molecular evidence of mucormycosis) is confirmed.
* Cases of diffuse mucormycosis will only be included if lung infection is confirmed pathologically or microbiologically by respiratory secretions or biopsy samples.
* Ability to tolerate bronchoscopy.

Exclusion Criteria:

* Pregnant and breastfeeding female patients
* Age \<18 years
* Patients with HIV infection
* Contraindications to bronchoscopy (including platelet count \< 100 x 109/L, active hemoptysis, severe respiratory or heart failure, severe arrhythmia, unstable angina or hypertension, severe pneumothorax or mediastinal emphysema, patients with acute myocardial infarction, cerebral infarction, and cerebral hemorrhage within 3 months
* Patients unable to tolerate bronchoscopy
Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation

This study aimed to evaluate the effects of a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation. The investigators conducted a prospective, randomized, cross-over study on stable chronic obstructive pulmonary disease (COPD) patients. Patients were studied in the hospital during two non-consecutive nights while using either fixed or adaptive EPAP. The primary outcome was the transcutaneous partial pressure of carbon dioxide. Secondary outcomes were: oxygen saturation, breathing pattern, oscillatory mechanics, patient-ventilation asynchronies, sleep quality and sleep-related respiratory events.

Study design: prospective, randomized, cross-over study. Study population: moderate to severe COPD patients, long-term users of nocturnal non-invasive ventilation for chronic hypercapnic respiratory failure. Inclusion criteria: age\<85 years; presence of tidal expiratory flow limitation in the supine position at an expiratory positive airway pressure of 4 cmH2O. Exclusion criteria: COPD exacerbation within the past two months; acute illness; clinical instability.

Study protocol: Patients were studied in the hospital over 2 non-consecutive nights while using either fixed or automatic EPAP.

Ventilation strategy: pressure-controlled NIV was delivered using a non-commercial version of BiPAP Synchrony Ventilator (Philips-Respironics) via an unvented facial mask (AMARA, Philips-Respironics). The ventilator evaluated the presence of tidal expiratory flow limitation by the forced oscillation technique. In the automatic-EPAP mode, the ventilator continuously adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation, with a minimum EPAP of 4 cmH2O and keeping the pressure support constant.

Measurements: During each study night, the investigators recorded transcutaneous partial pressure of carbon dioxide and oxygen saturation (TOSCA, Radiometer) continuously. Airway opening pressure, flow and volume tracings were exported from the ventilator. Full laboratory polysomnography (Alice5, Philips-Respironics) was performed according to the American Academy of Sleep Medicine recommendations.

Data analysis: the investigators compared parameters from the two nights using Wilcoxon signed-rank test. P-values \<0.05 were considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe COPD (GOLD 2017);
* long-term users of nocturnal non-invasive ventilation for chronic hypercapnic respiratory failure;
* presence of tidal expiratory flow limitation in the supine position at an expiratory positive airway pressure of 4 cmH2O.

Exclusion Criteria:

* COPD exacerbation within the past two months;
* acute illness;
* clinical instability.
Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor

This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.

The length of the second stage (pushing stage) of labor is highly correlated with the incidence of adverse outcomes for mother and neonate. More than 80% of laboring women in the US have epidurals for labor pain management. The length of second stage labor is increased in women receiving regional anesthesia for pain management during labor and delivery compared to women without anesthesia. This increased length of labor is largely due to lack of maternal sensation resulting in decreased physiologic feedback on the efficacy of maternal expulsive (pushing) efforts. Continuous maternal feedback regarding fetal decent during labor may result in more effective maternal expulsive efforts reducing the length of second stage and improving maternal and neonatal outcomes. This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.

The study device consists of a modification of the standard fetal scalp electrode and a separate apparatus designed to detect movement of the fetal head by detecting movement of the FSE. As the patient pushes, the amount of fetal movement will be measured and recorded. The movement will be recorded by a laptop computer which will provide optical and auditory feedback to the patient about descent of the fetal head with maternal expulsive efforts.

Eligibility Criteria:
Inclusion Criteria:

1. Laboring nulliparous women who are \> 36 0/7 weeks estimated gestational age undergoing epidural or combined spinal epidural (CSE) placement for labor pain management.

Exclusion Criteria:

1. Women with multiple gestations.
2. Women with contraindications to pushing during second stage labor.
3. Women with contraindications to Fetal Spiral Electrode (FSE) placement including women with a face or compound presentation, known HIV, Hepatitis B or Active Herpes.
4. Women who do not plan to initiate pushing immediately (those who plan to "rest and descend" prior to initiation of pushing).
Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

With thyroid surgery being performed as an ambulatory procedure, most recent studies concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine in thyroidectomy, as preemptive analgesia.

The hypothesis was bupivacaine with the addition of clonidine would help in reducing postoperative pain and thereby reduce the need for postoperative analgesia.

To find out if addition of BSCPB to general anesthesia with bupivacaine with or without clonidine prolongs the time needed for postoperative analgesic and facilitate to perform thyroidectomy as a day care procedure and to see if clonidine reduces postoperative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Consenting consecutive euthyroid patients undergoing elective thyroidectomy under general anesthesia, of either genders and more than 18 years of age, belonging to the ASA class I and II.

Exclusion Criteria:

* Patients unable to understand visual analog pain score (VAS) or unable to use patient controlled analgesia (PCA).
* Patients with malignancy requiring block dissection or with substernal goiters - Contraindications to superficial cervical plexus block like allergy to local anesthetics, bleeding diatheses and local infection or sepsis.
* Contraindications to morphine like bronchial asthma and hypothyroidism.
* Sensitivity to the anesthetic agent used or intolerance to the medications used in the study.
* Patients who received steroids or opioids or other analgesics recently.
* Patients with history of stridor.