cyrilzakka/clinical-trials huggingface dataset:
Effect of Early Implementation of Prone Positioning

Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.

Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.

Methodology: This retrospective study was conducted on critically ill patients needing mechanical ventilation with lung protective strategy and admitted to the Intensive Care Units of Al-Azhar University Hospitals between March 2020 to April 2022. All patients in the study were interpreted retrospectively by examining the patient's records. Group A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation, and Group B (n:31) included patients who had not been placed in prone positions. All patients received a lung protective strategy for ARDS. In both groups, PaO2, PaCo2, PH, SpO2, and PaO2/FiO2 ratio were checked initially and later every 24 hours for 6 days. All patients were evaluated for the total days of both hospital and ICU length of stay, number of successful discharges to home from the hospital, and the total number of tracheostomized patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients of both sexes.
* Aged from 18 to 70 years.
* Body Mass Index (BMI) from 25 to 35 kg/m2.
* Critically ill due to ARDS resulting from COVID-19 pneumonia.

Exclusion Criteria:

* Patients who spent more than 24 hours on mechanical ventilators before enrolment in the study.
* Patients who died within the first 24 hours of presentation.
* Patients with advanced cancer.
* Pregnant patients.
Evaluating the AMH Levels During Natural Cycle

To describe AMH serum levels dynamics during natural cycle using an automated assay.

The potential benefit would be using an automated assay for AMH, the dynamics of serum levels during the natural cycle and to check the inter-cycle variations.

Because of the many clinical decisions that are based on AMH levels alone the results of this study could bring reassurance to the continuous use of AMH in daily practice. More importantly, no studies to date have been performed on the newer automated assays evaluating variability of AMH levels.

Eligibility Criteria:
Inclusion Criteria:

* Women with written informed consent.
* Women between ≥ 18 and ≤ 37 years of age.
* BMI between 18 and 28.
* Normal physical examination and pelvic exam.

Exclusion Criteria:

* Pregnancy.
* Breastfeeding.
* History of any disease/iatrogenic intervention which could have had an impact on the ovarian reserve (e.g. ovarian surgery, chemotherapy, radiation of the pelvis, endometriosis)
* Intake of OCP for the two last menstrual cycles.
Hip Peak Torque in Running and Jumping Activities in Healthy Active Subjects

Hip-related groin pain is common in sports that involves change of direction, kicks and sprint accelerations such as football, ishockey, tennis and basketball. Groin pain symptoms either pre- or post-treatment may be load-related, there is limited information on how different sporting activities affect hip joint loading. Thus, the purpose of this explorative cross-sectional study is to investigate hip peak torque in running and jumping activities in healthy active subjects.

Such information may guide furture rehabilitation strategies and return to sport sport criteria.

Twenty healthy subjects from the Capital Region of Denmark with an age of 18-40 will be included.

Hip joint kinetics and kinamatics will be obtained during the following activities for each subjects:

1. Walking
2. Jogging (8-11 km/h)
3. Maximal 6 meters sprint acceleration
4. Single leg drop jump from 35 cm height
5. Horizontal jump with single leg landing with a distance of 100% and 150% of leg length
6. Maximal change of direction at 45, 135, 180 degrees
7. Single-leg cross-country skiing exercise


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are healthy and physically active.

Exclusion Criteria:

* Any history of lower limb surgery or fracture
* Lower limb injuries, joint or muscle pain with a duration of more than 6 weeks within the past year.
* Body Mass Index more than 30 kg/m2
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as sargramostim may protect normal cells from the side effects of radiation therapy.

PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.

OBJECTIVES:

* Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma.
* Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status, analgesic use, and days in the hospital.

OUTLINE: This is a randomized study.

Patients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins.

* Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14 of the course of radiotherapy.
* Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is healed, as well as at weeks 2 and 6 following the end of radiotherapy.

PROJECTED ACCRUAL: A total of 34 patients (17 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of laryngeal cancer with intention to treat by radiotherapy using a 16 fraction 3 week scheme

  * Stage I or II
* No known CNS disease

PATIENT CHARACTERISTICS:

Age:

* 20 to 80

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Hepatic function normal

Renal:

* Renal function normal

Other:

* Not pregnant or nursing
* No serious active infection requiring antibiotic therapy
* No autoimmune disease
* No known seizures
* No psychosocial factors that would preclude study compliance
* No allergies to sargramostim (GM-CSF)
* Willingness to cooperate for regular mirror examination of the larynx

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunotherapy

Chemotherapy:

* No concurrent chemotherapy

Endocrine therapy:

* No prior or concurrent corticosteroids
* No concurrent hormonal therapy

Radiotherapy:

* See Disease Characteristics

Surgery:

* No major organ allografts

Other:

* No other concurrent investigational drugs
Contribution of 3D Printing in Anatomical Lung Segmentectomies.

The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.

Between 28.10.2020 and 05.10.2021, we successively included all anatomic segmentectomies performed by full thoracoscopy in our department, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

We performed a prospective randomized controlled pilot trial on 2 parallel arms:

* The "Digital" arm
* The "Digital+Object" arm.

Eligibility Criteria:
Inclusion Criteria:

* all anatomic segmentectomies performed by full thoracoscopy, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

Exclusion Criteria:

* S6 segmentectomies
* S4+5 left bisegmentectomy
* Patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.
Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)

Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils.

The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients who met the diagnosis of major depressive episode (MDE)
* Patient right-handed
* Men and women aged over 18 years with major depressive episode IV (DSM-IV criteria), isolated or recurrent.
* Scores on the scale MADRS\> 20
* Resistance Criterion defined as the failure of two antidepressants effective dose for a minimum of six weeks.
* Drug Therapy stable for at least 2 weeks

Exclusion Criteria:

* Bipolar disorder type I or type II
* Depression With Psychotic Features
* Diagnosis according comorbid Axis I (DSM IV) with schizophrenia, alcohol abuse and / or toxic substances.
* Inpatient under stress or under legal protection measure (guardianship, curatorship)
* Counter to the practice of Transcranial Magnetic Stimulation : a personal history of seizure, history of neurological or neurosurgical pathologies, metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.).
* Pregnant or breastfeeding ongoing.
* Somatic disorder may affect cognitive abilities and brain structures
* Known allergy to any component of Fludeoxyglucose
Dual-task Training in Children With Cerebral Palsy

There are studies investigating the dual-task effect in sitting, standing up without sitting and walking in children with spastic CP. Some of these studies investigated motor-motor, some of them motor-cognitive dual-task states, and children with CP were compared to typically developing children. In all these studies, it is clearly seen that children with CP have more dual-task complexities than their typically developing peers. Some of these studies draw attention to dual-task education in children with CP. However, other than a randomized controlled study and a case report in the literature, we did not find any studies investigating the effectiveness of dual-task training in children with CP. When the literature is examined in detail, there is no study that examines the effect of dual-task exercise programs on walking activities and children's participation in daily life in children with CP.

This study has been planned based on this deficiency in the literature. Based on ICF, This study has been planned dual-task training for children with CP.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with cerebral palsy,
* Having spastic type unilateral and bilateral involvement,
* Being between the ages of 7-18,
* Being GMFCSS Level I and Level II,
* Continuing normal education (not being a mainstreaming student),
* Not having any surgical operation involving the musculoskeletal system in the last 6 months,
* Not having Botulinum Toxin application in the last 6 months.

Exclusion Criteria:

* Failing to accomplish the cognitive task (starting from a number between 0-100 and not counting back 1 each)
* Being a behavioral problem that makes it difficult to participate in the study,
* Inability to walk without support
Becker Muscular Dystrophy - A Natural History Study to Predict Efficacy of Exon Skipping

This is a multi-center natural history study that will be conducted at participating centers in the Cooperative International Neuromuscular Research Group (CINRG). Following a baseline evaluation, participants will have three follow-up visits over a three-year period. The investigators will characterize the Becker muscular dystrophy phenotype, and correlate specific abnormal dystrophin proteins with the range of clinical outcomes.

We will utilize the Cooperative International Neuromuscular Research group (CINRG) network to collect cohorts of Becker muscular dystrophy (BMD) patients with in-frame deletions in the dystrophin gene. We will collect clinical data across multiple body systems and correlate these findings to the high-resolution deletion break-point mapping performed from the tissue samples. We will investigate the observed variability to deepen our understanding of molecular mechanisms relevant to the optimization of exon skipping therapeutic approaches.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 4 or older
* Diagnosis of BMD with an in-frame deletion in the dystrophin gene, where the boundaries of the mutations are confirmed.

Exclusion Criteria:

• Investigator assessment of inability to comply with protocol
Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection

The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).


Eligibility Criteria:
Key Inclusion Criteria:

1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as assessed by a central reading center
2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
3. Willing and able to comply with clinic visits and study-related procedures.
4. Provide signed informed consent.

Key Exclusion Criteria:

1. Evidence of CNV due to any cause other than AMD in either eye
2. Prior IVT anti-VEGF in the study eye
3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
4. Any history of macular hole of stage 2 and above in the study eye
Comparison Between HD+ Endoscopy and Standard Videoendoscopy in Screening Colonoscopy

Colonoscopy is the accepted gold standard for screening of colorectal cancer. However, small and flat neoplastic lesions might be overlooked with standard video endoscopes. The new available EPKi system (Pentax, Japan) enables with HD+ imaging resolution above HDTV standard. Aim of the study was to test the efficacy of HD+ colonoscopy alone and in conjunction with I-Scan (newly developed post processing digital filter)in comparison to standard videoendoscopy


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients scheduled for screening colonoscopy

Exclusion Criteria:

* Inflammatory bowel disease
* Cancer
* Pregnancy
* Inability to obtain informed consent
* Prothrombin time \< 50% of control
* Partial thromboplastin time \> 50 seconds
Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.

The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* previous IBP
* concurrent medical conditions (e.g. diabetes, constipation)
* medications (e.g. opioids and tricyclic antidepressants)

Exclusion Criteria:

* previous colonic resection
* patients with IBD
* active CRC
* chronic kidney disease at any stage
* congestive heart failure at any stage
* liver cirrhosis
Increasing Optimal Use of HPV Vaccination in Primary Care

Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.

The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation.

The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.

Eligibility Criteria:
Inclusion Criteria

Practices:

* Community-based pediatric primary care practices with 2 or more providers.
* Providers who deliver wellness care to preteens and adolescents.
* Willingness to participate in the practice facilitator-guided QI process.

Providers:

* Providers who deliver wellness care to preteens and adolescents.
* Willingness to complete study questionnaires.
* Willingness to participate in the practice facilitator-guided QI process.

EXCLUSION CRITERIA

* Practices and providers may be excluded at the discretion of the PI.
"THE EFFECTS OF LOW LEVEL LASER THERAPY VERSUS STRAIN/COUNTER STRAIN TECHNIQUE IN ACUTE SOFT TISSUE INJURIES"

Muscle strain injuries are common in sports but are often misdiagnosed and maltreated.

Their significance is often underestimated because most athletes can continue their daily activities soon after the injury. Proximal hamstrings strains have attracted greater attention because they have a high incidence which is approximately 42%.

it will be randomized control trial with 60 patients with Acute hamstring Injuries divided into 3 groups. One group will be given Laser therapy, 2nd will be given Strain/Counter Strain technique and 3rd will be given both the techniques in combination This study will be conducted in Rehabilitation setup of Pakistan Hockey Federation Lahore, and Institute of Orthopedics and Rehabilitation Center Garden Town Lahore. Non probability Convenience Sampling technique will be utilized

Eligibility Criteria:
Inclusion Criteria:

hamstring injury patient with grade 2 or 1 both male and female local tenderness on palpation pain with resisted knee flexion pain with resisted hip extension pain on stretching of effected area

Exclusion Criteria:

* patient with fracture
* patient with grade 3 orthopedic condition like ankylosing spondylitis medically unstable
Phagenyx® Registry Study

A retrospective, open-label, matched-control registry study designed to characterize the effectiveness of Pharyngeal Electrical Stimulation (PES) to improve swallowing in patients with severe dysphagia post stroke when delivered using the Phagenyx® System in real-world clinical settings in hospitals in the United States of America (US).

The study will consist of a Treatment Group and a Control Group. The Treatment Group will include patients who have undergone PES treatment for severe dysphagia. The Control Group will consist of patients that qualify for PES treatment but are not treated with PES in the time period prior to implementing PES. Patients will be treated per standard of care at each institution. Each Treatment patient will receive treatment with PES in addition to other standard of care dysphagia therapies. Control subjects will receive standard of care dysphagia therapies only (no PES or other electrical stimulation therapies for dysphagia are permitted). Performance of the Phagenyx® System will be analyzed by comparing treatment outcomes for patients in the PES Group compared to patients in the Control Group.

The study will include patients with severe dysphagia post stroke. The main clinical outcomes will be assessed using the participating sites' standard of care methodology and will evaluate improvements in swallowing and reduction in associated treatments and complications.

Eligibility Criteria:
Inclusion Criteria:

1. Phagenyx® System Group Patients: Patients underwent treatment with the Phagenyx® System for a minimum of 3 treatments.
2. Control Group Patients: Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment.
3. Willing and able to provide appropriate informed consent (if required).

Exclusion Criteria:

1. Primary endpoint outcome data not collected or not available.
2. In the investigator or sponsor's opinion the patient is not considered suitable.
3. Participation in another interventional study (medicinal or device) that could influence the outcomes of PES.
4. Treatment of dysphagia with other forms of electrical stimulation.
Implementation of Standing Desks at School

Since sedentary time is related to various health outcomes and is already highly prevalent in childhood and adolescence, effective strategies are needed to tackle this health problem. Children and adolescents spend the majority of the day in a classroom while sitting at a desk. Therefore, the classroom is an important setting for implementing specific strategies to reduce sedentary time.

One of the strategies that gained more attention during the past years is replacing traditional desks and chairs with standing desks.

This project evaluates the implementation of standing desks in primary and secondary schools via a clustered randomized controlled trial using an intervention and control condition. Effects on sedentary time during in class, sedentary activities during leisure time, breaks in sedentary time, and related determinants (secondary outcomes) are evaluated.

Next to effect evaluation, it is also equally important to evaluate how teachers and pupils perceive this change in the classroom environment. Both groups need to be positive in order to obtain the adoption and sustainability. Therefore, focus groups with pupils and interviews with teachers are conducted, with a specific focus on the perceived barriers. Moreover, the process evaluation is conducted quantitatively as well by using questionnaires in pupils and teachers.

The project results will lead to recommendations on how to broadly implement standing desks into primary and secondary schools.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pupils of primary schools (5th grade) and secondary schools (10th grade)