cyrilzakka/clinical-trials huggingface dataset:
Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease

The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.

This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Parkinson's Disease
* Between the ages of 50 and 75
* Ability to walk 150 feet independently over level surfaces with or without an assistive device
* Stable medication usage for the duration of the study (10 weeks)
* Obvious gait dysfunction (Observational Gait Analysis)
* Score of greater than 22 on the Short Orientation-Memory-Concentration Test

Exclusion Criteria:

* Body mass index of greater than 35
* Dorsiflexion range of motion less than neutral (90 degrees)
* Any other uncontrolled health condition for which gait training is contraindicated
Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of disability including heart failure, atrial fibrillation, and sudden death, with an annual mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among patients with established cardiovascular disease, including hypertension and atrial fibrillation and when present may contribute to worse cardiovascular outcome. Although patients with HCM do not necessarily have typical characteristics of patients with OSA, such as obesity and increasing age, there is recent evidence that OSA is extremely common among patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among patients with HCM is independently associated with worse structural and functional impairment of the heart, including atrial and aorta enlargement, worse New York Heart Association functional class, and worse quality of life. Therefore, the recognition and treatment of OSA is a new area of research that may impact in the management of patients with HCM.


Eligibility Criteria:
Inclusion Criteria:

* both genders
* over 18 years-old
* hemodynamically stable
* with no other cardiac disease
* consent form signed

Exclusion Criteria:

* presence of pacemaker
* spontaneous withdrawal
* previous cardiorespiratory arrest
* atrial fibrilation during echocardiography
Gabapentin for Carpal Tunnel Syndrome

The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).

A variety of treatment options exist at present for carpal tunnel syndrome (CTS) with no universal agreement. Recent reports suggested that untreated CTS might improve or remain stationary. In this respect, treatment directing towards symptom suppression alone may have a role in the initial management of CTS. Gabapentin (1-\[aminomethyl\]-cyclohexaneacetic acid; Neurontin, Pfizer) is an effective drug for treatment of neuropathic pain and has been reported to be effective in case series for the treatment of CTS with relatively benign side effects profile. The purpose of this study was to evaluate the safety and efficacy of gabapentin in the treatment of CTS.

Eligibility Criteria:
Inclusion Criteria:

* Sensory symptoms over median nerve distribution for more than three months.
* Confirmatory electrophysiologic results defined as prolonged median nerve distal motor latencies (DML) \> 4 ms or median-ulnar palmer sensory latency differences \> 0.5 ms.

Exclusion Criteria:

* Patients with evidence of severe CTS: fibrillation potentials or reinnervation on needle examination of the abductor pollicis brevis muscle or clinical examination showing wastage of the thenar muscles. (These patients were referred for surgical decompression on presentation.)
* Clinical or electrophysiological evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as proximal median neuropathy, cervical radiculopathy, or significant polyneuropathy.
* Known epilepsy.
* Patients who have received previous steroid injection or oral steroid therapy for CTS.
Timing of COC Denudation and Embryo Quality

The relation between the timing of COC denudation and oocyte /embryo quality is controversial. The aim of this study is to examine whether timing of denudation of sibling oocytes has any effect on embryo quality.

Retrieved sibling cumulus-oocyte complexes (COCs) will be randomly divided into two groups, in the first group denudation will be in 30 minutes after oocyte retrieval, in second group denudation will take place after 2 hours of incubation.

Eligibility Criteria:
Inclusion Criteria:

* COH with GnRH antagonist cycle
* 5 or more oocytes collected

Exclusion Criteria:

* Fewer than 4 oocytes after retrieval
* Previous history of total fertilization failure or oocyte maturation arrest
* Male partner requiring surgical sperm retrieval (MESA or TESA).
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)

The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath\*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.

The investigators will determine the extent to which an online pathway to depression treatment (iPath\*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. iPath\*D will be designed to increase screening, mental health literacy, and treatment access. Patients will access their iPath\*D account online to review their PHQ-9 score and its interpretation, followed by an interactive depression decision aid comparing information on a range of online and in-person treatment options. Upon review of the decision aid, participants will be able to directly connect to a treatment path via embedded hyperlinks in the decision aid.

The investigators will determine the usability, acceptability, and feasibility of iPath\*D. The investigators will explore the hypothesis that iPath\*D will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access. The tool for the study was developed during a preliminary portion (Aim 1) of the project, under D-H IRB number STUDY02001240 .

This approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, St Johnsbury, VT (Dartmouth Cancer Center North) (n=30) with moderate-severe depression, Aim 2 of the project.

Eligibility Criteria:
Inclusion criteria

1. Adults (≥18 years)
2. New patients who are beginning treatment at Dartmouth Cancer Center North and returning for their chemo teach or radiation simulation visit
3. Can communicate in English
4. PHQ-9 ≥10 and ≤27

Exclusion criteria

1. Mild Depression (PHQ-9 ≥10)
2. Individuals who screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6 on the Columbia-Suicide Severity Rating Scale (C-SSR).
3. Individuals with bipolar disorder or psychosis (documented in the EMR)
4. Individuals currently receiving treatment for a mental health condition (documented in the EMR or self-reported during eligibility screening)
5. Significant cognitive impairment (Callahan's Six Item Screener of cognitive function ≤ 4; Self-reported during eligibility screening)
Molecular Markers in Thyroid Cancer

The purpose of this study is to evaluate how common gene mutations are in benign and malignant thyroid lesions.

The overall objective of this study is to evaluate the prevalence of molecular markers in patients with benign and malignant thyroid lesions. This study consists of:

Retrospective review of archived surgical pathology specimens at Oregon Health \& Science University (OHSU) from patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care. Molecular markers will be evaluated on archived tissue.

Molecular markers will be correlated with clinical information extracted from OHSU medical records: histologic subtype of cancer, measures of tumor aggressiveness (capsular and angiolymphatic invasion, local invasion, lymph node and distant metastases, TNM stage(TNM Classification of Malignant Tumours)) and clinical outcome (recurrence, distant metastases and death).

Patients with other malignancies presenting for standard of care services will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "positive" control for the DNA/RNA isolation techniques and mutation assays, as other cancers commonly express some of the same mutations. Normals will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a "negative" control for the DNA/RNA isolation techniques and mutation assays.

Eligibility Criteria:
Inclusion Criteria:

* Age 1 - 100
* Benign or malignant thyroid lesion, other malignancy or no thyroid abnormality
* Pathologic specimen available for analysis
* Ability to provide informed consent (for prospective study, Part Two)
* Age greater than age 18 (for normal controls)

Exclusion Criteria:

* Patients without adequate data for analysis
* Histopathologic or cytopathologic diagnosis of for medullary thyroid carcinoma (not derived from the thyroid follicular epithelium), thyroid lymphoma
* Unwilling to participate or unable to provide informed consent
Assessing Sustainable Behaviors and Health Impacts of Climate Change

The relationship between climate change, sustainability and child health is complex and important. These three concepts are interacting factors and have significant impacts on children's health. Sustainability measures are vital to protect child health by mitigating the impacts of climate change. At the same time, children's education and awareness is an important factor that will contribute to future generations living in a sustainable world. As a society, tackling climate change and striving for a sustainable future is crucial to ensure that children live healthy and safe lives. The aim of this study is to evaluate the effectiveness of the education program and educational videos to be applied to children in terms of environmentally sustainable behaviors and awareness of the health effects of climate change in 60-72-month-old children studying in Eskişehir Odunpazarı Municipality Day Care Center and Nurseries. In addition, in this study, it was aimed to measure the level of global climate change awareness of parents and to evaluate the relationship with children's environmentally sustainable behaviors.

The data will be obtained from 60-72 month old children and their parents who are studying in Day Care Centers and Nurseries of Eskişehir Odunpazarı Municipality in 2023-2024.

Within the scope of the study, a detailed explanation of the study, informed consent forms and questionnaire forms will be delivered to the parents and children through their teachers. The questionnaire form prepared by utilizing the literature will be applied to the parents and children who agree to participate in the study. Subsequently, the education program to be prepared for the intervention group will be implemented in selected day care centers and nurseries. Four weeks after the educational intervention, the children will be reached again and the children in the intervention group will be asked to fill out the questionnaire form for the second time.

The population of the study consisted of 132 children aged 60-72 months who were studying in Day Care Centers and Nurseries of Eskişehir Odunpazarı Municipality in 2023-2024.

In the study, when type 1 (α) error was taken as 5% and type 2 error (1-β) was taken as 90%, it was calculated with the G\*Power 3.1 statistical program that there should be at least 36 people in the intervention group when the effect size was accepted as 0.50. Considering those who could not continue the study, it was planned to be conducted with a total of 38 students in order to reach the required sample size.

Eligibility Criteria:
Inclusion Criteria:

* The study will include children aged 60-72 months and their parents, whose consent was obtained from parents and children.

Exclusion Criteria:

* Children with any condition that prevents them from attending school (any chronic medical condition that prevents them from participating in the study) and mainstreaming students (children in need of special education; children with adaptation difficulties, dyslexia, autism diagnosis, attention deficit and hyperactivity disorder) will not be included in the study.
The Perfect-CR Implementation Study

The goal of this open-label cluster-randomized effectiveness-implementation hybrid trial is to study whether a) audit and feedback of cardiac rehabilitation service delivery within a national quality registry and b) structured implementation support can improve center-level adherence to guidelines and short and long-term patient-level outcomes.

Administering secondary prevention via structured cardiac rehabilitation (CR) programs for patients who have suffered a myocardial infarction (MI) reduces mortality and morbidity and improves quality of life. Still, treatment goal achievement at patient-level and service delivery at center-level are sub-optimal and there is a large variation in program structure and delivery at center-level.

Using an open-label cluster-randomized effectiveness-implementation hybrid trial design, the primary objective of this study is to prospectively evaluate whether a) audit and feedback of CR processes and structures within the national cardiac registry SWEDEHEART and b) supporting CR centers in implementing CR guidelines can increase center-level guideline adherence. The secondary objectives are the following:

* At baseline, to cross-sectionally evaluate the association between center-level adherence to guidelines and patient-level outcomes
* To prospectively study whether audit and feedback of CR processes and structures within the SWEDEHEART registry can improve short- and long-term patient-level outcomes
* To prospectively evaluate whether supporting CR centers in implementing CR guidelines can improve short- and long-term patient-level outcomes
* To evaluate the acceptability, adoption, fidelity, implementation cost, and cost effectiveness of the implementation support

All CR centers in Sweden (approximately 75 centers) will be offered participation in the study. Collectively these centers attend to approximately 8000 patients/year. Patient-level outcome data will be retrieved from national registries.

Eligibility Criteria:
Centre-level

Inclusion Criteria:

* Centres report to the SWEDEHEART registry

Exclusion Criteria:

* Unwillingness to participate in the study

Patient-level

Inclusion Criteria:

* Diagnosis of a type 1 MI registered in the SWEDEHEART registry
* Age 18-79 years at discharge from hospital
* Attended at least two follow-up visits at CR centres included in the study

Exclusion Criteria:

* None
Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth

the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.

The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.

Eligibility Criteria:
Inclusion Criteria:

1. healthy children
2. age range 3-6
3. at least 2 early carious lesions

Exclusion Criteria:

1. Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases.
2. Application of fluoride varnish less than 3 months prior to study treatment.
3. Any metabolic disorders affecting bone turnover.
4. Concurrent participation in another clinical trial.
5. Patients receiving any antibiotic within 1 month prior to plaque sample collection
Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition

This study an open label prospective observational cohort study to evaluate the safety and efficacy of sodium citrate 4% locking solution in preventing central line associated blood stream infection in children requiring long term central venous catheters for home parenteral nutrition. Sodium citrate 4% is FDA-approved for dialysis catheters, but has not been formally evaluated for use in tunneled catheters for parenteral nutrition. The rate of central line-associated bloodstream infection (CLABSI) and other potential adverse events will be monitored for 12 months, with the option to remain in the study for a longer period of time.

In this prospective observational cohort study of pediatric patients requiring home parenteral nutrition for intestinal failure, participants will be enrolled from the pediatric intestinal rehabilitation clinic, and data collection will be obtained from the electronic medical record. Participant will receive daily sodium citrate 4% catheter locking solution for CLABSI prophylaxis, instead of heparin locks. Participants will be monitored for 12 months for adverse events, including CLABSI. Participants will have the same routine laboratory schedule and monthly outpatient follow up. After 12 months, participants will be given the option to continue to use sodium citrate 4% locks after the initial study period if no serious adverse events have occurred. The investigators anticipate enrolling 10-15 participants per year and anticipate enrollment to continue for 3-5 years.

Sodium citrate locks: 3 ml vials of locking solution will be prepared by the infusion pharmacy using commercially available 4% sodium citrate IV fluid (available in 500 ml bags). The sodium citrate locks will be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition. If subjects are hospitalized, sodium citrate locks will be temporarily held during the duration of the inpatient stay, and will be resumed once the participant is discharged home.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (\<18 years) and adult patients (up to 21 years still in our clinic)
* requiring long-term (\>3 months) home parenteral nutrition due to intestinal failure/short bowel syndrome
* has had at least one central line-associated blood stream infection

Exclusion Criteria:

* known cardiac arrhythmias
* hypersensitivity to citrate
* pregnancy
* receiving continuous parenteral nutrition (infusing over 24 hours)
Gut Microbiome in Orthopaedics

Patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. The role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. Probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes.

This study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. The main questions it aims to answer are:

* to compare implant migration between groups from baseline to six weeks post-surgery
* to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery
* to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery

Participants will take a daily probiotic (DE111®) or placebo once daily starting 3 weeks prior to surgery until six weeks after surgery. The following will be completed at baseline and 6 weeks:

* Bloodwork
* Fecal sample collection
* MRSA swab
* Patient-reported outcome measures
* CT imaging scan

In addition, the following will be done:

* Intraoperative fluid and tissue collection
* Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) scan at 6 weeks post-surgery

Researchers will compare the probiotic and placebo groups for any significant differences in implant stability, bone quality, inflammation, gut microbiome composition, and pain.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained prior to any study-related activities
* Postmenopausal female patients of London Health Sciences Centre (LHSC) aged 55-75 years
* Scheduled to undergo primary total knee replacement for osteoarthritis

Exclusion Criteria:

* Unable to understand and respond to the provided questionnaires
* Male sex
* Inflammatory arthritis
* Periprosthetic infection
* Prior surgery with hardware insertion in the target knee
* Metabolic syndrome
* Inflammatory bowel disease
* Body mass index \<18.5 kg/m2
* Immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
* Any contraindications for PET-MRI
* Allergy to cephalosporin antibiotics