cyrilzakka/clinical-trials huggingface dataset:
Neutralizing Antibody Seroprevalence Study With a Retrospective Component in Participants With Late-Onset Pompe Disease

The purpose of this study is to obtain information pertaining to the occurrence of antibodies to investigational SPK-3006 capsid and GAA, GAA activity and GAA antigen levels in the usual care setting of Late-Onset Pompe Disease (LOPD) participants on an enzyme replacement regimen. Additionally, a careful evaluation of laboratory and functional testing in patients with LOPD may provide information to better understand the disease features and better drive the design of a future interventional investigational gene therapy trial. An understanding of the underlying status of liver and muscle health in individuals with LOPD may also inform best surveillance during the conduct of gene therapy trials.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent and authorization to use protected health information in accordance with national and local privacy regulations
* Male or females ≥18 years of age
* Currently on ERT using regular recombinant human GAA infusions for at least 18 months prior to screening
* Documented history of clinically moderate late-onset Pompe disease.

Exclusion Criteria:

* History of HIV infection
* Requires any invasive ventilation (other than BiPAP at night) or noninvasive ventilation while awake and upright
* Previously received SPK-3006
* Previously dosed with any investigational or approved gene therapy product at any time or treated with an investigational drug within the last 12 weeks (vaccination studies are accepted)
* Any concurrent clinically significant condition that would not allow the potential participant to complete the Day 1 examinations, or other condition that, in the opinion of the Investigator and/or Sponsor, makes the subject unsuitable for participation in the study
* Unable or unwilling to comply with the schedule of visits and/or study assessments described in the clinical protocol.
Validation of Pre-clinical Nano-Based Analgesics in Cells From Human Dorsal Root Ganglia

This study investigates the pre-clinical nano-based analgesics in cells from human dorsal root ganglia (clusters of neurons). Collecting these neurons may help future research related to safe and effective pain treatment.

PRIMARY OBJECTIVE:

I. To identify translational mechanisms and therapeutics for neuropathic pain, a type of chronic pain that can arise due to injured nerves.

OUTLINE:

Patients' leftover dorsal root ganglia samples are collected during standard of care surgery.

Eligibility Criteria:
Inclusion Criteria:

---All patients undergoing surgery to resect spinal tumors

Exclusion Criteria:

---None
TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs

Clinical Trial with two groups, transcranial direct current stimulation aplication and sham; triple blinded. The protocol is applied 5 consecutive days during the training of a manual dexterity task. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.

Clinical Trial with two groups, transcranial direct current stimulation aplication (1 mA ) and sham (ramp up and down of 30 seconds in total) . Bouth interventions will last 20 minutes; at the same time of the aplication bouth are going to train the manual dexterity with Purdue Pegboard Test.

This protocol is applied 5 consecutive days, also it have a follow up of 5 days more.

It is triple blinded. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* metal or skin lesions on the head
* brain stimulation in the last 6 months
* family history of epilepsy or seizures
* pacemaker or any cardiac involvement
* inability to understand or execute the task
* taking drugs that may influence cognition
* pregnancy
Use of Cidofovir for Recurrent Respiratory Papillomatosis

Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx in the pediatric population. The impact of the disease on patients and families can be tremendous due to the need for frequent treatment. It would be highly beneficial to develop effective medical therapies as adjunctive measures to surgical ablation with the goal of reducing the frequency of reoccurrence.

The focus of the present study is to evaluate the usefulness of cidofovir injection in diminishing the frequency and magnitude of papilloma recurrences in adult and pediatric RRP patients. Briefly, patients will be randomized into either a treatment (cidofovir injection) or a placebo group. The following measures will be made at each of 6 data collection time points, over the course of one year: (1) tumor load, based upon a published staging system for papilloma, (2) degree of respiratory obstruction for phonation, as assessed by phonation threshold pressures, and (3) general health, on validated health inventories (SF12 and Voice Handicap Index for adults; PedsQL (Trademarked) for children) and via measures of height weight and days absent from school or daycare, where applicable, for children. A repeated measures analysis will allow examination of time by treatment interactions to determine if the cidofovir injection group has fewer, or less severe, recurrences than the placebo group.

Specifically, we will answer the following questions in this investigation:

1. Does cidofovir injection reduce the frequency of RRP recurrences?
2. Does cidofovir injection reduce the magnitude of RRP, as assessed with a proposed staging system for RRP (Derkay et al., 1998) and measures of phonatory threshold pressure?
3. Does cidofovir injection improve general health, as assessed by height, weight and days absent from school in pediatric patients and health inventories (general health and voice-related) in children and adults?

Eligibility Criteria:
Inclusion Criteria:

* 4 surgeries for RRP in last 12 months

Exclusion Criteria:

* Renal insufficiency
* Nephrotoxic drugs in the last 7 days
* Sulfa allergies
* Currently treated with systemic or topical HPV chemotherapeutic agents
* Females of childbearing potential with a positive pregnancy test
* Women who are breast feeding
NAFLD Study: US vs Liver Biopsy

Evaluate the diagnostic accuracy of the new ultrasound software vs hepatic histology, the current reference standard for the diagnosis of NAFLD and NASH in 20 obese patients (BMI\> 30) candidates for laparoscopic bariatric surgery and / or cholecystectomy


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are candidates for bariatric surgery between the ages of 18 and 65,

   * BMI\> 40 kg / m2, in the absence of any other comorbidity
   * BMI\> 35 kg / m2, in the presence of comorbidities among those classically considered to be associated with obesity
   * ICM\> 30 kg / m2, in the presence of T2DM not in glycometabolic compensation
2. Patients who are candidates for laparoscopic cholecystectomy for symptomatic calculi with BMI\> 30

Exclusion Criteria:

* Age ≤ 18 or ≥ 65
* Any concurrent surgical procedure except cholecystectomy and hiatal hernia repair
* Conversion into laparotomy surgery
* Post-operative complications requiring new surgical treatment
* Patient not compliant in the follow-up
The Effect of Exercise-Oriented Training on Physical Activity Level and Exercise Awareness in Overweight and Obese Women

This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants will randomized into intervention group (IG) and control group (CG) and followed-up for three months. The International Physical Activity Questionnaire Short Form (IPAQ) will be applied to both groups at the beginning and end of the study to determine the level of physical activity, and the Exercise Health Belief Model Scale (EHBM) will be applied to evaluate the exercise awareness level, and anthropometric measurements (weight, body mass index, waist circumference) will recorded. The CG will receive no other interventions other than routine recommendations. The IG will be given face-to-face training to increase exercise awareness along with routine recommendations after the first meeting, and they will be contacted by phone every two weeks for three months.

Obesity and insufficient physical activity are among the most important health problems of today. Both obesity and physical inactivity are risk factors for many chronic diseases. This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants (n=112) were randomized into intervention group (IG) and control group (CG) and followed-up for three months. The International Physical Activity Questionnaire Short Form (IPAQ) was applied to both groups at the beginning and end of the study to determine the level of physical activity, and the Exercise Health Belief Model Scale (EHBM) was applied to evaluate the exercise awareness level, and anthropometric measurements (weight, body mass index, waist circumference) were recorded. The CG received no other interventions other than routine recommendations. The IG was given face-to-face training to increase exercise awareness along with routine recommendations after the first meeting, and they were contacted by phone every two weeks for three months.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-34.9 g/m2
* Female
* Turkish

Exclusion Criteria:

* Individuals with disabilities to exercise
* pregnant/breastfeeding women
* Individuals with Stage 2-3 obesity (BMI \>35 kg/m2)
Transcranial Direct Current Stimulation Therapy for Major Depression

Depression is a prevalent and debilitating disorder. The most common treatments are antidepressant medications and talking therapies. However, for many individuals, these are not their treatment of choice. Furthermore, even following a full course of treatment with an antidepressant or talking therapy, over one third of patients continue to be unwell.

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. The present research question is whether tDCS can be provided as a home-based treatment for major depression for adults with major depression.

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from. tDCS does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT) and it does not induce brain cells to discharge like transcranial magnetic stimulation (TMS).

Clinical studies have shown that tDCS treatment could help to improve the symptoms of depression. The main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. Less commonly reported side effects include headache or tiredness. tDCS is a portable and safe treatment.

The studies to date have mostly looked at tDCS treatment which has been provided in a research setting. This is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. As tDCS is a portable and safe treatment, it could be provided in the community.

The study research question is whether tDCS could be provided as a home-based treatment for major depression. The study will include adults with major depression.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of major depressive disorder based on DSM-5 criteria
* minimum score of 16 on Hamilton Rating Scale for Depression (HAM-D)

Exclusion Criteria:

* history of treatment-resistant depression
* comorbid psychiatric disorder
* significant risk of suicide or self harm
* any contraindications to tDCS, including implanted electronic medical devices
Interferon-α After DLI for the Prevention of Relapse

This study aimed to evaluate the efficacy of interferon α after prophylactic donor lymphocyte infusion (DLI) among high-risk acute leukemia patients undergone unmanipulated blood and marrow transplantation. Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for high-risk acute leukemia (AL). However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.Prophylactic DLI can decrease the risk of relapse of high-risk AL patients. Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential value for high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b after prophylactic DLI following hematopoietic stem cell transplantation in patients with high-risk AL can further reduce relapse rate and improve leukemia-free survival.

High risk acute leukemia patients (except t(9;22)(q34; q11) cytogenetic abnormalities.) received interferon α-2b after prophylactic DLI at day 30-60 after unmanipulated blood and marrow transplantation. The end points were safety, leukemia-free survival, and immunologic response. Following time is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had high-risk acute leukemia after hematopoietic stem cell transplantation

Exclusion Criteria:

* Patients with t(9;22)(q34; q11) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure, or relapse
Prognostic Significance of Red Blood Cell

Red blood cell (RBC) distribution width (RDW), calculated by dividing the standard deviation of RBC volume by the mean corpuscular volume and multiplied by 100, is routinely reported as part of the complete blood count (CBC) using automated flow cytometry. RDW has been traditionally used as additional information in the differential diagnosis of the cause of anemia.

RDW has been recently reported as a strong prognostic factor in several diseases of various organ systems, including the cardiovascular, respiratory, renal, neurologic, and gastrointestinal systems.It also showed significant associations with ventilator-free days, postoperative outcome, intensive care unit (ICU) discharge outcome, out-of-hospital outcome, and all-cause mortality in critically ill patients. However, most studies were conducted in adult patients. Only a few studies have investigated RDW in children, especially in the critically ill pediatric population.

The aim of this study is to know the prognostic significance of red blood cell distribution width ( RDW ) in critically ill pediatric patients as regard ; the duration of hospital \& PICU admission ,the use of inotropic drugs and or mechanical ventilation (MV) and the outcome of the case .

Eligibility Criteria:
Inclusion Criteria:

* All critically ill pediatric patients, 1 month to 12 years age, admitted to Pediatric intermediate \& Intensive Care Unit ( PICU ) in Sohag University Hospital.

Exclusion Criteria:

* - patients who received blood transfusion prior to admission in PICU
* patients with incomplete data for pediatric risk of mortality (PRISM), pediatric sequential organ failure assessment (pSOFA), pediatric logistic organ dysfunction-2 (PELOD-2), and pediatric multiple organ dysfunction syndrome (pMODS) scores were excluded.
Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application

Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.

Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.

Design and Method: The study, which used a randomized controlled trial, included 124 preterm neonatal infants a gestational age of 28- 37 weeks and received nasal CPAP. The infants were treated with Mother's Voice, Therapeutic Touch, and Mother's Voice+ Therapeutic Touch. The Neonatal Infant Pain Scale (NIPS) and Premature Infant Comfort Scale (PICS) scores of the infants were measured before, during and after the nasal CPAP application.

Eligibility Criteria:
Inclusion Criteria:

* being checked in at Neonatal Intensive Care Unit
* being in the gestational ages of 28 to 37 weeks
* having nasal CPAP

Exclusion Criteria:

* having neurological disorders
* having comorbidity
* receiving sedation or analgesics
* having congenital anomaly
* receiving extra invasive procedures or surgical intervention
* being diagnosed with hearing loss
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.

To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.

Eligibility Criteria:
Inclusion Criteria:

* ages 3-16
* obstructive sleep apnea warranting adenotonsillectomy
* history of daytime nasal obstruction and or mouth breathing
* failed medical treatment with either oral anti-histamine or nasal steroid spray.
* turbinate hypertrophy on Physical Exam defined by \>50% obstruction

Exclusion Criteria:

* \<3 or \>16
* unwillingness to comply with study procedures
* congenital head and neck malformations, genetic syndromes, craniofacial anomalies
* no evidence of turbinate hypertrophy or symptoms of nasal obstruction
* pregnancy or breastfeeding
* bleeding disorders
* current therapy with coumadin or Pradaxa
Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-78 years old inclusive at Visit 1
* T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
* Patient agreement to maintain same dose of metformin throughout study
* HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
* Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury

Metacognition, in-the-moment awareness of performance while engaging in cognitive tasks, is negatively affected by traumatic brain injury (TBI). Metacognitive deficits can greatly reduce quality of life for individuals with TBI as functioning in this domain has been closely linked with successful independent living and community re-integration. Problematically, there are currently no empirically validated treatment options that address metacognitive deficits after TBI. Recent research in healthy samples demonstrates that specific listening interventions may alter neural activation in brain works associated with metacognition and can improve metacognitive functioning; however, it remains unknown if these effects generalize to individuals with TBI. Thus, the objective of the proposed study is to use a double-blind, placebo controlled randomized clinical trial to determine the efficacy of applying a specific listening intervention to improve metacognition after TBI and to employ functional magnetic resonance imaging (fMRI) to document the neural mechanisms by which the intervention operates.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate or severe brain injury
* between the ages of 18 and 59.
* able to read and speak English fluently.
* TBI at least 1 year ago.

Exclusion Criteria:

* pregnant.
* left-handed.
* color-blind.
* diagnosed with significant psychiatric illness (e.g., bipolar, schizophrenia).
* receiving or have received inpatient and/or rehabilitative treatment for substance use.
* diagnosis of a neurological condition other than TBI (e.g., epilepsy, multiple sclerosis, stroke).
* any metal in my body that has not been declared MRI-safe by my physician.
* impaired independent use of either hand.
* any of the following in/on my body that may interfere with MRI: pacemaker, implanted electrical devices, brain stimulators, particular types of dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
* history of engaging in welding and/or metal working activities.
* formal training or am a current practitioner of yoga, meditation, and/or mindfulness.
* currently involved in any other type of thinking skills and/or emotional treatment, such as psychotherapy.