cyrilzakka/clinical-trials huggingface dataset:
Prospective Follow-up of Patients With Glycogen Storage Disease Type III

The aim of this study is to improve knowledge of natural history and methods of monitoring the evolution of Glycogen storage disease type III regarding the muscle and to study the prospective approach of large series of patients, and using the same protocol for the follow up of the children and adults.


Eligibility Criteria:
Inclusion Criteria:

* patients with a debranching enzyme deficiency confirmed by enzymatic analysis (debranching enzyme deficiency).
* Written consent
* Age: at least 10 years
* Affiliated with a social security system

Exclusion Criteria:

* Pregnant and lactating women
Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia

Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and short duration. These properties make it an ideal drug to use for epidural anesthesia in patients undergoing postpartum tubal ligation. When epidural morphine is given after chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1). Several studies have hypothesized a specific opioid receptor mediated antagonism of chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due to a disparity between the time the chloroprocaine anesthesia resolves and the onset of epidural morphine analgesia, resulting in a time window of pain (2). The duration of action of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is 60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3). Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and morphine. There was no difference in postoperative analgesia between the two groups (3 and personal communication, Dr. Philip Hess). A literature search cross referencing epidural chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given before the procedure (in an attempt to time the onset of analgesia with the resolution of chloroprocaine anesthesia) to the standard administration time after the procedure.

Women undergoing post partum tubal ligation with an epidural in-situ will be randomly double blindedly selected into one of three groups for pain control. The groups are epidural 1) epidural morphine-chloroprocaine 2) epidural chloroprocaine-morphine 3) epidural morphine-lidocaine. Groups 1 and 3 will receive morphine 30 minutes prior to local anesthetic dosing followed by saline placebo after local dosing. Group 2 will receive placebo 30 minutes prior to local anesthetic dosing followed by epidural morphine. Pain scores and supplemental analgesic requirements will be evaluated 30 minutes, 1hr, 2hr, 4hr and every 4 hrs for the first 24hrs.

Eligibility Criteria:
Inclusion Criteria:

* All patients with an epidural catheter in situ for labor analgesia, status post a vaginal delivery, and scheduled for a postpartum tubal ligation under epidural anesthesia will be eligible

Exclusion Criteria:

* Allergy/hypersensitivity to morphine
* Allergy/hypersensitivity to ester-linked local anesthetics or para-amino benzoic acid (PABA)
* Body Mass Index \>40 kg/m2
* Patients using chronic opioids
* History of obstructive sleep apnea
* Any contraindication to epidural anesthesia
Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors

In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way.

The study's main aim is to check virtual reality's effect on conservative treatment in hemiparetic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Both ischemia and hemorrhagic stroke.
* Stroke Patients who were in Chronic phase diagnosed by Physician were included in the study.

Exclusion Criteria:

* Patient with the history of previous stroke attacks.
* Brainstem stroke
* Epilepsy
* Severely impaired communication and cognition
* Parkinson's disease and multiple sclerosis
* Other musculoskeletal and psychological disorder
Virtual Reality for the Treatment of Chronic Low Back Pain

Chronic low back pain is highly prevalent in US adults and is a major cause of missed work days and disability. While several treatment options exist, chronic opioids are commonly used for these conditions even though there are limited data supporting efficacy, and clear evidence of harm associated with chronic opioid administration.

Virtual reality has been proposed as a treatment option that may lead to decreased pain and improved physical functioning, while avoiding the harms associated with medication management. This study is intended to obtain preliminary safety and efficacy data to guide the design of a larger clinical trial.

This is a pilot study to evaluate the safety and efficacy of the Kauruna Virtual Reality program for the treatment of chronic low back pain. This study is intended to document the safety and efficacy of the use of virtual reality for the treatment of chronic low back pain. The primary outcome measure will be physical functioning as measured by the PROMIS 6. Secondary outcome measures include patient-reported pain intensity, adverse side effects, disability as measured by the Oswestry Low back disability questionnaire, and mental functioning as assessed using the PHQ-9 and GAD-7. Finally, impact on opioid use in patients on chronic opioids will be assessed by documentation of daily opioid dose in oral morphine equivalents.

Forty adult patients with chronic low back pain who are receiving care through the Penn Pain Medicine Center are eligible to participate in the study. The study will consist of a screening visit, followed by randomization into 1 of 2 study groups. Both study groups will participate in two 20-minute virtual reality sessions a week for 8 weeks. Study group 1 will participate in 20 minutes of mindfulness mediation. Study Group 2 will undergo initial sessions focused on graded motor imagery, followed by sessions focused on graded exposure. Patient-reported outcomes data will be obtained at baseline, then weekly during the 8-week study period, then 4 weeks following completion of the study sessions.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Able to speak and read English
* A history of chronic low back pain for at least 6 months
* No changes to medications within 30 days of randomization
* Able to provide outcomes data through the electronic patient-reported outcome data collection system

Exclusion Criteria:

* Age less than 18 years.
* Pregnant women
* Cognitive impairment that limits ability to participate in the study, including the provision of outcome data through the electronic patient-reported outcome data collection system.
* Unable to stand for at least 15 minutes
* Employees or students of the University of Pennsylvania
Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies

The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.

To do the bone marrow transplant, we must first kill the cells in the bone marrow that make the abnormal red blood cells that are found in patients with severe thalassemia or sickle cell disease.

We will do this by using three drugs: busulfan, cyclophosphamide, and CAMPATH-1H. CAMPATH-IH is an investigational drug. CAMPATH-1H is used to prevent participants from rejecting or refusing to let the donor blood cells grow in the body. After the drug treatment, participants will be given bone marrow from a brother or sister who has healthy bone marrow that matches.

Eligibility Criteria:
Inclusion:

* Patients with homozygous B0/+ thalassemia or severe variants of B0/+ thalassemia with an HLA genotypically identical donor.
* Patients with an HLA genotype identical donor and hemoglobin SS, hemoglobin SC, or hemoglobin Sb 0/+ and at least one of the following:

Previous central nervous system vaso-occlusive episode with or without residual neurologic findings; Frequent painful vaso-occlusive episodes which significantly interfere with normal life activities and which necessitate chronic transfusion therapy; Recurrent SCD chest syndrome events which necessitate chronic transfusion therapy.

* Severe anemia which prevents acceptable quality of life and necessitates chronic transfusion therapy.
* The patient must have an HLA genotype identical donor.
* Between the ages of birth and 65 years.
* Women of childbearing potential must have a negative pregnancy test.

Exclusion:

* Biopsy proven chronic active hepatitis or fibrosis with portal bridging.
* SCD chronic lung disease \>/= stage 3.
* Severe renal dysfunction defined as creatinine clearance \<40 ml/min/1.73 M2
* Severe cardiac dysfunction defined as shortening fraction \<25%.
* HIV infection.
* Severe but unspecified chronic toxicity serious enough to detrimentally affect the patient's capacity to tolerate bone marrow transplant (BMT).
* Inadequate intellectual capacity to understand the nature and risk inherent in the BMT process and give informed consent (in the case of minors, this criteria must be fulfilled by the legal guardian).
* Pregnant, lactating or unwilling to use appropriate birth control.
Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial

This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* 18 years of age or older
* Mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery
* Engaged in formal recovery supports (including but not limited to: Recovery Coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months
* Willing to receive parenting supports for the index child through EI
* Geographically based within the catchment area of participating EI programs

Exclusion Criteria:

* Severe mental health problems (suicidal, homicidal, psychosis episodes within the past year)
* Significant cognitive impairment (unable to give informed consent)
* Has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)
Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up

Constant improvements in the areas of diagnostics and treatment lead to an increase of patients surviving an oncological diagnosis ("cancer survivors") thus increasing the cost factor on both society and health care systems. Meta-analysis have shown the effectiveness of multidimensional rehabilitation programs concerning cost-effectiveness and for improving different health parameters. However when submitted to oncological rehabilitation in Switzerland there is no clear definition when to use which specific assessment during the different stages of oncological rehabilitation.

This cohort study aims to evaluate and systematically follow-up patients that are assigned for oncological inpatient rehabilitation at the Rehabilitation Center Walenstadtberg.

The main purposes are i) to evaluate disease onset of oncological patients during rehabilitation and to identify relationships between mobility and cancer-related fatigue at discharge; ii) to identify predictive factors for everyday functioning and social participation after three months discharge.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with "Cancer";
* Literacy and understanding German language;
* Signed informed consent;

Exclusion Criteria:

* Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study;
* Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc);
* Known or suspected non-compliance, drug or alcohol abuse;
* Inability to follow the procedures of the study: e.g. due to language problems, psychological disorders, dementia of the participant, etc;
* Enrolment of the investigator, his/her family members, employees and other dependent persons;
* Cognitive impairment: Mini-Mental State Examination (MMSE) \< 21;
* Major Depression or Hospital Anxiety and Depression Scale (HADS) \>11 at baseline.
Sleep and Memory in Children

Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning is necessary for knowledge consolidation. A key role of sleep has clearly been demonstrated in memory consolidation in adults. Sleep leads to strengthen memory by promoting brain plasticity. Surprisingly, sleep influence on learning stabilization has scarcely been studied during childhood and in children affected by sleep disorders. Yet, sleep disorders concern almost 30% of children and are frequently related to a worsening in academic performances. Classical neuropsychological evaluations of these children, based on daytime learning, often fail to determine cognitive profiles explaining their academic difficulties. The investigators hypothesize that a lack of sleep-dependent consolidation could take an active part in these children's cognitive and academic difficulties. This proposal aims at characterizing interactions between sleep, learning and memory processes that have not been studied in children of elementary school age (6-12 years). The investigators will evaluate sleep-dependent memory consolidation processes in children with sleep disorders before and after treatment and healthy controls. Neuropsychological testing and academic performances will be also evaluated.. The comparison of performances obtained before and after medical treatment, will allow to understand whether normalisation of sleep quality permits the restoration of sleep-dependent memory consolidation.


Eligibility Criteria:
Inclusion Criteria:

* aged between 6 and 12 y
* referred to the HFME for a suspicion of sleep apnea
* narcolepsy
* centro-temporal epilepsy
* high intellectual potential
* children without sleep disorders will be included in the healthy control group.
Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar

Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar

Platelet Rich Plasma may relieve the adverse effect of laser treatment. and it can be expected to improve acne treatment result.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe acne scar

Exclusion Criteria:

* taken procedures for acne scar within 6 months
* underlying diabetes mellitus, keloid, or malignancy
Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD

Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.

Daily physical activity (PA) is a predictor of survival in the general population and has become a significant outcome measure in patients with COPD. Recent studies have demonstrated an independent association between PA, hospitalizations and mortality. Increased PA has significant benefits for patients with COPD. In most studies PA has only been assessed at one time point. Little is known about longitudinal changes in PA and data on determinants of changes in PA are scant. Moreover, information on best approaches to enhance PA in a population with decreasing PA is missing. To evaluate the long-term effect of a coaching program which is aimed at helping patients with severe COPD (FEV1\<50%) to enhance their level of daily physical activity, in addition to usual care. Furthermore, this study aims to evaluate mechanisms that are responsible for changes of physical activity over time such as sociodemographic factors, lung function, comorbidities, vascular function, exacerbations, and medication.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age ≥ 40 years
* Severe COPD (FEV1\<50%) diagnosed according to GOLD-guidelines (www.goldcopd.org)

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Acute or recent (within the last 6 weeks) exacerbation of COPD
* Attending a pulmonary rehabilitation program within the last 6 months
* Pregnant patients
Union Rate of Transverse Tibia Fracture

The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.


Eligibility Criteria:
Inclusion Criteria:

* Closed Tibia Shaft Fracture Treated with an IMN

Exclusion Criteria:

* Unable to consent due to language
* Unlikely to follow-up for one year
A Trial Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Mechanical Ventilation in ICU

Poor glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. The Space GlucoseControl which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range safely and effectively through regulating insulin dose rate. This study is a random controlled trial involving the patients with mechanical ventilation in intensive care unit in order to evaluate the difference of safety and efficacy of blood glucose control between SGC directed and conventional treatment. At last, the trial results can determine whether the Space GlucoseControl can control blood glucose safely and effectively in the patients with mechanical ventilation in intensive care units.

Design: The study was conducted as a single-centre, open randomized controlled, parallel trial.

Study population: Adult medical ICU patients who were mechanically ventilated and assumed to require at least 3 days of intensive care were recruited. Patients fulfilling the inclusion criterion of glucose≥9.0 mM were randomly assigned using serially numbered to either the intervention group (BG control by SGC) or the control group (conventional empiric BG management). The both group aim to establish the BG levels 5.8-8.9mM.

Study protocol: BG measurements were performed using glucometer to test the fingertip capillary blood sample for the BG levels. As for patients with shock or required vasopressor, arterial BG was sampled to measure through the glucometer. Insulin \[40 IU of Actrapid HM (Wanbang Biopharmaceuticals, Jiangsu province, China)/40ml of 0.9% sodium chloride\] was infused intravenously applying the standard perfusor of the ICU (Perfusor®Space, B. Braun Melsungen AG, Melsungen, Germany). All trial-related activities were carried out until the end of the patient's ICU stay, or for a period of 72 hours. Meanwhile, enteral and parenteral nutrition was administrated to patients according to their condition.

Statistical analysis was performed on an intention-to-treat basis. The percentage of values in the target range (5.8-8.9mM) was defined as primary end point for the assessment of glucose control. Data are reported as mean±SD values if not otherwise indicated. Data analysis was performed using SPSS19.0.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted to the ICU
2. At least one BG measurement 9.0mmol/L or higher
3. Expected to stay in ICU ≥3 days;
4. Mechanical ventilation

Exclusion Criteria:

1. Aged \< 18 years;
2. Admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state
3. Pregnant
4. In a state in which death was perceived as imminent
5. Without written informed consent
Monogenic Lupus in Childhood Onset Systemic Lupus Erythematosus

The purpose of this study is to unravel the proportion of monogenic lupus in children onset Systemic lupus erythematosus (SLE), and to find out the diagnostic strategy for early detection of monogenic lupus.

Childhood Systemic Lupus Erythematosus (SLE) is a common autoimmune disease in children, with a high incidence in Asia. Compared with adult SLE, childhood SLE is more likely to involve multiple systems, the treatment is more difficult, and mortality is relatively high. With the improvement of diagnosis and treatment of SLE, the prognosis of children with SLE continues to improve, but there are still a small number of patients who are ineffective to existing treatments. The pathogenesis of SLE is complicated, and more and more evidences confirm that genetic factors are involved in the pathogenesis of SLE. In recent years, the concept of "Monogenic Lupus" has been proposed internationally, and more than 30 single gene variants have been found to be related to the onset of SLE. Such patients are clinically in line with typical SLE or lupus-like syndrome, with common characteristics of a very young age of onset (mostly in infants and young children), and/or a family history of rheumatic immune diseases. It is a huge difficulty to early identify these patients at present, and it has not been generally accepted in the field of rheumatology in China.

In this research, about 200 patients with childhood onset SLE that meet the criteria for inclusion and exclusion were tested for gene analysis, and clinical data were collected and entered into the SLE cohort database. The incidence of monogenic lupus in childhood onset SLE will be unraveled. Based on clinical key words, such as early onset, male, family history of rheumatic diseases, blood system involvement, kidney involvement, the incidence of monogenic lupus in these single or multiple keyword combination will be calculated and compared to obtain an early, cost-effective diagnosis strategy for monogenic lupus.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet the following criteria will be allowed to participate in the study:

1. onset age: birth to 18 years;
2. meet the diagnostic criteria of SLE according to ACR(1997), or SLICC(2012), or EULAR/ACR (2019);
3. obtain parental consent.

Exclusion Criteria:

1. Lack of clinical data;
2. Unable to finish the follow-up.