cyrilzakka/clinical-trials huggingface dataset:
Study on Tolerability of Levodopa/Carbidopa in Children With Angelman Syndrome

This study is designed to determine the highest dose of levodopa/carbidopa that can be tolerated without any serious side effects by children with Angelman syndrome.

It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with Angelman syndrome.

Data from this study will be used to design a phase II trial to determine the efficacy of levodopa in treating children with Angelman syndrome.

Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa. Animal studies have suggested that levodopa can reverse the excess phosphorylation of some enzymes involved in synaptic and neuronal function, including calcium/calmodulin-dependent kinase type 2 (CaMKII).

Recently, it was shown that excess phosphorylation of CaMKII may be responsible for some of the neurological deficits seen in Angelman syndrome. Therefore, it is hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with Angelman syndrome.

Although many children have used levodopa for a variety of medical conditions over the last 30 years, it has not been approved by the Food and Drug Administration (FDA) for use in children, and it has not been formally studied in children with Angelman syndrome, so we do not know what dose of levodopa is most appropriate for children with Angelman syndrome.

Therefore, the purpose of this study is to find out the highest dose of levodopa that children with Angelman syndrome can tolerate without any serious side effects.

Once we know the dose of levodopa that can be tolerated by children with Angelman syndrome, we will conduct a larger follow-up study to find out whether levodopa will lead to an improvement in their development and tremor.

Eligibility Criteria:
Inclusion Criteria:

* Angelman syndrome, confirmed by molecular testing
* Must be willing to come for research visit on 2 days, exactly 1 week apart

Exclusion Criteria:

* On levodopa, carbidopa, or any dopamine agonists in the 2 weeks prior to participation
* Other medical conditions that may be associated with developmental or cognitive delays
* More than 2 clinical seizures per month
* Used monoamine oxidase (MAO) inhibitors within the last 2 weeks
* Used phenytoin within the last 2 weeks
* Used phenothiazines, butyrophenones, and thioxanthenes within last 2 weeks
* Hypersensitive to levodopa or carbidopa
* Cardiovascular disease or instability
* Respiratory diseases, including asthma, emphysema, chronic cough, and shortness of breath
* Liver disease
* Stomach or intestinal ulcers
* Kidney disease
* Hematological problems, including anemia, leucopenia, and thrombocytopenia
* Used investigational drugs/interventions within the past three months
Precision of the Magnetocardiographer for Data Aquision and Analysis.

magnetocardiography has been extensively studied focusing on the possible clinical applications of the device. Evaluating the precision of a device is a prerequisite condition to know what are significant changes and how can these be trusted. A respectable reproducibility study for the MCG measurements is crucial for this new device to be used for clinical applications. In this study, we will focus on a critical portion of the heart cycle assessing for changes in time of the computerized analysis of this phase and comparing the analysis done by two examiners.

The studies involving magnetocardiography have almost exclusively focused on evaluating possible clinical applications of the device. Leder et al saw the need for investigating the reproducibility of High Temperature Superconducting (HTS-)MCG measurements. They tested 18 healthy volunteers, stating that assessment of the reproducibility of HTS-MCGs in the normal heart is a prerequisite condition for the definition of significant levels of changes which, for instance, may be observed in serial measurements of patients suffering from acute coronary syndromes. They also pointed out the potentially strong electromagnetic interference inside a hospital, likely to be very different from the noise found in engineering laboratories where the MCGs are originally calibrated and tested. A respectable reproducibility for the MCG measurements is crucial for clinical applications. Leder et al studied the reproducibility of QRS complexes, ST segments, and T waves. They found that the reproducibility of the measurements in the depolarization phase was high, whereas the reproducibility of their repolarization readings was considerably lower. The results led Leder et al to conclude that further technical development was needed to improve signal-to-noise ratio allowing for clinical application of repolarization abnormalities for recognizing Acute Coronary Syndromes. In this study, we will focus on the repolarization phase by assessing the reproducibility of the T wave only. Comparison of scores and results based on computer analyses will provide the basis for our evaluation. Visual interpretations by the two examiners will also be compared.

Eligibility Criteria:
Age less than or equal to 45 years
Exercise Into Pain in Subacromial Shoulder Pain

The aim of the randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program.

Exercise therapy is the first choice of treatment in the treatment of subacromial shoulder pain (SSP). Guidelines suggest exercise therapy for at least three months and research underlines the importance of progressive loaded exercise therapy at high dosage. However, it is not clear which is the best type of exercise and if pain should be provoked or avoided during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim is to investigate if one painful exercise can give better and faster results in the management of SSP than non-painful program.

Eligibility Criteria:
Inclusion Criteria:

* shoulder pain for at least 3 months, elicited in the anterolateral shoulder region
* at least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc, external resistance test
* resting pain should be at 2/10 maximum on verbal numerical pain rating scale (NPRS)

Exclusion Criteria:

* bilateral shoulder pain
* corticosteroid injections 6 weeks prior to the study
* pregnancy, inability to understand spoken or written Dutch
* clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test)
* evidence of adhesive capsulitis
* previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
* primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement; reproduction of shoulder pain with cervical rotation or axial compression
* primary diagnosis of acromioclavicular pathology, shoulder instability
* a radiologically confirmed fracture or previous medical imaging confirming the presence of calcification larger than 5 mm
* presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness, osteoporosis, hemophilia, rheumatic polymyalgia)
* more than 4h of training in sport overhead shoulder activities per week
Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block in Caesarean Section

Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block.

Peripheral nerve block is becoming increasingly popular technique for postoperative pain relief and is also established as a part of multimodal analgesia and enhanced recovery program. Transversus abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries.The Purpose of a TAP block is to infiltrate local anaesthetic agents in the plane between the internal oblique and transversus abdominis muscles thereby providing effective postoperative analgesia. Earlier the blind TAP block (through lumbar triangle of Petit) was commonly given but with widespread use of ultrasound nowadays it is almost always given under ultrasound guidance. Accuracy and efficacy of TAP block is significantly improved under ultrasound guidance because under ultrasound guidance the anesthetic agent can be properly deposited in the neurovascular plane. Ultrasound provides real time and direct visualisation of needle during infiltration of local anaesthetic drug.

Eligibility Criteria:
Inclusion Criteria:

* pregnant female elected for cesarean section
* ASAll

Exclusion Criteria:

* coagulopathy
* BMI\>35

  * heart Diseases
  * diabets
Total Joint Arthroplasty in a Pediatric Population

The primary purpose of this study is to examine the functional ability and quality of life in those patients who received a total joint arthroplasty (TJA) for reasons other than having a solid tumor at the location of the joint.

Patients who undergo a total knee arthroplasty (TKA) or total hip arthroplasty(THA) for non-solid tumor related reasons, are most often those children who developed osteonecrosis or avascular necrosis(AVN) as a side effect of their therapy for leukemia. Other patients undergo TKA or THA after degeneration of their joints secondary to trauma, infection, rheumatologic conditions, or congenital deformity. While not all cases of injury to the knee or hip result in the need for a joint replacement, the quality of life is believed to be improved in these children, as having a functioning joint without pain is believed to be better for the patients' quality of life than ambulating with a painful and/or partially necrotic joint.

Eligibility Criteria:
Inclusion Criteria: Populations 1,2,3

* Age between 10 years and 25 years
* Undergoing or have undergone total joint arthroplasty at Children's Hospital Colorado for non-solid tumor related reasons
* Treated at Children's Hospital Colorado by Dr. Nathan Donaldson, DO or Dr. Steven Thorpe, MD or previously by Travis Heare, MD

Exclusion Criteria: Populations 1,2,3

* Subjects and/or parents not capable of completing basic questionnaires in English (HRQL data will not be collected from non-English speaking subjects because we do not have access to versions of these questionnaires that have been validated in languages other than English. These patients may be included at a later date when validated questionnaires are available).
* Subjects who underwent hemiarthroplasties, failed rotationplasty to arthroplasty conversions, or joint arthroplasty directly related to a tumor at the location of the joint
* Subjects diagnosed with mucopolysaccharidoses (MPS), pseudorheumatoid chondrodysplasia, or diastrophic dwarfism

Inclusion Criteria: Population 4

* Age between 10 years and 25 years
* Treated at Children's Hospital Colorado by Dr. Nathan Donaldson, DO, or Dr. Steven Thorpe, MD or previously by Travis Heare, MD
* Symptomatic joint pain treated non-invasively via lifestyle modifications, over the counter or prescription pain medication, nerve blocks or steroid injections, and/or physical therapy
* Symptomatic joint pain treated via core decompression surgery at Children's Hospital Colorado by Dr. Nathan Donaldson, DO, or Dr. Steven Thorpe, MD, or previously by Travis Heare, MD

Exclusion Criteria: Population 4

* Patients who underwent a joint arthroplasty directly related to a tumor at the location of the joint at Children's Hospital Colorado. Patients undergoing or have undergone total joint arthroplasty at Children's Hospital Colorado for non-solid tumor related reasons
* Subjects diagnosed with mucopolysaccharidoses (MPS), pseudorheumatoid chondrodysplasia, or diastrophic dwarfism
How Much The Self-Reported Physical Activity Change in Patients With Physical Disabilities Hospitalized for Rehabilitation in A Physical Medicine and Rehabilitation Clinic

Disability was defined by WHOas a restriction or lack of ability to perform daily activity, but this definition was later changedto problems in functioning in the WHO classification of Functioning, Disability and Health (ICF). Osteoarthritis, back pain, neck pain, rheumatologic diseases, neurologic disorders (stroke, spinal cord injury, multiple sclerosis, Parkinson diseases) can cause physical disabilities.Recent studies have shown that; high levels ofdisability is related with low levels of physical activity.Individuals with disability are commonly hospitalized ininpatients clinicsfor rehabilitation, which aims to achieveoptimal functional level ofpatients within their own limitations.A rehabilitation program can be an excellent opportunity to integrate post-rehabilitation physical activity into their lifestyle.This study aimed to examine the short term effect of inpatient rehabilitation program on self -reported physical activity both participants with physical disabilities due to musculoskeletal, and neurological disorders


Eligibility Criteria:
Inclusion Criteria:

* Patients with physical disabilities, due to neurologic or musculoskeletal diseases and hospitalized in PMR clinic for rehabilitation between Patients over 18 years of age with cognitive functions able to fill the forms and patients with medical stabilization for neurological diseases.

Exclusion Criteria:

* Patients under 18 years of age,
* Patients with additional hearing, visual and mental disabilities
* Patients with metabolic instability for neurological diseases, history of malignancyand pulmonary and cardiac failure,
* Patients with recurrent hospitalization in the PMRclinic
Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device. (My Knee)

Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.


Eligibility Criteria:
Inclusion Criteria:

all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.

Exclusion Criteria:

distorded axes or laxity requiring the establishment of constrained prosthesis
Management of Threatened Preterm Labor by Cervical Length-based Approach or Conventional Approach

To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)


Eligibility Criteria:
Inclusion Criteria:

* Pregnant with symptoms of threatened preterm labor which refer to regular uterine contractions at least 1 time in every 10 minutes and persist for 30 minute without cervical dilatation or cervical dilation ≤ 1 cm and \< 80% of effacement.
* Age ≥ 18 years
* Singleton pregnancy
* 24 0/7 - 33 6/7 weeks of gestation
* Uneventful antenatal care or low-risk pregnancies

Exclusion Criteria:

* The definitive diagnosis of true labor
* Proceed to the active phase of labor
* Age \< 18 years
* Multiple pregnancies
* \< 24 or ≥ 34 weeks of gestation
* Fetal chromosomal or structural abnormalities
* Abnormal fetal growth
* Abnormal amniotic fluid
* Evidence of placenta previa
* Significant vaginal bleeding that cannot be ruled out placenta previa
* Evidence of rupture of membranes
* Evidence of intrauterine infection
* Evidence of uterine malformation
* Evidence of lethal fetal malformation
* Unable to communicate or understand the information of the study
Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment in Infants in the NICU

The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).

One hundred and four infants were randomized to one of four groups during a single np-ECHO examination, at the discretion of the medical team. Randomization to soother and water (Control) with and without facilitated tucking or to soother and 25% glucose (Intervention) with or without facilitated tucking will be determined by generating randomly permuted sequential blocks of four and six allocation numbers.

Eligibility Criteria:
Inclusion Criteria:

* Infants born between 26-42 weeks of gestational age admitted to the Neonatal Intensive Care Unit who require a np-ECHO for clinical purposes as indicated by the medical team.

Exclusion Criteria:

* Infants who have congenital anomalies, or a lethal condition in whom intensive care is not indicated;
* Infants below the gestational age of 26 completed weeks;
* Infants who have received analgesics or sedatives within 72 hours of the assessment;
* History of maternal abuse of controlled drugs and substances.
* Infants who are too unstable to receive oral medications or be exposed to a np-ECHO or who already have had an ECHO performed by a Pediatric Cardiologist within 4 hours.
Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)

The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes.

The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.

The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX System, or "DX," consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead which is an FDA approved ICD system that incorporates use of an implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.

The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary endpoints of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Fulfills standard indications for ICD implantation
* Subject or legally authorized representative can provide written authorization per institutional requirements
* Subject is intended to be implanted with a complete Biotronik DX system (consisting of a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX system no more than 30 days prior to the date of consent
* Able to comply with Home Monitoring

Exclusion Criteria:

* Subject has prior diagnosis of atrial fibrillation or atrial flutter
* Subject has need for atrial pacing
* Subject unwilling or unable to give informed consent or participate in follow-up
* Subject is unable to comply with Home Monitoring
* Subject is pregnant
* Subject has less than one year estimated life expectancy
* Subject was implanted with a cardiac device capable of detecting AHREs prior to implantation of the Biotronik DX system
* Subject was implanted with Biotronik DX system and had an AHRE detection before enrollment
Sleep Apnea Screening

To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* No previous diagnosis of sleep apnea
* Fulfilling at least one of the following:

  1. Pacemaker indication
  2. ICD or CRTD therapy indication
  3. Heart failure and preserved LVEF (40-50%)
  4. Heart failure and reduced LVEF (\<40%)
* Signed informed consent

Exclusion Criteria:

* Age younger than 18 years
* Renal hemodialysis
* Cardiac transplant indication
* Women who are pregnant
* Advanced cancer
* Enrollment in another investigational study
* Able and willing to comply with all testing and requirements
* Patient not suitable for inclusion due to psychiatric conditions or short life expectancy