cyrilzakka/clinical-trials huggingface dataset:
An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children

The purpose of this study is to determine the effectiveness and safety of OROS\*methylphenidate/CONCERTA\* vs. immediate release methylphenidate as a treatment for ADHD specifically for those children who have behavioural difficulties in the afternoon/after-school and evening periods.

Methylphenidate, namely immediate release methylphenidate is the primary stimulant used in the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD). Immediate release methylphenidate has limitations related to its time course of action.As the morning dose wears off, inattention may increase during late-morning classes. Similarly, when the midday dose is wearing off, the child may experience difficulty concentrating on homework. The second problem relates to compliance with midday and late afternoon dosing. Children feel stigmatized or embarrassed by trips to the nurse's office for medication and may skip doses as a result. In other cases, a school nurse may not be available or policies prohibit staff from administering drugs so children may be required to self-administer drug. CONCERTA® was developed to overcome these limitations. The purpose of this study is to see how effective and safe Concerta\* is vs. immediate release methylphenidate in children with ADHD.

Patients will take either Concerta\* (18, 27, 36, or 54 mg) or Immediate Release Methylphenidate tablets (maximum 60mg/day) orally every morning for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired
* Eligible patients will be evaluated after a minimum 3 day washout period without ADHD medication
* In addition, patients must also have a CGI-Severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible
* Patients could have had no prior treatment for ADHD or are presently taking something or could have had ADHD medication treatment in the past

Exclusion Criteria:

* No patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of Tourette's disorder, or a family history of Tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing
* No patient with inability to swallow the medication whole, those with any unstable medical illness were excluded
MDR - Longevity IT Oblique and Offset Liners

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years\*. The subject devices have been on the market since 2010 but have insufficient data to support 10 years of clinical history. A prospective aspect to the study will be utilized to collect long-term data.

Eligibility Criteria:
Inclusion Criteria:

* Study devices must have been implanted following the appropriate surgical technique and IFU
* Patient must be 18 years of age or older
* Patient must be willing and able to sign or verbally consent using the IRB approved informed consent
* Patient must have undergone primary or revision hip arthroplasty with the Longevity IT Oblique and/or Offset liners according to a cleared indication, which includes the following:
* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital, epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
* Revision where other devices or treatments have failed
* Patient must have reached full skeletal maturity

Exclusion Criteria:

* Off-label use of study devices
* Osteoradionecrosis
* Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
* Systemic or local infection
* Uncooperative patient or patient with neurologic disorders who is incapable of following directions
* Patient is known to be pregnant or nursing
* Patient is a prisoner
* Patient is a known alcohol or drug abuser
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
Effects of High-Flow Nasal Cannula on Exercise Outcomes in Lung Transplant Candidates: A Pilot Study

The study evaluated patients on the national lung transplant waiting list. It was pioneering in assessing high-complexity patients with severe pulmonary diseases subjected to a cardiopulmonary rehabilitation protocol using a treadmill. The main findings indicate that the distance covered in the six-minute walk test was greater when using the high-flow nasal cannula supplementation. The improvement in exercise performance in this group is associated with a reduction in arterial carbon dioxide, optimization of hydrogen potential, and a decrease in dynamic hyperinflation, leading to fewer symptoms of dyspnea.

Introduction: Pulmonary diseases have a significant global prevalence, and lung transplantation is indicated for advanced cases. Rehabilitation is essential for patients on the waiting list and requires ventilatory devices for symptom control during exertion. The high-flow nasal cannula is a promising alternative, but its effects on exercise outcomes are uncertain. Objectives: To assess the effects of high-flow nasal cannula on the outcomes of the six-minute walk test. Method: A randomized crossover clinical trial evaluated ten volunteers listed on the national lung transplant waiting list. Three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: high-flow nasal cannula and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers of both sexes
* Patients on the national lung transplant waiting list
* Chronic obstructive pulmonary disease
* Idiopathic or familial pulmonary fibrosis
* Bronchiectasis
* Sarcoidosis

Exclusion Criteria:

* Osteoarticular limitation,
* Neuromuscular disease,
* Anemia
* Hyperglycemia
* Arrhythmia
* Left heart failure
* Pulmonary hypertension
Rivaroxaban Post Coronary Bypass Surgery

Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low dose rivaroxaban

This study is a 1-year randomized, double-blind placebo-controlled trial to evaluate the effects of adding rivaroxaban to the treatment of patients after coronary bypass surgery. All patients referred for either off-pump or on-pump coronary bypass surgery to 3 academic hospitals in Shiraz, Iran were screened according to inclusion criteria. Clinicians at these sites were informed of this study and asked to refer patients after coronary bypass surgery.

A total of 414 patients were initially included in the study, but 171 of them were excluded based on the exclusion criteria (Figure 1). The remaining 243 patients were then randomly divided into two groups: group 1, receiving aspirin 80 mg daily plus placebo; group 2, receiving aspirin 80 mg daily plus rivaroxaban 2.5 mg twice daily.

Clinical outcomes were assessed at the end of first year post-operation. Subjects will undergo a complete history and physical examination and the study variables were assessed. Patients were followed every 2 weeks for any occurrence at these visits, patients' compliance was assessed, standard medication was adjusted as appropriate, and all interventions, outcome events, and adverse events were recorded. The patients were followed for the occurrence of major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist); and 3) cerebrovascular accidents. Occurrence of major bleeding and chest pain, and functional capacity exercise (assessed with exercise tolerance test) were also evaluated. Additional variables that will be collected at baseline include demographic and clinical characteristics of patients as follows: sex (male, female), age (mean (SD)), hypertension (yes/no), and diabetes mellitus (yes/no).

To document any unfavorable occurrences, the patients were questioned via telephone monthly about any potential side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 undergoing primary isolated coronary bypass surgery, with or without cardiopulmonary bypass

Exclusion Criteria:

* Other cardiac surgeries except for coronary bypass surgery
* Left ventricular ejection fraction \< 30 %
* Liver disease
* Clopidogrel or aspirin intake within 7 days of operation
* Need for perioperative warfarin
* Active gastroduodenal ulcer or post-operative gastrointestinal bleeding
* Profuse post-operative pleural effusion (drainage \>200 ml/h for 2 h or more
* Postoperative low cardiac output syndrome or requirement for high levels of hemodynamic support (more than 2 inotropes for more than 24 h and/or intra-aortic balloon pump)
* Clinical instability, such as perioperative myocardial infarction or malignant tumor.
Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)

The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.


Eligibility Criteria:
Inclusion Criteria:

* Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.

Exclusion Criteria:

* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.
* Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.
* Has been exposed to Ebola virus at any time prior to study entry.
* Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.
* Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.
* Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry.
* Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry.
* Has received systemic corticosteroids exceeding physiologic replacement doses (\~5 mg/day prednisone equivalent) within 14 days prior to study entry.
* Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.
* Has known or suspected impairment of immunological function (e.g., HIV positive).
* Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).
* Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.
* Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin).
* Has a history of malignancy \<=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
Dexamethasone for the Prophylaxis of Pain Flare Study

Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain (called a 'flare') a day or two after radiation treatment, that lasts about a day. The purpose of this sturdy is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.

Of all people diagnosed with cancer, 25% will have their cancer come back and spread to the bones. This often results in significant pain and suffering. Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain called a flare a day or two after radiation treatment that lasts about a day. Studies suggest that around a third of all people who receive radiation treatment to help pain from cancer in the bones will have a pain flare. This study is being done because it would be helpful to prevent extra bone pain from happening to people after they receive radiation treatments. The purpose of this study is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Documented bone metastases by radiological imaging
* Patients at least 18 years of age
* Written consent
* KPS ≥ 40
* Baseline worst pain at the planned radiated bony metastatic site ≥ 2
* Patient able to inform the pain score at the planned radiated bony metastatic site

Exclusion Criteria:

* Concurrent use of any corticosteroid medication other than topical or inhaled preparations
* Medical contraindications to corticosteroids such as diabetes mellitus, uncontrolled hypertension or active peptic ulcer
* Pathological fracture of the irradiated extremity
* Spinal cord compression
* Language barrier
* Immediate change in regular analgesic medication. If the oncologist thinks the patient is not receiving adequate analgesic, we recommend the oncologist to increase the analgesic first to stabilize ot lessen the pain before recruiting the patient to this study
The Study Of Probe-Based Confocal Laser Endomicroscopy Of Distal Airways In Diagnostics Of Lung Diseases

The study is devoted to the comparative analysis of the data received in patients with lung pathology using new method of probe-based confocal laser endoscopy of distal airways and two reference methods: high resolution computed tomography and morphology.

A relatively new technology in pulmonary medicine, probe-based confocal laser endomicroscopy of distal airways, which is also called alveoscopy, allows for real-time minimally invasive intraacinar imaging. This method has been developed that special miniprobe can be passed into the distal airway via the working channel of the bronchoscope and provide so called "optical biopsy". The method is based on the natural autofluorescence of pulmonary structures, detecting the elastin scaffold of central and peripheral airways, the structure of alveoli, blood vessels and alveolar macrophages. Taking into account the fact that in vivo endomicroscopy of distal airways is a novel diagnostic technique it needs correlating the obtained data at certain disease with the reference methods for the challenges of our current understanding of interpreting endomicroscopic images. We choose high resolution computed tomography and morphology as such reference methods.

Eligibility Criteria:
Inclusion Criteria:

* Patient Informed Consent;
* patients' fitness;
* the diagnosis of one of the following lung diseases: COPD, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis X, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease
* high resolution computed tomography scans performed not later than one month before pCLE;
* planned or performed histology

Exclusion Criteria:

* Severe respiratory failure,
* pregnancy or breast feeding,
* lung bleeding,
* any acute or chronic disease that may be a contraindication to bronchoscopy,
* any significant blood coagulation disorder,
* any diseases of hematopoietic system,
* alcoholism or toxic addiction,
* taking part in other clinical trials,
Effects of Hydrocortisone on Social Cognition and Memory

The effects of hydrocortisone on cognition will be investigated.

80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 10 mg hydrocortisone before testing. Tasks will on emotion recognition, memory and cognitive flexibilty will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* age 18 - 30
* medication free

Exclusion Criteria:

* any medication
* severe ilness
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair

The goal of this study is to determine whether introducing VR in the immediate post-operative period following scoliosis repair can reduce perceived pain and stress in pediatric patients and in turn ultimately decrease opioid use. Based on previous studies that have been performed in other fields of pediatrics showing a decrease in pain and stress with VR use, the investigators hypothesize that VR will significantly decrease patient's reported level of pain and stress immediately following the VR session, and that patients will require less opioids during their inpatient stay as a result.

This project evaluates whether providing pediatric post-operative scoliosis repair patients with a virtual reality (VR) session at specific time point following surgery can decrease pain and stress experienced and if this leads to a decrease in the use of pain medications required during the immediate recovery period. Virtual reality technology was ordered to use as a distraction tool as part of routine pediatric care for hospitalized patients. The study involves measuring pain and stress using validated scales as well as calculating opioid use in this specific pediatric post-operative scoliosis repair population. All post-operative scoliosis repair patients admitted to the inpatient pediatric floor above 7 years of age will be eligible for participation in this study. The goal is to collect data on at least 50 patients over the course of 12-18 months. Parental consent and child assent will be obtained on day 2 post-op surgery using a standardized consent and assent form, respectively. Data will be collected from the Numerical Pain Rating Scale and the State Trait Anxiety Inventory, which will be administered pre- and post-VR sessions, with the goal of comparing scores to evaluate for any decrease in pain and stress levels. Data on inpatient opioid use post-operatively will be used to compare with previous post-operative scoliosis patients to determine whether there a significant decrease in opioid use in the subjects exposed to VR. During the data collection process, results will be documented in an organized but deidentified manner.

Eligibility Criteria:
Inclusion Criteria:

* all pediatric patients post scoliosis repair
* age 7-21

Exclusion Criteria:

* age less than 7 years;
* history of seizures, epilepsy,
* history of motion sickness/balance problems,
* susceptibility to migraines
* currently pregnant
Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome

This study focuses on therapeutic targets for cognitive, motor, and social impairments in Williams syndrome by reversing brain myelin defects caused by GTF2I. The primary objective of the study was to test and evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome.

The primary objective of this study was to evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome. The secondary objective is to study Clomastine fumarate in relation to mechanisms of action, safety, and/or pathological mechanisms. This study was an open-label study with a randomized, cross-over, placebo-controlled design. Each participant will be randomly assigned to two groups through baseline assessment (see study results), with Group A receiving the FDA-approved drug Clemastine at a weight-dependent dose (see dosing table below) for the first cycle and placebo for the second cycle. Group B will be treated with placebo for the first cycle and the FDA-approved drug Clemastine for the second cycle.

Eligibility Criteria:
Inclusion Criteria:

1. Age 3-6 years old;
2. Positive fluorescence in situ hybridization (FISH) test confirmed Williams syndrome;
3. GTF2I gene mutation was detected by whole exon;
4. Heart safety variables are normal (e.g. normal ECG, blood pressure 120-129/80-84)

Exclusion Criteria:

1. WS patients with other gene mutations;
2. Used antihistamines, monoamine oxidase inhibitors, barbiturates and sedatives, as well as drugs affecting cognitive behavior, limb movement, white matter myelin, and MRI within 2 months before enrollment;
3. Patients with narrow-angle glaucoma, narrow peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy and bladder neck obstruction; Accompanied by severe immunodeficiency disease;
4. Allergic to Clomastine fumarate or other arylalkylamine antihistamines or any receptor;
5. According to the recent interpretation of MRI and neuroradiology experts or WS, there are obvious brain lesions that are not related to WS disease;
6. Clinically significant metabolic, hematological, liver, immune, urinary, endocrine, neurological, pulmonary, psychiatric, skin, allergic, renal, or other major diseases that may affect the interpretation of study findings or patient safety in WS's judgment;