cyrilzakka/clinical-trials huggingface dataset:
Telehealth BPT in DBP Practice

Access to evidence-based psychosocial interventions, particularly Behavioral Parent Training (BPT), for youth with Attention Deficit/Hyperactivity Disorder (ADHD) is limited. An approach to increasing such access is to utilize trained paraprofessionals (Family Peer Advocates; FPAs) in the delivery of BPT, particularly through modalities, like telehealth, that further improve access and availability. This approach, FPA-delivered BPT via telehealth has yet to be studied. This study will evaluate the benefits of a FPA-delivered BPT for parents of children identified with ADHD in Developmental Behavioral Pediatric (DBPs).

There are two aims of the study: Specific Aim 1: To determine the benefits of a FPA-delivered telehealth BPT model on children's ADHD symptoms, oppositional behavior, functional outcomes, parenting behavior and parental stress. Specific Aim 2: Understand the shared decision making process between the parent, physician, and FPA within the Pediatric- Family Peer Advocate (PEDS-FPA) model through qualitative interviews.

Eligibility Criteria:
Inclusion Criteria:

1. Child must be between the ages of 4-11 years
2. Child must be diagnosed with ADHD (any subtype) within the last 6 months
3. Parent/ legal guardian must be at least 18 years old
4. Parent/ legal guardian must be legal guardian of child
5. Parent/ legal guardian must speak English or Spanish
6. Parent/ legal guardian must not have previously received manualized, multi-session behavioral parent training (BPT)
7. Child must be under public or no insurance
8. Parent/legal guardian must be able to provide consent.

Exclusion Criteria:

1. Children with ADHD who have significant mental health comorbidities that warrant more intensive psychosocial/pharmacological intervention per physician recommendations
2. Parent/ legal guardian who does not have access to reliable internet service to participate in telehealth delivered BPT
3. Parent/ legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia, other significant mental illness)
4. Parent/ legal guardian who has limited, consistent contact with their child (i.e., less than 3 days/week)
Effects of Prevention in School (PS): a Swedish School-wide Positive Behavior Support Program at the Primary Prevention Level

Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the universal prevention level, developed by Swedish researchers for the school years 4 -9. By defining and teaching school rules to all teachers and students, and by consistently acknowledging students when meeting behavioural expectations, the program aims to reduce problem behaviours in school areas and to improve the classroom learning climate. Against this background, the purpose of this study is to examine whether PS is more effective than schools' ordinary practices in meeting these goals.


Eligibility Criteria:
Inclusion Criteria:

* Schools situated in Stockholm county and in bordering counties within travelling distance from Stockholm.
* Comprising the grades 4-9 (10-15 years).
* A minimum of 2 classes/50 students in each of the grades 5-7.
* A majority (min.80%)of the staff is positive towards program participation.
* School management willing to take active part in change/developmental work.
* A willingness to submit to study conditions (randomization etc)

Exclusion Criteria:

* Participation in other ongoing research projects.
Exercise in Patients Admitted With Recently Decompensated Heart Failure

An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.

With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown:

Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedaler for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes

All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity. Patients in the test group may start the program only on stage I or II according to clinical criteria.

At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test.

Eligibility Criteria:
Inclusion Criteria:

* Admission diagnosis of Decompensated heart failure
* More than 18 years old
* Capacity to provide informed consent

Exclusion Criteria:

* Osteoarticular pathology that impedes the performance of the exercise;
* Existence of inotropic infusions;
* Dysrhythmia or precordial pain in the last 24 hours,
* Acute pulmonary edema in the last 12 hours,
* SBP greater than 180mmHg or less than 80 mmHg (except in cases where this is the baseline value for the patient),
* Need for oxygen at a rate greater than 3 l / min,
* Glycemic decompensation in the last 12 hours,
Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique

Surgery plays a central role in kidney cancer management being the only therapy that offers the possibility of healing the patients. Currently, the partial nephrectomy is a standard technique because it meets the principle of nephron sparing surgery. A partial nephrectomy requires a control of the renal blood flow using a clamp, which can be parenchymal or vascular (pedicular). In France, most of the centers use pedicular clamping. It is well established that this technique results in warm ischemia of the entire healthy parenchyma and can lead to permanent kidney damages. Currently, no study evaluated the impact of parenchymal clamping on the healthy parenchyma.

The aim of the investigators study is to evaluate the nephrotoxicity of the healthy parenchyma due to parenchymal clamping during partial nephrectomy. This assessment will be done through a microdialysis technique. The microdialysis probe is directly implanted in the healthy unclamped parenchyma and will allow us to measure in real time, during the surgery, the biological changes related to anaerobic metabolism of renal interstitial space. All those measures will be completed by urinary and plasmatic assessments. Oxidative stress will be assessed using four markers of tubular viability : Interleukin 18 (IL18), Kidney Injury Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C and four parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose.

This is a prospective pilot study limited to 10 patients included over 12 months. Depending on the results, it will be further developed by a second study comparing parenchymal with pedicle clamping.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the urological surgery department with an indication of partial nephrectomy
* Patients with a renal lesion classified T1 (≤7cm) or for T2 eligible to a partial nephrectomy and having an possibility to benefit from a parenchymal clamping (decided on preoperative imaging)

Exclusion Criteria:

* Patient with a chronic kidney disease (functional or structural renal abnormality evolving for more than three months and Glomerular Filtration Rate \<60 ml/min)
* Patient carrying a renal lesion classified T1 but too close to the renal pedicle or not accessible for a parenchymal clamping
* Patients in whom tumor removal requires ice cooling or kidney pedicular clamping
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing heartburn in the past month if untreated
* Having heartburn that responds to heartburn medication
* Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria:

* Having history of erosive esophagitis or gastroesophageal reflux disease (GERD) diagnosed by a physician and confirmed by testing (endoscopy)
* Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

"Other protocol-defined inclusion/exclusion criteria may apply"
Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.

Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication

Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should be included in the hiatal reconstruction in order to reduce the risk of postoperative gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be recommend is yet to be determined.

One might argue that the overall durability and effectiveness of a partial fundoplication in the control of reflux might be less reliable than a total wrap, but on the contrary, the latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.

We therefore designed a double blind randomized clinical trial in which patients with symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total (Nissen) fundoplication after hernia reduction and crural repair.

Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery of para-esophageal hernia with addition of total fundoplication vs posterial partial fundoplication.

Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36: physical and mental component scores.

Time points: 1, 3 and 6 months after surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital and Karolinska University Hospital

Exclusion Criteria:

* age below 18 years
* axial sliding hiatal hernia only (type I)
* missing informed consent
* previous hiatal hernia surgery
* American Society of Anesthesiologists (ASA) score IV or above
* achalasia
* Zollinger-Ellison syndrome
* malignant tumor
* inability or unwillingness to complete questionnaires
Cardiovascular Effects of Very Low Nicotine Content Cigarettes

The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers

The FDA is planning regulatory actions to limit nicotine levels in cigarettes as far as it is not reduced to zero. The strategy is designed to reduce the addictiveness of cigarettes. However, nicotine related effects of the cigarettes with reduced nicotine content on various body systems are largely unknown. Following formal implementation of the regulatory policy what cardiovascular effects of reduced nicotine cigarettes, also called very low nicotine content cigarettes (VLNCC) are expected to persist is important to determine. This study will determine the cardiovascular effects of VLNCC such as change in heart rate, autonomic functions and indices of ventricular repolarization in smokers. Participants will be asked to smoke two VLNCC and one normal nicotine content cigarette (NNCC) while we will be recording their electrocardiogram (ECG) to see a change in heart rate, heart rate variability and indices of ventricular repolarization.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported cigarette smoking at least once in the past 30 days
* ≥21 years old
* Willingness to smoke research cigarettes or usual brand cigarettes during lab visit.
* Ability to speak, comprehend, and read English sufficiently to complete study procedures

Exclusion Criteria:

* Self-reported diagnosis of cardiovascular diseases like coronary artery disease, stroke, peripheral artery disease, cardiac arrhythmia, pulmonary embolism \& blood clots in legs and arm in the past 3 months
* Body temperature ≥ 100.4˙F
* Unstable health conditions interfering with electrocardiogram (ECG) measurements
* Self-reported diagnosis of hyperthyroidism or thyrotoxicosis
* Currently pregnant (as indicated by urine pregnancy test at the start of laboratory visit) or breastfeeding.
* Currently seeking treatment to quit smoking
Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically

This study aims to compare continuous femoral nerve block with adductor canal block after anterior cruciate ligament reconstruction arthroscopically，especially in the effect on quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients postoperatively.

Forty patients with American Society of Anesthesiologists（ASA） Ⅰ-Ⅲ（no limitation of age and gender）are randomized to receive either a continuous adductor canal block(ACB) or a femoral nerve block(FNB) via a catheter (a continuous infusion of 0.2% ropivacaine, 5 mL/h for 48 hours)in the PACU immediately after the anterior cruciate ligament reconstruction arthroscopically. Patients were under general anesthesia during the operation and received a femoral nerve block with 0.25% ropivacaine 10ml before the surgery.Both groups will receive postoperatively IV patient controlled analgesia (PCA) with morphine (bolus 0.8mg,lock-out time 15 minutes, background infusion 2ml/h)beside the continuous nerve block. Patients are going to be visited for follow-up on the day of surgery and in the following two days. Quadriceps strength is assessed with the displacement of patella.VAS at rest time、degree of knee flexion、VAS at 45°flexion of the knee、dose of opioids、whether the patient has sleep disturbance are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA Ⅰ-Ⅲ
* Anterior Cruciate Ligament Reconstruction

Exclusion Criteria:

* patient refusal
* chronic use of opioids
* coagulation disorders
* infection at the puncture site
* allergic to anaesthetic
* preexisting neurological disorders
* communication difficulties
Preliminary Evaluation of CASTLE Barrier North American Prototype

The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.


Eligibility Criteria:
Inclusion Criteria:

at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent

Exclusion Criteria:

presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results
Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

The purpose of this study is to compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously, global parameters of oxygen delivery and consumption will be compared with regional flow parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While continuous thermodilution cardiac output is used for patient management, pulse contour cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used for monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Indication for invasive hemodynamic monitoring with pulmonary artery catheter and arterial catheter
* Hemodynamic instability (need for vasoactive drugs, inotropics or volume).

Exclusion Criteria:

* Age \< 18.
* Patient with contraindications for the placement of arterial cannula.
* Patient with history or clinical findings of aortic valve regurgitation.
* Atrial fibrillation.
* Patient being treated with an intra-aortic balloon pump.
* Limitation of therapy due to bad prognosis
Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder

Post-Traumatic Stress Disorder (PTSD) is a public health problem due to both its chronic nature and the low response rate to conventional therapies.

Sleep disorders are the first cause of complaint in patients with PTSD due to night awakenings, difficulty to fall asleep and nightmares.

According to a part of the scientific community, replicative traumatic nightmares represent PTSD's basis mechanism. Traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. Traumatic nightmares may thus be a sign of PTSD seriousness and chronicity, although their physiological basis remain poorly known.

In the military population, which is highly exposed to psychological traumatism, PTSD prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies.


Eligibility Criteria:
Inclusion Criteria:

* Military or former military
* Age between 18 and 65 years old
* PTSD group : with a PTSD diagnosis
* Control group : without any sleep, psychiatric or neurologic pathology

Exclusion Criteria:

* Diagnosis of progressive psychiatric pathology prior to the traumatic event responsible for PTSD
* Sleep pathology prior to the traumatic event responsible for PTSD
* Neurological pathology or severe head injury within the last 3 years
Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)

The purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil.

The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.

Treatment of ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic drugs, and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. The standard induction therapy of a relapse of Wegener's granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone. Although this induction therapy is very effective, it is very toxic as well.

Searching for an alternative for cyclophosphamide, we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone. We will compare the effect and safety of the standard induction therapy with the new therapy. When relapses occur, patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil.

Eligibility Criteria:
Inclusion Criteria:

* First or second relapse ANCA-associated vasculitis
* PR3- or MPO-ANCA antibodies present or histological proof of relapse
* Adult

Exclusion Criteria:

* Severe alveolar bleeding or (imminent) respiratory failure
* Renal failure (serum creatinine \>500 umol/L or dialysis)
* Maintenance therapy before start of study consisting of: cyclophosphamide \> 100 mg/day or prednisolone \>25 mg/day
* Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine
* Gravidity or inadequate anticonception
Dynamics of Organ Damage and Immune Exhaustion During Sepsis

This is a prospective, non-randomized study investigating if organ damage and immune changes can be measured by liquid biopsy NGS through advanced analytical methods.

To determine the sample size needed to derive a signature matrix to identify novel biomarkers in sepsis, investigators performed a mathematical modeling exercise of the lower limits of sensitivity of this liquid biopsy approach. The detection limit of cell-free nucleic acid analysis is determined in part by the number of independent transcripts or "reporters" that are interrogated. Using an established and independently validated binomial model that was previously applied to the prediction of circulating tumor nucleic acid detection limits, investigators estimated the probability of cell-free nucleic acid detection in sepsis patients based on the number of unique tissue-specific reporters (i.e., hepatic transcripts that may reflect disease severity). This yields a result of n=18 per group to achieve 0.90 power at alpha=0.05. The investigators will thus plan to analyze data from n=18 per cell/tissue type to derive the signature matrix for this project.

Eligibility Criteria:
Inclusion Criteria:

• Patients who've developed a shocked state (Hypotension or Lactate grade \>4) or Clinical Concern

Exclusion Criteria:

* \<18 years of age
* Pregnant Women
* Nursing women
Analysis of Specimens From Patients With Orthopaedic Implants

The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.

The following tests will then be arranged:

* Tribological assessment. The investigators will measure the wear of the explants using: 1) 'out of roundness'; and 2) Coordinate measuring. Semi-quantitative assessment of damage to the explants will also be conducted
* Histological assessment. Tissue sent in formalin may determine the biomarker of diagnosis of metal ion synovitis where applicable
* Metal ion measurement in body fluids where applicable (in patients with metal implants)
* Diamond Light Source (this was approved in the 1st amendment). The tests will involve subjecting formalin fixed tissue to the high energy electron beam of the Diamond Light Source
* Destructive testing of the implant is allowed by the patient (after all non-destructive tests have been performed)
* Protein analysis of fluid and tissue if provided
* Titanium levels from blood samples if provided
* Gene expression testing to assess and understand mechanism of inflammation where applicable

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)

Exclusion Criteria:

* Patients not consenting to the study