cyrilzakka/clinical-trials huggingface dataset:
A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway

Drop out from upper secondary school represents a risk for the future health and wellbeing of young people. Strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. The COMPLETE study is a school based cluster randomized controlled trial (RCT) evaluating two school-based interventions, namely the Dream School Program (DSP) and the Mental Health Support Team (MHST) among 1st grade upper secondary school students in four counties in Norway. The interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence.

Specifically, the COMPLETE study will

1. Evaluate whether the DSP alone

   1. increases completion
   2. increases presence
   3. improves school achievements
   4. improves mental health and wellbeing
2. Evaluate whether the DSP and the MHST combined

   1. increase completion
   2. increase presence
   3. improve school achievements
   4. improve mental health and wellbeing

   The COMPLETE study will also evaluate the effect of the DSP and MHST combined and the DSP alone against secondary outcomes of school satisfaction and loneliness.
3. Evaluate through a process evaluation whether the interventions were implemented in line with guidelines for each of the interventions, and whether the degree of program fidelity has influenced the effect of the interventions on the primary and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* School inclusion criteria: not been or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects
* Student inclusion criteria: student enrolled at any of the included schools.

Exclusion Criteria:

* Schools previously or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects.
* Student exclusion criteria: students with special needs or who are illiterate in Norwegian are excluded from the survey assessment, but included in the interventions.
Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis

PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 18 years of age and in good general health condition
2. Signed informed consent
3. Existing Ostenil® Plus recommendation for the treatment of coxarthrosis

Exclusion Criteria:

1. Known hypersensitivity to one of the OSTENIL® PLUS components
2. Known pregnancy or lactating females
3. Previous/concomitant participation in clinical investigation within the last 3 months prior to study inclusion
4. Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
5. Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)
Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

This study is being done for two reasons: 1) to evaluate growth problems in the hip in patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults, and 2) to help doctors determine which patients are at risk for developing a SCFE on their opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a SCFE on their other side. Being able to better determine which patients are at risk for developing a SCFE on the other side will help physicians better monitor patients with a history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By studying the growth centers seen on X-rays of your child's legs and elbow, the investigators may be able to better predict which children with a SCFE are at risk for developing a SCFE on their opposite hip and potential growth problems as they continue to grow.

After obtaining informed consent, pediatric patients presenting to our institution with a SCFE will have a single radiograph of the elbow, in addition to those radiographs currently obtained as part of routine evaluation and treatment (e.g. AP pelvis, bilateral hip laterals, scanogram, and hand bone age). This additional radiograph, a single one-time lateral elbow radiograph taken on initial presentation with a SCFE, will be used to assess bone age and compared with other radiographic methods, i.e. hand bone age, currently used to assess skeletal maturity. Scanogram of the lower extremities, at initial presentation and at the completion of skeletal growth, will be used to accurately assess the length of the lower extremities and evaluate limb length discrepancy at maturity. Treatment of the patient's SCFE and post-operative management will be as per routine care at our institution. Patients will be followed until skeletal maturity.

The medical records and radiographs of patients with SCFE will be collected. Patient data will include:

* Patient demographics- chronologic age, gender, race/ethnicity, standing height, weight, BMI, clinical follow-up duration
* SCFE type- chronicity of symptoms prior to presentation, Loder classification of slip stability, laterality, time between sequential SCFEs
* Skeletal maturity data- bone age, triradiate closure, Risser sign, modified Oxford bone age, olecanon method and the Simplified skeletal maturity scoring system
* Radiographic data- slip severity, physeal slope angle, and leg length discrepancy
* Complications
* Additional procedures

In order to compare the various radiographic methods of skeletal age assessment, the elbow hand and AP pelvis radiographs will be reviewed once by three independent and experienced observers, two pediatric orthopaedic surgeons and one musculoskeletal radiology attending. The radiographic skeletal age assessment will be discussed by these three observers in order to minimize intraobserver and interobserver errors.

Eligibility Criteria:
Inclusion Criteria:

* Slipped capital femoral epiphysis

Exclusion Criteria:

* Prior Slipped capital femoral epiphysis not initially treated at our institution
Model 4296 Left Ventricular (LV) Lead Study

This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines
* On optimal medical treatment according to investigator opinion
* Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted
* Patient consent
* Geographically stable

Exclusion Criteria:

* Left Ventricular (LV) lead implant attempt in last 30 days
* Unstable angina or acute myocardial infarction (MI) in past 30 days
* Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days
* Contraindicated for transvenous pacing
* Heart transplant
* Contraindicated for less than 1 milligram (mg) dexamethasone acetate
* Enrolled or intends to participate in concurrent drug and/or device study which would confound results
* Life expectancy shorter than duration of the study
* Exclusion criteria required by local law
* Unable to tolerate urgent thoracotomy
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis.

Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D17\] \< 7).


Eligibility Criteria:
Inclusion criteria in the open-label phase:

* Outpatients
* Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception (Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception)
* Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features (If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.)

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or ER) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)
Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison

This study will evaluate the 3 drug-eluting stents presently marketed for intervention in the coronary artery with respect to the complications that may occur in case it becomes necessary to retract the stent during the intervention. It has been noted that stents carrying a drug for local application may be more difficult to retract than the more smooth bare metal stents.

Patients in whom DES implantation is planned will be randomized to one of the 3 commercially available stents (i.e., Cypher, Taxus-Liberté, Endeavor).

Sealed envelopes will be used for randomization purposes. Should additional stents be required in the same patient for the same or other lesions, another stent of the same type of stents will be implanted.

The following assessments will be made:

* Unblinded subjective operator assessment based on a questionnaire. The questionnaire will include questions on problems encountered during stent-balloon retrieval, special maneuvers performed (e.g., retrieval of the catheter during device removal, and possible complications associated with device retrieval).
* Blinded measurements of following parameters:

  1. Minimal and maximal distance between the tip of the guiding catheter and the proximal stent end during stent-balloon retrieval.
  2. Minimal and maximal distance between the tip of the guidewire and the distal portion of the stent during stent-balloon retrieval.
  3. To do so the retrieval of the stent-balloon will be documented on ciné-angiography. The measurements will be performed by a qualified technician/physician blinded to the type of device used.
* Clinical endpoints:

  d. In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.

  e. Myocardial infarction defined as creatine kinase MB-isoform \[CK-MB\] ≥3x upper limit of normal within 24 hours of the procedure or ≥2x upper limit of normal after 24 hours of the procedure in the presence of new ischemic symptoms.
* Target enrollment of 150 patients

Eligibility Criteria:
Inclusion Criteria:

* Patients with a planned angiography and percutane coronary intervention
* Age 18 years or above
* Informed consent to PCI and to participation in this trial

Exclusion Criteria:

* Patients who after angiography are deemed not suitable for stent implant (operators discretion)
The Prognosis of Graft Using Plastic Cannula in Hemodialysis

The purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients

1. Ultrasonography is performed to determine the maturity of vascular access 4 weeks after AVG creation.
2. The first puncture is performed with plastic cannula or metal needle when it is judged that the blood vessel has matured.
3. Four skilled nurses perform vascular access puncture with plastic or metal needle
4. Ultrasound are used to evaluate and record the complications related to the puncture in plastic or metal needle group every month.
5. Complications and dialysis adequacy between the two groups will be evaluated after 6 months

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving hemodialysis treatment using AVG

Exclusion Criteria:

* Age under 20 years old or over 75 years old
* Abnormal skin condition using immunosuppressants such as steroids.
* Skin disorder
* Metal allergy
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib in approximately 25 subjects. The study will consist of 11 visits over 15 months.


Eligibility Criteria:
Inclusion Criteria:

* Completed Study C-938788-050, including having received a post-treatment renal biopsy, and having had a clinically meaningful response (i.e. decreased proteinuria or improved renal histology)
* Able and willing to give written informed consent

Exclusion Criteria:

* Unresolved Grade 2 or greater toxicity in Study C-935788-050
Influence of Renal Function on the Circadian Variation of Cardiac Troponin

Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction. Whereas the diagnosis is based on an increase and/or decrease in the concentrations of cardiac troponins with at least one value above the 99th percentile value of the reference population together with the evidence of ischemia, serial sampling is needed. Knowledge of the variation in cardiac troponin levels over time in individuals in a normal rest state (not during an acute myocardial infarction), also called the biological variation, is important regarding the interpretation of the serial cardiac troponin levels. A recent study by our group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is important regarding the interpretation of the serial cardiac troponin levels.

Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The mechanism of the elevated concentration of cTn in these subjects is still unclear. It is hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it is not clear whether renal function affects the biological variation and circadian rhythm of cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with impaired renal function creates the opportunity to assess the effect of renal clearance on the circadian rhythm of cardiac troponins.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 3 or 4
* No dialysis
* No evidence of active, acute cardiovascular disease

Exclusion Criteria:

* History of acute myocardial infarction in the last year
* History of pulmonary embolism in the last six months
* Anemia (Hb \< 6.5 mmol/L)
Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures

The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater.
* Isolated distal radial fracture.
* Fracture treated with volar plates, stable fixation.
* Initial treatment within 4 weeks of trauma.

Exclusion Criteria:

* Complex fractures that require additional or different material than volar plates.
StressLess Yoga Study

The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Self-identification as "stressed"
* Scoring 8 or higher on the Perceived Stress Scale (PSS) indicating moderate-to-high stress
* Willingness to complete the 8-week yoga intervention
* Willingness to attend baseline and follow-up visits
* Ability to read and write in English
* Having practiced yoga ≤ 2x in the last 6 months

Exclusion Criteria:

* Serious or unstable psychiatric illness (e.g., psychosis, mania)
* Major coexisting medical illness (e.g., cancer, COPD, obesity)
Management of Acute Pain in the Emergency Department

Oligoanalgesia1 has been widely recognized as an issue in emergency department.The purpose of our study is to assess the impact of the implementation of a computer-assisted support program to improve pain management in our ED.

Inadequate pain management remains a major challenge for health care providers. Despite extensive research on the mechanisms of acute pain, identification of factors leading to poor pain management and development of evidence-based strategies, the transfer of this knowledge into effective clinical practices has been surprisingly slow. Oligoanalgesia1 has been widely recognized as an issue in emergency department (ED) patients. Acute pain is reported by 60-80% of ED inpatients but is frequently undertreated. Overall, an insufficient proportion of patients with acute pain receive any type of analgesia, and pain relief remains unsatisfactory. We showed that the implementation of guidelines improved pain management. However, rotation of the medical \& nursing staff leads to the forgetting of guidelines. The purpose of our study is to assess the impact of the implementation of a computer-assisted support program to improve pain management in our ED.

Eligibility Criteria:
Inclusion Criteria:

Any patient admitted to our Emergency Department who is

* age \> 16 years
* pain lasting =\< 1 week or
* no pain on admission but pain during the ED stay

Exclusion Criteria:

* life-threatening condition requiring immediate admission in the OR or ICU
* no pain or pain lasting \>1 week
* inability to give informed consent (intoxicated, psychiatric disorder, language problem, prisoner)
Text Message (SMS) to Help Cancer Patients in Chemotherapy Treatment

This study evaluates the text message (SMS) with orientation to help the management of chemotherapy treatment.

The investigators developed an app (called ChemotherApp) for Android that automatically sends text messages with homecare orientation to cancer patients in intervention group. The main features of this app are: to register information such as name, number of cellphone, gender, and chemotherapy schedule of the patient. Other feature is to register the orientation that will be sent to patients by text messages. Daily, the app send a registered orientation to each patient.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients who will start chemotherapy treatment in Hospital Escola of Federal University of Pelotas.

Exclusion Criteria:

* Illiterate patients; Patients who do not have their own cell phone
Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

This prospective, randomized trial asked whether subcutaneous indwelling of vacuum drainage has advantages over intraarticular indwelling in terms of blood loss, bleeding related complications, and functional outcomes in primary total knee arthroplasty (TKA). The investigators hypothesized that the subcutaneous indwelling method would reduce blood loss with comparable bleeding-related complications and functional outcomes. The subcutaneous indwelling group demonstrated reduced blood loss with comparable prevalence of bleeding-related complications and functional outcomes. In conclusion, the investigators' study verified the efficacy and absence of risks of subcutaneous indwelling method. So the investigators propose that the subcutaneous indwelling drainage can be a good option to address the problems related to postoperative bleeding after TKA.

There are numerous reports in the literature on drainage options after TKA, but there is no consensus. Many studies have shown no apparent advantage of drainage but routine intraarticular indwelling drainage after TKA has been extensively used to avoid complications associated with hematoma formation. It is of interest to determine if it is possible to reduce blood loss while still using drainage. So we came to think about a new and more convenient method-subcutaneous indwelling. Theoretically subcutaneous indwelling method which still has the advantages over the intraarticular indwelling method but is more convenient than drain-clamping method may be a better option. So we hypothesized that subcutaneous indwelling method of vacuum drainage has advantages over the intraarticular indwelling method.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary osteoarthritis
* primary total knee arthroplasty
* Signed written informed consent
* Spinal/epidural anesthesia

Exclusion Criteria:

* Patients with coagulation disorders
* Revision total knee arthroplasty
* Simultaneous bilateral total knee arthroplasty
* Diagnosis other than primary osteoarthritis
* Patients refusing consents