cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of an Anti-bullying Intervention for Adolescent Perpetrators

The investigators recruited school bullying perpetrators from the age of 12 to 17 by referral from the local police department. An anti-bullying intervention based on cognitive-behavioral therapy (CBT) principles was conducted, and addressed issues related to impulse control, empathy and communication enhancement. All participants completed brain magnetic resonance imaging, neurocognitive tests, and questionnaires before and after the intervention.

The present study included previous perpetrators of school bullying who were convicted for a minor offense, including physical or verbal assaults or theft, and who were referred by the police to participate in an anti-bullying intervention. The program consisted of 8 sessions over 4 weeks and was conducted by a board-certified psychiatrist and a therapist with previous training in psychosocial treatments. The intervention was based on CBT principles and addressed various factors that have been associated with perpetrators of school bullying, including impulse control, perspective taking (empathy), and the enhancement of communication skills.

All participants completed the Korean Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) administered by board-certified child and adolescent psychiatrists. The validity and reliability of the original and Korean versions of the K-SADS-PL have been established. Intelligence quotient (IQ) was measured using the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children.

Prior to and after participation in the program, all participants underwent brain magnetic resonance imaging (structural and functional) and completed neurocognitive tests that included the continuous performance test (CPT), the Stroop Word and Color Test, and the Wisconsin Card Sorting Test (WCST). The parents of the participants completed questionnaires including the Child Behavior Checklist (CBCL). Written informed consent was obtained from the parents and the participants after sufficient explanation of the study. The study protocol was approved by the institutional review board of the Seoul National University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* No psychiatric diagnosis or psychiatric diagnoses including conduct disorder, depressive disorder, oppositional defiant disorder, attention-deficit hyperactivity disorder, and adjustment disorder.
* IQ \> 70
* Agreement to participate
* Ability to cooperate in group therapy

Exclusion Criteria:

* Any psychotic disorder
* Severe impairment in impulse control
* Not cooperating with program participation
* IQ \< 70
* Current or past history of brain trauma or organic brain disorder, seizure disorder, or any neurological disorder.
A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A

This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A

The duration of the treatment will be 16 weeks and then will be a security perid with 2 visits (Week 12 post treatment and week 24 post treatment) The study in an open label study with a single arm .

Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic HCV genotype 1, 4 infection with or without HIV infection aged 18 years or above
* HCV RNA plasma concentration of at least 1000 IU / mL
* Subjects previously treated with NS5A-based regimens for at least 8 weeks.
* Patients with HCV relapse after receiving a complete treatment with NS5A-based AAD regimen for at least 8 weeks and becoming undetectable at the end of treatment. Relapse is defined as a confirmed HCV RNA detectable upon completion of therapy of A5 based on NS5A against HCV.
* Subjects with compensated hepatic cirrhosis (Child A) could be included.
* For patients with HIV coinfection:

  * Be infected with HIV-1, documented by any rapid HIV test with the corresponding license and confirmed by a Western blot or second antibody test using a method other than the initial rapid HIV and / or I / CIA method or by HIV-1 p24 antigen or viral load of HIV-1 RNA plasma.
  * Be on stable HIV antiretroviral therapy (ART) for at least 4 weeks prior to entry into the study using a dual ITN backbone of tenofovir or abacavir and emtricitabine or lamivudine PLUS raltegravir or dolutegravir or rilpivirine (with CD4 + T cell count\> 100 cells / mm 3 and undetectable HIV-1 RNA at baseline. Results from prior analysis will be accepted within 24 weeks prior to study entry).

Exclusion Criteria:

* Subjects with hepatitis other than C or steatosis.
* Subjects previously treated less than 8 weeks with regimens based on NS5A.
* Evidence of previous hepatocellular carcinoma although it has criteria of cure
* Subjects with past or current decompensated liver disease; Only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included.
* Subjects suspected of clinical or genotypic reinfection of HCV.
* Subject with HCV response regrowth while receiving NS5A-based ADA therapy against HCV. Said regrowth is defined as a confirmation of detectable HCV RNA after achieving undetectable HCV RNA during NS5A-based AADs against HCV.
* Recent history of drug or alcohol abuse.
* Important comorbidities.

  * Pregnant, lactating or non-lactating women Contraceptives, if they are women of childbearing age. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.
  * Subjects with a glomerular filtration rate of less than 30 ml / min.
Supported Treadmill Ambulation Training After Spinal Cord Injury

This is a randomized, controlled trial to compare supported treadmill ambulation training (STAT) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in SCI subjects injured more than six months prior to start of training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes of training within a one-hour period per day, five days per week. These subjects will be studied baseline, 4,8 and 12 weeks of training, and three months after the end of training with a battery of tests designed to evaluate the subjects' gait and muscle function.


Eligibility Criteria:
Spinal cord injury
Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.


Eligibility Criteria:
Inclusion criteria (Core Phase):

* Age ≥18 years
* Radiological confirmation of disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
* At least one measurable site of disease on CT/MRI scan
* Physically fit even if not able to work
* Normal organ, electrolyte, and bone marrow function

Inclusion criteria (Extension Phase):

* Patients whose tumors had progressed on the control arm and had crossed over to the nilotinib arm.
* The study was stopped due to meeting the primary efficacy endpoint of PFS at the interim analysis.
* Patients who were still being treated at the close of the Core study on the control arm or nilotinib arm (whose tumors have not progressed at the time of the end of the Core study).
* Patients must have had documented, confirmed stable, partial or complete response as defined by the RECIST criteria at the time of entry into the Extension study with the exception of patients who had progressed on the control arm.

Exclusion criteria (Core Phase):

* Previous treatment with nilotinib or any other drug in this class or other targeted therapy
* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks prior to study entry
* Impaired cardiac function
* Use of coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
* Women who are pregnant or lactating

Exclusion criteria (Extension Phase):

* Use of other anticancer treatments or investigational drugs (with exception of the study drugs)
* Patients with a history of noncompliance with study drug treatment in the Core study protocol.

Other protocol-defined inclusion/exclusion criteria applied
Hypoxic Conditioning in Heart Failure

Heart failure impairs quality of life and exercise capacity, despite an optimal medical therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be explored and describe

All heart failure patients will have a session of 45' of bicycle exercise training (in normoxia or hypoxia) AND a one hour rest session (in normoxia or hypoxia).

Exercise training sessions will consist in a continue bicycle exercise test at 70 to 80 % of the maximal heart rate, while breathing (single blind) normoxia or hypoxia gaz.

Rest conditioning consist in a one hour of rest, while breathing (single blind) normoxia or hypoxia gaz.

For hypoxia sessions, the oxygen saturation target will be fo 85-90 % for the 4 first weeks and 80-85 % for the last 4 weeks.

Three arms :

* exercise training in NORMOXIA and rest conditioning in NORMOXIA
* exercise training in HYPOXIA and rest conditioning in NORMOXIA
* exercise training in NORMOXIA and rest conditioning in HYPOXIA

Eligibility Criteria:
Inclusion Criteria:

* patient available for exercise training
* stable heart failure state I-II New York Heart Association (NYHA) with altered ejection fraction (EF ≤ 40 %)
* signed informed consent

Exclusion Criteria:

* unstable ischemic cardiopathy
* right ventricle dysfunction
* uncontrolled arrythmias
* rest elevated in pulmonary artery pressure (≥ 45 mmHg)
* migraine
* high altitude trip above 2500 m high during study period
* impossibility to realise a maximal bicycle exercise test
Start Treatment and Recovery for Opioid Use Disorder

The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.

The emergency department is a critical missed opportunity to engage patients with opioid use disorder in medication-assisted treatment, the most effective current treatment for the disorder. Patients presenting at the emergency department with opioid use disorder will be given the opportunity to immediately start medication assisted treatment with Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a local waivered provider for further treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Emergency Department
* Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual (DSM) 5

Exclusion Criteria:

* Participating in alternate treatment program for opioid use disorder
* Prisoner
* Inability to communicate
* Psychosis
* Suicidality
* History of Buprenorphine injection
* Critical Illness
Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen

Pressure ulcers associated with osteitis are frequent among patients with spinal cord injury (SCI), and optimal management is not well known. In a French referral center, debridement and flap coverage surgeries performed simultaneously are followed by a short antibiotic treatment targeting the bacteria involved. The aim of the study is to evaluate patient's outcome at Day 45 after surgery, and identify factors associated with failure.

Spinal cord injured (SCI) population is subject to pressure ulcers because of numerous risk factors: neurological disorders, which reduce ability to mobilization, potential, undernutrition, confinement to bed, and vascular disorders promoting the lesions.

Despite the attention given to preventative strategies, in this population, prevalence of pressure ulcers varies from 10% to 30%, with an annual incidence rates range ranging from 20%-% to 31%.

In community-dwelling SCI population, stages III and IV pressure ulcers account for 25% of total ulcers observed.

They are a major cause of healthcare centers admissions or homecare nursing. Duration of ulcers could vary from 1 week to 3 years.

Also, their occurrence is associated with potential repeated hospitalizations and with a longer length of stay. Furthermore, pressure ulcers are an important economic burden to the health care system.

Pressure ulcers interfere with the patient's physical, psychological, and social well-being and impact the overall quality of life.

Over recent years, an increased pressure ulcer prevalence has been reported. Therefore, they are frequent and their clinical spectrum is wide. They also readily become superinfected and can lead to sepsis.

Establishing the diagnosis of osteomyelitis in this setting is challenging, and physicians often struggle with the appropriate therapeutic management.

A recent review did not find evidence of benefit of antibacterial therapy in osteomyelitis associated with pressure ulcers without concomitant surgical debridement and wound coverage. But this type of management remains controversial.

In a French referral center, patients with pressure ulcer-related osteitis benefit from a one-stage surgical management with bone shaving and flap covering, followed by a probabilistic post-operative antibiotic treatment, secondarily adapted to peroperative samples, for a total duration of effective antibiotic treatment of 7 or 10 days.

Thus, the investigators aim to evaluate this original strategy, identify risk factors for failure, and focus on the role of antibiotic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years;
* Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.

Exclusion Criteria:

* Patient \< 18 years;
* Patient under under guardianship;
* Patient with concomitant infections;
* Patient having declare his opposition to study participation.
ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee

To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis (OA) grade 2 or 3.
* Symptoms in the treatment knee for at least 12 months.
* Fully ambulatory patient.

Exclusion Criteria:

* Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
* Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
Comparing NicoBloc to Nicotine Lozenges

To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges

Smoking remains the leading cause of preventable death in the U.S. with approximately 18% of the population continuing to smoke. However, smoking is concentrated in disadvantaged populations where the prevalence of smoking may be as high as 70-80 %. Participants will receive a sampling experience (use of nicotine lozenges or NicoBloc during sessions) with counseling focused around their experience of using these interventions, including side effects and smoking cessation expectancies.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. planning to live in the Birmingham Metro area for the next 3 months
3. Smoking at least 5 cigarettes per day for the past year and a Carbon Monoxide\>8ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of enrolling a large \>50% African-American average \<10 cigarettes per day compared to Whites who average \~15 cigarettes per day
4. exclusive use of filtered cigarettes
5. English speaking.

Exclusion Criteria:

1. Living in a restricted environment that does not allow smoking (e.g., prison or jail facility, etc.)
2. Pregnant or nursing (all women of childbearing potential will be required to use an acceptable form of contraception)
3. Currently enrolled in a smoking cessation treatment program, using nicotine replacement products, or prescribed bupropion or varenicline
4. Known allergy nicotine lozenge
5. Within one month post-myocardial infarction or untreated severe angina
6. Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)
7. Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).
Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery

Today complex vascular and cardiological interventions are performed in severely ill patients.

Autopsy is the reference standard for quality control for almost two centuries, but autopsy rates for patients dying in hospitals are decreasing rapidly.

Virtual autopsy has shown to be a good alternative for classic autopsy.

Patients dying within 96h after a cardiological intervention of a cardio-/vascular-surgery are eligible to be included in the study.

If the next of kin give oral informed consent a virtual autopsy based on a CT angiography followed by a classic medical autopsy will be performed.

Ante mortem findings will be compared to findings from both autopsy methods and presented to the clinicians.

Primary outcome will be the inter-method agreement. Secondary outcome will be the satisfaction of the clinicians evaluated by a standardized questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older AND
* dying after a cardiological intervention or a cardio-/vascular surgery AND
* oral informed consent from next of kind

Exclusion Criteria:

* not fulfilling all inclusion criteria
Individualized Elective Neck Irradiation in NPC Patients

To evaluate whether individualized elective neck irradiation for nasopharyngeal carcinoma based on the vertebral level of metastatic lymph nodes can reduce the incidence of radiation-related adverse effects and improve patients' quality of life，without reducing survival.

A multicenter phase III noninferiority randomized trial (NCT02642107) showed that upper-neck irradiation at the uninvolved neck resulted in comparable regional control and survival rate to standard whole-neck irradiation in NPC, reduced late toxicity of hypothyroidism, dysphagia, and neck tissue damage, and improved quality of life, including fatigue and swallowing.

However, the vertical range of the upper neck is extensive, necessitating further reduction in the scope of prophylactic irradiation. By integrating MRI and PET-CT to accurately assess metastatic lymph nodes and their corresponding vertebral levels, the investigators identified a pattern of sequential lymph node metastasis descending along the vertebral body in the vertical direction. Further correlative analysis revealed that nodal metastasis at any one of the vertebral levels strongly and positively correlated with metastasis at two adjacent vertebral levels, including one level above and one below.

Considering this, the investigators propose the following scientific hypothesis: individualized elective neck irradiation for nasopharyngeal carcinoma based on the vertebral level of metastatic lymph nodes can reduce the incidence of radiation-related adverse effects and improve patients' quality of life, without reducing survival. The investigators thus conduct a multicenter randomized phase 3 trial to verify their hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; nodes are diagnosed with PET/CT and MRI; staged as T1-4N0-2 or N3 category of non-bilateral lower node metastasis; aged between 18 and 70 years; Karnofsky performance-status score \> 70; adequate haematological function, with a leucocyte count \> 4 × 109/L, haemoglobin \> 90 g/L, and a thrombocyte count \> 100×109/L

Exclusion Criteria:

* The exclusion criteria include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.
Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis

The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients.

The project targets pediatric patients with cystic fibrosis (CF), and has to work packages (WP). WP1 is an observational study, and WP2 is a randomised placebo-controlled clinical trial. The goal of the study is to investigate the effect of probiotics on pediatric CF patients' quality of life (QoL). Moreover the investigators wish to explore effects of both a highly effective CFTR modulator and probiotics on gut microbiota and intestinal inflammation.

The primary question it aims to answer are:

• Can probiotics improve GI related QoL in children with CF?

Secondary aims are to:

* Investigate GI microbiota and GI inflammation before and after commencement of the highly effective triple-combination elexacaftor-tezacaftor-ivacaftor (ETI)
* Explore GI microbiota before and after treatment with probiotics vs. placebo
* Study intestinal inflammation before and after treatment with probiotics vs. placebo
* Examine body composition and its relation to lung function

In WP1 participants will during routine examination before starting treatment with ETI be asked to deliver stool samples, and fill in QoL questionnaires. In WP2 participants will be randomized to intervention with probiotics or placebo, and the same parameters as in WP1 will also be collected.

Eligibility Criteria:
Inclusion criteria for WP1:

* CFTR mutations eligible for treatment with ETI
* Age 2-18 years. Majority of patients will be 2-6 years of age as ETI was approved from 6 years of age in 2022, and will be available for children above 2 years from 2024.
* Included in the Norwegian CF Register and consented to participation in CF general research biobank

Exclusion criteria for WP1:

* Other CFTR modulators commenced the last 6 months before inclusion
* Use of probiotics or prebiotics last 2 months
* Current pulmonary exacerbation

Inclusion criteria for WP2:

* Age 3-18 years
* CFTR modulator treatment naïve or treated with CFTR modulator for at least 6 months
* Included in the Norwegian CF Register and consented to participation in CF general research biobank

Exclusion criteria for WP2:

* CFTR modulators commenced the last 6 months before inclusion
* Use of probiotics or prebiotics last 2 months
* Current pulmonary exacerbation