cyrilzakka/clinical-trials huggingface dataset:
In-Person Mindfulness-based Intervention for Adolescents with Autism Spectrum Disorder and Their Caregivers

Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms.

Adolescents with ASD and their parents will complete a 3-hour in-person screening visit to determine eligibility for the study.

Adolescents with ASD and their caregivers will participate in an 8-week mindfulness-based group intervention that meets once weekly at SARRC in Phoenix, Arizona. Each meeting will last approximately 2-hours. Teens and parents/caregivers will have separate meetings with separate group leaders but will reunite for approximately 15-minutes as a larger group to review home practice for the upcoming week. Teens and parents will each be given a free 1-year subscription to Ten Percent Happier, a commercially available mobile app focused on mindfulness meditations. Each week teens will be assigned home practice, which means we will ask participants to practice mindfulness meditation every day. The investigators will recommend specific meditations and activities to complete, but participants will have access to all mindfulness meditations on the Ten Percent Happier app.

Teens and caregivers will be asked to complete questionnaires assessing things like mood, anxiety, quality of life, mindfulness in day-to-day life, and their perception of the intervention. These questionnaires will be done immediately before the intervention, immediately after completing the intervention, and at 2-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents must be ages 13 to 18 years
* Formal clinical or educational ASD diagnosis confirmed by the study team (i.e., review of the formal diagnostic or educational report)
* Must be able to attend at least 7 of the 8 in-person group meetings
* English speaking: Adolescents and their parent/caregivers must be English-speaking because the screening and behavioral measures are in English, as well as the intervention content

Exclusion Criteria:

* Non-verbal participants will be excluded to ensure test compliance and increase sample homogeneity.
* Participants with IQ scores \<70 will be excluded because the intervention was developed for individuals without intellectual disabilities.
* Participants with a physical disability or co-occurring condition that may prevent participation in the weekly group meetings (e.g., selective mutism; aggressive behavior; inability to participate in a 90-minute video conference meeting each week)
* Participants who report active suicidal ideation
The Differences in the Psychological States of Patients with Different Chronic Hip Pain

Nowadays, studies related to the psychological state of patients with chronic hip pain are still limited, and there is a lack of research on the characteristics of the psychological state of patients with chronic soreness from different pain sources. The goal of this retrospective cross-sectional study was to reveal differences between the psychological states of chronic hip pain patients with different pain sources. The main question it aims to answer is whether there are differences in psychological states among hip pain patients with intra-hip pain, extra-hip pain, and intra-hip combined with extra-hip pain.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 16 years old and of sound mind；
* Chronic hip pain persisting for a duration exceeding 3 months.

Exclusion Criteria:

* Previous mental illness and cognitive impairment；
* Other serious illnesses such as heart failure, respiratory failure, malignant tumours, severe trauma and other serious illnesses;；
* Chronic pain lasting for more than 3 months in other parts of the body;；
* Use of prescribed opioid drugs exceeding 60 mg morphine equivalent per day or steroid analgesics.
The Role Of Local Anesthetics in the Management of Adverse Effects Associated With Intrauterine Device Application

Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations. Following IUD insertion, another 6ml of 1% procaine was injected into the Frankenhauser ganglia bilaterally. A final dose of 8ml of 1% procaine was injected into the abdominal trigger points and intracutaneously into the L4-S4 dermatomes as quaddles.


Eligibility Criteria:
Inclusion Criteria:

* not pregnant women
* healty women age between 18- 45 years old

Exclusion Criteria:

* chronic diseases which could cause chronic pelvic pain such as endometriosis
* which makes them prone to infections such as diabetes mellitus
* complication had arised during the IUD insertion, such as uterine perforation
Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis

The purpose of this study is to evaluate the efficacy and safety of Magnólia nasal gel in the treatment of moderate-severe persistent or moderate-severe intermittent allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, with age greater than or equal to 12 years;
* Clinical diagnosis of moderate-severe persistent or moderate-severe intermittent allergic rhinitis, according to the ARIA classification;
* Present the general status of rhinitis as moderate or severe;
* Total nasal symptom score greater than or equal to 6 points, with congestion and one or more of the other symptoms present (itching, runny nose, and sneezing) with a score greater than or equal to 2 at the screening visit;
* Present skin sensitization test to at least one aeroallergen;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year before this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to the formula components used during the clinical trial;
* Participants who present other clinical forms of rhinitis, such as, but not restricted to medicated rhinitis, vasomotor and atrophic;
* Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy;
* Participants with suggestive signs of upper airways bacterial infection;
* Participants with grade II or III septum deviation and/or presence of nasal polyps or other conditions that lead to nasal obstruction;
* Concomitant chronic or intermittent use of decongestants, antihistamines, or corticosteroids by inhalation, oral, intramuscular, or intravenous;
* Concomitant use of potent topical corticosteroids.
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of refractory epilepsy
* Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
* Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Exclusion Criteria:

* Seizures occurring in clusters
* Status epilepticus within 3 months of Visit 1
* History of non-epileptic seizures
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.

Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.

The objective of this trial is to compare the efficacy and safety of 2 therapeutic regimens for PDA treatment in a population of preterm newborns of gestational age (GA) \<31+6 weeks with respiratory distress syndrome (RDS) and HsPDA:

* Group A: experimental boluses of paracetamol at 15 mg/Kg four time a day for three consecutive days.
* Group B: standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.

The primary objective of the study is: to evaluate the efficacy of paracetamol versus standard ibuprofen regimen, by comparing the rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria)

The secondary objective of the study is: to evaluate the safety of the above 2 therapeutic regimens in term of incidence of transient renal impairment, intraventricular hemorrhage (IVH) or other bleeding disorders, necrotizing enterocolitis (NEC) and isolated bowel perforation (without signs of NEC), incidence of sign of liver toxicity.

Eligibility Criteria:
Inclusion Criteria:

* inborn neonates
* preterm neonates ≤ 31+ 6 days weeks gestation
* newborns with HsPDA
* parental written informed consent for participation in the study must be obtained

Exclusion Criteria:

* Serum creatinine concentration greater than 1,5 mg/dl (132MMole/L)
* Urine output less than 1 ml/Kg/h
* Severe IVH (\> grade II according to Volpe classification)
* Clinical bleeding tendency (as revealed by hematuria, blood in the gastric aspirate or in the stools, blood in the endotracheal tube aspirate)
* Necrotizing enterocolitis or marked abdominal distention with gastric bile residuals
* Thrombocyte count of less than 50.000/mm3
* Proved Sepsis
* Severe coagulopathy or liver failure
* Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH \< 7.0
* Known genetic or chromosomal disorders
* Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.
Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures

Wrist arthroscopy (WA) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (DRFs). Previous research on the contribution of WA to DRF treatment has shown different results.

Objectives of the study: (1) Validate wrist functional outcome questionnaires; (2) To determine whether arthroscopically assisted repositioning of fracture fragments in articular DRFs leads to a better treatment outcome; (3) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in articular DRFs leads to a better treatment outcome; (4) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in extraarticular DRFs leads to a better treatment outcome.

Research hypotheses: (1) Validated questionnaires will have satisfactory measurement properties (validity, reliability) and will be able to be used in a WA randomized controlled trial; (2) WA as an adjunct to DRF osteosynthesis improves the clinical outcome of treatment.

Subjects: 56 female patients with indication for DRF osteosynthesis aged 50-69 years divided into 2 groups: 1. examined - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) with associated WA, and 2. control - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) without associated WA.

Methods: As a primary outcome measure, functional outcomes of treatment will be analyzed with the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 6 months after surgery. As a secondary outcome measures it will be analyzed pain level according to a visual analog scale (VAS), preoperative and postoperative radiographic parameters of distal radius, and clinical outcomes of treatment with the Mayo Wrist Score (MWS) and Patient-Rated Wrist Evaluation (PRWE) score at 3 and 6 months after surgery. Expected scientific contribution: providing answers on the role of WA in the treatment of DRF and associated injuries as well as its impact on treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Distal radius fractures with an indication for surgical treatment according to the AO/OTA classification of patients aged 50-69 years who have signed an informed consent to participate in the research.

Exclusion Criteria:

* Distal radius fractures( DRF) that have an indication for surgical treatment in all patients and in patients younger than 50 and older than 69,
* DRF that do not have an indication for surgical treatment,
* Refusal to participate in the research,
* Inability to decide independently about participation in the research (persons under guardianship),
* Open fractures,
* Presence of severe soft tissue injuries,
* Infections,
* Poor general condition of patients and internal medicine contraindications.
Impact of the Implementation of CKD Coordination Function on Dialysis Initiation Frequency in Emergency

Kidney failure is a major public health problem. REIN registry shows that 33% of patients treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care is associated with an increased risk of morbidity and mortality, with less access to off dialysis center and kidney transplant. In addition, the emergency management has an impact on the organization of health structures. The High Authority of Health in 2012 issued a "care pathway Guide" aimed "to report in this process of the multidisciplinary nature of the management and coordination of principles and procedures for the Chronic Renal failure and cooperation between professionals involved. " A function of coordinator of the Chronic Renal Disease was set up in service since May 2013. Investigators propose to carry out a study to value its impact on the start of the dialysis in emergency and hypothesize that this feature innovative in France improves the patient pathway and thus reduce support emergency frequency of ESRD.

The objective of this study is to show the improvement of the quality of care for terminally chronic renal failure patients.

This is to evaluate an experiment aimed to facilitate a complex care path. If this experiment is successful, it could form part of "advanced practice".


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years with terminal chronic renal failure enrolled in the course of care

Exclusion Criteria:

* Patients under 18 years
* Patient Off Course
* Patient beginning dialysis with a method of transition
Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

Randomized trial in a primary prevention population

* all participants have high LDL cholesterol

Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil

This is a randomized primary prevention trial to compare the LDL lowering effects of an alternative regimen to statins(simvastatin) This alternative regimen is over the counter and available at health food stores. The alternative regimen consists of lifestyle changes including a Mediterranean Diet,exercise program, and stress reduction, with red yeast rice 1200 mg twice per day and fish oil 6 grams/day. The second group, run at the same time will take Zocor(simvastatin) 40 mg per day with standard counseling

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-75 yrs, who meet ATP III criteria to be treated for high cholesterol. All participants must be able to exercise and be willing to be randomized to either arm of the study

Exclusion Criteria:

* No history of bypass surgery, stents, or hx of myocardial infarction. Cannot have uncontrolled hypertension(SBP\>190 or DBP\>100), cannot have known intolerance to one of the study drug
Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy

The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

Liver biopsy will be the gold standard to assess fibrosis using Ishak score and morphometric evaluation of fibrosis. All children included will have a measure of liver stiffness using SWE with 5 measures performed in the area where the biopsy is performed and 5 measures in an other place in the liver. Fibrotest®/ Fibromax® will be performed on blood sample. All exams will be done within 1 month. diagnostic performance of SWE and Fibrotest®/ Fibromax® will be assessed respectively. algorithm using the results of both technics will be tested in order to test diagnostic performance and to obtain better performances.

Eligibility Criteria:
Inclusion Criteria:

* age \< 18 years;
* indication to liver biopsy;
* informed consent of both parents and child if applicable;
* social insurance

Exclusion Criteria:

-
Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer

Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. Since the publication of IBCSG23-01, ACOSOG Z0011 and AMAROS study, these studies indicated that there was no significant difference in recurrence and overall survival rates between the ALNB and SLNB+ALND followed by adjuvant radiotherapy. Therefore, an adaptation of the strategy to omit axillary lymph node dissection in patients with low-risk axillary involvement who are treated with curative surgery and systematic therapy. However, they also pose new challenges for adjuvant radiotherapy decisions. In the Z0011 study, patients were required to receive breast tangent field radiotherapy. In the AMAROS study, axillary radiotherapy included level I-III axillary lymph node drainage areas and the supraclavicular area, but the study results showed a local recurrence rate of only 1.19% at 5 years in the axillary radiotherapy group. Consequently, there is considerable controversy among clinical experts about whether a combined regional lymphatic drainage area radiotherapy strategy is necessary for low-burden sentinel lymph node metastasis breast cancer patients. In contrast, results from the EORTC-22922 and MA-20 studies, which included patients undergoing axillary lymph node dissection, showed that adjuvant radiotherapy to the entire lymphatic drainage area, including the internal mammary region, reduced the risk of disease-free survival and breast cancer-specific mortality. Therefore, the adjuvant radiotherapy strategy for early breast cancer patients with low-burden sentinel lymph node metastasis remains controversial, with a lack of high-level evidence to support it.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically confirmed invasive breast cancer; 2. Age between 18 and 80 years; 3. cN0 breast cancer underwent radical surgery combined with Sentinel Lymph Node Dissection (SLND) alone with SLND positive or SLND and axillary lymph node dissection (ALND) with positive lymph node metastasis; 4. for SLND alone cohort, the regional lymph node irradiation area was determined according to the clinical risk model and genomic risk model assessment; 5. Ability to understand and willingness to participate the research and sign the consent form

Exclusion Criteria:

* • Pathologically positive ipsilateral supraclavicular lymph node

  * Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes;
  * Pregnant or lactating women;
  * Insulin dependent diabetes;
  * History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix;
  * patients have simultaneous contralateral breast cancer;
  * clinical diagnosis of distant metastatic disease;
  * Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
Reliability and Validity of Turkish Version of the Diabetes Education Questionnaire (DATE-Q)

The Diabetes Education Questionnaire (DATE-Q) is a questionnaire that includes comprehensive care components of diabetes management and specifically questions the effect of exercise on blood glucose levels and the knowledge of the correct exercise intensity in patients with diabetes. It can be easily and rapidly applied. The aim of this study is to evaluate the translation into Turkish, validity and reliability of the DATE-Q, which questions the knowledge of diabetic patients about their disease.


Eligibility Criteria:
Inclusion Criteria:

. Age of 18 or above

* Those whose native language is Turkish
* Volunteer to participate in the study

Exclusion Criteria:

* Individuals who cannot cooperate (those who score below 24 points according to the Standardized Mini Mental Test)
* Those who have problems understanding and speaking Turkish
* Any visual or cognitive disorder that would prevent the participant from answering the survey
Prognostic Value of P30 After Cardiac Arrest

This study aims to examine whether P30 wave of somatosensory evoked potentials (SEP) is related with outcome after cardiac arrest. The study design is a prospective, multicenter-observational study. Patients survived after out-of-hospital cardiac arrest undergoing hypothermic-targeted temperature management will participate in the study. Relationship of P30 wave of SEP with the neurologic outcome on hospital discharge will be evaluated.

The absence of N20 of the somatosensory evoked potentials (SEP) is recommended as a valuable predictor of poor neurologic outcome in post-cardiac arrest patients. However, interpretation of N20 is affected by the background noise levels. Reliable analysis of N20 is limited with high noise levels and artifacts. Moreover, presence of N20 does not guarantee good neurologic outcome. P30 is a positive deflection of N20 occurring on 25-35 msec. According to our pilot study, N20 without following P30 is related with poor outcome, while N20 followed by P30 is highly related with good outcome. P30 is evident even when the N20 is ambiguous in patients with good outcome. We hypothesized that the negative-positive deflection of N20-P30 components is more valuable predictor than the N20 alone. In this observational study, we will identify whether presence of P30 checked on 24 and 72 hours after cardiac arrest predicts neurologic outcome more accurately than the presence of N20 alone.

Eligibility Criteria:
Inclusion Criteria:

* Comatose survivors after out-of-hospital cardiac arrest

Exclusion Criteria:

* Not treated by hypothermic-targeted temperature management