cyrilzakka/clinical-trials huggingface dataset:
Testing the Efficacy of the Ability School Engagement Partnership Program (ASEP)

This project is an up-scaled test of the Ability School Engagement Partnership (ASEP) Project. The ASEP is a partnership program that aims to increase school attendance and is grounded in the theory of Third-Party-Policing (TPP). In ASEP, school-based police officers partner with schools (i.e., the third-party) who have legal powers to control and prevent school absenteeism. The ASEP intervention includes an ASEP conference in which the legal requirements to attend school are explicitly communicated in a procedurally just way to young people missing school and their parents/guardians. Restorative Outcomes Australia (ROA) is a provide provider partner who will oversee the facilitation of the ASEP conferences. While the program is designed to re-engage these young people in school and/or facilitate transitions to work and reduce antisocial behavior (e.g., delinquency), this trial will also test the capacity of the program to improve collaboration between the schools and police and also monitor young participants' future life outcomes, such as future welfare dependence.

The ASEP is grounded in the theory of Third Party Policing (TPP). TPP interventions focus on controlling negative behavioral outcomes through partnerships that use a third party's legal powers. In ASEP, the police partner with the schools to work together to engage with young people, reduce their anti-social behavior and increase their school attendance. At the core of the partnership is communication of the legal lever: in ASEP, it is the Queensland Education (General Provisions) Act (2006) - requiring young people attend school up to age 16 and holding parents legally responsible. The laws are communicated to parents and young people who are not regularly attending school in a procedurally fair way within the context of an ASEP conference. The ASEP conference is especially designed to incorporate fair communication of the laws and consequences and involves a purpose-built script that seeks to increase willingness of both parents and young people to comply with the law. The ASEP conference participants include a trained facilitator (from Restorative Outcomes Australia; ROA), the young person missing a lot of school, their parent or guardian, a uniformed school-based police officer, and a school representative (e.g., teacher). An individually tailored Action Plan is developed during the conference which stipulate the "actions" that all conference participants are to take over the subsequent two months in order to ensure that the young person increases their school attendance and re-engages with school and/or transitions into paid work.

Eligibility Criteria:
Inclusion Criteria:

* High school aged young people only, aged 12 to 16;
* Have 15% or more unexplained absences over each other previous two school terms;
* Have no known legitimate explanation for absences (e.g., ongoing medical issue); and
* Have at least one responsibly adult in their lives (e.g., parent, guardian, or carer) who provides social and/or financial support.

Exclusion Criteria:

* None
Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke

While perinatal ischemic stroke is the most frequent form of childhood stroke, early determinants of outcome remain poorly understood. Two main structural biases limit the accuracy of most studies: heterogeneity of the population and short follow-up.

Perinatal ischemic stroke includes several conditions that differ in pathophysiology and timing of occurrence. Yet, it is not surprising that risk factors and outcome depend primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal insult. Even though the original lesion is static and focal in perinatal stroke, its consequences grow over time within the maturing brain and affect all fields of neurodevelopment.

The objective of the AVCnn study was to delineate the determinants, clinical and imaging presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the opportunity to regularly monitor a large cohort of children having suffered an NAIS.

Between November 2003 and October 2006, a cohort of one hundred symptomatic term newborns with AIS confirmed through early brain imaging has been constituted.

Regular contacts with the families and their local physician have been maintained since enrollment. In 2010, families were asked through postal mail to participate in the 7 years assessment (AVCnn7ans). Those who accepted were contacted by phone by the coordinators of the study during the months preceding the child's seventh birthday and invited to attend a presentation in person of the current project. This evaluation took place face-to-face for a whole day in a medical setting close to the family residence. The evaluation team included a neuropsychologist, a speech therapist and either a pediatric neurologist or a pediatric physical and rehabilitation medicine practitioner.

Eligibility Criteria:
Inclusion Criteria:

* Belonging to the AVCnn cohort

Exclusion Criteria:

* Lost to follow-up at 7 years.
* Refusal to participate in the current assessment.
Anxiety Before Non-cardiac Surgery in Adults

Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established.


Eligibility Criteria:
Inclusion Criteria:

1. patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary);
2. The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80;

4)be able to communicate normally in daily life, without serious hearing and visual impairment; 5)ASA:I-II; 6)sign informed consent and volunteer to participate in this study.

Exclusion Criteria:

1. Having a history of brain diseases, such as stroke, epilepsy, psychosis other history of neuropsychiatry.
2. Patients with serious diseases of heart, liver, lung, kidney or other organs.
3. Having a definite diagnosis of cognitive impairment, such as Alzheimer's disease;
4. Those who use sedatives before evaluation in this study;
5. Drug addicts;
6. Alcoholics;
7. pregnant women;
8. participated in other clinical trials as a subject in the past 3 months.
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal polyposis following sinus surgery. This project aims to further investigate that claim through a blinded randomized controlled clinical trial following patients who undergo functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly assigning participants to receive topical furosemide versus placebo nasal spray for 2 months post operatively. Outcomes would be compared at 6 months through endoscopic grading scores using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to measure the rate and degree of recurrence and impact on symptoms in the treatment group versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for functional endoscopic sinus surgery

Exclusion Criteria:

* Hypersensitivity to furosemide or sulfonamides
* pregnancy
* history of tinnitus
* history of sensorineural hearing loss
* poorly controlled diabetes
* current diuretic therapy
* known electrolyte disorder
* currently taking aminoglycosides
* BUN and creatinine levels out of the normal range
* history of renal disease
* allergy to sulfonamides
A Study of MK-8189 Human Absorption, Metabolism, and Excretion in Healthy Male Participants (MK-8189-010)

The purpose of this study is to learn what happens to MK-8189 in a healthy person's body over time.


Eligibility Criteria:
Inclusion Criteria:

Key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination, VS measurements, and ECGs performed before randomization.
* Has a BMI ≥19 and ≤32 kg/m2, inclusive, at screening

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has a history of cancer.
PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants

Although hepatic tumors are uncommon in the perinatal period they are associated with significant morbidity and mortality in affected patients. The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II) combining with alpha-fetoprotein in hepatic tumor of infant. This study is a multicenter study joined by several hospitals in China. Participants including hepatoblastoma, hepatic hemangioendothelioma and healthy control are consecutively recruited into the cohort. All the serum samples are collected before and after each treatment and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II, alpha-fetoprotein and biochemical indexes including alanine aminotransferase(ALT), aspartate aminotransferase(AST), gamma-glutamyl transferase(GGT), alpha-l-fucosidase(AFU), etc.

Hepatic tumors seldom occur in the perinatal period. They comprise approximately 5% of the total neoplasms of various types occurring in the fetus and neonate. Infantile hemangioendothelioma is the leading primary hepatic tumor followed by hepatoblastoma. Although alpha-fetoprotein has been well recognized as biomarker of hepatic tumors, it should be mentioned that this protein in normal infants is highly elevated during the first 2 months of life.

Protein induced by vitamin K antagonist-II (PIVKA-II), also known as des-γ-carboxyprothrombin (DCP) or acarboxy prothrombin, is an abnormal form of prothrombin induced by vitamin K absence or antagonist-II. An elevated serum level of PIVKA-II is reported to be associated with hepatocellular (HCC). Many studies have shown that PIVKA-II is applicable for HCC surveillance and has been written into the guideline of JSH, which achieves remarkably good results.

The study is intended to evaluate diagnostic and differential diagnostic accuracy of PIVKA-II combining with alpha-fetoprotein in hepatic tumor of infant.

This study is a multicenter study joined by several hospitals in China. Participants including hepatoblastoma, hepatic hemangioendothelioma and healthy control. All the serum samples are collected before and after each treatment and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II, Alpha-fetoprotein(AFP)， and biochemical indexes including ALT, AST, GGT, AFU, etc. The diagnosis of hepatoblastoma and hepatic hemangioendothelioma was based on enhanced CT scanning and/or histopathology. The Student's t-test (or Mann-Whitney test) was used to compare continuous variables, and the chi-square test (or Fisher's exact test) was used for categorical variables. A receiver operator characteristic (ROC) curve was used to assess the diagnostic and differential diagnostic efficiency of PIVKA-II and the combined tumor markers with AFP.

Eligibility Criteria:
Inclusion Criteria:

* Age between 1 month and 12 month
* Receiving no treatment before diagnosis
* With written informed consent

Exclusion Criteria:

* Clinical data missing
* Serum samples doesn't qualified
* Vitamin K absence
Radiation Therapy in Treating Patients With Brain Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with anaplastic astrocytomas.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.

OBJECTIVES: I. Compare the disease-free interval and survival in patients with supratentorial malignant brain gliomas randomized to radiotherapy alone vs. radiotherapy plus radiosensitization with mitolactol (DBD) followed by DBD and carmustine.

OUTLINE: Randomized study. Group I: Radiotherapy. External-beam cranial irradiation with megavoltage equipment. Group II: Radiotherapy with Radiosensitization followed by Maintenance Chemotherapy. Radiotherapy as in Group I; with Mitolactol, DBD, NSC-104800; followed by DBD; Carmustine, BCNU, NSC-409962.

PROJECTED ACCRUAL: A total of 212 patients will be entered over more than 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy

PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl Other: No major medical illness

PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)
MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

This project aims at performing a pilot study to provide data on safety and potential efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of pain caused by trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip OA, while exploring the potential application of MRgFUS to two different and central joints burdened by OA.

Pain caused by osteoarthritis is a matter of huge impact, in terms of quality of life, social and economic burden. Global aging of the population is going to worsen the problem. The hand is the most affected site in the upper limb, and involvement of the trapeziometacarpal joint is highly prevalent, with significant limitation of functionality when it happens. In the lower limb, the hip and the knee share the leading position in the clinical scenario, with the former being historically the most frequently submitted to joint replacement.

At any site, the vast majority of joint replacement surgery procedures are performed because of pain. MRgFUS has recently demonstrated a great potential in treating pain caused by different medical conditions, including osteoarthritis. The aim of the work is to study the feasibility, the safety and the potential efficacy of MRgFUS in treating pain from osteoarthritis in two "hot" spots: the hip and the trapeziometacarpal/scaphotrapezial joint.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged between 45 and 90 years
* Presence of activity-related joint pain
* Patients who have either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
* Patients who have not responded to previous treatments,
* Patients with a baseline pain intensity of 4 to 8 on a 10-cm VAS
* Patients who are not candidates for immediate surgery
* Signed statement of informed consent (approved by Ethics Committee)

Exclusion Criteria:

* Prior surgery or previous local treatment (infiltration, other) in the past 3 months
* Changes in medications used during the previous 2 months
* Intravenous drug use
* Corticosteroid use of more than 3 months within the preceding year
* Diagnosis of other rheumatologic disorders
* Trauma, fracture, or osteomyelitis of the investigated joints within the preceding year
* Any neurological disease or disorders potentially affecting pain perception
* Fibromyalgia
* Pregnancy
* Patients with large scar at skin or deeper soft tissue potentially included in the planned path of the ultrasound beam
* General contraindications to MRI and/or to anaesthesiological procedures planned for the patient
* Presence of internal hardware or devices potentially affecting MR thermometry
Impact of Galacto-Oligosaccharides on Adult Microbiome

The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years,
* Healthy participants, both male and female
* BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2
* Able to understand and to sign a written informed consent prior to study enrolment

Exclusion Criteria:

* Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
* Known food allergy and intolerance e.g. lactose intolerance,
* Habitually, have \< 5 spontaneous bowel movements on average per week,
* Chronic or recurrent diarrhoea with spontaneous bowel movements \> 2 per day
* Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
* Received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment,
* Medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment,
* Anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents,
* Currently participating in another interventional clinical trial or research project,
* Alcohol intake \> 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Or other chronic substance abuse,
* Changing diet patterns due to travelling and staying abroad for more than two weeks (Asia, Africa, or Latin America) during the two months prior to study enrolment,
* Food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets,
* Artificially sweetened beverage intake \>1000 ml/ per day,
* Female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating,
* Subject having a hierarchical or family link with the research team members,
* Occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.
Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to reduce dyspnea, improve exercise tolerance and improve health status. However,conventional lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) frequently fail to detect significant functional responses to bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical and scientific reasons to develop a new tool to objectively assess the effect of different treatments including bronchodilator on COPD. Our previous study showed that Ventilation-drive coupling may be more sensitive and accurate to evaluate the efficacy of inhaled bronchodilators in patients with COPD because it could better reflect the pathological and physiological characteristics of COPD.

Based on the above conclusion, the present study were performed using the experimental methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable basis for the clinical application of this index.

Patients were randomly assigned to one of two intervention groups:

1. Group A: Patients inhaled placebo, ipratropium 80μg, salbutamol 400 μg in sequence;
2. Group B: Patients inhaled placebo, salbutamol 400μg, ipratropium 80 μg in sequence.

The data were collected in 30 minutes after patients inhaled placebo,in 30 minutes after ipratropium and in 15 minutes after salbutamol.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 40-70 years old; Patients with pulmonary function test of FEV1/FVC \< 70% and FEV1%pred \< 50%; Patients in a clinically stable state; Patients who signed informed consent.

Exclusion Criteria:

Patients with signs of an airway infection; Patients with an acute exacerbation during the previous 4 weeks; Patients with giant bulla(≥3cm in diameter); Patients with recent upper abdominal surgery; Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index\>15/hr), neuromuscular disease, or significant heart failure; Patients with poor compliance.
Evaluation of Deltoid Exercises on Injection Site Pain After (BNT162b2) COVID - 19 Vaccination

Pfizer - BioNTech (BNT162b2) COVID - 19 vaccine is the first vaccine to be approved for emergency use by FDA. The most commonly reported side effect of the BNT162b2 vaccination is mild-to-moderate pain at injection site, i.e. deltoid muscle. Injection site pain may be observed during and after vaccine injection, and severity of pain may vary according to the type of vaccine, patients age, sex, level of anxiety, needle size, injection site and technique and patient positioning. Vaccination pain is one of the reasons of vaccine hesitancy and World Health Organization (WHO) recommended various measures to mitigate pain at the time of vaccination.

Exercise is one of the suggested methods to relieve the pain and anxiety in various conditions including vaccination site pain. However, we found no studies addressing injection site pain after the vaccination and pain associated with BNT162b2 vaccine. Aim of our study is to evaluate effectiveness of deltoid muscle exercises to relieve injection site pain observed after BNT162b2 vaccination.

The study was started at the designated COVID - 19 vaccination department of Bursa Yuksek Ihtisas research and training hospital Approvals was obtained from Republic of Turkey Ministry of Health and institutional review board and ethics committee and the study was conducted in concordance with Declaration of Helsinki.

Volunteers were selected among the healthy persons who admitted to our vaccination department to have BNT162b2 vaccine. Selection criteria were age being over 18, having no physical disability to perform the physical exercises given and willingness to participate in the study and sign an informed consent. People under the age of 18, patients with conditions that prevent them doing the exercises given and who did not want to participate in the study were excluded from the study.

Volunteers who accept to participate in the study, were randomized in to exercise vs. no-exercise groups according to a previously formed online randomization list. All volunteer's demographic data and vaccination status (first or second dose) were recorded. Both groups were asked to keep a five - day pain diary using numeric rating scale (NRS) and to also record any use of analgesics, any hospital admissions, any side effects other than injection site and arm pain and the time of cessation of pain.

Eligibility Criteria:
Inclusion Criteria:

* vaccination with Bnt162b2
* having no physical disability to perform the physical exercises given
* willingness to participate in the study and sign the informed consent form

Exclusion Criteria:

* vaccination with vaccines other than Bnt162b2
* having physical disability to perform the physical exercises given
* not willing to participate in the study and sign the informed consent form