cyrilzakka/clinical-trials huggingface dataset:
Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation

The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.

Dexamethasone is an effective medication to ameliorate radiation induced headache and vomiting. In our Toronto experience dexamethasone in low doses (1 mg/m2/day) is sufficient in treating these symptoms. However this experience is not shared from many neuro-oncology centers of excellence that more commonly use 5 mg/m2/day according to the results of the trans-Canadian survey. A prospective multicenter trial evaluating the effectiveness of dexamethasone in different dose regimens in symptomatic children while undergoing CNS radiation will elucidate the appropriate dose.

Eligibility Criteria:
Inclusion Criteria for Enrolment:

* Children between 2-18 years of age.
* Children who underwent resection of a brain tumour with ≤ 1.5 cm2 residual tumour after surgical resection.
* Children regardless of extent of leptomeningeal or spinal metastasis (M1-3) are eligible.
* Children who undergo focal or whole brain (± spinal) radiation as part of their brain tumour treatment.
* Children treated at one of the 16 tertiary care centers in Canada (CPBTC).
* Patients on any anticonvulsive treatment are eligible.
* Patients on concomitant chemotherapy while undergoing radiation are eligible.
* Patients must be ≥ 24 hours steroid-free prior to starting radiation.
* Parents/legal guardians have to have signed and dated an informed consent to allow study enrolment of their child. (As per institutional guidelines, patients over a certain age may have signed their own informed consent form.)
* Patients \> 8 years of age should assent to study participation.
* Patients less than 10 years of age should have a Lansky Score of \>/= 50.
* Patients 10 years of age or older should have a Karnofsky Score of \>/= 50. If ECOG performance scale is used, patient should have a score of 0, 1 or 2.

Exclusion Criteria for Enrolment:

* Children with residual brain tumour lesion \> 1.5 cm2 after surgical resection.
* Children on steroids (dexamethasone) that will not be stopped ≥ 24 hours prior to start of radiation therapy.

Inclusion Criteria for Randomization to a Dexamethasone treatment group:

* Patients must have been enrolled on the Dexamethasone study prior to the start of radiation therapy.
* Children who develop either symptoms of vomiting (defined as either retching or vomiting ≥ once per day) or headache (≥ 2 points increase in severity of the most intense headache/day) while undergoing irradiation.
* Patients who are currently undergoing focal or whole brain (± spinal) radiation.

Exclusion Criteria for Randomization to a Dexamethasone treatment group:

* Patients who were not enrolled on Dexamethasone study prior to start of radiation therapy.
Effects of an ICT-platform for Assessment and Management of Patient-reported Symptoms During Treatment for Breast Cancer

The purpose of this study is to evaluate the effects of an interactive Information and Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of breast cancer
* Patients who will receive neoadjuvant chemotherapy
* Literacy in the Swedish language

Exclusion Criteria:

* Patients who need an interpreter at the doctor's visit
* Patients who have a known severe cognitive impairment
Investigating Social Competence in Youth With Autism

Our treatment, SENSE Theatre, combines several well-documented, effective behavioral strategies and theatre techniques. The proposed project will extend previous findings showing improving improvement in memory for faces. The multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage Together).

Recent findings from a randomized control trial (RCT) show immediate between-group effects and evidence of target engagement on the hypothesized mechanism of action, memory for faces, which was evaluated by neuropsychological and event-related potential (ERP) measures. Moreover, the RCT demonstrated treatment effects on social communication skills that generalized to home and community settings. Finally, maintained treatment effects were observed on communication symptoms. The proposed project will extend these findings and provide a stronger test of efficacy using a multisite RCT of SENSE Theatre with a large sample of participants with ASD (8 to 16 years) randomized to an experimental and an active control group. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers. Thus, the overarching aim of the study is to determine whether detected changes in face memory and social interaction are due to the SENSE Theatre treatment and the extent to which these changes generalize and maintain. If predicted results occur, it will provide strong empirical support for a community-based treatment that has generalized effects on a set of core deficits that otherwise have life-long consequences for children and adolescents with ASD.

8/18/2021: Record was updated to delete the outcome measure "Computer memory for faces" as it was not included as a primary outcome variable in the Institutional Review Board (IRB) approved protocol dated 9/13/2017.

Eligibility Criteria:
Inclusion Criteria:

* Children with high-functioning ASD (IQ \> or = to 70).

Exclusion Criteria:

* Children who evidence aggression toward other people.
Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Between 18 and 75 years of age inclusive
* VAP - 48 hours after onset of mechanical ventilation
* BMI 18 - 35 inclusive
* Albumin \< 3.3 g/dL or clinical evidence of edema
* Negative Pregnancy test
* Expected survival of at least 7 days

Exclusion Criteria:

* Renal impairment (CrCl \< 80 mL/min)
* Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
* History of seizures
* Sustained shock, unresponsive to sympathomimetics
* Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, \>15% total body burn or significant third degree burn)
A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept

The primary objective of this study is to investigate whether an Educational Supported Program (ESP), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept SC at 12 months after treatment start (1st injection). In the scope of this objective the adherence is measured by the Medication Adherence Questionnaire (MAQ).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in the study signed by the patient
* Age ≥ 18 years at the date of consent subscription
* Diagnosis of active Rheumatoid Arthritis moderate to severe as per the 1987 American College of Rheumatology (ACR) criteria/2010 ACR/ European League Against Rheumatism (EULAR) RA Classification Criteria
* Naïve of abatacept
* Initiated with abatacept SC either as 1st or 2nd line biologic treatment after inadequate response to previous therapy with one or more DMARDs according to Summary of Product Characteristics (SmPC) locally approved

Exclusion Criteria:

* Participating in clinical trial or other non-interventional studies, excluding registries
* Inability to read and write
* Any condition that in the investigator's opinion might jeopardize the follow-up and the data collection for the entire study observation period (24 months)
Outcomes and Trauma Pattern in Penetrating Neck Injuries

It is an observational retrospective multicenter study

It is an observational descriptive, retrospective study. The study will be conducted in two centers: the Emergency and accident unit and Head and neck surgical unit Manchester Royal infirmary, Manchester, United Kingdom and Trauma unit and Otolaryngology department Assiut university Hospital, Assiut, Egypt. The study will include all the patients presented to both centers with open neck trauma in duration between April 2018 and October 2020. The following items recorded: gender, age, type of trauma (whether it is homicidal, suicidal, accidental trauma), time of the day the patients presented, Previous philological disorder in patients with suicidal types of trauma, number of neck wounds, site of the wounds ( in relation to the zones of the neck), size of each wound in centimeter, whether the wounds are deep or superficial to platysma, length of stay in the hospital, , injuries to any neck structures injuries in other parts of the body, involvement of other teams in management of the patent and type of involvement. Also the need of airway support (either intubation or tracheostomy), immediate and long term complications of the injury and if the patients needed neck exploration or just suturing of the wounds under local anesthesia.

Data of the patients who needed exploration will be reviewed to detect finding in neck exploration and try to find out the criteria of the patients who needed neck exploration and put a clear protocol for management.

The included patients will be categorized into 3 groups according to type of trauma (suicidal, homicidal or accidental) all the recorded data will be compared to detect the outcomes in each type of trauma and if there is a specific pattern of trauma in each category.

The study will be conducted after obtaining an institutional review board (IRB) approval from the committee of medical ethics, faculty of medicine, Assiut University. The study and all interventions and surgical procedures within it were done by scientifically qualified and trained personnel. The is no additional risk for participating in the study as it is a descriptive study

Eligibility Criteria:
Inclusion criteria:

1) All age groups regardless of sex. 2) Homicidal, suicidal and accidental type of trauma. 3) Patients with penetrating neck injuries due to sharp objects trauma. 4) Poly trauma patients having multiple body trauma as well as neck trauma will be included.

b. Exclusion criteria:

1. Patients with blunt neck trauma even if causing open wounds
2. Patients with neck burns
3. Patients with previous neck surgeries
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine

The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)

Main subjects:

The seroconversion rate for each antigen when EV71 is administrated with SIV

Secondary subjects:

The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV

Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
* Participant is aged ≥ 6 month to \<12 months.
* Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
* Body temperature ≤ 37.0#.

Exclusion Criteria:

* Known allergy to any constituent of the vaccine.

  * Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
  * Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
  * Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
  * Known bleeding disorder.
  * Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
  * Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
  * An acute illness with or without fever (temperature ≥ 38.0#) in the 3 days preceding enrollment in the trial.
  * Participation in any other intervention clinical trial.
  * Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
Oral Progesterone for Prevention of Preterm Birth

To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 \& 0/7 weeks' and 36 \& 6/7 weeks' gestation.

Exclusion Criteria:

* multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.
Varenicline for Co-occurring Cannabis and Tobacco Use

Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.

Treating co-occurring cannabis and tobacco use disorders might reduce the health burdens associated with both substances. However, few studies have evaluated pharmacological interventions, in combination with behavioral treatment, to address co-occurring cannabis and tobacco use; these are limited by high participant attrition, poor adherence to interventions, and lack of control. Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use. Participants were recruited from an urban, outpatient substance use disorder treatment program that offers both intensive behavioral counseling and medications for opioid use disorder (MOUD). Participants were randomized to receive either SCC or SCC and varenicline first and then were crossed over to receive the opposite intervention. The study consisted of two 4-week treatment periods with no washout period. Outcomes are reported in pooled analyses of all participants in each treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak English
* Uses cannabis at least 5 days in the past 7 days
* Current or former tobacco smoker
* Has not taken varenicline in the past 30 days
* Not pregnant, trying to conceive or breastfeeding
* Able to provide informed consent
* Test positive for cannabinoids by urine toxicology

Exclusion Criteria:

* Unstable medical or psychiatric illness
* Opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.
The Prevalence of Fibromyalgia in Adults at Al-Karak Jordan a Cross-sectional Study

Fibromyalgia is a chronic and intricate musculoskeletal disorder characterized by widespread pain, fatigue, and tenderness in specific anatomical regions. Although its prevalence varies among populations, understanding the prevalence in different geographical areas is crucial for healthcare planning. This cross-sectional study aims to determine the prevalence of fibromyalgia in adults residing in Al-Karak, Jordan. The city's unique demographic and environmental characteristics may influence the occurrence of fibromyalgia among its adult population. The study aims to address gaps in knowledge, provide localized insights, and shed light on fibromyalgia's burden on the community's health. Accurate prevalence data aids healthcare planning and resource allocation.


Eligibility Criteria:
Using google forms, this cross-sectional study was carried out, and the participants were reached via social media platforms (5)

. Participants' autonomy was maintained, and no direct benefit was gained in return for filling out the questionnaire. The ethics committee at the Faculty of Medicine, Mutah University, Karak, Jordan, provided the required ethical approval prior to the initiation of this study. Moreover, the committee ensured that the study was designed according to the principles of the Declaration of Helsinki (Date: 13 February 2023. Reference number: 992023). In this study, the authors targeted Karak government citizens, in Jordan. Accordingly, the required sample size to achieve a 99% Confidence interval was 663 participants.
The Effect of Solifenacin on Post Void Dribbling in Women

This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.

This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.

Secondary endpoints will include:

1. The % of patients with at least a 50% reduction in post void dribbling episodes.
2. Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life.

We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators

Eligibility Criteria:
Inclusion Criteria:

1. Women between the ages of 18 and 89
2. Incontinence in the form of post void dribbling that occurs at least twice weekly.

Exclusion Criteria:

1. Severe renal or hepatic disease.
2. Active urinary tract infection.
3. Glaucoma.
4. Stress incontinence as the only incontinence symptom
5. Urge incontinence as the only incontinence symptom
6. Chronic severe constipation.
7. History of bladder cancer.
8. Known or suspected hypersensitivity to anticholinergics.
9. Any clinical condition that would not allow safe completion of the study.
10. Pregnancy or lactation, intention to become pregnant during the study, or use of an unreliable birth control method in women of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera, implants), intrauterine device (IUD), and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or other form of birth control mentioned above if they become sexually active during the study.
11. Presently on systemic anti-cholinergic therapy or who have been on therapy within the last 4 weeks. Anti-cholinergic drugs include; darifenacin, fesoterodine, hyoscyamine, oxybutynin, solifenacin, tolterodine, and trospium.
12. Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.
Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures

Study is the first study after commercialization of brivaracetam. It is designed to collect real world information on the effectiveness of brivaracetam in patients with Partial Onset Seizure epislepsy who are treated in standard clinical practice.

EP0077 is a 12 months, multicenter, noninterventional study (NIS) conducted at specialized sites in approximately 10 European countries. Patients will be treated according to usual medical diagnostic procedures and therapy; commercially available brivaracetam will be prescribed according to normal clinical practice and the current Summary of Product Characteristics (SmPC) in Europe for brivaracetam (BRV). The prescription of BRV is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients.

The primary objective of this study is to determine BRV retention over a 12 month period as a measure of effectiveness in a real world setting. The secondary objective of this study is to assess seizure control with BRV treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient has never been treated with brivaracetam (BRV) prior to enrollment in this Non-Interventional Study (NIS)
* The decision by the treating physician to prescribe BRV is made independently of the participation in the NIS
* Patient is a male or female ≥16 years of age
* Patient has a clinical diagnosis of epilepsy with partial-onset seizures POS with or without secondary generalization
* Patient uses an epilepsy/seizure diary.

Exclusion Criteria:

No specific exclusion criteria