cyrilzakka/clinical-trials huggingface dataset:
The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families

This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.

The goal of the study is to evaluate the effectiveness of a program to improve mental health in families by reducing stress and supporting effective communication and conflict resolution.

Families will be randomly assigned to one of two conditions: in the self-study condition, families will receive information to review on their own, paired with regular (weekly) contact from a family coach; in the second condition, families will receive information to review on their own, regular contact from a coach, and will participate in video sessions with a family coach who will provide feedback on their interactions and coaching on their use of a communication technique. Data collection, management and analysis will be conducted by researchers at the University of Notre Dame, but the intervention will occur through community organizations in three cities in Indiana, allowing for tests of the effectiveness of the program when it is implemented in community settings. Families will participate in a pre-test assessment, a four-week intervention, a post-test assessment, and a one-year follow up assessment. Also evaluated will be organizational factors and factors that impact ultimate implementation and scalability of the program in community settings.

Eligibility Criteria:
Inclusion Criteria:

* Two parents or primary caregivers
* Child between 4 and 17 years old
* English literate
* Able/willing to participate through the 12-month follow up assessment.

Exclusion Criteria:

* Families who cannot communicate in English
* Single parent families
Adherence Intervention for Minority Children With Asthma

To evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.

BACKGROUND:

While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children.

DESIGN NARRATIVE:

The primary outcome that the study was designed to evaluate medical record documented emergency care for asthma at the JHPED over the eighteen-month follow-up period.

The secondary outcomes Adherence with asthma therapy based on Medicaid pharmacy claims for asthma medications, other asthma health care (urgent and primary), self-reported medication adherence, barriers to health care, restricted activity, nighttime symptoms, asthma medications, self and family asthma management behaviors, asthma management self-efficacy, functional status, and quality of life.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
1. Age 2-12 years.
2. A current diagnosis of asthma or reactive airway disease
3. Resident of Baltimore City.
4. Two or more ED visits at the JHPED for asthma in the past 12 months, or hospitalization for asthma at the JHPED in the past 12 months by parent report.
5. Not currently participating in other research studies (participation in previous studies will be noted).
Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior

Non suicidal self injury (NSSI) has become a serious social and public health problem allover the world, and the incidence rate is increasing year by year. Although the aim of NSSI is not to suicide, but its negative impact is extremely serious, which will seriously threaten the physical and mental health of adolescents. Virtual Reality (VR), a computer simulation technology, can enable people to enter and experience the artificial virtual world in an immersive way, has been used for the auxiliary treatment of anxiety disorder, post-traumatic stress disorder and other diseases. This study explored the impact of VR on the depression and mental health of NSSI adolescents, so as to reduce the incidence of non-suicide self-injury behavior in NSSI adolescent patients and improve the quality of life of such patients.


Eligibility Criteria:
Inclusion Criteria:

* According to the diagnostic criteria of NSSI in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.
* Have a past history of non-suicidal self-injury behavior.
* No virtual reality technology intervention before enrollment.
* age: ≥ 18 to\<24.

Exclusion Criteria:

* Those who have serious physical diseases
* Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content\<50%.
The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals

Observational survey study of transgender individuals who have undergone cosmetic neurotoxin and soft tissue filler for the purpose of influencing gender perception.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female transgender volunteer
* Has the desire to alter gender perception and is seeking treatment with neurotoxin and soft tissue filler
* Subjects with an already existing treatment plan
* Willing to sign photography release, with the understanding the de-identified photographs may be used in medical publications or presentations for the purposes of education
* Females of childbearing potential who are sexually active are using a reliable method of contraception1 at least one month before the beginning of the study, and throughout the study
* Must be informed about the study objectives and procedures, and be able to understand them
* Willing and able to fulfill the study requirements and schedule
* Willing to give their written informed consent

Exclusion Criteria:

* Individuals who underwent a neurotoxin procedure on the face within 6 months of study start
* Individuals who underwent an injectable filler procedure on the face within 1 year of study start
* Individuals who underwent surgical procedure on the face for the purpose of gender reassignment or cosmetic enhancement at any point in time before study start Individuals who have planned cosmetic treatments or surgeries during the course of the study
* Individuals with dental procedures performed 30 days before, during, or 30 days after the course of the study
* Individuals who participated within the 30 days before inclusion or currently participating in another clinical study involving the investigational areas
* Individuals with known or suspected defect of healing
* Individuals with any disease state or inappropriate physical skin condition that might impair evaluations or increase the health risk to the subject by participation in the opinion of the Investigator
* Individuals unable to be contacted by phone in case of emergency
* Individuals who are currently participating in any other clinical trial or have participated in any clinical trial involving the investigation area within 30 days prior to inclusion into the study.
Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia

The purpose of this study is to prove the clinical and bacteriological non-inferiority of ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women older than 18 years with signed informed consent
* Women in a childbearing age with sufficient conception protection or if necessary negative pregnancy test
* Infiltrates appeared newly in the x-ray thorax
* Breath-conditioned chest pain
* At least two of the following clinical symptoms of a pneumonia:

  * cough which is newly appeared or increasing,
  * dyspnea
  * mucopurulent or purulent sputum,
  * fever (body temperature \>= 37.8 degrees Celsius auricalary and/or \>= 38,3°C rectal), positive auscultation
* Negative legionella antigen test in the urine
* CRB-65-Index \< 3

Exclusion Criteria:

* Hospitalization within the last 28 days (except for the last 72 h)
* Participation in another therapy study within the last 4 weeks with studies admission
* intake of an antibiotic longer than 24 hrs within the last 72 hours before studies admission
* Patients in the pregnancy and nursing phase
* Existence of contraindications opposite the examining preparations or other B-Lactam antibiotics or fluorochinolons
* Patients with a CURB-Index \>= 3
* Patients with suspicion of retrostenotic Pneumonia because of bronchial obstruction
* Patients with suspicion of nosocomial Pneumonia
* Patients with an infection by a known or suspected resistant pathogene
Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients.

Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Prospective study designed to identify factors that would predict patient adherence to CPAP therapy.

Comparison between data recorded among patients and the data of the CPAP microchip.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 patients)
* All patients under CPAP (Continuous Positive Airway Pressure) therapy coming for annual visit in the Sart-Tilman Sleep Study Center

Exclusion Criteria:

* Patient refusal
Safety and Efficacy Assessment of Unani Formulation 'Dolabi' in Management of Diabetes Mellitus Type II

Diabetes is a chronic health condition that affects millions of people worldwide. In recent years, Pakistan has witnessed a significant increase in the prevalence of diabetes, making it a major public health concern. To address this growing problem, conducting clinical trials on diabetes in Pakistan is of utmost importance. Clinical trials play a crucial role in advancing medical knowledge, improving patient care, and finding effective treatments for diabetes.

This research aims to assess the safety and effectiveness of the Unani formulation Dolabi in treating type II diabetes mellitus. The study consists of two phases: a pre-clinical phase, which involves acute and subacute oral toxicity testing on animal models, and a clinical phase, which includes a single-blind, single-arm, multicenter, phase II clinical trial conducted at Shifa ul Mulk Memorial Hospital-Hamdard University and Haidery Herbal Care-North Nazimabad to evaluate its clinical efficacy.

Diabetes management plays a vital role in effectively controlling the disease and minimizing its complications. Lifestyle management plays significant role in managing blood glucose levels in all age and gender segments. Medications are prescribed to regulate blood glucose levels when lifestyle changes alone are insufficient. Regular monitoring of blood sugar levels, along with other important parameters like blood pressure and cholesterol, helps individuals with diabetes to track their progress and make necessary adjustments to their treatment plans.

Dolabi is a time tested formulation of HLWP and it is being used clinically for more than 05 years at Hamdard Matabs all around Pakistan and clinically found satisfactory. The current study is designed in accordance with ICH GCP E6 protocols as approved by WHO and DRAP. It will enable us to present this safer and locally produced combination for the large community suffering with this condition in improving their lives.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having Type II Diabetes Mellitus.
* Subjects having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
* Subjects over 30 years of age.
* Subjects agree to use study medicine throughout the study.

Exclusion Criteria:

* Subjects suffering from chronic liver diseases and kidney failure.
* Subjects currently taking any hypoglycemic agent(s).
* Subjects suffering from any type of cancer and any other comorbid condition.
* Subjects having history of adverse drug reaction.
* Pregnant and Lactating mother.
Alpha-Stim AID and Major Depressive Disorder

The study will be a multi-centre parallel group, double blind, non-commercial, randomised controlled superiority trial. Study participants will be referred from Primary Care GP practices via their GP and randomised into active Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) or sham Alpha-Stim AID CES.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16 years and above. There is no maximum age limit.
* Diagnosis of current Major Depressive Episode (MDE). This will be confirmed using the research version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) at baseline.
* A Score of ≥10 to 19 on 9-item self-rated Personal Health Questionnaire (PHQ-9).
* Have either been offered the option of antidepressant medication or have been prescribed antidepressant medication for a minimum of 6 weeks in the last 3 months.
* Capable of giving oral and written informed consent to the study.
* Agrees to return Alpha-Stim equipment at the end of the study and not to purchase this equipment privately during the study.

Exclusion Criteria:

* A score of ≥20 on the PHQ-9.
* Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery
* Requires urgent clinical care such as having persistent suicidal ideation, self-harm or suicidal intent.
* Known to be pregnant.
* Implantation with a pace maker, cochlear implant or an implantable cardioverter device (ICD).
* Major unstable medical illness requiring further investigation or treatment.
* A diagnosis of current substance use disorder or dependence, dementia, eating disorder, bipolar disorder or non-affective psychosis because the use of CES treatment would otherwise require additional supervision or is associated with additional risk e.g. of mania in bipolar disorder. Determination of these conditions will be confirmed using a diagnostic clinical interview (SCID-5-RV).
* Completed and benefitted from/responded to psychological treatment for depression in the last 3 months or planning to commence psychological treatment in the next 6 months.
* Involved with any other clinical trial at the time of consent or 6 months prior.
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot

The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria:

* Non-English speaking
* Self-inflicted injury
* Actively psychotic
* Incarcerated or in custody
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia

Patients with dyspeptic symptoms vary from 10% to 20% globally. Up to 70% of patients with dyspepsia who undergo endoscopy have unremarkable examination and are diagnosed with functional dyspepsia (FD). Given the lack of information related to its pathophysiology, the treatment is largely empirical and of limited efficacy. Previous small study showed therapeutic potential of transcutaneous auricular vagal nerve stimulation (taVNS) for FD. This study aims to investigate whether taVNS can improve the dyspeptic symptoms of patients with FD.


Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old
2. Patients who met the Rome IV diagnostic criteria of FD
3. Moderate to severe FD (functional dyspepsia symptom diary ≥10)
4. Normal upper endoscopy and abdominal ultrasonography within one year.

Exclusion Criteria:

1. Injury or inflammation on the ear
2. Asthma or COPD not under control
3. History of cardiac pacemaker planting or other medical digital devices
4. History of VNS treatment
5. Patients with local or systemic diseases which may cause dyspeptic symptoms:

   Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
6. Patients with serious mental disorders or tendency to suicide
7. Pregnancy or lactic women
8. Inability to give informed consent
A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by IV infusion for the treatment of allergen-induced asthma.


Eligibility Criteria:
Inclusion Criteria:

* Weight between 50 and 125 kg
* Mild, stable allergic asthma
* History of episodic wheeze and shortness of breath
* FEV1 at baseline ≥ 70% of the predicted value
* For women of childbearing potential, agreement to use an effective means of contraception while enrolled in the study
* For men with partners of childbearing potential, willingness to use condoms with spermicide during treatment
* Ability to comprehend and follow all required study procedures
* Positive skin prick test to common aeroallergens (e.g., cat, dust, mite, grass, and pollen)
* Positive allergen-induced early and late airway bronchoconstriction

Exclusion Criteria:

* A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
* Acute infection (including viral infection) within the 6 weeks preceding dosing (8 weeks for respiratory infections) or any ongoing chronic infection
* History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition, including (but not limited to), tuberculosis, parasitic infection, etc.
* Lung disease other than mild allergic asthma
* History of heart, lung, kidney, liver, neurologic or chronic infectious disease
* Concomitant disease or condition, which could interfere with the conduct of the study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
* History of serious adverse reaction or hypersensitivity to any drug
* Pregnancy or lactation or positive serum pregnancy test at screening
* Chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide
* Current (or history of) treatment with a monoclonal antibody or chimeric biomolecule within the past 5 months (5 half-lives of the drug), including omalizumab
* Regular use of tobacco products of any kind or within the previous 6 months, or smoking history \> 10 pack-years
Evaluation of Cardiac Affections in Patients With Mucopolysaccharidosis (MPS) in Assuit University Children Hospital (AUCH)

This study aims to evaluate the different cardiac changes in the various types of MPS disorder and define the outcome of these cardiac abnormalities in those patients admitted to assuit University Children Hospital

The mucopolysaccharidoses (MPSs) are inherited lysosomal storage disorders caused by the absence of functional enzymes that contribute to the degradation of glycosaminoglycans (GAGs). The progressive systemic deposition of GAGs results in multi-organ system dysfunction that varies with the particular GAG deposited and the specific enzyme mutation(s) present.

Cardiac involvement has been reported in all MPS syndromes and is a common and early feature, particularly for those with MPS I, II, and VI. Cardiac valve thickening, dysfunction (more severe for left-sided than for right-sided valves), and hypertrophy are commonly present; conduction abnormalities, coronary artery and other vascular involvement may also occur. Cardiac disease emerges silently and contributes significantly to early mortality. The clinical examination of individuals with MPS is often difficult due to physical and, sometimes, intellectual patient limitations. The absence of precordial murmurs does not exclude the presence of cardiac disease. Echocardiography and electrocardiography are key diagnostic techniques for evaluation of valves, ventricular dimensions and function.

Eligibility Criteria:
Inclusion Criteria:

- All the patients at any age up to 18 years with any type of MPS confirmed by the enzymatic assay

Exclusion Criteria:

* any patient other than MPS
Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117

Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial

Intracranial artery stenosis (ICAS) is a common cause of ischemic stroke worldwide. At present, percutaneous transluminal angioplasty and stenting serve as a possible treatment option for ICAS patients, however, intracranial in-stent restenosis(ISR) limited its use in clinical practice, which led to recurrent stroke even death, meanwhile, From the point of chinese medicine, in-stent restenosis(ISR) regard as the unhealthy environmental influences with shapes, therefore, we have design two control group on the basis of conventional secondary prevention, one use herbal medicine for blood-acting and stasis-dissolving, and another use the similar looking placebos, after 12 months of treatment, we will evaluate the rate of all-cause stroke and all-cause mortality, moreover, we also record the Vascular restenosis rate which may cause recurrent ischemic stroke, the aim of this study was to evaluate the safety and efficacy of herbal medicine C-117.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years of age
2. 70-90% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);after operation vascular stenosis less than 50%.
3. The score of mRS≤3
4. To rule out intracranial hemorrhage by CT orMRI
5. Adhere to the medication

Exclusion Criteria：

1. Together with intracranial tumors or AVM
2. The lesion area where implant stent previons
3. Fetch intracranial artery thrombus by emergency surgical operation
4. Vascular serious circuity
5. Myocardial infarction need to antithrombotic
6. MoyaMoya disease or cerebral vasculitis