cyrilzakka/clinical-trials huggingface dataset:
Children With ADHD and Emotional Dysregulation

Studies have shown that children with Attention Deficit Hyperactivity Disorder (ADHD) and emotional dysregulation are characterized by high severity of ADHD, comorbid behavior disorders and increased risk of chronic difficulties.

New studies have shown promising results by focusing on improving emotional regulation. We lack knowledge about differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress.

Children 6 to 12 years admitted to specialist and diagnosed with ADHD will be recruited. ADHD children with and without emotional dysregulation defined as fullfilling the criteria for the diagnosis Disruptive Mood Dysregulation Disorder (DMDD) with regard to differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress..

Children referred to outpatient psychiatric service will be informed about the study and asked to participate. The clinical assessments in the study will be those that are recommended as good clinical practice, so results will be included in the diagnostic work for the patient.

The data security will follow the Norwegian rules and be monitored by REC and the Data Inspectorate of the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Referred to outpatient psychiatric service.
* IQ within normal range.
* Child and parents: Good enough understanding of Norwegian language to give valid answers in interviews and tests.

Exclusion Criteria:

* IQ below normal range.
* Child and parents: Not good enough understanding of Norwegian language to give valid answers in interviews and tests.
* Unresolved crisis in the family.
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

The objective of this study is to determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to:

1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
2. Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing:

   1. the proportion of subjects at each dose level who develop a major cutaneous reaction;
   2. the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.
3. Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.

Eligibility Criteria:
Inclusion criteria:

* females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
* agree to be available for the entire study and agree to comply with all requirements.

Exclusion criteria:

* military service prior to 1989.
* history of previous smallpox vaccination.
* children 1 year of age or younger in the household or be in close contact
* smallpox vaccination within ten years
* known or suspected human immunodeficiency virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
* renal disease
* current or past history of eczema or a household member or direct contact who has eczema.
* known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
* known allergy or past allergic reaction to blood products.
* known allergy to cidofovir or sulfa-containing drugs.
* history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
* transfusion of blood or treatment with any blood product.
* current or history of drug or alcohol abuse
* inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Retrospective Study of ImmunoFormulation for COVID-19

Multicentre, retrospective, observational study to describe the course of SARS-CoV-2 disease in patients treated or not with IMUNO TF ® and a combination of nutraceuticals and who have tested positive in a COVID-19 diagnostic test based on the duration of symptoms.

SAMPLE SIZE JUSTIFICATION The primary objective of the study was to describe the course of SARS-CoV-2 disease in patients treated or not with IMUNO TF® and a combination of nutraceuticals and who have tested positive in a COVID-19 diagnostic test based on the duration of symptoms.

Sample size calculation was established according to the ICH guidelines, where it was specified that the number of patients should be sufficient to provide a safe response about the issues raised.

The mean duration of mild/moderate symptoms of COVID-19 was 11.5±5.7 days. A sample of 18 patients would be sufficient to estimate, with a 95% confidence and a precision of +/- 2.8 days, a mean duration of symptoms with a standard deviation of 5.7 days. Assuming a loss of 10% of patients, the sample size was 20 patients. Considering the two groups of patients (treated with IMUNO TF® / not treated with IMUNO TF®), the sample size was 40 patients, 20 patients per group. The calculations were performed with the help of the PASS package, version 2011.

DATA PROCESSING Study data were collected in a CRD and inserted the data in a database specifically designed for the study. The database included internal consistency ranges and rules to ensure data quality control.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older.
2. Patients who give written informed consent to participate in the study.
3. Patients who have consulted their physician for symptoms associated with SARS-CoV-2 infection between March 2020 and May 2020. Patients were included in one cohort or the other based on the treatment received for improvement of COVID-19 symptoms:

   1. IMUNO TF® cohort: patients treated\* with IMUNO TF® with a combination of nutraceuticals
   2. Control cohort: patients not treated\* with IMUNO TF® with a combination of nutraceuticals \*Without restrictions on the adjuvant treatment received.
4. Patients who have tested positive in a diagnostic test for SARS-CoV-2.
5. Patients with onset of COVID-19 symptoms ≥ 5 days prior to diagnosis of SARS-CoV-2.
6. Patients with data in the medical record from the first visit due to disease symptoms until recovery, or at least 1 month of follow-up of symptoms, whichever occurs first.

Exclusion Criteria:

1. Any medical or psychological condition that, in the physician's opinion, could compromise the patient's ability to give informed consent.
2. Patients requiring hospital admission due to the disease.
Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.

Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were randomly assigned either into experimental group (26 patients) received TENS plus the traditional physical therapy program( including range of motion exercise, stretching exercise of obturator internus muscle, clam shell exercise, relaxation exercise and underwater exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received only the traditional physical therapy exercise for the same period of time. Intensity of pain by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake are measured pre and post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male with ages ranged from 30 to 50 years.
* Suffering from pudendal neuralgia and its intractable perineal pain that persists for a minimum one month beyond the acute onset.
* Pelvic pain with sitting that relived by standing or toilet sitting.
* Anal pain, dyspareunia and genital pain

Exclusion Criteria:

* Those who had history of skin malignancy.
* Diabetic,
* Sensory disorders,
* Circulatory insufficiency
* Acute infection of the treatment area,
* Renal failure
Adherence Rate to DMARDS in Egyptian Patients With RA

The study aims at determining adherence rate to DMARDS and predicting factors affecting treatment adherence among sample of Egyptian patients with RA.

Rheumatoid arthritis (RA) is an autoimmune disease that causes inflammation of the joints. It is chronic disease and often progressive in course and has a strong impact on people's everyday lives.

Disease Modifying Anti-Rheumatic Drugs (DMARDS), such as methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine are the cornerstone of therapy in RA and are invariably used as initial therapy.

These drugs have shown to retard disease progression including joint destruction.

It is believed that adherence to treatment is crucial for successful therapy, however, non-adherence is a substantial problem in patients with chronic rheumatic conditions, including RA.

Previous studies have reported that DMARDS non adherence results in more disease activity, loss of function, and a lower quality of life.

The depression is a common co-morbidity in RA, its presence can alter the course of RA negatively via cognitive-behavioral or inflammatory pathways: patients with concurrent depression suffer from more pain, show a heightened disease activity.

As non-adherence to medication regimen is considered a serious public health issue that can have great impact on clinical and economic consequences. therefore, it is crucial for health care providers to assess the patient condition, predict the possible causes of non-adherence, and put a policy for increasing medication adherence and achieving the best health outcome.

Also, improving medication adherence enhances patients' safety and health condition.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than or equal 18 years old.
2. On current diagnosis of RA determined by a Rheumatologist according to 2010 ACR/EULAR classification criteria for RA.
3. On current treatment with one or more of DMARDS from at least 6 months duration.
4. Patients with cognitive level enabling them to interact in the study. -

Exclusion Criteria:

1. Age less than 18 years old.
2. Patients receiving one or more of DMARDS of period less than 6 months.
3. Patients with psychiatric diagnosis other than effective disorder.
4. Patients with associated disability due to neurological disorder or trauma.
5. Patients with major internal organ failure e.g. heart failure, end stage renal disease or hepatic failure.
6. Patients with severe cognitive impairment interfering with the proper communication and interaction within the study process.
Evaluating Patient Experiences in Skin Care Clinical Studies

Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.

This trial will evaluate the safety and efficacy of new skin care products and treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future skin care studies.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is able and willing to comply with the treatment/follow-up schedule and requirements
* Patient must provide written informed consent

Exclusion Criteria:

* Women who are pregnant, intend to become pregnant, or are lactating
* Inability to perform regular electronic reporting
* Participants who are vulnerable to any intervention
Urinary Incontinence and Transtheoretical Model

The aim of the study is to evaluate the effectiveness of nursing care given online to women with urinary incontinence based on the Transtheoretical (Change) Model.

The research was planned as a randomized experimental design with pre-test and post-test control groups. The research will be conducted in Kutahya, Turkey.

A total of seven online interviews will be conducted with the women in the experimental group, one of which is pre-test, one is the last interview where the post-tests are applied, and five of which are motivational. Women in the experimental group were interviewed every 2 weeks and the women will be followed up by phone/mail every 2 weeks. A total of two online interviews will be conducted with women in the control group, one of which is a pre-test interview and one is a final interview where post-tests are applied. No application will be made to women in the control group. All online calls to be made will be conducted via the WhatsApp application.

Eligibility Criteria:
Inclusion criteria

* 18 years or above
* Diagnosis of urinary incontinence according to the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
* Mild to moderate incontinence according to the Incontinence Severity Index (ISI)
* Having a smartphone
* Using the WhatsApp application
* Being at one of the stages of pre-contemplation, contemplation, preparation, and action according to the evaluation form for stages of change
* Volunteering to participate in the study

Exclusion criteria

* Having risk factors that are thought to affect urinary incontinence (pregnancy; giving birth within the last year; having been diagnosed with recurrent urinary tract infection; having any health problem affecting the muscle and/or nervous system; having been diagnosed with a disease that increases intra-abdominal pressure and causes coughing, such as asthma, chronic obstructive pulmonary disease; using drugs that may cause urinary incontinence, such as diuretics, anticholinergics, antidepressants, antiparkinsonian, antihistamines, sedatives, narcotic analgesics for the past year; having been diagnosed with pelvic organ prolapse; receiving education and treatment for urinary incontinence in the last year)
* Being at the maintenance stage according to the evaluation form for stages of change
* Not volunteering to participate in the study
Registry of Older Patients With Cancer

RATIONALE: Gathering information about older patients with cancer may help the study of cancer in the future.

PURPOSE: This research study is gathering information from older patients with cancer into a registry.

OBJECTIVES:

Primary

* To create a registry (to be called "Carolina Senior") of older patients with an appointment at North Carolina Cancer Hospital.
* To have these patients complete a Geriatric Assessment (GA).

Secondary

* To measure the response rates of GAs of Carolina Senior patients and their satisfaction with a GA by measuring the percentage of patients contacted who consent to complete the GA; the percentage of patients able to complete the self-administered portion of the GA without assistance; the length of time necessary to complete the GA; the variance and number of missing items; the percentage of GAs that contain all 3 of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status; and patient satisfaction with the questionnaire by identifying items that are distressing or too difficult to comprehend.
* To gather information, including patterns of patient care, that would lend support for future research in the 'Carolina Senior' population who receive a confirmed diagnosis of cancer (except for nonmelanoma skin cancer, cervical carcinoma in situ without evidence of disease, or prostatic intraepithelial neoplasia without evidence of prostate cancer).

OUTLINE: Patients complete a geriatric assessment, a multi-dimensional inter-disciplinary patient evaluation that includes an evaluation of a patient's functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, and nutritional status. Patients' medical records are also reviewed. Patients' health status at 1 year is incorporated into the registry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients must have an appointment at the North Carolina Cancer Hospital and agree to complete the Geriatric Assessment NOTE: Not all patients included in the registry will ultimately be diagnosed with cancer. Patients who complete a GA and are not diagnosed with cancer will remain in the database, but will be categorized into a separate group and will not have their medical records accessed.

PATIENT CHARACTERISTICS:

* Able to read and speak English

PRIOR CONCURRENT THERAPY:

* Not specified
The Role of Incretins in Bone Remodeling in Humans

The role of incretins (GIP and GLP-1) on cells and bone tissue has been shown in cellular and animal studies. In humans, the role of these hormones is mainly studied in the pathophysiology of diabetes, their effect on bone is unknown. The serum incretin concentration is low and increases rapidly after a meal. This increase is brief, incretins being rapidly degraded by dipeptidylpeptidase 4 (DPP-4). The dosage of these hormones is complex and the basal "normal" serum concentrations and after feeding in healthy subjects are unknown. Before any study on the effect of incretins on bone remodeling in humans, it is necessary to establish physiological concentrations of incretins in healthy subjects.

The aim of this study is to estimate physiological concentrations of incretins in healthy subject.


Eligibility Criteria:
Inclusion Criteria:

* healthy women and men

Exclusion Criteria:

* known osteoporosis
* osteoporotic fracture
* tobacco
* alcohol : \> 2 glasses/day
* type 1 and type 2 diabetes
* BMI \< 19kg/m² or \> 30kg/m²
* heart failure, kidney failure
* cancer
* bariatric surgery
* graft
* cirrhosis
* use in the past year : bisphosphonate, denosumab, raloxifene, teriparatide, oral or IV glucocorticoid during 3 months or more
An Alternative Way To Deliver Oxygen To People

The availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. Accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. In this regard, Respirogen Micro-Oxygen (RMO) technology holds considerable promise. Data from experimental animal models of lung injury suggest administration of RMO is a feasible method to deliver oxygen in a manner independent of pulmonary function. Our ultimate long-term goal is to provide a product that can be used to deliver oxygen to humans experiencing respiratory distress and pulmonary dysfunction In this first exploratory study, our goal is to begin to understand the physiological responses to enteral (rectal) delivery of RMO in low-oxygen environments in healthy adults at rest.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-40 years,
* body mass index between 19 and 30 kg/m\^2,
* resident at a similar altitude for a minimum of 1-year,
* no travel to/from areas varying by \~2000 feet of elevation within 4-weeks of initiation of study participation.

Exclusion Criteria:

* identification of overt chronic disease (including cardio-pulmonary disorders),
* prior diagnosis of asthma, cystic fibrosis, Chronic obstructive pulmonary disease, or ventilator therapy
* anemia,
* pregnancy,
* habitual use of tobacco/nicotine products,
* known allergy to sodium phosphate (or other common laxatives),
* habitual use of recreational drugs that require inhalation,
* history of seizures, kidney problems, stomach or bowel problems, ulcerative colitis, problems with swallowing or gastric reflux, gout, and and/or low blood sodium.
* irritable bowel
* ACUTE respiratory illness such as bronchitis, pneumonia, Upper Respiratory Infection OR ACUTE GI issues such as gastroenteritis.
* Anemia (as measurement of hemoglobin and/or hematocrit) .
* sickle cell disease.
* history of altitude sickness
Mitral Valve Area Assessment: Comparison With Transthoracic Echocardiography and Magnetic Resonance Imaging

To compare mitral valve area in rheumatic mitral valve stenosis with cardiac magnetic resonance imaging and conventional transthoracic echocardiography.

Clinical assessment of severity of mitral stenosis depends on both the presence of symptoms and mitral valve area . Evaluation of mitral valve area with transthoracic echocardiography maintains rapid, accurate analysis of valve disease and serves as a practical gold standard for clinical evaluation. Cardiac magnetic resonance imaging (CMRI) is a recently used method that allows to evaluate cardiac structures and function noninvasively. Direct visualization of valve area with CMRI is also possible and it has been shown that the valve area assessed by CMRI planimetry correlates reliably with the invasive assessment. Velocity-encoded cardiac magnetic resonance imaging can be used to quantify mitral valve area. The objective of this study was to evaluate mitral valve area with CMRI and compare it with echocardiographic methods including 2D planimetry, Doppler continuation equation and Doppler pressure half-time

Eligibility Criteria:
Inclusion Criteria:

* rheumatic mitral valve stenosis

Exclusion Criteria:

* Degenerative mitral valve disease
* EF\<50%
* atrial fibrillation
* inconclusive planimetric assessment
* moderate or severe mitral regurgitation
* moderate or severe aortic regurgitation
* history of previous mitral valve commissurotomy or balloon valvotomy