cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.


Eligibility Criteria:
Inclusion Criteria:

* Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained
* Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
* Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
* An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material
* Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.

Exclusion Criteria:

* Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder
* Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
* Patients at serious suicidal risk as assessed by the investigator
* Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
* Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis
Impact of Music in Colonoscopy

The study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. The music is chosen by the patients themselves.

The Null hypothesis: The comparison of the sympathetic - autonomic nervous system (operationalized by biopotentials) intensity between colonoscopy "with" vs. "without" music is not significant.

Alternative hypothesis: The comparison of the sympathetic - autonomic nervous system intensity is significantly higher in colonoscopy "without" music vs. "with" music.

In the field of endoscopy, stress and pain play a relevant role before and during the examination. A variety of methods have been evaluated to date to provide the patient with relaxation/distraction during the examination. Especially the use of relaxation music. However, the previous studies refer to a subjective assessment of the participants after the examination. Here at least one potential bias is to be assumed from the post-procedural euphoria through the use of propofol and/or midazolam. Pain reactions express themselves explicitly in autonomous function. In contrast to our previous work, the present study uses biopotential signals for the objective operationalization of stress reduction.

The activity of the sympathetic - autonomic nervous system is operationalized by biopotentials fixed to the body surface:

* in the face area (corrugator, zygomaticus)
* on the hand (skin conductance, temperature)
* on the torso (electrocardiogram) The satisfaction of the patient and endoscopist with endoscopical procedure were asked using questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Indication for colonoscopy
* conscious sedation with propofol
* ASA state 1 or 2

Exclusion Criteria:

* lack of written informed consent
* pregnancy
* General anaesthetics
* ASA state \>2
* deafness, Hearing impairment
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function

The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.

For this study an open-label prospective randomized approach is used. During the study 360 patients with or without ID, who hospitalized for myocardial infarction were signed up. Patients were randomised (1:1) to either intravenous. FCM or oral ferrous sulphate and received the treatment during hospitalisation. Patients are closely followed for 1 year. The primary outcome is a decrease in the Wall Motion Score Index value in FCM group compered to ferrous sulphate group. The main secondary outcome includes the composite of cardio-vascular mortality, non-fatal stroke, non-fatal MI, recurrent heart failure hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years of age) able to provide informed consent. Hospitalized myocardial infarction patients (that diagnosed according to Fourth Universal Definition of myocardial infarction and myocardial injury, ESC 2018) with hypokinesia or akinesia in at least two connected left ventricular segments according to echocardiography results obtained within the first 24 hours after myocardial infarction occurs.
* Hemoglobin \>9.0 g/dL and \<15,0 g/dl and serum iron \<12 µmol/l on screening visit.
* Serum ferritin \<100 μg/L, or 100-299 μg/L when transferrin saturation \<20%.

Exclusion Criteria:

* Known hypersensitivity reaction to any component of ferric carboxymaltose.
* History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, i.v. iron therapy, or blood transfusion.
* Heart failure Killip class II-IV on screening visit.
* Current or planned mechanical circulatory support or heart transplantation.
* Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
* Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase \>3 times the upper limit of normal range).
* Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
* Active gastrointestinal bleeding.
* Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
* Inability to return for follow up visits within the necessary period of time.
Effects of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects

The aim of this intervention study is to evaluate the acute and chronic effects of different intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40 to 70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and session control. After, the subjects will be randomly allocated into four intervention groups: mild intensity group, moderate intensity group, high intensity group and control group. In both phases, the subjects have blood pressure data recorded by ambulatory blood pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be registered biological signs of blood pressure (finometer), electrocardiogram (DII derivation) and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and peripheral vascular resistance.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 70 years
* Men or women
* Body mass index under 40 kg / m²
* Able to participate in exercise
* No regular physically active in the last 4 months

Exclusion Criteria:

- Smoking; with history of ischemic stroke or hemorrhagic; or coronary heart disease; or obstructive pulmonary disease or chronic restrictive; or diabetes mellitus; or chronic atrial fibrillation.
Positive Affect Regulation sKills at Northwestern University

The Positive Affect Regulation sKills (PARK) Course is an online program containing a series of positive emotion skills for individuals experiencing stress and distress as a result of COVID-19 and the return to "normal." The study specifically targets positive emotion, and offers an array of skills in a self-guided online delivery platform, making the program accessible and convenient in confusing and stressful times.

Our main aims are:

Aim 1: To explore the effects of PARK on anxiety, depression, feelings of social isolation, positive affect, and a sense of meaning and purpose.

Aim 2: To test whether age or gender moderate the effects of the program.

The goal of the proposed program, PARK, is to reduce feelings of anxiety, depression, and social isolation, as well as increase well-being and a sense of meaning and purpose through the practice of positive emotion skills via a self-guided online platform. We will compare baseline scores on PROMIS measures of Anxiety, Depression, Social Isolation, Meaning and Purpose, and Positive Emotion to scores after completing the online course (approximately 8 weeks later), and again at 6 months post-baseline.

Research will be based in Northwestern's Feinberg School of Medicine through the Department of Medical Social Sciences (MSS), with all study procedures conducted online. Eligibility screening, consent, and assessments will be conducted on REDCap. For the positive skills course (including weekly lessons and daily skills practice) and daily emotion check-ins, consenting participants will receive access to the online PARK platform, hosted by BrightOutcome.

The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Speaks and reads English
* Able to access the online platform through their phone, a public device (i.e., at the library) or at home.
* Lives in US

Exclusion Criteria:

* Inability to communicate in English
* Lives outside the US
* Under 18 years of age
Examination of Factors Associated With Fatigue in Individuals Diagnosed With Parkinson's Disease

Fatigue is defined as an overwhelming feeling of weariness, lack of energy, and a feeling of exhaustion. It is common in Parkinson's Disease (PD) and is one of the most disabling symptoms. Fatigue is affected by motor and non-motor symptoms in individuals diagnosed with PD. As a result of this impact, it manifests itself as difficulty in initiating and continuing mental and physical tasks. This study aims to examine the fatigue of individuals diagnosed with PD and the factors associated with this fatigue.

The study will be carried out in cooperation with Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation and Nigde Omer Halisdemir University, and the study data will be collected from individuals diagnosed with PD who applied to the Neurology Polyclinic of Nigde Omer Halisdemir University Training and Research Hospital. Necessary permissions have been obtained from all institutions. Modified Hoehn\&Yahr staging (HYS) and Unified Parkinson's Disease Rating Scale (UPDRS and its subtests) will be used for disease staging and grading. Parkinson's Fatigue Scale-16 (PFS-16) to evaluate fatigue, Parkinson's Disease Sleep Scale-2 (PDSS-2) to evaluate sleep, Hospital Anxiety and Depression Scale (HAD) to evaluate depression and anxiety, Mini-Mental to evaluate cognitive status (MMSE) will be used. In addition, "Timed Up and Go (TUG)" will be applied for lower extremity performance evaluation. All evaluations will be collected in a single meeting using the face-to-face interview method. It is calculated that 80% power will be reached with a margin of error of 0.05 when 84 individuals diagnosed with PD are included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* Being diagnosed with PD by a neurologist,
* Having stable medical treatment,
* Being able to stand independently for at least 60 seconds without any assistive device,
* Having received 18 points or more according to the MMSD evaluation.

Exclusion Criteria:

* Being illiterate or unable to communicate in Turkish,
* Having undergone a surgery that may affect lower extremity functions,
* Diabetes mellitus is a diagnosis of another neurological and rheumatic disease.
MR-Guided Cryoablation of Prostate Bed Recurrences

The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.


Eligibility Criteria:
Inclusion Criteria:

* Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa
* Surgery is not a desirable alternative therapy at the time of enrollment
* Radiation therapy has failed or not indicated or can be safely postponed
* Tumor size is \< 5 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Patient is able to undergo MRI

Exclusion Criteria:

* N/A
Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There is no data concerning the immunogenicity nor the security of the adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the effects of this vaccine on transplanted and hemodialyzed patients.

The serologic responses to the Pandemrix vaccine will assess the efficacy, with the determination of the seroconversion rate among the patients.

The anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. Haemodialyzed patients
3. Renal transplant recipients who have stable renal function for the last 3 months

Exclusion Criteria:

1. No pneumonia or severe infection during 1 month before vaccination
2. No Ivig (intravenous immunoglobulins) treatment during the last 3 months
Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.

Between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (OSA) develop a high-frequency of central apneas and/or disruptive Cheyne-Stokes respiratory syndrome after application of continuous positive airway pressure (CPAP), a pattern called the complex sleep apnea syndrome (CompSAS). The trial seeks to determine the efficacy of the ASV vs. CPAP modes for the treatment of CompSAS over time. Baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. Overall study participation is approximately 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of complex sleep apnea syndrome (CompSAS)
* Naive to PAP therapy
* Requires CPAP ≤15 cm H2O

Exclusion Criteria:

* Requires supplemental oxygen or with a baseline SaO2 \<90%
* Requires CPAP \> 15 cm H2O
* Primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure
* Any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status
Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims

Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. The aim of this study is to investigate whether alterations in the immune system of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure Therapy).


Eligibility Criteria:
Inclusion Criteria:

* PTSD diagnosis
* experiences of organized violence/torture

Exclusion Criteria:

* psychotic disorder
* chronic inflammatory diseases
Response Shift and Quality of Life in Patients Suffering From Schizophrenia and Their Caregivers

Quality of life (QoL) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. Understanding determinants of QoL in schizophrenia is of importance for developing effective interventions that would improve patient functional and subjective well-being. A challenge in the interpretation of QoL measures, especially in longitudinal studies, is that QoL is self-reported by the patient and might be influenced by psychological phenomena such as adaptation to illness. An important mediator of this adaptation process is a "response shift" (RS), which involves changing internal standards, values and the conceptualization of QoL. RS can be divided into three phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a change in the importance attributed to component domains constituting QoL) and 3) recalibration (i.e., a change in a patient's internal standards of measurements). Patients may change their frame of reference, rendering scores from different measurement occasions incomparable. An RS is a potential explanation when the QoL of an individual who has experienced a serious health event or chronic condition is similar to the QoL of a healthy individual. With an RS, the concept of QoL changes over time and cannot be compared longitudinally because of changes in internal standards, values, and/or concepts. True change may be over- or underestimated when a RS is present, leading to biased estimates of the magnitude of change.The objective is to examine whether a response shift, a change in the internal standards of a patient, occurs in patients suffering from schizophrenia and in their caregivers.

This is a monocentric and propective design study, with inclusion of patients and caregivers on a 12-month period, and a follow up on a 12-month period.

100 patients with schizophrenia and 100 caregivers

Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test - pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other statistical approaches such as confirmatory factorial analysis, multilevel models and CART method.


Eligibility Criteria:
Inclusion Criteria Caregiver::

* Person identified by the patient as the family member or friend who provided the most support or assistance,
* Informed consent obtained
* Being a native French speaker

Inclusion criteria patients:

* Suffering of schizophrenia according DSM IV,
* Informed consent obtained
* Being a native French speaker

Exclusion Criteria:

* Patient suffuring of demencia
Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study

Perioperative myocardial injury remains one of the most serious complications of cardiac surgery.

Numerous factors have been implicated during the pathogenesis process, including the technique of cardiac surgery, induction of cardioplegia and period of cardiac arrest.

Lactic acid is the normal endpoint of the anaerobic breakdown of glucose in the tissues. The lactate exits the cells and is transported to the liver, thus it's considered to be an indicator of ischemia as it is produced by most tissues in the human body, with the highest level of production found in muscle.

In any cardiac valve replacement surgery, patient must undergo cardiac bypass and arrest in diastole by using hyperkalemic cardioplegia solution; meanwhile the metabolism of myocardial cells is purely anaerobic.

Esmolol an ultra-short beta blocker is supposed to decrease the anaerobic insult to the myocardial cells.


Eligibility Criteria:
Inclusion Criteria:

- 20-50 years old patients, with either sex with solitary valvular disease

Exclusion Criteria:

* • Myocardial infarction within 2 weeks.

  * History of reaction or toxicity to esmolol or other beta blockers.
  * New York Heart Association class IV congestive heart failure despite treatment.
  * Persistent hypotension (systolic blood pressure \<80 mm Hg).
  * severe pulmonary hypertension
  * Ejection fraction less than 45%
  * Patients with coronary artery disease
  * Patients with congenital heart disease
  * Patients with previous cardiac surgery
  * Patients with liver disease (child class B and C)
  * Patients with second or third degree heart block
  * Patients having resting heart rate less than 50 ppm
  * Patients using calcium channel blockers