cyrilzakka/clinical-trials huggingface dataset:
ACTIVATE: A Computerized Training Program for Children With ADHD

A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking).

In an open clinical trial, ACTIVATE, a computer-based neurocognitive intervention will be evaluated to determine its effectiveness in improving symptoms of attention-deficit/hyperactivity disorder (ADHD) and related impairments. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). Youth between the ages of 7-11 will be recruited and assessed for ADHD and assigned to the ACTIVATE intervention. Assessment of outcomes will occur before, weekly during treatment, and immediately post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-11 with a diagnosis of ADHD
* Parent and child must be fluent English speakers
* Family has access to desktop/laptop computer at home with internet access (in order to implement the ACTIVATE intervention component, which is an online-based computer program)

Exclusion Criteria:

* Developmental delay or psychosis that impacts the child's ability to function and engage in the computerized intervention
* If the youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within a preventive intervention format (e.g. hospitalization, specialized placement outside the home)
* If the child has an estimated Full Scale IQ below 80, based on completing two subtests of the Wechsler Intelligence Scale for Children - Fourth Edition
Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia

An effectiveness-implementation sequential explanatory hybrid design type 2 was performed in two rural communities of Colombia. A quasi-experimental study with historical control (standard of care) was designed to estimate the effectiveness of community-based intervention using the Guaral+ST mobile application (app). Three implementation outcomes were evaluated: acceptability and usability by qualitative methods, and fidelity by quantitative methods

An effectiveness-implementation sequential explanatory hybrid design type 2 using mixed methods was performed in 2020 and 2021 in two study sites: Pueblo Rico, Risaralda, and Rovira, Tolima. A quasi-experimental study with historical control (standard of care) was designed to evaluate the effectiveness of the community-based intervention supported by mHealth, in terms of monitoring of treatment of patients with cutaneous leishmaniasis. The effectiveness indicators i. number of follow-up contacts, ii. Adherence to treatment, iii. adverse drug reactions, and iv. the therapeutic response were compared between the intervention and control groups.

After the effectiveness evaluation was completed, three outcomes were assessed to inform the implementation of the community-based use of the app: acceptability, usability, and fidelity.

Eligibility Criteria:
Inclusion Criteria:

Patients followed by CHL with the app (effectiveness evaluation):

* Diagnosis confirmed by microscopy of tissue smear or culture
* Any age and gender
* Medical prescription for antileishmanial treatment
* Approved and signed informed consent
* Availability of CHL to monitor treatment of the patients in the community

Inclusion Criteria patients who received the standard of care (effectiveness evaluation):

* Clinical records of patients with confirmed CL at most two years prior to the start of this study
* Any age and gender
* Received antileishmanial treatment based on national guidelines

Inclusion criteria for participants of implementation evaluation (Community Health Leaders)

* Residents of the rural areas of study sites
* Voluntary participation in the monitoring of patients using the mobile app
Non-intrusive Detection of Temporary Neurologic Impairment by Opioids

The investigators aim to prove the feasibility of a non-invasive means to identify temporary neurological impairment resulting from the use of a commonly prescribed opioid by identifying an oculomotor biosignature associated with temporary neurologic impairment in pain-free opioid-naïve subjects, and to initiate the development of such a signature. The investigators also sought to establish the presence of a dose-dependent biosignature for opioid impairment.

To determine the detrimental effects of opioid intoxication on normal oculomotor function, the investigators will collect data from up to 25 subjects before and during oxycodone induced intoxication. A within-subjects design will be used, and subjects will be tested under conditions of no dose (placebo), low dose, and high dose. Subjects will be tested during 3 sessions (baseline, placebo, oxycodone); separated by 7 days to allow for complete washout of any drug that was administered. Subjects will perform tests of visual fixation, saccade speed and saccade accuracy, cognitive control over saccades, cognitive control over visual scanning, and visual pursuit. Eye movement data will be collected using an SR Research EyeLink 1000 Plus eye tracking system.

Analysis of the data will be performed by comparing each subject state against the baseline measurements, where baseline represents an unimpaired subject state. Based on prior work with marijuana intoxication, the investigators expect that this data and analysis will successfully reveal a constellation of oculomotor dynamics that can be used to classify whether an individual is or is not currently impaired by oxycodone. Based on published studies, the investigators anticipate these changes will generalize across the opioid class, creating a biosignature of opioid impairment.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 21 and 59 years of age.
* Males and females; women must practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD).

Exclusion Criteria:

* Prior use of any opioids during the preceding 30 days.
* Positive urine drug test for any drug at any point during the study.
* Pregnancy
CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+

To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children


Eligibility Criteria:
Inclusion Criteria:

1, age 3-18 years old (including boundary value), male and female;

2. The patient was clinically diagnosed as relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoblastic

Patients with tumors who meet one of the following conditions:

• Complete marrow response (MRD\>1%) or not achieved after at least 2 courses of standardized induction regimen chemotherapy

Complete response at the molecular level and immunology (characterized by specific molecular markers and immunophenotypes prior to treatment)

Patients, did not turn negative after treatment);

* Recurrence during chemotherapy, early recurrence after drug withdrawal (\<12 months) or late recurrence after complete remission (≥

  12 months) and did not achieve complete remission after 1 course of standard induction regimen (MRD\>1%);
* Recurrence after bone marrow transplantation;
* Simple bone marrow, simple extramedullary (testicular leukemia, central nervous system leukemia) or combined

recrudescence

3. Lansky score ≥60;

4, the treatment related antigen test result is positive (CD19/CD20/CD22);

5. The expected survival period from the signing date of the informed consent is more than 3 months;

6, HGB≥70g/L (blood transfusion);

7, liver and kidney function, cardiopulmonary function meet the following requirements:

1. Creatinine ≤1.5×ULN;
2. Left ventricular ejection fraction ≥50%;
3. Blood oxygen saturation \>90%;
4. Total bilirubin ≤1.5×ULN; ALT and AST≤2.5 x ULN.-

   Exclusion Criteria:
   * 1, severe cardiac insufficiency, left ventricular ejection fraction \<50%;

     2, have a history of severe lung function impairment;

     3. Combined with other advanced malignant tumors;

     4, combined with serious infection and can not be effectively controlled;

     5, combined with serious autoimmune disease or congenital immune deficiency;

     6, active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBVDNA\] or hepatitis C virus ribonucleic acid \[HCVRNA\] positive);

     7, human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;

     8. Have a history of severe allergy to biological products (including antibiotics);

     9. Patients with allogeneic hematopoietic stem cell transplantation still had acute graft-versus-host response (GvHD) one month after immunosuppressant discontinuation;

     10, the presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in the study by the investigator.
Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have successfully completed PB-102-F50.

This is an open-label study to assess the long-term safety and efficacy of pegunigalsidase alfa treatment of 2.0 mg/kg administered intravenously every 4 weeks. The duration of treatment will be until pegunigalsidase alfa is commercially available to the patient, or at the discretion of the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Completion of study PB-102-F50.
2. The patient signs informed consent.
3. Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically accepted, effective contraception method. These include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) supplemented with a barrier method (preferably male condom), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) supplemented with a barrier method (preferably male condom), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. Contraception should be used for 2 weeks after treatment termination.

Exclusion Criteria:

Presence of any medical, emotional, behavioral, or psychological condition that, in the judgment of the Investigator, would interfere with patient compliance with the requirements of the study.
Role of Sleep in Cardiovascular Functions

Sleep and particularly deep sleep are playing an important role for brain and body health. Poor sleep has been associated with risk factors for cardiovascular disease and moreover, is hypothesized to increased mortality risk of cardiovascular diseases. Yet, the role of specific sleep processes for cardiovascular function remains unclear. Particularly deep sleep, which is manifested by large amplitude, low frequency oscillations is of importance for the restorative functions of sleep. Thus, the modulation of deep sleep by auditory stimulation will be of central interests to assess the cause-effect relationship of specific processes within sleep for cardiovascular regulation.

This study will assess the effects of slow wave modulating auditory stimulation on cardiovasuclar functions in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Good general health status
* Male subjects 18-84 years of age
* Native German speaker or good understanding of German

Exclusion Criteria:

* Contraindications on ethical grounds,
* Known or suspected non-compliance, drug or alcohol abuse,
* Regular medication intake that could pronouncedly affect outcomes of interest (e.g. beta-blocker)
* Long (\> 9.5 hours per night) or short sleepers (\< 6.5 hours per night),
* Smoking (regular smoker, \>10 days per year, smoking not allowed during study participation)
* Participation in another study with investigational drug/therapy/interventions within the 30 days preceding and during the present study (start date adapted accordingly),
* Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Pacemaker,
* Intake of on-label sleep medication,
* Presence or suspicion of sleep disorders (e.g., insomnia, sleep disordered breathing (apnea), restless legs syndrome). Possibility of apnea might be assessed in the screening night,
* Body Mass Index \< 18 or \> 30 kg/m2,
* Irregular sleep-wake rhythm (e.g. shift working),
* Bad sleep quality during screening night (e.g. \< 75% sleep efficiency in screening night)
* Significant sleep complaints in general or excessive daytime sleepiness (PSQI \> 5; ESS ≥ 11),
* Travelling more than 2 time zones in the 2 weeks before experimental session starts or during intervention (start of experiment will be adapted to fit with this criteria),
* Hearing disability/ hearing aid (only an exclusion if in a simple audiometry participants cannot hear intervention tone sound levels),
* Skin disorders/problems/allergies (face region) that will significantly worsen with electrode application,
* High caffeine consumption (\> 5 servings/day; including coffee and caffeinated energy drinks),
Pediatric Preoperative Virtual Reality Program

Does the introduction of a preparatory virtual reality (VR) program that is used in the home environment, have an effect on the anxiety level of children immediately before surgery, prior to administration of preoperative sedatives?

Up to 60% of children who require elective surgery report significant anxiety in the preoperative setting. Severe perioperative anxiety of a child poses a major challenge for the surgeon, since it is often accompanied by adverse behavioral and emotional reactions and associated with a complicated operative and postoperative course.

The investigators have made the personal experience that informing the children ahead of time about what to expect in the hospital, decreases child anxiety and increases parent satisfaction.

There is considerable debate on the best way how to inform children about what to expect during their hospital stay. The investigators had a virtual reality application developed that introduces the children to several aspects of the hospital environment. Therefore, these children now ahead of time what they will experience during their hospital stay.

The aim is to evaluate the effect of this preparatory virtual reality application on the anxiety level of children immediately before surgery.

Eligibility Criteria:
Inclusion Criteria:

1. The child is between the age of 7 and 13 years
2. The child is undergoing an elective surgical procedure under general anesthesia
3. The child understands Swiss German
4. The parent(s) understand(s) German
5. The parent(s) possess a smart phone
6. Internet access is given
7. The patient information has been explained
8. Informed Consent is signed

Exclusion Criteria:

1. The child has a hearing impairment
2. The child has neurologic disorder
3. The child requires postoperative intensive care
4. The child has previous experience of anesthesia
5. American Society of Anesthesiologists (ASA) score of III or greater
Efficacy of Dexmedetomidine vs Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning

Comparison of effect of dexmedetomidine and midazolam in icu patients who put on mechanical ventilation and show agitation on weaning.Selection of better agent minimises the drug related side effects like respiratory depression but also helps in weaning for early extubation,give hemodynamic stability and reduce morbidity and mortality in icu..


Eligibility Criteria:
Inclusion Criteria:

* all patients with age \<60 irrespective of gendre

Exclusion Criteria:

- Patients who refuse to give consent, severely altered conscious level (GCS \< 8/15), traumatic injury causing hypoxemia e.g., severe head / chest / facial trauma or pneumothorax, severe pneumonia, arrhythmia, impaired hearing or blindness, severe hepatic or renal disease, on neuromuscular blocking agents, recent myocardial infarction, use of anti-psychotics, hypersensitivity to any of the drug under study.
Quartet™ Bad Oeynhausen Trial

Primary objective of this study is to evaluate whether the use of a quadripolar left ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)


Eligibility Criteria:
Inclusion Criteria:

* Indication for CRT-D implantation according to current guidelines
* Ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM)
* Sinus rhythm
* NYHA II-IV
* Age ≥ 18 years
* Written informed consent to participate in the study

Exclusion Criteria:

* Right bundle brunch block
* Valvular cardiomyopathy
* Patient receiving a non-transvenous LV electrode
* Known pregnancy
* Age \< 18 years
* Life expectancy \< 1 year
* Atrial fibrillation / atrial flutter at the time of enrolment
* Inability to provide informed consent
* Participation in another study with active therapeutic arm
* Regular follow-up in the study center within the first 6 months after implantation not guaranteed
Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

The Ottawa score is a clinical predictive score aiming at stratifying thromboembolic recurrences in cancer patients according to identified clinical risk factors and histological type of the tumor. This score has never been validated externally in a prospective way in patients treated with tinzaparin. The objective of this observational prospective study is to enroll cancer patients with TED treated with tinzaparin for a planned period of 6 months and to collect data on thromboembolic recurrences, major hemorrhages, deaths and heparin-induced thrombocytopenia

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with histologically confirmed, active or evolving, solid or liquid tumour, or
* Suspected malignant tumour confirmed within a month of index VTE occurrence
* Treated with specific metastatic or adjuvant anti-cancer treatment
* Patients with recent diagnosis of documented symptomatic or incidental VTE and a prescription of tinzaparin for 6 months
* Proximal or distal VTE of lower limbs
* Pulmonary embolism
* Inferior or superior vena cava thrombosis
* Iliac vein thrombosis

Exclusion Criteria:

* Skin cancer other than melanoma
* Life expectancy less than 6 months
* Superficial isolated thrombosis
* Isolated subsegmental pulmonary embolism
* Cerebral, visceral thrombosis
* Superior limbs VTE or Central catheter thrombosis
* Patients being treated with anticoagulants by more than 7 days
Reversal of Obesity Cardiomyopathy

The overall purpose of this study is to determine if weight loss is beneficial for obese patients with diastolic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* All subjects will have obesity and have a BMI \> 35kg/m2.
* Subjects must be between the ages of 35 and 65 years, in order to limit the confounding affect of age on our endpoints.

To determine if potential subjects meet these criteria, they will:

1. be interviewed,
2. their clinical charts reviewed, by the research study coordinator and/or the PI, and
3. undergo a history and physical by a physician (Study Day 2). Subjects who are to undergo gastric bypass surgery will be in the intervention arm. They will be matched with control subjects. We will attempt to have no more than one control subject for each gastric surgery subject.

Exclusion Criteria:

* Subjects who have a condition that may masquerade as diastolic heart failure will be excluded (see Research and Design).
* Subjects who are \< 35 or \> 65 years, \> 400lbs (the weight limit of the MRI table) not obese, unstable, not able to lie flat for the imaging studies, not ambulatory, unable to give informed consent, pregnant, lactating, with atrial flutter or fibrillation, current smokers, or who will undergo a different type of bariatric surgery (not Roux-en-Y gastric bypass) will be excluded from participation.
* Those who have evidence of other major systemic diseases (e.g., cancer, significant lung disease, creatinine \> 2.0mg/dL, hemoglobin \< 10g/dL, and liver function tests twice the normal range) will be excluded.
* Subjects who have \> class I hypertension will be excluded. The investigators will exclude patients with an LV ejection fraction \< 45% and those with significant pulmonary hypertension (peak artery pressure \> 55mmHg).
Study on the Therapeutic Mechanisms of Dithranol Treatment in Patients With Chronic Plaque Psoriasis

Dithranol (known in the U.S.A. as anthralin and in Germany as cignolin) is one of the oldest and safest topical anti-psoriatic treatments. However, despite explorative investigations, the skin disease-clearing mechanisms of dithranol remain poorly understood (Painsi et al, JDDG 2015). The purpose of this study is to investigate the therapeutic mechanisms of dithranol in psoriasis.

Skins biopsies from psoriatic skin and blood samples will be taken before (day 0) and at several time points after start (day 4, week 2-3, and week 6-7) of dithranol therapy to be subjected to an explorative analysis (see outcome measures). A total of maximal 15 psoriasis patients will be enrolled. Normal lesion-adjacent skin from 10 patients undergoing surgery for non-inflammatory conditions will serve as control.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over 18 years of age
* Clinical diagnosis of chronic plaque psoriasis
* Dithranol treatment scheduled

Exclusion Criteria:

* Systemic anti-psoriatic therapy (DMARD, phototherapy and/or Biologics) within 4 weeks of study entry (start of dithranol treatment)
* Topical treatment with steroids and or vitamin D3 analogues within 2 weeks of study entry (start of dithranol treatment)
* Autoimmune disorders
* Poor general health status
* Intolerance of dithranol
* Pregnancy and lactation period