cyrilzakka/clinical-trials huggingface dataset:
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass

The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass
* Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.
* All subjects must meet the following criteria at the time of enrollment:
* Hemodynamics:

  1. cardiac index ≤ 2.2 L/min/m2
  2. For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg
  3. For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat
  4. Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.
* Placement of an intra-aortic balloon pump has been attempted unless contraindicated
* All possible measures have been attempted to correct low arterial pH, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, dysrhythmias and residual hypothermia
* Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted
* Written, signed, and dated informed consent

Exclusion Criteria:

* BUN \> 100 mg/dl
* Creatinine \> 5 mg/dl
* Presence of any investigational mechanical circulatory support device
* Known history of liver cirrhosis or portal hypertension
* Pulmonary infarction
* Stroke, TIA or history of either condition within the last six months and/or any confirmed, existing neurologic deficits
* Active systemic infection defined as positive blood cultures, core temperature \>100.5 degrees, white blood count \> 12,500, and treatment with antimicrobials
* Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
* Other serious disease(s) limiting life expectancy
Promoting Healthy Lifestyle Behaviors in Schoolchildren: an Online Video Intervention for Parents

1. Development of a method for parents of primary schoolchildren to teach parents parenting skills to obtain health gain in the family through videos and online feedback.
2. Effect- and procesevaluation of this methodology.
3. Development of an implementation guide together with VIGEZ as primary partner and in association with partner organisations on the field.

The current project aims to develop, test and implement online videos to teach effective parenting skills to parents of primary schoolchildren. This way we want to achieve health profit by stimulating PA en healthy diet, and reducing SB in children. The online videos, based on existing literature and focus group research, show parents via modeling how they can react in difficult parenting situations related to PA, SB and healthy diet. In the current study, these videos will first be tested in an effect and process evaluation study. 300 families with at least one primary schoolchild will be recruited and randomized into an intervention/control group. By using a survey at the pre-, post- and follow-up test, we will examine if parenting practices become more effective, if related parental self-efficacy enhances and if children perform more healthy behaviors after their parents watched the videos.

Eligibility Criteria:
Inclusion Criteria:

* having at least one primary schoolchild
* having a computer at home with internet access

Exclusion Criteria:

* primary schoolchild is on diet
* primary schoolchild has a physical disability which causes problems to move/sport
* being younger than 18 or older than 70
* having no internet access
Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters

This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised study, stratified by gender and with a hybrid crossover group design, to compare treatment with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included as a positive control in terms of the effect on cardiac repolarisation.

Study hypothesis:

Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers will not increase QTc interval compared to placebo.

A total number of 120 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be randomised.

Day 1: a baseline ECG profile. Day 1: Group 1 will receive prucalopride, Group 2a will receive moxifloxacin, and Group 2b will receive placebo.

On Day 5 (steady-state level is reached), a full ECG assessment day will be performed, enabling the comparison of prucalopride 2 mg with placebo.

Subsequently, the number of tablets will be escalated in all groups (blinded) with 1 tablet a day up to 5 tablets.

On Day 13 (steady state for the supratherapeutic dose level of 10 mg of prucalopride) another ECG assessment day will be performed, enabling a comparison of prucalopride 10 mg with placebo.

Group 2b will receive a single dose of moxifloxacin on Day 15. All subjects will be discharged on Day 16. Subjects will remain in the CRU throughout the treatment period.

All subjects will return for a follow-up visit on Day 30 (± 1 week) (approximately 14 days after the last dose).

Eligibility Criteria:
Main Inclusion Criteria:

1. Healthy volunteers aged between 18 to 50 years.
2. Body mass index (BMI) between 18 and 30 kg/m2.
3. Female subjects must:

   * be of childbearing potential with a negative serum β-human chorionic gonadotropin (β-HCG) test at screening, and be willing and able to use medically acceptable double barrier methods of birth control, throughout the whole study; or
   * be postmenopausal; or
   * have received surgical sterilisation at least 6 months before screening; AND
   * females must not be receiving hormone replacement therapy (HRT).

Main exclusion Criteria:

1. Abnormal QTcF and/or heart rate/blood pressure values at baseline.
2. Subjects with ECG abnormalities that may interfere with the accurate assessment of the QT interval.
3. Subjects with known cardiovascular disorders.
4. Subjects with known clinically significant arrhythmias.
5. Subjects with risk factors e.g., Torsades de Pointes.
6. Subjects with clinically relevant, abnormal serum electrolytes or complete blood count (CBC) at screening.
7. Female subjects who are lactating or pregnant.
8. Subjects suffering from other significant medical conditions.
9. Subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride.
10. Subjects with a positive screening test for hepatitis B, hepatitis C, or HIV at screening.
18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy

Purpose: The purpose of this study is to evaluate FFNP PET/MRI's utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC).

Participants: Eight women with histologically confirmed CAH or Grade 1 EC who have planned treatment with LR-IUD will be recruited..

Procedures (methods): The is a prospective, single arm, pilot study of 8 participants who will receive one FFNP PET/MRI scan. Medical records will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Female age 18 or older
* Histologically confirmed CAH or Grade 1 EC
* No prior surgical or hormonal treatment for CAH or Grade 1 EC
* Planned treatment with levonorgestrel-releasing intrauterine device (LR-IUD) for CAH or grade 1 EC

Exclusion Criteria:

* Inability to complete PET/MR scans due to severe claustrophobia
* Institutionalized subject (prisoner or nursing home subject)
* Implanted metallic devices, parts, vascular clips, or other foreign bodies.
* Known hypersensitivity to gadolinium or FFNP or to any component of gadolinium or FFNP refractory to standard medications (antihistamines, steroids)
* Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine (β-HCG) results, obtained within 24 hours before FFNP administration, or on the basis of patient history)
* Prior hormone treatment for breast cancer
The Use of N-acetylcysteine for Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation

We aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.

The thrombotic events are increasingly recognized complications of hematopoietic cell transplantation (HCT) associated with significant morbidity and mortality, which include transplantation-associated thrombotic microangiopathy (TA-TMA), sinusoidal obstructive syndrome (SOS), deep vein thrombosis (DVT), pulmonary thromboembolism (PTE), catheter-related thrombosis (CRT), superficial vein thrombosis (SVT), etc. There is a complex interplay on balancing the risk for thrombosis and bleeding in these patients, making treatment decisions particularly challenging. Emerging studies revealed that endothelial injury is the common underlying mechanism among different thrombotic disorders. There is increasing data that N-acetyl-cysteine (NAC) may prevent or improve endothelial dysfunction by inhibiting ROS production and preventing endothelial apoptosis. Our previous study showed low dose NAC could decrease the incidence of TA-TMA. In this study, we aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 16-70 years old
2. Diagnosed as myeloid malignancies, and about to undergo allo-HSCT;
3. ECOG: 0-2;
4. Expected survival longer than 1 month

Exclusion Criteria:

1. Allergic to any components of NAC;
2. Severe dysfunction of heart, liver, lung and kidney;
3. Relapse before HSCT;
4. A history of bronchial asthma, bronchospasm or moderate / severe gastrohelcosis.
Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)

This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Between 18 to 45 years old
* Body Mass Index of 18 to 33 kg/m2

Exclusion Criteria:

* Acute or chronic medical illness
* Positive for Human Immunodeficiency Virus, Hepatitis B or C
* Nose or nasopharynx abnormalities
* Abnormal lung function
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.

The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.

This is a Phase I, randomised, single-blind (in which the study centre staff including the Principal Investigator, remain blinded during the clinical conduct of a given cohort) placebo controlled, multiple ascending dose (MAD) study in male and female participants conducted at multiple centres.

Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 4 weeks, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection.

Eligibility Criteria:
Key Inclusion Criteria

1. Biopsy-confirmed NASH diagnosis with CRN score of fibrosis stage of F1 to F3 within the previous 12 months prior to screening or history of fatty liver disease by imaging plus clinical suspicion of NASH based on history of type 2 DM for at least 5 years or overweight/obesity with BMI 25 to 40 kg/m\^2 with 2 additional metabolic syndrome components.
2. Males and females of non-child bearing potential.
3. Willing to provide written informed consent and comply with study requirements.

Key Exclusion Criteria

1. Evidence of any clinical important condition which in the investigator opinion makes it undesirable for the participant to participate in the study
2. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention
3. History of liver transplant or presence or history of hepatic disease other than NASH or histological or imaging evidence of cirrhosis.
4. Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV)virus, seropositive for Hepatitis C virus (HCV)
5. History of excessive alcohol consumption
6. Uncontrolled high blood pressure
7. Any clinically important abnormalities in ECG
8. Suspected history of illicit drug abuse
9. Clinically important abnormalities in urine and blood laboratory results
10. Changes in concomitant medication within 1 month of screening
11. Received another investigational drug within 90 days of administration of study intervention in this study
12. Has received any chemical entity or investigational drug targeting HSD17B13 (eg, ARO-HSD or ALN-HSD).
Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic

To evaluate the effects of adding magnesium sulfate to atracurium with local anesthetic mixture on akinesia of globe and eyelid regarding onset and duration in cataract surgery using peribulbar technique

Regional anesthesia is a preferred technique for ophthalmic surgery. It's safe, inexpensive and provides efficient ocular anesthesia for ophthalmic surgery.

Among regional blocks, peribulbar block is safe to retrobulbar block due to lesser incidence of series complications such as brain-stem anesthesia globe perfusion and retrobulbar hemorrhage .

The effect of non-depolarizing neuromuscular blockers on peribulbar anesthesia has been described in many studies. According to these studies the use of atracurium as adjuvant to peribulbar anesthesia provides early onset of akinesia and improves the quality of anesthesia in absence of any adverse effect.

Magnesium sulphate is non-competitive N-Methyl-D- Aspartate (NMDA) antagonism and calcium channel blocker. Magnesium has endothelium derived Nitric Oxide induced vasodilation. It enhanced the activity of local anesthetic agent and improves the quality of anesthesia .

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cataract surgery (phacoemulsification and intraocular lens implantation).

Patients aged 20-80 years. Both sexes. ASA physical status I\&II.

Exclusion Criteria:

- Refusal of the patient to participate in the study. Any disorder of neuromuscular system known from history or clinical examination e.g., Guillarian barre syndrome, Myasthenia gravies and Myopathies.

Patients are known to have a history of fits. Patients on medication known to interact with neuromuscular blocking drugs as antipyretics (aminoglycosides and tetracyclines), antiarrhythmic (quinidine).

Local sepsis. Coagulation abnormalities (INR\>1.4). High myopia with axial length more than 30 mm or less than 21. Mentally retarded patients and failure of proper communication as in deafness. Morbidly obese patients (BMI\>40). Patients with glaucoma (increased IOP\>20mmgh). Patients with history of hypersensitivity to study drugs. Very dense or very soft cataract .
Intervention to Reduce Falls Incidence

The purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention.

The objective of this research is to verify if a simple multifactorial intervention program that is applicable in PC settings is more effective to decrease fall incidence than a brief advice for community-living people aged 70 or older.

Eligibility Criteria:
Inclusion Criteria:

* Patients residing in the community

Exclusion Criteria:

* to be institutionalized
* Immobilized or bedridden
* Present a terminal disease or severe psychiatric illness
* Have contraindications to physical exercise
Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD: A Randomized, Placebo-Controlled Study

1. Primary Aim: To evaluate the efficacy of atomoxetine in reducing the frequency of primary nocturnal enuresis episodes in children with ADHD.
2. Secondary Aim: To determine if improvements in attention symptoms correlate with reductions in nocturnal enuresis episodes.

Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental disorder affecting approximately 5-7% of school-aged children globally. It is characterized by inattention, hyperactivity, and impulsivity, impairing academic, social, and daily functioning (American Psychiatric Association, 2013). The Conners-48 scale is frequently used to assess ADHD severity, offering a standardized tool for research and clinical practice. Treatments for ADHD often combine behavioral therapies with pharmacological agents such as stimulants or non-stimulants, including atomoxetine (Cortese et al., 2016).

Primary nocturnal enuresis (PNE) refers to involuntary urination during sleep in children aged five or older, without any underlying organic or neurological disorder. While PNE typically diminishes with age, its persistence can cause significant psychosocial stress for children and their families. Studies suggest that children with ADHD experience PNE at higher rates than their neurotypical peers, underscoring the need for tailored management strategies (Hagerty et al., 2015).

Interrelationship Between ADHD and Enuresis:

Shared neurobiological pathways may explain the coexistence of ADHD and PNE. Both conditions involve dysregulation in arousal and inhibitory control mechanisms, leading to disrupted sleep patterns and impaired bladder control during sleep (Shreeram et al., 2009). Despite this overlap, current treatment paradigms rarely address both conditions concurrently, leaving a clinical gap in care.

Rationale for Atomoxetine in PNE:

Atomoxetine, a selective norepinephrine reuptake inhibitor, is a non-stimulant ADHD medication effective for managing attention deficits and impulsivity. It may also influence bladder control by enhancing norepinephrine activity in brainstem regions implicated in micturition (Kim et al., 2015). This potential dual benefit positions atomoxetine as a promising treatment option for ADHD and comorbid PNE.

Clinical and Research Gap:

Although extensive research has validated atomoxetine's efficacy for ADHD, limited studies explore its effects on comorbid conditions like PNE. This study aims to evaluate the frequency of nocturnal enuresis episodes and changes in ADHD symptoms, providing insight into atomoxetine's potential dual benefits. Findings may inform integrated therapeutic approaches for children with ADHD and PNE.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-12 years diagnosed with ADHD per Conners-48 scale. Children experiencing primary nocturnal enuresis.

Exclusion Criteria:

* Secondary causes of enuresis (e.g., urinary tract infections, diabetes). Use of other enuresis treatments. Known contraindications to atomoxetine.
Cognitive Training Combined With Transcranial Direct Current Stimulation in Older Adults in a Home-based Context

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training is feasible as a home-based intervention.

The goal of the present study is to assess feasibility (primary) and cognitive training and transfer effects of a home-based multi-session cognitive training combined with transcranial direct current stimulation (tDCS). tDCS, particularly in combination with cognitive training, represents a promising approach to counteract cognitive decline and restore impaired functions. However, combined interventions of cognitive training and tDCS involve frequent visits to the facility, which leads to the need of space, time and personnel, and imposes strains on the participants. This study will elucidate the feasibility of tDCS and cognitive training in a home-based context. Healthy older adults will participate in a two-week cognitive training with concurrent online tDCS application in their own homes. Feasibility, as well as cognitive performance will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. We hypothesize that with appropriate training of the participants and close supervision the use of combined tDCS and cognitive training in an ecologically valid environment by the participants themselves is feasible. In addition, we hypothesize this protocol will lead to improved performance on the trained tasks in both experimental groups. We expect increased performance on transfer tasks and long-term maintenance of the effects after anodal compared to sham stimulation. A successful implementation of the intervention in the home-based setting will contribute to the development of home-based tDCS as a widely available therapy option in clinical populations.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 60 - 80 years
2. Right handedness

Exclusion Criteria:

1. Neurodegenerative neurological illnesses, epilepsy or history of seizures
2. Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician
3. History of severe alcoholism or use of drugs
4. Severe psychiatric disorders such as depression (if not in remission) or psychosis
5. Contraindication to tDCS application
Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia

The study try to illustrate the possible mechanisms of tending to induce airway spasms and the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5, IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and non-asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Obtain informed consent
* Elective general anesthesia surgery, surgery time 1 \~ 3 hours.
* 20 patients with a history of asthma.
* 60 patients with no history of asthma.
* American Society of Anesthesiologists (ASA)classification:class I\~II.
* Aged between 18 and 65 years old.

Exclusion Criteria:

* SBP≥180 mmHg or \<90 mmHg, DBP≥110 mmHg or \<60 mmHg.
* Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections.
* Hematopoietic dysfunction or bleeding tendency and hemorrhagic disease.
* A neuromuscular system disease.
* Airway and lung surgery.
* Predict possible or happened difficult airway.
* Immune function defect.
* Sure/suspected abuse of narcotic analgesics or drugs or alcohol dependence.
* The test drug allergy or have other contraindications in patients.
* Childbearing age women not to take appropriate contraception, pregnancy or lactation.
* Participated in other clinical drug research in the last 30 days.