cyrilzakka/clinical-trials huggingface dataset:
Training Attentional Awareness and Control in ADHD

The purpose of this study is to evaluate the effects of different types of cognitive training on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using mobile software on personal mobile devices.

Different types of software-based cognitive training are thought to impact attention via different mechanisms. This study examines the nature of the effects on sustained attention of two different types of mobile software based training. Because the nature of the training method is behavioral, the investigators can not divulge the differences in the training methods and their hypothesized differences in their impact on attention.

Eligibility Criteria:
Inclusion Criteria:

1. Meet established Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
2. Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
3. No lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini-International Neuropsychiatric Interview (MINI)
4. Able in the opinion of the investigator to complete all required study procedures.

Exclusion Criteria:

1. History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
2. History of any general medical condition likely to require chronic use of medication with identified Central Nervous System (CNS) effects suspected to alter cognitive performance
3. History of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
4. Serious oxygen deprivation
5. Current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
6. Current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
7. Current treatment with guanfacine.
Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke

Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. A modified version of the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i) a home-based self-training program using an app for electronic tablets and (ii) weekly group sessions of musical playing strengthening the motivational and emotional components of music playing. A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention.


Eligibility Criteria:
Inclusion criteria:

* Presence of mild-to-moderate paresis of the upper extremity after a stroke (having a score between 1 and 4 in the Medical Research Council Scale for Muscle Strength at the distal muscles of the upper extremity);
* More than 6 months post-stroke;
* Completion of formal rehabilitation programs.

Exclusion criteria:

* Major language or cognitive deficits affecting comprehension (Mini-Mental State Examination \< 24);
* Neurological or psychiatric co-morbidity;
* Other musculoskeletal condition affecting upper extremity motor function (e.g. fracture or arthritis).
A Study of LY3437943 in Healthy Participants With a High Body Mass Index

The study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A. In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 157 days and 99 days for Part A and Part B, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
* Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive
* Are agreeable to receiving study treatment by injections under the skin or through a vein.

Exclusion Criteria:

* Have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form)
* Have a significant history of, or presence of, any of the following disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have known allergies to LY3437943, related compounds, or any components of the formulation
* Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day.
* Is a known user of drugs of abuse
Study Of Ispinesib In Subjects With Breast Cancer

The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions:

1. Does breast cancer respond to Ispinesib?
2. What are the side effects of Ispinesib?
3. How much Ispinesib is in the blood at specific times after it is taken?


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB or Stage IV breast cancer
* Previously received anthracycline and taxane therapy

Exclusion criteria:

* Actively receiving anti-cancer therapy agent(s).
Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation

Transforaminal lumbar interbody fusion (TLIF) had been favorable for effectively decrease pain and disability in specific spinal disorders; however, there has been concern regarding pedicle screw placement during TLIF surgery. Recently, several biomechanical studies had demonstrated that CBT technique achieves screw purchase and strength equivalent to or greater than the traditional method. Furthermore, Only 1 report examined the surgical outcomes of TLIF with CBT screws fixation compared with TLIF using traditional pedicle screws fixation. TLIF with CBT screws fixation may be effective for specific spinal disorders, but the evidence supporting this possibility is still limited.

Methods and analysis: Blinded Randomized Controlled Trial (RCT) will be conducted. A total of 108 participants will be randomly allocated to either a CBT-TLIF group or a PS-TLIF group at a ratio of 1:1. The primary clinical outcome measures are: change in back and lower limb pain with Visual analogue scale (VAS) and change in quality adjusted life years (QALY) will be assessed by EQ-5D-5L. Measurements will be carried out at five fixed time points (pre-operatively and at 3, 6, 12 and 24 months).

Ethics and dissemination: The study had been reviewed and approved by the ethics committee of the Second affiliated hospital of the Wenzhou Medical University, Wenzhou, China(batch:2017-03). The results will be presented in peer-reviewed journals and related website within 2 years after the last operation.

Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years;
2. All of participants will be informed consent;
3. Chronic low back pain (visual analogue scale at least 3 out of 10 at rest and at least 5 out of 10 under physical strain) after having failed conservative treatment for 6 months;
4. Single-segment lower lumbar vertebral disease (Including lumbar spinal cannal stenosis, foraminal stenosis, segmental instability, lumbar disc herniation, and painful disc degeneration (back disc);

Exclusion Criteria:

1. Serious deformity of lumbar vertebrae;
2. Dysplasia of lumbar pedicle or vertebral laminar;
3. Obvious osteoporosis of lumbar vertebrae;
4. Metabolic bone diseases such as osteomalacia or Paget's disease;
5. Spondylolisthesis \> grade 2 (Meyerding);
6. Caudaequina injury or severe radiculopathy;
7. Post inflammatory instability of the vertebral spine;
8. Body mass index \> 30;
9. Immunologic diseases or Metabolic syndrome;
10. Therapy with systemic corticosteroids or immunosuppressants;
11. Current using Coumadin (or Warfarin) or Heparin therapy for more than 6 months at the time of operation.
The Effects of Neuromuscular Exercise Training on Core Stability and Hip Strength in Healthy Adolescent Females

This study is an evaluation of the effects of a Neuromuscular training program on hip strength and core stability. It is a randomized clinical trial evaluating pre and post scores.


Eligibility Criteria:
Inclusion Criteria:

* healthy adolescent females between 12 and 18 years old

Exclusion Criteria:

* lower body injuries in the last 6 months or lower body injuries that they are currently receiving treatment
* inability to participate in 5 week NME training program
Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia

Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations.

Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia


Eligibility Criteria:
Inclusion Criteria:

Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age \>38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study

Exclusion Criteria:

1. Severe anemia \< 7 gm/dl.
2. Women received iron therapy during pregnancy.
3. Intolerance to iron preparations
4. Anemia due to other causes
5. Peripartum blood transfusion.
Effect of the Nasal Provocation on the Breathing Style

The purpose of this study is to find out how the provocation of the nose changes breathing style (specifically, frequency and tidal volume changes)

It is intended to clarify on both healthy and birch pollen allergic adults how the provocation of the nose with the birch pollen, dilutant and xylometazoline affect the breathing style (breathing pattern) and how these possible changes could be controlled in the measurement of the breathing with respiratory effort belts. In addition to this, our intention is to clarify the effect of the facial mask on the breathing.

The allergic and control subjects undergo nasal provocation in 2 sessions. The first is done with birch pollen extract (should block the nose in allergic subjects) and the second with xylometazoline (should open the nose).

The mask group undergo similar measurements without nasal exposures.

The second objective of the study is to clarify if there are differences between the allergic and control subjects in the function of the autonomous nervous system during these provocations. This is done with the heart rate variability analysis method.

Eligibility Criteria:
Inclusion Criteria:

* Birch pollen allergic subjects must have clear nasal symptoms during the birch pollen season and birch specific IgE \>= 0.70
* Healthy subjects: birch specific IgE \< 0.35
* The subjects are not allowed to be under medication that affects the function of their nose during a specific time period before the measurement
* They have to be free of any acute respiratory symptoms during the prior two weeks to the measurements
* Before measurement, they are not allowed to have heavy meal or sport
* They are not allowed to have caffeine or other stimulants for 12 hours or alcohol for 24 hours.

Exclusion Criteria:

* Heart diseases
* Brain circulatory disorders
* Surgical operations of nose
* Chronic nasal symptoms
* Pregnancy
* Smoker
Study of FYU-981 in Hyperuricemia With or Without Gout

The purpose of this study is confirmatory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.


Eligibility Criteria:
Inclusion Criteria:

* Hyperuricemic or gout patients
* Serum urate level:

\>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL

Exclusion Criteria:

* Gouty arthritis within two weeks before start of study treatment
* Secondary hyperuricemia
* HbA1c: \>= 8.4%
* Uric acid-overproduction type in the classification of hyperuricemia
* History of, clinically significant cardiac, hematologic and hepatic disease
* Kidney calculi or clinically significant urinary calculi
* eGFR: \< 30mL/min/1.73m\^2
* Systolic blood pressure: \>= 180 mmHg
* Diastolic blood pressure: \>= 110 mmHg
Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial

This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.

In February 2022, the IRB approved adding a small additional substudy for the collection of exploratory qualitative outcomes only, involving up to 8 primary care physicians. As no data for the primary and secondary outcome measures was collected for this substudy, and all data collection for this group was related to exploratory outcome measures and collected through qualitative interviews with clinicians, no inclusion exclusion criteria specific to the participants in this substudy are listed, nor does the data collection from them show in the study completion date or results data. However, these physicians (n=8) and their patients (n=9) are counted in the actual enrollment total since they were randomized to intervention arms and received study interventions.

Eligibility Criteria:
Inclusion Criteria for Patients:

* Enrollment with the Michigan Medicine anticoagulation monitoring service
* Currently prescribed warfarin with anticipated use for greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation
* Currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list

Exclusion Criteria for Patients:

* Prescribed a Proton Pump Inhibitor (PPI)
* Documented intolerance or allergy to PPI use
* Left ventricular assist device
* Heart transplant

Inclusion Criteria for Clinicians:

* Practicing cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study
* Practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria

Exclusion Criteria for Clinicians:

- Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department. Around 10% of patients will present to the psychiatric emergency unit with a violent episode that requires rapid tranquilisation. Surveys of practice and opinion has shown that variety of methods have been used and no universal option exists. This study will look at Haloperidol plus promethazine versus haloperidol plus promethazine plus chlorpromazine in violent aggressive psychiatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine.
* Gender - both male and female
* Age (18-64)
* Clinician is unaware on the effects of either treatment interventions

Exclusion Criteria:

* If the clinician KNOWS one treatment has benefit over another for a particular person
* If the clinician is aware of a contra-indication of one of the treatments
* If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting.
* If the clinician does not want to undertake for both personal and professional reasons.
* If the participant is known to be allergic to one or more of the interventions
* Already randomized
* Already sedated
* Accompanying person (Friend/Family/Police Officer) refuses patient trial entry
Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia

The main aim of this project is to elucidate the incidence of acute kidney injury (AKI) in newborns with congenital diaphragmatic hernia during stay in the Pediatric intensive care unit. (PICU). This patient group often presents with severe circulatory and respiratory dysfunction requiring intensive care treatment. Characterization of risk factors to AKI will also be performed.

There is an overwhelming number of studies showing that complication with acute kidney injury (AKI) in critically ill patients, including children and newborns results in increased morbidity and mortality. The more severe AKI, the higher risk of bad outcome. In the neonatal intensive care unit (NICU), the incidence of AKI is approximately 30 %, even higher in full-term babies (36 %).

Newborns with congenital diaphragmatic hernia (CDH) often present with severe cardio-respiratory dysfunction, often complicated by pulmonary hypertension (PPHN) requiring mechanical ventilation and vasoactive/inotropic drugs, especially during the first week in the intensive care. Some of these patients deteriorates and cannot maintain vital parameters despite conventional treatment and will therefore require extra corporeal membrane oxygenation). During the ICU-stay, the patients are subjected to several risk factors for developing AKI. Among physiological risk factors, PPHN, low oxygenation and blood pressure may result in renal dysfunction. Iatrogenic factors include the need for nephrotoxic drugs, not least antibiotics (Vancomycin, Gentamycin) and antimycotics. In addition, hyperchloremia may contribute to the development of AKI, since impaired renal blood flow is associated with hyperchloremia. The AKI incidence and its risk factors in CDH patients is not well studied.

The objectives of this well characterized retrospective cohort study is to establish AKI incidence in critically ill CDH-patients and investigate possible associations between risk factors and AKI (exposure to nephrotoxic drugs, degree of multiple organ failure, PPHN, vasoactive/inotropic requirement, oxygenation index, fluid overload and hyperchloremia) during PICU stay. The association of the risk factors to different stages of AKI will also be investigated.

Eligibility Criteria:
Inclusion Criteria: Newborns with congenital diaphragmatic hernia intubated and started invasive ventilation within 2 days.

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Exclusion Criteria:

* Invasive ventilation initiated after 2 days.
* Severe comorbidity not compatible with life and/or not possible to correct surgically.
* Death occurring within 2 days.