cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects

The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects.

The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure \[BP\], Pulse Rate \[PR\]), 12-lead Electrocardiogram \[ECG\], and clinical laboratory tests
* Age of 18 to 45 years (incl.)
* Body Mass Index \[BMI\] of 20.0 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice \[GCP\] and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including Blood Pressure \[BP\], Pulse Rate \[PR\] or Electrocardiogram \[ECG\]) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
An Evaluation of Virtual Student Health Center Among Incarcerated Juvenile Offenders

WestEd and its partners Efficacity and the Oregon Youth Authority (OYA), are conducting a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U, for youthful male offenders. This study involves male teenagers (age 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The innovative, non-curricular, technology-based intervention, Healthy U, is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. The purpose of this study is to test this intervention on a population of young men incarcerated at the OYA who will soon be released into the community. The intervention is tailored to this population by updating the design, videos, and examples to best reflect the youth in the study, and OYA staff are being trained to facilitate the self-guided intervention.

WestEd and its partners, Efficacity and the Oregon Youth Authority (OYA), were funded by the Department of Health and Human Services (DHHS) to conduct a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U (formally known as Virtual Student Health Center), for youthful male offenders to test the impact of this innovative, non-curricular, technology-based intervention, that is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. Healthy U was designed to give adolescents and teens the tools they need to reduce their risk of unintended pregnancy and sexually transmitted diseases (STDs), including HIV, using a low-cost, transportable platform that is user-friendly for youth (and staff to oversee). In this project, we take the innovative Healthy U intervention and modify its implementation for juveniles in custody of a correctional facility.

This study involved male teenagers (ages 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The findings from this study are intended to contribute to research on both teen pregnancy and crime prevention. Teen parents and their children are at greater risk for subsequent criminal offending, and the children of teen parents also have greater risk of child abuse and neglect victimization. The current knowledge base suggests that youth exposed to the juvenile justice system have sex more often with more partners at a younger age and without protection (Bryan, Rocheleau, Robbins, \& Hutchinson, 2005). This randomized study was designed to contribute to our understanding of what works with this population and to strengthen our knowledge base around developing and implementing technology-based interventions in a juvenile correctional environment.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 14-19
* OYA commits
* Have the cognitive ability to complete the baseline and follow-up surveys
* Need to be within 30-90 days of release

Exclusion Criteria:

* Female
* Outside of age criteria
* Oregon Department of Corrections commits
* Does not have the cognitive ability to complete the baseline and follow-up surveys
* Not within 30-90 days of release
Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction?

Anterior cruciate ligament (ACL) injury is a common sport injury in both professional and recreational athletes. Furthermore, persistent quadriceps weakness and wasting are frequently observed after anterior cruciate ligament reconstruction (ACLR). Several studies have demonstrated that muscular rehabilitation to normal strength is difficult, protracted, and often not achieved due to the inability to fully activate the quadriceps voluntarily. Pain and disuse are often blamed for the inhibition of muscle activation following joint injury. However, arthrogenic muscle inhibition (AMI) is often overlooked and not addressed. Thus, the magnitude of strength restoration of the quadriceps is frequently restricted despite solid rehabilitation protocols. As AMI is a reflex inhibition of musculature involving the neurotransmitter γ-aminobutyrate (GABA), Gabapentin may have a potential role in modulating AMI, therefore limiting muscle weakness after ACLR.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50
2. Unilateral isolated ACL tear for primary ACLR confirmed clinically and radiologically
3. No concomitant ligamentous, meniscal or chondral injuries.

Exclusion Criteria:

1. Concomitant multiple ligament injuries including posterior cruciate ligament, medial collateral ligament ligament, or lateral collateral ligament
2. Concomitant meniscal injuries
3. Concomitant chondral injuries
4. preoperative radiographic signs of arthritis
5. Revision ACL surgery
6. Contralateral knee with
7. Medical co-morbidities including Diabetes Mellitus, chronic renal failure
8. Documented hypersensitivity to Gabapentin
9. History of epilepsy
10. History of depression
11. Non-compliance to rehabilitation protocol.
Autonomic Differences in Heart Rate Variability Between Healthy and Chronic Low Back Pain Subjects

This study aims to evaluate the autonomic differences in heart rate variability (HRV) between healthy individuals and those with chronic low back pain. By analyzing HRV parameters, such as time-domain, frequency-domain, and non-linear metrics, this cross-sectional study seeks to explore the impact of chronic pain on the autonomic nervous system. The study will provide insights into parasympathetic and sympathetic modulation and its potential relationship with chronic pain symptoms. Participants include healthy adults and individuals with chronic low back pain aged 18-65.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 65 years.

For the chronic low back pain group:

* Diagnosis of chronic low back pain lasting at least three months.
* A minimum pain intensity of 3/10 on the Numerical Pain Rating Scale (NPRS).

For the healthy group:

* Absence of any chronic or acute pathology.
* No regular medication that could alter autonomic nervous system function.
* No episodes of low back pain in the past six months.

Exclusion Criteria:

* Presence of uncontrolled neurological or cardiac disorders.
* Use of medications that could influence autonomic function or pain perception (e.g., opioids, antidepressants, benzodiazepines, anti-inflammatory drugs, beta-blockers) within two weeks prior to the study.
* Body Mass Index (BMI) equal to or greater than 30 kg/m².
Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria: 1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control. 5. Subject has an identified, reliable caregiver. 6. Subject has a CT or MRI scan within 36 months prior to randomization. 7. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and ECG Exclusion Criteria: 1. Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia. 2. Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. 3. Subject has a history of any significant neurologic disease other than AD. 4. Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. 5. Subject has received any investigation product within 6 weeks prior to study drug administration.
TIRCON International NBIA Registry

TIRCON-reg aims to

* continue the provision of a global registry and natural history study for NBIA disorders
* harmonize and cover existing national and single site registries
* enable participation of countries and single sites that so far have no access to an NBIA registry
* join forces in order to recruit sufficient numbers of patients
* define the natural history of NBIA disorders
* define the most appropriate outcome measures
* inform the design and facilitate the conduction of clinical trials

The TIRCON international patient registry and natural history study for patients with Neurodegeneration Associated with Brain Iron Accumulation (NBIA) was initiated and funded for the first four years by TIRCON (Treat Iron-Related Childhood-Onset Neurodegeneration), an international consortium supported by the European Union between November 1st 2011 and October 31st, 2015. Since then, the registry has been sustained through donations form Patient Organizations and industry.

Harmonization of existing data has been performed by establishing and applying matching and transformation rules. The web-based registry is now fully functional for a critically needed natural history study of all NBIA subtypes. A focus has been set on scores that are most appropriate to reflect stage and progression of disease, e.g. the Barry Albright Dystonia scale, the Patient´s Global Impression of Improvement (PGII), the Unified Parkinson Disease Rating Scale (UPDRS; parts I-III and VI) and quality-of-life scores. The natural history data are collected yearly, or in rapidly progressing cases every six months, if applicable. Patients who present to one of our centers are eligible after informed consent to participate.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed NBIA
* willingness to participate

Exclusion Criteria:

* unwillingness to participate
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.

There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG.

On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights.

On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be ≥ 22 and ≤ 70 years old inclusive, including:

  * 8 subjects under 55 years old.
  * 7 subjects over 55 years old.
* Subjects who are under the care of a sleep clinician for experiencing insomnia symptoms.
* Subjects have wifi connection at their home.
* Subjects have a smartphone where they can install the Alfin App.
* Subjects agree to not having abnormal drugs or alcohol consumption 24 hours before the start of the measurement, and during the 3 days of measurement.
* Able to read, understand and sign an informed consent form.

Exclusion Criteria:

* Under 22 and above 70 years old inclusive.
* BMI ≥ 40.
* Obstructive sleep apnea diagnosis with ongoing CPAP therapy.
* Abnormal drugs or alcohol use during the measurement part of the study.
* Head circumference \< 53 cm or device fitting issues as determined during training.
* Not able to read, understand and sign an informed consent form.
Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia

Evaluate the benefit (rate of adherence to the treatment), based on the LDL-C reduction in the group that will be exposed to the program of reinforcement of orientation aimed to the patients, compared to the control group, both in previous use of rosuvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible for the treatment of dyslipidemia with statins according the current guidelines NCEP ATPIII and IV Brazilian Guidelines of Dyslipidemia and Atherosclerosis Prevention.
* Patients with previous use of rosuvastatin for, at least, 15 days and, for no longer than12 months prior to the inclusion in the study.

Exclusion Criteria:

Pregnancy and childbearing

* History of severe hypersensitivity (including myopathy) to other HMG-CoA reductase inhibitors.
* Subjects with indication of use of cyclosporine and other associations of other lipid lowering drugs.
* Subjects with underlying diseases that may influence lipid levels (i.e. uncontrolled hypothyroidism defined as a Thyroid stimulating hormone (TSH) \> 1.5 times upper level of normality (ULN) at Visit 1, AIDS, transplanted subjects, etc).
* History of drug and alcohol abuse.
* Current active liver disease or hepatic failure or elevations in ALT \>3 times the ULN.
* Elevation of CPK \> 3 times the ULN.
* Elevation in the seric creatinine \> 2,0 mg / dL.
* History of malignancy in the last 5 years, except basal cell or squamous cell carcinoma of the skin (women with a history of Cervical dysplasia must be included, unless they have t3 clear consecutive Papanicolaou (Pap) smears , before the entry in the study).
* Any other known clinical condition that, in the opinion of the investigator, may compromise the subject's safety.
Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria

The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram negative bacterial infection. The hypothesis of study is Polymyxin B would be the new antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes and minimal side effects.

* Investigator is notified by doctors who take care of gram negative infected patients.
* Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment.
* After patient or their relatives are appreciated to join this project, investigator collect data in case record form;electronics form, then implement the drug.
* Duration of treatment is determined by site and severity of infection, approximately 7-14 days.
* Sample size calculation, by prevalence formula, we estimate the mortality rate about 50 %, deviation 10 %,and 2-sided 95% Confidence interval, therefore,97 persons
* We estimate gather data about 100 persons.
* Statistical descriptive analysis for descriptive data.
* During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 year-old
* The infection caused by carbapenem-resistant (CR) Enterobacteriaceae, CR P.aeruginosa or CR A. baumannii which susceptible to colistin
* The duration of treatment approximately between 7-14 days
* Kidney function, according to Kidney Disease Improving Global Outcomes (KDIGO) classification, should less than stage 4 and no replacement therapy in all modality.
* The patients are anticipated to live more than 48 hrs after participation.
* In case of Colistin administration beforehand, it should not exceed 24 hrs.
* All of participants should be willing to join this project.

Exclusion Criteria:

* Pregnancy and lactation
* End stage renal disease who take renal replacement therapy
* Any type of Neuromuscular disease
* Body mass index exceed 30
* Infection that require treatment more than 14 days
Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis

This is a prospective cohort study of persons tested for latent tuberculosis infection at either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to tuberculosis disease. The study will assess the relative performance and cost of three diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This study will also determine the risk and rate of progression to active TB disease, overall and by the results of the three tests.


Eligibility Criteria:
1. Study participants must be at high risk for latent tuberculosis infection or at high risk for progression to tuberculosis disease, including being a:

   • Close contact of a person with pulmonary tuberculosis who is part of a current contact investigation and the index/source case meets the following criteria:
   1. Culture-positive, OR
   2. Culture-negative and smear positive and nucleic acid amplification test-positive.

   Participants may be enrolled before the culture results for the index/source case are available. If the criteria described above are not met once results are available, the participant will be terminated from the study and any collected data will be immediately destroyed.

   A close contact is defined as spending 15 or more hours over a week's period in a shared airspace with a person with active pulmonary tuberculosis while that person was presumed to be infectious.
   * Foreign-born person from a high risk country.
   * Foreign-born person from a medium risk country who moved to the United States within the past 5 years.
   * Person who has spent at least 30 days in total in a high risk country within the last 5 years.
   * Person belonging to a population with a prevalence of latent tuberculosis infection ≥ 25% as demonstrated by local surveys. These populations will vary by site; examples include Mexican immigrants in San Diego, California or homeless drug users in Baltimore, Maryland.
   * HIV-positive person.
2. Study participants (or a parent/guardian, if applicable) must be willing and able to provide informed consent.

4.2 Subject Exclusion Criteria

Subjects meeting any of the exclusion criteria will be excluded from study enrollment.

1. People with known current active tuberculosis.
2. People with a previous anaphylactic reaction to tuberculin.
3. Persons currently being treated for latent tuberculosis infection.
4. Persons anticipating or scheduled to permanently leave the United States (e.g., tourists, visiting scholars, exchange students) in less than 2 years from the time of proposed study enrollment.
5. Foster children.
Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery

According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions.

According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions. Patients with type C lesions can be managed by either stenting or bypass surgery. Despite the fact that aorta-femoral reconstructions long-term results are better than the diffuse aorta-iliac lesions endovascular treatment results, the surgery risk is significantly higher than the endovascular surgery risk regarding criteria of mortality, complications, and return to normal activity.

All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. The figure reaches 100% in the case of local lesions. The technical success of iliac arteries long occlusions recanalization reaches 80-85%. Improvement of endovascular equipment designed for the total occlusions treatment increases technical success of recanalization. The TASC II materials summarize the several large studies results which present the data on the operated segment artery patency at the level of 70-81% within 5-8 years of follow up. A large number of authors note the actuality of aortic-iliac type C and D segment lesions endovascular treatment recommendations revision according to the TASC II.

Eligibility Criteria:
Inclusion Criteria:

* Patients with occlusive lesions of C and D type iliac segment and CFA lesion, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford), age: 47-75 years old.
* Patients who consented to participate in this study.

Exclusion Criteria:

* Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
* Decompensated chronic "pulmonary" heart
* Severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 mL / min);
* Polyvalent drug allergy
* Cancer in the terminal stage with a life expectancy less than 6 months;
* Acute ischemic
* Expressed aortic calcification tolerant to angioplasty
* Patient refusal to participate or continue to participate in the study