cyrilzakka/clinical-trials huggingface dataset:
A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability of CMX157 and the amount of CMX157 that reaches the blood stream, the manner in which the body processes CMX157 and the time that it takes to eliminate CMX157 following one oral dose when given to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females of non-childbearing potential, 18 to 55 years of age. Males must be able and willing to use adequate contraceptive methods throughout the study.

Exclusion Criteria:

1. Currently nursing females, pregnant females, or females of child-bearing potential.
2. Hypersensitivity to tenofovir.
3. Use of any antiviral, corticosteroid, immunosuppressive, or anticoagulant prescription drug within 4 weeks prior to enrollment. Use of any other prescription drug within 14 days prior to enrollment.
4. Use of any over-the-counter medication, herbal/nutraceutical preparation, within 7 days prior to enrollment.
5. Administration of any potentially nephrotoxic drug within 14 days prior to enrollment.
6. Use of an investigational drug and/or treatment within 30 days prior to enrollment.
7. Use of illicit drugs within 6 months prior to screening and enrollment, based on history and a urine drug screen.
8. Infection with HIV, HBV or HCV.
9. History of abuse of alcohol or other substance (s) within 6 months prior to enrollment.
10. History or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease, cardiomyopathy, and cardiac conduction disorders.
11. History of clinically significant hypotension (including orthostatic), fainting, or lightheadedness.
12. History of gastrointestinal disease or impairment.
13. History of renal impairment or disorder.
14. History of liver disease or impairment.
15. History of cancer, except basal cell carcinoma.
16. History of pathologic bone fractures; history or risk of osteopenia
17. History of diabetes, metabolic disease, or autoimmune disease; history of immunodeficiency in healthy volunteers.
18. Acute illness or fever 38 C within 1 week prior to enrollment.
19. Supine blood pressure - systolic outside the range of 90-140 mmHg, or diastolic outside the range of 50-90 mmHg.
20. Resting heart rate \> 100 or \< 45 beats per minute.
21. Body Mass Index (BMI) \>31 or \<18, or body weight \<50 kg for men and \< 45 kg for women.
22. Whole blood donation within 56 days or plasma donation within 30 days prior to enrollment.
Intervention Effects of Intensity and Delivery Style for Toddlers With Autism

A multi-site randomized study of intensive treatment for toddlers with autism involving a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the progress of very young children with ASD ages 12-30 months old and their families, and the effect of children's developmental rates and autism severity on their response to intervention.

High quality, intensive early intervention is a powerful treatment for ASD, improving IQ and language markedly in randomized controlled clinical trials (RCTs), though little long term follow-up data exists. Few core characteristics that affect child change have been tested. Two potential core characteristics that invoke considerable debate among parents, professionals, and administrators are the delivery style of intervention: play-based versus discrete trial teaching, and the intensity (dosage) of intervention. This ACE treatment network conducted an RCTs to answer the following question: what are the effects of intensity and delivery style on developmental progress of toddlers with ASD?

87 young children with ASD, mean age 23.4 months who live within a specified radius near the university at each site were enrolled in one of three national sites and randomized into one of four cells varying on two dimensions: dosage - 15 or 25 hours per week of 1:1 treatment; and discrete trial teaching or naturalistic developmental-behavioral intervention. Other aspects of intervention held constant were: use of the principles of applied behavior analysis, 1:1 adult:child ratios, parent coaching in the assigned treatment, and treatment location. Developmental progress was measured frequently allowing for growth curve analysis to examine fine-grained differences in groups as well as interactions among major child and family initial variables and these two experimental variables.

Eligibility Criteria:
Inclusion criteria:

* 12-30 months of age at time of assessment;
* ambulatory and without impairments affecting hand use;
* meets criteria for Autistic Spectrum Disorder on the APA Diagnostic and Statistical Manual, 5th revision criteria and on the Autism Diagnostic Observation Schedule for Toddlers:
* clinical consensus of ASD diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review;
* developmental quotient of \>35 on Mullen Scales of Early Learning;
* normal hearing and vision screen;
* caregiver agreement to comply with all project requirements, including regular videotaping at home with provided equipment.

Exclusion criteria:

* English not a primary language spoken at home;
* absence at 2 or more appointments without prior notice during the intake assessment;
* more than 10 hours per week of 1:1 ABA based treatment;
* other health or genetic conditions (i.e. fragile X syndrome, seizures, prematurity).
The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions

The study evaluates if the relationship between total serum cholesterol is dependent on the total serum homocysteine. Fasting blood samples will taken from participants and two batteries of cognitive scales will be used to asses any cognitive decline.

The relationship between total serum cholesterol (TC) levels and cognition remains wily.

Some studies suggested that high TC level in old peoples is associated with a decreased risk of dementia.

Other studies have indicated that hypercholesterolemia may be a risk factor for cognitive decline and Alzheimer's disease (AD).

But a recent study published in 2014 by Cheng and colleagues, showed that, an inverse U-shaped relationship between total cholesterol level and cognitive score was found only in participants with normal homocysteine levels. Indicating that both low and high total serum cholesterol were associated with lower cognitive scores, ended to the relationship between cholesterol levels and cognitive function depends upon homocysteine levels, suggesting an interactive role between cholesterol and homocysteine on cognitive function in the elderly peoples.

The effect of high serum homocysteine (HHcy) levels on cognition was overwhelming regardless of the serum cholesterol levels but in peoples with normal homocysteine levels, both low and high cholesterol levels may be detrimental to cognitive health.

Eligibility Criteria:
Inclusion Criteria:

* Fifty hundred participants
* Participants are of both genders
* Aged 55 years old and over.

Exclusion Criteria:

* Patient with dementia.
* Renal and hepatic impairment.
* Parkinson's disease.
* Cerebrovascular stroke.
* Patient with chronic medical problems.
* Patients on statins.
Seated - Standing Passage of the Hemiplegic

This is a study for a new mechanical transport device adapted to the hemiplegic patients.

Healthy volunteers :

After explaining the protocol and presenting the movement laboratory, the subjects are equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are installed on a seat positioned in front of 2 force platforms installed on the ground. The seat is equipped with a force platform.

Phase 1 :

After being seated, the subject realizes :

* 3 seat to stand and stand to seat without assistance
* 3 seat to stand and stand to seat using a handle located in front of it (handle equipped with a 6-axis force sensor)
* 3 seat to stand and stand to seat using the experimental device This phase will last 45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing)

Phase 2:

After being seated, the subject performs a course comprising:

* A standing pass from sitting on a chair
* A straight line movement
* A succession of left and right turns
* An upward and downward travel of less than 1%.
* Standard doorway
* Standing on the toilet
* A sitting pass from the toilet
* One way to a bed
* A sitting pass on the bed
* A passenger seat sitting upright from the bed
* A return to the starting point
* A sitting pass on the starting chair Each stage is timed. A subjective analysis of each step is done by a lickert scale on the perceived comfort and safety.

This phase 2 will last 30mn (15mn of course and 15mn of questions).

Hemiplegic subjects :

At each session, the subject is examined by a physician who evaluates the motor control (Fugl Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale).

Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which are impossible.

Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each subject in therapeutic apartment in simulated living conditions. The validation in living lab is carried out by an ergonomist and by a questionnaire on the comfort and safety of the various steps identified by the ergonomist.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers :

* aged 18-75 years
* Subject having given his consent
* Free from any neurological or cardiorespiratory locomotor pathology that may interfere with standing seated passages.

Hemiplegic patients :

* Left hemiplegia in one of the following groups :
* Walking with difficulty or not walking and able to stand with a stick or an armrest
* Walking difficult or not walking and unable to stand with a cane or an armrest.
* aged 18-90 years
* Subject having given his consent
* Subjects with a trunk balance to sit without support

Exclusion Criteria:

* aged less than 18 or more than 75 (healthy volunteers) or more than 90 (hemiplegic subjects)
* Pain during seated-standing passages
* Unstable medical condition
* Unable to consent
* Subject under legal protection
* Left-hemineglect making standing or seated (wheelchair) displacements impossible autonomously (for hemiplegic patients)
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.

Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women age 18 years and older attending delivery room.
2. Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
3. Able and willing to read and sign an informed consent document.

Exclusion Criteria:

Subjects will be excluded from the study if any of the following will be present:

1. Prior use of any amniotic fluid detection test.
2. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
3. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
4. Sexual intercourse within the past 24 hours.
5. Confirmed diagnosis of any vaginal infection within the past 7 days.
6. Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..
7. Patients unable or unwilling to participate.
8. Patients in active labor (or with regular contractions).
Pelvic Floor Muscle Training and Kaatsu Training for Women With Stress Urinary Incontinence

This study examines the effect of adding so called Kaatsu training to pelvic floor muscle training. Half the participants will perform Kaatsu training on their thigh muscles followed by pelvic floor muscle training. The other half will receive pelvic floor muscle training alone.

Stress urinary incontinence (SU) is a common problem among adult women . Pelvic floor muscle training (PFMT) is recommended as first line treatment but PFMT is not always efficient and some women cannot comply with the intensive PFMT needed to obtain effect because of weakened or damaged muscles caused by vaginal delivery and age related changes.

Hypothetically alternative methods could be used to enhance the effect of a strength-training program. A low intensity training program with a simultaneous partial occlusion of the blood supply for the training muscle, so called "Kaatsu" training has been found to increase muscle strength faster than ordinary strength training but with much less effort. It seems difficult to make occlusion of the pelvic floor muscles during PFMT but a study found that low intensity training of the quadriceps femoris with partial occlusion of the blood supply did not only increase muscle strength of the quadriceps femoris muscle but also of the biceps humeri muscle if that muscle was trained with low-load training and no occlusion in the same training session. The specific reason for this this "cross-transfer effect" could not be fully explained but it was believed to be caused by a systemic effect caused by growth hormones. The aim of this study is therefore to examine if Kaatsu training offered in relation to a low-load PFMT program can increase the effect of PFMT in women with SUI

Eligibility Criteria:
Inclusion Criteria:

* ICIQ-SF ≥ 12
* Urinary stress incontinence
* Ability to contract pelvic floor muscles
* Normal bladder capacity and normal flow during micturition with at least one micturition of \> 350 ml

Exclusion Criteria:

* Urgency urinary incontinence
* Cognitive problems
* Physical inability to perform Kaatsu program
* Inability to understand and read Danish
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

This study will enroll adults with type 2 diabetes mellitus and elevated LDL-C or non-high-density lipoprotein cholesterol (non-HDL-C) levels on a stable, maximally tolerated statin dose of at least moderate-intensity at signing of the informed consent; statin therapy must remain unchanged during screening and the remainder of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years
* Type 2 Diabetes Mellitus
* Hemoglobin A1c \< 10%
* Stable diabetes therapy
* Must be on maximally tolerated dose of statin of at least moderate Intensity
* Fasting triglycerides ≤ 600 mg/dL
* Not at LDL-C or Non-HDL-C goal.

Exclusion Criteria:

* Moderate to severe renal dysfunction
* Uncontrolled hypertension
* Persistent active liver disease or hepatic dysfunction
* Has taken a cholesterylester transfer protein inhibitor in the last 12 months,
* Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.

Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older
* Able to undergo the informed consent process
* Stable spinal cord injury
* International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
* No ventilator dependency within the last year
* American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
* Medically stable in the judgment of the Principal investigator
* Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
* Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
* Spinal imaging of the stimulator system

Exclusion Criteria:

* Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
* Use of botulinum toxin (Botox) injections in the previous six months
* Clinically significant mental illness in the judgment of the principal investigator
* Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
* Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
* Current Pregnancy
* Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.
Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers

The investigators propose to test the feasibility of iSHIFTup (Internet Skin Health Intervention For Targeted Ulcer Prevention) for adults with spinal cord injury (SCI) to prevent serious pressure ulcers (PrUs) and promote protective health behaviors. This protocol is Phase 2 of a three phase project. In Phase 1, the investigators developed iSHIFTup. In Phase 2, the investigators will test the intervention by partnering with Woodrow Wilson Rehabilitation Center (WWRC) to conduct a randomized controlled trial (RCT) of 18 participants. In Phase 3, the investigators will focus on optimizing the intervention based on our outcome findings and feedback, sustaining the program at WWRC, and seeking future funding for a larger RCT.

The investigators will conduct an RCT of up to 18 participants (9 participants in treatment as usual (TAU) group, 9 participants in TAU + iSHIFTup intervention group) (18 participants are needed to obtain statistically significant results).

The investigators will meet with potential participants in-person to complete the informed consent process and confirm eligibility. Participants in the TAU+iSHIFTup group will use the program during the study period. Participants randomized to TAU will have usual treatment during the study period and an opportunity to use the program following trial participation. The investigators will collect information from participants at two times during the study, at enrollment and post-intervention at 6-weeks (42 days). The investigators will also collect qualitative information from participants in the TAU+iSHIFTup group, during an optional focus-group setting, to learn users' experiences with the program. The investigators expect participants in the TAU+iSHIFTup group as compared to the TAU group, to display greater awareness of personal risk for pressure ulcers; increased preventive behaviors; and increased skin care self-efficacy and knowledge.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* history of Traumatic Spinal Cord Injury resulting in paraplegia or tetraplegia.
* regular Internet access
* physical ability to use computer
* able to understand, read and speak English
* have identified healthcare provider

Exclusion Criteria:

* SCI of non-traumatic etiology such as:

  * tumor,
  * ischemia,
  * developmental disorders,
  * neurodegenerative diseases,
  * demyelinative diseases,
  * transverse myelitis,
  * vascular malformations.
* Severe pressure ulcer (stage 3 or stage 4).
* Currently pregnant or plan to become pregnant during the study period.
Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)

The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ADHD of at least moderate intensity
* Able to give consent
* Able to swallow capsules

Exclusion Criteria:

* Allergic or do not tolerate duloxetine
* Under psychotherapy for ADHD
* Taking a medication that interacts with duloxetine, including all psychotropic medication
* Treated with medication for ADHD
* Unstable medical condition
* Severe renal insufficiency
* Liver insufficiency
* Substance/alcool abuse or dependency in the last 6 months
* Pregnancy, nursing or inadequate contraceptive methods
* Suicide or homicide risk
* Organic brain syndrome
* Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder
Therapeutic Strategies in Sexual Function

Objectives: To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions.

Methods: This is a descriptive observational study involving 24 men with a mean age of 32.62 (CI 28.65 to 36.60), with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). The subjects underwent neurological evaluation in accordance with the guidelines of the International Standards for Neurological Examination and Functional classification of Spinal Cord Injury (ISNCSCI), the American Spinal Injury Association (ASIA), assessment of sexual function through the Erectile Function of International Index (IIEF) and answered a semi-structured form to identify therapeutic strategies used in sexual function. To collect information about medicinal plants, a search was made in the surroundings of public markets located in the Metropolitan Region of Recife (PE).

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of traumatic spinal cord injury
* injury time less than six months
* heterosexual
* sexually active

Exclusion Criteria:

* patients who had erectile dysfunction attributed to endocrine or metabolic disease order
* those who underwent surgery in the genital area, such as radical prostatectomy or penile implant
* cognitive impairment