cyrilzakka/clinical-trials huggingface dataset:
Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis

People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol.

People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol. Insulin resistance means that the body does not respond well to the insulin in your blood. Therefore, both blood levels of insulin and glucose (sugar) are high.

This causes inflammation (irritation) in the body. Inflammation can cause an unhealthy response in your body and blood vessels, and can lead to blockages in the heart and other vessels.

TNF-alpha is a substance made by fat and inflammatory cells that helps cause inflammatory reactions. TNF-alpha is thought to be important in causing psoriasis. The drug Etanercept blocks TNF-alpha's actions, and has been approved by the Food and Drug Administration (FDA) for the treatment of psoriasis. We think that Etanercept may also reduce the inflammation associated with metabolic syndrome and decrease the risk of heart disease. All subjects in this study will receive etanercept.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. Subject willing and able to give informed consent.
3. Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
4. PASI \> 10 and BSA affected with psoriasis \> 10.
5. Abdominal obesity defined by waist hip ratio \> 0.90 for men and \> 0.85 for women and BMI ³ 30 kg/m2

Exclusion Criteria:

* On insulin or other diabetes (anti-hyperglycemic) medication
* Congestive Heart Failure
* Heart Attack, Stroke or Transient Ischemic Attack in last 3 months
* Unstable angina
* Pulmonary disease requiring oxygen
* SLE, optic neuritis, transverse myelitis, epilepsy
* Positive PPD
* Scheduled for upcoming surgery
* Known immunosuppression (for example, HIV)
* Known autoimmune disease
* Hepatitis B or Hepatitis C
* Pregnant or nursing
* Renal insufficiency (Creatinine \>1.5)
* Latex allergy
* Use of live vaccination in past 90 days
* Organ transplantation
* History of severe infection
* History of malignancy (except cured non-melanoma skin cancer)
Return to Work Interventions for Patients With Low Back Pain

Low back pain has become a major concern to employees and employers because of its negative impact on employee health and productivity.

The objective of this study is to investigate whether a return-to-work intervention conducted during inpatient rehabilitation improves functional limitations that are related with low back pain and interfere with job performance.

In recent years most industrialized nations have been confronted with a dramatic increase in cases dealing with back pain; in Germany, back pain belongs to the major individual and societal health problems with associated costs that have put a strain not only on health care systems. Besides frequent demand for medical services, loss of production (due to temporal sick leave) and disability allowances are important economic factors. In total, the estimated annual costs caused by back pain range between 16 and 22 billion Euros. Population based studies revealed high life-time prevalence with 80% report having ever experienced back pain. The point prevalence lies between 30 and 40%. Approximately one-fourth to one-third of those affected suffer from clinically significant back pain. Epidemiological evidence for the prevalence of back pain, its severity, course and associated risk factors is extensive; however, little systematic knowledge is available about treatment of back pain especially about return-to-work interventions.

This study is designed as a quasi-experimental study to evaluate benefits of return-to-work interventions during medical rehabilitation. Positive effects are expected for low back pain related functional limitations and subsequently job performance. The intervention tested is based on the biomechanical model of chronic pain that assumes a relationship between external strain, body posture, muscle activity, and intravertebral pressure. According to this model, chronic low back pain is partially caused by overexertion and poor postural habits. The intervention aims at lowering the impact of biomechanical stress by training an adequate body posture while performing activities of daily living or job-related activities. Additionally, performing job-related activities target fear-avoidance beliefs especially assumptions about the connection between pain and work activities. The experimental group training good postural habits while performing activities of daily living or job-related activities (additionally to standard rehabilitation activities such as physiotherapy or education and counselling) will be compared with participants receiving a standard rehabilitation only.

Outcome measures are assessed at baseline, post-intervention, and 6 month post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain
* Undergoing inpatient rehabilitation
* Working age

Exclusion Criteria:

* Receiving or applying for retirement pension
* Diagnostic findings that require surgery
Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients

Long term safety follow-up of Cal-1 recipients

Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Previous treatment with the Cal-1 modified hematopoietic cellular products

Exclusion Criteria:

* Inability to understand and provide informed consent
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates

The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.

The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:

1. Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
2. Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
3. Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.

Eligibility Criteria:
* Inclusion Criteria:

  1. Clinically stable
* Exclusion Criteria:

  1. Clinically unstable
* Hypotensive requiring pressors
* Intubated

  2. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.
Prevalence of Pituitary Incidentaloma in Relatives of Patients With Pituitary Adenoma

The purpose of the study is to determine genetic links among blood-relatives and between spouses of patients with pituitary tumors.

The purpose of the family study is to investigate the genetic basis for the development of pituitary tumors by assessing the prevalence of pituitary tumors in relatives of probands with the disease as compared to the prevalence in unrelated spouses sharing a similar environment.

Eligibility Criteria:
Inclusion Criteria:

* patients harboring secretory or non-secretory adenomas and/or siblings and/or spouses

Exclusion Criteria:

* patient without consenting siblings and/or siblings and/or spouses
Withings ECG-Monitor Study

The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

* Male or female who are 22 years of age or older,
* Subject able to read, understand, and provide written informed consent,
* Subject willing and able to participate in the study procedures as described in the consent form,
* Subject able to communicate effectively with and willing to follow instructions from the study staff.

Exclusion Criteria:

* Vulnerable subject with regard to regulations in force

  * Subject who is deprived of liberty by judicial, medical or administrative decision,
  * Underage subject,
  * Legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form.
  * Subject within several of the above categories,
* Subject who refused to participate in the study,
* Subject mentally impaired resulting in limited ability to cooperate
* Subject with electrical stimulation by pacemaker
* Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able to hold still (e.g Parkinson disease)
* Patient unable to stay in an upright position for the duration of study measures
* Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, may increase the risk to the subject or renders data uninterpretable (e.g., recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
* Acute pulmonary embolism or pulmonary infarction, within 90 days of screening
* Stroke or transient ischemic attack within 90 days of screening
* Active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block).
* History of life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block)
* Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis over electrode attachment sites
* Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands
* Weight more than 180 kg
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.

Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.

Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.

The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.

Eligibility Criteria:
Inclusion Criteria:

• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

* Refusal or inability to sign informed consent for the trial
* Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
* BMI ≥ 40 or \< 18
* Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
* Women who are pregnant or lactating
* Diagnosis of IBS-D or IBS-M
* Organic or obstructive disease of the small or large intestine
* Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
* Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
* Unstable medical illness
* Bilirubin \> 3X ULN in the absence of a conjugation defect
* Any laboratory value \> 3X ULN unless discussed and approved by the study Medical Monitor
Atorvastatin in Active Vitiligo

Condition:

Non segmental and active vitiligo of adulthood.

Main objective:

To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB compared to UVB alone in active vitiligo after 6 months of treatment.

Methods:

Prospective interventional bicentric study with evaluation blinded to the treatment received.

Inclusion criteria:

Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the apparition or the modification of vitiligo lesions with the past 3 months and under Wood's lamp examination hypochromic borders and/or spotty depigmentation.

Interventions:

After central randomization

* Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice weekly narrowband UVB treatment for 6 months.
* Arm B: with twice weekly narrowband UVB treatment for 6 months.

Evaluation:

Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease of VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and biological tolerance. Variation of CXCL10 levels in the serum.

Length of the study:

Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and drafting the article: 6 months. Total length: 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Active non-segmental vitiligo defined by

  * Non- segmental vitiligo with new patches or extension of old lesions during the last 3 months AND
  * Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination
* Patient requiring a treatment by UVB
* Signed informed consent document
* Patient registered to the French Social Security

Exclusion Criteria:

* - Segmental or mixed vitiligo
* Pregnant (urinary pregnancy test will be done) or lactating patients
* Allergy to statin medications
* Use of statin or fibrate medications due to cardiac risks
* Use of statin medications in the past 8 weeks
* Use of any medications contraindicated with use of statin medications
* Use of vitiligo treatments (both topicals and phototherapy) in the past 4 weeks
* Treatment with immunomodulating oral medications in the past 4 weeks
* Hepatic disease and/or dysfunction
* Renal dysfunction
* Personal or familial history of myopathy or personal history of rhabdomyolysis or elevated baseline creatinine kinase
* Alcohol or drug abuse
* Untreated hypothyroidism
* Personal history of skin cancer
* Any other clinically significant findings that, in the opinion of the Principal Investigator, might interfere with study evaluations or pose a risk to subject safety during the study.
* Patients assessed to be uncooperative
* Participants in other clinical studies
Functional Manifestations of Pressure Changes in the Middle Ear System

This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and when the brain responds to pressure stimulations of the eardrum. The study requires 2 visits, 1 for screening to determine eligibility and 1 for the fMRI. This study will help to understand how the middle ear system is controlled, which may have an impact on how people with middle ear disease are treated.

Otitis media is a ubiquitous disease in young children which can persist through adolescence, and arise or recur in adults. A consequence of an infection and/or Eustachian tube dysfunction, it manifests as an effusion that disrupts the normal impedance matching function of tympanic membrane-ossicular chain system. Eustachian tube dysfunction prevents the equilibration of middle ear pressures and drainage of the accumulated effusion. It is thought that middle ear status modulates the function of the Eustachian tube via afferent signals processed centrally resulting in changes in its tonus or muscular function. This pilot study of right-handed 21-35 year olds of either sex will validate a published fMRI method for visualizing cortical brain activation in response to external ear canal pressure changes (N=5). The outcome measure is intensity changes of the cortex associated with applied stimuli.

Eligibility Criteria:
Inclusion Criteria:

* 21-35 years of age
* right-handed

Exclusion Criteria:

* left-handedness or ambidexterity
* fMRI safety reasons (ferromagnetic material in their bodies, epilepsy, claustrophobia
* history of middle ear/tympanic membrane surgery (tympanostomy tubes)
* abnormal otoscopic findings and/or tympanometry on physical exam
* pregnancy
Gut Microbiota and Immune Recovery

To explore whether gut microbiota would impact CD4 T cells recovery in HIV-infected patients on antiretroviral therapy (ART). We prospectively enroll patients initiate ART and collect their fecal at followup for one year.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV infection
* Antiretroviral therapy naive
* CD4 T cell counts\<350cells/mm3
* Agree to participate

Exclusion Criteria:

* Don't want to start antiretroviral therapy
* Cocurrent cancer or opportunistic infection
* Liver diseases
* received antibiotics within four weeks of enrollment
Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

To test the usability and effectiveness of a robotic device, called the Robotic Gait Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2) patients with stroke with gait abnormalities secondary to impaired knee function.

The device is designed to train stroke patients to correct abnormal gait patterns associated with exaggerated and uncoordinated movements of the pelvis by applying force fields to correct the movement of the pelvis. The focus will be on correcting hip hiking (i.e. exaggerated unilateral upward movements of one side of the pelvis) in post-stroke patients. The human-robot interface will be based on impedance control techniques so that the force-field actuators generate smooth virtual spring/damper restitution forces at the patient's pelvic area.

As part of the study we will determine whether the force fields applied by the actuated components of the device can effect an acute change in gait biomechanics, primarily pelvis motion during stance and swing phases, in healthy subjects and patients with stroke during ambulation. The investigators will also evaluate the usability of the orthosis in terms of donning \& doffing, user confidence, and comfort.

Eligibility Criteria:
HEALTHY

Inclusion Criteria:

* Can walk comfortably on a treadmill

Exclusion Criteria:

* any known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern
* Females in the second or third trimester of pregnancy

STROKE

Inclusion Criteria:

* single non-traumatic ischemic or hemorrhagic stroke at least 6 months prior to enrollment
* persistent hemiparesis, mild spasticity, and residual mild-to-moderate weakness of the lower extremity
* residual deficits of gait
* be able to ambulate without the use of assistive devices or assistance of a person
* able to walk at a comfortable walking speed of \~0.6 m/s
* able to walk safely on a treadmill
* medically stable
* No other neurological problems, or any known cardiovascular or musculoskeletal disorders that effects their gait or excludes them from exercise

Exclusion Criteria:

* unable to attend and follow instructions
* require physical assistance for ambulation
* other known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern
* severe joint contractures of the hemi-paretic knee
* females in the second or third trimester of pregnancy
Comparing Active and Passive Ankle-foot Prostheses

The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.

Eligibility Criteria:
Inclusion Criteria:

* weigh more than 200 lbs
* are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
* have the ability to follow multi-step commands.

Exclusion Criteria:

* score level D on the SIGAM mobility grade
* have experienced 1 or more falls in the last month before the study
* have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
* the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
* the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
* Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation