cyrilzakka/clinical-trials huggingface dataset:
Walking Gait Biomechanics Following Knee Joint Effusion

The purpose of this study is to determine the sensitivity of a wearable sensor to detect changes in knee joint loading using an experimental knee joint effusion as a model for a common clinical physiological alteration in joint status. The rationale for this project is that it will establish the efficacy of an inexpensive, clinically, and publicly available device that can detect changes in biomechanical loading due to acute physiologic change in joint status. The study will utilize a cross-sectional cohort study design and will seek to enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to the laboratory for three total sessions (Session 1: informed consent and task familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary outcomes of interest include lower extremity thigh and shank acceleration and velocity data (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and lower extremity muscle function (EMG data) during walking gait, as well as functional balance and patient-reported subjective outcomes. Data will be analyzed by calculating change scores from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre- to post-experimental effusion. Correlation statistics will be used to determine if there are association between the motion capture and wearable sensor data. The potential risks associated with an experimental joint effusion will be addressed by maintaining appropriate sterile conditions and having the participant check-in with the PI (licensed healthcare provider) at 48 hours following testing session.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Chronological age 18-35 at the time of study participation
* Physically active (at least 30 minutes of physical activity, 3x/week)
* Tegner Activity Scale score at least 5/10

Exclusion Criteria:

* History of lower extremity or lumbar spine surgery.
* History of lower extremity or lumbar spine injury in the prior 6 months.
* History of major ligamentous damage.
* Current knee pain.
* Known neurological condition, autoimmune condition, cardiovascular disease.
* History of epilepsy, seizures, concussion within the prior 6 months.
* Currently taking pain altering medication.
* Fear of needles
* Unable to read and understand English language
* Pregnancy
Safety and Efficacy of Next Science Gel on Toenail Fungus

This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.

Patients will apply Next Science Wound Gel daily to each study treatment hallux nail for 48 weeks once approved for participation. Analysis will be attained via potassium hydroxide examination (KOH test), nail culture, PCR analysis, and photographic imaging. Subjects may have both hallux nails sampled at screening for culture and KOH testing if both hallux nails appear to meet the criteria for study inclusion. Only subjects with both a positive culture and KOH examination will start study treatment. Subjects may have repeat KOH and culture testing both performed if the first screening test results in at least one of the tests being negative. At investigator's discretion, other affected toenails besides the study target hallux nail may be treated but will not be included for analysis. Patients will come for in-clinic visits at screening, baseline/randomization visit/week 0, week 4, week 8, week 12, week 24, week 36, week 48, and week 52.

If subjects achieve complete cure (as defined by mycological cure and 0% nail involvement) prior to Week 48, patients will be encouraged to continue in the trial with active treatment for the full protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 years old and above
2. Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail
3. Positive culture for dermatophytes and positive potassium hydroxide examination
4. Provide signed and dated informed consent
5. Willing to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

1. Known allergic reaction to the study products
2. Unable to provide signed and dated informed consent form
3. Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study
4. Thickness of mycotic nail is greater than 3mm
5. Less than 2mm of clear nail at the proximal aspect
6. History of rheumatoid arthritis
7. Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis
8. Unwilling or unable to limit use of nail polish for duration of study
9. Known history of PVD, immune system concerns, or ongoing chemotherapy
10. Severe moccasin tinea pedis
11. Prior systemic antifungal drugs 6 months before study start date
12. Prior topical therapy for toenail fungus 2 months before study start date
13. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
Study of Exparel Versus Epidural for Pain Control After Thoracotomy

Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.

In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).

Exclusion Criteria:

* Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;
* Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution);
* Daily opioid therapy;
* Current gabapentin or pregabalin therapy;
* Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement;
* Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals;
* Severe hepatic, renal or cardiovascular disorders.
* Women who are pregnant will not be included in this study.
Morphological and Functional Effects of a Foot Strengthening Protocol

The principal aim of this study is to investigate the effects of a four-week foot strenghtening protocol combining active voluntary exercises and assisted-active voluntary exercises by neuromuscular electrical stimulation on hallux toe flexion strength in comparison to a standard foot strengthening protocol in a healthy adult recreational active population.

The secondary objectives of the study are to investigate the effects of this protocol on lesser toes flexor strength, foot morphology deformation in one, two and three dimensions and kinetic parameters when walking and running.


Eligibility Criteria:
Inclusion Criteria:

- Level of weekly physical activity (recreational activity and regular non-competitive runners : at least 1 running session per week)

Exclusion Criteria:

* History of pain or episodes of foot or ankle sprains during the past 6 months;
* Foot or leg fractures during the past year;
* Severe deformity of the foot or leg;
* Self-declared disability due to neuromuscular impairment of the lower limbs;
* Neurological or vestibular deficit that could hinder balance (diabetes mellitus, radiculopathie lumbosacral, soft tissue disorder such as Marfan or Ehlers-Danlos syndrome) ;
* Any absolute contraindication to neuromuscular electrical stimulation (NMES) (cardiac pacemaker, epileptic disorders, pregnancy defibrillator);
* Participation in an exercise program specifically designed to strengthen the ankle or foot during the last 6 months
Assessment of Pituitary Adenylate Cyclase Activating Polypeptide-Brain Derived Neurotrophic Factor (PACAP-BDNF) Signaling System Involvement in Etiology and Treatment of Major Depression

The neuropeptide Pituitary Adenylate Cyclase Activating Polypeptide (PACAP) and its receptors PAC1 and VPAC2 are widely expressed in the nervous system. The investigators found that PACAP treatment of neuronal cell cultures increases expression of Brain Derived Neurotrophic Factor (BDNF) that plays an important role in the etiology of psychiatric disorders and action of antidepressants. For the first time, the investigators demonstrated that treatment by Paroxetine and Citalopram significantly decreases PAC1 and VPAC2 and upregulates PACAP mRNA expression, whereas Imipramine shows an opposite effect. Moreover, PACAP, PAC1 and VPAC2 expression is highly correlated with BDNF expression. Their in vivo studies show that Imipramine reduces BDNF and increases PAC1 mRNA expression in murine hippocampus, suggesting that antidepressants may affect neuronal plasticity through PACAP-BDNF interactions. Based on their observations in experimental systems, the investigators hypothesize that PACAP signaling system may be involved in the etiology of depression and mechanism of antidepressant action. The investigators will evaluate this hypothesis by examining serum PACAP levels, effect of antidepressants on PACAP levels, and gene polymorphisms of PACAP and its receptors in major depressive disorder patients. This study will enhance the investigators' understanding of PACAP's role in the etiology of depression and antidepressant treatment and will provide a basis to evaluate PACAP pathway as a potential target for diagnostics and novel antidepressants drug discovery.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women 18-65 age old
2. Patients with DSM-IV (or/and ICD-10) diagnosis MDD
3. Volunteers without DSM-IV (or/and ICD-10) diagnosis MDD
4. For patients with DSM-IV (or/and ICD-10) diagnosis MDD minimum 2 weeks free from benzodiazepines, mood stabilizers and neuroleptics.
5. All patients from MDD group treatment only by SSRI antidepressant medications.

Exclusion Criteria:

1. MDD with Co-morbidity
2. Alcohol and drug use less than 1 month before the study
Exercise to Reduce Obesity in Spinal Cord Injury

The purpose of this proposal was to evaluate and compare the health benefits of using upper extremity exercise versus functional electrical stimulation for lower extremity exercise. It was our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES LCE) exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise would increase whole body energy expenditure, thereby increasing muscle mass, insulin sensitivity, glucose effectiveness and improving lipid profiles in adults with paraplegia.

Objective: Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes, coronary artery disease, and upper extremity overuse syndrome as body weight increases. The specific objectives for the current proposal were to compare the impact of FES (functional electrical stimulation) lower extremity exercise versus upper extremity arm crank ergometry on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles, in adults with complete paraplegia. Research Plan: A randomized, baseline-controlled, prospective, 16-week interventional trial was employed to assess the impact of FES LCE versus volitional arm crank ergometry exercise on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles in adults with complete paraplegia. Methods: Twenty-four 18-65 y.o. individuals with motor complete T4-L2 SCI were assigned to either FES lower extremity exercise or upper extremity arm crank ergometry to compare impact on energy expenditure, obesity, and insulin sensitivity. Both groups were provided similar nutritional assessments and intervention. Exercise training consisted of five, 40-minute sessions at 70% maximal heart rate (HRmax) each week for a total of 16 weeks. Resting metabolic rate, exercise energy expenditure, body composition by DXA, insulin sensitivity, glucose effectiveness, lipid profiles, and lower extremity bone mineral density (BMD) were determined before and after 16-week exercise interventions.

Eligibility Criteria:
Inclusion Criteria:

Criteria for participation included men and women within the age range of 18-65 years old with BMI\>25 kg/m2 who have had T4-L2 Motor-Complete (ASIA A\&B) SCI for duration of greater than 12 months to ensure a homogenous sample.

Exclusion Criteria:

* persons who were unresponsive to surface neurostimulation
* had participated in an FES or ACE exercise (\> 60 minutes/week) program within the past 3 months
* and those with known orthopedic limitations
* CAD
* diabetes mellitus (fasting glucose\>126 or HgbA1c\>7.0) or known family history
* hypothyroidism
* and/or renal disease were excluded from the study.
* Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis, or pressure ulcers \> Grade II were excluded.
A Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice

This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians' and patients' treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.


Eligibility Criteria:
Inclusion Criteria:

1. Must have understood and voluntarily signed the Informed Consent Form (ICF).
2. Age ≥ 18 years at the time of signing the ICF.
3. Diagnosed with plaque psoriasis.
4. Initiated treatment with apremilast 6 months (+/- 1 month) previously (patients may or may not have completed 6 months of apremilast treatment)

Exclusion Criteria:

1. Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial.
2. Started apremilast as part of a clinical trial.
Effectiveness Comparison of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts

This is a double-blind randomized controlled clinical trial, that compares the percentage of epithelialization of skin defects using the conventional meshed split thickness skin grafts vs skin micro grafts.

Two techniques will be applied in the same patient. The skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two techniques.

Split thickness skin graft is the standard technique in skin defects reconstruction.

The etiology of this problem is diverse (burns, infections, trauma, cancer) however, many times the availability of donor areas are insufficient and morbidity and complications that may arise make prohibitive the use of this technique in many situations.

Skin micro grafts technique consists in using a very small part of skin (0.8x 0.8 mm) and keratinocyte growth-factor solution that allows a 1:50- 1:100 skin expansion. It has many advantages: it can be performed with local anesthesia and donor area is tiny.

The study consists in using the conventional and the new technique in the same patient. The skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two different techniques. The result variable will be the "percentage of epithelialization" and will be compared in the two halves. This variable will be measured at day 14 using clinical and image software methods. The patient and the investigator that record the outcome variable will be blinded to the type of technique.

The investigators will take skin biopsies of two halves and will perform pathology studies.

Eligibility Criteria:
Inclusion Criteria:

* Non complicated wounds (no infection, no cancer)
* Wound area: 20 x 20 cms or less
* Located in diverse anatomical regions (except axillar, groin, genital, sole, scalp and flexion or extension areas)

Exclusion Criteria:

* High cardiovascular risk
* Patients with indication of a different technique
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).


Eligibility Criteria:
Inclusion Criteria:

* A definite or probable diagnosis of PBC
* Qualifying ALP and/or bilirubin liver biochemistry values
* Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1

Exclusion Criteria:

* History or presence of other concomitant liver diseases
* Presence of clinical complications of PBC
* History or presence of decompensating events
* Current or history of gallbladder disease
* If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
* Treatment with commercially available OCA or participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
* Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

The purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.

Pediatric obsessive-compulsive disorder (OCD) is a common, chronic, and severe psychiatric disorder. Currently, many youth with OCD are treated with medication, such as a serotonin reuptake inhibitor (SRI); however, only a subset of them responds to SRI. Data show that the addition of cognitive-behavioral therapy (CBT) to SRI partial responders is effective although extended SRI use with CBT can attenuate combined treatment outcomes. This placebo-controlled study will enroll pediatric OCD patients to examine if those who benefit from CBT augmentation can discontinue their SRI successfully without relapse over 24-weeks. This study will also bank genomic samples for future analysis when polygenic risk scores for OCD may become available.

This study will be conducted in two phases. In Phase I, all participants will receive a web-based CBT for 12 to 18 weeks. At the end of Phase I, those who achieve wellness indicated by CY-BOCS ≤ 12 and ≥ 50% reduction since baseline for 3 consecutive weeks, will go on to the next phase. In Phase II, participants will be randomized into two groups: 1) Continued SRI and 2) Discontinuation titration to placebo. In this phase, all participants will receive web-based CBT maintenance sessions and attend medication visits for 24 weeks. At 12 months after the end of Phase II, all participants will complete a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* The child is between the ages of 7 to 17 at enrollment with a primary diagnosis of OCD of \> 6 months duration based on the Kiddie Schedule for Affective Disorders and Schizophrenia Lifetime Version for DSM-5 (KSADS-PL) and have a CY-BOCS ≥ 16.
* The child is on stable and maximally tolerated SRI medication (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, citalopram, escitalopram) for ≥12 weeks given that they are persistently and moderately symptomatic. Paroxetine is exclusionary due to safety concerns.
* Both the child and parent participating in the study are English speaking.
* Both the child and their parent participating in the study reside in Texas.

Exclusion Criteria:

* The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
* The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
* The child is receiving concurrent psychotherapy for OCD.
* Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
Epidemiology and Management of Metastatic Breast Cancer

This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.

Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A retrospective cohort study

Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 years and over Diagnosis of breast cancer according to ICD-10 diagnostic criteria with confirmed metastasis
* Confirmed diagnosis between 1st July 2010 - 30th June 2011
* Female patient managed for her disease at the same setting where final diagnosis of MBC was performed

Exclusion Criteria:

* History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer)