cyrilzakka/clinical-trials huggingface dataset:
Footwear Minimalism Study

The following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. All participants will be randomized to receive one of three different shoes: a full minimalist shoe (Vibram 5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes to be investigated are pain, footwear perception, and number of injury events.

The hypothesizes is that participants using the minimalist footwear during their running program will experience a reduction in running related pain. A greater degree of footwear minimalism will result in a greater reduction in pain (compared to the partial minimalist shoe, Nike Free).


Eligibility Criteria:
Inclusion Criteria:

* Minimum of 5 years experience running
* Have been running on a regular basis (minimum once per week) over the past 6 months
* Able to run for 60 minutes continuously
* Can tolerate 20-40km per week in training
* Neutral foot posture according to the Foot Posture Index.

Exclusion Criteria:

* Have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months
* History of surgery to their plantar fascia or Achilles tendon
* Have already been running in a minimalist shoe
* Have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity
* Are currently taking analgesic medication.
Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

The study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University.

The aim of this work is to compare the efficacy of Levetireacetam and Phenytoin in management of pediatric status epilepticus.

Eligibility Criteria:
Inclusion Criteria:

* Children suffering from convulsive generalized tonic clonic status epilepticus at any age.

Exclusion Criteria:

* Non convulsive status epilepticus.
* Children with known contraindication or allergy to levetireacetam or phenytoin.
Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)

This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."

SAD is a condition in which people experience depression as a result of seasonal variations in sunlight. Although light therapy is a common treatment for SAD, a large proportion of people with SAD are resistant to this treatment. CBT is effective for nonseasonal depressive disorders, but its use for SAD has not been thoroughly explored. This study will determine whether CBT, alone and combined with light therapy, is as effective as light therapy alone in reducing SAD symptoms.

Participants in this study will be randomly assigned to light therapy, CBT, a combination of light therapy and CBT, or a control group (no therapy) for 6 weeks. CBT will be conducted twice a week; light therapy will be conducted twice a day. Assessments will be made before, during, and after the study treatment. Depression scales, questionnaires, and behavioral tasks will be used to assess the depressive symptoms of participants. A 6-month and 1-year follow-up visit will also be conducted. During the follow-up visits, participants will be interviewed and will complete a questionnaire and a survey.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of seasonal affective disorder (SAD)
* Willing and able to participate in the study procedures

Exclusion Criteria:

* Major psychological diagnoses other than SAD
* Current psychological or psychiatric treatment
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents

The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  * 6 to 16 years old
  * Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
  * Pharmacological naïve
  * Normal intelligence as assessed by investigator
  * Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

Exclusion Criteria:

* Exclusion criteria

  * History of bipolar disorder, any history of psychosis or autism spectrum disorder
  * History of any seizure disorder
  * Significant prior or current medical conditions
  * History of alcohol or drug abuse within the past 3 months
  * Patients who are taking concurrently any of the excluded medications in the study.
A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis

The purpose of this study is to determine if infliximab (anti-TNF) is effective in the treatment of plaque psoriasis.

This is an experimental medical research study. The purpose of this study is to determine if infliximab is effective in the treatment of plaque psoriasis. A total of about 375 patients primarily in Europe will participate in this study. The time of participation in this study is about 17 months. Infliximab is the active drug in Remicade. Infliximab is currently approved for the treatment of Crohn's disease (an irritable bowel disease), and rheumatoid arthritis. The usefulness and safety of infliximab in those diseases has been proven in previous research studies, which included more than 1300 patients in North America and Europe. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement.

Patients will be assigned to one of two treatment groups (Group 1 and Group 2). Group 1 will receive 5mg/kg infliximab infusions at wks 0, 2, 4, 6, 14, 22, 30, 38 and 46 with placebo infusions at wks 24 and 26. Group 2 will receive placebo infusions at wks 0, 2, 6, 10, 14, 22, with placebo infusions at wks 24, 26, 30, 38 and 46. All study medication is given though an intravenous (into the vein) line.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. There are 2 different treatment groups: Group 1 will receive 5mg/kg infliximab infusions at wks 0, 2, 4, 6, 14, 22, 30, 38 and 46 with placebo infusions at wks 24 and 26. Group 2 will receive placebo infusions at wks 0, 2, 6, 10, 14, 22, with placebo infusions at wks 24, 26, 30, 38 and 46. All study medication is given though an intravenous (into the vein) line.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a diagnosis of plaque-type psoriasis for at least 6 months
* Patients who have plaque-type psoriasis covering at least 10% of the body

Exclusion Criteria:

* Patients must not have nonplaque forms of psoriasis
* Patients must not have current drug-induced psoriasis
* Patients must not be pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment
* Patients must not have had any previous treatment with infliximab or any therapeutic agent targeted at reducing TNF
A Prospective Registry of Patients With Congenital Penile Anomalies

Prospective registry and biobank in pediatric patients with congenital penile anomalies

According to the U.S. Center for Disease Control and Prevention, in the United States, one in 200 babies is born with congenital penile anomalies. In Korea, there is a rapid increase rate among other types of congenital anomalies from 1993 to 2010, from 0.7 to 10,000 to 9.9 per 10,000 cases. It leaves long term sequelae into adulthood even after the corrective operation has been performed. Some of the sequelae that patients experienced were difficulties in micturition, dissatisfaction with the appearance of the penis, and decreased sexual function, as well as psychosexual well-being.

Despite its high prevalence, hypospadias and related penile anomalies have no specific known etiology and mechanisms. However, numerous studies have shown that both gene and environment play a significant role in making etiologies multifactorial. Furthermore, a molecular trial shows that both genetics and environmental factors disrupt the normal development course of the phallus, or penis. Penis formation, growth, or the formation of the male urogenital system, in general, have shown to be androgen dependent. Any defect in the androgen synthesis leading to androgen deficiency or receptors may play a role, specifically, in the development of penile anomalies.

Pediatric patients between the ages of 0 to 18 years, with congenital penile anomalies and scheduled to undergo penoplasty will be enrolled. In this prospective observational study, our aims are to collect dartos fascia, which is a tissue in penile region, and examine histochemistry of the sample.

Eligibility Criteria:
Inclusion Criteria:

* Those with congenital penile anomalies (e.g. hypospadias, chordee, webbed penis) and receiving penoplasty at the institution.
* Those who understand the registry's content and are signed and dated by the patient (or the patient's legal guardian or representative).

Exclusion Criteria:

* Those who are unwilling to participate and do not sign the informed consent.
* Unable to read or understand Korean.
A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber

This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

This trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase III trial. Approximately 202 subjects will be randomised (1:1) to receive treatment with HDM SLIT-tablet or placebo. The trial will be conducted in China, with subjects recruited and treated in China. Two EEC assessments (baseline and end of treatment) will take place at a validated EEC facility in Austria.

The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet (12 SQ-HDM) once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24.

Eligibility Criteria:
Inclusion criteria

* Male or female Chinese subjects aged ≥18 years
* A clinical history of HDM AR/C with or without asthma
* Positive SPT and IgE to Der p or Der f at screening
* A TNSS of at least 6 of 12 within the first 2 hours of the screening EEC session prior to randomisation

Exclusion criteria

* Sensitised and regularly exposed perennial or seasonal allergens
* Asthma requiring treatment with high-dose ICS
* Reduced lung function
* Has a nasal condition that could confound the efficacy or safety assessment
* A relevant history of systemic allergic reaction
Piezosurgery in the Treatment of Class II Furcation Involvement

The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment of class II furcation involvement using biomaterials and new surgical techniques


Eligibility Criteria:
Inclusion Criteria:

* previous subgingival instrumentation with adequate plaque control (FMPS \< 20%) and bleeding on probing (FMBS \< 20%).
* one or more mandibular molar with buccal class-II furcation involvement

Exclusion Criteria:

* diabetes mellitus
* pregnancy and lactation period
* subjects smoking \> 10 cigarettes/day were excluded
* subjects in chronically treatment with calcium antagonist, immunosuppressive drugs and Antiepileptic Drugs
Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model

Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the remaining bone.

Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be selected from the database (50 males and 50 females, between 20 and 60 years old). First, they will be anonymized (except the sex and age/date of birth). Afterwards, they will be segmented using Materialise Mimics software. The segmented mandibles will then be used to create a statistical shape model (SSM) using principal component analysis. This model will afterwards be used to predict the mandibular shapes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy mandibles

Exclusion Criteria:

* Mandibles with major deformities
* Mandibles with obvious problems
* Mandibles that already underwent surgery
Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantation (staged procedures) in patients with multi vessel native coronary artery lesions

Major concerns were addressed to the delayed healing process of drug-eluting stents in off-label indications. To date no studies have detailed the in-vivo completeness of DES coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following paclitaxel-eluting stent implantation, in patients with multivessel disease treated with staged PCI procedures. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time point. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and 9 months elective follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents
2. Native coronary artery disease with \>= 75% diameter stenosis
3. Vessel size in between 2.5 and 3.5 mm.
4. Written informed consent signed

Exclusion Criteria:

1. No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter).
2. significant left main coronary artery disease,
3. lesions in bypass grafts,
4. acute myocardial infarction,
5. poor cardiac function as defined by left ventricular ejection fraction ≤ 30%.
6. allergy to aspirin and or clopidogrel/ticlopidine,
7. Renal failure with creatinine value \> 2.5 mg/dl
Daily Ultrasound-screening for CVC-related Thrombosis

The central venous catheters (CVC) related thrombosis is an issue of importance to ICU clinicians.This study conducts the daily ultrasound-screening for CVC-related thrombosis (DUCT).Its aim is to evaluate the characteristic and regularity of the central venous catheters (CVC) related thrombosis in ICU patients, and optimize the screening program of CVC-related thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients at least 18 years of age, expected to need a central venous catheterization for at least 48h in ICU.

Exclusion Criteria:

* Patients with infection or inflammation or local trauma at the insertion site.
Influence of Reduced Daily Step Count and Anabolic Interventions on Muscle Protein Metabolism in Older Persons

As the loss of muscle mass with aging is associated with a dysregulation of muscle protein synthesis (MPS) that is generally characterized by an 'anabolic resistance' to nutrients, the primary outcome of the trial is to investigate the effect of a mixed macronutrient beverage on post-prandial myofibrillar MPS. However, the 'anabolic resistance' of aging may be predominantly influenced by the contractile activity of skeletal muscle; for example, the investigators have demonstrated that 2 weeks of reduced habitual activity (i.e. daily step count) induces anabolic resistance in otherwise healthy older adults. In contrast, resistance exercise is well-known to enhance muscle mass and can increase the sensitivity of skeletal muscle to dietary amino acids. Therefore, all participants will undergo a 2-week reduced step count intervention combined with a unilateral leg resistance exercise protocol to induce an 'unhealthy' or 'anabolically resistant' leg and a relatively 'healthy' or 'anabolically sensitive' leg, respectively; this within subject model will be utilized to investigate the effect of the mixed macronutrient beverage in both relatively 'healthy' and 'unhealthy' older muscle. The investigators will also measure changes in muscle mass, muscle function, and cardiovascular health of both legs before and after the 2-week intervention to determine the effect of reduced activity and the protective effect of minimal, low-intensity exercise on these outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker

Exclusion Criteria:

* Health problems such as: heart disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put the participant at risk for this study
* Failed clearance for exercise participation by the participants family physician/medical doctor
* Failed an exercise strength test.
* Regular consumption of any analgesic or anti-inflammatory drug(s), prescription or non-prescription, chronically will be excluded.
* Taking any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
* Factors that may exclude a participant from an MRI scan (i.e. various implants, metal in the eyes etc)
* Participants who complete fewer than 5000 steps per day (as assessed by pedometer prior to the study).
Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines

A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)

Exclusion Criteria:

* Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
* History of facial nerve paralysis or ptosis
* Significant facial asymmetry
* Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
* Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
* Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)
Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients

The aim of our study is to investigate the effects of hippotherapy simulator exercises in addition to the conventional rehabilitation program on the balance, postural control, mobility, functional capacity, and independence levels of stroke patients.

Twenty-six 18- 65 years of patients with stroke were included in the study. Patients were divided into two groups as hippotherapy simulator group (HSG) (n = 13) and conventional exercise group (CEG) (n = 13). Patients were evaluated with Berg Balance Scale (BBS) for balance, Postural Assessment Scale for Stroke (PASS) for postural control, Rivermead Mobility Index (RMI), and Time Up- Go Test (TUG) for mobility, 2min. Walking Test (2mWT) for functional capacity and Barthel Index (BI) for the level of independence respectively before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Getting a diagnosis of stroke by a specialist physician,
* Being between the ages of 18-65,
* Having a stroke history of 3- 36 months,
* To be able to sit without support while both soles are in contact with the floor,
* To be able to walk independently with or without using a walking aid,
* To be able to understand and follow audio and visual warnings,
* Scoring 24 points or more from the Mini-Mental State Exam.

Exclusion Criteria:

* Multiple stroke stories,
* Hemorrhagic type stroke history,
* Those with a history of falling in the past 1 year,
* Those with a history of epilepsy,
* Uncontrolled history of Hypertension and Diabetes
Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays

The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.

The design strategy for this study is to validate the detection of COVID-19 antibodies in subjects at HFHS who test positive with RT-PCR for SARS-CoV-2 using fully automated test systems already in the core automated laboratory at HFH. This is a study of the immune response and kidney health of subjects who have recovered from COVID-19 infection.

There are 4 aims:

Aim 1. Assess detection of COVID-19 antibodies in subjects before discharge from HFHS who tested positive with RT-PCR for SARS-CoV-2 using fully automated immunoassays.

Aim 2. Evaluate emergence of immunity over a one-year period in subjects who tested positive with RT-PCR for SARS-CoV-2 using a fully-automated immunoassays.

Aim 3. Monitor renal function and kidney health at 6 and 12- months post diagnosis with COVID-19.

Aim 4. Determine if SAR-COV-2 can be detected in the saliva of patients over a one year period after a positive PCR test.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age
* Positive COVID-19 by RT-PCR SARS-CoV-2 assay
* Patients must have a serum sample stored by pathology or within the TCRC biorepository around the date of their COVID-19 RT-PCR positive test

Exclusion Criteria:

* \< 18 years of age
* negative for RT-PCR
* no serum sample