cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)

Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)

On a yearly basis, millions develop different skin scarring. These scars are a public reminder of the traumatic incident, past or present disease or a surgery which caused them.

Scarring is a common consequence of wound healing process, and it is one of the most complex biological processes in human. This healing process is affected by numerous factors and thus can be disrupted, leading to pathological scarring.

Pathological scarring is common in people with genetic predisposition, those undergone complex and massive surgeries, burns or those wounded in unsanitary environments. Apart from being aesthetically unpleasant, scars are associated with functional and psychosocial morbidities.

Despite clinical, pathologic and pathogenic differences between keloids and hypertrophic scars, treatments are similar.

Scars have a negative external impact causing social distress and impaired self-image, and as a consequence, low satisfaction rates following surgical and cosmetic procedures.

The first line treatment is monthly intralesional corticosteroid injections with a response rate of 50-100% and recurrence of 50%.

There are a few steroids available and used for abnormal scars treatment, including Celestone chronodose (Betamethasone acetate + Betamethasone sodium phosphate), Dexamethasone sodium phosphate, Methylprednisolone acetate, Methylprednisolone sodium succinate, Methylprednisolone hemisuccinate, Triamcinolone acetonide.

Steroids are different by their hydrophilic properties, potency and half-life, although the half-life of intralesional injections is not known. Inspite of being widely used, there have never been a comparative study of the different steroid treatments.

Eligibility Criteria:
Inclusion Criteria:

* 20 participants with at least 4 keloids
* 20 participants with a hypertrophic scar of at least 11 cm length

Exclusion Criteria:

* current or planned pregnancy
* breastfeeding women
* participants suffering from diabetes mellitus or coagulation disorders
* infection at planned injection sites
* systemic treatment of corticosteroids, 5-fluorouracil
* known allergy to any of the following: Betamethasone acetate + Betamethasone sodium phosphate, Triamcinolone acetonide, Dexamethasone sodium phosphate, Methylprednisolone acetate
Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

The aim of the research study will be assess the effectiveness of a long-term interdisciplinary lifestyle in many aspects including food intake, psychological symptoms, physical activity habits, energy expenditure, body composition and anthropometric measurements in adults obese.

Participants will be recruited after dissemination of the program in the local media and internet.

They will go through a short interview to evaluate inclusion and exclusion criteria. Thus, all obese adults will be submitted to an interdisciplinary lifestyle modification therapy according the inclusion criteria.

The interdisciplinary therapy will consist of nutritional, physical exercise, psychological and physiotherapy support during the course of one year, according the literature the investigators promote a long term therapy to control obesity and metabolic diseases.

The participants will be evaluated at baseline and after the therapy in accordance with Ethical guidelines.

The main purpose of this therapy is to enhance the quality of life of the participants promoting an active lifestyle and quality of life, adherence a healthy nutritional habits and a healthy weight loss.

Our focus will be on teaching strategies to maintain a healthy life style behaviors after therapy, our protocol is in agreement with public health field in this way.

Eligibility Criteria:
Inclusion Criteria:

* Age from 30 to 50 years and body mass index (BMI) between 30 and 39.9 Kg/m2

Exclusion Criteria:

* Musculoskeletal limitations preventing the practice of physical exercise, other metabolic or endocrine diseases, identified genetic diseases, pregnancy, previous drug utilization and excessive chronic alcohol consumption
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction

The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment. The main question it aims to answer is the effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration, exposed or not, through the preservation and neoformation of bone tissue in the tooth extraction socket procedures.

Patients will be submitted to tooth extraction, the surgical procedure of guided bone regeneration using regenerative membranes and synthetic bone graft, and subsequent installation of dental implants. The 05 groups will be compared to observe if the proposed medical devices effectively will maintain the socket's bone volume during the healing phase before the installation of the dental implants (1. socket filled only with clot, 2. socket associated with exposed absorbable membrane, 3. socket associated with covered absorbable membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5. socket filled with synthetic bone graft and exposed absorbable membrane).

Eligibility Criteria:
Inclusion Criteria:

* Possess the four bone walls after the extraction procedure;
* Over 18 years old;
* And who have signed the TCLE.

Exclusion Criteria:

* Uncontrolled systemic impairments;
* Teeth in areas of tumor lesions;
* Acute infectious processes;
* Deciduous dental elements;
* Untreated periodontal problems;
* Smokers;
* Radiated in the head or neck region;
* Allergy to any component used in the research;
* Psychological disorders;
* Pregnant and lactating women.
Assessment of Potential Interactions Between Methamphetamine and Bupropion - 1

The purpose of this study is to assess potential interactions between intravenous (IV) methamphetamine and oral bupropion.

This is a human laboratory clinical pharmacology study to assess potential interactions between IV methamphetamine challenge and treatment with oral sustained-release bupropion.

Eligibility Criteria:
Inclusion Criteria:

Please contact site director for more details.

Exclusion Criteria:

Please contact site director for more details.
Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy

Hip Osteoarthritis (HOA) is the most common joint disorder and a major cause of disability in the adult population. Thus, the early diagnosis, prevention, and treatment of the early stages of the disease and of the pre-arthritic condition, in particular in adolescents and young adults, is crucial to reducing the incidence of end-stage HOA and the need for total hip replacement (THR).

Evidence has mounted for a prominent etiologic role of femoroacetabular impingement (FAI) in the development of early HOA leading to the development of early cartilage and labral damage in the non-dysplastic hip. Therefore, the surgical treatment of FAI with mini-invasive arthroscopy is crucial. To improve the outcome after surgery, cortisone is routinely injected during the procedure for anti-inflammatory purposes.

The aim of the study is to compare the use of cortisone (gold-standard) (C) to a new class III medical device based on hydrolysed Collagen Peptides PEP-52, Peptys (P) and to investigate potential associations among the preoperative symptoms and hip function, the outcomes after arthroscopic surgery and biomarkers in synovial fluids (SFs).

Patients scheduled for hip arthroscopy for treatment of FAI and/or labral pathology will be enrolled. The two treatments, C or P, will be administrated to patients with random sampling. SFs samples, when available, are obtained by aspiration just prior to surgical intervention, collected and stored for biomarkers analysis.

At the baseline, OA severity will be assessed with a radiographic scoring system (Tönnis classification). Physical examination and clinical assessment using the Hip disability \& Osteoarthritis Outcome Score (HOOS) and VAS score for pain will be performed at the time of surgery and at 1-6 months of follow up. At the time of surgery, chondral (Outerbridge score) and labral pathology based on direct arthroscopic visualization will be also evaluated.

The presence of inflammatory molecules at the baseline in the SFs will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* candidates for hip arthroscopy for femoroacetabular impingement (FAI)
* ability to provide informed consent

Exclusion Criteria:

* inability to provide informed consent;
* patients suffering from cancer or with poor general health conditions;
* patients suffering from coagulation diseases;
* positive history of tumor, infection, rheumatic or metabolic disease in the joint undergoing surgery;
* systemic inflammatory rheumatic diseases;
* pregnant or breastfeeding women;
* patients with proven hypersensitivity to collagen of bovine origin or vitamin C.
Mitochondrial Respiratory Function in Mammalian Skeletal Muscle

The purpose of this study is to determine whether skeletal muscle mitochondrial function is altered in patients with head and neck cancer compared to healthy controls.

20 men and women, 30-60 years, equally divided between patients diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC) (n=10) and healthy age matched control subjects (n=10) will be studied.

Muscle biopsies will be collected from cancer patients before and after a 4 week standard of care (SOC) treatment. Muscle biopsies from healthy control subjects will be collected at baseline only.

Lean body mass and fat mass will be determined by a DEXA scan before and after 4 week SOC treatment (cancer patients) to document any change in body composition (cachexia), and at baseline only in the age-matched healthy controls.

Blood will be collected from both cancer patients and healthy subjects to examine hormone levels at the time of biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 30-60 years.
2. Diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC) and being treated at UTMB (n=10).
3. Healthy sex and age matched controls (n=10.)
4. Able to comprehend risks and sign a consent form.
5. Fluent in English

Exclusion Criteria:

1. Significant renal or heart disease or any acute metabolic disease.
2. Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
3. Diabetes mellitus or other untreated endocrine disease.
4. Recent (within 3 months) treatment with anabolic steroids.
5. Ongoing anticoagulant therapy.
6. Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
7. Non-classical adrenal hyperplasia.
8. Cushing's syndrome.
9. Pregnancy.
10. Hyperprolactinoma, hypothyroidism.
11. Granulocyte Count below 1.5x103/µL
12. Platelet Count below 150 x 103/µL
13. White Blood Cell Count below 1.0x103/µL
14. Hemoglobin below 8.0 g/dL
15. Organ transplant, HIV, or other criteria deemed immunosuppressing by the PI or study physician.
16. Any other circumstance deemed exclusionary by the PI or study physician.
Sodium Bicarbonate Supplementation in Combat Sports Athletes

The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and placebo (PLA) supplementation on physical and specific performance capacity, as well as concentrations of the selected biochemical blood markers in trained combat sports athletes, in a randomised, double-blind, placebo-controlled trial.

Sodium bicarbonate (NaHCO3) was proposed as an ergogenic agent, because it improves high-intensity and resistance exercise performance. Until now the major limitation to NaHCO3 supplementation has been the gastrointestinal (GI) side effects. Therefore, this study aims to examine the effect of chronic, progressive-dose NaHCO3 ingestion on physical capacity and specific performance capacity, and concentrations of the selected biochemical blood markers in trained combat sports athletes, in a randomised, double-blind, placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent from all participants before the study (included aslo informed consents to the participation in the study of athletes under the age of 18 obtained from their parents)
* a current medical clearance to practice sports,
* training experience: at least 4 years (of combat sport training),
* minimum of 4 workout sessions (combat sport) a week,

Exclusion Criteria:

* current injury,
* any health-related contraindication,
* declared general feeling of being unwell,
* unwilling to follow the study protocol.
Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

The general aim of this research is to gain insight in the role of SSCT in the etiology and progression of CTS. We hypothesize that (degenerative) damage of the SSCT occurs early on in the pathogenesis of CTS. Fibrotic damage to the SSCT will lead to altered morphology and biomechanical characteristics. This eventually may lead to damage of the median nerve. To examine the SSCT an ultrasound technique described by Van Doesburg et al. 2012 will be used First, the reliability of the US technique to characterize morphology of the SSCT will be investigated. Secondly, cross-sectional data will be collected in healthy subjects and CTS patients to provide descriptive parameters and to describe differences between patients and controls. In the final part a prospective study will be conducted to look at changes of SSCT thickness over time and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* For CTS patients
* Human adults, 18 years and older
* Complaints compatible with CTS (Katz Hand Diagram\[31\] rating of 'classic', 'probable' or 'possible' or typical clinical signs)
* Indication for electrodiagnostic testing
* Informed consent to participate
* For Healthy subjects
* Human adults, 18 years and older
* Negative electrodiagnostic testing and scoring 'unlikely' at Katz Hand diagram
* Informed consent to participate

Exclusion Criteria:

* Pregnancy
* History of renal disease, diabetes, chemotherapy, tumors, other neurological diseases (e.g., polyneuropathy), thyroid disease
* Problems of the upper limb, e.g., degenerative and inflammatory joint disease, gout, tendinopathy at the wrist, acute trauma of the upper limb
Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms

This research aimed to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues.

By combining economical, ergonomic principles and user-friendly features, the proposed device offered individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms. Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed with Calf Strain and Spasm
* Age above 18
* Participants who are volunteer for the study
* Patients who suffer from leg pain or functional disability

Exclusion Criteria:

* Unconscious patients
* Patients with difficulty in seeing and hearing
* Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
* Patient history of severe mobility disorder
* Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)
* Decline to participate in this study
* Active fracture and dislocations
* Arthritic disorders (such as osteoarthritis, Rheumatoid Arthritis, Psoriatic Arthritis, and Fibromyalgia)
Minor Increase Over Minimal Risk Research in NICU

Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with "more than minimal risk" without the prospect of direct benefit. Parents are the surrogate decision makers for infants. When asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. There are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations.

This study involves a questionnaire for both staff (nurses and physicians) and parents. The questionnaire represented 4 different infant scenarios in a random order. Respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.


Eligibility Criteria:
Inclusion Criteria:

* Parents of infants in the NICU
* Parents of infants on well-baby nursery
* NICU Staff (nurses and physicians)

Exclusion Criteria:

* Non-English Speaking
* Less than 18 years old
Minimally Invasive Cardiac Output Monitoring Device

The overall goal of this collaborative study is to advance the novel "pulse contour analysis" to the point at which it can be incorporated into a real-time device. The specific objective is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in units of liters-per-minute. To achieve this objective, the waveforms for analysis and reference pulmonary artery catheter CO measurements will be recorded from critically ill patients and then analyzed off-line at Retia Medical. Successful completion of this study may ultimately help lead to improved outcomes of critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the University of Michigan ICU following cardiac surgery with both a pulmonary and radial artery catheter.

Exclusion Criteria:

* Adult patients with mechanical cardiac support including intra-aortic balloon pumps, LVAD, or ECMO, and persistent ventricular arrhythmias.
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.

GERD is a significant public health problem and when it is severe it may have a considerable impact on patients' QOL. Relatively new treatments such as proton pump inhibitors (PPI) and laparoscopic fundoplication (wrapping or gathering the stomach around the lower end of the esophagus to reduce or prevent reflux) are now available. Patient derived outcomes such as QOL and satisfaction are rarely taken into consideration when evaluating such new treatments. Outcome analysis of the results of medical and surgical treatments using an ongoing database of patients will enhance our ability to treat patients with GERD.

This study's goal is to build a database to collect the outcome information on patients who are having medical or surgical treatment of GERD. In addition we want to measure standard outcomes such as morbidity, mortality, medication use and patient derived outcomes such as general and disease specific QOL, and patient satisfaction with the treatment. We also want to assess if and how long QOL is improved by medical and surgical treatment methods. In addition we want to see if low QOL scores on medical treatment as well as the standard medical criteria can help to identify which patients may benefit from surgical (an operation) rather than the medical treatment. It is hoped that we can also identify which factors might predict or help to determine which patients will have failure of both medical and surgical treatments of GERD. Using this information we want to identify if a psychological profile done before treatment will influence or predict the outcomes of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with reflux symptoms present for at least 6 months, caused by documented reflux. Reflux symptoms include:

  * heartburn
  * acid regurgitation
  * waterbrash
  * non-cardiac chest pain
  * dyspepsia
* Reflux diagnosis either by endoscopy, upper gastrointestinal (GI), or 24 hour pH.
* Patients scheduled for surgical management of GERD and/or hiatal hernia
* Patients currently or commencing treatment with at least proton pump inhibitors or pro-motility agents.

Exclusion Criteria:

* Patients unable to comprehend or complete the QOL instruments.
* Patients less than 18 years of age.
Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle health and function, and cardiovascular fitness.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 25-43
* Weight stable (no more than 5% change in body weight the previous 3 months)
* \>5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors (Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension) and/or LDL-Cholesterol \>120 mg/dl.
* Stable doses of medications for 90 days
* Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Exclusion Criteria:

* Smoking
* Previous use of statins
* Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)
* Diagnosis of chronic diseases including CVD, other metabolic diseases (e.g., thyroid), current diagnosis and active treatment of cancer, HIV, or acquired immunodeficiency syndrome.
* Diagnosis of type 1 or type 2 diabetes at the time of screening (fasting blood glucose \>126mg/dL). If evidence of type 2 diabetes outcome measures is detected during the course of the study (fasting glucose \> 126 mg/dl or HbA1c \> 6.5%) we will notify the participant to contact their physician.
* History of abnormal bleeding problems
* Currently taking (within the last 10 days) anti-platelet medication (Plavix), Warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications.
* \>2 fold upper normal limit (UNL) for alanine aminotransferase (ALT) or creatinine
* Women who are pregnant or breastfeeding
* Individuals with polymorphisms (SLCO1B1 and GATM) known to be associated with susceptibility for statin induced myopathies (tested at screening)
* Currently enrolled in another research study