cyrilzakka/clinical-trials huggingface dataset:
PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds

Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds

The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding infected chronic and acute wounds consisting of Pressure ulcers, Leg ulcers, Diabetic ulcers, Post-operative surgical wounds, Graft and donor sites, Cavity wounds, Trauma wounds (dermal lesions, trauma injuries or incisions) and Superficial and partial thickness burns. The performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
* Patients who are able to understand and give informed consent to take part in the study.
* Have one or more of the following: Pressure ulcer, Leg ulcer, Diabetic ulcers, Post-operative surgical wounds, Graft and donor sites, Cavity wounds, Trauma wounds (dermal lesions, trauma injuries or incisions) and superficial and partial thickness burn wounds that are infected, or are at high risk of infection , that are moderate to heavy levels of exudate.
* For Partial Thickness Second Degree Burns that require grafting - only those grafts with single thickness mesh grafts that have X % epithelialization will be enrolled \[Note: % epithelization to be added once sites/countries are chosen as this is specific to the territory where the Silver II Non Woven Dressing study is likely to be performed\].

Exclusion Criteria:

* Patients who are known to be non-compliant with medical treatment,
* Patients who are known to be sensitive to any of the device components
* Subject is pregnant or actively breastfeeding;
* Subject has a known sensitivity to Silver;
* Life expectancy of \<6 months;
* Maximum burn area of \> 20% total body area. Using the rule of nines assessment tool. \[Note: criteria to be confirmed once sites/countries are chosen\]
* Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study;
Clinician Managed Interpersonal Psychotherapy

This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.

CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.

Eligibility Criteria:
Inclusion criteria:

* Women between 8 and 24 weeks postpartum
* Meet DSM-IV criteria for Major Depression
* Hamilton Rating Scale for Depression score of 12 or more

Exclusion criteria:

* Active substance abuse
* Psychotic disorders
Genzyme Osteopenia/Osteoporosis Study

Gaucher disease is a most common genetic metabolic disease characterized by low platelet number, liver and spleen enlargement and various forms of bone diseases including low bone mineral density leading to brittle bones. Various treatment options are now available for this disease.

The purpose of this research study is to determine the prevalence of Gaucher disease in patients with low bone mineral density as observed by DEXA scan, which is a form of X-Ray of the bone.

Gaucher disease is a potential secondary cause of low bone mineral density and it is prevalent among patients with low BMD. This cross sectional design study will measure point prevalence of Gaucher disease in patients with low bone mineral density (BMD).

Eligibility Criteria:
Inclusion Criteria:

* Patients \> or equal to18 years and able to provide written consent.
* Patients who have had a bone density test demonstrating T-score \<-1.0 on a DEXA scan within the past year or those who are prospectively referred for DEXA scan and who are later identified by their physician to have a DEXA T-score \< -1.0.

Exclusion Criteria:

* Subject unable to read and sign consent form.
* Terminally ill subjects or subjects with serious co-morbidities (malignancy), which would limit the ability of the patient to participate in the study.
* Subjects with the following disorders or exposures
* Underlying skeletal dysplasia
* An endocrinologic/metabolic disease known to cause bone demineralization: including parathyroid dysfunction, hyperthyroidism, Cushing syndrome, hypogonadism, panhypopituitarism
* Cystic Fibrosis
* Exposure to medications that are known to cause low BMD including chemotherapy within past 2 years, chronic corticosteroid or phenytoin use within past 2 years
* Radiation exposure within the past 5 years
* Vitamin D deficiency is not an exclusion criteria as this is highly prevalent in the adult population under investigation as well as in patients with Gaucher disease. (9, 10)
* Subjects previously diagnosed with Gaucher Disease
The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.

The advantages of laser acupuncture are a non-invasive, painless, low risk of infection and high safety. Laser acupuncture as a treatment tool has the following advantages1.Painless, 2. Non-invasive treatment, the subject is highly accepted, the risk of infection and needle stick is low, 3. Very few side effects such as fainting, bleeding, 4. The therapeutic dose is easy to operate, and the instrument output frequency, power and time can be controlled. Through the clinical physiological function test plus the verification and analysis of the quantitative test values, it will be more able to define the new role of laser acupuncture treatment in patients with heart failure from the perspective of Chinese medicine.

From the perspective of ancient books, the discussion of heart failure in the etiology and pathogenesis of traditional Chinese medicine was first seen in the "Shu Wen". It is clearly pointed out that "heart qi" is the basic pathogenesis of heart failure. The "qi" and "blood" of Chinese medicine are closely related. The blood line is driven by the gas, the blood is bloody, and the qi deficiency is unable to push the blood to blood. If the qi deficiency, it would lead to blood stasis; There were studies have indicated that traditional acupuncture treatment can increase exercise tolerance and adjust autonomic nerve activity in patients with chronic heart failure, and can reduce their readmission rate and mortality rate in patients with acute heart failure. Studies using laser acupuncture to treat patients with heart failure have also found that they can increase the subject's six-minute walking distance.

Eligibility Criteria:
Inclusion Criteria:

* Age over 20 years of age, with written informed consent.
* NYHA:stage II-III.
* All patients had LVEF \<40% caused by dilated or ischemic cardiomyopathy.
* Acute HF patient presenting with dyspnea related to cardiogenic pulmonary edema.
* All patients had sinus rhythm, were stable and compensated with individually optimized standard heart failure medication as well as oral anticoagulants for at least 3 months before (including prophylactic defibrillator placement).
* Systolic blood pressure \> 95 mmHg at admission.
* B-type natriuretic peptide (BNP) \> 150 pg/mL or NT-pro BNP \> 600 pg/mL.

Exclusion Criteria:

* Age under 20.
* Major cardiovascular events and treatments occurred four weeks before hospitalization.
* Major cardiovascular surgery or treatment will be performed in the next 6 months.
* Pregnant or expected to pregnancy within a year.
* Require a heart transplant in 6 months.
* Uncontrolled atrial or ventricular dysrhythmias.
* Uncompensated congestive heart failure.
* Heart failure due to congenital heart disease or obstructive myocardial disease
Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem

The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions.

The results collected will be used to clinically confirm the performance and safety of the LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF. Furthermore the results can be used for future regulatory processes if needed.

Post Market Clinical Follow-ups (PMCF) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine conditions \[2,3\]. Against this background a prospective multi-center outcome study of the LINK® SP-CL® is planned.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Subject agrees to comply with the required postoperative management and follow-up evaluations
* Undergone at least six (6) month of unsuccessful, conservative, non-surgical treatment
* Patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and the prescribed postoperative management.
* Patient signed Informed Consent.

Exclusion Criteria:

* Body Mass Index (BMI) \> 40 kg/m2
* Poor general state of health
* Acute and chronic infections, local and systemic
* Pharmaceutical or other drug abuse, alcoholism
* Allergies to implant materials
* Distinctive muscular, nerve, vascular or other diseases which put the affected limb at risk
* Insufficient / inadequate bone mass- or quality which prevents a stable anchorage of the prosthesis
* Severe osteoporosis
* Foreseeable overload/ overstressing of the joint prosthesis
* Acetabular defects
* Female patient who is pregnant or plans to became pregnant during the course of the study
* Prisoner
* Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule
* Patient who has not signed the Informed Consent
Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill ACR criteria of knee osteoarthritis
* Fulfill ACR criteria of fibromyalgia

Exclusion Criteria:

* Athletes
* Drugs stable for at least three months before entering the study
* No limitations to resistance training
Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment. Probiotics may have beneficial effects on symptoms as supported by one small open-label study (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of probiotics. This study aims to determine (i) whether 60 days of Vivomixx probiotics result in greater GI symptom improvement than placebo in SSc outpatients, assessed using an interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60 days versus 120 days of probiotics result in greater GI symptom improvement in SSc outpatients, assessed using the GIT questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* SSc that fulfills the American College of Rheumatology (ACR, 1990) classification criteria or the proposed European League Against Rheumatism (EULAR) criteria for very early diagnosis of systemic sclerosis.
* SSc overlap syndromes (ie SSc occurring in overlap with other connective tissue diseases)
* SSc-associated GI symptoms (heartburn, dysphagia, vomiting, bloating/distension, faecal soilage, diarrhoea, constipation) not due to other causes as determined by clinical evaluation, with a total GIT score of at least 0.10
* Stable doses of immunosuppressive treatment, corticosteroids, and GI medications for 30 days.

Exclusion Criteria:

* On anti-biotics or probiotics within the last 30 days
* Current serious infections requiring hospitalization
* Long-term indwelling catheter, including patients on total parenteral nutrition
* Females who are lactating or pregnant
Effect of Vitamin D Supplementation on Inflammatory Markers

Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.

Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects deficient in vitamin D
* Subjects having type 2 diabetes
* Non-obese subjects

Exclusion Criteria:

* Subjects having hyperparathyroidism
* Subjects suffering from hepatic disease / kidney disease
Online Learning of Veterinary Anatomy During COVID-19 Pandemic

This study aims to analyze the online learning of veterinary anatomy during COVID-19 pandemic lockdown.

Analysis of the online learning of veterinary anatomy during COVID-19 pandemic lockdown.

Eligibility Criteria:
Inclusion Criteria:

* Veterinary Medical students who are studying anatomy online during the pandemic lockdown

Exclusion Criteria:

-
Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders

This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.

Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are common childhood behavior disorders. Children with ADHD experience hyperactivity, distractibility, poor concentration, and impulsivity. If left untreated, ADHD can continue into adulthood, and can cause problems in family, social, and work environments. Children with ODD exhibit an ongoing pattern of uncooperative, defiant, and hostile behavior toward authority figures. Symptoms of ODD, including frequent temper tantrums, anger, resentment, and vindictiveness, may interfere with a child's everyday functioning. The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their child's behavior. This study will evaluate the effectiveness of the Incredible Years training program within a pediatric office setting at improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.

Participants in this open-label study will be randomly assigned to the Incredible Years training program or a waitlist condition, in which they will begin the program after a 1-year waiting period. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. Self-report assessments and phone interviews will be used to assess outcomes. Additionally, follow-up visits will occur immediately post-intervention and 6 and 12 months post-intervention. Children will attend one visit before the program begins, as well as the follow-ups held immediately post-intervention and 12 months post-intervention. These visits will include videotaped observations of children and their primary caregivers.

Eligibility Criteria:
Inclusion Criteria:

Parent or primary caregiver of a child who fits the following criteria:

* Receives a positive result on behavioral screening

Exclusion Criteria:

Parent or primary caregiver of a child who fits the following criteria:

* Diagnosis of pervasive developmental disorder or global developmental delay
Association Between Different Blood Groups and Sepsis in Preterm Infants

To investigate whether there is a relationship between sepsis and blood groups in preterm infants.This retrospective cohort study included preterm neonates born at \<32 weeks of gestation with a birth weight \<1500 g. Neonates were grouped by blood type (O, A, B, AB) and sepsis were compared among these groups.

This retrospective study was conducted on data collected between 1 January 2011 and 31 August 2018 in the neonatal intensive care unit (NICU) of the Health Sciences University Zekai Tahir Burak Women's Health Education and Research Hospital.

Neonates born at GA \<32 weeks with birth weight (BW) \<1500 g were included in the study.

Data pertaining to the neonates were recorded from medical records for each patient, and their ABO blood type was recorded.

The neonates were grouped by blood type (O, A, B, AB) and also separated into non-O (A, B, AB) and O groups and non-A (O, B, AB) and A groups for comparison of early and late onset sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates born at \<32 weeks of gestation with a birth weight \<1500 g.

Exclusion Criteria:

* Neonates born with severe congenital defects, birth weight ≥1500 g and gestational age ≥32 weeks were excluded.
Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction

The purpose of this study is to Predicting female pelvic tilt and lumbar angle using machine learning in case of urinary incontinence and sexual dysfunction

92 patients were distributed randomly into two groups. The first group will be measured pelvic tilt, lumbar angle by spinal mouse and force of contraction of pelvic floor muscles by ultrasound imaging, UDI-6 and FSFI questionnaires for urinary incontinence female The second group will be measured pelvic tilt, lumbar angle by spinal mouse device and force of contraction of pelvic floor muscles by ultrasound imaging, UDI-6 and FSFI questionnaires for normal females.

Patients will be examined by radiologist with medical ultrasound imaging and by me with spinal mouse device.

Eligibility Criteria:
Inclusion Criteria:

* - Their ages varied from 30to 40years, their body mass index (BMI) was 25-30 kg/m2 and a number of parities ≤ three normal vaginal deliveries, at least two years and Subjects hadn't received drugs, patients with mild and moderate urinary incontinence with sexual dysfunction

Exclusion Criteria:

- 1. History of spinal surgery or spinal fracture. 2. Volunteers with a history of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection, diabetes, intrauterine device, chest and/or cardiac disease and using any drugs for urinary incontinence 3. Serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer.

4. A history of bronchial asthma or any chest disease. 5. Uncontrolled diabetes or hypertension. 6. Patients with peacemaker or any metal implant on the treated area. 7. Cancer or patient with past history of tumor excision.
Thromboelastography-Guided Fluid Management in Spinal Surgery

The Researchers are trying to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.

Multi-level instrumented spinal fusions represent an important treatment modality for degenerative scoliosis and sagittal malalignment. These surgeries remain a significant physiologic burden with high blood loss and long operative times. Thromboelastography provides a quantitative measure for blood product transfusion surrounding procedures. We aim to utilize thromboelastography to guide transfusions for multi-level spinal instrumentation. This two-arm, randomized, non-blinded prospective analysis will clarify reduced transfusion requirements for TEG-arm compared to non-TEG arm. We will also evaluate postoperative outcomes at the 1 year time-point.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing elective multi-level spinal fusion for sagittal malalignment, multi-level spondylolisthesis, multi-level lumbar spinal stenosis, and adult degenerative scoliosis with ages between 18-89

Exclusion Criteria:

* patients with tumors, infection, or trauma
The Effects of Bobath Method and Task-Oriented Approach in Stroke Patients

Trunk impairment and asymmetry that occur after stroke negatively affect many functional activities in the daily lives of patients. There are different neurophysiological approaches such as Bobath method and task-oriented approach used in post-stroke rehabilitation programs in the literature. However, there are not many studies that comprehensively evaluate and compare the effects of these neurophysiological approaches on trunk muscles, balance and gait in stroke patients. The aim of this study is to examine and compare the effects of Bobath method and task-oriented approach on architectural features and activation of trunk muscles and functional performance in stroke patients. In addition, this study will demonstrate with muscle thickness and activation the asymmetry that may occur between the hemiparetic and non-paretic trunk muscles of stroke patients, and will allow examining the effects of these features on functional performance. This study was planned to include two treatment groups. The Bobath group will receive Bobath based trunk, balance and walking exercises, while the task-oriented group will receive exercises for oriented task. Trunk impairment, motor functions, thickness and activation of trunk muscles, spatio-temporal parameters of gait, balance and goal attainment will be assessed before and after 8 weeks treatment program. As a result; effectiveness of Bobath method and task-oriented approach will be compared and relationship between muscle thickness, activation and functional performance will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke for more than 3 months
* Being over the age of 18
* Having trunk impairment (not having full points in the Trunk Impairment Scale)
* Being able to walk without support or with walking aid.

Exclusion Criteria:

* Having recurrent stroke
* Having an orthopedic or neurological disorders other than stroke that may affect motor performance
* Having a cognitive problem (Not having Mini Mental State Examination score ≥ 24)
Using Beta Blockers to Treat Mitral Regurgitation

The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.

The purpose of this study tests 1) whether Toprol xl, a beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation; 2) investigate the effects of chronic mitral regurgitation on left ventricular remodeling, left ventricular function,exercise capacity and clinical symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sever primary mitral regurgitation
* Normal subjects

Exclusion Criteria:

* Left ventricle ejection fraction of \<55% pre and post operation
* Pregnancy or Lactation
* Secondary mitral regurgitation due to coronary artery disease, cardiomyopathy, uncontrolled hypertension, or severe aortic stenosis.