cyrilzakka/clinical-trials huggingface dataset:
the Effects of a Nursing Trauma Care Bundle

To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries. A longitudinal and two group experimental design will be used. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes.

Background: Over 50% of injuries are accompanied by musculoskeletal injuries that are life-threatening, require amputation or lead to major extremity dysfunctions. Some barriers exist to deliver evidence-based care in the trauma group. Based on recent research findings, this project will be an evidence-based project and evaluation of care bundles combined with e health care to establish and refine evidence-based care guidelines for patients with extremity injuries in Taiwan.

Aims: To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries.

Methods: A longitudinal and two group experimental design will be used. The trauma care bundles combined with internet platform will be implemented over 24-hour admission and ended in 10-14 days after hospital discharge. Participants will be patients with extremity injuries that meet the criteria. The experimental group and the control group will be given the same routine care except for the trauma care bundles. Both groups will be followed up at 3 and 6 months after hospital discharge. Fifty-eight participants for each group will be expected. The generalized estimating equations will be used to analyze the data. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire.

Expected outcomes: This is an innovation project as it combines a comprehensive trauma care bundles with internet platform, and applied in the biggest injury population in Taiwan. It may be the pioneer study to integrate care bundle and e-health care in trauma care. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes. The internet platform established by the research team may be an important template for domestic e-health in hospital-based settings and long-term care facilities.

Eligibility Criteria:
Inclusion Criteria:

* ISS (Injury Severe Score)\>9
* Agree to participate in this examination for 6 months after discharge
* Accidental extremity injuries
* Have a smart phone and access to the Internet

Exclusion Criteria:

* Discharged within 24 hours
* Cognitive dysfunction and unable to provide formal consent
* Severe brain damage
* Burned patient
* Severe psychosis
Improving ADHD Behavioral Care

Though the most effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD) consists of combined medication and behavioral strategies, the vast majority of children with ADHD are treated with medication only. One reason for the low rates of behavioral treatment is that primary care pediatricians, not mental health professionals, are responsible for treating the vast majority of children with ADHD. The investigators have developed, tested, and are beginning to disseminate web-based software (mehealth for ADHD) that has been shown in randomized clinical trials to improve the quality of ADHD medication care delivered by pediatricians. The goal of the proposed study is to develop and test the integration of behavioral tools into the evidence-based myadhdportal.com software in order to improve access to behavioral treatment strategies, and ultimately improve outcomes for children with ADHD. The automated algorithms and decision rules the investigators have developed for creating and monitoring the behavioral tools ensure that behavioral treatments like daily report cards and token economies are delivered in a manner that is consistent with the evidence-base. The investigators are conducting a cluster randomized controlled trial in community pediatric settings to test whether integration of the behavioral tools into the myADHDportal.com software (1) increases rates of behavioral treatment; (2) facilitates better integrity of behavioral interventions when implemented; (3) improves functional impairment in children with ADHD; and (4) generates higher satisfaction with ADHD care. By continuing to expand the functionality of the myADHDportal.com software, the investigators are increasing patients' access to evidence-based care. This is especially critical for rural and underserved communities who have no or limited access to evidence-based mental health services. Moreover, by putting these behavioral tools in the hands of parents, teachers, and pediatricians, the investigators are making it more likely that children will receive a high quality of care that includes both medication management and behavioral strategies, thereby improving the overall treatment outcomes of children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* child in grades K-5
* child has been diagnosed with ADHD by pediatrician or other mental health professional
* child's ADHD care is currently being managed by pediatrician
* if child is being prescribed ADHD medication, is currently on a stable dosage of medication
* child is experiencing impairment at school as evidenced by a rating of 3 or higher on parent- or teacher-ratings of "academic progress" or "problems in classroom" and on the Impairment Rating Scale.

Exclusion Criteria:

* parent does not have access to a computer or smartphone
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects

A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]EDP-305 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (inclusive)
* able to comprehend and willing to sign an Informed Consent Form
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
* Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis

Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The intention of this study is to assess if patients can improve their QOL and hepatic encephalopathy during a physical training program, and to address its safety.

Patients with cirrhosis and portal hypertension experience a marked deterioration in health-related quality of life (QOL), as it has been shown with the use of questionnaires such as Short-Form-36 (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The deterioration in QOL is progressively accentuated as liver failure advances. There is a positive association between the level of physical activity and the sense of QOL, and physical training programs have proved to be useful in improving QOL in cardiovascular and pulmonary diseases, and in conditions affecting cognition. Thereby, it is hypothesized that a physical training program may improve QOL and hepatic encephalopathy in patients with cirrhosis and portal hypertension. Data supporting physical activity as a way to improve hepatic encephalopathy derives from experimental models showing that skeletal muscle is able to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. However, it is uncertain whether such a program is safe, or if it can lead to an increase in portal hypertension and progression of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven or clinically evident cirrhosis
* Able to perform exercise

Exclusion Criteria:

* Overt hepatic encephalopathy grades 3 or 4
* Cardiovascular complications (pulmonary hypertension, heart failure)
* Diabetes mellitus and microangiopathic complications, or under treatment with insulin
* Renal failure
* Portal hypertension with high risk for variceal bleeding
* Hepatocellular carcinoma
Study on Sodium and Caffeine in Children and Adolescents

This study will compare different methods (24 hour urine collection, evening and morning spots, and questionnaires) to measure the consumption of sodium and cafeine in children and adolescents.

Sodium consumption among adults is high in Switzerland, as in most parts of the world. It is expected to be high in children as well, but little is still known. 24 hour urine collection is the golden standard to assess sodium consumption. However, this method is logistically difficult, especially for children. Therefore, alternatives are needed. Urinary spots have been used as a proxy to estimate sodium excretion over 24 hour in adults, but not in children. This study will assess whether urinary spots can be used to estimate sodium consumption in children in comparison to 24 hour urine collections.

Caffeine consumption has risen in children over the past years, mainly before of the increase in consumption of soda drinks. A precise way to measure caffeine consumption is by assessing the concentration of caffeine and its metabolites in 24 hour urine samples. An alternative to 24 hour urine collection is using questionnaires, however this remains difficult due to the multiples food sources of caffeine. This study will compare caffeine consumption estimated by 24 hour urine collection and by a semi-quantitative food frequency questionnaire targeting caffeine containing products.

Eligibility Criteria:
Inclusion Criteria:

* Between 6 and 16 years of age

Exclusion Criteria:

* A sickness that affects the consumption and excretion of sodium and caffeine (for example, diabetes, cardiovascular or gastrointestinal problems, chronic kidney disease, renal insufficiency)
* Taking medication that affects sodium excretion (for example, diuretics)
* A intravenous perfusion during the urine collection
* Insufficient knowledge of French to understand the instructions
A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)

This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

To participate in the study, participants must meet the following requirements:

1. Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2.
2. Must be a non-smoker.
3. Must agree to use an acceptable double-barrier method of birth control.
4. Must provide written informed consent after the study has been fully explained.

Exclusion Criteria:

Participants are not eligible if they meet any of the following:

1. Pregnant or breastfeeding.
2. History of clinically significant diseases, as determined by the investigator.
3. Safety laboratory abnormalities at screening which are clinically significant.
4. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
5. Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

The purpose of the study is to investigate how high the prevalence of diabetes (known and unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40 %.

Another purpose is to investigate whether patients with diabetes have a worse and more painful frozen shoulder than patients without diabetes, and whether the diabetes have an influence on the prognosis.

Patients who are not diagnosed with diabetes would be ask to give a blood sample to investigate if they have an unknown diabetes.

All patients with frozen shoulder will be asked to fill out a questionnaire (Oxford Shoulder Score) to clarify how bad their frozen shoulder is. All patients will receive the questionnaire 6 and 24 month following the date on inclusion.

Eligibility Criteria:
Inclusion Criteria: All newly referred patients who is being diagnosed with frozen shoulder -

Exclusion Criteria: age below 25 or above 75, pt. who don't read or understand danish, not danish citizen, patients with mental illness, pt. with a abuse of alcohol or substances, pregnancy, pt. who within 4 months have been injected with adrenocortical hormone, arthrosis in the glenohumeral joint, avascular necrosis of caput humeri, rotator cuff lesion.

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Glycolic Acid Plus Salicylic Acid in Treatment of Plane Wart

To determine clinical efficacy of glycolic acid 15%plus salicylic acid 2% gel in treatment of Plane wart .

Warts are typically small, rough, hard growths that are similar in color to the rest of the skin. They typically asymptomatic , except when on the bottom of the feet, where they may be painful While they usually occur on the hands and feet, they can also affect other locations One or many warts may appear They are not cancerous .

Warts are caused by infection with human papillomavirus(HPV). Factors that increase the risk include use of public showers, working with meat, eczema and a weak immune system. The virus is believed to enter the body through skin that has been damaged slightly.

Warts are classified to common wart, plane wart, plantar wart, genital wart. Plane warts are circumscribed papules with hyperkeratotic surfaces that can occur singly or in groups. In these types of warts, the human papilloma virus (HPV) has been shown to infect the keratinocyte. Although no viral subtype is absolute, typically the infection is with HPV types 3, 10, 28, and 41 These warts are small in size (1-5mm), flat, or slightly elevated lesions. Plane viral warts typically present as skin-colored or light brownish,papules on the face, beard area, or on the back of the hands, and primarily affect children.

Plane warts can greatly affect a patient's quality of life, and their persistence or recurrence cause frustration.

Their evolution is variable, and although two thirds of cases regress spontaneously in the course of two years due to immunological mechanism

The following therapies have been used in the treatment of Plane wart with varying success: salicylic acid, cryotherapy, retinoic acid, photodynamic therapy (topical 5-aminolevulinic acid photodynamic therapy), pulsed dye laser (PDL), and Candida antigen.

New medication is a combination of glycolic acid 15% plus salicylic acid 2% gel.

Glycolic acid has been used in the treatment of Plane wart . It has been suggested that alpha-hydroxy acids can produce an authentic exfoliation and dehiscence of the coenocytes from recently formed layers of the stratum corneum. Alpha-hydroxy acids also reduce the number of desmosomes and tonofilaments.in this study all patients will be instructed to avoid sun exposure during the treatment and to use broad spectrum sunscreen The treatment was started once daily over the entire face and maintained for two months. A fine layer of face gel was applied on the whole surface where the warts were present, avoiding the eyelids and lips. In children 7 to 10 years of age, face gel was applied by their parents. Clinical controls were performed at Weeks 2, 4, 6, and 8.

Eligibility Criteria:
Inclusion criteria Site: face

Exclusion criteria :

1. Photosensitivity
2. Scaring keloid
3. Herpes simplex
4. Pregnancy \& Lactation
Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study

The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.

One of the biggest challenges in wound care today is the accurate and timely diagnosis of infection in complex wounds. Despite efforts, it still remains difficult to determine whether complex wounds are infected or not. There is no single gold standard for wound infection: clinicians use a multitude of methods in addition to the history and their examination to reach an overall conclusion as to potential wound infection status - each with its own strengths and weaknesses (associated performance characteristics).

To aid accurate and timely detection of wound infection in clinical practice, ConvaTec and partners have developed a new technology intended to detect infection biomarkers. This is based on the combined measurement of the following three biomarkers: wound pH, and activity of human neutrophil elastase (HNE) and myeloperoxidase (MPO) host enzymes.

The overall aim of this proof of concept study is to demonstrate that the three infection biomarkers (HNE/MPO/pH) surpass clinical judgement in detecting infection status using a standard of reference.

The primary objective of the proof of concept study is to demonstrate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.

The secondary objective of the proof of concept study is to explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with an exuding chronic wound, presenting at study sites or associated clinical or home setting
* Aged 18 years and over
* Subjects who are able and willing to provide informed consent.

Exclusion Criteria:

* Subjects with a wound in which it is not possible to take a wound swab:
* Wounds ≤ 2 cm2 in diameter.
* Subjects who are taking or have taken systemic antibiotics in the previous 7 days
* Wounds with scant or no exudate
* Wounds that do not have sufficient exudate to complete swab collection
* Wounds where the wound bed consists predominantly of exposed bone.
* Subjects currently confirmed positive for Methicillin-resistant Staphylococcus aureus (MRSA), extended spectrum beta-lactamase (ESBL) producing bacteria, Human immunodeficiency virus (HIV), hepatitis or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
* Subjects on immunosuppressive or cytotoxic drugs
* Anticoagulated patients who cannot undergo wound biopsy
Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.

Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Hystological diagnosis of breast cancer
* Availability of tumor tissue
* Availability to assess the response to Trastuzumab according to RECIST criteria
* Availability of clinical data

Exclusion Criteria:

* Unavailability of tumor tissue
* Impossibility to assess the response to Trastuzumab according to RECIST criteria
Combined Medication for Improved Analgesia in Superficial Pain

This research study is being done to assess if a combination of medications can enhance the relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The investigators also want to find out if certain genes may be linked to individual differences in experienced efficacy of pain killers. The combination of medications under investigation is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain types of poisoning, heartbeat problems, and other diseases but atropine is not approved to treat pain. However, atropine has been used for many years in different European countries to treat painful conditions such as stomach cramps.This research study will compare diclofenac and atropine to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy volunteers.
* 18-40 years of age.
* Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures.

Exclusion Criteria:

* Chronic pain condition or chronic or current treatment with any pain medication.
* Presence of any illness or medication use that is judged to interfere with the trial. For example: psychiatric disorder, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids.
* Unwillingness to receive brief pain stimulation administered by a heat probe on the hand.
* Allergy or contra-indication to receiving nonsteroidal anti-inflammatory medication and atropine (Treatment with antidepressants, neuroleptics, antihistaminic, levodopa, anti-acids. Pregnancy, breast-feeding, myasthenia gravis, pyloric stenosis, gastro-esophageal reflux, gastric ulcer, constipation, prostatic enlargement, glaucoma, cardio-pulmonary condition -including tachycardia, arrhythmia, arteriosclerosis-, hyperthyroidism, high blood pressure, genetic disease, kidney failure)