cyrilzakka/clinical-trials huggingface dataset:
Effect of Nd-YAG Laser on Hypertrophic Scar

A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.

T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures.

Background: A hypertrophic scar is a serious health concern in the industrialized world. Objective: The impact of this study was to investigate the effect of the Nd-YAG laser at 532nm wavelength on hypertrophic scars. Patients and methods: Forty male and female patients with hypertrophic scars, ranging in age from fifteen to forty-five, were recruited from the burn patients' clinic within the Faculty of Physical Therapy, Cairo University, for this study. They were randomized into two equivalent groups. Group A (the control group) consisted of 20 patients who were given standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment. In contrast, Group B (the study group) consisted of 20 patients who were given 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy. Treatment was conducted every 2 weeks for 14 sessions. Outcome measures included Vancouver Scar Scale score and scar volume. The assessment procedures were applied before the initiation of treatment (Pre), after 3 months (Post1) and after 7 months (Post 2) from the beginning of the treatment.

Eligibility Criteria:
IInclusion Criteria:

• Adult patients with hypertrophic scars.

Exclusion Criteria:

* Patients were excluded if they had taken oral retinoids in the last year.
* Patients had any skin defects.
* Patients had any history of photosensitivity.
* Patients experienced active skin diseases in the treatment regions (such as psoriasis, cancer, or autoimmune disease).
Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis

This study investigates the potential of the ultrasound imaging technique to diagnose the severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.

Knee osteoarthritis (OA) is a common degenerative disease of synovial joint becoming more frequent with age. Among techniques have been used to diagnose and classify the severity of knee OA, the imaging techniques, such as ultrasonography (US), provide physical quantitative informations for better understanding and assessing of the pathology of the knee joint.

The present study aim to investigate the diagnostic performance of ultrasonography for femoral condyle cartilage evaluation using MRI and histology analysis as reference tools. To validate this approach, evaluations are conducted to determine, whether the UltraSound Speed Of Sound (US-SOS) propagation is associated with the variation of the arthrosis stage, in order to improve the diagnosis of the surgeon. For this purpose, measurements are conducted using selected human cartilage samples with different stage of OA (early stage and advanced stage).

This research is the first "preclinical" study of a new unlabelled medical device developed by Cartimage Medical SAS. Cartilage is a prospective, monocentric, unrandomized and uncontrolled study. This study doesn't modify the medical care of the patient.

Eligibility Criteria:
Inclusion Criteria:

* patient over 18 year old
* knee osteoarthritis which total knee arthroplasty indication
* who have signed a non-objection form.

Exclusion Criteria:

* person who refuse to sign a non-objection form
* person deprived of liberty by judicial or administrative decision
* person under legal protection or unable to express their consent
* person hospitalized for psychiatric care
Oxygen Nanobubble Drink Impact on Exercise in Pulmonary Fibrosis

Approximately 1 in 5 (or 12.7 million adults) in the UK have longstanding respiratory illnesses, and 6.5 million patients report taking prescription medication to ease the burden. Many patients suffer from lung tissue damage, which impairs adequate blood oxygenation and reduces blood saturations, and causes breathlessness. The current method of treatment is palliative - with the patient breathing supplemental oxygen through an oxygen cylinder and tube. This severely compromises patients' quality of life, as they are tethered to a heavy, unwieldy oxygen cylinder, limiting their ability and willingness to leave home.

Several recent studies in both animals and humans have indicated that orally administered oxygenated nanobubbles is a safe intervention that can improve tissue oxygenation. This randomized, double-blinded, cross-over, placebo-controlled study will evaluate the effect of an oxygen nanobubbles drink on the exercise performance of patients with chronic lung disease, such as pulmonary fibrosis. Patients will conduct the 6 Minute Walk Test (6MWT) twice, once with a placebo drink and once with the oxygen nanobubbles drink, based on a double-blind randomization protocol, and this study will evaluate the distance walked, heart rate, oxygen levels, breathlessness, and time to recovery in both cases. The investigators hypothesize that drinking the oxygen nanobubbles drink will improve the delivery of oxygen to vital organs, improving the distance a patient can cover in the 6 Minute Walk Test by 30m, which is the minimum clinically important difference.


Eligibility Criteria:
Inclusion Criteria:

* Patient is Male or Female, aged 18 years or above
* Participant is willing and able to give informed consent for participation in the study.
* Patients diagnosed with Pulmonary Fibrosis as per ATS/ERS guidelines, and in whom the lung fibrosis is considered the dominant cause of symptoms (i.e. no severe other disease such as COPD or heart failure)
* The patient must be able to walk independently without a walking stick
* The patient can, in the view of their respiratory clinician, adequately participate in a 6MW test

Exclusion Criteria:

* Pregnant or breast feeding
* History of current neurological condition (e.g., epilepsy)
* Patient has consumed liquorice in the last 24 hours.
* Patients with TLCO \<30%
* Patients with known unstable ischaemic heart disease or pulmonary hypertension
* Patients with a history of smoking in the previous 30 days
* Patients that are allergic or intolerant towards: Liquorice, Lecithin derived from soya or sunflower, Citric acid, Glycerol
* Patients with known severe Renal Dysfunction
* Patients with known severe Liver Dysfunction
Acceptability and Tolerance Study of Adult Tube Feed with Food with Food Derived Ingredients.

Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) submission for Ireland for product registration.

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult tube-feed formula with ingredients derived from food for the dietary management of participants who require a tube feed. .

The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service

Executive (HSE) for Ireland. Participants will be provided with one month supply of tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:

* Gastrointestinal tolerance
* Compliance with prescribed feed volumes

Eligibility Criteria:
Inclusion Criteria:

* Require a tube feed (taking \>75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
* Adults and children requiring an adult enteral formula as assessed by the dietitian.
* Patients well-established and stable on a standard formula or currently on Isosource® Junior Mix.
* Willingly given, written, informed consent from patient or consultee. For those who lack capacity to provide formal consent for themselves, this may be provided by a personal or consultee in accordance with the Mental Capacity Act.
* Willingly given, written assent (if appropriate) on behalf of patients under 18.

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator
* Known food allergies to any ingredients (see ingredients list)
* Patients with significant renal or hepatic impairment - Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
* Participation in another interventional study within 2 weeks of this study.
Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-49 years.
2. Healthy as determined by the PI or designate
3. Willing to give informed consent.
4. Willing to attend follow-up appointments and undergo study procedures.
5. US passport holder residing in Bangkok
6. If military, have a letter of approval for participation from the chain of command (Unit Commander).

Exclusion Criteria:

1. History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
2. Severe or life-threatening reaction to any previous vaccine.
3. History of chronic respiratory illness, including asthma and sinusitis.
4. History of heart disease
5. History of kidney disease
6. Metabolic disease such as diabetes
7. Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual.
8. History of Guillain-Barre syndrome.
9. Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records).
10. Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine.
11. Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up.
12. Blood donation within the preceding 3 months, or screening hemoglobin value of \<12.5 g/dl.
13. Receipt of blood products including immunoglobulins within the preceding 3 months.
14. Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs,
15. Receipt of any antiviral agents within 48 hours of vaccine administration.
16. HIV positive on screening blood tests.
17. Any other condition that in the opinion of the study investigator warrants exclusion from the study.
iEAT 2.0 Open Trial

The purpose of this study is to learn more about the eating behaviors of children with chronic food refusal. Specifically, investigator's aim to see how the integrated Eating Aversion Treatment (iEAT) may affect a child's food consumption. The manual is a structured multidisciplinary treatment, including a psychologist and dietitian with consultation from a speech-language pathologist. The treatment is designed to increase the volume of foods a child eats and decrease their reliance on a feeding tube or formula. The manual includes informational handouts, data collection forms, and instructions to guide the increase in feeding demands while reducing reliance on formula to meet a child's nutritional needs.

Children with chronic food refusal will participate in this study at the Marcus Autism Center. All children who enroll will receive the iEAT treatment. This involves 10 bi-weekly sessions that last approximately one hour, over the course of 5 months and a 1 month follow-up visit. Therefore, the study will last a total of 6 months.

This study seeks to further the development of iEAT by including participants that demonstrated improvements in a previously conducted pilot study, and finalize the treatment manual to include the standardized decision rules to increase feeding demands, further integrate the multidisciplinary team (nutrition and speech pathology), and include supplementary sessions to better address individual treatment needs.

Investigators propose to enroll participants with chronic food refusal and formula or feeding tube dependence. Treatment will involve 10 biweekly outpatient appointments and 1 follow-up appointment of about 1 hour in length. Assessment and treatment will involve a multidisciplinary team including behavioral psychology, speech pathology and nutrition. Target behaviors including grams consumed, percent dependence on formula/feeding tube, and the clinical global impression scale, which will be assessed during a meal observation, 3-day food record, and evaluation with the dietitian and independent evaluator. Participants will be assessed pre-treatment, mid-treatment, and post-treatment and complete a one month follow-up to assess long term effects.

Eligibility Criteria:
Inclusion Criteria:

* Present with partial food refusal as evidenced by greater than 75% of caloric needs met by bottle, formula, or tube feedings
* Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which influenced the development of feeding concern
* Safe to consume up to 100% of his/her needs orally
* Parents of subjects must be English literate
* Ability to complete at least 2 structured meals each day

Exclusion Criteria:

* Active medical diagnoses requiring hospitalization or significant oversight from a physician
* Active medical, structural, or functional limitations preventing safe oral intake of pureed foods
Effect of Exenatide on Cortisol Secretion

The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.

Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.

The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.

The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Body weight \>65 kg

Exclusion Criteria:

* Presence of chronic illness
* daily use of any medicines
* pregnancy, lactation
* use of oral contraceptives during previous 2 months
Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities

The purpose of this study is to increase treatment of acute stroke with tissue plasminogen activator (tPA) across the District of Columbia. This study, however, will not evaluate tPA as an intervention.

There are a number of well-known barriers to receiving tissue plasminogen activator (tPA) including transit time to hospital, paramedic and provider training, tPA standing orders, and provider guidelines. Among underserved populations, limited stroke knowledge, socioculturally determined attitudes, and beliefs and myths held by community members may serve as additional barriers that hinder these populations from receiving tPA and acute stroke care. Targeted multilevel interventions designed to overcome specific barriers may significantly increase the number of individuals with stroke who are appropriately treated with intravenous tPA (IV tPA) in underserved communities. Identification of the specific components of healthcare interventions that are the most effective is critical to improve delivery of acute stroke therapy.

The goal of this study is to learn more about public knowledge, attitudes, beliefs and perceptions regarding stroke and stroke treatment in order to identify sociocultural and environmental barriers to receiving tPA and acute stroke care in an underserved community. This study will also determine if implementation of a multilevel intervention program can significantly increase the number of people with ischemic stroke who are appropriately treated with IV tPA in a predominantly underserved community.

In the study, researchers will evaluate the different levels of the intervention to determine which efforts are most effective.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute ischemic stroke
* over the age of 18

Exclusion Criteria:

-
Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit

Pain (nociception), stress and discomfort are difficult to detect in sedated and intubated patients during mechanical ventilation. In order to improve this several nociception level monitors (NOL) were developed that objectively track nociception in sedated or anesthetized patients. Earlier studies showed that for sedated and intubated patients in the operating room, using such monitors is beneficial in reducing stress hormones and post operative pain scores. In this study the investigators aim to observe whether the NOL could be equally beneficial in managing nociception in sedated and intubated ICU patients.

To date it remains challenging to adequately titrate analgesic medication in sedated and anesthetized patients. Recently, nociception monitoring was introduced to guide analgesic treatment in sedated and anesthetized surgical patients. One such monitor is the Nociception Level (NOL; Medasense Biometrics Ltd., Israel). The NOL combines various measurements such as, skin conductance, heart rate, heart rate variability and photoplethysmograph amplitude, and translates these inputs into a single index ranging from 0 (no nociception) to 100 (maximal nociception). Earlier studies have shown that during surgery, the NOL-guided opioid treatment resulted in improved hemodynamics and reduced postoperative pain.

In the COVID-19 pandemic, patients admitted in the Intensive Care Unit (ICU), needed excessive amounts of sedatives, analgesics and muscle relaxants during mechanical ventilation. To determine its value in the ICU, the investigators measured NOL values in COVID and non-COVID ICU patients in an earlier study. The aim of the investigators was to verify the assumption that COVID-19 patients were overdosed on opioids. Since the investigators indeed did observe lower NOL values in COVID-19 patients than in non-COVID patients in an earlier study, the investigators expanded the study to determine whether sedatives were equally overdosed, by also measuring the bispectral index (BIS). With this extra information the investigators also hope to determine whether it is feasible to use the NOL in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* mechanical ventilation for any reason
* deemed suitable by the investigators

Exclusion Criteria:

* aged 17 years or younger
* severe peripheral edema
* veno-arterial (VA) and veno-venous (VV) exctracorporeal membrane oxygenation (ECMO)
* heart rate below 35
* abdominal position
* not deemed suitable by the investigators
Observational Cohort Study of Adult Patients With Congenital Heart Disease

The aim of this retrospective and prospective single-center observational study is to evaluate the correct management of adult patients with congenital heart diseas (ACHD), based on the experience of a reference center such as the Institute of Pediatric Cardiology at Policlinico Sant'Orsola Malpighi. The patients participating in this study will not be subjected to any procedures beyond normal daily clinical practice; likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves naturalistic observation of current clinical practice without the application of any kind of intervention.

To date, there are an estimated 1 million patients, a population that is expected to grow by about 5%.annually. Given the increase in the number of such patients and their complexity, there is an increasing need to train experienced cardiologists and cardiac surgeons.

Our study is part of this panorama with the aim of assessing the correct management, taking into account the important psychological and sociological impact of these diseases, based on the experience of a reference centre such as the Institute of Paediatric Cardiology of the Policlinico Sant'Orsola Malpighi. The primary objective of the study is to identify the clinical and epidemiological characteristics of adult patients with heart disease congenital heart disease (in natural history or previously undergoing corrective or palliative intervention) and to define the need for intervention at a distance, both in terms of interventional and surgical procedures. 1) to describe cardiovascular adverse events and mortality in the target population during follow-up and any non-cardiac comorbidities; 2) to provide data defining the level of utilisation of healthcare resources (diagnostic tests withhigh complexity/cost diagnostic tests, hospital admissions, hospital admissions in high intensity wardscare, percutaneous interventional procedures, surgical procedures); 3) to assess data on quality of life, reproductive health (for the sub-population of female sub-population).

Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital heart disease in natural history or previously undergoing palliative or corrective surgery in the time period after 14/02/2014
* Obtaining informed consent

Exclusion Criteria:

* Age \< 18 years
* Inability to obtain longitudinal data after the first follow-up performed at our Center.
Protocol for a Feasibility Cluster Randomised Controlled Trial of a Home-based Depression Care for Older People Delivered by Lay Providers in Nigeria

The aim of this hybrid (Effectiveness-Implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-Age) in routine home-based care of older Nigerians with depression. The main questions it aims to answer are:

1. Whether the emhGAP-Age demonstrate sufficient signals of effectiveness in the identification and home management of late life depression to permit for further exploration in a fully powered clinical trial?
2. What are the logistical, programmatic, and operational requirements for a home-delivered emhGAP-Age in a sample of older people with depression in Nigeria? Consenting older participants with depression in the intervention arm will receive treatment based on emhGAP-Age which consists of;

   * Adapted electronic generic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-IG)
   * Adapted Problem-Solving Therapy (PST-PC)
   * Support/supervision of providers
   * Links to social support resources. Researchers will compare with treatment based on the basic specification in the generic emhGAP-IG (consisting of basic psychoeducation and stress reduction) for effects on depression remission.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years,
2. PHQ-9 score of ≥11 during routine consultation

Exclusion Criteria:

1. Severe co-morbidity requiring urgent attention.
2. Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) .
3. Active suicidal intention.
4. Evidence of bipolar/psychosis/severe substance use disorders.
5. Planning to move out of the study catchment area within 6 months.
6. Refusing/lacking capacity to consent/accent