cyrilzakka/clinical-trials huggingface dataset:
Indigenously Developed Ultrasound Phantom Model

Point of care ultrasound (POCUS) is used ever more increasingly across the emergency medicine departments in India.

Guided procedures like nerve blocks, vascular access, abscess drainage and foreign body exploration are done more conveniently and efficiently utilising visualisation under ultra sonography.

Several training models are available commercially that aids in training the novice and expert in the field alike. The commercially available models are expensive and inaccessible for most, while the utility of POCUS in Emergency Department (ED) is on the rise. This has lead people to experiment with various models for training which ranges from basic gelatin moulds to ballistic gel. There are only a few studies that compare these with the commercially available products for educational purposes.

The home made models are cheaper and more easily procurable for training making it a relatively favourable choice in financially constrained situations. The investigators have been using a gelatine based training model to train their emergency medicine residents for many years. In this study they intend to assess whether their indigenously developed ultrasound phantom model is comparable to commercially available models for vascular access training.They also sought to assess the better preliminary teaching model for ultrasound guided vascular access: in-plane or out-of-plane approach?


Eligibility Criteria:
Inclusion Criteria:

- All the participants of the ultrasound training module who underwent the vascular access course were considered eligible to participate if they consented for the study

Exclusion Criteria:

- Participants of the ultrasound training module who underwent the vascular access course not giving consent to participate or

Participant ultrasound training module who underwent the vascular access course withdrawing consent for using the data
Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma

This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.

This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ORIF under GA for Maxillofacial fractures
* Patients between with ages of 16-65
* No cardiac comorbidities (hypertension, congenital heart malformation)
* No known coagulopathy
* No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
* ASA I and II patients

Exclusion Criteria:

* Patients younger than 16 and older than 65
* Patients with known coagulopathy
* Patients with cardiac comorbidities
* Patients with a family history of bleeding disorders
* ASA III or higher
Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer

The purpose of this study is to determine whether platinum-based chemotherapy (either cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective in improving response to treatment in triple negative breast cancer patients. This treatment is being studied in this type of breast cancer because it does not respond well to commonly used treatments such as tamoxifen or herceptin.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be \> or = 18 years of age
* Patient must be female
* Patient must have primary invasive ductal breast adenocarcinoma that either:

  1. is newly diagnosed, without previous systemic treatment OR
  2. has failed to respond to \< or = 4 cycles of neoadjuvant anthracycline based therapy as assessed by clinical exam or imaging studies (mammogram, ultrasound or breast MRI).
* Patient's tumor must be classified as clinically stage T2, T3, or T4 with any N (NX, N0, N1, N2, or N3) prior to any neoadjuvant treatment.
* Patient must have an ECOG Performance Status of \< or = 1.
* Patient must have adequate organ function defined as:

  1. Renal Function:

     1. CrCl ≥ 60 ml/min for patients receiving cisplatin
     2. CrCl ≥ 30 ml/min for patients receiving carboplatin.
  2. Liver Function:

     1. ALT, AST, ALK Phos \< or = 1.5 x upper limit of institutional normal.
     2. Bilirubin \< or = 1.5 x upper limit of institutional normal.
  3. Normal left ventricular function (LVEF \> 50%) by MUGA or ECHO.
  4. Hematologic:

     1. Absolute Neutrophil Count \> or = 1500/mcl
     2. Platelets \> or = 100,000/mcl
     3. Hemoglobin \> or = 8.0 g/dl
* Patient must be able and willing to sign informed consent document.

Exclusion Criteria:

* Patient must not have evidence of distant metastasis present by CT, bone scan, or PET-CT. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI at the discretion of the treating physician.
* Patients having received neoadjuvant anthracycline based therapy must undergo restaging to exclude distant metastases prior to enrollment.
* Patient must not have had any prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
* Patient's tumor must not express the following biomarkers or must have Allred score \< 4 for: estrogen receptor, progesterone receptor, and is not Her2/neu amplified.
* Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
* Patient must have \> or = grade 2 peripheral neuropathy.
* Patient must have a known hearing impairment (hearing loss or severe tinnitus). Hearing test will be performed at the discretion of the treating physician.
* Patient must not have been previously treated with cisplatin or carboplatin for any condition.
Dermogenesis With Mesenchymal Stem Cells

Dermogenesis With Mesenchymal Stem Cells in treating Post Acne Depressed Spots

management at two different stages of the course of the disease. First one at the stage of active disease which needs cleansers, antibiotics, retinoids, anti inflammatory agents and hormonal manipulation. Once active disease is over, patients report to clinician with depressed spots which are caused by localized dermal disruption and fat atrophy post inflammation or spontaneous epithelial rupture or scratching by the patient. These acne spots are hard to treat due to many reasons. Firstly, excision is difficult as size of most of them is small and they are in a large in number. Secondly, filling with and without subcision is not adequately addressing the deformity. Currently, a combination of filling with synthetic filler or fat and resurfacing by peeling, LASER or dermabrasion is in practice. In-spite of all, a treatment is still required to address post acne spots (Ice Spec Spots) adequately.

Eligibility Criteria:
Inclusion Criteria:

* Acne spots

Exclusion Criteria:

* Active acne
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with plaque psoriasis by a dermatologist
* Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast)
* Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes

Exclusion Criteria:

* Participation (current or planned) in an interventional clinical trial (does not include observational registry or study)
* Restart of treatments with the study eligible therapies previously received at any time during the participants' treatment history
The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV

Quality of life of people living with HIV is strongly affected by the presence of one or more symptoms, such as sleep problems, fatigue, muscle pain, anxiety and depressive symptoms. Autogenic training has shown positive effects on these symptoms in different populations, but there is very little evidence on the effects of this relaxation technique in people living with HIV.

The aim of this project is to evaluate the effectiveness of a relaxation technique, autogenic training, on the quality of life and the physical and psychological symptoms in people living with HIV.

Eligibility Criteria:
Inclusion Criteria:

* Being older than 18 ;
* have a diagnosis of HIV;
* present at least one of the following symptoms during the preceding two weeks: sleep problems, fatigue, pain, anxiety or symptoms of depression;
* understand and speak French and;
* be able to follow the instructions to learn the relaxation technique.

Exclusion Criteria:

-
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer: Continued Avastin Plus Chemotherapy After First Progression in Clinical Practice

This local, non-interventional, cohort study of patients with metastatic colorectal cancer (mCRC) will prospectively collect data from standard clinical practice of second-line treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional diagnostic or therapeutic procedures required by this study, apart from those performed in everyday clinical practice for second-line treatment of mCRC in Croatia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \>/=18 years
* Metastatic colorectal cancer (mCRC) previously treated with systemic treatment for advanced disease containing Avastin and chemotherapy; first-line Avastin received according to the Summary of Product Characteristics (SmPC)
* First line progression-free survival (PFS) \>6 months
* Eligible for second-line chemotherapy regimen
* Period between first progression and start of second line treatment with Avastin and chemotherapy \</=6 weeks

Exclusion Criteria:

* Contraindications, warnings and precautions for use specified in the Avastin SmPC
Postoperative Gastroesophageal Reflux Symptoms After Laparoscopic Sleeve Gastrectomy Based on the Presence of Preoperative Symptoms

This study aims to investigate the patterns of reflux symptoms after laparoscopic sleeve gastrectomy based on the presence or absence of preoperative gastroesophageal reflux symptoms.

Obesity is a well-known risk factor for gastroesophageal reflux disease (GERD), and laparoscopic sleeve gastrectomy (LSG) is the most commonly performed bariatric/metabolic surgery. However, patients often experience reflux symptoms after LSG, and those with severe reflux symptoms or severe erosive esophagitis have been excluded from candidates for LSG. This study aims to analyze the patterns of postoperative reflux symptoms based on the presence of preoperative reflux symptoms.

Prospectively established databases of patients assessed for reflux symptoms at a single institution will be retrospectively reviewed. A total of 64 patients who underwent LSG between April 2020 and March 2023 will be included in this study. The modified GERD-HRQL (GERD- health-related quality of life) questionnaire was used to evaluate gastroesophageal reflux symptoms before LSG and at 1, 3, 6, 9, and 12 months after surgery. Reflux symptoms will be categorized into heartburn and regurgitation, and the patterns of heartburn and regurgitation scores included in the modified GERD-HRQL questionnaire will be analyzed. The patients will be classified based on the presence or absence of preoperative reflux symptoms, and the patterns of symptom scores within each group will be analyzed. We will also measure the correlation between whether hiatal hernia repair was performed with laparoscopic sleeve gastrectomy and adiposity-related parameters, including preoperative and postoperative body mass index (BMI), preoperative and postoperative waist circumference (WC), the percentage of total weight loss (%TWL), and the percentage of WC reduction, and changes in postoperative symptom scores.

Eligibility Criteria:
Inclusion Criteria:

1. patients with age greater than 19 years
2. patients who underwent laparoscopic sleeve gastrectomy from March 2019 to March 2023
3. patients with postoperative follow-up longer than one month after LSG
4. patients who answered preoperative and postoperative GERD questionnaire (Korean translated version of modified GERD-HRQL)

Exclusion Criteria:

1) patients with missing or incomplete postoperative GERD questionnaires
Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial

We want to investigate if early follicular phase downregulation and androgen priming, by use of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs of improvement compared to standard short antagonist protocol


Eligibility Criteria:
Inclusion Criteria:

* Indication and wish for IVF/ICSI treatment
* Womens age 20-39 years (both inclusive)
* Regular menstrual cycle within normal range
* Body Mass Index: 18-30 kg/m2 (both inclusive)
* Negative pregnancy test before treatment
* A maximum of 3 earlier IVF/ICSI treatments that did not result in pregnancy

Exclusion Criteria:

* serious systemic disease
* Presence of polycystic ovarian syndrome (PCOS)
* Earlier poor response with less than 4 mature follicles
* Earlier participation in the investigation
Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

Chronic fatigue syndrome (CFS) is a debilitating condition of unknown etiology. Recent studies have shown that CFS is associated with impaired cellular energetics and low levels of phosphocreatine. Since guanidinoacetic acid (GAA) acts as a highly bioavailable precursor of creatine it may provide an ideal dietary supplement to facilitate treatment and perhaps prevention of CFS. The overall hypothesis to be evaluated is that medium-term supplementation with GAA will improve clinical outcomes in well-defined adult CFS patients via augmented provision of creatine. Specific aims: (1) To determine the effects of GAA on CFS symptomatology using a fatigue severity inventory, soreness of locomotive apparatus scales, and a health-related quality of life survey; (2) To determine the effect of GAA on creatine metabolism using laboratory studies and magnetic resonance spectroscopy; (3) To characterize the physiological effects of GAA on work capacity via actigraphy and exercise performance tests; and (4); To determine the prevalence of subjectively reported side-effects and biochemical adverse events associated with GAA intervention.

A variety of dietary interventions have been used in the management of CFS, yet no therapeutic modality demonstrated overall positive results in terms of effectiveness (Whiting et al. 2001). Previous studies have evaluated the effects of essential fatty acids, vitamins, minerals and/or enzymes, with findings do not support the use of a broad-spectrum nutritional supplement in treating CFS-related symptoms (Brouwers et al. 2002). Considering the fact that patients with CFS have lower levels of high-energy compounds (e.g. phosphocreatine, adenosine triphosphate) (Block et al. 1998), effective dietary treatment of CFS should be focused on providing compounds that facilitates cellular bioenergetics. Besides other candidate agents, guanidinoacetic acid (GAA) could be of particular interest since it occurs naturally in the human body and acts as an immediate precursor of creatine (Wyss and Kaddurah-Daouk, 2000). Due to its low cost and high bioavailability (Baker 2009), if proven effective dietary GAA may be suitable for use in broad CFS population.

Eligibility Criteria:
Inclusion Criteria:

* Adults who fulfilled the 1994 CDC criteria for CFS
* Older than 18 years of age will be candidates for inclusion in the study.

Exclusion Criteria:

* Psychiatric comorbidity
* Use of any dietary supplement within 4-weeks prior to the study commencing
* Pregnant
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place

Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail

The purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):

(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives

This study is to make an inventory of the knowledge of patients with AMD about their disease and risk factors using a questionnaire (Appendix 1) and to identify their needs, the impact of the disease on their daily lives during individual interviews by raising the recurrent data and confronting them during the focus group. The information gathered will enable the construction of a therapeutic education program for better patient care and to strengthen the patient's capacities so that he becomes an actor in his change throughout his care project.

This a 3 steps study:

1. 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
2. Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
3. Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Patient with AMD (neovascular and atrophic) whatever the stage of the disease
* Patient over 50
* Patient affiliated to a social security scheme
* Written informed consent of the patient

Exclusion Criteria:

* Patient unable to understand the information, fill out the questionnaires
* Patient with diabetic retinopathy
(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF

The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.


Eligibility Criteria:
Inclusion Criteria:

* Male or females from 40 to 80 years of age
* Diagnosis of IPF
* Honeycombing (fibrosis in the lung) on high-resolution computerised tomography (HRCT) scan of less than or equal to 5%
* Willing and able to have 2 right heart catheterizations performed
* Willing to have monthly lab tests to monitor liver function
* Able to perform the 6 minute walk test (indicated adequate physical function)
* Must have meet lung function requirements
* Normal liver function tests
* Negative serum pregnancy test
* Willing to use at least 2 reliable methods of contraception
* Able to understand and willing to sign informed consent form

Exclusion Criteria:

* No restrictive lung disease (other than usual interstitial pneumonia or IPF)
* No obstructive lung disease
* No recent or active respiratory exacerbations
* No recent hospitalization for an IPF exacerbation
* No recent history of alcohol abuse
* Chronic sildenafil (or same drug class) use for pulmonary hypertension
* Chronic treatment with certain medications for IPF within 30 days of randomization
* No other serious medical conditions
Spanish Version of the KBILD Questionnaire

The purpose of the present study is to advance in the knowledge of quality of life in patients with ILD by translating a ILD quality of life questionnaire.

There are no specific tools validated in Spanish to evaluate the quality of life in patients with ILD, although these measures are useful for an comprensive evaluation of these patients.

Patients with ILD have a significant impact on their health. If we improve our Knowledge of the different domains affected by the disease, and not only in the pathophysiological ones, we will be able to develop tools to improve their management.


Eligibility Criteria:
Inclusion criteria

1. Subjects older than 18 years.
2. Diagnosis of ILD, established according to the consensus documents of the ATS and ERS \[1,2\].
3. Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits.

Exclusion criteria

1. Another chronic respiratory disease other than EPID.
2. Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).
AI in GIM Diagnosis

This study will use artificial intelligence (AI) for diagnosing gastric intestinal metaplasia.

The patients with previously diagnose gastric intestinal metaplasia (GIM) and have the surveillance gastroscopy will be enrolled. The routine surveillance program will be performed additional to taking photo at both GIM and normal mucosa at least 5 pictures in each. Biopsy will be done to confirm the diagnosis of GIM and normal mucosa. All pictures will be inserted to AI algorithm based on the convolutional neural network (CNN). Then, the AI program will be validated in daily endoscopy compared with pathology. Accuracy, sensitivity and specificity can be calculated by 2x2 table.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years of age
* Able to sign a consent form

Exclusion Criteria:

* History of gastric surgery
* Coagulopathy
* Pregnancy/Breast feeding