cyrilzakka/clinical-trials huggingface dataset:
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.

PRIMARY OBJECTIVE:

I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.

SECONDARY OBJECTIVES:

I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy.

ARM II: Patients receive standard of care during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy
* Age 18 or older
* ECOG PS 0-2
* The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)
* Signed study-specific consent form

Exclusion Criteria:

* Prior head and neck radiotherapy
* Participants is unable to fit a tongue-lateralizing or tongue-depressing stent
* Severe trismus with an incisal opening of \<10 mm
* Inability to comply with the study procedures
* Participants younger than 18 years of age
* Participants must not be pregnant
* Cognitively impaired subjects
Virtual Reality Music in Geriatric Inpatients

Older adults, especially those in acute care require accessible non-pharmacological interventions, such as music to improve their mental health. Immersive 360 virtual reality (VR), is an innovative technology that has been found to be feasible, safe, and enjoyable by older adults. However, VR based music intervention to improve older adults' mental health has not been studied in acute in-patient settings.


Eligibility Criteria:
Inclusion Criteria:

* Age of 60 years or older;
* Medical stability to participate in the trial as determined by treating physician (defined as stable vital signs, absence of new medical events and deteriorating signs),
* Admitted to the GAU (5 north) at St. Mary's hospital.

Exclusion Criteria:

* Medical instability which limits ability to participate in the study (unstable vital signs, delirium, new medical events, deteriorating signs),
* Unablility to communicate in English or French,
* Behavioural issues/delirium that limit participation in the study,
* Those who have very severe dementia (using the Reisberg stage 7 which is defined by very limited communication ability, and dependence for all self-care
* Those without sufficient auditory acuity to undergo assessment and participate in the intervention, which affects their ability to communicate their consent for this study and to listen to music
* Ophthalmological conditions which affects their ability to participate in the immersive VR (recent eye surgery, severe macular degeneration, severe glaucoma, epilepsy and seizures, etc.).
Diaphragmatic Echography in COVID-19 Pneumonia

We hypothesized that diaphragm thickness is concerned in acute respiratory failure of COVID19 patients and its ultrasound measure at the begining of hospitalisation is a good predictor of poor outcome.

A prospective observational non intervention study is designed.

To answer our hypothesis we will perform diaphragm ultrasound in the first 24hr hospitalized COVID19 patients.

In the ultrasound exploration we will assess diaphragm movility and thickness. We will also assess other clinical, biochemistry and radiological variables. The main outcome we want to analyze is the destination on discharge: home, respiratory intermediate critical unit or exitus.

Eligibility Criteria:
Inclusion Criteria:

* COVID19 Pneumonia Acute respiratory failure (PaO2 \<60mmHg)

Exclusion Criteria:

* Invasive or non invasive ventilation within first 24h Neuromuscular disease Diaphragmatic paralysis
Relation Between Carotid Atheroscerosis With DM &Fatty Liver

To determine the risk of atherosclerosis in NAFLD patients who have T2DM by meauring Carotid intima media thickness (CIMT) using carotid doppler ultrasound.

Fatty liver is one of the most common chronic liver diseases in the world. It's prevalence is reported to be 10-40% in the adult populations. At least 57% to 80% of them are associated with diabetes (1.2).Atherosclerosis and cardiovascular diseases are also highly prevalent in this group of patients(10).

Non-alcoholic fatty liver disease ( NAFLD) is characterized pathophysiological by hepatic fat accumulation independent of excessive alcohol use(3.4). Fatty liver index (FLI) has been demonstrated good diagnostic accuracy in different populations(6.7)...FLI will be based on BMI, waist circumference (WC), triacylglycerols (TG) and g-glutamyl transferase (GGT).

The individuals with NAFLD have a higher risk of 10-year cardiovascular events than healthy individuals.(10) .NAFLD and T2DM are common conditions that regularly co-exist and can act synergistically to drive adverse outcomes(5). Diabetic macrovascular complications are the major chronic complications and the leading cause of death among the patients with T2DM, of which the pathological basis is atherosclerosis.(8) Atherosclerosis usually starts in the vascular intima, progressing to the medial arterial wall(9).Carotid intima-media thickness (CIMT) is an indicator of the risk of vascular disease. Increased CIMT and presence of atherosclerotic plaque are considered as a reliable ultrasound biomarker of subclinical atherosclerosis and can be used for cardiovascular risk assessment\[9\].

In this study the investigators have the aim of evaluating the possible association between non-invasive index of fatty liver (FLI) and the presence of carotid atherosclerosis in T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fatty liver (diabetic\& not diabetic).

Exclusion Criteria:

* 1-Other causes of Liver disease ( (viral hepatitis, drug-induced liver disease, hepatolenticular degeneration, autoimmune liver disease, schistosomiasis liver disease, cirrhosis, etc.) 2- Heavy smoker.
The Implication of Plasma ctDNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas

This is a multicenter, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, multicenter, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

Healthy Individuals:

* Written informed consent must be obtained from healthy individuals to comply with the requirements of the study.
* Healthy individuals who received colonoscopy.

Patients with Colorectal Cancer or Adenomas:

* Male or female ≥ 18 years of age on the day of signing informed consent.
* Patients need to receive surgical resection or endoscopic resection.
* Patients must have histologically confirmed stage I-IV colorectal cancer or adenomas
* Patients must have a performance status of ≤1 on the ECOG Performance Scale.
* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria:

* Patients received adjuvant treatment prior to the surgical resection.
* Patients received blood transfusion two weeks before or during the surgical resection.
* Patients with unresected advanced colorectal adenoma.
* Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
* Patients who are pregnant.
* Patients who are alcoholic or drug abusers.
* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.

Eligibility Criteria:
Inclusion Criteria:

* women affected by endometriosis showing recurrence of pain symptoms, previous surgery for endometriosis

Exclusion Criteria:

* presence of other systemic diseases
OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

The investigators are seeking healthy adult volunteers 18-60 years and healthy pregnant women in their 2nd trimester of pregnancy for a research study to assess a new imaging device. The Tearney Laboratory at the Wellman Center for Photomedicine at Massachusetts General Hospital is developing high-resolution imaging devices that can be used to improve diagnostics in gastrointestinal diseases.

The investigators have developed a device that can image the duodenum (the first part of the small intestine). The device consists of a thin, flexible tube with a small internal camera inside of it that takes high-resolution images of the gastrointestinal tract. The device will be introduced through the nose and then advanced into the stomach and duodenum. Participant tolerability, imaging quality and the optimal imaging technique will be evaluated. The results of this study will be used as the basis for a larger study to be conducted at the Aga Khan University Hospital in Pakistan where subjects with suspected or diagnosed EED will be imaged.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Subjects who are in their 2nd trimester of pregnancy
* Subject must be 18-60 years of age Subject must be able to consent to the procedure.
* Subject must fast (no solid food) for at least 8 hours and have no liquids within 2 hours prior to the procedure.

Exclusion Criteria:

* Subjects with a history of upper respiratory disease or surgery
* Pregnant women with high-risk pregnancies such as history of: hyperemesis gravidarum, HIV, severe anemia or any other high-risk pregnancy conditions at the discretion of the subject's physician and the PI
* Subjects with a history of upper gastrointestinal surgery
* Pregnant women with Type 1 diabetes
* Pregnant women with Type 2 diabetes on medication and gestational diabetes requiring medication
* Pregnant women with gestational thrombocytopenia
* Subjects with upper respiratory infection at least 7 days prior to the procedure
* Subjects with any contraindications to the placement of the NJ tube including deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc.
* Subjects on medications that delay gastric emptying.
* Patients on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
* Subjects using nasal steroids or any steroids for environmental allergies.
Clinical Protocol CERN Feasibility Study

The goal of this clinical trial is to learn if the intravaginal Cern device works to treat bacterial vaginosis and fungal vaginitis in premenopausal women. It will also learn about the safety of the device. The main questions it aims to answer are: Does the device accomplish symptom resolution and negative diagnostic tests post-treatment? What medical problems do participants have when using the intravaginal device? Participants will use the investigational intravaginal device for 5 consecutive days, participate in teleconferences and weekly follow-ups, attend in-clinic visits, and maintain a study diary.

The CERN Feasibility Study is an interventional clinical trial designed to evaluate the Cern Medical Device in the treatment of bacterial vaginosis and fungal vaginitis. The study assesses both the efficacy and safety of this innovative technology, which combines 450nm visible spectrum light with a natural photosensitizer (carboxy methyl cellulose and curcumin). The primary objective is to determine the device's effectiveness by measuring symptom resolution and negative diagnostic tests post-treatment. The secondary objective focuses on safety, monitoring adverse effects and patient tolerance during and after treatment. The study design involves recruiting up to 30 premenopausal women with culture-confirmed bacterial vaginosis or fungal vaginitis. Participants are divided into two groups, in the bacterial vaginosis group, the device is used for 30 minutes daily for 5 consecutive days. And in the fungal vaginitis group, the device is used for 60 minutes daily for 5 consecutive days. Following treatment, participants undergo a 45-day follow-up period, which includes daily telecom check-ins during treatment, weekly follow-ups, and a final assessment at 28 days post-treatment. Adherence is tracked through daily diaries and telecom follow-ups, ensuring treatment compliance, effectiveness monitoring, and adverse reaction tracking. Treatment success is determined by self-reported symptom resolution and negative diagnostic cultures, while safety is assessed through self-reported adverse events and clinical examinations.

Eligibility Criteria:
Inclusion Criteria:

* Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis

Exclusion Criteria:

* Postmenopausal status, current use of intravaginal devices, concurrent medical therapy for fungal vaginitis or bacterial vaginosis, recent medical therapy for vaginitis in past 7 days, immunosuppressive medication ≤ 3 months before screening, radiation therapy ≤ 3 months before screening, known allergy to curcumin, acrylic, or silicone, major organ disease or clinically significant infection or conditions that may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy, history of intolerance to intravaginal devices, symptomatic pelvic organ prolapse stage 2 or greater.
Evaluating the Efficacy and Safety of Preoperative Administration of Duloxetine for Pain Management in Women Undergoing Hysterectomy Via Vaginal Route

Hysterectomy performed through the vaginal route (HVR) is the preferred method for women seeking hysterectomy to address uterine concerns such as premalignant conditions and fibroids. Compared to abdominal or laparoscopic approaches, HVR has shown to lead to quicker recovery times and faster resumption of daily activities. However, effectively managing postoperative pain remains a significant challenge for HVR patients.

Duloxetine, a serotonin-norepinephrine reuptake inhibitor typically prescribed for major depression and anxiety, has also been utilized in treating chronic pain conditions like osteoarthritis and musculoskeletal pain. However, research into its use for alleviating acute postoperative pain is currently limited to a single trial. Additionally, it's unclear whether perioperative duloxetine could enhance overall recovery quality after surgery. This study hypothesized that perioperative duloxetine could improve postoperative recovery for HVR patients, with evaluation using the Quality of Recovery-15 questionnaire (QoR-15).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing HVR ( vaginal natural orifice transluminal endoscopic surgery) hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, colporrhaphy, or sentinel lymphadenectomy
* American Society of Anesthesiologists grade 1-3

Exclusion Criteria:

* patients with chronic non-gynecologic conditions (liver-renal or pulmonary disease)
* those using psychiatric drugs (antidepressants, neuroleptics, lithium) in the last 1 year,
* those with duloxetine allergy
* those using opioids for gynecologic or non-gynecologic conditions
* additional concurrent abdominal procedures
* Total vaginal prolapsus (POPQ 4)
An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

To explore the risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus (PPDM-C).

The present study was an observational study aimed to explore risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus. The observation items included clinical characteristics, blood glucose control and incidence of complications of PPDM-C.

Eligibility Criteria:
Inclusion Criteria:

1. patients with diagnosis of chronic pancreatitis and diabetes mellitus.
2. participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
3. participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.

Exclusion Criteria:

1. participants with suspected malignant tumors of the pancreas or other sites of body, or participants in the terminal stage of severe disease
2. serious mental illness, lesion of liver or kidney, pregnancy, breast-feeding or planning pregnancy
3. definitely diagnosed type 1 diabetes, type 2 diabetes, or other metabolic diseases that affect blood glucose
4. autoimmune pancreatitis
5. Scarcity of information related to HbA1c
6. death or loss of follow-up during follow-up
Time Course of Postprandial Protein Metabolism

The anabolic action of 'fast' whey protein on the regulation of postprandial muscle protein synthesis has been established to be short-lived in healthy young adults. Our aim was assess the time course of anabolic signaling events and stimulation of muscle protein synthesis rates (MPS) after ingestion of a food source that represents a more typical meal-induced pattern of aminoacidemia, namely milk protein concentrate, in healthy young males.


Eligibility Criteria:
Inclusion criteria

* Males
* Aged between 18-35 years
* Healthy, recreationally active
* BMI \< 30 kg/m2

Exclusion criteria

* Smoking
* Allergies to milk proteins
* Vegetarians
* Diagnosed GI tract diseases
* Female
* Arthritic conditions
* A history of neuromuscular problems
* Previous participation in amino acid tracer studies
* Predisposition to hypertrophic scarring or keloid formation
* Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients

This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.

A PBM program will be implemented stepwise in four University Hospitals, with the intention to optimize preoperative hemoglobin concentration of patients and to standardize transfusion practice within hemotherapy. The PBM program includes 1) an algorithm with the aim to correct preoperative anemia in elective surgery, 2) a strict indication for the transfusion of red blood cells defined by the "Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives" for all surgical patients, and 3) a perioperative checklist for different blood-sparing techniques (e.g. cell-saver, normothermia, reduced blood samples, point-of-care diagnostics for bedside coagulation management).

Primary endpoint: Safety of the use of PBM program will be determined by comparability of the composite outcome (in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital) between patients treated after implementation and patients treated before implementation (control cohort) of the PBM program.

The primary composite endpoint defined as described above will be registered electronically by analysis of Diagnosis Related Groups (DRG) codes. The frequency of these events will be compared between PBM and control cohort stratified by center with a one-sided Mantel-Haenszel test in a non-inferiority setting with significance level of α=2.5% and a non-inferiority margin of 1% for the incidence of the composite endpoint.

Eligibility Criteria:
Inclusion Criteria:

* All non- ambulant, surgical, anesthetized patients (≥18 years)
* General Surgery, Cardiac Surgery, Thoracic Surgery, Trauma Surgery, Vascular Surgery, Urology, Gynecology, Otolaryngology, Neurosurgery, Crania-Maxillofacial Surgery

Exclusion Criteria:

* ambulant and all non-surgical anesthetic procedures
* Surgery in the field of Dermatology or Ophthalmology