cyrilzakka/clinical-trials huggingface dataset:
Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty

The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.

A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of a tympanic membrane perforation
2. Patient at PI's clinic

Exclusion Criteria:

1. Presence of cholesteatoma
2. Prior surgery on the same-sided TM or middle ear
3. Ossicular chain abnormalities
4. Congenital deformities involving the middle ear or eustachian tube
5. Refusal to undergo surgery
Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months
* BMI (Body Mass Index) between 24 and 35 kg/m\^2 (both inclusive)
* Fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
* Anti-GAD (glutamic acid decarboxylase) negative

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Receipt of any investigational drug within three months prior to this trial
* Recurrent severe hypoglycaemia as judged by the investigator
* Cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
* Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere
* with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
* Liver or renal disease
Impacts of a Report-back Training Program

Researchers participate in a hands-on training program on returning personal exposure results, and pre- and post-tests assess outcomes shifts in knowledge and perspectives on its value, and willingness to implement report-back in current or future studies.

The investigators study the outcomes from a program that trains researchers to implement report-back, informs perspectives on the value of report-back, increases likelihood of adoption, and promotes insights from visualization of results. The investigators evaluate the training using pre- and post-tests. The training program includes an introductory module on ethical and practical benefits and best practices for report-back. This is followed by a session where researchers gain hands-on practice in report preparation using Digital Exposure Report-Back Interface (DERBI), a digital report-back tool. Pre- and post-tests assess outcomes related to their prior concerns about report-back, knowledge about report-back, shifts in perspectives on its value, novel insights about data from Researcher- DERBI, and willingness to implement report-back in current and future studies.

Eligibility Criteria:
Inclusion Criteria:

* Must be affiliated with a study that collects biomonitoring or personal exposure data

Exclusion Criteria:

* Under 18
PENG Block vs Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After THA: a Randomized Controlled Non-inferiority Clinical Trial.

To compare the impact of pericapsular nerve group block (PENG) versus the supra-inguinal fascia-iliaca compartment block (SFICB) in postoperative analgesia, opioid sparing and enhanced recovery after surgery of total hip arthroplasty by poster-lateral approach.

ASA physical status 1, 2 and 3 patients scheduled to undergo elective total hip arthroplasty by poster-lateral (Moore) surgical approach with spinal anesthesia.

The investigators want to confirm the non-inferiority of the SFICB compared to the PENG block on postoperative first 6 hours after surgery NRS pain score and 48 hours opioids consumption, and the difference between these in terms of early recovery and motor impact on two first day after surgery. The principal investigator perform these regional anesthesia techniques with ultrasound guided injections.

Eligibility Criteria:
Inclusion Criteria:

- Adults patients scheduled to undergo elective primary total hip arthroplasty by posterior surgical approach with spinal anesthesia

Exclusion Criteria:

* Patient refusal
* Allergy to administrated drugs or local infection
* Pregnancy
* History of chronic pain
* Drugs addiction
* Mental ou neurological diseases
* Kidney or liver serious diseases
Evaluation of Efficacy and Tolerance of JOE on 4 to 11 Years Old Asthmatic Patients of GINA 2,3,4 and 5 Grades

The main objective of this study is to evaluate efficacy and safety of patient's learning in self-taking of prescribed asthma maintenance treatments and provided by JOE (a new DTX), on the number of severe exacerbations in children with an asthma graded 2, 3, 4 and 5 according to GINA classification.

A new device, named JOE, manufactured by Ludocare, is available since 2019 in France. This new device, compact and connected, was designed to be easy to use by children suffering from chronic disease. JOE is a robot designed to improve compliance with asthama maintenance treatments.To confirm efficacy and safety of a patient's learning in self-taking of asthma maintenance treatments provided by JOE, it has been decided to carry out a clinical study in 4 to 11 years old patients and suffering from asthma graded 2, 3, 4 or 5 according to GINA classification. These patients will be recruited by pneumo-pediatricians at hospital or in private practice. The study is a phase 3, multi-center, prospective, open, 2-parallel groups, randomized and controlled study. Each patient will be randomly allocated in one of two studied treatment groups: standard asthma maintenace treatment (group SCT) vs standard asthma maintenance treatment + JOE (a new DTx) (group SCT + JOE). Patients meeting eligible criteria will be included at Day 0 (Visit V0). For each patient the maximal duration of this study will be 12 months. At day 7 a phone call is planned to evaluate patient/parent's motivation and to detect potential technical and/or therapeutic problems. Three visits are planned then after at4 (M4), 8 (M8) and 12 (M12) months.

Eligibility Criteria:
Inclusion Criteria:

* 4-11years old,
* able to use JOE
* persistent uncontrolled asthma, graded 2, 3 , 4 or 5 on GINA classification
* maintenance treatment since at least 3 months
* having given their informed written consent

Exclusion Criteria:

* asthma naïve-treatment child
* without regular follow-up with the investigator
* participating to another interventional study, with another disease, other treatments or planned modification of prescribed treatments that could interfere with studied disease
Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room

The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption.

The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption. Low-risk (non-cardiac) chest pain patients with anxiety will be recruited to participate in the study using the SBIRT (screening, brief intervention, and referral to treatment) model and enrolled participants will be randomly assigned to one of three treatment arms: 1) referral to primary care with enhanced care coordinated (low intensity); 2) online CBT with support from a certified peer recovery specialist (medium intensity); and 3) therapist-led CBT via tele-health (high intensity). We expect improved symptoms and functional capacity, reduced ED return visits, and heterogenous treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* Adult emergency department (ED) patients (≥18yoa) presenting to the ED
* Within 1 week of ED presentation if discharged at time of screening.
* Chief complaint of chest pain or similar chief complaint leading to a standard of care diagnostic protocol to rule out possible acute coronary syndrome.
* HEART Score of 0-3 indicating Major Adverse Cardiac Events (MACE) risk equivalent to ≤2%
* "Functionally" low risk status - (moderate HEART score of 4-6) plus diagnostic protocol evaluation with at least two serial normal troponins spaced at least six hours apart with or without cardiovascular stress testing in the observation unit.
* Moderate to severe anxiety as defined by a GAD-7 score ≥ 8 or a PHQ panic screener score ≥ 2
* Expected to be discharged from the ED or only undergo observation \<24 hours.

Exclusion Criteria:

* \> 1 week from ED discharge
* Traumatic reason for chest pain
* Those admitted to the hospital (inpatient status) as part of their ED presentation (those placed in the observation unit for planned observation less than \<24 hours are eligible)
* Active psychosis or behavioral issues requiring psychiatric monitoring or consultation of psychiatry for psychosis, schizophrenia, or suicidal ideation
* Hemodynamic instability as assessed by the treating provider
* Issues likely to affect follow up, including prisoners and homelessness
* Inability to understand and speak English to participate in telehealth therapy sessions and peer support.
Diclofenac add-on to Treatment as Usual for Suicidal Patients

The purpose of this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.

The study will start with a feasibility study including treatment of 10 patients with diclofenac.

Eligibility Criteria:
Inclusion Criteria:

* Depressive disorder
* Montgomery Asberg Rating Scale Score more than 20 p.
* Recent suicide attempt (Treated as inpatient due to a recent suicide attempt)
* Informed consent
* Competence to give informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Serious somatic disease e.g. serious heart, vascular, hepatic, kidney, pulmonary, intestinal, endocrine, haematological or neurological diseases
* Ongoing substance abuse
* Schizophrenia or other psychotic disorders
* Ongoing psychosis
* Risk factors for cardiovascular events
* Ulcer or gastrointestinal bleeding
* Ongoing Electroconvulsive therapy
* Previous allergic reaction to NSAID, acetylsalicylic acid, sulfonamides or the diclofenac or sugar pill content
* Galactose intolerance, lactase deficiency or glucose-galactose malabsorption
* Ongoing treatment with warfarin or other anticoagulants
* Ongoing treatment with ACE inhibitors or angiotensin II antagonists Ongoing treatment with drugs known to effect the immune system Ongoing treatment with rifampicin, carbamazepine or barbiturates
Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes

Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity including a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established, three-pronged approach places BMC in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population.

For this first exploratory study, 75 enrolled participants will be given a free mobile application with recipes designed to build habits. Participants will cook at least three meals weekly for two months using the app. Self-reported survey data and activity on the app will be collected and used to assess the feasibility of teaching cooking skills through a mobile application.


Eligibility Criteria:
Inclusion Criteria:

* Access to an oven OR microwave, stovetop OR hot plate, and food storage.
* Access to the internet on a smartphone
* Owns a smartphone with iOS Apple Store or Google Play
* Reading proficiency in English
* Has a diagnosis of diabetes or prediabetes(Hb A1C\> 5.6)

Exclusion Criteria:

* Inability to provide informed consent
* Taking any medications or has a condition that limits the ability to increase intake of fruits and vegetables (including warfarin and end-stage renal disease)
* Attended a Diabetes Self-Management Education (DSME) at BMC within the past year or plans to attend during the study.
Are Sporadic Colorectal Cancers in Young Distinct From Elderly?

In this study, the investigators compared and evaluated the clinicopathological and oncological characteristics of sporadic colorectal cancer (CRC) in young adults without genetic mutations associated with hereditary CRC syndrome and sporadic CRC in elderly individuals.

The ambiguity in the findings among several previous studies might be because of the difference in the age of the study population, yCRC and eCRC. The family history of CRC and cancer due to Crohn's disease or ulcerative colitis were also not excluded in such previous studies. Most importantly, those studies did not rule out the risk of hereditary cancer through the genetic testing in yCRC. Since hereditary CRC accounts for approximately 34% of those under the age of 35 years, it is necessary to exclude it to accurately compare the clinicopathological characteristics of sporadic cancer developed in yCRC and eCRC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cases of adenocarcinoma in the colon and rectum
* The age at the time of diagnosis should be ≤ 40 years (for yCRC) or ≥ 70 years (for eCRC)
* Genetic testing confirmation of non-hereditary cancer.

Exclusion Criteria:

* Inflammatory bowel disease
* A family history of CRC
* A history of other cancers
* Underwent any emergency operation or palliative surgery
* The Amsterdam criteria with mutations in genes associated with APC, MLH1, MSH2, MSH6
Effect of Advertisements on Treatment Compliance in Women With Breast Cancer

RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in women with breast cancer.

OBJECTIVES:

Primary

* Evaluate the consequences of advertisement on treatment compliance in women with breast cancer.

Secondary

* Determine the factors favoring or not favoring adherence to the medical recommendations.

OUTLINE: Patients and their medical and nonmedical caregivers are interviewed by a sociologist or anthropologist twice over 1 year. The first interview is at the consultation visit and the second interview is at the patient's home. The impact of advertisement on treatment compliance is measured.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Development of a Robotic Ankle Assist Device

The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy.

The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention.

The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention.

Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.

Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.

Exclusion Criteria:

Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.

Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.
Chest Physiotherapy in Pediatrics Patients With Pneumonia

Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)

Exclusion Criteria:

* Severely ill patients (hospitalized in intensive care units)
* Pleural effusion treated with chest drainage
* Atelectasis detected by x-ray
* Pneumonia or pleural effusion in the previous six months
* Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency
Safety and Efficacy of Travoprost/Timolol BAC-free

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).


Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma or confirmed ocular hypertension.
* Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 \& 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 \& 2.
* Sign an informed consent form.
* Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
* Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
* History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
* History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
* Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
* Severe central visual field loss in either eye.
* Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
* History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
* History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
* Other protocol-defined exclusion criteria may apply.
Psychometric Validation of Cognitive Endpoints

The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old (inclusive).
* History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis
* Physically able to see the testing materials and complete the tests
* Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.

Exclusion Criteria:

* A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.
* Untreated major depression or untreated anxiety disorder.
* History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.
* History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.
* A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.
* History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day 1.
* Active bacterial or viral infection.
* Use of marijuana within 2 months prior to Study Day 1or at any time during the study
* Alcohol consumption within 24 hours of either test session.
* Unable to comply with study requirements.
* Expected survival time of less than 3 months.