rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Dysphagia After Thyroidectomy
Status: Recruiting

The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.

Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.

The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.

In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of goiter or thyroidectomy.  Exclusion Criteria:  Diagnosis of other neurological disorders or disorders involving the aerodigestive tract that could cause swallowing disorders. Previous surgery of the neck or involving the aerodigestive tract. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: In the first phase, the study will recruit patients with diagnosis of goiter who are candidates to thyroidectomy and patients who have undergone thyroidectomy. Patients will be interviewed by the researchers. The interviews will face the symptoms of goiter or thyroidectomy, dealing (not exclusively) with throat and swallowing symptoms. The interviews will be recorded and analysed. The content of the interviews will be used to develop the items and the response categories of the questionnaire.  In the second phase, the study will recruit patients who are candidates for thyroidectomy. The questionnaire (and the other outcome measures of the study) will be administered to the patients before and after surgery. All patients who are candidates for thyroidectomy at the Istituto Auxologico Italiano in Milan, Italy, will be recruited (if they comply with inclusion and exclusion criteria and if they provide consent). General, clinical and surgical data will be collected. - SamplingMethod: Non-Probability Sample
Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB).
Status: Recruiting

Specifically, the project aims to pursue the following objectives:

To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise;
To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction.

The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI standard deviation score (SDS) > 2; absence of structured programs of physical activity (regular activity for more than 120min/week) for the 6 months before the study; absence of signs/symptoms related to cardiovascular, respiratory, gastrointestinal, skeletal-muscle pathologies contraindicated for the test execution  Exclusion Criteria:  BMI standard deviation score (SDS) < 2; presence of structured programs of physical activity (regular activity for more than 120min/week) for the 6 months before the study; presence of signs/symptoms related to cardiovascular, respiratory, gastrointestinal, skeletal-muscle pathologies contraindicated for the test execution - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Health Outcomes of Parents With Cystic Fibrosis-Aim 2
Status: Not yet recruiting

The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are:

H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression.

H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress

H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators

Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with cystic fibrosis via sweat test or genotype analysis Became a first-time parent (including foster parent, step parent, adoptive parent, or legal guardian) to a child under 5 years of age within the last 90 days  Exclusion Criteria:  Undergone a lung transplant Does not speak/read English or Spanish - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Individuals with cystic fibrosis who have become first-time parents to a child under 5 years of age. - SamplingMethod: Non-Probability Sample
Normative Values for Peripheral Muscle Strenght in Critical Patients and Healthy Individuals
Status: Not yet recruiting

Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients. Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability. Recently, the use of digital handheld dynamometers in intensive care has gained support; however, analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population. Our aim is to develop reference equations for the Brazilian population and define specific cutoff points for men, women, healthy individuals, and critical patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy individuals of both sexes Patients and volunteers aged between 18 and 90 years old (youth/adults/elderly). Patients admitted to the ICU. No recent muscle injuries of both limbs for a past 6-months.  Exclusion Criteria:  Patients and volunteers < 20 years and > 90 years  Healthy individuals  Unable to follow command completely Severe osteoporosis or neuromuscular disease leading to decreased muscle strength Presence of opened or infectious wound Presence of pain in evaluating muscle groups  Patients in ICU  Unable to follow command completely Acute stroke Hip fracture, unstable cervical spine or pathological fracture Recent surgery involving the upper airways, chest, abdomen, or limbs Presence of opened or infectious wound Presence of pain in evaluating muscle groups - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The population comprised adult and elderly individuals of both sexes able to do volitional tests. For the healthy sample, volunteers without barriers to the assessment of peripheral muscle strength will meet the inclusion criteria while, for the critical patient population, the sample will include individuals hospitalized in the Intensive Care Unit (ICU) who also do not have barriers to the assessment. - SamplingMethod: Non-Probability Sample
DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
Status: Not yet recruiting

The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.  Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator. Age ≥ 60 years at the time of consent. New patient to either the hematologic malignancies clinic or the bone marrow transplant/cellular therapy clinic.  Exclusion Criteria  All subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:  1. Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Impacts of Warning Labels on Ultra-Processed Foods
Status: Not yet recruiting

Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).

Participants: ~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.

Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Identifying as Latino or Hispanic Ages 18-55 years old Currently resides in the United States  Exclusion Criteria:  Not identifying as Latino or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Message Framing and Policy Support for Front-of-package Labeling
Status: Not yet recruiting

This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Identifying as Latino or Hispanic Ages 18-55 years old Residing in the United States  Exclusion Criteria:  Not identifying as Latino or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Rubber Hand Illusion in Anorexia Nervosa
Status: Recruiting

The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Right-handed diagnosis of Anorexia Nervosa according to the APA criteria  Exclusion criteria:  • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: Participants with anorexia nervosa will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital. - SamplingMethod: Non-Probability Sample
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
Status: Recruiting

The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female patient of at least 18 years old Patient presenting apical pelvic organ prolapse and being eligible to surgical treatment Surgeon having decided to treat the patient with a Restorelle mesh as per its CE mark indication and IFU, before patient inclusion Patient having received appropriate information and counselling before mesh implantation Patient has been provided written informed consent  Exclusion Criteria:  Patient currently pregnant or breastfeeding Patient being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult female patients presenting with apical pelvic organ prolapse which is clinically indicated for a surgical treatment with Restorelle mesh - SamplingMethod: Non-Probability Sample
Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients
Status: Not yet recruiting

Purposes of the study

To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient age ranges from 20 -45 Unilateral chronic lumbosacral radiculopathy Intervertebral disc herniation confirmed by MRI  one of the following :  H- reflex amplitude side to side difference 0.67 in absence of latency difference. H- reflex amplitude side to side difference smaller than 0.5 in p of latency difference.  3 - Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec.  Exclusion Criteria:  Systematic disease Lumbar canal stenosis Pervious surgeries Scoliosis Kyphosis Spinal fracture Bilateral symptoms Steroid injection - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 45 Years - StdAgeList: Adult
Mechanical Ventilation in Surgical Patients
Status: Not yet recruiting

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults; and Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery  Exclusion Criteria:  Receiving intraoperative IMV outside of an operating room; and Receiving intraoperative IMV during extracorporeal life support - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner - SamplingMethod: Probability Sample
Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture
Status: Not yet recruiting

The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.

The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient aged at least 18 years old Patient with an A-DIVA (Adult Difficult Intravenous Access) score > 1 Supported by a nurse trained in all the techniques used in the protocol Patient having given free, informed and oral consent -  Exclusion Criteria:  Patient who has already been included in the study Patient whose inclusion in the study would lead to a delay in treatment Adult patient protected by law Pregnant woman Patient not benefiting from French Social Security system - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase
Status: Not yet recruiting

It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.

The investigations will be carried out by a specialized physiotherapist from the neurology department.

The experiment consists of three successive phases:

First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.
Second : Rest period
Third: control phase with measurement of the maximum grip force every ten minutes without vibration.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age:18 to 85 Acute stroke (less than 7 days) Paretic upper limb: 3 or 4 to the MRC score and able to obtain a value of at least 10 kilograms on the handgrip strength Able to sign a consent form Affiliated to a social insurance  Exclusion Criteria:  Person under tutorship or curatorship, Sleepiness Pregnancy or breastfeeding woman - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Music, Virtual Reality for Inpatients in IUGM
Status: Not yet recruiting

Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.

Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  be hospitalized at the URFI of the IUGM, be 60 years of age or older, not have an acute intercurrent pathology in the week preceding the procedure and during the two days of the procedure, have no psycho-behavioural disorders, no major neurocognitive disorder at a severe stage, no severe visual or hearing impairment, no vestibular balance disorders, give written consent to participate in the study.  Exclusion Criteria:  Participate in another concurrent experimental clinical study, to avoid interference with our study. Do not understand written or spoken French or English. The participants are French and/or English speakers, and the questionnaires are only available in these 2 languages. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Massed Prolonged Exposure for PTSD in Substance Use Treatment
Status: Not yet recruiting

The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:

Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?
Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Veterans age 18+ who have served since September 2001 who are enrolled in a SUD IOP at a participating VA meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone not sufficient for inclusion) meet DSM-5 criteria for PTSD report substance use at least 20 of the last 90 days are able to give informed consent.  Exclusion Criteria:  severe cognitive impairment current suicidal or homicidal intent requiring immediate treatment current unstable psychotic or manic symptoms not attributable to SUD - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult