cyrilzakka/clinical-trials huggingface dataset:
Healthy Mind Healthy You: A Study of Mindfulness

Most people experience stress at some point in their lives. Stress, especially when severe, can not only make you feel bad, it can also worsen existing health problems like heart disease, type 2 diabetes, obesity, high blood pressure, depression, and even cancer. Healthy Mind, Healthy You is a new study about how mindfulness can help people cope with stress. Funded by the Patient Centered Outcome Research Institute (PCORI) and involving 19 Patient Powered Research Networks (PPRNs), Healthy Mind Healthy You will be able to study the effects of mindfulness on a wide variety of populations and conditions.


Eligibility Criteria:
Inclusion Criteria:

* Must be a member (patient/member of special population or caregiver) of one of the 19 PCORI Patient-Powered Research Networks (PPRN)
* Must be age 18 or older

Exclusion Criteria:

* Under the age of 18 years
* Unable to read, understand, and/or participate in mindfulness exercises
Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer

The general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. To this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. This methodology is very promising, but also recent and therefore little studied and standardized. Our objective is also to investigate how to optimize it from a purely methodological point of view.

In this study, all PET images with 18F-PSMA will be considered, but also the CT or MR images associated with them to allow better anatomical localization.

This study will allow us to investigate the diagnostic and prognostic role of l8F-PSMA PET, also evaluating its predictive value in terms of disease course, development of metastases and mortality. The retrospective part of this protocol is necessary for the acquisition of a sufficiently large amount of data to guarantee adequate statistical power for the study.

Eligibility Criteria:
Inclusion Criteria:

* adult male patients;
* patients with histopathological diagnosis of prostate cancer undergoing staging or restaging;
* patients with clinical indication for PET examination with 18 F-PSMA;

Exclusion Criteria:

* medical conditions that do not allow the acquisition of PET images;
* allergic reactions to iodinated contrast medium or creatinine levels \>2mg/dL.
Fluorescence Cholangiography During Cholecystectomy - a RCT

The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
* Complicated gallstone disease

Exclusion Criteria:

* Open cholecystectomy
* Allergy towards iodine, urografin or indocyanine green
* Liver or renal insufficiency
* Thyrotoxicosis
* Pregnancy or lactation
* Legally incompetent for any reason
* Withdrawal of inclusion consent at any time
Exercise Based on Proprioceptive Neuromuscular Facilitation in Older Individuals

The goal of this clinical trial was to determine whether an intervention using resisted sit-to-stand and walking exercises with Proprioceptive Neuromuscular Facilitation (PNF) techniques improved gait and sit-to-stand in older individuals with poor functional capacity compared to a control group that performed the same activities, but without manual resistance. The main questions it aimed to answer were:

Did an exercise program based on the PNF concept improve functional capacity and strength performance?

Was there a difference between an exercise program with or without PNF techniques on functional capacity and strength in older adults?

Researchers compared the effects of an exercise program based on the PNF concept to a similar exercise training without manual resistance on functional capacity and strength performance.

Participants participated in an intervention using resisted sit-to-stand and walking exercises with or without PNF and performed functional capacity and strength tests at the beginning and end of the intervention.

The proposal consisted of investigating an exercise intervention based on the Proprioceptive Neuromuscular Facilitation concept (PFNG), compared to a control group (CG), which performed the same exercises as PNFG under a therapist's supervision, but without resistance imposed by the therapist's hands as in PFNG, in older individuals.

Before data collection, individuals participated in a familiarization procedure for each test. Each specific test was conducted on the same equipment with identical participant/equipment positioning. Functional assessment and intervention were conducted at the participants' residences.

The CG intervention consisted of the same activities carried out in the PNFG during Stages 1 and 2, for the same amount of minutes, sessions, and weeks. However, the CG intervention did not include specific techniques and basic principles (i.e., approximation and optimal resistance) and procedures of the PNF concept. The activities were instructed and supervised by a trained professional through verbal commands. The professional was in a stand-by assistant position to prevent accidents. Each intervention lasted 30 minutes and took place twice a week, for 4 weeks, totaling 8 meetings. The interventions were supervised by researchers blinded to pre-intervention assessment results and randomly assigned for both PNF and control groups. The researchers responsible for the interventions were physical therapists with basic IPNFA® (International Proprioceptive Neuromuscular Facilitation Association) instruction.

Eligibility Criteria:
Inclusion Criteria:

* Short Physical Performance Battery score lower than 10 points.

Exclusion Criteria:

* Neurodegenerative diseases;
* Illnesses contraindicating exercise (e.g., uncontrolled arrhythmias, acute myocardial infarction);
* Unstable medical condition.
Emotional Changes Between Emergency and Intensive Care Unit and On-site Counter Staffs After COVID-19 Infection

The emotional and work changes of the staffs and the on-site counter staffs will have a certain impact during this pandemic period. Because a large number of critically ill patients are obstructive in emergency and critical care uint. It will induce a huge impact on the deployment of medical team manpower The purpose of this study is to understand the situation of emergency and intensive care unit personnel after covid-19 infection. It will help the hospital superintendent to understand the impact of emotional adjustment on its own work, understand the emotional situation of on-site personnel, future planning and r deployment.

The emotional and work changes of the staffs and on-site counter staffs will have a certain impact during this pandemic period. Because a large number of critically ill patients are obstructive in emergency and critical care unit. It will induce a huge impact on the deployment of medical team manpower The purpose of this study is to understand the situation of emergency and intensive care unit personnel after COVID-19 infection. It will help the hospital superintendent to understand the impact of emotional adjustment on its own work, understand the emotional situation of on-site personnel, future planning and r deployment.

1. Explore the emotional changes of on-site emergency department and critical care unit staffs and on-site counter staffs by filling in questionnaires
2. Understand the emotional changes of personnel in various units and on-site counter personnel and how to adjust.
3. Arrange the Likert scale questionnaire with Meleis Nursing Transitional Theory. The different aspects of the questionnaire to quantify the emotional changes of the emergency and critical unit personnel and the on-site counter personnel. Each questionnaire takes about 20 minutes to 30 minutes to fill this questionnaire.
4. Analyze the emotional adjustment of the staffs in the acute and severe unit that affects their own work and how to affect the relationship between colleagues and medical practice execution.
5. This study uses empirical evidence to analyze and evaluate the emotional changes of emergency department and intensive care unit personnel and on-site counter personnel, understand the rationality of hospital manpower deployment and make the assistance needed

Eligibility Criteria:
Inclusion Criteria:

* emergency department and intensive care unit personnel after facing their own infection with COVID-19.

Exclusion Criteria:

* Exclude those who fill in the questionnaire with incomplete information
Long Time Metabolic Changes Induced by Genetically Modified Potatoes

In this study the effects of genetically modified potatoes on the human metabolism will be observed. Healthy volunteers receive for one week muffins, produced with starch from a genetically modified potato or with a normal available starch, in a randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers

Exclusion Criteria:

* acute oder severe chronic diseases
A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)

A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery.

The question of preoperative supplementation raises another issue about how this might be provided for patients, especially at home.

The Chief Investigator has formulated a new biscuit 'Fitabisc' that contains the key antioxidants; vitamins C and E, selenium and glutamine. The advantage of a biscuit is that all ingredients of interest are combined within the one item and so this may be easier for patients to 'take' than other types of supplement. A survey involving 17 community pharmacies in England and Northern Ireland found that 60% of patients aged 60 - 89 years had difficulty swallowing tablets and capsules. The consistency of the biscuit is softer than traditional shortbread and crumbs readily which we hope will make it easy to eat.

The aim of this study is to test the palatability of Fitabisc and whether patients undergoing abdominal surgery can eat it in the desired quantities for 10 days before they are admitted to hospital.

In summary, most studies to date have looked perioperative or postoperative supplementation with antioxidants alone. No attempt has been made to do this using a palatable biscuit that would facilitate preoperative oral supplementation. If this study confirms the palatability of the biscuit and there is adherence to eating it then it would be our intention to set up a prospective randomized study in which the potential efficacy of Fitabisc would be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 16 and 80 years inclusive.
* Patients who are having colorectal surgery.
* Patients who are able to give voluntary, written informed consent to participate in the study and from whom written consent has been obtained.

Exclusion Criteria:

* Those who cannot or do not provide informed consent
* Patients with a known or suspected allergy to any of the ingredients of Fitabisc e.g. gluten or dairy products
* Patients with one of the following co-morbidities:

  * Haemochromatosis
  * Thalassaemia
  * Kidney disease
  * Liver disease
  * Reye syndrome
* Patients who already take supplements of vitamin C, E, selenium or glutamine.
* Patients with type 1 diabetes, or type 2 diabetes that requires them to have insulin or a hypoglycaemic drug such as Metformin.
Hybrid Telehealth in Pediatric Physical Therapy

The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. This is a mixed methods study.

The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. Research questions include:

Is a hybrid of telehealth and in-person physical therapy service better than in-person services alone for improving in-home functional skills in children with moderate to severe disability?

Is there a difference in the satisfaction of caregivers and children with physical therapy services which consist of a hybrid of telehealth and in-person physical therapy services compared to in-person services alone?

What is the experience of children and caregivers who receive a hybrid of telehealth and in-person physical therapy services during an episode of care?

Eligibility Criteria:
Inclusion Criteria:

* Children 2-17 years old with moderate to significant disability.
* Families have access to minimum technology necessary to participate in a telehealth visit. ---The child's insurance covers telehealth visits.

Exclusion Criteria:

-Caregiver does not speak English
Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

To undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6.


Eligibility Criteria:
Inclusion Criteria:

* pseudophakia
* without previous vitreoretinal surgery
* diagnosed with a full-thickness macula hole on the optical coherence tomography exam.
* duration of symptoms less than 6 months
* inform consent

Exclusion Criteria:

* ocular trauma
* allergy to any of the products used in the study,
* need to travel by plane in the first 60 postoperative days
* myopia over 6 diopters or axial diameter over 26 mm
* retinal dystrophies
* retinal detachment
* abnormal eye shape
* glaucoma
* diabetic retinopathy or other eye comorbidities.
Psychoactive Drug Uses Among Medical and Pharmacy Students

Drug addiction to psychoactive substances, widely consumed in France, represents a major public health issue. The three main motivations identified for the consumption of psychostimulants would be self-medication, the party aspect and the improvement of school performance. Students of medicine and pharmacy are a population exposed to academic and professional stress, vulnerable to health problems and psycho-social disorders (anxiety, depression), with direct access to many drugs at their workplace. Almost a third of these students declared to consume these products to improve their cognitive performance, while a recent study showed that they take them instead to manage their stress and sleep. However, no study has characterized all the different uses of psychoactive drugs (PAD) in this population, nor the motivations for consumption, while an analysis of motives would help to develop better screening and prevention strategies. The main objective of the research is to characterize the motivations for PAD consumption among students of medicine and pharmacy in France. The most represented motives will be analyzed on the questionnaire of motivations for consumption (threshold frequency ≥20%). The secondary objectives are to identify the risk factors linked to the individual, to the environment and to drugs in students with PAD use disorders regardless of their motivation and in those using to improve their performance.


Eligibility Criteria:
Inclusion Criteria:

* Being of legal age
* Studying medicine or pharmacy in France from the 2nd to the 6th year
* Have read the newsletter and validated its no objection
* Have answered all the questions
* Validate the return of the questionnaire

Exclusion Criteria:

* partial filling of the online questionnaire
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis


Eligibility Criteria:
Inclusion:

* A history of spring/summer seasonal allergies.
* Positive skin prick test for the currently prevalent allergen of the area.
* Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
* For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.

Exclusion:

* History of chronic sinusitis.
* Asthma, with the exception of intermittent asthma.
* Smokers.
* Known non-responders to antihistamines.
* Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
* Chronic use of long acting antihistamines.
* Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
* Relatives of study site staff or other individuals who had access to the clinical study protocol.
* Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.

The study included a dose-finding evaluation of a 3-dose regimen of V503 and GARDASIL, a safety/efficacy evaluation of a 3-dose regimen of the selected V503 dose formulation and GARDASIL, and an extension consisting of 2 substudies: an evaluation of immune memory in participants receiving a fourth vaccination with V503 (Cohort 1), and an opportunity for participants who received GARDASIL in the Base Study to receive a 3-dose regimen of V503 (Cohort 2).

Eligibility Criteria:
Inclusion Criteria:

* Female between 16- to 26-years-old
* Has never had Pap testing or has only had normal Pap (Papanicolaou) test results
* For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in the base study and was in the per-protocol immunogenicity population for ≥1 HPV type
* For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized to GARDASIL in the base study and received ≥1 dose of GARDASIL

Exclusion Criteria:

* History of an abnormal cervical biopsy result
* History of a positive test for HPV
* History of external genital/vaginal warts
* Currently a user of any illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received marketed HPV vaccine or participated in an HPV trial
* Currently enrolled in a clinical trial
* Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent.)
Ondansetron Reduce Vomiting Associated With Ketamine PSA

Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.


Eligibility Criteria:
Inclusion Criteria:

* age 1-21 years, ASA I or II, fracture of dislocation reduction

Exclusion Criteria:

* age \< 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer

Despite performing colonic surgery with strict asepsia measures, minimizing the contact of the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just the necessary for introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the suture is performed.

Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than after handsewn ones.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
Clinical Trial of H2-BP Electronic Sphygmomanometer

The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm. After confirming wrist and upper arm circumference, H2-BP is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. Each subject undergoes alternating measurements of H2-BP on one wrist and the auscultatory sphygmomanometer on the same arm until three valid measurement pairs are obtained per subject, with a maximum of eight repetitions allowed. The two auscultatory sphygmomanometer measurers operate independently and cannot see each other's measurements during the test. Measurements are repeated for 10 to 30 minutes until three valid blood pressure values are obtained and recorded. Validity assessment variables are derived from the recorded values to evaluate the accuracy of H2-BP.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients and inpatients aged 19 years or older showing hypotension, normal blood pressure, prehypertension, and hypertension
* Individuals who meet the criteria for wrist circumference, age, gender, and upper arm circumference as specified in the target number of participants.
* Those who have listened to a detailed explanation of the clinical trial, fully understand it, voluntarily decide to participate, and provide written consent to comply with precautions.

Exclusion Criteria:

* Patients who do not consent to participate in the study.
* Individuals who may not maintain stable blood pressure for approximately 30 minutes due to conditions resembling hypovolemia or similar conditions.
* Those who may not maintain stable blood pressure for approximately 30 minutes due to short-acting vasodilators or similar medications.
* Individuals with arrhythmia.
* Those who have eaten within 30 minutes before blood pressure measurement.
* Individuals who have consumed caffeine-containing beverages within 1 hour or smoked within 15 minutes before measurement.
* Participants who have exercised immediately before blood pressure measurement.
* Other patients deemed unsuitable for the study at the discretion of the researchers.