cyrilzakka/clinical-trials huggingface dataset:
Nutritional Counseling Based on Self-compassion Vs. Diet Approach on Body Dissatisfaction and Disordered Eating

Current evidence has shown that the accepted standard of beauty, where women must be skinny, has increased body dissatisfaction and disordered eating. In order to deal with body dissatisfaction, the practice of restrictive diets - called the diet approach - becomes very often, although it can reinforce disordered eating and has questionable effects on body dissatisfaction. Self-compassion is an approach that proposes a kind and gentle look at body image issues and eating problems, which can be an alternative tool to deal with them. So, this study aims to compare a nutritional approach based on self-compassion techniques x a diet approach on dissatisfaction with body image, food restriction, and disordered eating in women who feel dissatisfied with their bodies.

A randomized clinical trial will be conducted with adult women randomly allocated into two groups - self-compassion (n=38) or diet approach (n=38) - that will follow over eight weeks. Each group will have weekly meetings of 1 hour, working on different subjects related to self-compassion or dietary choices each week, according to each group. The study outcomes are body dissatisfaction, disordered eating, and self-compassion levels, measured through validated questionnaires. Data will be analyzed using Statistical Package for Social Science for Windows software, and differences between the two groups will be evaluated by the Student's T-test or the Mann-Whitney U test, according to sample distribution. The Chi-square test will analyze the associations between the type of approach and all measured outcomes. Significant differences will be considered when the P value \<0.05. As a result, the investigators expect that self-compassion will improve body dissatisfaction and attenuate disordered eating more than the diet approach.

Eligibility Criteria:
Inclusion Criteria:

* age between 25 and 59 years;
* access to cell phone and communication apps.

Exclusion Criteria:

* diagnosis of depression, mood disorders (anxiety, bipolar, borderline), eating disorders, or a history of suicidal ideation;
* diagnosis of non-communicable diseases such as diabetes, kidney disease, cardiovascular or neurological diseases.
Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19

The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.

Between December 2019 and January 2020, a new type of coronavirus, named as "coronavirus disease 2019 - COVID-19" by the World Health Organization, has widely spread throughout the world, becoming a global health threat. The new COVID-19 is similar to other two types of coronavirus that in the past two decades have emerged as cause of severe human disease: Severe Acute Respiratory Syndrome CoV (SARS-CoV) and Middle East Respiratory Syndrome CoV (MERS-CoV). Severe respiratory disease or respiratory failure are the principal symptoms of critical patients, needing a management in ICU with mechanical ventilation.18 Data coming from laboratory results show a leucopenia mainly represented by a lymphopenia, that is a cardinal feature of COVID-19. Moreover, the concentration of several serum pro-thrombotic cytokines, such as interleukins (mainly IL-6, increased in 52% of patients), TNF-α, D-Dimer are reported to be significantly higher in COVID-19 patients, and significantly higher in ICU-patients than in non-ICU patients, suggesting an increased hypercoagulable state that, joined to the other main risk factors (immobilization, ICU admission, mechanical ventilation, infective disease), place these patients to a potential greater risk of developing VTE complications.

Eligibility Criteria:
Inclusion Criteria:

* aged \>= 18 years
* needing admission to a medical hospital division or to an ICU
* with a confirmed infection for COVID-19

Exclusion Criteria:

* aged \< 18 years
Assessment of What Patients and Healthcare Providers Value

To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life \[QOL\], cost, experience), and how these patientsâ€™ views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).

PRIMARY OBJECTIVE:

I. To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life \[QOL\], cost, experience).

SECONDARY OBJECTIVES:

I. To assess which attributes of value (i.e., outcomes, QOL, cost, experience) health care providers (i.e., physicians, nurses, administrators) feel are most important in health care delivery.

II. To assess how these patients' views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).

III. To assess how patients' view differ to health providers.

OUTLINE:

Patients and healthcare providers complete a survey over 10-15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has been treated, or is anticipated to be treated, for potentially resectable, biopsy-proven pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric adenocarcinoma
* Providers involved in the care of gastric and pancreatic cancer patients. Providers will include non-collaborative surgical oncologists, medical oncologists, radiation oncologists, administrators, nurses, mid-level providers
* Able to understand the description of the study and willing to participate

Exclusion Criteria:

* Inability to read and answer questions in English
Ketamine Long Therm Follow Up Study

Results of the study and of 5 years follow up of depressed patients who participated in the study during 2014-2015. We will locate the participants and will interview them will use the same questionnaires to evaluate their depressive symptoms. We will also measure the time to relapse.

Anamnestic data will be collected from the patients, in addition, depressive symptoms will be measured using Montgomery Asberg Depression Scale (MADRAS). In addition, the Clinical Global Severity Scale (CGI-S) and Clinical Global Improvement (CGI-I) were performed 2 hours after treatment. In addition, we performed to prolong the time to relapse in this patient.

Eligibility Criteria:
Inclusion Criteria:

* Participants in the ketamine study

Exclusion Criteria:

-
Mental Health, Intellectual and Neurodevelopmental Disorder Detection with Artificial Intelligence Models

This study investigates whether AI-driven analysis of speech can accurately predict clinical diagnoses and assess risk for various mental or behavioral health conditions, including attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, bipolar disorder, generalized anxiety disorder, major depressive disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and schizophrenia. We aim to develop tools that can support clinicians in making more accurate and efficient diagnoses.


Eligibility Criteria:
Inclusion Criteria

1. Participants aged between 16 and 60 years.
2. Individuals currently undergoing or referred for clinical assessment of mental or behavioral health conditions (including but not limited to ADHD, ASD, BPAD, GAD, MDD, OCD, PTSD, SSD)
3. Fluent in English
4. Capable of providing informed consent, or in the case of minors, having a parent or legal guardian who can provide consent on their behalf.
5. Access to a device (smartphone, tablet, or computer) with a microphone and stable internet connectivity, necessary for completing the speech tasks.

Exclusion Criteria

1. Individuals experiencing acute mental health crises or severe symptoms that would preclude meaningful participation in the study, including acute intoxication.
2. Severe cognitive impairment or intellectual disability that would prevent understanding of the study procedures or completion of the speech tasks.
3. Lack of fluency in English.
4. Technical limitations: Inability to access a suitable device or internet connection for completing the speech tasks
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans

The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD.

The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms?

Participants will undergo non-drug preparatory therapy sessions before their MDMA-assisted therapy sessions. After, they will undergo non-drug integrative therapy sessions.

To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a Phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA (120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later), along with non-drug preparatory and integrative therapy administered in both individual and group sessions.

The Primary Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years old.
* Are a U.S. Military Veteran
* Are fluent in speaking and reading the predominantly used or recognized language of the study site.
* Are able to swallow pills.
* Agree to have study visits recorded, including Experimental Sessions, outcome assessments, and non-drug psychotherapy sessions.
* Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
* If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
* Must not participate in any other interventional clinical trials during the duration of the study.
* Have a current PTSD diagnosis at the time of screening.

Exclusion Criteria:

* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments.
* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
* Have evidence or history of significant medical disorders.
* Have symptomatic liver or biliary disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
* Have an active illicit drug or prescription drug substance use disorder
Use of Tranexamic Acid in Facial Fillers

The overall purpose of this study is to evaluate the safety and efficacy of co-administration of tranexamic acid (TXA) with hyaluronic acid (HA) in reducing swelling, bruising and pain after facial injection. This will be done by comparing HA to HA+TXA in participants undergoing facial filler injections. Patients undergoing facial filler injections almost always have the same type of injection performed bilaterally in order to maintain symmetry. This provides a unique opportunity where participants can serve as their own controls. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Swelling, bruising, pain, and overall satisfaction will be assessed using participant self-reported surveys, physician surveys, and review of medical records.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 but less than or equal to 89 years.
* Medically appropriate to undergo elective facial filler injection at UW Health by principal investigator
* English speaking

Exclusion Criteria:

* Minors or under the age of 18
* Patient over the age of 89
* Pregnant or breast-feeding women
* Individuals unable to give consent due to another condition such as impaired decision-making capacity.
* Participants with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis
* Concurrent use of estrogen
* Participant undergoing unilateral facial filler injections
* Participants with history of hypersensitivity to TXA or any of the other ingredients
* Participants that are on current therapeutic anticoagulation therapy
* Participants with stage 2 or greater renal failure
* Participants on hemo- or peritoneal dialysis
Effectiveness of Extended Reality CPR Training Methods

The aim of this study is to explore the efficacy and safety of the extended reality (XR)-based basic life support (BLS) training.

Conventional CPR training is based on the use of a manikin and a training video. Though several feedback devices have been developed to improve the effectiveness of the training, they were neither realistic nor immersive. In addition, in conventional training programs, trainees are constrained in terms of time and location, as they are usually kept to a schedule.

Virtual reality (VR) technology, which was designed to maximize immersion, could be used to overcome those limitations, which in turn may improve the effectiveness of CPR training. However, even with VR technology, procedures such as chest compressions, ventilation, and defibrillation cannot be implemented as in the real world. Extended reality (XR), which combines the virtual and real worlds, could overcome these limitations by facilitating the use of real-world manikins in the virtual environment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are not healthcare providers and are 18 years old or older

Exclusion Criteria:

Participants who

* are not capable of performing either the training or the CPR test due to physical or cognitive limitations
* have upper extremity injuries
* are pregnant
* experience dizziness, headache, or motion sickness during the 2-minute XR device adaptation period that prevents them from participating in the simulation study
DECISION+, a Training Program to Improve Optimal Drug Prescription

Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.


Eligibility Criteria:
FAMILY PHYSICIANS:

Inclusion Criteria:

* All FP (teachers and residents) providing care in the walk-in clinic in each Family Practice Teaching Unit (FPTU) will be eligible to participate in the trial.

Exclusion Criteria:

* he/she was involved or participated in the DECISION + pilot RCT
* he/she is not expected to be practicing at the FPTU for the whole duration of the study (e.g. residents ending their residency program or doing rotations outside of the FPTU, planned pregnancy/delivery, planned retirement).

PATIENTS:

Inclusion Criteria:

* if 17 years old and under, must be accompanied by a parents or a guardians)
* they are consulting a participating physician for an ARI, for which treatment with an antibiotic is considered
* they are able (patients or the accompanying parent or guardians) to read, understand and write French (expected level: 8th grade)
* they give informed consent

Exclusion Criteria:

* Patients with a condition requiring emergency care will be excluded.
Prevention of Asthma With Levocetirizine (36 Month Treatment) in Young Children Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and House Dust Mite and Having Completed the Previous EPAAC Trial (NCT00152464)

Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).

36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9)

* Having completed the previous 18-month treatment period of the EPAAC trial - NCT00152464

Exclusion Criteria:

* None
Pringle Time Exceeding 120 Min in Liver Resection

Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy, without an established time-limit. However, many authors claims its danger for patients' outcome. The investigators check the short term outcome of a consecutive cohort of patients who underwent hepatectomy with intermittent clamping exceeding 120 minutes.


Eligibility Criteria:
Inclusion Criteria:

* patients in whom total cumulative clamping time exceeded 60 minutes.

Exclusion Criteria:

* patients in whom total cumulative clamping time was less than 60 minutes
Efficiency Study of S-Tenatoprazole-Na to Treat Erosive or Ulcerative Esophagitis

STU-Na belongs to the proton pump inhibitors (PPI), a group of drugs that reduce gastric acidity. PPI are used to treat acid related diseases like erosive or ulcerative esophagitis. This trial aims to find out the therapeutic dose of STU-Na required for healing patients with erosive or ulcerative esophagitis. One of four dosages of STU-Na (15 mg, 30 mg, 60 mg, or 90 mg daily), or Esomeprazole 40 mg daily, an already marketed PPI, will be given to patients. The attribution to one of the 5 treatment groups will be by chance. Neither the patient nor the study physician will know, which treatment is administered to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged 18 to 75 years inclusive
* Symptomatic ulcerative or erosive esophagitis
* Presence of heartburn (daytime and/or nighttime).
* Understanding the study and agreeing to give a written informed consent
* Able to communicate well with the investigator him(her)self or his/her representatives
* Able and agreeing to comply with all study requirements

Exclusion Criteria:

* gastrointestinal bleeding
* gastric or esophageal surgery
* Zollinger-Ellison syndrome
* primary esophageal motility disorders,
* esophageal stricture,
* inflammatory bowel disease,
* upper gastrointestinal malignancy,
* pancreatitis,
* malabsorption
* Barrett's esophagus (\> 3 cm)
* Severe disease/condition such as malignancy
* Hypersensitivity to PPIs
Genomic Analysis of Pediatric Bone Tumors

To determine whether gene expression analysis of primary tumor samples before and after chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas (Ewings sarcoma (ES) and Osteosarcoma(OS)).


Eligibility Criteria:
Inclusion Criteria:All patients with bone x-rays suggestive of a malignant bone tumor Exclusion Criteria:Patients with a known diagnosis of cancer.
One Session Vs Staged Management of Calcular Obstructive Jaundice

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management

Eligibility Criteria:
Inclusion Criteria:

* age from 18-70 year
* combined CBD and gall stone
* stone less than 1.5 cm
* fit for surgery
* no upper abdominal surgery

Exclusion Criteria:

* age \<18 and \>70
* unfit for surgery
* stone more than 1.5 cm
* upper abdominal surgery
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season

Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.

An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.

Eligibility Criteria:
Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.

Exclusion Criteria

1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
2. A serious adverse reaction after a previous (influenza) vaccination.
3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
5. Having any condition which suppresses the immune system and autoimmune disorders.
Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other words, can the investigators detect the high risk strains of the human papilloma virus (HPV) that are associated with cervical cancer in self-collected menstrual blood, as an alternative to collecting vaginal swabs.


Eligibility Criteria:
Inclusion Criteria:

There will be two study groups: 1) menstruating women over the age of 18 who have previous history of HR-HPV in the last 18 months and 2) menstruating women over the age of 18 who do not have a previous history of HR-HPV.

Exclusion Criteria:

* Women younger than 18 years old or are not menstruating regularly