cyrilzakka/clinical-trials huggingface dataset:
The Effect of Toy-Type Nebulizer on Fear and Anxiety in Children Receiving Inhaler Treatment

The aim of this study is to determine the effect of toy-type nebulizers on fear and anxiety in children receiving inhaler therapy.

The research hypotheses are as follows:

H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" during and after the inhaler treatment with a toy-type nebulizer. H1: During and after the s inhaler treatment with the toy-type nebulizer, the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" is significantly higher in the intervention group compared to the control group.

In this study, there will be two groups as the intervention (who will receive inhaler treatment with an education and toy type nebulizer) and the control group (who will not receive training and will receive inhaler treatment with a classic-looking nebulizer). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital.

Inhaler treatment will be applied to both the intervention and control groups. Both the parent and the child in the intervention group will be trained on the use of a nebulizer/mask. The children in the intervention group will be treated with a toy-type nebulizer and the group will be treated with an inhaler, and the control group will be given inhaler treatment with the standard nebulizer in the hospital. Two researchers were employed for the inhaler treatment both for the intervention and control groups. One researcher performed the inhaler treatment for all children and the other researcher helped the children to assess their fear and anxiety level. Fear and anxiety in children were evaluated by the children and their parents who before, during, and the procedure, and five minutes after the procedure. The inhaler treatment procedure was performed by the same researcher both in the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* The child is between the ages of 4-10
* The child's application to the Pediatric Emergency Unit
* Child receiving inhaler treatment for the first time
* Parent and child agreeing to participate in the project
* Absence of speech and visual impairment of the child and his parents

Exclusion Criteria:

* The child is not between the ages of 4-10
* The child's application to another department except for the Pediatric Emergency Unit
* Child not receiving inhaler treatment for the first time
* Parent and child not agreeing to participate in the project
* Having speech and visual impairment of the child and his parents
Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility.

The proposed study aims to perform a split cohort study where each patient's cohort of fertilized zygotes, (two pronuclei or 2PNs) is split into two groups and randomized, thus allowing each patient to serve as their own control and decreasing confounding variables. Half of the cohort will proceed with the current standard of day 3 or cleavage assisted hatching and the other half of the cohort will receive the sequential hatching and trophectoderm biopsy procedure at the blastocyst stage of embryo development.

Eligibility Criteria:
Inclusion Criteria for participants:

1. Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo
2. \<4 2PNs prior to randomization
3. Female partners age \<42 years old at start of VOR cycle
4. Normal ovarian reserve:

   1. AMH ≥ 1.2 ng/mL
   2. AFC ≥ 8
   3. FSH ≤ 12IU/L
5. BMI \<38
6. Patients who desire to transfer the best quality embryo for their embryo transfer.

Exclusion Criteria for participants:

1. All patients who do not voluntarily give their written consent for participation
2. Patients with a prior failed IVF cycle - defined as no blastocysts
3. Patients with a history of more than one failed euploid embryo transfer
4. Donor oocyte cycles
5. Gestational Carriers
6. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
7. Use of surgical procedures to obtain sperm
8. Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
9. Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
10. Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis than standard PGT-A
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.

Medeor Therapeutics is developing a novel cell-based therapy to reprogram the recipients' immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs.

The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.

Eligibility Criteria:
Recipient Inclusion Criteria:

* Planned recipient of a first kidney allograft from an HLA-matched, living related donor
* Age ≥18 and ≤70 years
* Single solid organ recipient (kidney only)
* ABO matched with donor

Recipient Exclusion Criteria:

* Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
* Baseline positive donor-specific anti-HLA antibody testing
* Is taking immunosuppressive therapy
* Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)

Donor Inclusion Criteria:

* HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling or half sibling) relative of the prospective recipient participant
* Age ≥18 and ≤70 years
* Prepared to be a living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells

Donor Exclusion Criteria:

* History of autoimmune disorders
* History of type 1 or type 2 diabetes mellitus
* Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV, T. cruzi, or syphilis
* History of infection with Zika virus
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis

This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients living in Japan with allergic conjunctivitis with itching and redness
* Able and willing to discontinue wearing any contact lenses during the study period.

Exclusion Criteria:

* Eye surgical intervention and/or a history of refractive surgery within 6 months
* History of retinal detachment, diabetic retinopathy, or progressive retinal disease
* Presence of active eye infection (bacterial, viral, or fungal)
* History of an eye herpetic infection
* Use of corticosteroids within 6 months or anticipated use during the study.
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Panorama

The study will enroll up to 375 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of GAD per DSM-5
2. Male or female aged 18 to 74
3. HAM-A Total Score ≥20

Exclusion Criteria:

1. Certain psychiatric disorders (other than generalized anxiety disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
4. Any clinically significant unstable illness
Mindfulness to the Clinical Setting: The Mind Hand Connection Study

This is a single center, randomized study that assessed the effects of mindfulness training on physician teaching teams at a VA hospital.

The primary objective of this study was to evaluate changes in hand hygiene compliance pre- and post- intervention in Internal Medicine physician and medical student inpatient teaching teams. Half of the teaching teams received the intervention of mindfulness education. Blinded observers collected data on hand hygiene compliance and mindfulness behaviors for both teams during patient care rounds for 1-week pre and post intervention. Additionally, the intervention group participated in focus group/interview discussions.

Eligibility Criteria:
Inclusion Criteria:

Internal Medicine attendings, residents, interns and medical students on inpatient patient care teams, able to provide consent

Exclusion Criteria:

Surgical attendings, residents, interns or subspeciality teams, Internal medicine attendings rotating on non-resident teams
Emergence of Fluoroquinolone Resistance in Commensal Flora

The emergence of resistance to fluoroquinolone (FQ) is a major problem worldwide. The commensal flora is the main reservoir for antibiotic resistance. Understanding the factors (environmental, patient-related, dosis-related, drug-related...) involved in the emergence of resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help prevent it and preserve the efficiency of these important antibiotics. Samples of rectal, nasal and pharyngeal flora will be collected from hospitalized patients before receiving a FQ, at the end of the treatment and 1 month after the end of treatment. Clinical data will be collected. The incidence and risk-factors associated with the emergence of resistance to FQ will be assessed by comparing groups with and without resistance both at the end of treatment and 1 month later.

Population involved: Patients hospitalized (\>1day) in one of the two participating university hospitals and receiving a treatment by a fluoroquinolone (FQ) antibiotic.

Number of centers : 2 (SAINT LOUIS and BEAUJON Hospitals, ASSISTANCE PUBLIQUE HOPITAUX DE PARIS, Paris, France).

Expected number of patients : 720

Aim : To study the incidence and risk-factors involved in the emergence of resistance to FQ in the commensal flora during and after treatment by a FQ.

Methods: Nasal, rectal and pharyngeal swabs were performed before, during, and one month after the end of FQ treatment. Microbiological analysis will focus on 3 target bacterial species: Escherichia coli from the faecal flora, alpha-haemolytic streptococci from the pharyngeal flora and non-coagulase staphylococci in the nasal flora. Patients carrying resistance at day 0 in all three flora will be excluded. The incidence and risk-factors of the emergence of resistance to FQ will be assessed at the end of treatment by FQ and 1 month after the end of treatment. Patients having resistant bacteria in their flora at the end and/or after treatment will be compared with those with no resistance.

The same swabs will be collected from a reference group of patients not receiving FQ treatment, but hospitalized in the same wards at the same time as the case patients in order to eventually detect horizontal transmission of FQ-resistant strains in the hospital ward.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation \>24hours in one of the participating wards Treatment by a fluoroquinolone antibiotic.

Exclusion Criteria:

* Pregnancy or breast feeding Patients refusal to participate
Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.

Length of hospitalization for COVID-19 infection may be increased due to the persistence of fatigue in 29-46% of cases. Its management is essential to prevent the chronic fatigue . Chronic fatigue syndrome affected between 30 and 40% of patients with SARS in 2003 or MERS in 2005 and persisted beyond 3 years. There is currently no specific treatment for acute or \<4 months asthenia. To avoid the transition to chronicity, some authors recommend respecting a long rest period. However, a program combining adapted physical activity and therapeutic patient education has already shown significant benefits for combating recent or semi-recent fatigue following a cardiovascular pathology and even during cancer treatments. Therefore, the existing care pathway for hospitalized patients with COVID-19 was adapted, combining exercise training and therapeutic patient education workshops.


Eligibility Criteria:
Inclusion Criteria:

* Patient living in the Loire region, France
* Patient showing post COVID-19 fatigue (RT PCR positive \<1 month)
* Non-intubated patient if hospitalization in intensive care (\<72h)
* Patient hospitalized in a Covid unit at the Saint Etienne Hospital

Exclusion Criteria:

* Patient hospitalized in intensive care \>72h
* Intubated and ventilated patient in intensive care
* Non-hospitalized patient and community-based medical follow-up
Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention

Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are: 1) Black men (self-report); 2) adult age 18 years or older; 3) Life's Essential 8 total average score \< 80; 4) English speaking; and 5) lives in Metropolitan Columbus, Ohio.

Exclusion Criteria:

* healthcare provider-imposed limitations on physical activity.
PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.

Design: The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding chronic and acute wounds consisting of Pressure ulcers and Donor sites.

The rationale for the chosen study design and objectives is based on the requirement for further confirmation of the clinical effectiveness and safety of the dressing in routine clinical use, in terms of management of wound, management of bioburden, maintaining a moist wound environment, and exudate management.

This post market study has been designed to be an in-market clinical evaluation. Using the assessment scale of "satisfactory" or "not satisfactory" will indicate whether the device is acceptable to the Healthcare Professional and therefore demonstrate the acceptability of the Silver I Alginate Non-Woven dressing (Hydro-Alginate).

It is intended to recruit 25-30 subjects per wound type in support of providing evidence of effectiveness and safety of wound dressings. The prior CE-marking evaluation for this device lacked information pertaining to the use of the device in pressure ulcers or donor site wounds. Therefore, this study will address this gap. This study analysis will be descriptive in nature, for each wound type and will not be based on any stand-alone statistical hypotheses.

The study endpoints have been chosen because they will demonstrate the safety and effectiveness of the dressing in routine clinical use.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should provide a negative pregnancy test at screening).
2. Patients who are able to understand and give informed consent to take part in the study.
3. Have one or more of the following: Pressure ulcer or Donor site wounds that are infected, or are at high risk of infection (in the opinion of the Investigator), that are moderate to heavy levels of exudate.
4. Pressure ulcers that are moderate to high exudate, typically Category 3 and 4.
5. Only one primary wound may be treated per patient for the study.

Exclusion Criteria:

1. Patients who are known to be non-compliant with medical treatment,
2. Patients who are known to be sensitive to any of the device components
3. Subject is pregnant or actively breastfeeding;
4. Subject has a known sensitivity to Silver;
5. Life expectancy of \<6 months;
6. Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study;
7. Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.
A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus

The purpose of this study is to collect historical data in real life conditions in a large group of people who have type 1 or type 2 diabetes and were treated with Tresiba® (insulin degludec) for at least 6 months. Data will be collected beginning 6 months before the participant started Tresiba® up to around 6 months after the participant started taking insulin degludec.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient
* Male or female age greater than or equal to 18 years at the time of insulin degludec initiation
* Type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus patients
* Switched to insulin degludec (± prandial insulin) after any basal insulin (± prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with insulin degludec at the time of patient selection
* Previously treated with any basal insulin (± prandial insulin) for at least 6 months prior to switching to insulin degludec
* At least one documented medical visit in the first 6 months (closest value in 3 to 9 months window) after insulin degludec initiation
* Minimum available data at the time of insulin degludec initiation: age, type of diabetes, HbA1c, duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site for at least 1 year, and an estimated glomerular filtration rate (eGFR) value in the last 12 ±6 months (full data period)

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having signed the Informed Consent in this study
* Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba