cyrilzakka/clinical-trials huggingface dataset:
Psychoeducational Simulation Game for Adults in Stepfamilies

Recent evidence has shown that intervention programs for remarried people are scarce.

Furthermore, from what is known, no specific intervention models (traditional or web-based) has yet been developed for remarried Portuguese population. This study evaluates the efficacy of a web-based Psychoeducational Simulation Game on marital adjustment on marital social skills, on remarriage beliefs, on parenting attitudes, and on the stepfamily functioning.

This study will compare the efficacy of a Simulation Game Intervention versus control (no game) in remarried people that have (step)children. The participants will be randomized to the two groups. The Simulation Game contains three different modules to play: Module 1 - Conjugality (emotional divorce, financial issues, positive communication skills, conflict and stress management strategies, social support); Module 2 - Step-parenting (positive stepparent-stepchild relationships, development of relationships within stepfamily, step-parenting roles negotiation, stepfamily' unrealistic beliefs and develop share meaning); Module 3 - Co-parenting (positive co-parenting strategies and loyalty binds).

Eligibility Criteria:
Inclusion Criteria:

* Live in a Stepfamily
* Relationship length minimum of six months

Exclusion Criteria:

* Not having (step)children
* Not cohabiting with the spouse
Self-Compassion Against Burnout in Dentistry

Although studies have highlighted the relationship between stress-related psychopathological symptoms and changes in biochemical parameters, no study in dentistry has concurrently evaluated the association of stress and relaxation with biochemical markers and psychological parameters. Moreover, the impact of mindfulness-based self-compassion training programs on these variables has yet to be explored within this context. To enhance the well-being of dentists, an evaluation of a test group participating in an 8-week Mindfulness-Based Compassionate Living (MBCL) program was conducted. This assessment included daily cortisol curves, as well as salivary IL-6, IL-1β, and oxytocin levels. Additionally, empathy, burnout, self-compassion, depression, and mindfulness levels were measured before and after the training. In this study, the main hypothesis was that, compared to the control group, the test group would exhibit lower IL-1β, IL-6, and cortisol levels, along with higher oxytocin levels. Furthermore, as the secondary hypotheses was that the test group would demonstrate increased empathy, self-compassion, and mindfulness levels, accompanied by reductions in depression and burnout scores.


Eligibility Criteria:
Inclusion Criteria:

* dentists in their final year of specialty training at the Faculty of Dentistry,
* systemicaly healthy

Exclusion Criteria:

* individuals who received a diagnosis of mood disorders based on DSM-5 criteria following a standard diagnostic assessment conducted by psychiatrists from the Department of Psychiatry
Senescence in Chronic Kidney Disease

The study goal is to assess the effect of senescent cell clearance on senescence burden, physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC) functionality in patients with chronic kidney disease (CKD).

The proposed studies will examine cellular senescence and the effect of senolytic therapy on senescent cell burden, frailty, and adipose-derived mesenchymal stem cell function in individuals with diabetic chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40-80 years
2. Chronic kidney disease estimated glomerular filtration rate (eGFR) 15-45 ml/min/1.73m2
3. Diabetes mellitus and taking diabetes medications

Exclusion Criteria:

1. Concomitant glomerulonephritis,
2. Nephrotic syndrome,
3. Solid organ transplantation,
4. Autosomal dominant or recessive polycystic kidney disease,
5. Known renovascular disease,
6. Pregnancy,
7. Active immunosuppression therapy,
8. Hemoglobin A1c≥10% at screening,
9. History of active substance abuse (including alcohol) within the past 2 years,
10. Current alcohol abuse (\>3 alcoholic beverages/day or \>21 per week),
11. Body weight \>150 kg or body mass index\>50
12. Human immunodeficiency virus infection
13. Active hepatitis B or C infection
14. Tyrosine kinase inhibitor therapy
15. Known hypersensitivity or allergy to dasatinib or quercetin
16. Inability to give informed consent
17. Uncontrolled systemic lupus erythematosus
18. Uncontrolled pleural/pericardial effusions or ascites
19. New invasive cancer except non-melanoma skin cancers
20. Invasive fungal or viral infection
21. Inability to tolerate oral medications
22. Total bilirubin\>2x upper limit of normal
23. Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.
24. Subjects on strong inhibitors of CYP3A4.
25. Subjects on therapeutic doses of anticoagulants (Warfarin (Coumadin);Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa) or Other).
26. Subjects on antiplatelet agents ((Clopidogrel (Plavix); Dipyridamole + Asprin (Aggrenox); Ticagrelor (Brilinta); Prasugrel (Effient); Ticlopidine (Ticlid) or Other) who are unable or unwilling to reduce or hold therapy prior to and during the 3-day drug dosing. Subjects may continue their previous regimen on day 4.
27. Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days
28. Subjects taking H2-antagonists or proton pump inhibitors and unwilling to discontinue therapy 1 week prior and 2 weeks following enrollment.
29. Corrected QT interval (QTc)\>450 msec
30. Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial.
LACH-Trial: LAparoscopic Correction of Hernia

Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain.

The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.

One of the complications in laparoscopic incisional / ventral hernia repair is postoperative pain. Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of this postoperative pain. Fixation of the mesh might also influence other outcome parameters such as return to preoperative activities, costs and recurrence rate.

The study hypothesis is that there is no difference in postoperative pain when comparing three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia repair.

Eligibility Criteria:
Inclusion Criteria:

* Non-acute incisional hernia of the abdominal wall or ventral hernia of the abdominal wall
* Informed consent
* Elective surgery

Exclusion Criteria:

* \< 18 years and \> 80 years
* Prednison \> 15 mg/24hr, started more than 2 weeks prior to surgery
* Chronical cough (severe COPD etc)
* Ascites
* Peritoneal dialysis
* Current abdominal infection
* Complete loss of abdominal domain due to hernia (diameter more than 10 cm?)
* Re-laparoscopic correction of ventral hernia
Acute Effects of Passive and Proprioceptive Neuromuscular Facilitation Stretching Techniques in Youth Basketball Players

The aim of this clinical trial is to learn the acute effects of passive stretching and proprioceptive neuromuscular facilitation (PNF) stretching techniques on agility, speed and lower extremity explosive strength in young basketball players. It will also provide information about the comparison of two different stretching techniques. The main questions it aims to answer are:

Does passive stretching have positive acute effects on agility, speed and lower extremity explosive strength? Does PNF stretching have positive acute effects on agility, speed and lower extremity explosive strength? The acute effects of passive stretching and PNF stretching on agility, speed and lower extremity explosive strength will be compared.

Participants:

First tests were performed after the same warm-up program. Then, one of the two different stretching techniques was applied and the same tests were repeated immediately afterwards.

The aim of this study was to examine the acute effects of static passive and proprioceptive neuromuscular facilitation (PNF) stretching techniques on agility, speed and lower extremity explosive power in youth basketball players. Twenty male basketball players were randomized as passive and PNF groups. A single session of technique was applied to each group. Outcome measurements consisted of the T Agility Test, 30-Meter Sprint Test, Standing Long Jump Test, and Lateral Jump Test.

Eligibility Criteria:
Inclusion Criteria:

* being male
* being between 14-18 years of age
* having at least 2 years of basketball experience
* participated in regular team training for at least 2 months
* having a body mass index of \&lt;29.9 kg/m2

Exclusion Criteria:

* presence of pain and/or history of injury in the lower extremity within the last 6 months
* history of orthopedic surgery of the lower extremity
Memorisation of Phonologic Information Among Children With Oral Language Developement Disorder

The disorder of oral language development is defined by the delay in language acquisition in children who possess efficient auditory acuity and normal non verbal intellect.

The diversity of language developement disorders depends either in the expressive level or in the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms are regrouped under the name of STOL (Specific Troubles of Oral Language).

In the current project the visual exploitation and learning capability of children presenting a STOL condition will be compared to patients with a normal development. The investigator's hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7 years of age will present a better performance at verbal memorisation, compared to patients with a persistent STOL condition after the age of 6.


Eligibility Criteria:
Inclusion Criteria for STOL patients:

* Child aged between 45 and 95 months at inclusion
* A score \> or equal to 5 percentile on the non verbal intelligence test (PM47)
* Patient diagnosed with STOL by the neuropediatric medical team
* Coverage of the social insurance
* Consent form signed by the parents or the legal representative of the child
* Normal or corrected sight
* Normal hearing

Inclusion Criteria for control patients:

* Child aged between 45 and 95 months on the day of inclusion
* A score \> or equal to 5 percentile on the non verbal intelligence test (PM47)
* Child who did not receive any speech therapy
* Coverage of the social insurance
* Consent form signed by the parents or the legal representative of the child
* Normal or corrected sight
* Normal hearing

Exclusion Criteria for STOL patients:

* Mother language other than French
* Score \< to 5 percentile on the non verbal intelligence test (PM47)
* Child with pervasive developmental disorder

Exclusion Criteria for control patients:

* Mother language other than French
* Score \< to 5 percentile on the non verbal intelligence test (PM47)
* Child who received speech therapy
The Clinical Study of Botulinum Toxin Type A Injection in the Treatment of Wilson Disease

In order to expand the treatment of Wilson disease and improve the quality of life of patients with Wilson's disease, the clinical effect of botulinum toxin type A injection on Wilson's disease was discussed.


Eligibility Criteria:
Inclusion Criteria：1.Conform to the diagnosis of "2012 European Liver Study Guidelines for Diagnosis and Treatment of hepatolenticular degeneration". 2. Aged from 15 to 65 years.

Exclusion Criteria:Non-Wilson's disease
Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels

The primary objective of this study is to determine any causative or associated factors for the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), or related diagnosis. Our primary focus will be on the previous administration of gadolinium to these patients, but we will also look at other postulated causes and risk factors.

The secondary objective of this study is to assess tissue gadolinium (Gd) levels in five groups of subjects:

* Those affected by NSF.
* Those with normal kidney function who have undergone a medical imaging procedure using Gd-based contrast agent (GBCA) in the 2 years prior to a skin biopsy.
* Those with normal kidney function who have never been exposed to GBCA and have had a skin biopsy.
* Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have had a medical imaging procedure using GBCA in the 2 years prior to skin biopsy.
* Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have never been exposed to GBCA and have had skin biopsy.

We hypothesize that there is a correlation between the administration of Gd-containing agents usually associated with MRI procedures and the development of NSF in those with renal failure and some other predisposing condition. We also hypothesize that tissue Gd levels in those with NSF will be higher than in those who have been exposed to GBCA but do not have NSF. Of the two groups without NSF but with exposure to GBCA, we hypothesize that those with kidney dysfunction will have higher tissue Gd levels than those with normal kidney function. We hypothesize that in the two groups of subjects without exposure to GBCA, there will be no detectable levels of Gd, regardless of kidney function status.


Eligibility Criteria:
NSF group

Inclusion Criteria:

* Biopsy-confirmed diagnosis of NSF

Exclusion Criteria:

* Does not have NSF

Normal renal plus gadolinium exposure

Inclusion Criteria:

* eGFR \>30
* Existing skin tissue sample
* Gadolinium exposure in 2 years preceding skin biopsy

Exclusion Criteria:

* Does not fit inclusion criteria

Abnormal renal plus gadolinium exposure

Inclusion Criteria:

* eGFR \<30 or on dialysis
* Existing skin tissue sample
* Gadolinium exposure in 2 years preceding skin biopsy

Exclusion Criteria:

* Does not fit inclusion criteria

Abnormal renal without gadolinium exposure

Inclusion Criteria:

* eGFR \<30 or on dialysis
* Existing skin tissue sample
* No gadolinium exposure ever

Exclusion Criteria:

* Does not fit inclusion criteria

Normal renal without gadolinium exposure

Inclusion Criteria:

* eGFR \>30
* Existing skin tissue sample
* No gadolinium exposure ever

Exclusion Criteria:

* Does not fit inclusion criteria

Controls (neonatal)

Inclusion Criteria:

* Existing skin biopsy tissue that was performed within the first 6 months of life

Exclusion criteria:

* Does not fit inclusion criteria
Burning Mouth Syndrome Mouth Guard Prospective Study

This study will seek to test the effectiveness of a nonpharmacologic therapy for burning mouth syndrome (BMS). This nonpharmacologic therapy approach will be the fabrication a protective acrylic mouthguard for the maxillary arch and palate.

The study involves a nonpharmacologic and non-invasive treatment method for BMS which will be administered randomly (flipping a coin) to half of the study subjects, (case group) in addition to normal condition treatment protocol for BMS.

Eligibility Criteria:
Inclusion Criteria:

• New patients diagnosed with BMS seen in the oral medicine clinic for the study period.

Exclusion criteria includes:

• Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis

Inclusion Criteria:
Dietary Analysis for Caries Prevention in Children Using a Computer Software

Children will be recruited from the pediatric dentistry clinic of Marquette University at their first or recall appointment and will be asked to fill a questionnaire regarding their dietary habits. Afterwards a dietary analysis will be performed using a computer software, developed for this study and dietary instructions will be given to the children.


Eligibility Criteria:
Inclusion Criteria:

* Free medical history
* Informed Consent

Exclusion Criteria:

* General disease
Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App

This project addresses three important research questions. First, adolescents and young adults (AYA) with sickle cell disease (SCD) and their parents/caregivers will be engaged to inform the (1) domains of health-related quality of life (HRQOL) most important to them, (2) frequency at which they are willing to complete them, and (3) other procedures related to the use, uptake and effect of the HU-Go app as a tool to improve hydroxyurea (HU) adherence. Second, this study seeks to utilize novel modern mobile technology using a multi-functional personalized platform to improve adherence to HU and measure HRQOL in youth with SCD, using NIH-endorsed PROMIS® measures, based on a conceptual model with predefined behavioral targets and mediators. Third, we plan to assess HRQOL changes and identify modifiable behavioral strategies that could serve as surrogates or predictors for HU adherence. This real-time feedback might empower self-directed changes in behavior that could improve adherence to HU.

Aim 1: Identify the needs, desires, concerns, and expectations of AYA patients with SCD and their parents/caregivers that will guide implementation of a mHealth tool, HU-Go, designed to improve adherence to HU. We will conduct semi-structured interviews with patients and their parents/caregivers. Transcripts will be independently coded and thematic analysis will be conducted.

Hypothesis 1: AYA patients with SCD and their parents/caregivers will identify specific features, content, and usability requirements of HU-Go.

Aim 2: Assess the longitudinal relationship of HU adherence to HRQoL domains, including fatigue and depression. HU adherence will be measured using electronic pill bottles, self-report measures, laboratory markers, and medication possession ratio (MPR). HRQOL will be assessed using PROMIS® measures.

Hypothesis 2: Low HU adherence is associated with impairment of HRQoL domains.

Aim 3: Conduct a single-arm, pilot study to determine the effect size associated with improvement in HU adherence after using HU-Go for 12 weeks. Adherence will be measured using self-report measures, laboratory markers and MPR.

Hypothesis 3: HU-Go will improve HU adherence by at least 20%.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 years old at the time of study enrollment
* Diagnosis of sickle cell disease (hemoglobin SS or SC or S/B 0 thalassemia) confirmed by hemoglobin electrophoresis
* On hydroxyurea
* Own or have access to a smartphone
* Be able to speak and read English

Exclusion Criteria:

* Chronic monthly transfusion support
* Any hemoglobinopathy other than sickle cell disease
Nepafenac Once Daily for Macular Edema - Study 1

The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
* History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
* Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
* Understand and sign an informed consent document;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pre-existing macular edema in the study eye;
* History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
* Planned cataract surgery in the fellow eye after randomization and prior to the Day 90 postoperative study visit or through study exit;
* Planned multiple procedures for the study eye during the cataract/intraocular lens implantation surgery;
* Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
* Participation in any other clinical study within 30 days of the screening visit;
* Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
* Other protocol-defined exclusion criteria may apply.
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management

Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)

Comparing effectiveness of single dose 0.2mg/kg Ivermectin (IVM) plus hydroxychloroquine (HCQ) 400mg BID in first day then 200mg BID for 5 days plus azithromycin (AZT) 500mg in first day then 250mg for 5 days.

The comparison group was a historical control population and data collected from the current study were compared to that historical control population

Eligibility Criteria:
Inclusion Criteria:

-1. Patients with age above 18 years and any gender with definite Dx of covid19 and pneumonia in the ward according to the clinical, laboratory, and imaging criteria.

2. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

1. Patients with hypersensitivity or severe adverse effects to Ivermectin
2. Renal impairment
3. Hepatic impairment.
4. Pregnancy or a desire to become pregnant (drug considered pregnancy category c)
5. Breast feeding.
6. Patient with covid 19 positive and mild no pneumonia
7. Children under the age of five or those who weigh less than 15 kilograms
Nasopharyngeal Packing and Rhinologic Surgery.

The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old adult patient
* nasal and/or paranasal sinus surgeries
* general anesthesia

Exclusion Criteria:

* patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy)
* patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment)
* patients presenting contraindications for using nonsteroid anti-inflammatory drugs