cyrilzakka/clinical-trials huggingface dataset:
Impact of the Systematic Closure of the Epigastric Trocar on Postoperative Incisional Hernia After Sleeve Gastrectomy Rate of First Intention. Monocentric Study, Before / After Prospective.

The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic booming in recent years.

This is an effective intervention on weight loss over the long term with few early postoperative complications and low morbidity in the long term.

Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a relative risk of 29% in connection with cholecystectomy.

Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical evaluation.

Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric bypass with a rupture rate increased on epigastric trocar. The assessment in the context of this series was ultrasound.

Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an SG of first intention was associated with a hernia rate of 17% with a scannographic evaluation.

Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site would not be as effective as lateralize inserting the trocar from the white line of the abdomen. Change the positioning of this trocar induce an additional difficulty in handling instruments for the realization of the SG with an désaxassion instruments, a conflict between the instruments for the realization of the SG and the optical laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* major patients (≥ 18 years) who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity.

Exclusion Criteria:

* antecedent of previous gastric band.
* History of SG (repeat-SG).
* median laparotomy history or subcostal right.
* SG performed as an ambulatory surgery.
* Patients with early postoperative complications (≤ J90) specific to the SG (postoperative gastric fistula, postoperative bleeding, hematoma or postoperative intra-abdominal abscess)
The Effectiveness of Augmented Reality to Enhance CPAP Therapy in OSA Patients

The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. The main questions it aims to answer are:

Does AR guided CPAP therapy increase the adherence of CPAP therapy among OSA patients? What barriers do participants have when using AR guided CPAP therapy? Researchers will compare AR guided CPAP therapy to a control (standard of care) to see if AR guided CPAP therapy works to enhance the adherence of CPAP therapy.

Participants will:

1. Take AR guided CPAP therapy or standard of care every day for 6 months
2. Visit the clinic on baseline (t0), receiving CPAP therapy at the 1st month (t1), for checkups and tests, receiving CPAP therapy at the 3rd month (t2), receiving CPAP therapy at the 6th month (t3).
3. Response their symptoms on each following time.

Participants will randomly assign to two group, for experimental group will be received AR guided CPAP therapy. In the control group will be received standard of care.

Eligibility Criteria:
Inclusion Criteria:

* (1) Diagnosed with moderate to severe obstructive sleep apnea (AHI≥15) through polysomnography (PSG).
* (2) Age is equal to or greater than 20 years old or equal.

Exclusion Criteria:

* (1) individuals who have previously used positive pressure ventilators for treatment,
* (2) those diagnosed with central sleep apnea,
* (3) those with uncontrolled acute mental illness,
* (4) terminally ill patients.
Evaluation of the Brothers United Fatherhood Program

The Brothers United Fatherhood Program (BUFP) will be conducting an evaluation that builds on literature and existing research from the healthy marriage/responsible fatherhood initiatives developed by ACF over the last 10 years, in particular the Supporting Healthy Marriage Program initiative that established a randomized clinical trial. The Brothers United Fatherhood Program will provide important data to expand the area of fatherhood development with the target population. This program is funded through an initiative of the Administration for Children and Families, Office of Family Assistance (OFA).

The study is intended to measure if the identified interventions improve the well-being and relationship between targeted participants and their families. The study intends to focus on the following outcomes:

* Demonstrate increased intake \& knowledge of systems that help fathers
* Improvement in knowledge of employment \& learn new opportunities for economic mobility
* Improvement communication \& empathy skills towards partner
* Increase in understanding of healthy marriage \& its value to fathers
* Demonstrate an understanding of financial planning
* Demonstrate improved conflict resolution, behavior patterns, including those leading to domestic violence
* Increase in reports of improved adult \& child relationships
* Demonstrate an increase job readiness skills such as employment preparedness \& career direction

Do those who participate in the program result in more positive self-reported attitudes and behaviors than the control group relative to the following:

1. Improved healthy relationship and marriage skills.
2. Improved co-parenting skills
3. Increased frequency of father/child engagement
4. Increased financial responsibility of fathers
5. Progress toward a greater economic stability, including skill attainment and employment.
6. Reduce recidivism?

This reflects intention-to-treat (ITT) analysis where all participants who are enrolled and randomly assigned to treatment are included in the analysis regardless of their adherence with the entry criteria, regardless of subsequent withdrawal from treatment or deviation from the protocol. This will preserve the pragmatic balance generated by the original random treatment allocation.

Also, "per protocol analysis" will be conducted to evaluate if full project participation results in more positive self-reported attitudes and behaviors than the control group participants.

What personal characteristics and other external factors are related to achieving successful outcomes in the program?

Eligibility Criteria:
Inclusion Criteria:

* Participants must be parents between the ages of 20 to 24.

Exclusion Criteria:

* Participants cannot be younger than 20 years of age.
Urine Biomarkers for Renal Function Monitoring in Preterm Infants

The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr) levels in infants are unreliable as a detector of renal function in the first few days of life because they may continue to reflect maternal levels. Although few candidates appear to be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine the reliable urinary biomarkers to detect kidney injuries in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* premature infants born before 37 weeks of gestational age

Exclusion Criteria:

* cardiac or renal anomalies
* transferred in 2 days after birth from other hospitals
A Real-world Study of Tafasitamab in Combination With Lenalidomide in Patients withR/R DLBCL

To evaluate the real-world efficacy of Tafasitamab combined with Lenalidomide base regimen in patients with relapsed or refractory DLBCL, with objective response rate as the primary end point.

This study retrospectively collected the data of patients previously treated with Tafa and divided them into two coords according to different protocols received. Cohort 1 was Tafa combined treatment group, which could include Tafa combined with lenalidomide, Tafa combined with Lenalidomide plus BTK inhibitor, Tafa combined with Lenalidomide plus chemotherapy (including ADC). Cohort 2 was treated with sequential CAR T or graft after Tafa combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathological diagnosis of DLBCL, including but not limited to non-specific DLBCL (NOS-DLBCL); Large B-cell lymphoma (THRLBCL) rich in T cells/histiocytes; EBV positive DLBCL (EBV-positive DLBCL); According to the revised REAL/WHO classification, it was grade 3b follicular lymphoma, including DLBCL component, followed by DLBCL recurrence. In addition, patients with low-grade lymphomas such as follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia have histological evidence of transformation to DLBCL and subsequent recurrence
* Patients who, as determined by the treating physician, would benefit from Tafa treatment

Exclusion Criteria:

* Known allergy or metabolic disorder to any drug in the regimen
* Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
* Have a history of uncontrolled medical disease (including uncontrolled diabetes, severe heart, lung, liver, renal insufficiency), blood, endocrine system, and other malignancies
* Severe mental illness
* Patients deemed unsuitable for inclusion by the investigator
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis

Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe psoriasis involving 3-20% of the body surface area

Exclusion Criteria:

* Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment
* Subjects having psoriasis that involves the scalp, face, or groin
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V

A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.

All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face.

The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI).

Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 60 years old
* Fitzpatrick skin type IV - V
* diagnosed with melasma

Exclusion Criteria:

* pregnancy and breastfeeding
* use of oral contraceptives within six months
* use of topical or systemic melasma therapy within two weeks
* history of superficial peeling within four weeks
* history of dermabrasion within six months
* use of photosensitizer drugs
* history of thrombosis or currently using antithrombotic or anticoagulant drugs
* history of TA allergy
* experiencing any COVID-19 symptoms
Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers

This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples.

General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.


Eligibility Criteria:
CASES:

Inclusion criteria:

* Leishmania positive patient from Italy (n=30) and from Sudan (n=30);
* patient with a clinically or laboratory confirmed diagnosis of leishmaniasis;
* signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM)
* being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp.
* adult subjects (equal or older than 18 years)

Exclusion criteria:

* lack of the necessary data and/or of biological samples
* subjects younger than 18 years

COMMUNITY CONTROLS:

Inclusion criteria:

* Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp.
* signed informed consent to Tropica Biobank
* adult subjects (equal or older than 18 years)
* being negative to two different serological tests for leishmaniasis

Exclusion criteria:

* subjects younger than 18 years
* being positive to one serological tests for leishmaniasis.

VALIDATION CONTROLS (VC):

Inclusion criteria:

* serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy.
* informed consent signed to Tropical Biobank
* adult subjects (equal or older than 18 years)
* being negative to two different serological tests for leishmaniasis.
* being clinically diagnosed with Chagas disease or TB, or malaria or leprosy

Exclusion criteria:

* younger than 18 years
* positive result to one serological test for leishmaniasis.
Friendship Bench for Women Who Use Methamphetamine in Vietnam

The high comorbidity of mental health issues and meth use in women worsens both their mental health and meth use outcomes. The study team proposes to evaluate the potential of Friendship Bench to be used as a low-threshold, task-shifting mental health intervention among women who use methamphetamine in Vietnam - a lower-middle-income country. The study will provide preliminary data for a R01 trial testing the effectiveness Friendship Bench to improve mental health and methamphetamine use outcomes among women who use methamphetamine in Vietnam.

The specific aims of this research proposal are to: (1) assess the mental health needs of WWUM in Haiphong, (2) adapt Friendship Bench to the specific needs of Vietnamese WWUM and (3) assess the feasibility, fidelity, and acceptability of the adapted Friendship Bench for common mental disorders among WWUM and preliminary indicators of its impact in improving their mental health and methamphetamine use in a two-arm randomized trial, comparing Friendship Bench with usual psychiatric care.

Eligibility Criteria:
Inclusion Criteria:

* Adult women (\>=18 years old)
* Moderate or greater risk for meth use (ASSIST ≥ 4)
* Moderate or greater CMD symptom severity (Depression ≥ 10, Anxiety ≥ 8, and/or Stress ≥ 15 on DASS-21)

Exclusion Criteria:

* Severe psychotic disorders or other interfering problems that require specialty care;
* Inability to understand study procedures by the research team's judgment.
Pilates Based Exercises in Patients With Behçet and Familial Mediterranean Fever.

Behcet's disease (BD) is a chronic systemic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthritis, arthralgia, enthesitis and sacroiliitis can be seen in the course of BD. Familial Mediterranean fever (FMF) is the most frequent autoinflammatory disease (AID) and characterized by selflimited episodes of fever and polyserositis. It is the most common monogenic periodic fever syndrome that affects mainly the people of Mediterranean descent. Regular physical activity involving aerobic and strengthening programs in inflammatory rheumatic diseases has a long-term anti-inflammatory effect. Eccentric exercises cause an acute increase in TNF alpha level and should be avoided especially at the beginning. It has been stated that patients should be encouraged about aerobic exercise programs where the intensity is gradually increased, starting with low intensity. Pilates method is the mind and body centering technique developed by Joseph Hubertus Pilates, based on providing lumbopelvic stability. FMF and BH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. When we look at the literature, there is no study on the effectiveness of exercise applications in FMF and Behçet patients. The purpose of our study; It is the comparison of the effectiveness of physical activity in patients diagnosed with Behçet and FMF and healthy individuals. In this context, with the short form of the International Physical Activity Evaluation Questionnaire, Behçet's patients whose physical activity level is inactive will be Group 1, FMF patients Group 2 and healthy controls with similar demographic characteristics will be Group 3. Pilates based exercise program will be applied to all 3 groups for 8 weeks, 2 times a week.


Eligibility Criteria:
Inclusion Criteria:

* Being inactive or minimally active according to the International Physical Activity Survey
* Being between the ages of 18-65
* Being diagnosed with FMF at least 1 year ago according to diagnostic criteria
* A diagnosis of BH at least 1 year ago according to the International Behçet Working Group
* Having a cooperative level that can adapt to the evaluation and exercise program

Exclusion Criteria:

* Those with any central nervous system involvement that may interfere with exercise
* Those who do not want to participate in the study
* Pregnant women
* Having other chronic diseases
* Psychiatric disorders and treated
* Those with cognitive impairment
Obeticholic Acid in Pediatric Subjects With Biliary Atresia

This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in pediatric subjects with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterosomy). The OLE will continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of OCA. In addition, a change in vitamin A and D levels, and where possible the degree of change in liver stiffness, will be assessed during the OLE.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female pediatric subjects ≥2 to \<18 years old
2. Diagnosis of biliary atresia
3. Demonstrated successful HPE (also known as Kasai portoenterostomy) as defined by total bilirubin \<2 mg/dL (34.2 μmol/L) at least 3 months post-HPE procedure.
4. Able to swallow tablets (ie, tablet or mini-tablet formulation)

Key Exclusion Criteria:

1. Prior liver transplant or active status on transplant list
2. Conjugated (direct) bilirubin ≥ULN of site specific reference range
3. If conjugated bilirubin is not available: total bilirubin ≥2 mg/dL (34.2 μmol/L)
4. Platelets \<150,000/μL
5. INR ≥1.5
6. Current or history of complications of decompensated chronic liver disease including:

   1. high-risk gastroesophageal varices and/or variceal bleeding
   2. clinically evident ascites related to portal hypertension
   3. hepatic encephalopathy
   4. prior placement of portosystemic shunt
   5. hepatopulmonary syndrome or portopulmonary hypertension
   6. hepatorenal syndrome
7. Current intractable pruritus or requires systemic treatment for pruritus within 3 months of Screening (e.g., with bile acid sequestrants or rifampicin)
8. Height and weight Z-score \<-2 per site specific ranges
9. Acholic (pale) stools
10. AST \>4x ULN
11. ALT \>4x ULN
12. GGT \>500 U/L
13. Anticoagulation therapy
14. Albumin \<3.5 g/dL
15. Ongoing current cholangitis
16. Choledochal cystic disease
17. Renal disease defined as serum creatinine \>ULN for subject's age, prior to enrollment
New in Town-Internet Intervention for Migrants

New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. The study aim is to evaluate its effectiveness.

The number of migrants worldwide is growing rapidly over the past years. Migration often requires creating a whole new social network. There is something that can help migrants to do it-their beliefs. Social self-efficacy is confidence in ability to engage in social interactional tasks necessary to initiate and maintain interpersonal relationships. These beliefs are positively related to social adjustment and negatively related to acculturative stress, depression, and loneliness. Therefore, social self-efficacy may be potentially beneficial for the psychological adjustment of migrants helping them establish new connections in the social environment. Based on this observation the investigators have created New in Town, an internet intervention. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states.

The effectiveness of New in Town intervention will be tested in a two-arm randomized controlled trial with waitlist control group. Primary outcome is social self-efficacy, and secondary outcomes include loneliness, perceived social support, and satisfaction with life. Other measure of interest is system usability. Participants will be assessed at pre-test (T1), 3-week post-tests (T2), as well as 8-week follow-up (T3). The investigators aim to analyze the effect size of the intervention and between-groups comparisons at post-test and follow-up.

This study will provide insights into the effectiveness of an internet intervention in increasing social self-efficacy, perceived social support and satisfaction with life, and reducing loneliness.

Eligibility Criteria:
Inclusion Criteria:

* age of at least 18 years
* having changed the place of residence in the last 6 months

Exclusion Criteria:

- no access to a internet
Role of Irisin/FNDC5 (rs3480) Single Nucleotide Polymorphism in Breast Cancer

Breast cancer is the most frequent cancer in women worldwide. Its incidence is increasing but mortality has decreased in a considerable way due to the combined effect of early detection and improvement in treatment .

Irisin is encoded by the FNDC5 gene, whose expression is controlled by the peroxi- some proliferator activated receptor gamma coactivator 1 alpha (PGC-1α). PGC-1α is a transcriptional co-activator which does not bind directly to DNA. Studies indicated that the estrogen-related receptor alpha (ERRα) could be a factor that plays a role in PGC-1α binding to DNA. ERRα is encoded by the ESRRA gene and is an orphan nuclear receptor, which has two domains. One of them allows the interaction with DNA, and the second one with a ligand. The ERRα structure is similar to that of the estrogen receptor alpha (ERα), but this receptor does not bind to natural estrogens. ERRα interacts with a canonical sequence of the estrogen response elements (ERRE). ERRα and ERα could compete with each other to bind to similar DNA elements. Together, ERRα binds to DNA, in complex with PGC-1α, to regulate the activity of genes such as FNDC5 .

CA15-3, a high molecular weight glycoprotein (300-450 kDa), is produced by the epithelial ducts and acinic breast cells and is then secreted in milk normally. It has been widely used for the prediction of bone metastases in patients with breast cancer .


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed breast cancer

Exclusion Criteria:

* • History of other tumors.