cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Games for Elderly Socialization

A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course for beginners will participate in the study. The evaluation will consist mainly in answering two validated questionnaires on socialization, the short Social and Emotional Loneliness Scale for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and performance will also be measured by three virtual reality games, namely Reaction Time, Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics classes which includes 15 minutes for practicing virtual reality games.

Background: The use of new Technologies, such as the resources of augmentative and alternative communication (AAC), appears as a valuable tool to promote socialization in many groups of people. Serious games with virtual reality are an example of these resources and might bring benefits also to the elderly population, allowing an enjoyable and safe interaction that uses various sensorial stimuli. The purpose of this study protocol is to evaluate the effects of practicing virtual reality games on elderly socialization.

Method/Design: It will be an experimental, prospective longitudinal study which will use serious games with virtual reality to improve the socialization of elderly people. A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course for beginners will participate in the study. The evaluation will consist mainly in answering two validated questionnaires on socialization, the short Social and Emotional Loneliness Scale for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and performance will also be measured by three virtual reality games, namely Reaction Time, Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics classes which includes 15 minutes for practicing virtual reality games.

Discussion: This study will determine whether the practice of virtual reality games in addition to the usual informatics classes contributes to elderly socialization. The evolution in socialization, the evolution of reaction time and performance in virtual reality games and the correlation of motor learning to socialization will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* people aged over 60 years;
* both sexes
* spontaneously enrolled in the informatics beginner class for seniors of the Center of Reference for Elderly (CRI) in Ribeirão Pires

Exclusion Criteria:

* Less than 75% of frequency in the classes between the assessments;
* do not completion of the three moments of assessment;
* having motor impairment of the upper limbs or cognition impairment,which prevents them to practice the games.
Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy

The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal).

A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of bladder carcinoma (\>50% urothelial carcinoma)
* Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy
* Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0
* ECOG performance status of 0-1 (Appendix 2).
* No evidence of metastases within 4 weeks of registration
* Adequate organ and marrow function obtained within 14 days of registration

Exclusion Criteria:

* Severe or uncontrolled acute or chronic medical or psychiatric condition
* Prior antiangiogenic therapy
* Prior pelvic radiation for bladder cancer
Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle

Multicenter prospective observational cohort study, comparing ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of the transfer versus those who have a stable or greater endometrial thickness with respect to the estrogenic phase.

Multicenter prospective observational cohort study. Based on our sample size calculation, the study group will consist of 206 women (exposed or "compaction" group: 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase and the day of embryo transfer; non-exposed "non-compaction" group: 103 women with similar or greater endometrial thickness between these time points). The main objective of this study is to compare the ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of transfer versus those who with a stable or greater endometrial thickness with respect to the estrogenic phase. The estimated duration of the study is 24-30 months. Inclusion criteria are: 18 to 50 years of age, with primary or secondary infertility, subjected to endometrial preparation in a modified natural cycle for transfer of a genetically euploid blastocyst, from their own oocyte or oocyte donation, with a normal uterine cavity. Exclusion criteria are: uterine or endometrial disease (e.g., multiple myomatosis, severe adenomyosis, Asherman syndrome, refractory endometrium), conditions that prevent correct ultrasound assessment (tilted uterus), or a history of recurrent implantation failure or repeated miscarriages.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 50 years
* Primary or secondary infertility
* Normal uterine cavity
* Endometrial preparation in a modified natural cycle for single embryo transfer
* Embryo in blastocyst state from own oocyte or oocyte donation cycles, who had normal results on preimplantation genetic testing for aneuploidy (PGT-A) via trophectoderm biopsy.

Exclusion Criteria:

* Uterine or endometrial disease (multiple myomatosis \[\>3 fibroids of \> 3 cm\], adenomyosis, Asherman syndrome)
* Difficulties in correctly measuring endometrial thickness due to a retroverted or tilted uterus
* History of recurrent implantation failure (3 or more transferred blastocysts of good quality, from their own oocyte \[\<35 years\] or oocyte donation); recurrent early Pregnancy Loss (the loss of two or more pregnancies before 10 weeks of gestational age.
* Suboptimal endometrial response (endometrium \< 6 mm on the day of ovulation triggering).
Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?

To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.

The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.

Eligibility Criteria:
Inclusion Criteria:

* Age group: 3 years to 18 years
* General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)

Exclusion Criteria:

* Patients who are allergic to acetaminophen and/or ibuprofen
* Patients being evaluated by SANE or evaluated for nonaccidental trauma
* Patients admitted post-op

The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.
Pilot Study of Immediate HIV Treatment in Guangxi, China

The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to decrease mortality related to HIV.

The study's proposed mechanism of decreasing mortality rates is to shorten the time between initial HIV screening and ART implementation to within two weeks.

The study population consists of participants who received an initial HIV infection diagnosis within the study period. Medical institutions will provide "one-stop services" by following detailed guidelines regarding reporting of positive HIV antibody screenings, further testing procedures, and treatment referrals in accordance with a pre-determined timetable. In addition, additional strategies focusing on policy development, medical personnel training, and a broad general public education campaign will be implemented.

Main assessment measures are HIV-related mortality rates, treatment coverage, or other health outcomes.

The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to decrease mortality related to HIV/AIDS. In past years, Guangxi has experienced a relatively high rate of late HIV diagnoses, which has contributed to a significant proportion of HIV-related deaths occurring in the same year of initial diagnosis. The study's proposed mechanism of decreasing mortality rates is to shorten the time between initial HIV screening and ART implementation to within two weeks.

Two pilot sites were selected based on past core assessment indicators. The study population consists of participants who received an initial HIV infection diagnosis within the study period. Medical institutions will provide "one-stop services" by following detailed guidelines regarding reporting of positive HIV antibody screenings, further testing procedures, and treatment referrals in accordance with a pre-determined timetable. In addition, additional strategies focusing on policy development, medical personnel training, and a broad general public education campaign will be implemented.

The study will be performed from July,2012 to July,2015. Main assessment measures are HIV-related mortality rates, treatment coverage, or other health outcomes.

1. HIV-related mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.
2. Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of HIV infection as defined by having positive HIV antibody screening results between July 1, 2012 and July 1, 2015 OR
* Having a current residential address inside of pilot site limits

Exclusion criteria:

* Current residing outside of the borders of the designated study sites
Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

Sixty female patients with lymphedema post mastectomy, aged 30-55 years, will be selected from Minia Oncology Institute. The participants will be randomly distributed into two equal groups:

1. Group A (CDT + Underwater Galvanic Stimulation group):

   This group includes 30 patients who will receive underwater galvanic stimulation by 4-cell bath with CDT for 2 months (3times/week) in addition to their medical treatment.
2. Group B (CDT group):

This group includes 30 patients who will receive only CDT for 2 months (3times/week) in addition to their medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* ▪ Female patients with lymphedema post mastectomy

  * Aged 30-55 years
  * No history of cardiac or renal disease
  * No contraindications to electrotherapy
  * All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* ▪ Cardiac diseases.

  * Patients with active cancer
  * Patients with pacemakers or other implantable devices
  * Patients with a history of seizures or epilepsy
Effectiveness of Educational Games to Implementation Clinical Practice Guidelines to Family Medicine Residents in Spain.

A multicenter study to evaluate the effectiveness of a teaching strategy based on the incorporation of educational games with simulated settings versus usual practice based on diffusion for the implementation of clinical practice guidelines in Family Medicine Residency Program. The impact of the new strategy will be measured in improving knowledge and skill acquisition in clinical decision making of Family Medicine Residency Program after 6 months. Effectiveness will also be measured a month and 12 months after intervention.

Objective: To evaluate the effectiveness of educational games to implementation practice guidelines to acquire skills in clinical decision-making by family medicine residents in Spain.

Secondary objectives: To describe the strategies utilized in Residency Program in Family Medicine in Spain to teach the use of practice guidelines. To identify barriers and facilitators for the use of practice guidelines for family medicine residents.

Setting: Unit Family Medicine in Spain. Study design: Multicentric cluster randomised controlled clinical trial. Population: Family Medicine Residents of second and third year. Sample size: 394 residents (197 in each arm). The randomization units will be units (clusters). The units of analysis are professionals (residents). Variables: Main outcome variable measured in both groups: assess of skill levels and number of correct answers about clinical questions in diabetes, anxiety disorders, antibiotic prescription and insomnia clinical practice guidelines in primary care.

Sociodemographic variables and educational variables for each subject and variables regarding Residency Program in Family Medicine.

Intervention: EDUCAGUIA plan. Incorporating educational games online for each guideline.

Statistical Analysis: Primary and secondary effectiveness. Adjusting by contextual and individual variables factors with mixed effects models (lineal regression) (dependent variable: points obtained in educational games in each guide).

Eligibility Criteria:
Inclusion Criteria:

* Second and third year residents in Family Medicine Program.

Exclusion Criteria:

* Giving up the Family Medicine Program.
Aerobic Versus Combined Exercise and Diastolic Dysfunction

Thirty-two stable patients with chronic heart failure participated in an exercise rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic and strength training (COM). Before and after the program, they underwent a symptom-limited maximal cardiopulmonary exercise testing and serial echocardiography evaluation examining the indices of diastolic dysfunction (DD).

Thirty-two stable patients with chronic heart failure (age: 56 ± 10 years, EF: 32 ± 8%, 88 % men) participated in an exercise rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic and strength training (COM), based on age and peak oxygen uptake, as stratified randomization criteria. Before and after the program, they underwent a symptom-limited maximal cardiopulmonary exercise testing (CPET) and serial echocardiography assessment to evaluate peak oxygen uptake (VO2peak), peak workload (Wpeak), DD grade, right ventricular systolic pressure (RVSP) and EF.

Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure

Exclusion Criteria:

* atrial fibrillation COPD
Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

In this double-blinded randomized clinical trial, patients presenting periodontal intrabony defects requiring regenerative surgery and showing BoP will be included. Experimental sites at T-0 will be randomly treated with gentle debridement and administration of local DOX (test group) or with debridement alone (control group). After 2 weeks (T-1), defects will be treated by means of minimally invasive surgical technique. 14 days after the surgery (T-2) the EHI will be evaluated by a blinded examiner. Patients will be recalled each 2 months up to 12 months (T-3). At T-0, T-1 and T-3 periodontal examination and radiographic analysis will be done.


Eligibility Criteria:
Inclusion Criteria:

* 1) diagnosis of Stage III or IV periodontitis (Tonetti et al. 2018);
* 2) FMPS and FMBS \< 15% at the time of enrollment;
* 3) etiological periodontal therapy completed at least 3 months prior to screening;
* 4) presence of one natural tooth having a vertical defect with residual PPD ≥ 6 mm and a radiographic intrabony component ≥ 3 mm and BoP + requiring periodontal regenerative surgery.

Exclusion Criteria:

* 1) age \< 18 years;
* 2) smoking habits (\> 10 cigarettes/day);
* 3) contraindications for periodontal surgery;
* 4) systemic diseases affecting periodontal healing;
* 5) pregnancy and lactation;
* 6) history of periodontal surgery at the experimental teeth;
* 7) allergies to doxycycline and tetracyclines;
* 8) assumption of antibiotics in the last 3 months.
Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill

In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome.

Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.


Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients requiring ICU admission for at least 48 hours
* Adults

Exclusion Criteria:

* Chronic small bowel disease
* Chronic renal failure (clearance of creatinine \< 50 mL/min)
* Pregnancy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy (ENCORE)

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.

Eligibility Criteria:
Inclusion Criteria:

* Completed the treatment period of Study AXS-12-301
* Willing and able to comply with the study requirements

Exclusion Criteria:

* Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12
Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization

The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria:

* None
Study of Eteplirsen in DMD Patients

The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658) in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51. Additional objectives include evaluation of safety, biomarkers and the long-term effects of eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).

This is an open-label, multi-center study to evaluate the efficacy and safety of eteplirsen in patients with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic deletions amenable to exon 51 skipping (treated group), with a concurrent control arm of DMD patients not amenable to exon 51 skipping (untreated group). Following primary efficacy endpoints, dosing will continue to week 144 to evaluate the long term effects of eteplirsen.

Patients in the treated group will receive once weekly intravenous (IV) infusions of 30 mg/kg Eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks). Patients in the untreated group will not receive treatment.

Clinical efficacy will be assessed at regularly scheduled study visits, including functional tests such as the six minute walk test. Patients in the treated group will undergo a muscle biopsy at Baseline and a second muscle biopsy over the course of the study. Patients in the untreated group will not undergo muscle biopsy.

Safety, including adverse event monitoring and routine laboratory assessments, will be continuously monitored for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Male 7-16 years old
* Diagnosed with DMD, genotypically confirmed
* Stable dose of corticosteroids for at least 24 weeks
* Have intact right and left alternative upper muscle groups
* Mean 6MWT greater than 300m (primary analysis on 300 to 450 meters)
* Stable pulmonary and cardiac function: predicted FVC equal to or greater than 50% and LVEF of greater than 50%

Exclusion Criteria:

* Previous treatment with drisapersen or any other RNA antisense agent or any gene therapy within the last 6 months
* Participation in any other DMD interventional clinical study within 12 weeks
* Major surgery within 3 months
* Presence of other clinically significant illness
* Major change in the physical therapy regime within 3 months

Other inclusion/exclusion criteria apply.
Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies

To evaluate the performance of uterocervical angle (UCA) in the prediction of latent phase duration in post term pregnancies


Eligibility Criteria:
Inclusion Criteria:

* Patients with singleton pregnancies
* Post term pregnancies
* Patients with vertex presentation,
* Patients with intact membranes
* Patients with no uterine contractions

Exclusion Criteria:

* women with BMI \>30,
* multiparity and multiple pregnancies,
* patients with macrosomia (\>4500 gr),
* patients with major fetal congenital abnormality or fetal death and any contraindications to vaginal birth (e.g. active genital herpes),
* patients with abnormal Pap smears,
* patients with a history of previous cesarean section, myomectomy, hysteroscopic surgeries, dilatation and curettages, loop electrosurgical excision procedures, and cervical conization.