cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of greater than or equal to (\>=) 18.5 and less than (\<) 35.0 kilogram per square meter (kg/m\^2)
* Healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
* All women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test at screening, have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last vaccination
* Participant must be available and willing to participate for the duration of the study visits and follow-up

Exclusion Criteria:

* Has been vaccinated with a candidate filovirus vaccine
* Has received any Ad26- or MVA-based candidate vaccines in the past
* Has been diagnosed with disease caused by Ebola virus (EBOV), Marburg virus (MARV), Sudan virus (SUDV), or Taï Forest virus (TAFV) or exposed to EBOV, MARV, SUDV, or TAFV, including participants who traveled to epidemic filovirus areas in West Africa during the last 2 years (that is, since the start of the last Ebolavirus outbreak) should be excluded from the study
* Chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
* Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (\>=) 38.0 degree Celsius on Day 1
Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

To explore in a pilot randomized clinical trial, the impact of Home Blood Pressure Monitoring with patient directed information as compared to usual care on the postoperative management of blood pressure.

The intervention and control groups will be defined by, 1) preoperative home blood pressure monitoring with a detailed report sent to the patient, and 2) usual standard of care including a suggestion during the pre-operative clinic appointment to follow up with Primary Care. Both groups will receive a brief questionnaire about their blood pressure treatment and medication adherence. We will examine the rate of primary care follow-up and changes in hypertension treatment at 60 days post-operative, through a telephone call. This information, along with information regarding patient acceptance of the intervention will be used to inform the design of a future clinical trial powered to outcomes, including follow-up visits and blood pressure management.

Eligibility Criteria:
Inclusion Criteria:

* We propose to recruit patients who present for ambulatory surgery, aged \>18 years, with a preoperative blood pressure \> 140/90 mmHg taken as the mean of two readings during the pre-admission testing visit.

Exclusion Criteria:

* Patients who are unable or unwilling to be contacted by telephone, are non-English speaking, or are unable to operate an automated home blood pressure monitor will also be excluded.
* Healthy patients with blood pressure readings that fall within the American Heart Association (AHA) guidelines.
Proton Radiation Therapy for Spinal Tumors

The purpose of this study is to determine if Proton Therapy can provide effective and safe treatment for Malignant Peripheral Nerve Sheath Tumors of the spine and Neurofibromas of the spine.

Proton therapy may provide the benefits of local control or palliation, while reducing the risk associated with photon radiation, by delivering therapeutic doses to a well-defined target area with significant reduction in the integral dose. A dosimetry comparison of protons and photons at the University of Florida Proton Therapy Institute confirmed the feasibility of proton irradiation of these tumors with less exposure of normal tissue to radiation than expected with photon techniques. This reduced radiation exposure to uninvolved normal tissues is expected to decrease the risk of radiation-induced second malignancies and neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* MPNSTs that are biopsy-positive and resected, subtotally resected or unresectable.
* Symptomatic (pain, numbness, or weakness) NF1 neurofibromas that are biopsy-positive and unresectable or subtotally resected.
* Symptomatic NF1 neurofibromas that are unbiopsied and PET-negative, if the patient refuses biopsy/surgery or is medically inoperable.
* Asymptomatic NF1 neurofibromas with radiologic progression after surgery.
* PET-positive, unbiopsied lesions in NF1 patients who refuse biopsy/surgery or are medically inoperable.

Exclusion Criteria:

* Spinal instability.
* Metal stabilization hardware within the target area.
* Previously irradiated at this disease site.
* Spinal cord compression with complete loss of function.
Results of Gamma Nail in Trochentric Fractures of the Adults

We prospectively reviewed the results of 30 patients who had undergone intramedullary fixation with a gamma nail for femur trochentric fractures in AUH. within 1 year

Hip fractures are considered one of the major health problems in aging societies . These fractures are correlated with increased disability and mortality and a decreased quality of life . Early mobilization of patients with these fractures is essential to improve fracture healing, minimize immediate postsurgical morbidity, and reduce care costs. One essential prerequisite for early mobilization is mechanically stable fracture fixation . Nowadays, most hip fractures are treated by extramedullary or intramedullary implants, which allow a stable fixation in the majority of cases

A dynamic hip screw (DHS) is the most commonly used implant for intertrochanteric fractures . Load bearing in the proximal femur is predominantly through the intact calcar femoral; the lever arm of the laterally placed plate is increased, thus, there is a risk of implant cutout if the calcar is not intact .

Biomechanically, compared with a laterally fixed side plate, an intramedullary device decreases the bending force of the hip joint on the implant by 25-30%. This has advantages especially in elderly patients, in whom the primary treatment goal is immediate full weight-bearing mobilization.

It has been postulated that cephalomedullary nails have an advantage over DHS fixation because of the load-bearing axis being closer to the hip joint fulcrum, and also less blood loss, minimal tissue dissection, shorter operation time, and faster ambulation after surgery . However, other studies have reported that fixation with DHS is better . One of the major drawbacks discovered with the use of the gamma nail is a higher reoperation rate as a result of new fracture around the implant . In this study, we present our results for the treatment of trochentric fractures using a gamma nail in terms of the outcome, drawbacks, and possible complications.

Eligibility Criteria:
Inclusion Criteria:

* Age (20-70)
* unstable trochentric fractures

Exclusion Criteria:

* pathological fractures due to neoplasia
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
Effect of Multi-Media Tool on Enrollment in Oncology Clinical Trials

The purpose of this research study is to test a touchscreen computer program, which allows patients to see information on a computer screen regarding cancer care, and specifically clinical trials. The purpose of this research is to help the investigators learn more about how to use technology in the medical setting to improve health outcomes.

Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. The purpose of this project is to pilot a multi-media technology intervention designed for patients with diverse health literacy skills with the aim of improving patient receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials. The intervention is comprised of multi-media touchscreen computer program components for clinical trial education and assessment of patient-reported outcomes. Patients presenting for their first oncology appointment were eligible. Patients viewed an interactive teaching video concerning clinical trials that was adapted from the National Institutes of Health. Validated surveys assessing receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials were administered before and after the test.

Eligibility Criteria:
Inclusion Criteria:

* Adult, English-speaking women and men
* Newly diagnosed with lung, gastric or pancreatic cancer
* Coming to the University of Chicago outpatient oncology clinics for their first oncology visit

There are no Exclusion Criteria.
Virtual Reality for Youth Phobias

The purpose of this study is to examine the effectiveness of virtual reality (VR) delivered exposure therapy for youth with phobias or social anxiety, with and without autism spectrum disorder. The study team is also interested in collecting information to better understand phobias and social anxiety.


Eligibility Criteria:
Inclusion Criteria:

1. The target population for this project are 48 youth (ages of 8-16) that meet criteria for a specific phobia or social anxiety disorder within Miami-Dade County.
2. Youth will be eligible if they or their parent report clinically significant symptoms of social anxiety disorder or a specific phobia targeted with the VR program, based on self- or parent-report scores on online screening measures (\>1 average total scores on Severity Measure for Specific Phobia-Child or Social Anxiety Disorder-Child) or clinician-report diagnosis (i.e., diagnosed with Social Anxiety Disorder or Specific Phobia during clinical interview).
3. Youth are able to complete study procedures, speak/read English or Spanish sufficiently.
4. Youth have at least one caregiver who can complete all study measures in English or Spanish.
5. Youth have a caregiver who is available to sign study consent forms, remain present during assessments, and fill out study questionnaires.

Exclusion Criteria:

1. Youth who would be inappropriate for a brief VR-exposure therapy protocol will be referred to local resources for additional support or provided with alternate cognitive behavioral therapy services through the clinical center in which this program takes place.
2. Research staff will review all measures and the youth's psychological history and consult with the PI to ensure that the participant does not have a current diagnosis of psychosis, bipolar disorder, acute suicidality, alcohol/substance dependence, or eating disorder.
3. Youth will also be excluded if they are currently receiving psychotherapy elsewhere.
4. Youth with co-occurring intellectual disability may be eligible, but youth who are non-verbal will not be eligible, as some verbal abilities are necessary in order to communicate with the clinician during the intervention.
5. Youth who are currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded (or discussed on a case-by-case basis).
6. Youth who engage in self-harm behaviors (e.g., cutting) and who do not present with suicidal intent will be allowed to participate.
7. If youth develop psychiatric problems (e.g., severe depression, acute suicidal ideation/intent, severe conduct problems) that require a higher level of care, youth will be withdrawn from the study and referred for appropriate treatment.
8. Youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay intervention).
Effects of a Four Weeks Social Emotional and Ethical Learning Training in Brazilian Public School Teachers

Social Emotional Learning (SEL) has gained importance in recent years and has been taught in several schools to support students in how to recognize and manage emotions, develop empathy, build cooperative relationships, solve problems effectively, and gain skills of communication. The objective of this study is to evaluate the effects of a training of 4-week Social Emotional and Ethical Learning on stress, well-being, socioemotional learning literacy, positive and negative affect, attention, and competent. This study will also assess the perception of teachers about training and its impact on their teaching skills and in personal life. Methods: Elementary and Secondary School Teachers public in Brazil (N = 1,500) will be invited to participate in the SEE training Learning. After signing the Free and Informed Consent Term, the they will be randomized into two groups A and B. Both groups will be before the experiment (T0), after one month (T1) and after two months (T2). ONE SEE Learning Training (SEELT) and B will be a checklist control group. Standby (WLC) for one month. After that, B will receive SEELT and A will not receive intervention, but will be guided to maintain the practices learned. RESULTS EXPECTED: The groups after receiving the SEELT should present better results relating to their socio-emotional skills, stress management, increase in well-being and knowledge about these skills, are still so, better prepared to teach their students.


Eligibility Criteria:
Inclusion Criteria:

* Teachers from the public schools in Brazil

Exclusion Criteria:

-
Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Age under 40 for women
* Signed informed consent by both members of the couple
* Medical indication of MAP by AI (artificial insemination), IVF(in vitro fertilization) or ICSI (intracytoplasmic sperm injection) method
* Well understanding of information letter

Exclusion Criteria:

* Age over 40 for women
* Informed consent form not signed by one or both partners
* Co-infection of one of the partners or both by HIV (human immunodeficiency virus) , HBV (hepatitis B virus) and/or HCV (hepatitis C virus)
* IVF by only frozen embryo transfer at the time of inclusion
* Severe oligospermia in male partner (\<500 000 sperm cells)
Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

The purpose of this study is to determine whether the use of light and a topically applied photosensitizer can relieve symptoms and clinically improve patients with chronic rhinosinusitis.

This clinical trial will be a prospective, randomized, single-center study utilizing two treatment assignments and a control group. The study is expected to enroll a total of 48 subjects. The intent of the study is to evaluate a single versus double treatment of photodisinfection in men and women suffering from chronic persistent rhinosinusitis with and without nasal polyposis. Each photodisinfection treatment group will be compared to a control group receiving saline irrigation.

Eligibility Criteria:
Inclusion Criteria:

* history of chronic rhinosinusitis with and without nasal polyposis
* no antibiotics within 4 weeks
* no oral steroid use within 4 weeks
* no topical steroid use within 2 weeks
* endoscopic sinus surgery greater than 6 months previously

Exclusion Criteria:

* acute respiratory infection within last 2 weeks
* septal deviation restricting sinus access
* known allergy to methylene blue
* pregnant or breast feeding
Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care

The number of lung biopsies has increased steadily in recent years. Pneumothorax is the most common complication of a lung biopsy and can occur during the procedure, immediately after the procedure or within a few hours (delayed pneumothorax). The incidence of pneumothorax in the literature is very different from one study to another: it has been reported to be from 9 to 54% in patients undergoing percutaneous transthoracic needle biopsy. This difference of incidence could be explained by the absence of consensus for the definition of an iatrogenic pneumothorax.

The characteristics of pneumothorax and the management of patients with iatrogenic pneumothorax will be evaluated in different centres in a retrospective manner. This study will contribute to refining the criteria for defining pneumothorax occurring during lung biopsy and will provide a better understanding of the condition and its management.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old and more at the time of the biopsy procedure in year 2020
* Having had a pneumothorax following their transthoracic percutaneous lung biopsy in year 2020

Exclusion Criteria:

* Objection to the use of the data (French sites only)
Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.


Eligibility Criteria:
Inclusion Criteria:

* A woman between, and including, 10 and 25 years of age at the time of the first vaccination.
* Written informed consent from the subject prior to enrolment.
* Subject must be free of obvious health problems.
* Subject must have negative urine pregnancy test.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.
* Previous vaccination against human papillomavirus (HPV).
Chronic Kidney Disease-Education (CKD-EDU)

The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults.

Half of the participants will receive Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions.

Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.

Older adults ≥75 years represent the fastest-growing population to initiate dialysis in the US; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. This study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. This research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years old
* Has advanced kidney disease with kidney function less than 30%
* Speaks English
* Has not yet made a dialysis decision

Exclusion Criteria:

* Has already decided on dialysis or active medical care without dialysis.
* Has already been seen by a Palliative Care (PC) clinician for kidney-related issues or is enrolled in hospice
* Currently on dialysis
* Unable to provide informed consent or complete verbally administered surveys due to health, sensory, or cognitive impairment.