cyrilzakka/clinical-trials huggingface dataset:
esTOCma, an App Used by Teachers: an RCT

The aim of the present study is to assess the efficacy of a mobile application called esTOCma in promoting mental health literacy, reducing stigmatizing attitudes related to the Obsessive-Compulsive Disorder (OCD) and improving teachers' confidence in dealing with students that might have OCD. A parallel, randomized controlled trial with two conditions (experimental and control group) will be carried out in a sample of teachers that work in primary and secondary education. Pre-post changes will be assessed. Experimental group will use the app until they finish it (within a set period of 10 days), whereas control group will do nothing for 10 days. Primarily, it is expected that after the use of the app, participants will show an improvement in OCD-related literacy, stigmatizing attitudes, desired social distance and their comfort, confidence and perceived ability in teaching and handling students with OCD. Secondarily, the investigators hypothesize that experimental group might show a reduction in obsessive-compulsive symptoms.

Adolescence is a critical stage that is associated with a high vulnerability to developing obsessive-compulsive disorder (OCD). Schools are part of the natural developmental context of adolescents, and teachers are involved in their education and personal development. In this sense, teachers play an essential role in the early detection and referral of students with possible obsessional symptoms and will also have to deal with the management of this symptomatology in the classroom. Moreover, teachers often have low knowledge of mental health problems and lack strategies for handling mental symptomatology in the classroom.

esTOCma is a mobile health (mHealth) application that has been developed to promote mental health literacy and reduce stigmatizing attitudes associated with OCD. Previous studies have shown that it is a tool with great potential in terms of intervention on stigma and OCD literacy in the general population. Thus, it could be of great interest to use this app in the field of education, and especially in non-university education since adolescents, a highly vulnerable collective to the development of OCD, spend much of their time in the classroom, and often seek help from school staff.

Eligibility Criteria:
Inclusion Criteria:

* Being a practising teacher in non-university education.
* Working in the education field as a guidance counsellor, language teacher or therapeutic pedagogue.

Exclusion Criteria:

* Working in a field other than those mentioned above.
* Having less than 18 years old.
Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes

To determine whether inhaled Yabro protects against progression of COVID19-induced respiratory failure preventing the passage to non-invasive ventilation (NIV) and promotes recovery from COVID19 lung disease in hospitalized patients.

All patients will be treated with state of the art COVID19 treatment as per the treating clinician (Remdesivir, systemic corticosteroids, monoclonal antibodies, convalescent plasma, biologic cytokine inhibitors and other interventions as per the latest guidelines). Patients randomized to the active intervention group will also receive HMW-HA (Yabro®, 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer, while patients randomized in the control group will receive a matching placebo two times daily.

Due to increased risk for SARS-CoV-2 transmission via the usual mask nebulization procedure, patients will receive the nebulized treatment via high-flow oxygen tubing as described in the literature 36-38. Patients will be treated until there is a qualitative change in oxygen requirement, i.e. either progression to assisted ventilation (non-invasive or invasive), or weaning from oxygen supplementation. Because COVID19 may result in long-term O2 dependency, the study and treatment period will be limited to a maximum of 10 days.

Moreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Diagnosis of COVID19 by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal \[OP\], or saliva) and no alternative explanation for current clinical condition.
* Respiratory failure requiring oxygen therapy
* Has symptoms consistent with COVID-19, and is in non-fibroproliferative stage of disease, as determined by investigator.

Exclusion Criteria:

* Respiratory arrest or the need for immediate intubation;
* Upper airway obstruction;
* Facial trauma;
* Inability to cooperate (e.g. agitation or dementia)
* Inability to give informed consent
* Participation in another study for COVID19 treatments
* Deterioration due to other reasons than progressive COVID19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc.
* Palliative care or expectation that patient will not survive \> 72 hours post randomization per clinical judgment of the investigator.
Rubella Susceptibility in Multiparous Women

The purpose of this study is to determine the reasons why multiparous women (women who are pregnant and have been pregnant before) might still be susceptible to rubella.

This study is designed to investigate why multiparous women might still be susceptible to rubella. All pregnant women are checked for rubella immunity, and if they are non-immune, there are standard orders in our hospital to administer the rubella vaccine on the post-partum floor prior to discharge home from the hospital. Despite this, some multiparous women are found to be susceptible (non-immune), and this study will explore the reasons for this.

Eligibility Criteria:
Inclusion Criteria:

* All rubella susceptible women who delivered during the study period.
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.

It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. age \< 18 years,
2. Expected to stay in the ICU for 48 hours or more,
3. Vitamin A deficiency (VA \< 0.2 mg/L)

Exclusion Criteria:

1. Severely impaired gastrointestinal function
2. Premature infants and low birth weight (LBW) infants
3. Condition of underlying organ dysfunction
4. Having received chemotherapy or radiotherapy
5. Hematological malignancies
6. Primary or acquired immunodeficiency
Taxotere + Cisplatin in Nasopharyngeal Carcinoma

Primary objective:

To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.

Secondary objective:

To assess tumor control and survival


Eligibility Criteria:
Inclusion Criteria:

* International Union against Cancer stages III and IV newly diagnosed NPC

Exclusion Criteria:

* Inadequate bone marrow reserve
* Inadequate renal function
* Other primary malignancy
* Evidence of distant metastases

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks

The overall goal of this study is to develop and evaluate a brief, video-based, group-level intervention designed to reduce sexual risk taking among culturally diverse English- and Spanish-speaking Latino men who have sex with men (MSM).


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 - 49
* Self-identify as Latino or Hispanic
* Speak English and/or Spanish
* Reside in NYC and not plan to move in the next 3 months
* Have had 2 or more sex partners in the last 3 months
* Have had at least 1 male sex partner in the last 3 months
* Have engaged in unprotected anal intercourse with at least one male partner in the last 3 months
* Be HIV negative or not know their status

Exclusion Criteria:

* Participated in a program (research or non-research) during the past 6 months where they have received HIV prevention education (e.g. an in-person or online group session, workshop, support group).
* Report being HIV-positive
MIND Diet and Cognitive Function in Adults With MCI

To examine the effects of a 1-year cluster-randomized controlled intervention of MIND diet on cognitive function among 240 participants with mild cognitive function (MCI) aged 50 years and above from 4 communities.

The current study is a 1-year cluster-randomized controlled intervention trial designed to examine whether the a localized modified Mediterranean-Dietary Approaches to Stop Hypertension (DASH) dietary intervention for neurodegenerative delay (MIND) diet will improve cognitive function among 240 participants with MCI from 4 communities. The modified MIND diet recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry, olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and products, animal oil, pastries and sweets, and fried/fast food). This study will randomly assign 240 MCI participants to two groups: A) MIND diet intervention group and B) control group, and estimate the cognitive and biological impacts of the 1-year intervention.

Eligibility Criteria:
Inclusion Criteria:

* At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8\>=3 and/or 5-min MoCA \< 11)
* Free of physical disabilities that preclude participation in the study
* Willing to complete all study-related activities for 24 months
* Willing to be randomized to either intervention group

Exclusion Criteria:

* Allergic to more than one type of food (nuts, berries, olive oil, or fish)
* Diagnosed of dementia, severe diabetes mellitus, cardiovascular disease, cancer, thyroid disease, kidney disease, or liver disease
* Diagnosed of major depression or other neuropsychological diseases
* Severe loss of vision, hearing or communicative ability
* Substance abuse within 6 months or heavy alcohol consumption (\> 2 drinks/day for women; \> 3 drinks/day for men).
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.

The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 to 70 years old;
2. Histologically confirmed triple negative breast cancer;
3. No more than one-line prior treatment for locally advanced or metastatic breast cancer;
4. Have at least one measurable lesion as per the RECIST criteria (version 1.1);
5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
6. Patients with life expectancy of at least 3 months;
7. Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
8. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
9. Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria:

1. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
2. Brain metastasis;
3. Recurrence or metastasis within 6 months after capecitabine withdrawal;
4. Recurrence or metastasis within 6 months after platinum withdrawal;
5. Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
6. Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
7. Patients who had Grade 2 or above Peripheral neuropathy;
8. Patients with severe systemic infection or other serious diseases;
9. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
10. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
11. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
12. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
13. The researchers considered the patients who were not suitable for enrollment.
Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients

This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.

This is a non-confirmatory, randomized, placebo-controlled, blinded, proof-of-concept study in kidney transplant recipients. Approximately 96 eligible subjects are planned to be randomized 2:1 to receive MAU868 or placebo. At least 78 subjects are expected to complete the study. The study will consist of a pre-treatment (screening) consenting period, a 24 week treatment period (consisting of 6 monthly i.v. doses of MAU868 or placebo) and a 24 week follow-up period. Subjects who complete the study per protocol will attend a total of 16 visits over a period of 48 weeks.

Eligibility Criteria:
Inclusion criteria;

* Male or female recipients of a first or second kidney or kidney-pancreas transplant who weigh at least 30 kg and are at least 7 years of age (in the US, 18 years of age or above) at the time of transplantation.
* Recipients of organs from a heart-beating deceased, non-heart-beating deceased, living unrelated, or human leukocyte antigen (HLA)-mismatched living related donor.
* Recipients who are treated with lymphocyte-depleting induction therapy (e.g., rabbit antithymocyte globulin, alemtuzumab). Subjects treated with rabbit antithymocyte globulin must receive a total dose of at least 3 mg/kg. Subjects treated with alemtuzumab must receive a total dose of at least 20 mg.
* Recipients of a kidney with a cold ischemia time (CIT) \<36 hours.

Exclusion Criteria:

* Recipients of organs from identical twins or living, HLA-matched, related donors.
* ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant (isolated positive B cell crossmatches are not an exclusion criterion).
* Recipients who are treated with non-lymphocyte-depleting induction therapy (e.g., basiliximab) or no induction therapy.
* Recipients who are treated or planned to be treated with mTOR inhibitors as part of their initial immunosuppression regimen post-transplantation.
* Recipients who require antibody-depletion prior to transplantation and in the opinion of the investigator are likely to require antibody-depletion after transplantation. Antibody-depleting therapies include but are not necessarily limited to plasmapharesis, immunoadsorption, and IVIg.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by hCG testing.
* Current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (TB) or any history, in the opinion of the investigator, that confers a risk of reactivation of TB and precludes the use of conventional immunosuppression.
* History of splenectomy or asplenia.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug.
Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.

To maximize the yield of surveillance colonoscopy, minimize risk to patients, and deliver cost-effective care, it is imperative to resolve whether random biopsies are warranted for patients with long standing Inflammatory Bowel Disease (IBD) undergoing dysplasia and colorectal cancer (CRC) surveillance with high-definition white light colonoscopy (HDWLC). For this protocol, dysplasia surveillance refers to the process of identifying precancerous dysplasia, sessile serrated adenoma (SSA) or CRC. This protocol describes a pragmatic, multicenter randomized trial of patients with IBD undergoing dysplasia surveillance with HDWLC, the most common type of surveillance colonoscopy performed in the US, to definitively answer this question.

The primary objective of the study is to determine if HDWLC using a limited biopsy strategy is non-inferior to HDWLC using a random biopsy strategy to detect dysplasia or sessile serrated adenoma (SSA) in patients with IBD.

Secondary objectives include:

1. Determine if HDWLC using a limited biopsy strategy is superior to HDWLC with a random biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD
2. Determine whether the number of targeted biopsies differs based on the number of random biopsies obtained.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of left-sided (greater than 15 cm of disease but not beyond the splenic flexure) or extensive (extending beyond the splenic flexure) ulcerative colitis or IBD-U or colonic Crohn's disease involving at least 1/3 of the colon for at least 8 years
* Patients who are scheduled to undergo colonoscopy as part of routine care.
* At least one indication for the index colonoscopy must be to perform dysplasia surveillance.
* Has not had a colonoscopy in the last 11 months

Exclusion Criteria:

* Any condition that the endoscopist feels is a contraindication to random biopsies
* History of visible (high or low grade) dysplasia not completely removed
* History of sessile serrated adenoma not completely removed
* History of colorectal cancer
* Any condition for which the endoscopist feels that pancolonic contrast or virtual chromoendoscopy is mandatory
* Inability to provide informed consent
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation

The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw. Patients included in the study are ages 15-45 scheduled to undergo BSSO surgery at the University of California, San Francisco. One side of the patient's mandible will be instrumented with either the Stryker Sonopet ultrasonic saw or traditional reciprocating saw, while the other side will receive the remaining intervention (determined via randomization on the day of surgery). Patient paresthesias will then be analyzed on each side for 3 months postoperatively (at postoperative days: 1, 7, 14, 28, and 84). Sensory examinations will be carried out by blinded examiners using von Frey hairs and two point discrimination testing. Patients will also subjectively rate their sensation on each side. The results will then be analyzed to determine if patient paresthesias, including the severity and duration, differed depending on which instrument was used, the ultrasonic or reciprocating saw.


Eligibility Criteria:
Inclusion Criteria:

* Must be undergoing bilateral sagittal split osteotomy surgery with Dr. Saghezchi at UCSF
* Must agree to return for all follow up visits.
* Must not have any preexisting V3 nerve paresthesia
* Must be below the age of 45.

Exclusion Criteria:

* Persons with preexisting V3 nerve paresthesias
* Pre-pubertal children will be excluded (per routine practice for this type of surgery).
* Patients with syndromic genetic conditions that demonstrate clearly different anatomy in the two sides of their jaws will be excluded since the two sides may not be "exchangeable".
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients

Prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for IVF (in vitro fertilization) / ICSI (intracytoplasmic sperm injection) compared to standard procedures.


Eligibility Criteria:
Female:

Inclusion Criteria:

* With ovarian reserve of between 8 and 30 antral follicles counting both ovaries
* Treatment planned for embryo transfer at the blastocyst stage

Exclusion Criteria:

* Any diagnosed sexually transmitted infection (STI)
* Diabetes or other metabolic disorders.
* Recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth).
* Previous failures in two or more IVF cycles

Male:

Inclusion Criteria for IVF:

* Age: 20-55 years
* Fresh sample (not cryopreserved )
* Sperm motility (TOTAL) ≥ 40% in spermogram
* Normal sperm morphology (Kruger criteria) ≥ 4% in spermogram
* Sperm count after swim up ≥ 5x10\^6
* Treatment planned for embryo transfer at the blastocyst stage

Inclusion Criteria for ICSI:

* Age: 20-55 years
* Fresh sample (not cryopreserved )
* Sperm concentration ≥ 10x10\^6 /ml in spermogram
* Sperm motility (TOTAL) ≥ 20% in spermogram
* Normal sperm morphology (Kruger criteria) ≥ 3% in spermogram
* Treatment planned for embryo transfer at the blastocyst stage

Exclusion Criteria:

* Any diagnosed sexually transmitted infection (STI)
* Total failure of in vitro fertilization in previous cycles.