cyrilzakka/clinical-trials huggingface dataset:
Induction Chemo-Nivo in Unresectable Stage III NSCLC

The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated
* PD-L1 level needs to be measured with values 0-100% eligible
* EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes
* ECOG Performance Status ≤ 1
* Adequate organ and marrow function
* Adequate pulmonary reserve (e.g., FVC, FEV1, TLC, FRC, and DLCO) capable of tolerating the proposed lung resection
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification class 2B or better
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment
* Any prior radiotherapy to the lung
* Any prior treatment for NSCLC
* Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Any history of a severe hypersensitivity reaction to any monoclonal antibody
* Any history of allergy to the study drug components
* primary tumors involving the esophagus
* pancoast tumors
* Patients cannot have primary tumors which would remain unresectable
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in study
* Any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications
* Ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg
* previous malignancies
* history of interstitial lung disease
* Patients requiring continuous supplemental oxygen
* Use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy
* Active systemic infection requiring therapy
* Patients with uncontrolled intercurrent illness
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or lactating women
Phase I Double-blind, Placebo-controlled Study of AZD7442

AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.

Severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first emerged in China in November 2019 causing cases of atypical pneumonia. Since then, the COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. As of 22 December 2020, the virus had spread to all corners of the globe, involving 218 countries/regions with over 78.00 million confirmed cases reported and more than 1.71 million associated deaths. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's receptor binding domain, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, are expected to block infection. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.

Randomization of approximately 40 Japanese participants is planned.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Negative results from both SARS-CoV-2 qRT-PCR and serology tests
* Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators

Exclusion Criteria:

* Fever above 37.5°C by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation.
* History of infection with SARS or MERS
* Any drug therapy within 7 days prior to Day 1
In Favor of My Resilient Self- Effects of an Academic Course on the Emotional Resilience of Students.

The course " In Favor of My Resilient Self" will guide participants to develop their strength sources, as well as practice self-calming and self-controlling exercises.

The main goals of the course are to:

1. Measure the effects on the emotional resilience and confidence of participants.
2. Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies.
3. Understand the mechanisms of the effects.

Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the course.

The online Bachelor's degree course " In Favor of My Resilient Self" provides updated information regarding the term 'emotional resilience' and its mediating factors. Through weekly lessons and assignments, it will guide participants to developing an internal perspective on their strength sources, as well as practice self-calming and self-controlling exercises.

The main goals of the course are to:

1. Measure the effects on the emotional resilience and confidence of participants.
2. Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies.
3. Understand the mechanisms of the effects.

Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the course. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. All participants, in the intervention (course participants) and in the control group (students of both faculties that didn't attend the course), received information about the program and the study and were asked to provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Students at Tel Hai College that are interested in participating in the study, and provided informed consent.

Exclusion Criteria:

* Students that did not provide informed consent to participate in the study.
Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

Patients with previously untreated diffuse large B-cell lymphoma will receive standard treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison) for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD 20-expression.

Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Histologically confirmed (according to the WHO classification) diffuse large B-cell lymphoma stage II-IV
* No previous treatment for lymphoma. Corticosteroids for alleviation of lymphoma associated symptoms are allowed
* WHO performance status 0-2
* HIV negativity
* Seronegativity for HCV, HBsAg, anti-HBc, or other active infection uncontrolled by treatment
* Absence of psychiatric illness or condition which could interfere with the subjects ability understand the requirements of the study
* Absence of neurological or neuropsychiatric disorder, interfering with the requirements of the study
* Absence of hearing impairment \> grade 2
* Absence of porphyria
* In females: absence of pregnancy and lactation
* All subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
* All subjects must agree not to share study medication with another person, and to return all unused study drug to investigators
* Written informed concent according to ICH/GCP and Swedish regulations
A Randomized Study to Abate Truancy and Violence in Grades 3-9 in Chicago Public Schools

In partnership with the Chicago Public Schools (CPS), the goal of this project is to test the effectiveness of a manualized mentoring and case management program for students in grades 1-8. Most of the current policy and research attention on dropout has focused on the dropout decision itself, even though dropout is more likely to be simply the end point of a longer-term developmental process. This project seeks to learn more about the relative effectiveness of preventing dropout through mentoring and case management programs, and to learn more about the relative effectiveness of intervening early vs. later.

High school graduation is tremendously protective against involvement with crime and violence, as well as against the risk of adult poverty, unemployment, and poor health. Most of the policy and research attention on dropout has focused on the dropout decision itself. Yet dropout is almost always the end point of a longer-term developmental process. For this project the investigators have raised nearly $7 million in external support from the U.S. Department of Education, the National Institutes of Health, and the William T. Grant Foundation to learn more about the relative effectiveness of preventing dropout by trying to re-engage children in school much earlier during their academic careers.

Specifically, this project is motivated by findings from the late University of Chicago sociologist James Coleman indicating that one of the strongest protective factors against school failure for children is having a strong relationship with a pro-social adult - something that far too many children do not currently have, particularly those growing up in distressed family and community environments. The investigators are partnering with other researchers at Northwestern, Duke, and the University of Minnesota to test at large scale the effects of a structured mentoring and monitoring programs called Check \& Connect. To date, the project has completed its pilot year, and starting this academic year will work with nearly 500 elementary and middle school students distributed across 23 CPS schools on the West and South sides of the city. Students will receive Check \& Connect assistance for two academic years total.

Eligibility Criteria:
Inclusion Criteria:

* Student with 10-27 total absences in prior school year
* Students in Grades 1-7 at start of 2011-2012 or 2013-14 school years
* In attendance at one of the Chicago Public Schools elementary/middle schools randomly selected to be offered the intervention

Exclusion Criteria:

* None
Safety and Efficacy Study of Lithium in Bipolar Disorder

The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar 1 Disorder;
* Hospitalized or in the process of being hospitalized for a manic or mixed episode

Exclusion Criteria:

* History of rapid cycling;
* History of hypersensitivity or adverse reaction to lithium
Comparison of Visual Instructions for Inserting a Laryngeal Mask in a Neonatal Mannequin.

This research project compares the effectiveness of two visual instructions for inserting laryngeal masks. Researchers will assess the procedure performed by undergraduate health students on neonatal mannequins. The student's performance will be evaluated by assessing the results, timing and sequence recorded in videos during the simulation. An Ethical Committee reviewed and approved the protocol.

This research project compares the effectiveness of two visual instructions for inserting laryngeal masks. Researchers will assess the procedure performed by undergraduate health students on neonatal mannequins. The students will participate voluntarily after signing an informed consent. The participating students will be randomly assigned to one of the two groups, each receiving a different visual instruction. The student's performance will be evaluated by assessing the results, timing and sequence recorded in videos during the simulation. An Ethical Committee reviewed and approved the protocol. The Universidad Nacional Mayor de San Marcos funded the investigation through the 2024 grant contest for Research Groups.

The project aims to provide evidence of the advantages of visual instructional methods for inserting laryngeal masks, which contribute to advancing knowledge in medical training and neonatal procedures. The results are expected to inform the selection of more effective educational materials, thus improving student preparation and neonatal care. This research has the potential to bridge the gap between academic theory and clinical practice, benefiting both society and scientific development in neonatal medicine.

Eligibility Criteria:
Inclusion Criteria:

* Students, Health Occupations
* In the last year of studies at the University of San Marcos or any other similar University, and having basic knowledge of neonatal procedures.

Exclusion Criteria:

* Student not registered or withdrawn from courses
* Not having signed the informed consent
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients

Autologous CAR-T cell therapy in HIV-1/AIDS patients


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years;
2. Confirmed diagnosis of HIV-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained HIV-RNA levels \<50 copies/mL for the 12 months preceding enrollment;
3. CD4+ T-cell count \>350/μl within 30 days prior to enrollment;
4. Female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the screening period until the end of the study, participants should have no plans for conception and must voluntarily adopt effective contraceptive measures;
5. Willingness to provide true identity information and comply with follow-up requirements;
6. Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
2. Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
3. History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
4. Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
5. Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
6. Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
7. Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
8. Abnormal laboratory results within 14 days prior to enrollment meeting any of the following:

   Hemoglobin \<10 g/dL (female) or \<11 g/dL (male) Absolute neutrophil count \<1 ×10⁹/L Platelet count \<100 ×10⁹/L Serum creatinine \>110 μmol/L INR \>1.5 or PTT \>45 seconds ALT or AST \>2.5 × upper limit of normal (ULN) Total bilirubin \>1.5 × ULN
9. Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
10. Any other condition deemed inappropriate for participation by the investigator.
Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil

Our long-term goal is to decrease cervical cancer incidence and mortality among women in low- and middle-income countries (LMICs) by using the most efficacious and acceptable screening method, particularly among women who do not come to the clinic for their regular Pap testing. The purpose of this feasibility study is to compare three cervical cancer screening modalities (self-collection and HPV testing, Pap testing at the public health clinic, and choice between self-collection and HPV testing and Pap testing) among women who have not undergone cervical cancer screening within the past four years using a theory-based, culturally relevant intervention implemented by Community Health Workers (CHWs) via door-to-door visits. Three Basic Health Units (BHUs) within the public health system will be randomly assigned to one of the three screening modalities/conditions (self-collection and HPV testing, Pap testing at the local public health clinic, and choice between self-collection and HPV testing and Pap testing). CHWs will invite women who report not having been screened for cervical cancer in the past four years to participate in the study, and deliver a brief educational/behavioral session on cervical cancer and screening using a door-to-door approach under of one of the three conditions. The primary outcome will be adherence to cervical cancer screening. We hypothesize that (1) Women in the "choice" and "self-collection" groups will be more likely to engage in cervical cancer screening and display higher satisfaction with their screening than women assigned to the "Pap" with women assigned to the "choice" group having the highest adherence of the three groups; and (2) Within the "choice" group, more women will choose and complete self-collection than Pap test.


Eligibility Criteria:
Inclusion Criteria:

* No personal history of cervical cancer
* Not have engaged in cervical cancer screening for the past 4 years

Exclusion Criteria:

* None
Confocal Laser Endomicrospy in Colonic Diverticular Disease

Confocal laser endomicroscopy detects inflammatory markers undetectable during high definition endoscopy. The investigators aimed to evaluate the role of peridiverticular and colonic mucosa inflammation in the prediction of the complicated diverticular disease using confocal laser endomicroscopy evaluation in the peridiverticular area in consecutive patients.

Diverticular disease of the colon is a prevalent condition in the western hemisphere. Currently there is an endoscopic classification system for classifying diverticular disease; however, white light endoscopic fails to accurately detect inflammation.

Confocal laser endomicroscopy offers a real-time, in-vivo evaluation of the colonic mucosa, with an adequate correlation to histological findings. The investigators aimed to evaluate the role of peridiverticular and colonic mucosa inflammation in the prediction of complicated diverticular disease.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Writeen informed consent provided.
* Endoscopic visualization of diverticular disease during colonoscopy.
* Adequate bowel preparation BBPS \>2 in each colon segment

Exclusion Criteria:

* Under 18 years old.
* Refuse to sign written informed consent.
* Pregnancy or nursing.
* Previous colorectal surgery
* History of colorectal cancer
* Known allergy to fluorscein
* Uncontrolled coagulopathy
* History of complicated diverticular disease
* Patients with inflammatory bowel disease
* Patients with severe comorbidities: kidney and liver failure
* NSAIDs and antibiotics two weeks prior enrollment
* Historyh of alcohol or drug abuse
* Patients with severe mental illness
* Patients with incomplete evaluation of the colon
Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain

This study aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder ﬂexion/extension.


Eligibility Criteria:
Inclusion Criteria:

* women aged between 18 and 65 years old
* chronic lumbar pain (at least 3 months)
* average pain intensity of ≥3 on a 10-point scale

Exclusion Criteria:

* presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);
* history of back surgery
* pregnancy
* less than 3 months of therapeutic treatment (physiotherapy) for low back pain