cyrilzakka/clinical-trials huggingface dataset:
Impact of COVID-19 on Sinus Augmentation Surgery

The risk of Schneiderian membrane perforation and the postoperative complications of the sinus floor elevation surgery were evaluated for patients with and without history of COVID-19 infection.

COVID-19 induced chronic sinusitis with subsequent increased Schneiderian membrane thickness could increase the risk of its perforation during the sinus floor elevation. The aim of the study is to compare the incidence of Schneiderian membrane perforation and the postoperive complications of the sinus floor elevation in patients with and without history of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* 4 mm or less residual alveolar bone height
* Age more than 18 years
* Highly motivated patients

Exclusion Criteria:

* Patients who suffer from any systemic disease
* sinus pathosis other than sinusitis induced covid 19
* Patients under any medication that may interfere with the normal bone healing
Visual and Refractive Outcomes of a New Diffractive Trifocal Toric Intraocular Lens

The purpose of this study is to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL. Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as photic phenomena, rotational stability and spectacle independence will be investigated. The follow-up period is 3 months after which vision and refraction should have stabilized.

This prospective study was performed to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL (PhyslOL, Belgium). Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as rotational stability have been analyzed. The follow-up period was 6 months. All IOL implantations were performed by the investigators Dr. Filomena Ribeiro and Dr. Tiago B Ferreira (Hospital da Luz, Lisboa, Portugal). The study population consists of patients undergoing routine cataract surgery. The study patients underwent binocular implantation of Finevision IOLs depending on the preoperative amount of corneal astigmatism (either a toric POD FT IOL in both eyes or a POD FT in the study eye and a non-toric POD F IOL in the contralateral eye).

Eligibility Criteria:
Inclusion Criteria:

* age 21 and older
* bilateral implantation of a Finevision trifocal diffractive IOL (either a POD FT in both eyes or a POD FT in the study eye and a POD F in the contralateral eye)
* bilateral cataract surgery with grade 1-4 cataract
* regular corneal astigmatism of 1.00 D or more before surgery in the study eye
* previous written informed consent to surgery. Written informed consent to participation in the study and data protection

Exclusion Criteria:

* relevant concomitant ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. Marfan syndrome)
* irregular corneal astigmatism, any abnormality in corneal topography
* systemic disease with impact on visual outcome
* disability to understand and/or fill in patient questionnaires
* history of other relevant previous ocular surgery (such as corneal surgery, glaucoma surgery, vitreoretinal surgery) which might affect capsular stability or visual outcomes
* expected residual cylinder ≥ 0.50 D
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )

Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV.

Secondary objective (s): to evaluate Intellectual Quotient, Child development, Behavior, Language and investigate link between executive functioning disorders, exposure to ARVs, HIV and family environment.

The objective of the study is the exploration of executive functions (EF) and screening for neurodevelopment and learning disorders in children born to HIV-infected mothers, exposed to the virus and to antiretrovirals (ARVs).

The evaluation of the executive functioning will be done by the score obtained at the preschool BRIEF for patients and control group issued from questionnaires filled by the mothers of the cases and the mothers of the controls, with matching on age, sex, level of parental education and socio-economic and cultural environment.

Within the group of exposed children, factors associated with executive dysfunction including HIV infection, antiretroviral exposure, maternal socio-demographic data, sociocultural and environmental level will be investigated.

Evolution of the scores between J0, M12 and M24 will be compared within the group of exposed children.

Compared with a control group, the child's intelligence quotient, overall development, behavior and language will be compared at each follow-up time (D0, M12 and M24).

Eligibility Criteria:
Inclusion Criteria:

* experimental:

  * HIV-positive children born to mothers living with HIV antiretrovirals during pregnancy and in the neonatal period, aged 3 years +/- 3 months on the date of inclusion.
  * Parents mastering the French.
* control:

  * children, aged 3 years +/- 3 months on the date of inclusion, from the same socio-economic and cultural environment, no infected or affected by HIV.
  * Parents mastering French.

Exclusion Criteria:

* great prematurity (28-32 weeks)
* genetic anomaly
Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

Primary objectives

1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives
2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation

Eligibility Criteria:
Inclusion Criteria:

* 5 Years to 70 Years, Male and female;
* Expected survival \> 12 weeks;
* Performance score 0-2;
* Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
* Creatinine \< 2.5 mg/dl;
* ALT/AST \< 3x normal;
* Bilirubin \< 2.0 mg/dl;
* Adequate venous access for apheresis, and no other contraindications for leukapheresis;
* Take contraceptive measures before recruit to this trial;
* Written voluntary informed consent is given.

Exclusion Criteria:

* Patients with symptoms of central nervous system
* Accompanied by other malignant tumor
* Active hepatitis B or C, HIV infection
* Any other diseases could affect the outcome of this trial
* Suffering severe cardiovascular or respiratory disease
* Poorly controlled hypertension
* A history of mental illness and poorly controlled
* Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
* Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
* Reaching a steady dose if receiving anticoagulant therapy before assignment
* Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
* Pregnant or lactating women
* Subject suffering disease affects the understanding of informed consent or comply with study protocol.
A Grapefruit Feeding Trial in Healthy, Overweight Adults

Folklore has suggested that consuming grapefruit may promote weight control. Sparse data exist to support this hypothesis, though there is some evidence of health promotional effects regarding blood pressure and lipid profiles. The aims of this randomized controlled trial are to determine the role of grapefruit in:

1. Reducing weight
2. Reducing blood pressure
3. Reducing inflammation
4. Improving the lipid profile.

The investigators hypothesize that six weeks of daily consumption of grapefruit will reduce weight, blood pressure, and inflammation while improving the lipid profile in overweight, healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Adults, men and premenopausal women
* BMI: 25-45 kg/m2
* Willing to maintain current exercise regimen (not to exceed 10 hours/week)
* Willing to follow a diet low in bioactive rich fruits and vegetables and with no citrus

Exclusion Criteria:

* History of chronic disease
* Metabolic disease
* Inflammatory disease
* High cholesterol (\>225 mg/dL)
* Smoker
* Taking medications metabolized by the Cytochrome P450 3A enzyme
* History of alcohol or drug abuse
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation

This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation. This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects with CF, homozygous for the F508del-CFTR mutation.


Eligibility Criteria:
Inclusion Criteria:

* Homozygous for the F508del-CFTR mutation
* Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis
* Stable CF disease as judged by the investigator
* Forced expiratory volume in 1 second (FEV1) at least 40% and not greater than 90% of predicted

Exclusion Criteria:

* History of any comorbidity that might confound the results of the study, interfere with the use of cardiopulmonary exercise tests (CPETs) as an assessment, or pose an additional risk in administering study drug to the subject
* Any previous exposure to LUM or IVA
* History of cardiac arrhythmia, ischemic heart disease, congestive heart failure, or other clinically significant cardiac condition, or medical condition requiring chronic use of a beta blocker, non-dihydropyridine calcium channel blocker, or other cardiac medication known to affect exercise tolerance
* History of solid organ or hematological transplantation
* For subjects under 18 years of age at Screening, except those who have had bilateral lens removal, selected findings on a screening ophthalmologic examination will be exclusionary
* Using or expected to require any concomitant medication that is prohibited in this study
* History of alcohol or drug abuse, as deemed by the investigator, in the past year, including but not limited to cannabis, cocaine, and opiates
* Participation in an investigational drug study within 30 days before the Screening Visit
* Pregnant or nursing females; males with a female partner who is pregnant or nursing
* Colonization with organisms associated with a more rapid decline in pulmonary status
Impact of Video Presentations on Medical Students' Attitudes Toward Mental Illness

This is a randomized controlled trial examining the impact of videos on medical students' implicit and explicit attitudes and knowledge related to mental illness in Nepal. Medical students are randomized to one of three conditions: (a) no video, (b) a didactic video based on the mental health Gap Action Programme (mhGAP) modules for depression and psychosis; and (c) videos with personal testimonials from mental health service users with depression and psychosis.

Stigma towards mental health patients exists within health systems worldwide, affecting high- and low-income countries alike. Stigmatizing beliefs held by health professionals toward mental illness can have detrimental health impacts on the patients. These stigmatizing beliefs against mental health patients within the health system have been noted across South Asia, including Nepal. Two sources of stigmatizing beliefs towards mental illness are explicit (conscious) and implicit (unconscious) attitudes held by health professionals. There is a dearth of research that investigates both explicit and implicit attitudes of health professionals towards mental health in South Asia though. One method to reduce stigma is through contact with people who suffer from mental illness. However, there is a gap in the literature on low- and middle-income countries integrating contact with mental health service users in health provider trainings. Forthcoming research in Nepal is exploring the causal impact of service user involved mental health trainings of health professionals on explicit and implicit attitudes as well as clinical care, but this research has yet to investigate the effects of service user training on health professional students (in progress). Research efforts on mental health trainings should be expanded to student populations to reduce negative attitudes before providers enter the workforce.

The purpose of this study is to evaluate whether information-based training with or without service user testimony is more effective at reducing implicit and explicit biases toward mental health patients and increasing clinical care in Nepali health professional students. The findings from this study will fill the gap in research that evaluates intervention efficacy of reducing stigma towards mental health patients in Nepali student health education. By implementing mental health trainings, the long-term goals of this intervention are to reduce stigma held by health professionals against mental health patients and improve clinical care in Nepal by reducing negative implicit and explicit attitudes.

Eligibility Criteria:
Inclusion Criteria:

* Medical students in universities in Nepal

Exclusion Criteria:

* Medical students are excluded if they have already completed their psychiatric clinical rotation
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.

The purpose of this study is to determine whether Levamisole plus prednisone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.

The first line treatment in warm antibody autoimmune hemolytic anemia (WAIHA) is the glucocorticoid, but most of the patients, hemolytic events will frequently recurred after end of treatment or during the gradual reduction in dosage of prednisolone. As a result, many patients will finally accepted long-term glucocorticoids or other immunosuppressive drugs. How to reduce the relapse rate of AIHA is still difficult. Levamisole（LMS）is a immunoregulator.Recent studies have shown LMS has been widely used to treat autoimmune diseases ,such as rheumatoid arthritis, systemic lupus erythematosus and idiopathic thrombocytopenic purpura. The purpose of this study is to determine whether LMS combined with prednisolone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and biochemical signs of hemolytic anaemia
* Positive Coombs test with anti-IgG or and with anti-CD3d
* Newly diagnosed Warm Autoimmune Hemolytic Anemia
* Adequate contraceptive measures for women of childbearing potential
* informed consent signed

Exclusion Criteria:

* Active infection which requires antibiotic treatment
* Pregnant or lactating women
* Epilepsy and mental illness
* Kidney and liver function abnormal
Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer

Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.

Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with controlled diabetes
* Any phototype and all skin types

Exclusion Criteria:

* Pregnant women
* Subjects that not match the inclusion criteria
A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda

Multiple randomized and controlled studies (WHO, USAID, UNAIDS) have proven that circumcised men in high risk areas reduce their risk of HIV infection by 60%.

The Government of Rwanda has ranked HIV prevention as a top priority item, and wishes to decrease the HIV incidence in the country by 50%. As part of a holistic HIV prevention approach, we decided to embark upon a process of national scale up of adult male circumcision. The national HIV prevention plan calls for voluntary MC of 2 million adults by the end of 2012.

The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs, to support global public health efforts to stop the spread of HIV.

The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, in urban or rural settings, without the need for sterile, hospital settings. As such, The PrePex System places minimal burden on the existing health care infrastructure to accomplish national circumcision programs.

The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda.

Eligibility Criteria:
Inclusion Criteria:

* Male of ages 18 - 54 years
* Subject wants to be circumcised
* Uncircumcised
* HIV sero-negative Agrees to undergo measurements of width of the penis at different areas in flaccid status
* Able to understand the study procedures and requirements
* Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, until the end of the follow-up that may take up to 6 weeks
* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

Exclusion Criteria:

* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
* HIV sero-positive
* Subject with the following diseases: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias
* Diabetes mellitus
* Subject who have an abnormal penile anatomy or any penile diseases
* Subject that to the opinion of the investigator is not a good candidate
New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis

Current diagnostic tools such as interferon gamma release assay (IGRA) and purified protein derivative (PPD) can not distinguish patients with latent tuberculosis infection (LTBI) and persistence of live mycobacteria. This inability to rule out living mycobacteria in patients investigated for LTBI leads to unnecessary and potentially harmful treatment regimes all around the globe.

The goal of this observational study is to identify candidate biomarkers for viable bacilli in latent tuberculosis in order to decrease the use of unnecessary and ineffective antibiotic treatment.

Tuberculosis (TB) is the second leading cause of death due to a single infectious agent, with the main burden in resource-limited settings and in vulnerable populations. It is estimated that approximately 25% of the global population is infected with TB. LTBI is a condition where the mycobacteria rests within the body instead of creating active disease. About half of the active TB cases develop within 2 years of exposure and the other half reactivates as distant as several decades post exposure. Persistence of viable bacilli is a prerequisite for the reactivation of TB.

Through sampling of peripheral blood the investigators will investigate how selected cytokines, enzyme activity and gene expression changes during course of treatment, 4-6 months, and during follow up, 1 year. These patterns will be compared to the patterns of patients with: latent TB without treatment, active TB with treatment as well as healthy controls. Samples will be drawn at 0, 1, 6 and 12 months, after treatment initialization when applicable. Healthy controls will only be sampled once. Most of the analysis will be performed on TB-antigen stimulated blood.

The investigators hypothesize that there is a substantial fraction of latent TB patients who do not harbor live mycobacteria and that this is reflected in study outcome measures when given treatment. Furthermore, the investigators hypothesize that this fraction of latent TB patients will resemble healthy controls in terms of outcome measures whereas their counterpart, latent TB patients harboring living bacteria, will not.

Eligibility Criteria:
LTBI (2 groups)

Inclusion Criteria:

* latent tuberculosis: Interferon gamma (IFN-γ) \>0.70 IU/ml in the Quantiferon-TB Plus assay
* age 15-25 years OR high likelihood of recent TB transmission
* informed consent

Exclusion Criteria:

* active tuberculosis
* chronic illness
* immunosuppressive treatment
* pregnancy (including 6 months post-partum)
* previous treatment for either active or latent TB infection

Controls

Inclusion Criteria:

* age 15-25 years
* informed consent

Exclusion Criteria:

* latent- OR active tuberculosis
* chronic illness
* immunosuppressive treatment
* pregnancy (including 6 months post-partum)
* previous treatment for either active or latent TB infection

Active TB

Inclusion Criteria:

* diagnosed with active TB
* informed consent

Exclusion Criteria:

age \< 15 years
miRNA in Chronic Kidney Diseases

Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. These are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. Chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (ESRD). MicroRNA molecules (miRNA) also play an important role in these processes. MicroRNAs (miRNAs) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. Although the pathophysiological contribution of microRNAs (miRNAs) to kidney damage has also been highlighted, the effect of miRNAs on kidney damage under conditions of oxidative and ER stress remains understudied.


Eligibility Criteria:
Inclusion Criteria:

* healthy normotensive adults (eGFR CKD-EPI \>90 mL/min/1.73 m2, BP \<140/90 mmHg)
* hypertensive adults (eGFR CKD-EPI \>90 mL/min/1.73 m2, BP \>140/90 mmHg)
* patients with chronic kidney disease stage 3-5 (eGFR CKD-EPI\< 60 mL/min/1.73 m2)

Exclusion Criteria:

* cardiovascular diseases, but hypertension
* diabetes
* cerebrovascular diseases
* peripheral artery disease