cyrilzakka/clinical-trials huggingface dataset:
C5a Receptor Expression - COVID-19 (C5-COV)

The pathophysiology of ARDS is linked to an uncontrolled inflammatory response at the level of alveolo-capillary membrane, mediated by neutrophils and mononuclear cells. The complement system and anaphylatoxin C5a have shown central role in the recruitment of these pro-inflammatory cells and more broadly in the genesis of cytokinic storm syndrome. C5a acts via receptors C5aR and C5L2.

This is a preliminary study aimed at studying the expression of the C5a receptor on myeloid cells in peripheral blood of patients with ARDS secondary to COVID-19.

This study has of primary objective to show there is an overexpression of the C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers).

The medium-term objective is to develop a clinical trial to test the effectiveness of anti-C5aR antibody in this condition.

The pathophysiology of ARDS is linked to an uncontrolled inflammatory response at the level of alveolo-capillary membrane, mediated by neutrophils and mononuclear cells. The complement system and anaphylatoxin C5a have shown central role in the recruitment of these pro-inflammatory cells and more broadly in the genesis of cytokinic storm syndrome. C5a acts via receptors C5aR and C5L2.

This is a preliminary study aimed at studying the expression of the C5a receptor on myeloid cells in peripheral blood of patients with ARDS secondary to COVID-19.

This study has of primary objective to show there is an overexpression of the C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers).

The medium-term objective is to develop a clinical trial to test the effectiveness of anti-C5aR antibody in this condition.

Eligibility Criteria:
Inclusion Criteria:

For patients in resuscitation unit with ARDS linked to COVID-19:

* Patient under invasive mechanical ventilation
* PaO2 / FiO2 \<300
* PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample

For control patients with COVID-19 without ARDS

* Oxygen flow always less than 5 L / min
* PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample
* No passage in resuscitation unit
* Favorable evolution

Exclusion Criteria:

* Minors
* Patient deprived of liberty
* Patient's refusal to participate at study
* Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued
* Medullar aplasia
Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer

Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced immunosuppression has been implicated in the development of post-operative septic complications and neoplasm metastasis. General anesthesia is considered to not only suppress surgical stress, but also affect the immune function directly，such as altering the number and activity of immune cells. It is reported that some anesthetics increase susceptibility to tumor metastasis, apparently by suppressing natural killer cell activity. Different anesthetic techniques and anesthetics used in anesthesia have shown different effects on immunity. Many of the studies were animal trials or performed in vitro; in addition, most are focused on a single drug. To date, there is little published prospective clinical research designed specifically to investigate the effects of different general anesthetic technique on immune function in patients with oral malignant tumors. The aim of this study is going to characterize the immune response of patients undergoing surgery for tongue cancer under 3 types of general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* All the patients were scheduled for elective surgery for tongue cancer under general anesthesia. None of the patients had a history of endocrine, immune and circulatory system diseases;
* Exclusion criteria were also contraindications for receiving chemotherapy

Exclusion Criteria:

* contraindications for receiving chemotherapy,
* receiving perioperative blood transfusion, or
* preoperative and perioperative treatment with hormones and immunomodulatory agent.

Patients who suffered from any surgical complications such as infection were also excluded from our study.

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Efficacy of Novel Titania Nanoparticles Enriched Mouth Wash in Treating Dentine Hypersensitivity

Randomized Clinical trial to compare the reduction in dentin hypersensitivity after incorporating biogenically fabricated titania nanoparticles enriched Mouth Wash and Conventional Mouth Wash.Participants ranging between 20-50 years were allocated in two groups. Group A will use Conventional Mouth Wash without Nanoparticles. Group B will use titania nanoparticles enriched Mouth Wash. Both will use them for three months and then their VAS scoring will be checked.

In this study Novel biogenically fabricated titania nanoparticle reinforced Mouth Wash will be evaluated for dentine sensitivity . Participants following Inclusion criteria will be allocated in this study by Consecutive random sampling technique. Participants will be divided into two groups i.e Group-A and Group-B with dentin sensitivity of 30-80. Group A will be given Conventional Mouth Wash for three months and Group-B will be given titania nanoparticles enriched Mouth Wash for three months for the sensitivity. Sensitivity will be assessed using Visual analog scale (VAS) mean score after 1 month and then three months.

Eligibility Criteria:
Inclusion Criteria:

* Participants ranging between 20-50 years, good general health but developed dentine sensitivity associated with tooth surface wear and loss during the past 6 months.
* There was no history of allergy.
* Participants did not use any mouth wash , dentifrice or medication in the last 3 months.
* The involved teeth were viable, non-shaky, devoid of any decay, cracks and fillings.
* There was an essential positive response to the provoking Air stimuli.
* These teeth should display the visible signs of tooth loss and wear such as : attrition, abrasion, erosion and abfraction.

Exclusion Criteria:

* Participants that might have developed allergy or used medications during the last 2 weeks or more.
* The teeth having cracks, decay and fillings were also excluded. Patients who have undergone any periodontal surgery or gross periodontal issues.
* Participants who used any desensitisizing toothpastes/mouthwashes and tooth bleaching agents within 2 months of the trial were also excluded positively.
A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects

To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after administration of single oral doses of 900mg in healthy Male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects;
2. Age：≥18 and ≤45 on the date signing informed consent
3. Body mass index (BMI): 18-25 kg/m2 and the weight ≥50 kg；
4. Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.

Exclusion Criteria:

A subject will be excluded if the answer to any of the following criteria is "yes":：

1. Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
2. Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination
3. Positive serology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test.
4. Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening
5. Participation in any investigational drug or medical instrument study within 3months prior to screening, participation in 3 and more than 3 drug tests in a recent year;
6. Serious infection, trauma and major surgery within 4weeks prior to screening;
7. Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 4 weeks prior to screening, receiving blood transfusion treatment within 8 weeks prior to screening ;
8. Use of any prescription medicine or herbal remedy, over the counter medication or dietary supplements such as vitamin, calcium within 2 weeks prior to screening.
9. Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening；
10. Vegetarian or person with dietary restrictions
11. Subjects able to father a child are unwilling to use highly effective physical form of birth control from the trial period until 3 months after the completion of study.
12. With diseases which could impact on the absorption, distribution, metabolism and excretion (ADME) of study drugs or protocol adherence in the opinion of the investigator (such medical disorder/disease may relate to ccardiovascular, liver, kidney, digestive, immune, blood, endocrine, metabolic, cancer, neuropsychiatric,etc );
13. Subjects may be allergic to GV-971 in the opinion of the investigator.
14. Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.
A Resiliency and TIC Intervention for PMHNP Specialty DNP Students

The goal of this observational study is to explore the impact of a resiliency and trauma informed care educational intervention for Psychiatric Mental Health Nurse Practitioner (PMHNP) students at the University of Arizona College of Nursing during the final, clinical year of the program. Specifically, the investigators will examine if the educational intervention is feasible, acceptable and helpful to students, and can decrease burnout and increase resiliency.

Students in the Doctor of Nursing Practice (DNP) and certificate programs during their final, clinical year of the program will be asked to complete anonymous online surveys before each semester (Spring, Summer, and Fall) that measure levels of burnout, resiliency, Adverse Childhood Experiences (ACEs), perceived stress, and knowledge related to trauma-informed care principles and ways to promote their resiliency. Students in the Psychiatric Mental Health Nurse Practitioner (PMHNP) specialty will receive an educational intervention related to trauma-informed care and resiliency during an in-person clinical immersion in January, May, and August 2023; after each session, they will be asked to complete an anonymous online post-intervention survey. Each survey includes a disclosure statement and list of University and national mental health resources in case participants experience any emotional distress related to the topics/questions related to the survey.

Eligibility Criteria:
Inclusion Criteria:

* Doctor of Nursing Practice (DNP) and post-Masters certificate students at the University of Arizona College of Nursing in the final, clinical year of their program.

Exclusion Criteria:

* None.
Evaluation of the SCALED (SCaling AcceptabLE cDs)

This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* admitted with a TBI

Exclusion Criteria:

* Patients who die within 24 hours of hospital admission and patients documented as "comfort cares" during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.
The Effect of Antimicrobial Therapy on the Serum Level of P-cresol in Peritoneal Dialysis Patients

An important subgroup of protein-bound toxins are generated as a result of protein fermentation in the colon. P-cresol is a fermentation metabolite of tyrosine. In renal failure, the colonic generation rate of p-cresol is markedly elevated. After absorption, the majority of p-cresol is conjugated to form p-cresyl sulphate. There is clear evidence, both in vitro and in vivo, that accumulation of conjugated fermentation metabolites is correlated with clinical important endpoints. Free p-cresol is an independent predictor for mortality in hemodialysis patients.

Moreover, in renal failure patients, neither hemodialysis nor peritoneal dialysis is capable of normalising the clearly elevated serum concentrations of p-cresyl sulphate. Removal is at least partially diminished by the important protein binding of p-cresol. Besides adaptation of renal replacement therapies to improve removal of protein bound solutes, another approach is to lower the generation of uremic toxins.

The mechanisms underlying colonic carbohydrate and protein fermentation, responsible for the generation of p-cresol, are only partially understood. On the one hand, the ratio of fermentable carbohydrates to proteins has been shown to be an important determinant of protein fermentation. On the other hand, changes in the colonic bacterial flora influence the generation of p-cresol in dogs and in healthy human individuals.

The effect of antibiotic therapy on bacterial protein fermentation and thus on the generation of p-cresol is not known. A reanalysis of data abstracted from a recent longitudinal study in peritoneal dialysis (PD) patients suggests that antibiotic therapy may lower p-cresol levels substantially. The current study aims at confirming these data in a prospective manner.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Exit site infection, requiring antibiotic treatment
* Maintenance therapy with peritoneal dialysis

Exclusion Criteria:

* Signs of peritonitis
Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar

The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.


Eligibility Criteria:
Inclusion Criteria:

* Any patient attending the study sites and reporting history of fever within past 48 hours or other symptoms compatible with malaria and giving their informed consent, will be eligible for the study.

Exclusion Criteria:

* Patient's refusal to consent will disqualify participation in the study.
Tooth Whitening With Hydrogenperoxide in Adolescents

The specific objective of this study is:

* Evaluate and quantify colorimetric changes in young permanent anterior teeth;
* Compare the efficiency and efficacy of three gels used for self-administered home whitening and an over the counter whitening strip;
* Analyze the increase in dental sensitivity in adolescent patients submitted to home whitening with 6% and 7.5% hydrogen peroxide with and without the addition of calcium (whitening strips);
* Assess sensitivity, comfort and acceptance of whitening strips by patients;
* Assess patient satisfaction with the method and material used for home whitening.

The aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with 6% and 7.5% hydrogen peroxide using home kits with whitening strips. Adolescents aged 12 to 20 years will be allocated to different groups based on treatment (n = 16 per group): 1) placebo; 2) 6.0% hydrogen peroxide (White Class with calcium - FGM); 3) 7.5% hydrogen peroxide (White Class with calcium - FGM); and 4) 7.5% hydrogen peroxide (Oral B 3D White - Oral-B). After the whitening procedures, the participants will be evaluated using a visual analogue scale for tooth sensitivity and digital spectrophotometry for the measurement of changes in color.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 to 20 years; diagnosis of altered color on maxillary and mandibular anterior teeth with initial color equivalent to A2 on the Vita scale (Vita Zahnfabrik); signed statement of informed consent

Exclusion Criteria:

* Dental anomalies (malformation, carious lesions, fractures); presence of at least four maxillary and/or mandibular anterior teeth; known adverse reaction to peroxide; use of whitening agents (administered in dental office or at home) in the previous year; currently undergoing orthodontic treatment, orthopedic treatment of the jaws or psychological treatment; use of medication that can alter the color of the teeth, such as ferrous sulfate.
Massachusetts Healthy Families Evaluation-2

Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide home visiting program for first time parents aged 20 years and under. The evaluation uses a mixed-method design to assess participant outcomes in five program goal areas: 1) prevention child abuse and neglect; 2) optimal child development; 3) educational achievement and economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged births.


Eligibility Criteria:
Inclusion Criteria:

* age between 16 and 21 years
* first-time parent

Exclusion Criteria:

* cognitive delay
* not fluent in either Spanish or English
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.

In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
* At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
* Hs-CRP equal or greater than 8 mg/L.
* Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

Exclusion Criteria:

* Evidence of untreated or inadequately treated latent or active TB.
* Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
* History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
* May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
* Any second DMARD must be washed out prior to the first study dose.
A Study on the Clinical and Psychological Characteristics of Patients With COVID-2019

A study on the clinical and psychological characteristics of patients with coronavirus disease 2019 (COVID-2019)

The main objective of this study is to study the clinical and psychological responses of patients with COVID-2019 during the whole treatment process. Including clinical symptoms, auxiliary examination results, and corresponding psychological changes, including depression, anxiety, insomnia, etc. This study will draw lessons about treatment and other better advices for other countries and regions.

Eligibility Criteria:
Inclusion Criteria:

* patients with COVID-2019

Exclusion Criteria:

* No
The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly

Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.

The main hypothesis of the present study is therefore that manual therapy applied to the cervical spine may have a beneficial impact on the balance and motor performance of seniors. The study also aims to propose an assessment of the physical parameters of balance, in order to validate the contribution of the cervical spine in compensatory mechanisms.

To do so, an interventional study was designed, monocentric, prospective, controlled, randomized double-blind (patient and evaluator performing the measurements). The experiment will take place over three measurement periods on D0, D7 and D21.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older, of either sex
* Autonomous, able to walk ten meters alone without walking aid
* Able to understand instructions necessary for the correct performance of the measurements.

Exclusion Criteria:

* Patients suffering from a locomotor handicap or severe chronic progressive pathologies preventing the protocol from being carried out correctly
* Patient who has an history of surgery - fracture - dislocation of the cervical spine
* Patient who has cognitive impairments (Mini Mental Statement \<20)
* Patient who has life expectancy less than 6 months.