cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of Purified Verocell Rabies Vaccine PVRV Administered Intramuscularly and Intradermally

Rabies is fatal disease but preventable with rabies vaccines and immunoglobulins, conventionally involves intramuscular (IM) administration of the vaccine. However, switching the intradermal (ID) route offers potential advantages in dosing, time and cost without compromising efficacy and safety. Therefore, this study aims to compare the safety and immunogenicity of a short-term three-doses intradermal regimen (3D-ID) with a conventional five-doses intramuscular regimen (5D-IM) of the purified Vero cell rabies vaccine (PVRV), administered via both intramuscular (IM) and intradermal (ID) routes as post-exposure prophylaxis (PEP).

Rabies vaccines can be used ID for PEP, according to a WHO Expert Committee recommendation. The administration of short-term PEP through ID (3-doses) offers a safe, immunogenic, dose-sparing, and cost-effective alternative to the conventional protocol (IM, 5-dose regimen) while reducing the volume by up to 60 to 80% and vaccination schedules by 3 weeks. This strategy has the potential to reduce the overall requirement and cost of such vaccines, along with minimizing the burden on healthcare professionals and facilities. Furthermore, this strategy is more likely to improve vaccination compliance compared to conventional protocol, and will certainly improve treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 2 year or older
* Both male and female
* Dog-bite cases only
* Informed consent form signed by the individual participant and/or their parents or guardian in case of minor age or major Trauma

Exclusion Criteria:

* Subject is participating in any other clinical trial.
* Pregnant and lactating women
* Have a plan to donate blood while participating in the study
* Received any other vaccine except rabies vaccines in last 6 months
Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial

The purpose of this study is to determine whether corneal collagen crosslinking is effective in the treatment of progressive keratoconus.

Keratoconus is a noninflammatory, asymmetrical, progressive corneal ectasia caused by biomechanical instability of the corneal stroma. Treatment modalities are primarily glasses or contact lenses. It has been estimated that one out of five patients will progress to such an extent that a corneal transplant is necessary to regain useful vision.

Corneal collagen crosslinking (CXL) is a treatment modality that intends to halt progression of keratoconus. This study investigates the efficacy av CXL in stabilizing the cornea in keratoconus by means of a randomized controlled clinical trial.

Participants are eligible for inclusion if progressive keratoconus is confirmed and the inclusion criteria are met. Follow-up after inclusion is at 1 week (treatment group), 1, 3, 6 and 12 months. Pre- and post-inclusion examinations include measurement of uncorrected distance visual acuity (UCDVA), best spectacle corrected distance visual acuity (BSCDVA), Scheimpflug-topography and slitlamp examination.

Eligibility Criteria:
Inclusion Criteria:

* Keratoconus diagnosis determined clinically and topographically (KISA%- index)
* Significant progression is defined as change (increase) of Kmax by at least

  1D from baseline at 6 months and/or change (increase) of Sim-K-ast by at least 1D from baseline at 6 months. Kmax is defined as the steepest radius of curvature (either the maximum simulated K-reading or the maximum K-reading in the 3-mm zone or the 5-mm zone) of the anterior corneal surface that progressed the most during 6 months observation
* Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam
* Signed written informed consent

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Breast feeding
* History of corneal surgery
* History of ocular herpes simplex infection
* Minimal corneal thickness \< 300 micrometers
* Recurrent corneal erosions
* Other corneal (e g endothelial) or conjunktival diseases
* Neurodermatitis
* Severe forms av atopic disease
* Collagenoses, autoimmune or other systemic disease
* Systemic treatment with high doses of steroids
* Severe scarring och striae of the cornea

Relative exclusion criteria:

* Kmax \> 58D
* Minimal corneal thickness \< 400 micrometers (a modified CXL-treatment will be used swelling the cornea before UV-illumination treatment).
Effect of Deproteinization on the Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets

The aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a Raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.


Eligibility Criteria:
Inclusion criteria:

- All patient with orthodontic treatment involving bicupids extractions

Exclusion criteria:

- Patients with damaged teeth
Corneal Epithelial Stem Cells and Dry Eye Disease

To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments. This pilot study will carefully observe and monitor each qualifying and willing individual for response to treatment, signs of toxicity and adverse effects from the treatment, and for ability of the treatment to improve comfort and restore vision.

Eligible patients presenting with severe dry eye disease that have failed treatment with conventional measures will be screened for inclusion into the study. The treatment will consist of administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived product. These eye drops will be transplanted by topical self-administration by the patient four times daily in both eyes for a three month interval.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of advanced dry eye disease
* Severe dry eye symptoms despite having tried over a half dozen treatments

Exclusion Criteria:

* Not willing to undergo clinical trial
* Unable to comply with treatment regimen
The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)

The purpose of this study is to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR).


Eligibility Criteria:
Key Inclusion Criteria:

* Adults 18 through 80 years of age (inclusive)
* Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)
* No evidence of central involved diabetic macular edema
* ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better)

Key Exclusion Criteria:

* Ocular disease other than DR that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases
* Evidence of neovascularization on clinical examination or imaging
* Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients

International recommendations advocate dynamic or isometric strength training as an adjunct to aerobic exercise. Due to a lack of consensus, this research addresses the acute effects of isometric exercises by handgrip or lower limb isometry as a hypotensive strategy in hypertensive adults.

This study is characterized as a randomized, controlled and blinded clinical trial for the evaluators and carried out integrally in the Laboratory of Clinical Investigation (LIC) of the Cardiology Institute of Rio Grande do Sul / University Foundation of Cardiology (ICFUC). The project follows all recommendations proposed by the CONSORT Statement.

The study will consist of individuals of both genders, aged between 40 and 70 years who have blood pressure above 120mmhg by 80mhg. The participants, after signing the informed consent, answered a questionnaire that will evaluate the habitual level of physical activity and will be submitted to isometric exercises of palmar grip or quadriceps muscle. Pre- and post-exercise blood pressure will be monitored through the ambulatory blood pressure monitoring (ABPM) method.

Eligibility Criteria:
Inclusion Criteria:

* Controlled hypertensive patients (use of medication) sedentary or physically inactive

Exclusion Criteria:

* Pregnant women;
* Unstable angina;
* Class II, III or IV heart failure;
* Recent cardiovascular event (last 3 months);
* Chronic renal insufficiency;
* Diabetes;
* History of malignant diseases with life expectancy \<2 years;
* Or Orthopedic limitations or any physical or mental limitation that impedes the performance of physical exercises.
Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)

This study including two parts，one part is a randomized clinical trial design，another part is a registration study.

This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study.

The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients.

The primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).

Eligibility Criteria:
Inclusion Criteria:

* Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer;
* Has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy;
* Patients between 18 and 70 years old, no gender restriction;
* Eastern Cooperative Oncology Group (ECOG) PS of two or less;
* Before the start of the study, patient fully understands the study and is willing to sign the informed consent form;

Exclusion Criteria:

* Receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection;
* Refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection;
* Suspected malignant pleural effusion;
* There is no clear pathological diagnosis;
* Combined with other cancer;
* Patient have a positive surgical margin;
* Accept other treatment for lung cancer of postoperative；
* Combined with severe idiopathic disease of liver, kidney and hematopoietic system;
* Combined psychosis or AIDS;
* Allergy to the test drug;
* Pregnant or lactating women;
* Participation in any other clinical trial within three months;
* Conditions that are considered not suitable for this study investigators.
Comparison of Once Daily 40 mg Torsemide With Twice-daily 40 mg Furosemide

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion.

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice-daily Furosemide on changes in body weight after two weeks of treatment. To compare the frequency and volume of urine passed in 24 hours. To compare the patients' quality of life and levels of natriuretic peptide between the two sets of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.

Exclusion Criteria:

* Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.
Testing a Prediction Algorithm Into a Running Telehealth System for Patients With COPD

This trial will test a COPD prediction algorithm into a telehealth system from the previous Danish large-scale trial, TeleCare North (NCT01984840). The COPD prediction algorithm aims to support clinical decisions by predicting exacerbations in patients with COPD based on selected physiological parameters (blood pressure, oxygen saturation, and pulse). A prospective, parallel two-armed randomized controlled trial with approximately 200 COPD participants will be conducted.

Several studies call for research investigating telehealth' ability to predict exacerbations. Use of clinical prediction tools might be promising to improve telehealth services related to prediction of exacerbations and to support decision-making. However, more research is needed to further develop, test, and validate prediction algorithms to ensure that these algorithms improve clinical outcomes before they are widely implemented in practice.

This trial seeks to demonstrate that through telehealth, the implementation of a COPD prediction algorithm might have potential to support early detection of exacerbations. The COPD prediction algorithm might initiate timely treatment, which can potentially led to improvement in COPD patients' health and fewer hospitalizations. The primary outcome is the number of exacerbations defined as an all-cause acute hospitalization from baseline to follow-up in both groups. The trial hypothesizes that integrating a COPD prediction algorithm into the telehealth system will lead to a significantly lower number of exacerbations through early identification and timely preventive treatment. The primary outcome will be statistically analyzed, and the hypothesis will be tested between groups.

All participants are familiar with the telehealth system in advance. In addition to the participants' usual monitored measurements, they are asked to measure their oxygen saturation twice a week during the trial period.

The participants will receive the questionnaires; EuroQol-5D-5L, Short-Form 12 item, version 2 Health Survey, The European Health Literacy Survey Questionnaire, The Danish Test of Functional Health Literacy in Adults, Danish Telehealth Usability Questionnaire, and a questionnaire containing selected demographic characteristics at baseline and at 6-month follow-up.

Eligibility Criteria:
The trial population consists of patients with COPD who already use the telehealth system.

Inclusion criteria:

* Men and women \>18 years
* Diagnosis of COPD
* Fixed residence in Aalborg Municipality.

Exclusion criteria:

* Unable to monitor vital signs
* Unable to complete study questionnaires
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety \& tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese adults aged 20 to 60 years

Exclusion Criteria:

* History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
* Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
* Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
* History of progressive or severe neurological disorders
Individualized Blood Pressure Management During Endovascular Stroke Treatment

Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. Low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. Retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. Some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. Intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. We aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. For this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (PROBE).


Eligibility Criteria:
Inclusion Criteria:

1. Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
2. Age 18 years or older, either sex
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 8
4. Acute ischemic stroke in the anterior circulation with isolated or combined occlusion of: Internal carotid artery (ICA) and/or middle cerebral artery (MCA)
5. Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment

Exclusion Criteria:

1. Intracerebral hemorrhage
2. Coma on admission (Glasgow Coma Scale ≤ 8)
3. Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
4. Intubated state before randomization
5. Severe hemodynamic instability (e.g. due to decompensated heart insufficiency)
Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy

Prostate cancer is the first cancer in men. The treatment of metastatic prostate cancer with chemotherapy is based on the intravenous administration of docetaxel chemotherapy. Symptoms of anticipatory nausea, linked to anxiety caused by the treatment, may occur. Hypnosis is already used to treat the anxiety of people with cancer and can help treat the symtoms of nausea and vomiting of women with breast cancer.

The purpose of the study is to evaluate the effect of medical hypnosis in virtual reality on the anxiety of patients with metastatic prostate cancer receiving Docetaxel chemotherapy treatment in comparison with a control group.

After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after the 12 courses of docetaxel or premature termination of the study.

Eligibility Criteria:
Inclusion Criteria:

* Man aged ≥ 18 years
* Histologically proven metastatic prostate adenocarcinoma,
* Patient undergoing chemotherapy according to the following conventional scheme: 12 courses of Docetaxel every two weeks
* Patient who signed their informed consent
* Patient benefiting from social security coverage
* Patient treated and followed in the center for the duration of the study (6 months maximum).

Exclusion Criteria:

* Patient participating in another clinical trial on an experimental molecule
* Patient who received previous chemotherapy
* Patient unable to submit to protocol monitoring for psychological, social, family or geographic reasons
* Patient deprived of their liberty or under guardianship
* Patient with underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®

MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®.

The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.

Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque psoriasis.

This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
3. Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening.
4. Plaque psoriasis of moderate or severe severity of stable course with:

   * PASI ≥ 12 points;
   * BSA ≥ 10 %;
   * sPGA ≥ 3 points.
5. Patients who have been shown to undergo systemic therapy and/or patients who have had insufficient therapeutic efficacy of at least 1 previous standard systemic therapy for psoriasis, including phototherapy, therapy with cytostatic and immunosuppressive drugs, or who have had intolerance to standard systemic therapy.

Exclusion Criteria:

1. Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
2. A history of severe hypersensitivity reactions of any etiology.
3. Other (other than plaque) forms of psoriasis.
4. Drug-induced psoriasis.
5. Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
6. The presence of Adalimumab antibodies.
7. Extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period.
8. Active or latent tuberculosis
9. Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma.
10. Any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured.
11. Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the screening period.
12. Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C, HIV.
13. Vaccination with live or attenuated vaccines within 8 weeks before the screening period.
14. Hepatic and/or renal insufficiency.
15. Pregnancy or lactation.