cyrilzakka/clinical-trials huggingface dataset:
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 inclusive
* Male, non-child-bearing female or fertile female with appropriate contraception.
* Mild to moderate confirmed active ulcerative colitis
* Able and willing to give informed consent

Exclusion Criteria:

* Colitis of other cause
* Pregnancy, inadequate contraception for fertile female patients
* Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.
* Other significant medical condition that preclude participation at investigator criteria
* Allergy or hypersensitivity to salicylates
* Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments
Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome

The administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness.

As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and \< 90 years
* PCR confirmed diagnosis of COVID-19. As an alternative to PCR, a determination of antigens or any other test that in the future is considered equivalent to these in its diagnostic value may be accepted as evidence
* Radiological image compatible with inflammatory pleuropulmonary exudate or patients with onset of symptoms in the last 7 days and with an uncomplicated respiratory infection for outpatient follow-up.
* Signature of direct or delegated informed consent

Exclusion Criteria:

* Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
* Intolerance or allergy to Calcifediol or its components
* Pregnancy
Aging Brain Structure and Memory in Response to Exercise

This study will measure brain structure through its mechanical properties, assessed with magnetic resonance elastography, and determine whether it improves with aerobic exercise in older adults with low memory abilities. Additionally, this study will determine if memory abilities improve with exercise and if they are related to brain structure. Overall, this project has the potential to identify how brain health is impacted by exercise in older adults.

Mechanical properties of the human brain, measured with magnetic resonance elastography (MRE), reflect the health of brain tissue. Our previous research has shown that these mechanical properties of the hippocampus are highly sensitive to memory function in young adults. Based on these findings, we believe that these mechanical properties may be strong indicators of memory health in older adults and populations experiencing decline in memory function (i.e. mild cognitive impairment, MCI). Further, our results indicate these properties and associated functions are positively impacted by fitness and exercise training, thus making them potentially ideal markers for brain health in assessing rehabilitation.

The objective of this research is to examine these properties in older adults with and without MCI. We will do the following: (1) determine if there are differences in mechanical properties of memory systems in older adults with and without MCI; (2) establish structure-function relationships between mechanical properties and memory performance in the older adult population; and (3) determine if both mechanical properties and memory performance are impacted by cardiovascular health, both through cross-sectional assessment of aerobic fitness and longitudinal response to exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation
* age 60-90 years
* MMSE score \>24 at time of initial consent

Exclusion Criteria:

* major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years)
* neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct)
* other systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure, diabetes, chronic obstructive pulmonary disease, liver diseases, hypertension)
* current medication use likely to affect CNS functions (e.g. long active benzodiazepines)
* failed outcome on the baseline graded exercise test
* hypertension (systolic 130+ mmHg OR diastolic 80+ mmHg) from baseline blood pressure measurement
* claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning
* concussion within last 2 years and more than 3 lifetime concussions
* current smoking (including marijuana) within the past 3 months
Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML

Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (\>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.

A prospective,Multicenter,open,single-arm clinical study.The research process is divided into three phases: the screening phase, the treatment phase, and the follow-up phase. The treatment phase includes pre-transplant pretreatment, cord blood transplantation, and consolidation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. AML patients diagnosed by bone marrow morphology and Immunology;
2. Exclusion of APL by Bone marrow morphology or molecular level;
3. A patient who has obtained bone marrow cytology remission after inductive treatment;
4. Aged from 60 to 75 years;
5. Liver and kidney function: blood bilirubin ≤ 35μmol / L, AST or/ALT \<2 times the upper limit of normal (ULN), serum creatinine;≤ 150μmol / L;
6. The function of Heart is normal;
7. Physical condition score 0-2 (ECOG score);
8. Get informed consent signed by patient or family member.

Exclusion Criteria:

1. APL patients, treatment-related AML;
2. Retreatment of patients;
3. Allergies to any of the drugs involved in the protocol;
4. There are obvious contraindications to chemotherapy drugs;
5. Liver and kidney function is obviously abnormal, exceeding the inclusion criteria;
6. Serious heart disease, including myocardial infarction, cardiac insufficiency;
7. Suffering from other organ malignant tumors at the same time ;
8. Active period of tuberculosis patients and HIV-positive patients;
9. Suffering from other blood system diseases at the same time;
10. Pregnancy or breastfeeding;
11. Cannot understand or follow the research plan;
12. A history of intolerance or allergies to similar drugs;
13. Patients under 60 years of age or over 75 years of age;
14. Participate in other clinical researchers at the same time;
15. There are other situations that hinder the conduct of the study.
Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis

To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis

The Intraoral scan is digital optical scan method, that has advantages such as being more comfortable, easy to transfer, and full digital workflow. Conventional impression using silicon rubber and gained stable accuracy of impression. This study aims to compare the accuracy of two methods.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old (including 18 and 70 years old);
* The patient's maxilla or mandible cannot be preserved due to missing teeth or remaining teeth proposed for implant-retained restoration;
* The patient's missing teeth area is available for placement of 4-6 implants;
* Completion of osseointegration of the patient's implants after implant surgery;
* The patient has at least 2 mm width of keratinized mucosa in the remaining alveolar ridge;
* The patient voluntarily participates in the trial and signs an informed consent form

Exclusion Criteria:

* The patient has a severe gag reflex;
* The patient has an intermaxillary distance of less than 20 mm in the posterior region;
* The distance between the two implants is less than 10 mm;
* Implants fitted with composite abutments with the abutment screw holes penetrating at an angle greater than 60 degrees to the alveolar ridge;
* Other patients judged by the investigator to be unsuitable for inclusion
Water-jet Assisted ESD vs Conventional ESD Technique for Treating Early Gastric Cancer

1. Introduction The aim of the study is to evaluate the efficacy and safety of ESD by use of a new water-jet assisted ESD system using the HybridKnife® in patients with early gastric neoplastic lesions in comparison to the conventional ESD established in Japan. The water-assisted ESD technology allows pressure controlled injection of fluids through the tip of a recently developed HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions as well as coagulation of bleeding can be performed with the same device without need for changing the instrument. These options should accelerate the procedure and may increase its safety and efficacy.
2. Hypothesis The water-jet assisted ESD technique using the HybridKnife® bears the advantage of less instrument changes due to the combination of high-frequency cutting and water-jet application in one single instrument. This should lead to a simplified ESD procedure, shorter learn-ing curve and especially to a shorter procedure time.

The water-jet assisted ESD technique should be shorter than the conventional ESD techniques using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* adults (≥ 18 years) with confirmed diagnosis of gastric adenoma or early gastric adenocarcinoma
* differentiated mucosal adenocarinoma without ulcer findings ≤ 60 mm in diameter.
* Lesions with ulceration ≤ 30 mm in diameter.
* undifferentiated type of mucosal cancer is ≤ 20 mm.
* The patient has given written informed consent.

Exclusion Criteria:

* pregnancy
* coagulopathy (INR\>2.0, platelets \< 70/nl)
* mucosal lesions which did not meet the inclusion criteria
* evidence of local or distant metastases according to endoscopic ultrasound (EUS) and/or CT scan, EUS (7.5 MHz probe) findings of tumor infiltration into deep layers of the submucosa or muscularis propria. -Patients unfit for deep sedation by use of propofol
Characterization of Chronic Pain in Elderly Population with Emphasis on Differences Between Gender

Introduction: It is estimated that by 2025 there will be approximately 1.2 billion people above 60 years old. Global projections indicate that by 2050 there will be about 2 billion elders, 80% of them living in developing countries. Researches on the relationship between pain and aging are currently much valued within the health sciences, the ultimate goal being the provision of adequate pain control for the growing number of elders in society. Objectives: To characterize chronic pain in the elderly population and evaluate pain threshold to mechanical stimulation, with emphasis on gender differences. Methods: This study refers to a cross-sectional study to be conducted in convenience samples of a primary care unit (Geraldo Horacio de Paula Souza) that follows elders and the Department of Geriatrics of the university hospital of the School of Medicine of Universidade de São Paulo (Hospital das Clínicas). At least 200 participants of each gender, aged 65 or above, will be selected to participate. Chronic pain will be that lasting for six or more months (either continuous or recurrent, as recommended by the International Association For the Study of Pain). Participants will be searched about their demographic and socioeconomic backgrounds, and asked to answer the following questionnaires: the Mini Mental State Examination, a structured questionnaire for activities of daily living, a structured questionnaire for instrumental activities of daily living, Beck Anxiety Inventory, Geriatric Depression Scale, the five dimensions European Quality of Life assessment (EQ5D) and Brief Pain Inventory. Participants will also be evaluated regarding pain threshold to mechanical stimuli using algometer. Descriptive statistics of the sample will be displayed as means, medians, standard deviations and proportions. For testing for differences between males and females, a significance level of 5% will be used. Keywords: elderly, chronic pain, gender.


Eligibility Criteria:
Inclusion Criteria:

* Patient of the geriatrics clinic at the Central Institute (IC) of the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) or the Geraldo Horácio de Paula Souza School of Public Health Center of the University of São Paulo
* Be over 65 years old
* Accept study participation
* Have read, understood, agreed and signed the TCLE

Exclusion Criteria:

* Cognitive difficulty in understanding and responding to research questions
* Do not accept participation in the study
Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo

The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.

Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side.

Treatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session.

Treatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months.

Fractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm.

Tacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session.

Applied on the lesions on the other half of the body (not treated with fractional CO² laser) twice daily for 4 months.

Eligibility Criteria:
Inclusion criteria:

* Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions.
* Age ≧ 12 years.
* Symmetrical vitiligo.
* Three month treatment-free period.

Exclusion criteria:

* Patients younger than 12 years of age.
* Non-stable lesions.
* Non-symmetrical vitiligo.
* Patients currently on other lines of treatment.
Evaluation of PD1 / PDL1 Expression on Blood Cells & Tumor Tissue, Their Role as a Prognostic Target in NSCLC Patients

Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1 (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer patients, particularly in those with lung cancer, has not been sufficiently studied. The purpose of this study is evaluate the expression of PD1 and PDL1 in subpopulations of peripheral blood and tumor cells patients with lung cancer non-small cell (NSCLC), associating with clinicopathological features of the patients studied.

This is a prospective cohort study including patients with NSCLC stages IIIA, IIIB and IV lung cancer clinic of the National Cancer Institute (INCAN)

Clinical samples. Prior and informed consent before receiving any treatment, sample be obtained 15 ml peripheral blood of each subject included in the study (patients and controls). mononuclear peripheral blood cells (PBMC) from different groups of subjects separated by centrifugation gradient (Polymorphprep, Accurate Chemical) are used. The cells are resuspended in dimethylsulfoxide (DMSO) and 10% fetal bovine serum (FBS) to 90% at a concentration of 1 million cells per ml and kept in liquid nitrogen until use.

Evaluation of PD-1, PD-L1 by flow cytometry. The following monoclonal antibodies directed against cell surface antigens of human are used: anti-PD-1, anti-PD-L1, anti-PD-L2, anti- cluster of differentiation (CD) 3, anti-CD4, anti-CD8, anti-CD14, anti-CD16, anti-CD56, anti-CD19, anti-CD20.

Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC). Lung biopsy is obtained paraffin blocks, and are processed by IHC technique for antitumor expression of PD1 / PDL1.V PD-L1 immunostaining was classified into two groups according to intensity and extent: (a) negative, when no staining or positive staining was detected in \<5% of the cells; and (b) positive, when membranous staining was present in P5% of the cells.

Eligibility Criteria:
Inclusion Criteria patient :

1. Patients who have understood and signed the informed consent.
2. Diagnosis of lung cancer, histologically or cytologically documented (stage IIIA / B or IV) non-small cell adenocarcinoma, which had not received radiotherapy and / or chemotherapy prior to the first sample.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and evidence of measurable disease.

Exclusion Criteria patient:

1. Subjects with Non-small cell lung cancer with a different histological type to adenocarcinoma.
2. Subjects with acute inflammation and uncontrolled infections.

Inclusion Criteria healthy subjects :

1. Informed consent in writing (signed) to participate in the study.
2. No diagnosis of oncological disease.
3. Subjects without symptoms of any respiratory illness in the two weeks prior to sampling.

Exclusion criteria healthy volunteers.

1. Any unstable systemic disease (including active or metabolic infection, congestive heart failure, liver disease, kidney).
Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy

In France, it has been recommended since 2022 that pregnant women be vaccinated against pertussis from 20 to 36 weeks' gestation.

This vaccination schedule is inspired by the Anglo-Saxon model and studies showing the effectiveness of this practice.

The aim of this vaccine is to protect the newborn by transferring antibodies from the fetus to the placenta, because Pertussis is a particularly serious disease in newborns.

The aim is to describe pregnant women's knowledge concerning pertussis, vaccination against pertussis during pregnancy and the cocooning strategy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant between 20 and 41 weeks of amenorrhea
* Primiparous
* aged more than 18
* Agreed to participate in the study

Exclusion Criteria:

* Multiparous
* Protected by law (guardianship, guardianship, safeguarding of justice)
* Not agreed to participate in this study
Second Line Therapy to Treat Age-related Macular Degeneration (AMD) for Patients Not Responding Well to Lucentis Therapy by Itself

The purpose of this study is to demonstrate that Visudyne-Lucentis-dexamethasone (V-L-D) triple therapy will give similar efficacy and safety results as Lucentis monotherapy.

Study Design:

Patients who have received 2-6 previous treatments with Lucentis monotherapy and who have exudative activity associated with the choroidal neovascularization (CNV) lesion, as confirmed by fluorescein angiography (FA) or optical coherence tomography (OCT), will be eligible. Patients will be randomly assigned at 4-8 weeks after the previous Lucentis treatment to either

1. continuation of Lucentis monotherapy
2. triple therapy with half fluence Visudyne (300 mW/cm2 for 83 seconds) followed within 2 hours by intravitreal Lucentis 0.5 mg (first injection) and then dexamethasone 0.5 mg (second injection) (V-L-D).

Both groups will receive treatment at baseline and then as needed (PRN), according to retreatment criteria, with monthly assessments thereafter for 12 months. In the triple therapy group, patients may only be retreated with the V-L-D combination at intervals of no less than 3 months; if retreatment is needed 1 or 2 months after a previous V-L-D treatment, the patient will receive a Lucentis injection at that visit; however, if retreatment is needed and the previous V-L-D treatment was at least 3 months prior, then V-L-D treatment is mandatory. OCT, visual acuity (VA) testing, and possibly FA will be conducted at each assessment visit to define the need for retreatment.

Eligibility Criteria:
Main Inclusion Criteria:

* Patients with subfoveal CNV due to AMD who, after 2-6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4-8 weeks after the last treatment. Exudative activity is defined as one or more of:

  * CNV leakage confirmed by FA
  * New hemorrhage associated with the CNV lesion
  * Subretinal fluid or cystoid macular edema by OCT showing retinal thickness ≥ 230 μm
* All lesion composition types with a lesion greatest linear dimension (GLD) ≤ 5400 microns (approximately ≤ 9 disc areas \[DA\])
* Best corrected ETDRS VA score of 25-73 letters (approximate Snellen equivalent of 20/40-20/320)

Main Exclusion Criteria:

* Subfoveal geographic atrophy or subfoveal fibrosis in the study eye
* Intraocular surgery within 3 months of enrollment
* Inability to attend the protocol-required visits
* Known allergies or hypersensitivity to any of the study treatments