cyrilzakka/clinical-trials huggingface dataset:
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung

Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. The hypothesis is that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.

The primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. Once these criteria have been defined, the diagnostic parameters and the reproducibility of pCLE will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years of age
* Willing and able to comply with study procedures and provide written informed consent to participate in the study
* Indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic bronchoscopy
* Newly discovered \&/or prior discovered non classified nodules, hard to define based on CT scan
* Purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary nodule or multiple lesions
* All lesion locations are acceptable
* Any patient undergoing clinically indicated bronchoscopies after lung transplantation
* Patients post transplant showing clinical signs of acute rejection \>3 weeks; \< 1 year
* Patient with single or double lung transplant

Exclusion Criteria:

* Contraindication to short-acting anesthetic agents;
* Contraindications to transbronchial biopsy
* Bleeding diathesis;
* A pacemaker/defibrillator;
* A diagnosis by other means (sputum cytology, microbiology).
* Unwilling To Consent
* Unable To Safely Tolerate A Bronchoscopic Procedure
* Unwilling To Comply With Surveillance Bronchoscopy Follow Up
* Chronic Rejection
* Fungal Disease
* Ax Histological Assessment Or Incomplete Biopsy Procedure Should Be Considered As A Screen Failure
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics

The ageing population and the increase in diabetes raise the prevalence of chronic skin ulcers (CCU). In diabetics, precursor cell mobilization decreases. In wounds, the inflammation is prolonged and oxidative stress increases. This is an unfavorable microenvironment for healing. A major risk factor in the development of CCU is nutritional deficiency. Healing needs energy and nutrients for regeneration. In diabetics the malnutrition can be more than 60%. However, although the provision of certain nutrients can improve the healing capacity, it is not a common clinical practice to nutritionally evaluate diabetic with CCU. Exosomes are extracellular vesicles that reflect the physiological state of the cells producing them. Stem cell derivatives exosomes are rich in factors, that can provide a favorable microenvironment for tissue regeneration.

The aim of this project is to develop a therapeutic process to accelerate the healing of diabetic CCU, based on the correction of nutritional deficiencies, to improve the regenerative capacity, together with the application of exosomes from mesenchymal stem-cell (MSC) in the wound, creating a microenvironment that favors tissue regeneration. For this, a pilot clinical trial with diabetic patients with CCU is proposed, to evaluate the effect of personalized nutritional supplementation on healing and regenerative capacity.


Eligibility Criteria:
Inclusion Criteria:

* Signature of the informed consent
* Age between 50 and 80 years
* Diagnosis of Diabetes Mellitus for more than 1 year
* Documented diagnosis of peripheral artery disease
* HbA1c \< 9%
* Category 5 in the Rutherford-Becker classification

Exclusion Criteria:

* Poor cognitive function, dementia or psychiatric conditions
* Osteomyelitis, gangrene, malignancy or immunocompromised disease
* Thromboangiitis obliterans or Buerger's disease
* Clinical evidence of invasive infection in the target limb requiring IV antibiotherapy
* Presence of neuropathic ulcers only
* Human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) positive.
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.

Fecal microbial transplantation is to transplant functional microbiota from the feces of healthy people into the gastrointestinal tract of patients, reconstruct new intestinal microbiota, and realize the treatment of intestinal and extra-intestinal diseases. Compared with ordinary commercial probiotics, FMT is more consistent with the composition of the intestinal microecological structure and can recover intestinal flora to the maximum extent and faster. FMT increases intestinal bacteria production function and helps to restore the systemic immune response so that sepsis pathogens are removed. The aim of this trial was to investigate the clinical effect of FMT in the treatment of patients with severe infections.

The gastrointestinal tube access was established, and the standard preparation of fecal bacteria solution 20ml (frozen at -80 ° C, melted at room temperature before use) was injected through the gastrointestinal tube once a day for 6 consecutive days. The other treatment measures were the same as those of the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with severe infections, which is infected patients SAFA≥2 OR APACHE Ⅱ≥15
* Aged ≥14 years
* Patients or their family members agreed to participate in this study

Exclusion Criteria:

* Advanced tumors or diseases associated with systemic immunosuppression
* Pregnant women
* Patients with severe intestinal ulcer or perforation
* Unable to complete oral administration and no effective artificial feeding pipeline.
Food Modification to Alter Glycaemia and Insulinaemia

The study specifically aims to determine glycemic and insulinemic response of added low GI ingredients, beta-glucan, resistant starch and isomaltulose to foods.

There will be a total of 9 test sessions and each session will last up to 3 hours. At each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations. Subject will be served the test food and to consume within15 minutes. Following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Males
* Chinese ethnicity
* Age ≥21 and ≤ 40 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure ≤140/90 mmHg
* Fasting blood glucose \<6.0 mmol/L
* In general good health

Exclusion Criteria:

* Current smoker
* Have metabolic diseases (such as diabetes, hypertension etc)
* Have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
* Have an ongoing infection or currently undergoing treatment at the time of screening
* Have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
* Have active Tuberculosis (TB) or currently receiving treatment for TB
* Intolerances or allergies to any foods
* Partake in sports at the competitive and/or endurance levels
* Intentionally restrict food intake
Customized Choice of Oral P2Y12 Receptor Blocker

A subset of patients recruited in the main MATRIX study will be randomized after intervention but before discharge to standard of care (the treating physician will decide which oral P2Y12 inhibitor will be added on top of aspirin) versus a customized approach based on an algorithm which integrates phenotypic information, including but not limited to residual on-treatment platelet reactivity assessed via VerifyNow P2Y12 Assay.

Up to 20-30% of clopidogrel treated patients do not adequately respond to the drug and are at higher risk for ischemic events including death, myocardial infarction, stroke and stent thrombosis.

Residual high on-treatment platelet reactivity while the patient is on clopidogrel depends on a complex interplay of phenotypic (spontaneous platelet reactivity, inflammatory status, acuity of the clinical presentation, age, renal function) and genetic variables.

Two main Loss of function alleles have been identified: 1) CYP450 2C19\*2 is present in around 25% of the Caucasian population and result in a lower amount of clopidogrel active metabolite. Carriers of 2C19\*2 are at higher risk for death or MI and 2.7 fold increase in the risk of stent thrombosis if treated with conventional clopidogrel; 2) ABCB-1 C carriers have reduced clopidogrel absorption and they have similarly been shown to be at higher risk for ischemic adverse events if treated with clopidogrel. Many investigators have recently shown however, that the positive predictive value of genetic testing alone at the time of PCI is limited and the knowledge of genetic status alone with respect to the two previously described loss of function alleles is only poorly able to identify to long-term clopidogrel poor responders. An Algorithm has therefore been developed, combining phenotype information which has been shown to risk stratify both ischemic and bleeding events up to one year follow-up in PCI patients.

This algorithm has been developed from a single center retrospective registry. To prospectively validate it in the context of a prospective multicenter study, the first 320 patients recruited in the present study will undergo phenotype at discharge and at 30 days and genotype assessment at the time of randomization, irrespective of the group which they have been assigned to (i.e. standard of care or gene and phenotype). The hypothesis behind this mechanistic sub-study is that the use of this combined phenotype-genotype algorithm will increase the proportion of patients at 30 days who will be in the therapeutic range according to PRU values from 50% in the standard of care versus 70% in the gene and phenotype group.

Eligibility Criteria:
Inclusion Criteria:

* patients recruited in the main MATRIX study who underwent coronary angioplasty with stent placement.

Exclusion Criteria:

* unwillingness to sign this sub study specific informed consent
S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement

Evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.

Primary purpose:

Evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.

Secondary purpose:

1. Evaluate the efficacy by comparing the change in blood pressure for each drug pattern (monotherapy or combination therapy) at 6 months after administration of the drug to be studied in patients with essential hypertension.
2. Evaluate the safety by checking the incidence (%) of adverse events after administration of the drug to be studied in patients with essential hypertension.
3. Evaluate the safety by checking the peripheral edema incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.
4. Evaluate the safety by checking the headache incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years of age
2. A person who was diagnosed with essential hypertension at the time of participation in the study or was previously diagnosed with essential hypertension and is taking antihypertensive drugs for treatment (Essential hypertension: Systolic blood pressure greater than 140mmHg or diastolic blood pressure greater than 90mmHg)
3. A person whose prescription for the study drug under study was confirmed at the time of participation in the study
4. A person who voluntarily decided to participate in this observational study and gave written consent to the consent form

Exclusion Criteria:

1. Patients who are contraindicated in administration of study drug according to the permission

   * Patients with a history of hypersensitivity to the study drug or its components or other dihydropyridine-based drugs
   * Women who are pregnant or may be pregnant, and women who are lactating
   * Patients with shock (including cardiogenic shock), severe aortic valve stenosis, unstable angina, within 1 month after myocardial infarction, severe hypotension, severe liver dysfunction
2. Patients who are inappropriate to participate in the study in the judgement of the investigator
Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases

Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.

Background: Dietetic effects of mare's milk have been reported for a long time and can be based on bactericidal and immunological components of mare's milk.

Objective: Dietetic effects of oral intake of mare's milk in adolescent patients with chronic inflammatory bowel diseases were investigated.

Design: In a randomized, placebo-controlled, double-blind, cross-over intervention study, eight Crohn's disease patients and nine ulcerative colitis patients received daily 250 mL mare's milk or placebo drink.

Eligibility Criteria:
Inclusion Criteria:

clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.

Exclusion Criteria:

lactose intolerance and pregnancy
Rituxmab Versus IL-6 in Treating ILD

All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test

All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive shortness of breath is the most frequently presentation going to ER pulmonary unit first. It should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with SSc. an etiological assessment must be conducted in order not to mistakenly attribute ILD to the SSc.

Eligibility Criteria:
Inclusion Criteria:

* active ILD scleroderma

Exclusion Criteria:

* abnormal liver enzymes renal impairment neutropenia \<1000 cells/mm3 thrombocytopenia \< 50,000 cells/mm3
Esmolol for the Treatment of Hypertension After Intracerebral Hemorrhage Study (ETHICHS)

Because of its pharmacokinetic characteristics, such as short half-life and its safety profile, esmolol hydrochloride is a beta blocker suitable for venous use in the form of continuous infusion. Strategies that improve the blood pressure control of patients with hemorrhagic stroke during the first hours of hospitalization are determinant in controlling the hematoma expansion and determining factor in its prognosis. This study was designed with the objective of evaluating the beneficial effects of combining esmolol hydrochloride with sodium nitroprusside for the blood pressure control of participants with hemorrhagic stroke.

Participants with parenchymal intracranial hemorrhage (diagnosis confirmed by computed tomography or magnetic resonance imaging), and:

* with systolic pressure \> 150 mmHg,
* not contraindicated for treatment with beta-blockers,
* who can start the drug treatment within 6 hours of the stroke,
* having a target of ≤ 140 mmHg of systolic pressure within 1 hour after initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signature of the TCLE by participant or companion.
2. Spontaneous intracerebral hemorrhage confirmed by computed tomography or magnetic resonance imaging and fit to be included in the study and initiate therapy with study medications within 6 hours after the event.
3. Intracerebral hemorrhage (volume \< 30 cm3).
4. No immediate surgical indication.
5. Both sexes, aged above 18 years.
6. Systolic blood pressure (\> 150 mmHg and \< 220 mmHg) measured on two occasions with a minimum difference of 2 minutes.

Exclusion Criteria:

1. Cerebral hemorrhage secondary to structural lesions in the brain, vascular malformations, coagulopathies or traumatic brain injury, if known at the time of randomization.
2. Participant in deep coma, defined by the Glasgow Coma Scale score of 3 to 5.
3. Uncontrolled asthmatic or COPD participants, if known at the time of randomization.
4. Participants with Grade IV Heart Failure, defined as heart rate \< 50 beats per minute.
5. Previous hemorrhagic stroke, if known at the time of randomization
6. Participants with Cerebral Vascular Stroke.
7. Participants who have presented previous ischemic cerebrovascular accident, if known at the time of randomization.
8. Chronic diseases with life expectancy less than 3 months.
9. Score ≥ 4 on the ICH score at the time of recruitment.
10. In use of anticoagulants in the last 48 hours, if known at the time of randomization.
11. Patients with contraindication to any of the study medications.
12. Intubation Orotraqueal on arrival at the service.
13. Pheochromocytoma, if known at the time of randomization.
14. Patients with hyperthyroidism, if known at the time of randomization.
15. Known pregnancy or breastfeeding . At the discretion of the investigator, an examination for confirmation may be requested.
Cluster-randomized Trial Measuring Integration of Professional Midwives and Obstetric Nurses in Rural Clinics in Mexico

Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled attendance during pregnancy and delivery. This project uses an innovative strategy of integrating professional midwives and licensed obstetric nurses into rural medical centers in the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services, and puerperium care. The goal of the research is to increase use of best practices in intake, labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and improve maternal and neonatal outcomes. We posited that medical centers receiving the intervention would provide better care and have better maternal and neonatal outcomes than those that did not receive the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Clinics containing one medical team only (1 doctor and accompanying staff)
* Clinics less than 2 hours away from a referral hospital
* Clinics where at least 25 deliveries took place in the previous year

Exclusion Criteria:

* Clinics inaccessible by car
* Clinics undergoing remodeling
Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections in Cystic Fibrosis

The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

In cystic fibrosis (CF), patients face polymicrobial airway infections. Besides bacteria, viruses are now also considered as important agents in lung function deterioration. No strategy has been established on the optimal sampling for respiratory viral molecular diagnostic in CF. Nasopharyngeal swabs (NP) are recommended for respiratory viral screening in non-CF patients but are invasive and sometimes painful for patients. As sputa are non invasive and collected for bacterial monitoring in CF patients they could represent a convenient alternative to NP swabs.

This study's aim is to define whether viral screening give concordant results between sputa and NP swabs.

Eligibility Criteria:
Inclusion Criteria:

* Participant with Cystic Fibrosis
* Participant able to expectorate
* Participant with sign of acute respiratory infection

Exclusion Criteria:

* participant not able to expectorate
* patient refusing to participate
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation

This is a Phase 2a, open-label, multicenter study to evaluate the safety and efficacy of HMO (PBCLN-010) and B. infantis (PBCLN-014) on the gut microbiome and GI domination by pathobionts in participants receiving allo-HCT.

Approximately 60 participants will be enrolled in this study, and all participants will undergo screening assessments up to 28 days before the first study drug dose (D 7). Participants meeting all the eligibility criteria based on the screening assessments will be enrolled and randomly assigned to 1 of the 3 cohorts:

* Cohort A (HMO 9.0 g and B. infantis) BID
* Cohort B (HMO 4.5 g and B. infantis) BID
* Cohort C (Control Cohort): Participants in this cohort will not receive any study drug.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to initiation of any study-specific procedure or treatment.
2. Male and female participants 18 to 75 years of age at the time of informed consent.
3. Planning to receive a first allo-HCT.
4. Able to comply with protocol requirements.

Exclusion Criteria:

1. Participants with prior bowel resection resulting in colostomy
2. Serious medical or psychiatric illness likely to interfere with participation in study.
3. History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions.
4. Female participants who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.