cyrilzakka/clinical-trials huggingface dataset:
Identification of Biomarkers of Mastitis

Breastfeeding is the optimal feeding for infants. WHO currently promotes breastfeeding and recommends it to be exclusive until the baby is 6 months old. Breastfeeding has a positive impact on both the mother's and the infant's health and is directly associated with the decrease in diseases such as cancer, diabetes, cardiovascular disease, and inflammatory and infectious diseases. Currently, in Spain, only 39% of infants at 6 months are breastfed. The factors that influence the abandonment of breastfeeding are returning to work, the sensation of hypogalactia, problems to breastfeed, and breast complications, like mastitis, being the pain its main cause. Recent studies have associated pain while breastfeeding with mammary gland inflammation (mastitis) caused by dysbiosis.

In order to increase breastfeeding rates, it is necessary to find factors related to the progression of mastitis in breastfeeding women. In this context, the discovery of predictive biomarkers based on metabolic markers is key to act before or at the beginning of the progression of mastitis and thus reduce the rates of abandonment of breastfeeding due to pain.

The present project aims to identify and validate metabolic biomarkers capable of predicting mastitis. For this purpose, a prospective observational case-control hypothesis-free study will be carried out in order to identify and validate biomarkers of mastitis in breastfeeding women. The study will be performed in two phases: the discovery of the possible biomarkers and the validation of the biomarkers.

Breast milk will be collected at the beginning of the study and when women present symptoms compatible with mastitis. The presence or not of mastitis will be confirmed with a milk culture. Milk samples will be analyzed using non-targeted metabolomics approach. Using multivariate statistical models, the potential metabolites capable of discriminating the presence of mastitis in maternal milk will be identified. Later, these potential markers will be validated in independent samples.


Eligibility Criteria:
Inclusion Criteria:

* Breastfeeding women with healthy full-term, singleton infants older than 1 months weeks and younger than 6 months.
* Provide written informed consent

Exclusion Criteria:

* Immunocompromised suppressed women (i.e. HIV, following treatment with immunosuppressants or chemotherapy).
* Currently being treated for cancer
* Current infection being treated with antibiotics.
* Women who carry out a complete deferred breastfeeding.
* Women with babies presenting any syndrome, cleft lip or facial malformations.
* Currently tandem breastfeeding.
* Women who have had a premature delivery
Research of Burden of Interstititial Lung Diseases in Turkey

The aim of our study is to investigate the etiological distribution of ILD, epidemiological characteristics of ILD cases such as age, gender, geography, smoking, occupation, economic status, education, and comorbidities. Another aim is to make the cost calculation from the first to the diagnosis in the patients diagnosed. Obtaining the missing data related to the ILD of our country is one of our goals.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are not previously diagnosed with ILD will be included in the study.

Exclusion Criteria:

* under 18 years old
* older 80 years old
Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease

Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive of progression of CKD and predict mortality in CKD. Although studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been reported. Our objectives are to determine if phosphate reduction through the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will also be investigating associations of elevation in FGF 23 levels with commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and Hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adults between ages 18-80 years old, with a GFR less than or equal to 50 ml/min/1.73 m2 as determined by the Modification of Diet in Renal Disease (MDRD) formula will be included.

Exclusion Criteria:

* Patients will be excluded if they have a history of renal transplant or are pregnant. In addition, patients with dysphagia, swallowing disorders, severe GI motility disorders, severe constipation, history of major gastrointestinal surgery and patients taking levothyroxine for hypothyroidism will be excluded.
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.


Eligibility Criteria:
Key Inclusion Criteria:

* Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader
* Has the following laboratory parameters at the screening visit:

  * Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
  * Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  * Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
  * Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)

Key Exclusion Criteria:

* Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
* Child-Pugh (CP) score \> 6, as determined at screening, unless due to therapeutic anti-coagulation
* Model for End-stage Liver Disease (MELD) score \> 12, as determined at screening, unless due to therapeutic anti-coagulation
* Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology.
* History of liver transplantation
* Current or history of hepatocellular carcinoma (HCC)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Prevention of Left Ventricular Dysfunction During Chemotherapy

The investigators' objective is to assess the efficacy of the combined treatment with enalapril and carvedilol in the prevention of left ventricular systolic dysfunction in patients with hematological malignancies submitted to intensive chemotherapy with potential cardiotoxicity.

The hypothesis is that these drugs administered during chemotherapy may prevent left ventricular systolic dysfunction.

The prognosis of patients with hematological malignancies has greatly improved in the last years with the use of new chemotherapeutic drugs and regimens at the cost of significant adverse events such as cardiac toxicity. Asymptomatic left ventricular systolic dysfunction limits the specific treatment of the patients and their long-term survival, since a significant proportion of them will relapse within 5 years after front-line therapy and will require further salvage treatment, including hematopoietic stem-cell transplantation in most instances.

Angiotensin-converting enzyme inhibitors (ACEIs) have showed to have preventive effects against chemotherapy-induced cardiotoxicity in animal models, and in patients with early cardiotoxicity. Carvedilol prevent free radical release, mitochondrial dysfunction, apoptosis, and dilated cardiomyopathy in animals treated with anthracyclines, and have shown promising results in preventing chemotherapy-induced left ventricular dysfunction in patients.

As demonstrated in post-infarction patients, the combined treatment with an ACEI and carvedilol could have additive effects to prevent LV dysfunction in patients with hematological malignancies at high risk of cardiac toxicity. Therefore, we designed the OVERCOME (preventiOn of left Ventricular dysfunction with Enalapril and caRvedilol in patients submitted to intensive ChemOtherapy for the treatment of Malignant hEmopathies) study, a prospective, randomized trial to evaluate the combined effect of enalapril and carvedilol on the prevention of left ventricular dysfunction in patients with malignant hemopathies undergoing intensive chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-70 years old
* Sinus rhythm
* Normal LVEF (\>=50%)
* Patients recently diagnosed of acute leukemia to be submitted to intensive chemotherapy or
* Patients with other hemopathies submitted to autologous peripheral blood stem cell transplantation
* Signed informed consent

Exclusion Criteria:

* Congestive heart failure
* LVEF\<50%
* Coronary artery disease,
* significant valvulopathy or myocardiopathy
* Renal failure (MDRD\<30)
* Liver failure
* Ongoing or expected need to be treated with angiotensin-converting enzyme inhibitors (ACE-i),angiotensin II receptor blockers (ARB) or beta-blockers
* Prior allergy to ACEI or ARB
* Systolic blood pressure \<90 mmHg
* Asthma
* Auriculoventricular (AV) block or sinus bradycardia (HR\<60 bpm)
* Persistent atrial fibrillation
* Need to be treated with Class I antiarrhythmic drugs
* Pregnancy
* Inability or unwillingness to give unformed consent
Self-care in Older Frail Persons With Heart Failure Intervention

The overall purpose of the randomized controlled study is to evaluate the effects of physical exercise, nutrition and symptom management on physical capacity in older, frail persons with heart failure.

The randomized controlled study will be conducted in order to evaluate the effects of individual needs of physical exercise, nutrition, and symptom management in patients with heart failure who are frail and older. Patients discharged from a geriatric hospital will be recruited and included after informed consent. Two weeks after hospital discharge patients are randomized to intervention or control group. The intervention period is 3 months. With support from a physioterapeut, dietician and a registered nurse, the intervention will be performed in the participants´ home. Once a week participants will come to the hospital for physical exercise led by a physiotherapist. Once a week or every other week participants will meet a dietician and a nurse. Data will be collected at baseline, and 3 and 6 months after baseline. Data consist of e.g. study flow description, number of eligible patients, number of drop-outs, patients sociodemographic- and clinical data, physical function and performance, nutritional status, symptom burden, self-care, appetite, thirst, health-related quality of life. At 12 months after baseline, data will be collected on hospital admissions, reasons for hospital admissions, length of stay and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients at geriatric clinic
* Diagnosed with heart failure (independent of Ejection Fraction (EF): both patients with preserved EF or reduced EF can be included
* New York Heart Association functional class II - III
* Clinical frailty level 4-6 (moderate frailty)
* Discharge from hospital to home

Exclusion Criteria:

* New York Heart Associacion functional class I or IV
* Clinical frailty level 1-3 (no/mild frailty) and 7-9 (severe frailty)
* The patient is unable to perform gait tests due to visual (see a TV screen at a 3 meter distance), cognitive (assessed by nurse or doctor) or motor impairment (the patient should be able to stand up from sitting and have the ability to walk with or without a walker or other walking aid).
* The patient is unable to follow instructions (assessed by nurse or doctor)
The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia

Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers.

Traditional blind exploration of spinal canal puncture has many limitations, often forcing changes in anesthesia methods due to multiple puncture failures. However, the application of real-time ultrasound guidance technology in spinal canal puncture can completely solve this clinical difficulty. The ultrasound-guided real-time paramedian approach epidural puncture for labor analgesia is a new type of labor analgesia technology, and its specific operating standards and diagnostic and treatment routines have not yet been established, including the selection of puncture path, puncture needle model, distance between puncture hole and epidural injection point, drug type, dosage, solubility, volume and other parameters, all of which have great research space.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) Class I or II;
2. Single healthy pregnancy;
3. Head showing first;
4. 37 to 41 weeks;
5. The labor process is active, and the cervix dilates\<5cm;
6. Require epidural labor analgesia;
7. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;
2. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;
3. Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;
4. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.
5. Patients with long-term use of opioids, steroids, and chronic pain.
Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects in 2 visits to determine the effect of topical nitroglycerin on radial artery vasodilation. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours.

During the first study visit, as a dose-optimizing study, each subject will be randomly assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. On the second study visit, the same participants will be randomly assigned to one of two Combination-Test arms to receive bilateral topical application of either 20mg or 40mg of lidocaine; the lidocaine will be applied in combination with 30mg of nitroglycerin on one wrist and in combination with placebo on the other wrist. Measurements of radial artery diameter will be performed as in the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent and comply with study requirements
* Patient who speak English

Exclusion Criteria:

* Presence or history of liver, cardiovascular, rheumatologic, cancer or renal disease.
* Current treatment with any vasodilator therapy
* Systolic blood pressure of less than 90 mmHg
* History of radial artery catheterization within the previous year
* Absence of radial artery blood flow in one or both arms
* Pregnancy.
* Active infection
* Staff members of the Cardiac Catheterization Laboratory.
Comparison of General Anaesthesia and Sedation on the Stone Fragmentation in Lithotripsy

The aim of the study is to compare the impact intravenous sedation versus general anesthesia on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.

The newer lithotriptors were reported to be less efficacious than the Dornier HM3 lithotriptor; and it is not clear the reason why there is decrease in efficacy of the new lithotriptors. Is it due to their small focal point or to increased patient movement while under intravenous sedation.When the patients get sedated then it will be difficult to control their respiratory movements. Retrospective comparisons suggest that intravenous may facilitate earlier discharge if no manipulation of the airway was done; but they are often associated with pain, hypoxemic respiratory episodes and disruptive movements during lithotripsy Instead of intravenous sedation, general anesthesia offer pain free procedures, no movement of the patient and controlled movement of the respiration leads to stable position of the urinary stones and receives persistent shock wave energy on to the stone bringing about better and early fragmentation. Hence we work on the hypothesis that the new generation shock wave lithotripters have a small focal point, every movement of the stone during the respiration or patient movement, will take the stone out of the focus and there results in loss of shocks leading to lithotripsy failure and use of more fluoroscopy for refocusing the stone.

Thus we think the proper choice of anesthetic technique will improve the efficacy of stone fragmentation in shock wave lithotripsy treatment at least in those who are obese and suffers from occult sleep- apnoea syndrome

Eligibility Criteria:
Inclusion Criteria:

1. Renal or upper ureteral stone of less than 2cm
2. A.S.A Grade 1.2.3
3. Age above 18 years

Exclusion Criteria:

1. Mid or lower ureteral stones
2. Bilateral renal stones
3. Multiple stones
4. Use of regional anesthesia
5. Coagulopathies (thrombocytopenia, anticoagulation drugs)
6. Suspected or documented difficult intubation
7. History of chronic opioid abuse
Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.


Eligibility Criteria:
Inclusion Criteria:

* Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
* Body mass index between 18 and 27 kg/m\^2 (both inclusive)
* Non-smoker
* Fasting blood glucose maximum 6 mmol/L
* HbA1c below 6.4%

Exclusion Criteria:

* Pregnant or breast-feeding women
* Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
* Clinically significant abnormal laboratory values (as judged by the Investigator)
* Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
* Intake of alcohol within the last 24 hours prior to screening and drug administration visits
* Blood donation or blood loss of more than 500 mL within the 3 last months before screening
* Strenuous exercise within 48 hours before screening as well as drug administration and followup
* Smoking during the past month before drug administration
Influence of Decision Aids on the Choice of Mother-infant Rooming-in or Separation Care for Pregnant Women

During early postpartum period, mother-infant proximity is important for breastfeeding success. Rooming-in and separate care are both traditional practices. Rooming-in involves keeping the mother and the baby together in the same room after birth during hospitalization, whereas separate care keeps the baby in the hospital baby room. Shared decision making with decision aid (DA) is a way to provide information to pregnant women and to involve them in making decisions about their strategy on baby care. We have developed a DA to be administered during consultation for pregnant women, and conducted a randomized controlled trial (RCT) to evaluate the benefit of DA on decision making. The measurements include a battery of interview-based questionnaires and evaluations of decision regret. We expect the DA would benefit the intervention group in the aspects of knowledge and communication in choosing mother-baby care options.

Background:

During early postpartum period, mother-infant proximity is important for breastfeeding success. Rooming-in and separate care are both traditional practices. Rooming-in involves keeping the mother and the baby together in the same room after birth during hospitalization, whereas separate care keeps the baby in the hospital baby room. Using decision aid (DA) is one way to provide information to pregnant women and to involve them in making decisions about their mother-baby care approaches.

Patients and Methods:

Decision aids are interventions designed to help pregnant women to choose their options of mother-baby care by providing information on those options and any potential outcome relevant to different mother-baby care options. Pregnant women considering mother-baby care approaches are randomly assigned to receive a DA or the standard oral information (control condition) during consultation.

By asking the pregnant women to look into a series of paired-comparisons, the DA leads the pregnant women to consider the competing attributes (i.e. specific risks/benefits) of the care options. The primary outcomes are decision conflicts and decision-making difficulties after consultation.

Hypothesis:

The pregnant women of the DAs group are predicted to have lower decisional conflict scores before labor and lower decision regret scores after labor compared with controlled women. Our study hopes to support the efficacy of DAs in helping pregnant women to arrive at mother-care decision.

Eligibility Criteria:
Inclusion Criteria:

Women delivered by cesarean section or induction between 37 weeks, 0 days and 41 weeks, six days.

Exclusion Criteria:

Pregnant women with preeclampsia, mental disorder, do not understand Chinese, and newborn baby with infection, or not suitable for rooming-in care.
Comparison of the Efficacy of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis

-Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be evaluated


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 70years
* Patients of decompensated liver cirrhosis who present with spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascitic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that has responded to standard medical care.

Exclusion Criteria:

* Allergic to quinolones
* Advanced HCC (Hepatocellular Carcinoma)
* Post liver transplant
* HIV (Human Immunodeficiency Virus) positive patients
* Patients on immunosuppressive therapy
* Pregnancy
* Acute Liver Failure
* History of hematological malignancy or bone marrow transplantation
* No informed consent