cyrilzakka/clinical-trials huggingface dataset:
Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort

The aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants.

Newborns are faced with many painful interventions including tactile stimulation such as diaper change, axillary temperature measurement, intraoral and endotracheal aspiration during the postnatal period in the Neonatal Intensive Care Units (NICU) at the beginning of their lives. Painful interventions negatively affect the physiological parameters, comfort, sleep, growth and hospital stay of newborns. As a result of these interventions, the stress level increases in preterm infants. Increased stress level can cause long-term sequelae, risk of intraventricular hemorrhage, increased oxygen consumption and hypertension. In addition, the increased stress experience may make the infant sensitive to pain and stress in other periods of his life.

This randomized controlled prospective study was planned to be conducted in the NICU of a private hospital with branches in Istanbul until the whole sample group would be reached.

In the NICU, where the study will be conducted, preterm infants will be divided into two groups as control and experimental groups. Non-nutritive sucking (NNS) combined with breast milk will be used during diaper change for newborns in the experimental group, and only NNS will be used in the control group. NNS will be given to both groups 5 minutes before diaper change. The comfort level of the newborns will be measured with the Premature Infant Comfort Scale before the NNS, 5 minutes after the NNS, during the procedure, immediately after the procedure and 5 minutes after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* The preterm infants whose parents agree to participate in the research and sign the informed consent form;
* Who have no congenital anomaly;
* Who have no chronic disease;
* Who have undergone no surgical procedure;
* Who have no neurological symptoms;
* Who have no NEC (necrotizing enterocolitis) diagnosis;
* Who are not sedated;
* Who are not hypoglycemic;
* Who have been administered no pharmacological analgesic method 4 hours before;
* Who are born between ≥28 and ≤36+6 gestation weeks, or are in between ≥28 and ≤36+6 gestation weeks during the procedure.

Exclusion Criteria:

* The infants whose parents do not agree to participate in the research and do not sign the informed consent form;
* Who have a congenital anomaly;
* Who have a chronic disease;
* Who had undergone a surgical procedure;
* Who have neurological symptoms;
* Who have NEC (necrotizing enterocolitis) diagnosis;
* Who are sedated;
* Who are hypoglycemic;
* Who have been administered no pharmacological analgesic method 4 hours prior;
* Who were between \<28 and \>36+6 gestation weeks.
Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient

Contrast media induced nephropathy (CIN) is considered to be a serious complication in patient who underwent coronary angiogram (CAG). The pathogenesis of CIN does not well understood. The probable one is the contrast media makes the afferent vessel in glomeruli constrict and results in renal shut down. Limb ischemic preconditioning, a procedure that makes muscles become ischemic and adapt themselves to produce some cytokines for signaling the vessel more dilated. After the reperfusion, these cytokines are getting back to systemic circulation and effect the afferent vessel in glomeruli to become more dilated and prevent CIN.


Eligibility Criteria:
Inclusion Criteria:

* Documented diabetic kidney disease
* Elective coronary angiogram
* Glomerular filtration rate \< 60 ml/min by Cockroft-Gault or Modification of Diet in Renal Disease or CKD-EPI

Exclusion Criteria:

* Refuse or reject to inform consented
* Hemodynamic compromise (Heart failure, need for intraaortic balloon pump)
* Expose to drug or chemical substances potentially to be a nephrotoxic agent with in 1 mo (Not include preexisting Angiotensin converting enzyme inhibitor or Angiotensin receptor blocker with stable serum creatinine)
* Documented or suspected of peripheral arterial disease, upper or lower limb
* Bleeding diathesis
* Contraindicated for coronary angiogram
* currently on renal replacement therapy
Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer

The overall aim of this feasibility study is to develop new technologies for improved detection of cholangiocarcinoma using the SFE-based molecular-imaging mini-cholangioscope (MC) system. This study will combine the use of a fluorescent-labeled peptide dimer that binds specifically to know biomarkers of cholangiocarcinoma for use as a novel imaging agent to guide endoscopic biopsies. This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets that are specific for biliary intra-epithelial neoplasia. A dimer is needed because cancer in the biliary tract is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects having a medical condition requiring an ERCP to diagnose a potential biliary disorder. The Phase 1A first-in-human studies of safety with topical administration by ingestion of KSP/QRH dimer (HUM00141420) has been completed.


Eligibility Criteria:
Inclusion Criteria:

Subject meets all of the following criteria:

* Scheduled for an outpatient ERCP to diagnose a potential biliary disorder (such as an indeterminate biliary stricture)
* Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
* Age 18 to 100 years
* Willing and able to sign informed consent

Exclusion Criteria:

* Subjects with known allergy or negative reaction to any components of the study drug (list these)
* Subjects on active chemotherapy or radiation treatment
* Pregnant or trying to conceive
* Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening
* Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)

Exclusion Criteria:

* Participant must not have history of brain metastases.
* Participant must not have impaired cardiac function or clinically significant cardiac disease.
* Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.

Other protocol-defined inclusion/exclusion criteria apply
COVID-19 STAndard of Care in Sub-Saharan Africa

This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 positive at RT-PCR

Exclusion Criteria:

* Asymptomatic patients
Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients

The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control. miRNAs can also block HIV production through disruption of Gag assembly on cell membranes. miRNA expression can characterize HIV disease phenotype, as has been shown in HIV elite controllers who have a well-defined miRNA expression profile. However, the studies of miRNA in acute infection and co-infections like tuberculosis are lacking. The investigators showed that during immune reconstitution syndrome (IRIS) in HIV/TB coinfected patients, innate immune response play a role as through NK cell degranulation, therefore testing for this could be used as a predictive marker of IRIS.

One of the limitations of miRNA detection is the technique, which is time-consuming, and needs laboratories that are specialized and equipped for molecular biology techniques. In contrast, flow cytometry has been developed in routine labs and has well-standardized techniques. For the routine detection of miRNA, flow cytometry could be the best way to perform high throughput screening for clinical applications.

Flow cytometry is a simple and effective way to evaluate miRNAs expression. In this project the investigators propose to evaluate, using flow cytometry, whether circulating miRNA pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. The investigators propose to study the miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution. As controls, the investigators propose to analyze expression of miRNAs in healthy controls as well as TB and HIV mono-infected patients.

AIMS OF THE PROPOSAL

1. Identify miRNA expression profile as potential novel predictive and prognostic biomarkers for IRIS.
2. Identify the miRNA expression profile in HIV patients, in TB patients and in HIV/TB co-infected patients.


Eligibility Criteria:
For HIV+/TB+ participants:

Inclusion Criteria

* cf the CAMELIA clinical trial (NCT00226434)

Exclusion Criteria:

* cf the CAMELIA clinical trial (NCT00226434)

For HIV+/TB- participants:

Inclusion Criteria

* Age ≥ 18 years
* HIV+
* CD4 cell count ≤ 200 x 106 cells/l
* No evidence of tuberculosis infection.

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breastfeeding
* CD4 cell count \> 200 x 106 cells/l
* Evidence of tuberculosis infection
* Non ART naive at inclusion

For HIV-/TB+ participants:

Inclusion Criteria

* Age ≥ 18 years
* HIV-
* Confirmed tuberculosis infection.

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breastfeeding
* AFB negative or MTB/RIF negative for MTB,
* History of TB infection
* HIV+

For HIV-/TB- participants:

Inclusion Criteria

* Age ≥ 18 years
* HIV-
* No evidence of tuberculosis infection.

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breastfeeding
* Evidence of tuberculosis infection
* HIV+
Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure

The goal of this observational study is to assess the effect of the different combination of drugs in the treatment of heart failure.

The main questions it aims to answer are:

* \[question 1\] The changes of BNP and LVEF in patients of each groups with different drugs co-administration.
* \[question 2\] The days of hospitalization, degree of lower limb edema (mild, moderate, severe) and 6-minute walking test in each groups.

Participants will be asked to do nothing. All the records of the patients will be download from the Big Data Cloud Platform of Health Care in the First Affiliated Hospital of Shandong First Medical University.

There is not a comparison group.

The purpose of this study is to evaluate the efficacy and cost-effective of different drugs co-administration in the treatment of heart failure. For different reasons, patients with heart failure took different drug prescriptions. Now there are five kinds of drugs for the treatment of heart failure, such as angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACEI/ARB), beta-blokers, spironolactone, sodium-glucose cotransporter (sglt) 2 inhibitors and vericiguat. Our purpose is to assessment the efficacy and cost-effective of different drugs co-administration in the treatment of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as "heart failure" or "cardiac insufficiency" on the first page of the medical record

Exclusion Criteria:

* Severe impairment of liver, kidney and lung function (transaminase increased more than 2 times; Scr \> 265umol/L); malignant tumor
Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension

This study aimed to assess the effect of the supplementation with grape seed extract (GSE) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension.

Muscle metatoreflex (MMR) has been known to play an important role in adjusting hemodynamic responses during exercise. The reflex increases sympathetic activity to heart and blood vessels to increase blood supply to contracting skeletal muscles. On the other hand, studies demonstrated that abnormal cardiovascular responses occurred by the overactive MMR in pathological conditions such as hypertension, diabetes, and congestive heart failure. Excessive blood pressure (BP) responses to exercise induce cardiovascular events such as stroke, heart attack, and coronary artery disease. Previously, a study found that dietary supplementation with grape seed extract (GSE) reduced BP response to dynamic exercise in individuals with elevated and stage 1 hypertension (ES1H) and associated with peripheral vasodilation. However, mechanisms underlying this phenomenon are not clear. Purpose: therefore, the purpose of this study is to investigate whether chronic dietary supplementation with GSE can decrease BP responses to exercise and this observation is associated with reduced MMR. Methods: 12 ES1H males were studied. Changes in cardiac output (Q), mean arterial pressure (MAP) and total peripheral resistance (TPR) were compared between the GSE and placebo supplementations during static handgrip exercise (SHE) and post exercise muscular ischemia (PEMI). Participants completed 3 min of SHE at 40% of MVC followed by 2 min of PEMI.

Eligibility Criteria:
Inclusion Criteria:

* systolic blood pressure: 120-139 mmHg and/or a diastolic blood pressure: 80-89 mmHg

Exclusion Criteria:

* taking medications that could affect cardiovascular function or BP
Success of Lesion Sterilization and Tissue Repair Therapy

This study aimed to assess the clinical and radiographic success of lesion sterilization and tissue repair (LSTR) therapy with different antibiotic combinations, focusing on evaluating whether the alternative combination of clindamycin instead of minocycline is as effective as the standard 3Mix-MP formulation.

All the clinical procedures were carried out by one clinician with 2 years of clinical experience in pediatric dentistry under rubber dam isolation and local anesthesia via mandibular nerve block. (Maxicaine Fort Ampoule, VEM, Turkiye). After the removal of carious tissues, an endodontic cavity was prepared, and infected coronal pulp tissue was removed up to the canal orifices via a sterile round steel bur. A sterile round steel bur was then used to prepare a medication cavity 2 mm deep and 1 mm wide. The root canals were not instrumented, and only the access cavity was irrigated with a 2.5% NaOCl solution. In cases where hemostasis could not be achieved, a sterile cotton pellet soaked in 5% NaOCl was placed in the pulp chamber and left for 1 minute. Once hemostasis was achieved, the endodontic cavity was dried using a sterile, dry cotton pellet. Pastes were then applied to the medication cavity and covered with a glass ionomer cement (Nova Glass II F, Imicryl, Turkiye) and a stainless steel crown (Kids Crown, Shinhung, Seoul, Korea) at the same visit. Clinical and radiographic evaluations were performed at 1, 3, 6, 9, and 12 months. During follow-up, the teeth were assessed on the basis of the following clinical criteria: pain, dentoalveolar abscess and/or fistula, and tooth loss. The radiographic criterion was periapical radiolucency.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous pain
* Pain on percussion
* The presence of abnormal or pathological mobility
* The presence of a sinus tract or dentoalveolar abscess
* Widening of the periodontal ligament
* Periradicular radiolucency
* Evidence of external and/or internal resorption.

Exclusion Criteria:

* Who required infective endocarditis prophylaxis
* Who had used antibiotics in the two weeks prior to treatment
* İndividuals allergic to the medications used in the study
* Teeth with pulp floor perforation
* Advanced internal and/or external root resorption
* Root canal obliteration
* Excessive bone loss in the furcation area involving the permanent tooth follicle
* Teeth with severe coronal destruction, nonrestorable.
Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma

Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.

Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.

Eligibility Criteria:
Inclusion Criteria:

* Review and sign informed consent;
* Between 15 and 80 years of age at time of trial enrollment;
* Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
* Radiologically documented tumor size of \> 5 centimeters;
* Radiologically documented liver cirrhosis.

Exclusion Criteria:

* American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia;
* Uncontrollable ascites;
* Deep persistent jaundice;
* Hepatic encephalopathy;
* Coagulopathy;
* Severe uncorrectable thrombocytopenia;
* Unable or unwilling to attend follow up visits and examinations;
Testosterone for Men With Insulin Treated Type 2 Diabetes

The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.

There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.

Eligibility Criteria:
Inclusion Criteria:

* males over 40 years old
* type 2 diabetes treated with insulin
* serum testosterone less than 12nmol/L on 2 consecutive morning samples
* symptoms attributable to hypogonadism

Exclusion Criteria:

* current or previous breast cancer
* current or previous prostate cancer
* raised prostate specific antigen or abdominal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy
* severe symptoms of benign prostatic hypertrophy
* treatment with testosterone in the three months prior to the trial
* investigational drug treatment in the three months prior to the trial
Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults

To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* adults 18 - 40 years of age in good health
* HP uninfected
* not pregnant and agree to use birth control throughout the study (females who can become pregnant)

Exclusion Criteria:

* remote or current HP infection
Assessment Micro-anatomy of the Menisci and Cartilage After Isolated Acute ACL Injury With MRI at 7T

Study population The investigator set the sample size to 200 patients.

Primary outcome

* Diagnostic accuracy of ultrahigh field MRI (T7) compared to high field MRI (T3 or less) for detection of meniscal injuries associated with acute ACL injury Secondary outcome
* Influence of 1) Location of injury and 2) meniscal tear pattern (modified WORMS18,19) on the sensitivity of high field MRI compared to ultrahigh field MRI for detection of meniscal tears

However, there is no evidence that ACL reconstruction can actually prevent the development of knee osteoarthritis. However, concomitant meniscal injuries, either at the time of the ACL injury or secondary to the ACL injury, significantly increase the risk of secondary knee osteoarthritis. Therefore, the treatment strategy for ACL injuries is strongly influenced by the presence of concomitant meniscal injuries on initial magnetic resonance imaging (MRI).

To achieve higher spatial resolution and faster image acquisition, there is a clear trend toward higher field strength MRI.

Meniscal injuries repeatedly occur during the course after isolated ACL ruptures, and the question is whether these injuries occurred during the original trauma or as a result of the torn ACL.

Therefore, the primary objective of the current study was to evaluate the potential utility of ultrahigh-field MRI (T7) in detecting occult meniscal tears or cartilage injuries associated with presumed isolated acute ACL injuries compared with high-field MRI (T3 or less). The secondary objective was to evaluate the influence of meniscal tear location and meniscal tear pattern on the sensitivity of high-field MRI compared with ultrahigh-field MRI in detecting meniscal tears. Subsequently, different orthopedic surgeons and radiologists will evaluate the images.

Eligibility Criteria:
Inclusion Criteria:

* Presumed isolated, acute rupture of the anterior cruciate ligament (trauma not older than 4 weeks) diagnosed by high-field MRI (3 Tesla or less) at Balgrist.
* Written informed consent of the study participant
* Age 18 years or older

Exclusion Criteria:

* Previous knee surgery or trauma
* Presence of concomitant meniscal injury on high-field MRI (3 Tesla or less)
* Advanced gonarthrosis (Kellgren-Lawrence score greater than 2).
* Contraindication to the performance of MRI
* Unsigned informed consent
* Inability to follow study procedures (e.g., due to cognitive impairment) or inadequate knowledge of project language
* Pregnancy