cyrilzakka/clinical-trials huggingface dataset:
Characterization of Acute and Recent HIV-1 Infections in Zurich.

Aim of the study: To study and to describe factors which could influence the course of primary HIV infection (PHI) and factors that in turn could be influenced through PHI.

In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies.

The ZPHI is a longitudinal, observational, multi-center study. The ZPHI study started in 2002: The first patient visit (FPFV) was in January 2002. Since then, we continuously enrolled patients fulfilling the inclusion criteria. Because the ZPHI is an observational, longitudinal study and the HIV epidemic in Switzerland evolves continuously a clear study end point is not possible. We plan to critically revise the current protocol every 5 years and at that point, also evaluate whether the study should be continued.

This study so far has been highly successful in the recruitment of patients with a PHI. To date we have enrolled more than 480 patients with a documented PHI since project start in 2002.

Eligibility Criteria:
Inclusion Criteria:

A) acute HIV-1 infection, defined as:

* negative or evolving immunoblot in the presence of positive p24 Ag and/or detectable plasma HIV-1 RNA and/or
* documented HIV seroconversion within 90 dayswith or with-out symptoms and/or clinical signs of PHI (e.g. acute retro-viral syndrome).

B) recent HIV-1 infection, defined as:

* documented seroconversion of more than 90 days but within 180 days and/or
* evolving immunoblot after unambiguous transmission risk (e.g. iv drug use, sexual contact) within 180 days and/or
* documented HIV infection and unambiguous transmission risk (iv drug use, sexual contact) within 180 days and/or
* documented HIV infection and possible transmission risk (iv drug use, sexual contact) within the last 180 days after infection AND \< 0.5% fraction of ambiguous nucleotides

Exclusion Criteria:

• Documented HIV infection, however, established diagnosis more than 180 days after presumed date of infection.
Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject

The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of \[14C\]AZD9668 in healthy male subjects.

This is an exploratory study to assess the absolute bioavailability of a single oral dose of AZD9668 with respect to an intra-venous microdose of \[14C\]AZD9668 in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM

Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an contributes to the development of many of its complications. Multiple defects, e.g. impaired insulin secretion and impaired insulin action, contribute to the development of the disease. The aim of this study is to test the efficacy and durability of combination of drugs which correct the defects that lead to the development of diabetes on achieving adequate and durable control of blood sugar levels. Achieving adequate and durable control of blood sugar will prevent many of diabetes complications.

Subjects will be randomized (using a table of random numbers) to receive, in open label fashion, one of the following treatment regimens: (i) Group I will be started on pioglitazone (15 mg/day) plus metformin (1000 mg/day) with the supper meal and exenatide (5 mcg s.c. bid 30 min before breakfast and supper) and up-titrated to 45 pioglitazone plus 2000 metformin and 10 mcg s.c. bid exenatide to achieve HbA1c \<6.0%; (II) Group II will be started on metformin, 1000 mg with breakfast and 1000 mg with supper, glyburide and basal insulin will be added and up titrated to achieve HbA1c \<6.0% The study team will compare the efficacy of two therapeutic regimens: (i) triple therapy (pioglitazone, metformin, exenatide) at the time of diagnosis of T2DM versus (ii) stepwise therapy starting with metformin and subsequent addition of sulfonylurea and basal insulin (i.e., the "standard" approach) in achieving this goal. The first intervention is based on the novel concept of initiating therapy at the time of diagnosis with combination therapy using agents that correct specific pathophysiologic defects that are characteristic of T2DM (insulin resistance and beta cell failure). The second intervention is based upon stepwise addition of antidiabetic agents to reduce the HbA1C according to the current ADA therapeutic recommendation.

Eligibility Criteria:
Inclusion Criteria:

* subjects with type 2 diabetes diagnosed during the past 2 years,
* above 18 years of age,
* drug naive, or have been on metformin less than 3 months

Exclusion Criteria:

* subjects with type 1 diabetes or GAD positive subjects or subjects with long standing diabetes (\>2 years) or subjects who are not drug naive or have been on metformin more than 3 months.
The Effect of Lixisenatide on the Effect of Pituitary Hormones

The current study has two aims:

1. to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test;
2. to test if the growth hormone-stimulating effect is mediated by changes in blood glucose.

The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).

The randomized, blinded, placebo-controlled clinical trial is conducted on 5 healthy volunteers and 5 patients with type 1 diabetes.

All study subjects receive once a placebo and once 10 micrograms of lixisenatide.

The order of administration of study medication is decided on randomization. The placebo and lixisenatide are administered at least 2 days apart.

Blood samples are taken 30 minutes and immediately before study medication administration and 30, 60, 90, 120, and 150 minutes after study medication administration,.

The primary endpoint is the peak value of growth hormone measured during the 2,5 hours after study medication administration.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers:

   * male sex
   * age 18-60 years
   * body weight \> 65 kg
2. Patients with type 1 diabetes:

   * type 1 diabetes
   * male sex
   * age 18-60 years
   * body weight \> 65 kg
   * c-peptide in fasting blood sample \<0,1 nmol/l
   * HbA1c \< 8,5%

Exclusion Criteria:

1. Healthy volunteers:

   * use of aldosterone antagonist
   * use of glucocorticosteroid
   * use of other medication that potentially significantly affects pituitary function.
2. Patients with type 1 diabetes:

   * use of aldosterone antagonist
   * use of glucocorticosteroid
   * use of other medication that potentially significantly affects pituitary function.
   * The patient is excluded from the study if a significant change in blood glucose occurs in the study center.
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies

This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the pre-operative assessment of the patient being considered for liver resection or TACE.

The liver is unique among the abdominal organs for the capacity to regenerate post-operatively. However, a minimum functional liver remnant (FLR) is required for patients to survive the initial perioperative period. At present, the assessment of the FLR is based on volume alone, in the context of clinical judgment and surrogate markers of liver function based on blood tests. Recently, Perspectum Diagnostics have developed and validated LiverMultiScan, an MRI-based technology that can non-invasively quantify fibroinflammatory disease in addition to steatosis and iron content. In this project, we plan to use LiverMultiScan as an additional direct measurement of liver health prior to resectional surgery or transarterial chemoembolization (TACE), so that liver volume and function can be combined. For example, surgery with a predicted FLR of 21% might be survivable if the liver tissue was in extremely good health, whereas surgery with a predicted FLR of 40% might be lethal if the liver tissue was in poor health. Occasionally, portal vein embolization (PVE) is performed to promote hypertrophy of the FLR. Furthermore, non-resectional intervention, for example TACE for primary liver cancers, is well-tolerated by patients with healthy livers, but can lead to serious liver decompensation and liver failure if TACE is delivered to a liver in poor health. Currently, the available imaging modalities are limited in their ability to assess liver health in liver resection or TACE candidates. Liver fat content (steatosis) can be assessed with CT, or more accurately with MRI. However, fibroinflammatory disease, which has been shown to correlate with post-resection morbidity, typically requires an invasive biopsy to diagnose accurately.

This research project will support the definition, development and technical validation of Hepatica, which aims to build on the MRI technology underlying LiverMultiScan and develop the additional functionality required to meet this clinical need.

Eligibility Criteria:
Inclusion Criteria:

* Patients being considered for liver resection

Exclusion Criteria:

* i. Patients under the age of 18 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Persons unable to have an MRI scan (including but not limited to claustrophobia, implanted metallic devices, metal foreign body) iv. Adults with incapacity v. Non-provision of consent
Betaferon Use in Children and Adolescents With Multiple Sclerosis

The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents


Eligibility Criteria:
Inclusion Criteria:

* patients with symptoms consistent with the diagnosis of a demyelinating CNS disease
* patients who received at least one injection of Betaferon before age 18 (before their 18th birthday)
* recorded use of at least one dose of Betaferon before January 1, 2008

Exclusion Criteria:

* Diagnosis other then MS or a demyelinating CNS disease
Incidental Coronary Calcification Quality Improvement Project

This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.


Eligibility Criteria:
Inclusion Criteria:

* Non-gated chest CT between 2014-2019
* The presence of CAC confirmed by manual review by an experienced radiologist
* Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018

Exclusion Criteria:

* Current or prior statin or PCSK9 inhibitor therapy
* Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
* Prior coronary imaging (cardiac CT, invasive coronary angiography)
* Dementia
* Metastatic cancer or active cancer undergoing chemotherapy
* History of medical nonadherence
Correlative Study on Cancer Patients and Healthcare Professionals Exposed to Infection by Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-Cov-2), COVID-19 Causative Agent.

Translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics.

The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.

The outbreak of COVID-19 infections is spreading in Italy with unprecedented severity characteristics. In this context, it is essential to collect data relating to the epidemiology of the disease, to outline further useful tools for diagnosis and to define the correct use of rapid molecular and / or serological tests in the surveillance of high-risk subjects (cancer patients and healthcare operators), in order to identify any new disease control strategies, crucial to reduce the transmission and to outline specific guidelines for cancer patients healthcare management. It is also necessary to identify the factors that determine the evolution of the viral genome over time in the various geographical areas and also the potential susceptibility markers in the different types of affected subjects (symptomatic, mildly symptomatic and asymptomatic).

Eligibility Criteria:
For epidemiologic analysis:

Inclusion Criteria:

* Age \> 18 years
* asymptomatic
* One of the following three conditions: • Healthy subjects who have had contact with COVID-19 positive patients • Healthcare workers • oncological patients candidates for cytotoxic chemotherapy at myeloablative doses (such as transplants) or treated with immune-check point inhibitors.
* informed consent to the study and processing of data

Exclusion Criteria:

* presence of symptoms for COronaVIrus Disease 19 (COVID-19) (fever \> 37.5 °, cough, shortness of breath)

For analysis of viral/host genetic factors involved in susceptibility/resistance to infection, samples from patients with confirmed diagnosis of COVID-19, residual from diagnostic procedures will be analyzed. All samples for genetic analysis will be anonymized.
Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

The aim of the present study is to evaluate the clinical and microbiological efficacy of moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria. The primary outcome variable to determine the superiority of one treatment over the others would be differences between groups for means CAL changes at 6 months post-treatment. Secondary outcome variables include differences between therapies for the mean changes in the mean levels of PD and the proportion of BOP.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≤30 years of age
* minimum of six permanent teeth, with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and a minimum of six teeth other than first molars and incisors with at least one site each with PD and CAL ≥5 mm.

Exclusion Criteria:

* diabetes
* cardiovascular diseases
* immunological disorders or any other systemic disease that could alter the course of periodontal disease.
* Pregnant or nursing women
* smoking
* allergy to amoxicillin, metronidazole, fluoroquinolones or moxifloxacin
* consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months
* periodontal therapy during the last 6 months
Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients

Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores.

Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders.


Eligibility Criteria:
Inclusion Criteria:

* Admission to ICU during the study period (the patients already in the ICU at the time the study starts will not be included);
* Age ≥18 years;
* In participating centres in part B, serum Pi should be measured daily.

Exclusion Criteria:

* Age \<18 years;
* Patients with restrictions of care such as "no intubation" or "no RRT" on ICU admission and patients admitted for treatment as organ donors;
* Continuous chronic home ventilation for neuromuscular disease;
* Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study);
* Readmission to ICU during the study period
Reversal of Neuromuscular Blockade During the General Anaesthesia

There are individual reports indicating that after the reversal of nondepolarizing neuromuscular blockade with neostigmine, some patients starts to relax spontaneously again after the tof ratio has already recovered to the safe level (\>90%).

The mechanism behind this in not well understood, and the incidence of the phenomenon is unclear. In this study the investigators try to determine the incidence of the aforementioned postrecovery relaxation.

There are individual reports indicating that after the reversal of nondepolarizing neuromuscular blockade with neostigmine, some patients start to relax spontaneously again after the tof ratio has already recovered to the safe level (90%). The mechanism behind this in not well understood and the incidence of the phenomenon is unclear.

The aim of this study is to monitor the reversal of rocuronium induced neuromuscular blockade with neostigmine. The neuromuscular blockade is monitored with train of four stimulations using electromyography. After the reversal agent is given and train of four ratio has recovered to the level of 90%, the neuromuscular blockade is monitored another 30min to see if tof ratio starts to spontaneously fall again under the 90%. If aforementioned postrecovery relaxation happens, the investigators are able to calculate the incidence of the phenomenon.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery requiring general anaesthesia
* Surgery is assumed to last more than 45 minutes
* Body mass index less than 35kg/ m²

Exclusion Criteria:

* Disease of central nervous system
* Trauma of central nervous system
* Disease affecting peripheral nervous system
* Medication affecting peripheral nervous system
Determination of the Effect of Case Management-Based Electronic Fetal Monitoring Training Given to Midwifery Students on EFM Monitoring Self-Efficacy

This study was planned to examine the effects of case management-based electronic fetal monitoring (EFM) training on midwifery students' EFM monitoring self-efficacy.

The research population will consist of second-year students studying at the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBÜ) in the spring semester of the 2023-2024 academic year (N: 80).

In this semi-experimental pre-test and post-test design and control group study, in order to determine the sample size; the data were normally distributed, the standard deviation of the main mass was estimated as 1 and the effect size (effect size, difference) was estimated as 0.8. For the analysis to be conducted, it was calculated that the highest power value of the study would be 0.942182 if two independent n₁=40, n₂=40 samples were taken at a significance level of 5%. The G-power analysis result is given below.

The students who volunteer to participate in the study will be assigned to the intervention and control groups with the computer-aided simple random sampling method. Computer-aided randomization will be used in the study, and the number of cases will be entered through the program with the URL address https://www.randomizer.org and random assignment will be made to the intervention and control groups. The study will be conducted single-blind. Before the application, all groups will be given 4 hours of theoretical information about EFM interpretation with a power point presentation. After the information, the "Electronic Fetal Monitoring Self-Efficacy Scale" will be applied as a pre-test. After the training, all students will be applied the "Electronic Fetal Monitoring Self-Efficacy Scale".


Eligibility Criteria:
Inclusion Criteria:

* Being a volunteer to participate in the research.
* Being an active student in the 2nd year of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences.

Exclusion Criteria:

- Being a passive student in the 2nd year of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences.