cyrilzakka/clinical-trials huggingface dataset:
Investigation of The Prevalence of Sepsis in Adults in Multicenter Intensive Care Unıts in Turkey

The pathophysiology and treatment of sepsis disease are still not fully known. International guides often refer to the studies done in the developed countries and suggest some treatments. The infrastructure of the developing countries is quite different. For this reason, it is not exactly scientific how much these proposals are reflected in patient treatment. In our study, We will try to reveal the treatment of sepsis.

Sepsis is a clinical syndrome that has physiologic, biologic, and biochemical abnormalities caused by a dysregulated inflammatory response to infection. Sepsis and the inflammatory response that ensues can lead to multiple organ dysfunction syndrome and death. In the late 1970s, it was estimated that 164,000 cases of sepsis occurred in the United States (US) each year. Since then, rates of sepsis in the US and elsewhere have dramatically increased as supported by the following studies, although many of these are derived from academic institutions. The increased rate of sepsis is thought to be a consequence of advancing age, immunosuppression, and multidrug-resistant infection. It is also likely to be due to the increased detection of early sepsis from aggressive sepsis education and awareness campaigns, although this hypothesis is unproven. Guidelines should focus on pre-hospital assessment and triage. Indeed, respiratory infections represented the most common cause of sepsis in that cohort, and postoperative infections were another important part of the problem. Whether these conditions apply to patients with shock in low-income and middle-income countries (LMIC) is unknown, but the incidence of community-acquired infections would be higher, with a greater prevalence of gastroenteritis, septic abortion, and skin and soft tissue infections as causes of septic shock. The bacteriology of bloodstream infections across LMICs varies substantially depending on regional and population characteristics. In a meta-analysis of 19 prospective studies on community-acquired bacteraemia in Africa, the most common organisms isolated were Salmonella spp (predominantly non-typhi), Streptococcus pneumoniae, and Gram-negative organisms such as Escherichia coli.11 Among cases for which mortality data were recorded, patients with bloodstream infections had an average mortality of 21.5%. Although data are lacking, appropriate antibiotic treatment for these infections on the basis of bacterial resistance patterns will ultimately depend on the ecological pressures resulting from local antibiotic availability and patterns of use.

We aimed to evaluate the approach to sepsis in Turkey as a multi-centered study.

Eligibility Criteria:
Inclusion Criteria:

* 18 year old over

Exclusion Criteria:

* Non-life expectant Those who live longer than 24 hours not that consent
Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption

The overall objective is to study if training and support, financial reimbursement and referral to an internet based brief intervention programme, singly or in combination, may increase implementation of evidence based methods of identification and brief intervention for excessive alcohol consumption in routine primary health care.

The study will be a stepped cluster RCT in 5 countries and the endpoint of the study is the number of interventions delivered during a certain time period. More specifically, the RCT will examine:

* The effect of Continuous Medical Education (CME) to PHC providers
* The effect of financial reimbursement to PHC providers as a pay-for-performance of brief alcohol interventions
* Whether an alternative internet based method of delivering brief intervention can increase the proportion of patients reached
* If one implementation strategy will give an added value to one already enforced.

Eligibility Criteria:
Inclusion Criteria:

* Primary Health Care Units (PHCU) of approximate size of 5.000-20.000 registered patients
* Primary Health Care Units (PHCU) located in Spain, Poland, Sweden, England or The Netherlands
* Providers must be physicians or nurses

Exclusion Criteria:

* Primary Health Care Units with less than 5.000 registered patients or over 20.000 registered patients
Health Tourism in Bariatric Surgery

The aim of the study is to examine whether patients who come to our country for bariatric surgery via health tourism have any concerns during this process, and if they do, to determine the level of their concerns through psychometric tests, to determine the reasons for their concerns (is it related to travel, going to another country, hospital, surgery, etc.) and whether their concerns decrease after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who came to our country through health tourism
* Patients with indications for bariatric surgery
* Patients over the age of 18

Exclusion Criteria:

* Patients under 18 years of age
* Patients with psychiatric, neurological diseases or mental retardation that prevent them from completing psychometric tests
* Patients with bariatric surgery indications other than health tourism
* Patients who do not agree to participate in the study
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Nasopharyngeal Carcinoma.

The transformation process of nasopharyngeal carcinoma is complex, so it is particularly important to explore the relationship between various disease states on its clinical pathway. Therefore, we carried out this study to explore the changes of plasma and urine metabolites at different stages during the occurrence and development of nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* EBV virus infector: QPCR/EBV antibody, diagnosed as EBV infection patient with previous infection;
* Nasopharyngeal carcinoma patients:Patients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard);
* Healthy people: Healthy people who have no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism and have been hospitalized in the Physical Examination Center of Southern Hospital.

Exclusion Criteria:

1. People who have a history of non research related liver diseases or other diseases known to affect blood metabolism (except for controlled type II diabetes);
2. Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ;
3. Diseases requiring long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency diseases or active central nervous system metastatic cancer, active infection or uncontrolled heart disease;
4. Suffer from other uncontrolled serious diseases at the same time, such as unstable heart disease requiring treatment, diabetes with unsatisfactory control (fasting blood glucose\>1.5 × Upper limit of normal value), mental illness and severe allergic history.
5. BMI is less than 18 or more than 25. -
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery

Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.

The optimal sympathomimetic drug to support blood pressure without adverse vasoconstriction of free flap circulation remains unknown. This study examined the effects of four agents (epinephrine, norepinephrine, dobutamine and dopexamine) on free flaps following resection of head and neck cancer.

Twenty five patients were recruited to the study. Each patient received an infusion of the four drugs in a random order with an intervening washout period between drugs, at four infusion rates. Continuous free flap skin blood flow monitoring was performed using laser Doppler velocimetry, with a second sensor on normal skin acting as a control. Global cardiovascular variables were monitored using the LiDCO Rapid pulse contour analysis system.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.

Exclusion Criteria:

* Pregnancy
* Weight \>100kg
* Contraindications to pressor infusions
* Overnight ventilation not indicated
Analgesic Efficacy of High Frequency Spinal Cord Stimulation

The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* treated with spinal cord stimulation
* stable pain relief achieved

Exclusion Criteria:

* failure to give informed consent
* unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.
Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis

The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.

This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).

Eligibility Criteria:
Inclusion Criteria:

* Enrollment on previous Amgen study 20030211 (NCT00078819)

Exclusion Criteria:

* Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept
Pharmacokinetics of New HepBQuin

Sanquin Plasma Products BV developed a new manufacturing process for the Quin plasma products in order to improve viral safety and to remove procoagulant activity. Since the new manufacturing process will be the same for all Quin products, a clinical study with one of the Quin products is sufficient for marketing authorisation of all new Quin products. HepBQuin will serve as model for all other Quin products. Pharmacokinetic (PK) data are considered as a surrogate indicator of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, male and female, aged 18 to 65 inclusive.
* Negative serology test for HBsAg, anti-HBs, and anti-HBc at screening.
* Body-mass index (BMI) of 18.5 to 32.0 kg/m2 (inclusive).
* Female volunteers must have a pregnancy test at screening.
* Willing to participate by signing the written signed informed consent form.

Exclusion Criteria:

* Vaccinated against Hepatitis B
* Having a Hepatitis B infection or suffered from a Hepatitis B infection in the past.
* Known with allergic reactions against human plasma, plasma products or blood products.
* A history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Known with or having a history of arterial or venous thromboembolic events.
* Pre-existing risk factors for thrombotic events.
* Any clinically significant history of or current clinically significant other disease or disorder.
* Any clinically significant abnormality following the investigator's review of physical examination, and clinical laboratory tests obtained at screening.
* An abnormal pulse rate and/or blood pressure measurements at the screening visit.
* Pregnant or breast-feeding at screening or at Day 0
* Women of childbearing potential not using a highly effective method of birth.
* Any use of drugs or abuse within 3 months prior to screening and during study.
* Alcohol abuse within 3 months prior to screening and during study
* Participated in another interventional clinical trial a month before the start of the study, or having received an experimental drug during the previous 30 days.
* Having IgA deficiency with anti-IgA antibodies.
* Blood or plasma donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial.
Combination of Taliderm® and Vacuum-assisted Closure (VAC) for Treatment of Pressure Ulcers

Background: The wound healing promoting effect of negative wound pressure therapies (NWPT) takes place at the wound foam interface. Implementation of bioactive substances at this site represents a major research area for the development of future NWPT devices.

Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices with or without the implementation of a thin interface of poly-N-acetyl glucosamine nanofibers (sNAG) was studied in a prospective randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Ischial/sacral Pressure ulcer between 4 and 15cm diameter
* Greater than or equal to 18 years of age
* Ability to obtain informed consent

Exclusion Criteria:

* Connective tissue disorders
* Immunosuppression, Hemodialysis, Steroids
* Pregnancy
* Sepsis
PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

The purpose of this study is to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain.

Long-term treatment in schizophrenia begins in acute hospitalization. However inadequate treatment options in non-compliant patients discharged from acute inpatient settings are often leading to recidivism and frequent re-hospitalization. The objective of this epidemiologic survey is to evaluate epidemiological characteristics of relapse and readmission in acute psychiatric units. If long-term treatment in schizophrenia begins in acute hospitalization the use of the new long-acting injectable antipsychotics after an acute psychotic episode as a standard maintenance medication could prevent relapse and readmissions. This is a pharmaco-epidemiological study, which collects structured safety data and it is carried out in Spain. All data collected will be cross-sectional or retrospective and will include the following: demographic data, diagnosis, psychiatric history and co-morbidities, hospitalization record (previous 3 years), treatment record and physician's opinion on patient's treatment compliance. The primary objectives are to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain, to determine the most important risk factors which predicts the number of hospital re-admissions and to identify the impact of the clinical profile of patients with schizophrenia, and schizoaffective/schizophreniform disorders who suffer relapses. The second objective is to describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient. as prescribed

Eligibility Criteria:
Inclusion Criteria:

* Patients with Schizophrenia or Schizoaffective disorder with a diagnosis over 2 years and that are hospitalized in a Short-Term Psychiatric Hospitalization Unit or Acute Unit

Exclusion Criteria:

* Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
* Patients with Schizophrenia or Schizoaffective disorder with a diagnosis less than 2 years
Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis

The purpose of this study is to provide patients and their physicians with greater understanding of the risks and benefits of commonly used therapies for treatment of non-CF bronchiectasis

Non-CF bronchiectasis is a chronic inflammatory lung disease that is closely linked to pulmonary NTM disease. Both are rare but rising in incidence and disproportionately affect the elderly and women. Therapy of non-CF bronchiectasis aims to reduce inflammation via either ICS-induced immunosuppression or antibiotic-associated immunomodulation and/or suppression of pathogenic organisms. Both strategies, pursued long-term alone or some cases concomitantly, have inherent risks, and the relative risks and benefits of these differential approaches are poorly studied to date. Ultimately, our study will provide patients and their physicians with greater understanding of the risks and benefits of these therapeutic choices.

Eligibility Criteria:
Inclusion Criteria:

* Within Medicare data, indicated diagnosis of Bronchiectasis by a Pulmonologist (ICD-9 code 494.0 and/or 494.1)

Exclusion Criteria:

* cystic fibrosis diagnosis, HIV infection, history of organ transplant
A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis

This is a Phase 1 study of IMS001, given as a single dose to subjects with Multiple Sclerosis who experience inadequate response and/or intolerability to disease modifying treatments. IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC). MSCs have the potential to modulate disease course.


Eligibility Criteria:
Inclusion Criteria:

* Provides signed and dated informed consent in accordance with local regulations.
* 18 to 65 years of age.
* Diagnosis of MS.
* Has had an inadequate response DMTs.
* EDSS within protocol parameters.
* Able and willing to undergo MRIs.
* Must be clinically stable for 1 month prior to Day 1.

Exclusion Criteria:

* Has a known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.
* Has history of excluded medications, per protocol, prior to Day 1.
* Has a history of neoplastic disease except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin that has been excised with clean margins, or adequately treated in-situ carcinoma of the cervix.
* Prior history of any other autoimmune disease, myelodysplasia, or hematologic disease.
* Prior treatment with any allogeneic cell therapy or tissue transplant.
* Prior history of smoking equivalent to ˃20 cumulative pack years of cigarettes.
* Recent clinically significant infection during the Screening Phase.
* Has any medical or psychiatric condition that would impact outcome or participation in the study.
* Has clinically significant abnormal findings on the electrocardiogram (ECG) during the Screening Phase.
* Has known or documented human immunodeficiency virus (HIV) infection or active Hepatitis B, or C.
* Has an elevated liver function test abnormality during the Screening Phase.
* Has abnormalities of blood count during the Screening Phase.
* Has laboratory abnormalities of renal function during the Screening Phase.
* Has other clinically significant laboratory abnormalities during Screening Phase.
* Body weight ≥120 kg.
* Women pregnant, breast feeding, or planning to become pregnant during the study.
* Is unavailable for the duration of the trial, is likely to be noncompliant with the protocol, or is generally felt to be unsuitable by the principal investigator.
* Current or recent participation in any other clinical or device trials within 3 months prior to Day 1.
Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

This study measures and compares the effect of silver diamine fluoride (SDF) on caries increment in removable partial denture wearers. Half of the participants will SDF and while the other half will receive placebo.

Removable partial dentures are commonly constructed to replace missing teeth. It is observed that removable partial denture wearers are susceptible to dental caries.

The mode of action of silver diamine fluoride on caries prevention is dual: fluoride ions interact synergistically with silver to react with hydroxyapatite to form fluorapatite, and silver is bactericidal by reacting with the thiol groups of the amino and nucleic acids that halt the metabolic and reproductive functions of the cariogenic bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited

Exclusion Criteria:

* If they have less than 4 teeth in any dental arch, have advanced periodontal disease in 2 or more sextants, have received therapeutic radiation of the head and neck region, have concurrent systemic illness that alters salivary flow, or have participated in a clinical trial within 6 months before the commencement of participation in this study.
Hormonal Management of Heavy Menstrual Bleeding in Adolescents

The goal of this study is to evaluate whether hormonal medications (such as contraceptive pill, patch, injectable progestins and hormonal intra-uterine device) have similar efficacy at managing heavy menstrual bleeding in adolescents with a bleeding disorder compared to those without. We also aim to assess the quality of life and hemoglobin and iron levels in this population.

Adolescents with heavy menstrual bleeding and willing to start a hormonal medication to reduce menstrual flow are included. At baseline and during the study period, questionnaires and blood tests are performed. Adolescents with a bleeding disorder are compared to those without. Follow-up is 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults aged \< 26yo
* Presenting to the gynecology consultation at HUG
* Diagnosed with heavy menstrual bleeding (PBAC \> 100)
* Willing to initiate a hormonal medication to manage heavy menstrual bleeding

Exclusion Criteria:

* Pregnancy or planning to become pregnant during the study period
* Already using hormonal medication for menstrual management and/or contraception
* Known anatomical uterine pathology
* Using anticoagulant or antiaggregant agents
Bed-side Ultrasound in Neutropenic Enterocolitis

Neutropenic enterocolitis (NEC) is a life-threatening complication of leukemic and solid tumors patients (pts) treated with chemotherapy (CHT) with high mortality rate up to 50-100%. Perforation occurs in 5%-10% of cases. Early diagnosis is crucial to start conservative medical management (CMM), which appears the optimal strategy for most cases.

NEC should be always suspected in Neutropenic pts with abdominal pain, fever and diarrhea.

Ultrasound (US) can be used to evaluate bowel-wall thickening (BWT). The objective of this study is to evaluate prospectively if US can detect early signs of NEC and guide a prompt treatment (CMM or surgical) and thus reduce mortality.


Eligibility Criteria:
Inclusion Criteria:

All patients admitted in Hematology Ward University of Pisa (Italy) to receive chemotherapy who experienced neutropenia related to chemotherapy

Exclusion Criteria:

Patients admitted in Hematology Ward University of Pisa (Italy) who did not receive chemotherapy