cyrilzakka/clinical-trials huggingface dataset:
Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.

Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.

The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed


Eligibility Criteria:
Inclusion Criteria:

* Supportive mechanical ventilation for more than 48 h
* LOD \> 5 with with ailing body systems
* Candida colonisation of at least one site in addition to the digestive tract
* Suspected nosocomial infection with antibiotic treatment
* Informed consent

Exclusion Criteria:

* Patients treated with oral or systemic antifungal agents within 15 days prior to inclusion
* Patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the EORTC criteria
* Patients with a SAPS score \> 65
* Patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy
* Blood creatinine \> 220 µmol/L
* Hemodyalysis
* Pregnant women
Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.

To investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive and anti-HBs negative for more than 6 months
* Being currently treated with ETV ≥1 years
* HBeAg positivity and HBV DNA \<60IU/mL with HBsAg \<1500IU/mL and HBeAg \<200S/CO at screening
* ALT ≤5\*ULN and total bilirubin ≤2\*ULN
* Age ≥ 18 yrs but ≤ 55 yrs
* Written informed consent

Exclusion Criteria:

* Patients who have contraindications for Thymosin alpha 1 in accordance with the approved summary of product characteristics
* Patients with ALT \> 5 x ULN or total bilirubin \>2\*ULN
* Patients with evidence of hepatocellular carcinoma at screening
* Patients with Child-Pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites
* Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
* Patients with a history of excessive drinking: male \>40g/d,female \>40g/d
* Pregnant or breast-feeding women
* A history of liver transplantation or planned for liver transplantation
* Patients of autoimmune disease
* Patients with other diseases combined
* Patients with creatinine \>1.5\*ULN
* Investigator considered not proper for participating the trial
* Patients with other maliginant tumor
Templates as Cognitive Aids in Emergency Airway Equipment Preparation: the Template Airway Trial

Comparison of preparation times (in seconds) for emergency airway management (equipment only) with and without a template.

Comparison of time (in seconds) needed to prepare all necessary equipment for one form of emergency airway management with and without a template. Participants will be randomized to "preparation with template (A)" and "preparation without template (B)" and all participants will be measured twice for both arms A and B, however, evaluation will take place on two separate days. Methods of airway management evaluated will be endotracheal intubation, supraglottic airway device and oral fiberoptic intubation, with a total of three measurements per participant per study day and two study days per participant. Participants will be nurses in the intensive care unit and, as a control group, anesthesia nurses will also be evaluated in order to factor in the effects of experience. The study will take place in the usual work environment of participants and with the standard equipment.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years and older
* written informed consent
* Qualification as a nurse (ICU or anesthesia)
* employed with University Medical Centre of Johannes Gutenberg University (JGU) Mainz

Exclusion Criteria:

* none
Efficacy of the New Closure Device in Improving Patient Compliance in Treatment of Hypertension With Valsartan+/-Hydrochlorothiazide (HCTZ) at 6 Months

This study will evaluate the efficacy of the reminder device Remind Cap® in improving patients' compliance in the consumption of Valsartan +/- Hydrochlorothiazide (HCTZ) in the treatment of hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension that have newly started using Valsartan+/-HCTZ

Exclusion Criteria:

* Pregnancy or Hypersensitivity to Valsartan+/-HCTZ

Other protocol-defined inclusion/exclusion criteria may apply
Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 18-50 years
* Seronegative for H5N1
* Seronegative for H1N1 (with antibody titers ≤1:20)
* Written informed consent to participate in this study

Exclusion Criteria:

* Acute febrile illness
* Signs of acute or chronic upper or lower tract respiratory illnesses
* History of severe atopy
* Seasonal influenza vaccination from 2006/2007 onwards and/or pandemic influenza vaccination against H5N1
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values
* Simultaneous treatment with immunosuppressive drugs
* Clinically relevant history of renal, hepatic, GI, cardiovascular,haematological, skin, endocrine, neurological or immunological diseases
* History of leukaemia or cancer
* HIV or Hepatitis B or C seropositivity
* Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
* Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application
* Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
* Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

The goal of the proposed study is to evaluate the comparative efficacy of Lamictal (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective than placebo in patients with neurotic excoriation. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

The study will consist of 12 weeks of double-blind treatment with Lamictal (lamotrigine) compared to placebo (1:1) in 30 subjects with neurotic excoriation.

Eligibility Criteria:
Inclusion Criteria:

1. men and women age 18-65;
2. current diagnosis of neurotic excoriation.

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal;
6. clinically significant suicidality;
7. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
8. current or recent (past 3 months) DSM-IV substance abuse or dependence;
9. illegal substance use within 2 weeks of study initiation;
10. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
11. previous treatment with Lamictal (lamotrigine);
12. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
13. current treatment with an anti-epileptic medication.
Focus Group Interview Study on Patient Experiences and Satisfaction

In order to improve quality of care at the department, the investigators will perform a focus group interview study with patients and family members. They will perform 6 (3 in the French, and 3 in the Dutch language) focus group interviews with patients and 6 (3 in the French, and 3 in the Dutch language) with family members.

In order to improve quality of care at the department, the investigators will perform a focus group interview study with patients and family members. They will perform 6 (3 in the French, and 3 in the Dutch language) focus group interviews with patients and 6 (3 in the French, and 3 in the Dutch language) with family members. Following research questions will be answered:

* What elements of care (ie infrastructure, interpersonal contact, information, communication) are good to the opinion of patients and family members?
* What elements of care can be improved?
* What are priorities in improvement of the care for patients and families?
* What actions could possibly be taken in order to improve the care for future patients?

Because the radiotherapy ward exists of 3 clusters, one per type of treatment conducted, the investigators will perform 6 focus group interviews with patients (3 in the French, and 3 in the Dutch language) and 6 focus group interviews with family members (3 in the French, and 3 in the Dutch language).

Investigators will collect sex, main diagnosis (of patients), age and nationality of all participants at the beginning of each focus group interview. They will transcribe all interviews verbatim and analyze them in Nvivo software as provided by the VUB. Participant characteristics will be analyzed by descriptive statistics.

Eligibility Criteria:
Inclusion criteria for patients:

* Patients (18+) who were treated for cancer, receiving radiotherapy, and followed thereafter in the UZ Brussel
* Dutch and French speaking
* Start date of treatment max 6 months before inclusion
* Estimated sample size: 5-8 x 6 patients

Inclusion criteria for family members:

* All family members (+18) of patients who were treated for cancer, receiving radiotherapy, and followed thereafter in the UZ Brussel
* Dutch and French speaking
* Start date of treatment of patient max 6 months before inclusion
* Estimated sample size: 5-8 x 6 family members
Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms

The Eye Movement Desensitization and Reprocessing Protocol (EMDR) was first developed by Francine Shapiro in 1987 and can be adapted for online and in presence administration. The aim of this study is to assess if a EMDR program (administered both online and in presence, depending on different conditions of patients) may help people recruited from general population suffering from COVID19 second (November 2021 to February 2022) and third (March 2022 to May 2022) quarantine in improving post-traumatic stress (PTSD) and obsessive-compulsive-related (OCD) symptoms, as well as disgust, guilt, shame and their subjective unit of distress (SUD) and validity of cognition (VoC) levels.


Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 18 to 75 years
2. Participants experienced a full COVID19 pandemic-related quarantine during red zones of the second and third lockdowns in Italy
3. Participants have reasonable comprehension of spoken and written Italian language
4. Participants have an adequate understanding of Italian

Exclusion Criteria:

1. Concurrent enrollment in other intervention trials
2. Participants that already experienced EMDR therapy in the past
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon

Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting.

The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.


Eligibility Criteria:
Inclusion Criteria:

* First NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st January 2013 to 30th June 2017 (index date).
* Age of at least 18 years at index date.
* Continuous enrollment in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
* A verified ambulatory or primary/ secondary hospital discharge diagnosis of NVAF in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).

Exclusion Criteria:

* A verified ambulatory or primary/ secondary hospital discharge diagnosis of valvular atrial fibrillation, indicating pregnancy, transient cause of atrial fibrillation or venous thromboembolism (VTE).
* A claim for hip or knee replacement surgery in the 60 days prior to or on the index date.
* A prescription of more than one oral anticoagulant (rivaroxaban, apixaban, edoxaban or phenprocoumon) on the index date.
* A prescription of warfarin or dabigatran in the baseline period or on the index date.
* A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period.
* Patients receiving an initial dose of rivaroxaban 10 mg/ 2.5 mg or edoxaban 15 mg (these dosages are not indicated for the treatment of NVAF).
A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

Participants in this study will have Multispectral Optoacoustic Tomography/MSOT imaging of both breasts immediately before their ultrasound-guided breast biopsy procedure begins. After the MSO imaging is completed, participation in the study will end.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a female or male who is 18 years of age or older.
* Participant must meet one of the following:

  * Suspicious breast imaging finding detected on either mammography, ultrasound, or MRI that is visible on ultrasound and therefore recommended for ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy)
  * No previous treatment for breast cancer
  * Diagnosis of melanoma

Exclusion Criteria:

* Life expectancy \< 3 months
Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.

An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D090 in healthy male adults

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adults aged 19 to 45 years
2. Body weight more than 50kg and within ideal body weight ±20%
3. signed informed consent form

Exclusion Criteria:

1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
2. Have a gastrointestinal disease history that can effect drug absorption or surgery
3. Systolic Blood pressure≥140mmHg or Systolic Blood pressure\<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure\<60mmHg
Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

Primary Objective:

To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM).

Secondary Objectives:

* To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
* To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM.
* To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.

The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.

Eligibility Criteria:
Inclusion criteria :

* Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history.
* Patients aged 20 to 75 years at screening.
* Body mass index ≤35 kg/m\^2 at screening.
* Glycohemoglobin ≥7.0% and ≤10.0% at screening.
* Fasting C-peptide ≥0.6 ng/mL at screening.

Exclusion criteria:

* Diabetes other than T2DM.
* History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
* History of hypoglycemia unawareness.
* Hemoglobinopathy or hemolytic anemia.
* History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment.
* Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
* If female, pregnancy or breast-feeding.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study

This is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Environmental exposure and daily within and out-of-school activities will be evaluated in a random subgroup.

Myopia is the most common refractive error and a major reason for reducing uncorrected visual acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted in a significant increase in myopia due to the changed lifestyle of schoolchildren dramatically. However, it is unclear which kind of risk factors should be the first to bear the brunt before and during COVID-19. And which factors should be emphasized and confronted as the optimum strategy for myopia prevention and control? This cohort study aims to determine the risk factors, prevalence, and incidence of myopia, and SE changes among schoolchildren before and during COVID-19, hence identifying the factors that impact the onset and progression of myopia.

This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged 6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China will be analyzed. Over a 3-year follow-up period, students will receive detailed eye examinations annually and complete questionnaires about eye-use environment, eye-use habits, lifestyle, and family and subjective factors. In a 5% random sample size of this cohort study, outdoor activity, light intensity, eye use habits, and eye use environment data will be obtained using objective measuring devices. Myopia was defined as spherical equivalent refractive (SER) of ≤ -0.5D.

Eligibility Criteria:
Inclusion Criteria:

* All 6-18 years students

Exclusion Criteria:

* No eye diseases such as cataracts, glaucoma, keratoconus, etc.
* No psychiatric disorders
* Astigmatism ≤ -6.00D