cyrilzakka/clinical-trials huggingface dataset:
The eHealth Diabetes Remission Trial - Pilot Study

Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c \< 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended.

The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with diabetes duration 0 to 6 years
* BMI 27-45 kg/m2
* Owning a smartphone
* HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication)

Exclusion Criteria:

* Insulin treatment
* Weight loss 5 kg or more during the past 6 months
* Treatment with weight loss medication
* Diagnosed eating disorder
* eGFR \< 30 ml/min/1.73m2
* Substance abuse
* Cancer
* Myocardial infarction during the past 6 months
* Severe heart failure
* Pregnancy
Conversion to Embeda With Rescue Trial

The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.

The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.

Eligibility Criteria:
Inclusion Criteria:

* Be able to read, speak and understand English
* Have chronic moderate to severe pain for at least 3 months
* Require around the clock opioid medication for the relief of pain
* Have been taking a daily opioid for at least 30 days prior to starting the study
* Be able to be safely switched to a different pain medication
* Be practicing acceptable birth control methods for female patients of childbearing potential
* Be willing to participate in the study and able to comply with study procedures

Exclusion Criteria:

* Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse
* Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
* Be currently taking tramadol and/or extended release morphine products
* Have respiratory depression
* Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
* Have migraines as your main source of pain
* Have any form of bowel obstruction
* Be pregnant or breast feeding
* Have had 2 or more surgeries for low back pain
* Be planning a major surgery during the study
* Be staying in a hospital or nursing home
* Be planning to have steroid injections for your chronic pain during the study
* Have a life expectancy of less than 2 months
Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>40 kg/m2
* Age \>18 years old
* Eligible for laparoscopic surgery

Exclusion Criteria:

* Prior bariatric surgery
* Sleeve gastrectomy as a part of a duodenal switch
* Second time surgery before 18 months
* Other procedures done during the surgery
* Conversion to laparotomy
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women

High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.

Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a potent regulator of energy metabolism by promoting insulin production and adiponectin synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic ovary syndrome (PCOS).

Eligibility Criteria:
Inclusion Criteria:

* Lean women BMI 25 or less
* Hyperandrogenic clinically and/or biochemically.
* Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria

Exclusion Criteria:

* BMI more than 20
* Other causes of hyperandrogenism
* Other causes of metabolic disorders or diabetes.
A Shared Decision Making Training for Inpatients With Schizophrenia

Patients suffering from schizophrenia who attend the communication skills program engage more deeply in therapeutic reasoning and treatment decisions. This results in stronger preferences to participate, greater perceived involvement and better long term adherence compared to patients who do not attend the training.


Eligibility Criteria:
Inclusion Criteria:

* Male and female inpatients with a diagnosis of schizophrenia/schizoaffective disorder according to ICD 10
* between 18 and 60 years of age are eligible for the study
* informed consent
* inpatients

Exclusion Criteria:

* poor German language skills
Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

The performance of keratoplasty is hampered by the limited availability of donor cornea in many countries, especially in Asia. For this reason, attempts have been made to fabricate artificial substitutes for natural human cornea. So far, all polymeric biomaterials, such as collagen configurations and plastic compression, could mimic the functional optically transparent but failed to replicate the complicate three-dimension microstructure of natural cornea. Therefore, despite some favorable results yielded by polymeric biomaterials, they cannot be suited for long-term use. To overcome these disadvantages, in recent years, porcine cornea appeared specifically attractive for xenotransplantation, because of its accessibility and similarities to natural human cornea. However, xenotransplantation using fresh porcine cornea can occurs hyperacute immune rejection, resulting in graft failure. Such transplant rejection can be substantially lessened by using acellular porcine cornea (APC), which preserves the constructure of natural cornea, whilst having well biocompatibility and low antigenicity. These properties feature APC particularly suitable for high-risk keratoplasty, such as corneal grafting in infectious keratitis.

Use of APC in LK has been shown promise in many preclinical animal studies and initially in human clinic trail. However, to optimize APC biological and biomechanical properties, the strategies for its preparation has evolved extensively over recent years, like various decellularization approaches (e.g. detergents, enzymes, human sera, hypertonic solutions and et al) and additional procedures (e.g. collagen re-crosslinking and repeated frozen-dry). Therefore, in the current study, the investigators analyzed the early surgical outcomes of deep anterior lamellar keratoplasty (DALK) using the APC that was very recently approved by the National Institutes for Food and Drug Control (NIFDC) of China for clinic practice, for management of infective keratitis, including fungal, viral and acanthamoeba keratitis. Here major concern of this study was to clarify the behavior of APC after implantation in participants.


Eligibility Criteria:
Inclusion Criteria:

corneal diseases not involving the endothelial layer

Exclusion Criteria:

* corneal diseases involving the endothelial layer
* allergic to pig tissue
* do not accept xenotransplantation
Effects of a Patient Directed Web-portal to Improve Health Literacy Skills

Access to the best available evidence, and the ability to obtain and understand such information is seen as necessary to protect the public's interests and critical to empowerment, but is also a precondition for participation in the decision making.

A web portal serving as a generic (non disease- specific) tailored tool was developed in the conceptual framework of shared decision making and evidence based practice to improve the lay- public's critical and social literacy skills and activation. A randomized controlled parallel trial using a simple randomization procedure will be conducted, including 200 parents of children \<4 with internet access. Parents will be allocated to receive either the portal or no intervention. Primary and secondary outcomes include: the ability to find research based information, critical appraisal skills, perceived behavioural control, attitudes and perceived pressure associated with searching for information, and participation.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children age \<4 will be recruited with access to internet.

Exclusion Criteria:

* Participants will be excluded if one other in the household already participates in the study (due to spill-over effect) and if they do not have children \<4.
* Since the recruitment will be done online, there is no need to screen for access to internet.
Immunogenicity of Influenza Vaccinations

This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax) versus a licensed comparator influenza vaccine (Flublok or Fluzone). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Serum and peripheral blood mononuclear cells (PBMC) and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity, and duration of antibody responses.

Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms; those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws (acute \[\<10 days after symptom onset\] and convalescent \[28 days after acute visit if lab-confirmed positive for influenza\]).


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-64 years that have not received the current season's influenza vaccine
2. English literate
3. Email or text message capability for weekly follow-up
4. Intention of receiving influenza vaccine based on ACIP-CDC guidelines
5. Willing to provide written/electronic informed consent
6. Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits

Exclusion Criteria:

1. Receipt of the current season's influenza vaccine (receipt after July 1, 2024)
2. History of severe allergic reaction after a previous dose of any influenza vaccine or to an influenza vaccine component
3. Receipt of any licensed or investigational live vaccine within 6 weeks or non-live vaccine within 2 weeks prior to enrollment in this study or planning receipt of any vaccines between visits 1 and 2 of the study (approximately within 4 weeks after the receipt of study-administered vaccine)
4. History of Guillain-Barré syndrome
5. Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report
6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
7. Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives

Temporary Delay Criteria (Visit 1)

1. History of febrile illness (\> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration
PET-CT After Nellix Implantation

To determine FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis. Does uncomplicated EVAR using the nellix endoprosthesis result in increased FDG uptake and false positive PET imaging?

One of the most devastating complications following endovascular aneurysm repair (EVAR) is infection of the used endoprosthesis. Because of the high mortality of secondary surgery following infection, patients with a possible endoprosthesis infection are treated using broadspectrum antibiotics during months, years or even life-long. Unfortunately, the diagnosis of an endoprosthesis infection is difficult and based upon clinical suspicion and non-specific symptoms (e.g. fever and weigth loss) only. Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) is often used as a diagnostic tool to identify infection following EVAR. Like infection, sterile physiologic inflammation following EVAR is also associated with increased metabolism and FDG uptake. This could result in (false-)positive PET imaging resulting in diagnostic errors and antibiotic overuse.

The Nellix endoprosthesis is a relatively new device used for EVAR. In present literature there is no data on the degree of physiologic inflammation following implantation of a Nellix device and the value of postoperative FDG-PET imaging to detect infection is not known. This makes the diagnosis of infection following Nellix implantation extremely difficult. This pilot is designed to determine physiologic FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Nellix endoprosthesis

Exclusion Criteria:

* Diabetes Mellitus (Type 1 and type 2)
* Current known inflammation or malignancy
Amino Acids Expression Profiling of Patients With Sepsis

The patients with sepsis are in the state of hypermetabolism, increased resting energy expenditure, protein and fat catabolism disorder, negative nitrogen balance, insulin resistance, hyperglycemia, and amino acid metabolism disorders. However, it is remain unclear the changes of amino acids expression profiling in sepsis patients. In this study, the investigators has planned to enroll 100 subjects, including 20 cases with systemic inflammatory response syndrome (SIRS), 20 cases with sepsis, 20 cases with severe sepsis and 20 with septic shock. In addition, this study also include 20 normal cases as control. The serum sample of patients with sepsis is draw on days 1, 3, 5, 7, 10, and 14 after first ICU admission. High-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of amino acids. The amino acids expression profiling contain Arginine, Ornithine, Histidine, Cystine, Isoleucine, Cystathionine, Leucine, Homocystine, Lysine, α-Amino-n-Butyric Acid, Methionine, Alanine, Phenylalanine, Anserine, Threonine, β-Alanine, Tryptophan, β-Amino-Isobutyric Acid, Valine, Carnosine, γ-Amino-n-Butyric Acid, Ethanolamine, Glycine, δ-Hydroxylysine, Serine, Hydroxy-L-Proline, Taurine, 1-Methyl-L-Histidine, Tyrosine, 3-Methyl-L-Mistidine, α-Amino-Adipic, Phospho-Ethanolamine, Asparagine, Phospho-L-Serine, Aspartic acid, Proline, Citrulline, Sarcosine, Glutamic acid, Argininosuccinic Acid, Glutamine, Homocitrulline. The investigators speculate that measurement of amino acids expression profiling could be taken as an indicator for assessment in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18 years old and over;
2. Clinically confirmed infection;
3. Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

1. parenteral nutrition;
2. diabetes and other metabolic-related diseases;
3. chronic liver disease;
4. neutropenia (≤ 500 neutrophils/mm3);
5. HIV infection;
6. patients or their relatives refused.
The COGCOV Study in ICU Patients

Acute Respiratory Distress syndrome (ARDS) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. COVID-19 evokes a viral pneumonia, which may result in ARDS as well. It is not yet clear if COVID-19 disease behaves like the typical ARDS. Corona virus causes primarily deep hypoxia. Hypoxia, on its own, can lead to long term cognitive impairment. However, critical illness also affects long-term neurocognitive functioning. The investigators will be researching the possibility of long-term cognitive impairment in COVID-19 ICU patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.

The investigators will conduct a single centre, prospective cohort study. COVID-19 patients from the Ziekenhuis Oost-Limburg cohort will be contacted by phone 6 months after admission at the ICU. Patients will be asked to participate in a study surrounding long term symptoms of COVID-19. When consent is given by the patiënt, the experimenter will conduct a short questionnaire over the phone with the patient or relative that is present at the time of the call. If the participant is fluent in Dutch, the experimenter will ask permission to visit their home to conduct more testing.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the intensive care unit of Ziekenhuis Oost-Limburg
* Being hospitalized between March 2020 and May 2020, and therefore being admitted 6 months prior to the study
* The reason of hospitalization was COVID-19 disease

Exclusion Criteria:

* No willingness to participate, and therefore not having signed the informed consent
Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

The purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.

Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* regardless of diabetes duration and retinopathy severity level
* one or both eyes with focal clinically significant macular edema
* treated with selective or focal photocoagulation
* visual capacity under subjective refraction before treatment
* adequate quality 6mm fast macular map on the day of photocoagulation
* signed of inform consent

Exclusion Criteria:

* ocular surgery in the last 4 months
* previous selective photocoagulation
* topic or systemic antiinflammatory therapy in the last week
* allergic to antiinflammatory non-steroids therapy
* lent contact used in tha last 2 days before photocoagulation
* history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months
* history of uveitis or ocular inflammation in the last 12 months
* any ocular external disease, infection or inflammatory process during evaluation
* corneal abnormalities that could modify visual capacity per se
* actual corneal disease
* pregnancy
* myopia over -6.00 diopters
* any retinal disease different from diabetic retinopathy
* adverse event of the drug
* desert to pharmacology therapy after the second visit
* no assistance after the second visit
* inadequate quality 6mm fast macular map after the second visit
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation

This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dizziness (Meniere's) only, who understand the nature of the study and are willing to participate voluntarily.
* The frequency of the hearing loss is between 250 kHz and 1 kHz.
* Patients with bilateral 500, 1000, and 2000 Hz hearing threshold averages within 65 dB HL
* Patients who have received conventional pharmacotherapy for other dizziness conditions with a washout period of 2 months.
* To be eligible for subjects in the active phase of the disease, there must be at least 1 vertigo attack in the 6 months before study entry.
* If tests for renal function, electrolytes, etc. are performed and no problems are found

Exclusion Criteria:

* Patients with an otologic condition other than Meniere'ss (dizziness) (otitis media, profound hearing loss, hyperacusis, etc.).
* Patients' conditions that may affect EEG measurements, such as a stroke, brain hemorrhage, or brain tumor.
* Patients with kidney disease
* Patients Have or have had a serious medical condition, such as cancer (including leukemia, blood cancers, epilepsy, and neuropsychiatric conditions).
* Patients with an artificial implant in the body (cochlear implant, hip joint, pacemaker, etc.)
* Women of childbearing potential, pregnant women, or nursing mothers
* Patients who can have Injuries or dermatologic abnormalities at the site of application of the equipment.
* Patients with coronary artery disease, uncontrolled high blood pressure, or other serious medical conditions (including kidney disease).