cyrilzakka/clinical-trials huggingface dataset:
Early Integration of Supportive Care for Metastatic Uveal Melanoma Patients (EarlyTogether)

The study main objective is to assess whether the early introduction of supportive care demonstrates a benefit on patients' psychological care needs at 6 months (M6), versus oncological standard of care in patients with metastatic UM.

Supportive care in patients with metastatic Uveal Melanoma (UM)

Before the start of the study, medical oncologists and supportive care physicians from both the sites will attend Communication Skills Training (CST) workshops provided by an expert team in the field. The training sessions will focus on practicing the required communication skills needed in consultations.

The randomization will assign patients, with a 1:2 ratio, to "Introduction of supportive care when medically needed" (Arm A: Control Group) or "Initial concomitant management by the oncologist and the supportive care team" (Arm B: Early Together Group).

Selected and validated questionnaires will be filled at baseline, 6 and 12 months by the patients before the consultation, in the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

1. adult patients with metastatic UM;
2. no surgery or loco-regional treatment of metastases in a curative intent;
3. systemic treatment planned or started since less than 2 months;
4. ECOG PS 0-1;
5. no uncontrolled symptoms;
6. liver function tests in normal range or ≤ grade 2;
7. signed informed consent;
8. able to fill the questionnaires.

Exclusion Criteria:

1. patient\<18 years old;
2. patient condition requiring supportive care before any systemic specific treatment for metastases;
3. acute psychopathological disorder incompatible with the study;
4. prior medical condition incompatible with the study.
Antibiotic Prophylaxis in Primary Joint Arthroplasty of the Hip and Knee.

A retrospective study will be performed to compare the incidence of revision procedures performed for the treatment of postoperative periprosthetic joint infection (PJI) between patients treated with a single preoperative antibiotic prophylaxis and patients treated with multiple shot antibiotic prophylaxis following primary arthroplasty of hip or knee.

This study will be conducted in two phases. In phase 1 the investigators will evaluate which antibiotic prophylaxes (type of antibiotic and duration of prophylaxis) are regularly used in the Netherlands, by contacting all orthopaedic centres implanting total hip and total knee prostheses. In phase 2 the investigators will compare infection rate (defined as revision for infection as registered in the LROI database) between a single-shot and multiple shot antibiotic prophylaxis.

Knee and hip primary arthroplasties will be considered separately.

In phase 1 of this study all Dutch hospitals and clinics performing hip and/or knee arthroplasty will be contacted to supply data concerning type and duration of antibiotic prophylaxis. The investigators will also ask whether debridement with implant retention for early infection is registered in the LROI. The investigators will ask permission to have access to unblended data on institutional level to be able to connect the type of antibiotic prophylaxis to outcome.

In phase 2 the investigators will include all adult patients whom have a primary hip or knee arthroplasty and are registered in the national joint implant registry (LROI) between 2011 and 2016.Those patients will be followed until they are revised (irrespectively of the indication), they died or the end-point of the study, i.e. end of 2016 (to allow at least one year follow-up for those operated late 2015).

Exclusion criteria are patients aged under 18. Patients with no primary procedure recorded in the LROI for the period of interest but records of revision surgeries will be excluded.

The investigators will compare the results found in the LROI database in two groups for both hip and knee arthroplasties. Group one will consist of patients receiving a single shot antibiotic prophylaxis, while group two will consist of patients receiving multiple shot antibiotic prophylaxis.

Analyses will be adjusted for known and available confounders such as age, gender, BMI, and ASA score.

In the LROI debridement without exchange of mobile parts for early infection, is only scarcely reported. The authors realise not all early infection treatments, such as debridement with or without exchange of mobile parts, are registered in the LROI database.

Eligibility Criteria:
Inclusion Criteria:

- All adult patients whom have a primary hip or knee arthroplasty and are registered in the national joint implant registry (LROI) between 2011 and 2014

Exclusion Criteria:

* Patients aged under 18.
* Patients with no primary procedure recorded in the LROI for the period of interest but records of revision surgeries will be excluded.
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis

The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 50 years in age
* Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
* Zurich Claudication Questionnaire Score ≥ 2.0,
* Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
* Has completed at least 6 months conservative therapy

Exclusion Criteria:

* Axial back pain only without leg/buttock/groin pain
* Has had any prior lumbar spine surgery at any level
* Significant scoliosis, defined as Cobb angle \> 10°
* Spondylolisthesis \> Grade 1 or isthmic spondylolisthesis at affected level
* Osteoporosis
* Morbid obesity, defined as BMI \> 40 kg/m2
The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, aged equal to or greater than 18 years at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)
* Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)
* Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator
* HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))

Exclusion Criteria:

* Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
* Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed
* Known proliferative retinopathy or maculopathy requiring acute treatment
* Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
* Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
* History of acute or chronic pancreatitis
* Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L
Effects of Variable Ventilation on Respiratory System of Acute Respiratory Distress Syndrome (ARDS) Patients

The purpose of this study is to determine the effects of variable ventilation on respiratory system of patients affected by acute respiratory distress syndrome.

In this interventional study we want to evaluate the effect of Variable ventilation (1) in patients with ARDS. Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and "traditional" CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period we will record the gas exchange parameters and the mechanics of the respiratory system.

1. Arold S, Mora R, Lutchen K, et al. Variable ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Resp Crit Care Med 2000; 165: 366-71.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ARDS criteria

Exclusion Criteria:

* Age less than 18 years
* Severe haemodynamic instability
* Patients with clinical or instrumental evidence of flow-limitation (i.e., PEEPi)
Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study

This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.

This study aims to evaluate the efficacy and safety of multimodal ablation combined with Tislelizumab, lenvatinib, and TACE in the treatment of primary liver cancer. By comparing preoperative and postoperative immune markers, the study seeks to clarify the clinical value of multimodal ablation combined with systemic therapy and TACE in the management of primary liver cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years, no gender restriction.
2. Clinically or pathologically confirmed hepatocellular carcinoma (HCC).
3. CNLC stage IIb-IIIa with tumors deemed unresectable after multidisciplinary discussion.
4. No prior systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma.
5. Presence of an ablation-eligible lesion with imaging-evaluable target tumor(s), with the maximum diameter of the target lesion \>5 cm.
6. ECOG performance status (PS) of 0-1 and an expected survival of more than 3 months.

Liver function Child-Pugh score ≤7.

Exclusion Criteria:

1. Liver function classified as Child-Pugh grade C.
2. Presence of tumor thrombus in the main portal vein or hepatic vein.
3. Extensive systemic metastases with an expected survival of \<3 months.
4. Severe failure of major organs, including liver, kidney, heart, lungs, or brain.
5. Recent esophageal (or gastric fundus) variceal rupture and bleeding within the past month.
6. History of other malignancies.
7. Concurrent use of other antitumor therapies, such as radiotherapy or systemic chemotherapy.
8. Active infection, including:HBV infection with HBV DNA \<2000 IU/mL (\<10⁴ copies/mL) or reduced by one log after antiviral therapy.HCV infection requiring antiviral treatment per clinical guidelines.HIV infection or biliary system inflammation.
9. History of organ transplantation or hepatic encephalopathy.
10. Uncorrectable coagulation disorders.
11. Refractory massive ascites, pleural effusion, or cachexia.
12. Pregnancy, altered consciousness, or inability to cooperate with treatment.
13. Interval of less than one month since the last local therapy.
14. Any other factors deemed by investigators to contraindicate study participation or significantly impact the patient's involvement in the study.
Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial

The goal of this randomized control trial is to test the efficacy and safety of a bioglass wound dressing in patients with chronic wound in different stages. The main question it aims to answer are:

* Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in necrosis stable stage？
* Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage？ Participants will be assigned with a 1:1 ratio into intervention group and control group.

Participants of intervention group will receive bioglass wound dressing in addition with clinical optimal treatment plan. Participants of control group will only receive clinical optimal treatment plan.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is aged 18-80 years old;
2. Ulcerative wounds;
3. In the stage of stable necrosis or granulation growth;
4. Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
2. Uncontrolled blood glucose, Glucose test#Fasting blood sugar\>15mmol/L, Glycated hemoglobin\>12%;
3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
4. Serum albumin \< 20 g/L; Hemoglobin\<60 g/L; Platelets\<50 × 10\^9/L;
5. Spreading infection status, currently or about to be treated with antibiotics;
6. Patients with advanced malignant tumors;
7. Active period of autoimmune diseases;
8. Previous allergies to bioactive glass ointment dressings (self originating);
9. The patient is unable to cooperate or has mental disorders;
10. According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
TMC 125 Blood Levels Study

The purpose of the study is to look at whether changing directly from one medication for HIV (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in the blood, compared to when TMC125 is taken without efavirenz having been taken immediately beforehand.

The study aims to help the investigators understand whether it is safe to change directly from efavirenz to TMC125 (with no gap between the treatments) in patients who need these treatments.

The study will investigate the blood levels of TMC125 when it is taken both once and twice a day.

Pharmacokinetic parameters of TMC125 will be evaluated when TMC125 is given without and with a 14-day efavirenz intake preceding period in order to evaluate the risk of achieving sub therapeutic concentrations of TMC125 when switching straight from efavirenz containing regimens

Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.

Eligibility Criteria:
Inclusion Criteria:

1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
2. Male or non-pregnant, non-lactating females
3. Between 18 to 65 years, inclusive
4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive
5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study

Exclusion Criteria:

1. Any significant acute or chronic medical illness
2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
3. Positive blood screen for hepatitis B and/or C antibodies
4. Positive blood screen for HIV-1 and 2 antibodies
5. Current or recent (within 3 months) gastrointestinal disease
6. Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
7. Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
8. Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within 1 week of first dose of study drug and for the duration of the study
9. Use of any other drugs, including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
10. Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
11. Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
Imaging Lens Deposits in Exfoliation Syndrome

The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the eye without requiring contact with the eye. We will compare lens images of subjects with exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis of exfoliation syndrome to track disease progression and see how they respond to possible treatments. We also hope that with this imaging technology we can detect early changes in currently unaffected eyes, which could be useful for predicting which patients may develop the disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of exfoliation syndrome, primary open angle glaucoma (POAG), or cataracts

Exclusion Criteria:

* Unable to provide or sign consent
* Pseudophakia
* Other prior intraocular surgery
* Other eye diseases other than refractive error
Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers

Randomized Control Trial (RCT), were healthy but sedentary women are selected in their first trimester of pregnancy. This RCT has two interventions arms (pedometer plus a goal of 11,000 steps / day and pedometer without goal) and a control group arm, without the use of pedometer. The main objective is to promote physical activity in pregnancy decreasing the prevalence of insomina at their third trimester of pregnancy.

General Objective: To determine the effect of a walking program during pregnancy in the prevention of the appearance of insomnia in the third trimester of pregnancy, in the increase of the quality of sleep and in the improvement of the quality of life throughout pregnancy.

Specific Objectives: Comparison of the interventions group versus the control group; at the beginning, middle and end of the program of the following indicators: 1. Average steps/day; 2. Frequency of insomnia; 3. Hours of night sleep and quality of sleep; 4. Quality of life level.

Methodology: Randomized Control trial in parallel in healthy sedentary pregnant women belonging to the Virgen de las Nieves Hospital in Granada, Spain. At 12 weeks of gestation (GW) they will be invited to participate and randomly assigned to the intervention group I2 (pedometer, with goal of 11,000 steps / day), intervention group I1 (pedometer without goal) and control (without pedometer). Duration of the intervention: 13-32 GW. At 12, 19 and 31GW the average steps/day will be measured in groups I2 and I1. In weeks 13, 20 and 32GW, the following variables will be collected: the Athens Insomnia Scale, the Sleep Quality Index (Pittsburgh), adherence to the Mediterranean Diet (Predimed), physical activity (short IPAQ), quality of life (PSI), the consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco), the anthropometric variables of pregnant woman.

Eligibility Criteria:
Inclusion Criteria:

* Low risk pregnancies that are attending in the Unit of Obstetrics and Gynecology of the Hospital Materno-Infantil de Granada.
* Sedentary women (\<5 days/week of moderate-vigorous physical activity at least \>30 min.; equivalent to \<7.000 steps/day).
* With mobile phone and e-mail
* Without intellectual deficits or difficulty to understand the language.

Exclusion Criteria:

* Chronic disease: diabetes, high pressure, cardiac or respiratory disease, liver or kidney disease or mobility problems.
* Women with relative or absolute repose.
* Active women (\>5 days/week of moderate-vigorous physical activity at least \>30 min.; equivalent to \>7.000 steps/day).
* Insomnia at beginning of pregnancy or having drugs for sleep problems.
Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring

Change and predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation

Fluid therapy for sepsis patients has always been a research hotspot. Early studies suggest that early goal-directed therapy (EGDT) can reduce mortality in patients with sepsis and septic shock, which is included in the guidelines. However, recent studies suggest that EGDT does not reduce mortality. This may be related to the fact that EGDT only pays attention to systemic circulation and neglects microcirculation.

In the past few decades, arterial blood pressure, blood lactic acid and other circulatory indicators have been the target of septic shock treatment, but normal systemic circulation does not mean normal tissue perfusion. Obstacles to tissue perfusion, oxygenation and microcirculation may still exist. At the same time, compared with systemic hemodynamic parameters, microcirculation parameters may play a stronger role in predicting the prognosis of sepsis patients. It is believed that the ideal goal of resuscitation therapy for sepsis should be based on whether microcirculation function has been restored or not.

Objective:to observe the success rate of microcirculation imaging and oxygen saturation of peripheral tissues in sepsis patients under the guidance of current guidelines and procedures. At the same time, we compared the predictive value of microcirculation indicators to the prognosis of septic shock patients.

Eligibility Criteria:
Inclusion Criteria:

* patients fullfilled the diagnostic criteria of Sepsis 3.0

Exclusion Criteria:

* Patients who were younger than 18 years old，
* pregnant women
* patients who had been admitted to the Intensive Care Unit(ICU for\<24 h)
Research Exploring Sleep Education & Technology

A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking technologies, and optimal sleep health educational strategies among users of mobile wearable technologies that track sleep.


Eligibility Criteria:
Inclusion Criteria:

* A current user of the OURA ring activity and sleep tracker device.

For Aim 3 MOST message testing, the inclusion criteria include the following:

* Health conscious.

Exclusion Criteria:

* Non English speakers.