cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility

Susceptibility testing is commonly employed in patients with bacterial infections in order to guide rational use of antibiotics; however, the use of antifungal susceptibility testing is limited due to lack of availability, costs, and delays in receiving results. The goals of antifungal susceptibility testing should mirror those of antibacterial susceptibility testing: to predict clinical response or failure. Additionally, susceptibility reports should be used as a guide for physicians when transitioning patients from parenteral to oral antifungal agents. Currently, it is unknown whether antifungal susceptibility testing impacts treatment decisions in hospitals that routinely perform Candida susceptibility testing. The purpose of this study is to evaluate the changes in antifungal treatment based on in vitro susceptibility reports and how these decisions affect mortality, recurrence of infection, and length of hospital stay in candidemia patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with bloodstream infections due to Candida species

Exclusion Criteria:

* Patients will be excluded from this study if their medical charts contain incomplete outcome or susceptibility data. Patients treated empirically or definitively with amphotericin-based products will also be excluded
3D Augmented Reality Mirror Visual Feedback Applied to the Treatment of Unilateral Upper Extremity Neuropathic Pain.

This study has two objectives. First, to introduce a new virtual reality method that incorporates the mechanisms used in mirror visual feedback through a three-dimensional (3D) augmented virtual reality system. Second, to evaluate the efficiency of this new method on a convenience sample of patients presenting with unresolved neuropathic pain (CRPS, PLP, plexopathy, stroke) who were not responding adequately to both pharmaceutical management and traditional mirror therapy.

Each patient receives 5 treatment periods over a total period of 1 week, where each treatment period lasts a total of 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Neuropathic pain in the unilateral upper extremity scored by DN4 questionnaire
* At least 3 months symptom duration following injury
* Minimum pain of 40 on a visual analogue scale (VAS);
* A drug treatment regimen that was stable for at least 2 weeks.
* Subjects were allowed to participate if they presented with any of the following: (1) A CRPS diagnosis, in accordance with the International Association for the Study of Pain criteria, Phantom Limb Pain (PLP), or spinal cord injury or plexopathy; and (2) an history of being treated before by conventional mirror therapy but, in their case, the mirror therapy failed.

Exclusion Criteria:

* Bilateral injury,
* Patients with epilepsy
* Side effects known to 3D (such as nausea, cephalalgia)
* Cognitive disorder
* Poor knowledge of the French language.
Core Strength and Coordinative Skills

Evaluation of healthy young adults regarding balance, core strength/core stability and physical fitness. Correlation of primary outcome parameters and selected secondary parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adequat cognitive and lingual competence
* Written informed consent

Exclusion Criteria:

* low back pain or other painful disorders regarding the spine during the last 6 weeks
* Previous spine surgery
* Neurologic disease or disease of the vestibular organ
* Previous arthroplasty of joints
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for MDD
* Current major Depressive episode of at least 4 weeks and not exceeding 24 months in duration at visit 1
* Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 1 month before Visit 1.
* Lifetime history or currently meet DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study.
  5. Dissociative disorder
  6. Posttraumatic stress disorder
  7. MDD with psychotic features
* Significant homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
* Prior participation in any investigational study of rapastinel/GLYX-13
ICU-VR Prior to ICU Admission

Rationale: A substantial proportion of the Intensive Care Unit (ICU) survivors develop psychological impairments due to their ICU admission. Several interventions to mitigate these impairments have been explored but lack a proper effect. Intensive Care Unit-specific Virtual Reality has proven to be potentially effective in treating PTSD and depression-related sequelae in ICU-survivors.

Objective: To evaluate the contribution in terms of information provision and patients' perspectives of ICU-VR to prepare lung transplant patients for their future ICU admission

Study design: A monocentre randomized controlled study

Study population: Lung transplant patients who are on the waiting list and understand the Dutch language. Due to the criteria for lung transplantation, these are 18-71 years of age. Participants need to have signed the informed consent formular.

Intervention: The ICU-VR intervention is designed by an interdisciplinary team of intensivists, ICU nurses, a psychiatrist, a psychologist, and a former ICU patient, to expose patients to the ICU environment while offering treatment- and department-related information. During the 12-minute lasting intervention, patients experience different facets of ICU treatment and receive information on the ICU environment, treatment, and workflow. The intervention group will receive this treatment during the appointment with the lung transplantation nurse. The control group will receive the regular hospital preparation care.

Primary endpoints: The primary endpoint will be the difference in information provision of the ICU care of lung transplant patients on the waiting list.


Eligibility Criteria:
Inclusion criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Be on the waiting list for lung transplantation
* Age 18-71 years (maximum age for lung transplantation is 71 years)
* Understand the Dutch language
* Signed informed consent

Exclusion Criteria:

While patients on the waiting list for lung transplantation are intensively monitored and only placed on the waiting list under strict conditions, no additional exclusion criteria above these are identified to exclude specific patients.
Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration

Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains high. This may at least be partly due to the insufficient removal of (especially protein-bound) uremic toxins which have been associated with cardiovascular morbidity and mortality. It is unknown whether the combination of long-hour haemodialysis (HD) with convection increases the removal of these toxins. Long-hour HD and long-hour haemodiafiltration (HDF) may also improve haemodynamic stability which is an important factor in treatment quality. The investigators aim to study the removal of uremic toxins in long-hour HD and HDF and to compare the haemodynamics between 4-hour and 8-hour HD and HDF.

Objectives: The primary aim is to study the removal of (especially protein-bound) uremic toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic response between 4-hour and 8-hour HD and HDF.


Eligibility Criteria:
Inclusion Criteria:

* prevalent conventional HD patients
* AV-fistula enabling double-needle vascular access with blood flow rate of at least 350 ml/min
* informed consent
* age more than 18 years

Exclusion Criteria:

* withdrawal of consent
* acute intercurrent illness (infection, malignancy, cardiovascular event, uncontrolled diabetes)
Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency

This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.


Eligibility Criteria:
Inclusion Criteria:

* ALS diagnosed by a neurology and
* chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS

Exclusion Criteria:

* impaired cognition to give informed consent to participation
* contraindication to NIV therapy
* another severe disease with a prognosis of less than one year
* ventilation via an artificial airway, tracheostomy
IssuEs in Palliative Care for People in Advanced and Terminal Stages of Young-onset and Late-Onset Dementia in GErmany

From a scientific view, palliative care issues in dementia are neglected in Germany. Neither in Germany nor internationally research has been conducted on palliative care issues in young onset dementia (YOD), although significant differences compared to late onset dementia (LOD) are expected. Most international studies have focused on patients in long term care (LTC) facilities but have neglected patients that are cared for at home. We hypothesize that in advanced and terminal stages of YOD and LOD unmet care needs exist and that they differ between YOD and LOD. By prospectively assessing and surveying 200 patients with YOD and LOD in advanced stages who are cared for in LTC facilities and at home and investigating circumstances of death of 100 YOD- and LOD-patients, it is possible 1) to describe symptoms and management, health care utilization, palliative care provision, quality of life and death, elements of advance care planning, family caregivers' needs and satisfaction; 2) to compare YOD and LOD; 3) to develop expert-consensus recommendations derived from study results for the improvement and implementation of strategies and interventions for palliative care provision. 4) to communicate the recommendations nationally and internationally in order to improve and adapt guidelines, to implement the recommendations into daily practice and to give a basis and perspectives for future research projects; to communicate the results to patients and their families in order to counsel and support them in their decision making processes and their dialogue with professional caregivers and physicians.


Eligibility Criteria:
Inclusion Criteria:

* Patient with moderate or severe dementia (CDR = 2 or 3)
* Patient lives at home or in long term care
* Patient has got a family caregiver \> 18 years
* Family caregiver has sufficient knowledge of German language
* Written informed consent of family caregiver
* Written informed consent of patient or legal representative, respectively
* Documents of legal representative/ Power of attorney

Exclusion criteria

• at least one inclusion criterion is not met
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008

To evaluate the safety and pharmacokinetic characteristics after the administration of JT-001, JT-002 and JLP-2008

A randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of JLP-2008 and the co-administration of JT-001, and JT-002 for healthy subjects in fasted state

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults between 19 and 55 years of age at the time of screening test
2. At the time of the screening test, a subject weighing more than 50 kg for men and 45 kg for women, and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
3. After receiving a detailed explanation of this clinical trial and fully understanding it, those who voluntarily decide to participate and give written consent before the screening procedure

Exclusion Criteria:

1. Those with a clinically significant history of hypersensitivity, intolerance, or anaphylaxis to the main ingredient or other components of the investigational product
2. Those who have clinically siginificant medical history of liver (severe liver disorders, etc.), kidneys (severe renal disorders, etc.), digestive system (pancreatitis, etc.), respiratory system, musculoskeletal system, endocrine system (diabetic ketoacidosis, diabetic coma and precoma, type 1 Diabetes mellitus), neuropsychiatric, hematologic/oncological, and cardiovascular (heart failure, orthostatic hypotension, etc.)
3. Those with a history of Gastrointestinal disease (e.g. Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia surgery, endoscopic polyp surgery, hemorrhoids, dentition, and fistula surgery) that may affect the absorption of the investigational product
4. Persons judged to be unsuitable as trial subjects in the test items conducted during screening

   * Blood ALT, AST, Total bilirubin \> 2 times the upper limit of normal range
   * eGFR \< 60 mL/min/1.73m2 (using CKD-EPI formula)
   * HBsAg, HCV Ab, HIV, Syphilis regain test (RPR) results are positive
   * Vital signs measured in the sitting position after resting for more than 3 minutes: systolic blood pressure \> 160 mmHg or \< 90 mmHg, or diastolic blood pressure \> 100 mmHg or \< 50 mmHg
An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China. The aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with NAFLD.

Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. Silymarin is a mixture of flavonoids extracted from seeds of Silybum marianum or milk thistle, and its major active compound is silibinin. Because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in NAFLD. Furthermore, some traditional liver protective Chinese medicines are also helpful in controlling the progression of NAFLD, such as pueraria, schisandra and salvia miltiorrhiza. At present, there are few reports on the combination of silymarin and these traditional Chinese medicines in the treatment of NAFLD. This study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* Subject's BMI is ≥ 22.0 kg/m2 and \< 33.0 kg/m2;
* Subject is diagnosed with NAFLD according to the Chinese Non-alcoholic fatty liver disease prevention guide 2018;
* A mildly elevated of ALT level (≥ 30 U/L for male, ≥ 19 U/L for female) or an AST/ALT ratio \< 1.0;
* Must be able to swallow tablets.

Exclusion Criteria:

* ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female;
* Patients with certain hepatic diseases such as gallstones, hepatitis C, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease;
* Be taking medicines or supplements that would influence the liver function, lipid metabolism;
* Patients with total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, Mauriac syndrome, etc;
* Patients with hereditary diseases, coronary heart disease, mental disorder, cancer, cirrhosis and renal disease;
* Body weight change are more than 10% in previous 3 months;
* Patients who have participated in or are participating in other clinical trials within 3 months of their first administration of the study product;
* Subjects are allergic to the ingredients in the test or control samples;
* Woman who is pregnant or breastfeeding;
* Subjects cannot meet the requirements of compliance in the pre-experiment period;
* Subjects who fail to sign the informed consent forms.
The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections

The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.

The study method was experimental in design and recruited 331 medical intensive care unit patients with placement of central catheters in one regional hospital in northern Taiwan. The investigators used block randomization to assign patients to the study group or control group. In study group which included 163 participants, the investigators used aseptic coverings during dressing and in the control group which included 168 participants the process of dressing was as routine. Study period started from the first day of catheter insertion and ends with either the removal of catheter or discharge from intensive care unit. The investigators defined the infection outcome according to culture results, and the guidelines by Infectious Diseases Society of America and Centers for Disease Control and Prevention, USA. Analysis was done by SPSS version 23. The investigators used percentage and average to study characteristics of participants. The investigators used Chi-Square or Fisher's exact test and Poisson distribution to analyze the incidence rate of bloodstream infections and the infection density. The investigators used Kaplan-Meier curve to demonstrate the catheter infection-free days and the catheter redness symptoms days of the two groups. The investigators used logistic regression model to analyze factors associated with development of bloodstream infections.

Eligibility Criteria:
Inclusion Criteria:

* Adults older than 20 years old
* Patients with central venous catheters
* Agree to participate in this study, and fill out the study consent

Exclusion Criteria:

* PICC patients placed
* Patients with bloodstream infection
* Patients with immunocompromised patients (such as HIV, AIDS, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)
Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient

A randomized double blind placebo control trial study will be conducted in critically ill patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3 supplementation, compare to placebo, on skeletal muscle mass and body composition.

There is a high prevalence of vitamin D deficiency in critically ill patient which is associated with muscle wasting and physical disability. Recent study showed that treatment of vitamin D deficiency with high dose vitamin D improved muscle wasting and may prevent further muscle breakdown.

Investigator want to explore whether a high dose vitamin D3 supplementation, compare to placebo will be able to improve muscle wasting in critically ill patients.

The eligible participant will be asked to sign and date the informed consent document then they will be randomized to receive vitamin D3 supplement or placebo, using the computer generated code in conceal envelope.

Vitamin D3 or placebo will be given orally or feeding tube via feeding tube at a dose of 100,000 IU on day 1 and 3 then 50,000 IU on day 5,7,9,12 followed by 150,000 unit per week for 4 week.

Serum 25-Hydroxyvitamin D, 1,25-dihydroxyvitamin D will be measured at baseline (day 0) then day 10 and day 43 after vitamin D supplementation. Moreover, Investigator will assess the diameter of rectus femoris by using ultrasonography on day 0,10 and 43.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 70 years old
* Expected ICU stay ≥ 48 hrs

Exclusion Criteria:

* Participate in other clinical trial
* Contraindication to receive oral or enteral feeding
* Do not resuscitate /imminent death
* Vegetative state, generalize weakness, denervation of leg, both leg amputation
* Hypercalcemia or Hypercalcemia at risk
* Hyperphosphatemia,
* History of nephrolithiasis
* End stage renal disease on renal replacement therapy
* Pregnancy/lactation
* Consent refusal
A Study to Learn More About How Safe Dienogest is and How Well it Works Under Real World Conditions in Indian Women With Endometriosis

Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that normally covers the inside of the womb grows outside the womb. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life. It also requires long-term treatment to control the symptoms.

The study drug, dienogest, has already been approved as a treatment for endometriosis associated pelvic pain. Sometimes, researchers continue studying a treatment after it has been approved to learn more about its safety.

In this study, the researchers want to learn more about any medical problems the patients have while taking dienogest. To answer this question, the researchers will collect the medical problems the patients have after taking dienogest and that may or may not be related to dienogest. These medical problems are also known as adverse events.

They will also collect information about the endometriosis associated pelvic pain. The pain measured with a standard rating scale called EAPP (endometriosis-associated pelvic pain) before treatment start and after 6 months of treatment will be compared.

The trial will include women with endometriosis associated pelvic pain whose doctors have decided to start treating them with dienogest. It will include about 160 women in India who are at least 18 years old.

All of the patients will take dienogest based on their doctor's instructions. They will then visit their study site 3 times over 6 months. At these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. The doctors will do tests to measure the pain caused by the patients' endometriosis and any other symptoms. The doctors will also do physical examinations and check the patients' overall health.


Eligibility Criteria:
Inclusion Criteria:

* Female patients in India at least 18 years of age
* Clinical or surgical diagnosis of endometriosis: Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst)
* Patients diagnosed with endometriosis associated pelvic pain who have not been previously treated with Dienogest
* Decision to initiate treatment with Dienogest was made as per investigator's routine treatment practice
* Signed informed consent

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Contra-indications according to the local summary of product characteristics (SPC)