cyrilzakka/clinical-trials huggingface dataset:
Fast-track Discharge With Telemedicine

Evaluation of discharge after arrival at emergency unit, Kolding Hospital combined with treatment and rehabilitation in the home either by telemedicine or the usual treatment

Participants are acute in-patients at the Medical Department, Kolding Hospital. Participants shall be informed about the project, and all screened initially within 30 minutes. After 3-4 hours adjusted treatment and possible need for new investigations are conducted. Patients are randomized at discharge to home treatment with rounds via telemedicine with support of emergency team of nurses or hospitalization in emergency unit. Observations, treatment and rehabilitation follow the same standards and guidelines for all patients. The cohort of patients is recruited between Oct 1, 2015 until January 1, 2016. The study is a randomized quality evaluation study of patient satisfaction, of the emergency team at Kolding Municipality, re-admittance rate, use of other health services, and new services from the municipality.

Eligibility Criteria:
Inclusion Criteria:

* municipal home care at admittance
* admitted to medical emergency care unit at Kolding Hospital

Exclusion Criteria:

* ketoacidosis,
* hyperosmolar diabetic coma,
* serious hypercalcemia,
* acute renal insufficiency with serum-creatinin \> 175 mmol/l,
* serious cardiac failure
* septicemia
* acute coronary disease
* apoplexia cerebri
* neuroinfection
* progressive or active cancer
* hepatic disease
* serious psychiatric disease
Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid

The research study aims to evaluate the synovial fluid to highlight the presence of possible micropolymers (micro/nanoplastics) in order to better understand the pathophysiology of joint degenerative processes. For patients with liquid under tension at the joint level, the symptomatology often requires evacuation by puncture under ultrasound guidance. The intervention will be performed only for patients for whom this therapeutic indication exists anyway by their physician.

The investigators want to use this liquid for Microscopic and Spectrophotometric evaluation.


Eligibility Criteria:
Inclusion Criteria:

* arthritis of the knee with liquid aspiration recommendation
* age \>18 years

Exclusion Criteria:

--refusal of the patient to participate

-age\<18 years
Effect of Intravitreally Administered AIV007 in Subjects With Neovascular Age-Related Macular Degeneration

To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration

AIV007 is a multiple kinase inhibitor of vascular endothelial growth factor receptors (VEGFR 1, -2 \& -3); fibroblast growth factor receptors (FGFR-1, -2, -3 \& -4); and platelet-derived growth factor receptors (PDGFR-α \& β)1. Lenvatinib is the active pharmaceutical ingredient in AIV007 formulation that is FDA-approved for oral administration for patients with advanced renal cell carcinoma (RCC), differentiated thyroid cancer (DTC), unresectable hepatocellular carcinoma (HCC), and advanced endometrial carcinoma (Lenvima USPI 2021; NDA 206947). AIV007 is a novel, thermoresponsive gel suspension for intravitreal administration proposed to form a durable depot inside the eye. This monotherapy is being evaluated for the treatment of retinal and choroidal vascular disease. A single intravitreal treatment in 3 subjects was evaluated using 2 doses to evaluate depot formation, safety and biological activity by measuring visual acuity, reduction in retinal fluids associated with vision and effects of fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥ 50 years
2. Subjects must provide written informed consent before any study-related procedures are performed
3. Active subfoveal CNV in the study eye secondary to AMD that has previously been treated with at least 3 intravitreal injections of an anti-VEGF agent
4. BCVA in the study eye

   1. Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse
   2. All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent)
5. Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging

Exclusion Criteria:

1. Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy
2. Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline
3. Presence of diabetic retinopathy or glaucoma in either eye
4. Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery)
5. Presence of active infection or inflammation within 30 days prior to screening
6. Presence of contraindications to anti-VEGF treatment, including myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke within the last 3 months of baseline
7. Uncontrolled hypertension or diabetes mellitus
Good Schools Study

The purpose of this study is to determine whether use of the Good Schools Toolkit is effective in reducing violence against children in primary schools.

Violence against children has profound effects on both children's health and their ability to do well at school. Fear, anxiety and injuries caused by violence may play a large role in both children's absenteeism and low educational achievement, and there is increasing interest from large bilateral donors in investigating this link in low income countries. The Good School Toolkit has been developed and refined for 6 years in Uganda by Raising Voices. The toolkit takes a systemic approach, involving an entire school in a process of change to reduce violence and improve teaching techniques. The Toolkit draws on the Transtheoretical Model and incorporates standard behaviour change techniques such as setting a goal and making an action plan, which are effective in modifying behaviour. This study aims to determine whether use of the Good School Toolkit reduces children's experience of violence by school staff. The investigators will also examine the effects of the Toolkit on children's educational outcomes, mental health and well-being.

The investigators will conduct a cluster randomised controlled trial in 40 primary schools in Luwero District, Uganda. More than 3500 children in Primary 5, 6 and 7 will be surveyed (aged about 11-16 years). Half of the schools will receive the Toolkit, and other half will be put on a waiting list to receive the Toolkit at the end of the study. The results from this evaluation will be used to brief policy-makers within the Ministry of Education and Sports involved in developing country-wide policy and practice around violence against children in schools.

Eligibility Criteria:
1. Inclusion Criteria:

   * Schools

     * in Luwero District, Uganda
     * more than 40 students registered in Primary 5
   * Participants

     * registered as a Primary 5, 6 or 7 pupil
     * any school staff member
2. Exclusion Criteria:

   * Schools

     -- existing program related to prevention of violence against children or school governance
   * Participants -- not able to understand consent and study procedures
Implementation of Clinical Pathway to Improve Quality of Healthcare in Stroke Inpatients

With the extension of the average life expectancy, the incidence of cardiovascular diseases is also rising. Stroke in Taiwan has been the leading cause of morbidity and mortality, but also in countries around the world), stroke and the impact of socio-economic and health spending are large how to reduce the degree of disability after stroke is an important issue in medicine. For a long time, the resident will fill the clinical pathway form before the stroke inpatients were discharged. We also analyzed the data of clinical pathway every three months.

According to the current data of stroke clinical pathway included demographic data, length of hospitalization days, complications, functional independent measure, Brunnstrom motor recovery stage, mini-mental state examination, geriatric depression scale, blood pressure data, and post-stroke checklist for a retrospective analysis to provide more complete and more comprehensive information on follow-up care for stroke patients and effective use of medical resources, to improve the quality of future medical care and quality of life for stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic and hemorrhagic stroke patients
2. MRI confirmed the diagnosis of stroke
3. Within three months of onset of unilateral limb hemiplegia in patients

Exclusion Criteria:

1. Initial tracheostomy impantation and hospital stay is less than 5 days
2. Combined with other neurological diseases, such as epilepsy, multiple neuropathy, Meniere's disease, vestibular neuritis, Parkinson's disease, dementia or cerebellar atrophy, etc.
3. Significant lesions of the lower limb joints, including joint contractures, lower limb fractures, joint replacement or long-term pain in patients with osteoarthritis
4. Unstable signs of life (if not through the tilt bed test) or severe cardiopulmonary disease
5. Those who can not cooperate with the study or who have not signed the inform consent
The Impact of Sodium and Fructose on Blood Pressure and Inflammation

The goal of this study is to determine the impact of dietary sodium and fructose on blood pressure and inflammation in young healthy adults.

Excess dietary salt is associated with an increased risk of cardiovascular diseases. Some healthy adults have been determined to be more sensitive to dietary salt than others, which can result in a 10% or more increase of blood pressure. The mechanisms underlying salt sensitivity of blood pressure are not fully understood. Previous research has suggested excess intake of added sugars, especially fructose, can increase salt sensitivity of blood pressure. Chronic elevated consumption of salt and fructose independently have been shown to have damaging effects on the body, however, the combination of both salt and fructose has not been fully studied in humans. The purpose of this research study is to determine if increased dietary fructose consumption will stimulate salt-sensitive hypertension and induce proinflammatory cytokines through activation of the immune system. Understanding how the body regulates blood pressure during times of elevated salt and fructose is important for determining cardiovascular risk in a population with normal blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* normal blood pressure
* males, females, minorities

Exclusion Criteria:

* high blood pressure
* body mass index (BMI) of \> 30 kg/m2
* smokers or nicotine users
* pregnancy
Acute Sore Throat Pain Study

"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature.

The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."


Eligibility Criteria:
Inclusion Criteria:

* male or female patients 18 years and older
* patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A

Exclusion Criteria:

* patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
* patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
* patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry
* patients having taken antibiotics within 14 days before study entry.
PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS).

The main question it aims to answer is:

• Does Procalcitonin/Presepsin-guided antibiotic prophylaxis of (EOS) increase survival without major morbidities, including IVH \>3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS.

Infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight \<1500 g will be eligible for enrollment in the study.

Participants will be randomized to receive standard antibiotic prophylaxis for EOS (standard group) or to receive antibiotic prophylaxis for EOS on the basis of PCT/P-SEP measured within 3 h of life (intervention group).


Eligibility Criteria:
Inclusion Criteria:

* infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.

Exclusion Criteria:

* Risk factors for EOS:

  * maternal GBS colonization without adequate prophylaxis;
  * clinical chorioamnionitis diagnosed by maternal intrapartum fever (either a single documented maternal intrapartum temperature of ≥39.0°C or a temperature of 38.0-38.9°C that persists for \>30 minutes) and 1 or more of the following: (1) maternal leukocytosis, (2) purulent cervical drainage, and (3) fetal tachycardia;
  * pre-labor rupture of membranes (ROM) \>1 h before delivery.
* Surgery within the first week of life,
* major congenital malformations,
* chromosomal syndromes,
* inherited metabolic disorders,
* fetal hydrops
Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

The ERAS programs has been proved to be a useful solutions in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.

But few studies reported about the ERAS programs in the laparoscopic hepatectomy.

The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

Eligibility Criteria:
Inclusion Criteria:

* If patients were diagnosed with tumors

  1. Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
  2. The tumor location and size do not affect the dissection of hepatic hilar region
  3. Tumor size less than 10cm
  4. Without portal vein tumor thrombus
  5. Without intrahepatic or distant metastasis
* Partial resection or half liver resection
* Willingness to participate in the study
* Able to understand the nature of the study and what will be required of them
* Body mass index of between 18 and 35
* Child-Pugh classification of A to B
* American Society of Anesthesiologists (ASA) grading of I to III

Exclusion Criteria:

* Pregnant or lactating women
* Unwillingness to participate
* Inability to give written informed consent
* Child-Pugh classification of C
* ASA grading of IV to V
* Tumor invasion of the inferior vena cava or confluence part of hepatic vein
* Decompensated liver cirrhosis
Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion

This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery.


Eligibility Criteria:
Inclusion Criteria:

-Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks

Exclusion Criteria:

* If fetus and placenta expelled together
* Obstetrical haemorrhage needs intervention
* Known prostaglandin allergy
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.

An opened label trial designed to evaluate CG0070 and DDM in combination with Pembrolizumab in patients with NMIBC who have failed prior BCG therapy.

The target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1 papillary disease will be enrolled.

BCG failure is defined as persistent or recurrent disease within 12 months of completion of adequate BCG therapy.

Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)
* Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the sub- epithelial connective tissue) disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was performed within 12 months after completion of adequate BCG therapy.

  * Adequate BCG is defined as at least 5 treatments with induction BCG followed by at least 2 BCG treatments as reinduction or maintenance
* Ineligible for radical cystectomy or refusal of radical cystectomy
* Adequate organ function

Key Exclusion Criteria:

* Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
* Prior treatment with adenovirus-based cancer therapy
* Prior therapy with or intolerant to prior checkpoint inhibitor therapy
* Clinically significant or active cardiac disease
* Active autoimmune disease
The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer

Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer

Exclusion Criteria:

* contraindication to MRI
Effect of ANI on Intraoperative Opioid Consumption

The aim of the study is to compare the analgesic nociception index (ANI), which is used to determine the dose of analgesic agent needed in the intraoperative period, with the conventional method in patients with erector spinae block who underwent gynecological surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II-III risk group
* Patients who underwent gynecological surgery under general anesthesia, who underwent erector spina block, and whose pain was followed by analgesia nociception index or conventional methods for intraoperative pain monitoring
* Patients whose informed consent was read and consent was obtained from them and their guardians

Exclusion Criteria:

* cardiac rhythm disorder
* central-autonomic nervous system disease
* neuropsychiatric disease
* receiving opioid therapy
* Use of drugs that will affect cardiac autonomic regulation
* Known allergy to the drugs to be applied
* Contraindicated for ESP block
* Patients who do not agree to participate in the study will not be included in the study.
* Patients who were administered drugs to stabilize the patient's hemodynamics during the operation