cyrilzakka/clinical-trials huggingface dataset:
Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.

The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.

Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.

The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years and older with the diagnosis of Vitiligo.

Exclusion Criteria:

* Female patients currently pregnant or lactating
* Female patients with plans to come pregnant during the next 3 months
* Allergic reactions to topical or oral prostaglandins
* Uncontrolled skin disease
* History of glaucoma
* Concomitant disease or therapy that interferes with the diagnosis that might interfere with vitiligo diagnosis sand evaluation.
* Patients currently using other treatments for Vitiligo, such as topical steroids, calcineurin inhibitors, and Vitamin D analogs within 2 weeks of study initiation
* Inability or unwillingness of subject or legal guardian/representative to give
ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP

Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important techniques in the treatment of bile duct stones. A number of studies have been conducted using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In those studies, the authors suggested that EST plus LBD might lower the risk of post procedure pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than the pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary drainage catheter can prevent PEP. However, it is still unclear that nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative pancreatitis in treating of large bile duct stones.The investigators therefore designed a prospective randomized trial to determine whether nasobiliary drainage prevent PEP after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.

Patients enrolled were confirmed the presence of CBD stones using magnetic resonance cholangiopancreatography. Patients with large bile duct stones were randomly assigned to EST+LBD+ENBD group and EST+LBD group. A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients with visualized bile duct stones ≥12 mm in maximum transverse diameter. - Males and females, age \> 18 years.
* Normal amylase level before undergoing ERCP.
* Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

* Bleeding diathesis
* Prior EST or EPBD or ENBD
* Billroth II or Roux-en-Y anatomy
* Distal extrahepatic bile duct stenosis
* Acute pancreatitis
* Intrahepatic bile duct stones.
Effect of Re-education on Rebleeding Rate After Endoscopic Treatment in Liver Cirrhosis

A prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis

After receiving esophageal variceal ligation and （or） gastric fundus variceal sclerotherapy, patients with outside hospitalthe rate of bleeding due to liver cirrhosis shall be re-educated outside the hospital, including diet, drugs, anticoagulation of portal vein thrombosis,regular endoscopic treatment, reexamination , nutrition, etc. The patients were divided into the first treatment group and the more thanonce treatment group according to whether they had received endoscopic treatment in the past

Eligibility Criteria:
Inclusion Criteria:

* Esophageal and / or gastric varices ；
* liver cirrhosis ；
* patients receiving endoscopic treatment (esophagogastric variceal sclerosis and/or ligation) ；
* All subjects or their guardians must sign the subject consent form before entering the test

Exclusion Criteria:

* Patients with mental illness, severe hearing loss and unable to take care of themselves ;
* ASA score ≥ grade IV at discharge ;
* Hepatic encephalopathy ≥ stage II;
* Patients with liver cancer;
* Pregnant and lactating women;
* Patients who cannot sign informed consent
Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study

In a 20-year retrospective study, all skiers and snowboarders with a peroneal nerve injury at the fibular head treated surgically at the Department of Plastic, Reconstructive and Aesthetic Surgery at the Medical University of Innsbruck, Austria, were included. Covering a period from 1999/2000 to 2018/2019.

All data were gained in a clinical routine context, and the study design was retrospective. The work was approved by the local ethics committee of the Medical University of Innsbruck, Innsbruck, Austria (EK Nr.: 1300/2019). We reviewed medical charts from over a 20-year period, including all patients with a PNI after a ski- or snowboard-related accident requiring surgical intervention at the Department of Plastic, Reconstructive and Aesthetic Surgery of the Medical University of Innsbruck, Austria.

We analyzed the demographical data, including age, gender, and citizenship, as well as included variables concerning the winter sport activity (i.e., ski or snowboard, owned or rented, self-inflicted without collision or collision caused by another skier or snowboarder, professional or recreational athlete). We also analyzed the injury itself (i.e., PNI as main injury, open or closed, motoric, sensible or both, fracture, muscle injury, complete or incomplete transection), as well as the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Skiers and snowboarders
* treated with a peroneal nerve injury at the fibular head
* time frame January 1999 to Dicember 2019

Exclusion Criteria:

* Different injury mechanism
* injury of a different nerve than peroneal nerve
Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.

The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks.

It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.

This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1 year from enrollment of the last patient. Each enrolled patient will have his or her port flushed five times in 3 month intervals.

Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes, they will be followed for one year. At the end of the year patients will return to standard PAC flushes. If patients experience any PAC malfunction, it would be considered a PAC failure and the flushing will reverted back to the schedule recommended by the manufacturer.

Eligibility Criteria:
Inclusion Criteria:

1. All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy)
2. Without active disease
3. Able to give informed consent

Exclusion Criteria:

1. Minors, prisoners
2. Previous PAC failure
3. Disease recurrence
4. Patients who had their PAC removed immediately following therapy.
18F-AmBF3-TATE PET/CT for Imaging NET Patients

Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs.

This study proposes 18F-AmBF3-TATE positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the biodistribution and safety of 18F-AmBF3-TATE PET/CT for neuroendocrine tumour imaging.

Each subject will have a PET/CT scan using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.

After providing informed written consent subjects will complete a medical history questionnaire.

Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 18F-AmBF3-TATE . Eighteen to seventy-two hours after 18F-AmBF3-TATE administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire.

Follow-up Assessments

The following information will be collected up to 12 months following the PET/CT scans:

Initiation of a new treatment, Laboratory results and pathology reports, Results of imaging studies, Final clinical diagnosis by physician and relevant clinical notes. The study is expected to take up to 1 year for accrual.

Eligibility Criteria:
Inclusion Criteria:

All subjects:

* Participants with newly diagnosed or documented neuroendocrine tumours (NET), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-FDG, 18F-FDOPA or 68Ga-DOTATOC/DOTATATE scan) or scintigraphy (with 111In-pentetreotide imaging).
* ECOG performance status of 2 or less.

Exclusion Criteria:

* Pregnancy
* Medically unstable (eg. acute illness, unstable vital signs)
* Unable to lie supine for the duration of imaging
* Unable to provide written consent
* Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
* Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes.
* Patients with baseline ALT or AST higher than 5× ULN or 250 U/L.
* Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR \>1.2, or platelet count below the lower limit of normal (typically \<150 000/μL.
* Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin.
Placental Inflammation in Prenatal Care

Objective of study is to explore expression of stress-related genes and inflammation in placentas and umbilical cord blood for women participating in group prenatal care compared with women receiving individual prenatal care.

This study aims to evaluate levels of inflammatory markers and genetic indicators of stress an inflammation in the placentas and umbilical cord blood in pregnancies that undergo group prenatal care as compared to traditional prenatal care. The investigators know that women receiving group prenatal care have fewer spontaneous preterm deliveries. What is not known is the mechanism behind this difference. By collecting umbilical cord blood samples and placentas of 40 women at the time of delivery, the investigators hope to study expression of stress-related genes and levels of inflammatory markers at the maternal-fetal interface.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Singleton pregnancy

Exclusion Criteria:

* Presence of known fetal congenital anomalies (lethal anomaly or anomalies that may lead to early delivery or increased risk of neonatal death).
* Presence of known chromosomal abnormalities
* Progesterone treatment during the current pregnancy after 14 weeks
* Chronic corticosteroid (i.e. Prednisone or other steroids) treatment during the current pregnancy (not including inhalers or topical)
Advanced MRI in AAA

This study aims to determine whether advanced MRI sequences can provide robust and clinically relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and intraluminal thrombus inside AAA.

Robustness of these MRI sequences will be determined with testing of feasibility and reproducibility. Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.

It is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression.

This prospective study evaluates the feasibility, reproducibility and clinical relevance of MRI sequences in adults with an abdominal aortic aneurysm (AAA).

The MRI sequences and their primary outcomes are:

* Four-dimensional (4D) flow MRI and wall shear stress (WSS)
* Dynamic Contrast-Enhanced (DCE) MRI and kinetic transport constant (Ktrans)
* T1 and T2 mapping (T1 and T2 relaxation times)

Feasibility is tested by the production of high-quality images that enable calculation of the primary outcomes. Reproducibility is tested by calculating interscan, intra- and interobserver variability. Clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by AAA diameter

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years of age)
* Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm

Exclusion Criteria:

* Contra-indications for MRI
* Severely reduced renal function (eGFR \< 30)
* Previous allergic reaction to intravenous contrast agents
* Suprarenal AAA
* Pararenal AAA
* Previous aneurysm repair
* Inflammatory aneurysm
* Mycotic or other infectious aneurysm
* Vasculitis
* Connective tissue disease
A Randomized Controlled Trial of a Web-based Platform for Cancer Pain Management

Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Investigators plan to develop a convenient patient self-reporting applet to help participants report their symptoms to primary care physicians promptly and monitor pain levels and medication in real-time. This project aims to improve the efficiency of cancer pain management, integrate cancer pain into chronic disease management, improve the quality of healthcare services for rural participants, and promote the construction of a healthy China.


Eligibility Criteria:
Inclusion Criteria:

* Patients with tumors that are confirmed by pathological findings.
* Presence of tumor-related pain that is moderate or higher and requires intervention with morphine-based pain medication (++).
* Have a life expectancy of more than 6 months.
* Understand and sign a consent to participate in the study, or if the patient is unable to understand the study, his/her direct caregiver must have a good understanding of the study.

Exclusion Criteria:

* Presence of other chronic non-cancer pain/have an unresolved pain-related condition.
* Moderately severe cognitive impairment/cognitive impairment.
* Have schizophrenia or other psychiatric illness.
* Neither the patient nor his/her direct caregiver can understand how to use the Cancer Pain Management applet.
* Being pregnant.
Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions

In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.

Hypertension and physical inactivity are the most common risk factors for stroke. Patients with minor stroke or transient ischemic attack (TIA) have short-lasting symptoms, often with remission within hours or days. Though patients experience a quick remission, they have an increased risk of a recurrent stroke and progressive cognitive dysfunction. The patients are also likely to have other disposing risk factors such as diabetes, smoking, and hypercholesterolemia which may increase the risk of a recurrent stroke. Following hospital discharge, the patients are offered preventive medication, but no standardized rehabilitation or exercise. Previous studies have shown that physical exercise decreases cardiovascular risk factors for patients after stroke and increases physical function and quality of life.

The aim is to develop and evaluate a standardized exercise program (a stroke school) for patients with minor stroke or TIA. The intervention consist of 6 weeks of supervised aerobic exercise at the hospital combined with patient education including knowledge on stroke risk factors. Subsequently, 6 weeks of supervised aerobic exercise in their local municipality. After the 12 weeks of exercise, patients are offered individual, motivational follow-up sessions with the purpose to facilitate the patients to stay physically active in their everyday life.

This intervention will increase the patients´ knowledge regarding risk factors for stroke and cardiovascular disease, increase their cardiorespiratory fitness and facilitate the patients to be physical active and hopefully slow the progression of vascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a minor stroke or TIA without the need of rehabilitation after hospital discharge, but need physical activity in order to prevent cardiovascular diseases
* Patients spending ≤ 5 hour of leisure time on high-intensity physical activity on weekly basis within the last 3 months
* Able to speak and read Danish and to provide informed consent
* Individuals ≥ 18 years of age

Exclusion Criteria:

* Previous large-artery stroke or hemorrhagic stroke
* Unstable cardiac condition, e.g. pacemaker
* Uncontrolled hypertension (patients not responding adequately to antihypertensive medication when applying treatment according to guidelines)
* Symptoms or comorbidities not allowing exercise on a stationary bicycle (e.g. claudication)
* Dyspnoea caused by heart or pulmonary disease (e.g. COPD)
* Aphasia, or dementia that interferer with understanding the protocol and/or physical examinations.
* Patients diagnosed with dementia at hospital admission (a score ≤23/30 on the Mini-Mental State Examination are not invited into the study)
Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients

Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.

This is an open label, single treatment arm clinical pilot study. The study is targeted to enroll twelve evaluable patients

OBJECTIVES:

Primary

* Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric patients undergoing HCT

Secondary

* Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral LLLT for prevention of OM
* Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric patients undergoing myeloablative HCT

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at Boston Children's Hospital.
* 4 years of age to 25 years of age.
* WHO Oral Toxicity score of 0 at baseline evaluation (first day of conditioning).
* Ability to understand and the willingness to sign a written informed consent document (for patients under the age of 18 this applies to parent/guardian)
* Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.

Exclusion Criteria:

* Treatment with oral LLLT within 4 weeks of HCT.
* Participants may not be receiving any other agents intended for the prevention/management of mucositis (including palifermin and ice chips/cryotherapy).
* WHO ≥1 at baseline evaluation.
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics

This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants ≤3 months, with gestational age ≥28 weeks
* Documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment
* Expected to survive beyond the first 7 days after enrollment
* Sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site
* Parent's / legally acceptable representative's informed consent to participate in the study

Exclusion Criteria:

* Major birth defect or malformation syndrome
* Proven presence of an immunodeficiency
* HIV or other congenital viral or fungal infection
* Significant laboratory abnormalities including: hematocrit \<20%; absolute neutrophil count \<0.5x10⁹/L; platelet count \< 50x10⁹/L; alanine aminotransferase or aspartate aminotransferase \>3 times the age-specific upper limit of normal
* Impaired renal function or known significant renal disease
* Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study