cyrilzakka/clinical-trials huggingface dataset:
Ischemic Preconditioning. Prospective Comparison

Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion) causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can lead to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to protect the liver parenchyma during liver resection consists of an initial flow clamping for 10 minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad clamping during transection.

Detailed Description:

This is a prospective controlled trial, conducted between July 2011 and July 2012. This study has been initiated by Liver \& Transplant Division, Hospital Dr Cosme Argerich, Buenos Aires Argentina. The protocol was approved by ethics committees and an informed consent was obtained from each patient before they were enrolled. Sixty patients were randomized to either receive ischemic preconditioning prior to liver resection under intermittent pedicle clamping or Intermittent Pringle ischemia. Ischemic preconditioning was performed through a sequence of 10 minutes vascular inflow occlusion and 10 minutes of reperfusion prior to continuous pedicle clamping during resection. Intermittent pedicle clamping was conducted through a sequence of 15 minutes of vascular inflow occlusion and 5 minutes of reperfusion. The randomization process which was centralized was held in the operating room after inclusion criteria had been check and exclusion criteria ruled out.

Eligibility Criteria:
Inclusion Criteria:

* patients' age ≥ 18 years old
* Portal vein embolization allowed

Exclusion Criteria:

* laparoscopic liver resection
* pregnant women
* lack of patient consent
* lack of acceptance of the operating surgeon
* Hilar cholangiocarcinoma
* Simultaneous hepaticojejunostomy
Locally Optimised Contouring With AI Technology for Radiotherapy

LOCATOR is a multicentre phase II randomised clinical trial that is looking at the process of contouring in radiation treatment for breast cancer patients. This study looks at whether contouring aided by artificial intelligence (AI) is comparable in quality to that of contouring done completely manually by a radiation oncologist. We are also looking at whether AI assisted contouring saves radiation oncologists time when compared to fully manual contouring.

LOCATOR uses the LOCATOR software which is an in-house software developed locally and trained on local data.

LOCATOR is a multicentre phase II non-inferiority randomised controlled trial looking at comparing AI assisted contours (with in-house LOCATOR software) against fully manual contouring in breast cancer patients. The primary endpoint is to show non inferiority in grade of AI assisted contouring when compared to fully manual contouring with a poor contour (score \<= 2) as per the MD Anderson Contouring Grade Scale. Secondary endpoints include geometric assessments of contour accuracy, dosimetric differences based on contours, performance (geometric) when compared to commercially available tools as well as economic cost-benefit analysis if in-house AI contouring tools.

The study will randomise patients 3:1 to the intervention arm of LOCATOR assisted contours to manual contours. An initial AI contouring model for each tumor type will be trained on contours from 45 previous breast cases using a nnUNetv2 framework. The model will then be iteratively updated every 20-50 patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older who are planned for primary breast malignancy
* ECOG performance 0-2
* Ability to understand and willingness to sign a written informed consent document
* The target volume must be able to be objectively reviewed by current published national or international clinical guidelines

Exclusion Criteria:

* Patients under 18 years of age
* Patients unable to understand consent documents
Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis.

Multicenter prospective observational cross-sectional study with non-commercial (non-profit) objectives.

The study population consists of consecutive patients who present to the Emergency Departments of the participating hospitals with hemoptysis.

The diagnosis of pulmonary embolism will be made using the diagnostic algorithm suggested by the 2019 European guidelines. The pre-test clinical probability of pulmonary embolism will be defined based on the simplified Wells score, which classifies pulmonary embolism as "likely" or "unlikely". In patients with a low pre-test clinical probability ("unlikely") and a D-dimer level below the threshold value (negative), the diagnosis of pulmonary embolism will be excluded, and further testing will not be necessary in this regard. The D-dimer level will be measured using the quantitative assay routinely used in each participating center; the threshold value for a positive result compared to a negative result is 500 μg per milliliter for patients under 50 years of age. For each additional decade of age, the exclusion cutoff will increase by 100 μg per milliliter.

For patients with a high pre-test clinical probability ("likely"), a positive D-dimer test, or both, a pulmonary CT angiography will be the diagnostic test of choice.

The criterion for the presence of pulmonary embolism is the detection of an intraluminal filling defect on CT.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who present to the Emergency Department of the participating centers with hemoptysis
* consent to participate.

Exclusion Criteria:

* Pregnancy.
* Age below 18 years.
* Terminal illnesses with an estimated prognosis of less than 3 months.
Robotics Plus VR in Improving Cognition

Stroke can be classified as ischemic, i.e. due to the lack of blood flow, and haemorrhagic, caused by bleeding. Stroke results in focal signs and symptoms, with a devastating impact on a patient and his family. Although robotic rehabilitation is very useful in improving motor function, there is no a clear evidence on its role in improving cognitive abilities, which are often compromised in stroke patients.

To this end, the investigators designed a randomized controlled experimental study on stroke patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat with and without virtual reality on cognitive functioning in stroke patients, compared to traditional therapy.


Eligibility Criteria:
Inclusion Criteria:

Neurological diagnosis of stroke in the post-acute phase (3 months from the acute event); age between 40 and 80; and Caucasian ethnicity; a FIM motor score equal to or greater than 30 and moderate to mild cognitive impairment (MoCA\> 18); Fugl-Meyer scale score of\> 18;

Exclusion Criteria:

Patients with a history of concomitant neurodegenerative diseases or brain surgery; severe cognitive or language impairment; systemic, bone or joint disorders; presence of disabling sensory alterations; concomitant medical and psychiatric illness that could interfere with VR training.
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).

Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.

Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.

Efficacy will be evaluated by change from baseline (Day 0) to Day 63 Â± 3 Days of the global ocular discomfort evaluation (VAS).

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye

Exclusion Criteria:

* Monophtalmia
* Eyelid dysfunction
* Facial paralysis.
* Severe dry eye syndrome.
* Ocular metaplasia.
* Filamentous keratitis
* Schirmer test \< 5 mm.
* Best far corrected visual acuity \< 1/10.
Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer

Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic pancreatic adenocarcinoma
2. Patients aged between 18 and 75
3. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy greater than 3 months
6. Subjects must have measurable disease as defined by RECIST 1.1 criteria
7. Satisfactory organ and bone marrow function: White blood cell count (WBC) ≥ 3.0×10\^9/L, Platelets ≥ 70×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5 × upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration
8. Karnofsky score ≥ 60
9. Ability to give informed consent

Exclusion Criteria:

1. Previously treated with any gene therapy products
2. Patients who are receiving any other investigational agents
3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
4. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
6. Concurrent opportunistic infections
Study on Fermentable Carbohydrates in Healthy Infants

The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.

Eligibility Criteria:
Inclusion Criteria:

* Infants born in Reus and Tarragona area
* Healthy
* Normal feeding behaviour

Exclusion Criteria:

* Serious respiratory, neurological, gastrointestinal or metabolic disorders
* Infections or other serious diseases that could interfere in normal feeding or growth
* Parents or guardians cannot be expected to comply with protocol
* Parents or guardians have not command on Catalan or Spanish language
PICO Above Incisions After Vascular Surgery

The wound infection rate in the groin after vascular surgery has been denoted to be high since the wound surveillance register started in 2005. The current wound infection rate based on a validation study was 22.9% (24/105 patients with groin incision(s) between 1 March to 30 June in 2012). This randomized controlled trial aims to evaluate if negative pressure wound therapy on closed inguinal incisions (INPWT) after vascular surgical procedures can reduce the risk for surgical site infections and other wound complications.

As published in the study´s rational and design paper (DOI: 10.4236/ss.2015.612080), we conducted a reanalysis of the material that the original power calculation was based on and included elective cases only which led to a slightly different number of cases needed. Furthermore, it became clear that there were big differences in the infection rates of EVAR (endovascular aortic repair) and open vascular procedures and therefore the need to split the study into two arms, an EVAR arm and an OPEN arm.

To prove a significant effect of the treatment intervention in the EVAR arm with a wound infection rate reduction from previously 4.4% to 1%, 80% power, 5% significance level and Including a margin for loss to follow-up, the EVAR arm requires 497 inguinal incisions. Assuming a surgical site infection rate reduction from 30% to 10% in the OPEN arm of the study, 80% power and 5% significance level, a total of 147 inguinal incisions is required.

We conducted an unannounced interim analysis for a conference presentation that was conducted by the study's principal investigators Stefan Acosta and Julien Hasselmann. Staff in charge of the day-to-day activities of the trial were not involved or actively informed of this. We believe that using an objective wound assessment tool (ASEPSIS score) minimizes any potential bias associated with the interim analysis.

Since the vascular center Malmö has started using closure-devices for almost all EVAR cases and thereby creating virtually no wounds to assess, we have started a multi center extension of the EVAR arm to Örebro University Hospital to be able to include the outstanding cases.

FUNDING

The trial has been funded by public Swedish funds stemming from the Southmost region in Sweden (Region Skåne), the Skåne University Hospital and the Hulda Almroth foundation since 2015 and adds up to a total of 2.81 million SEK (about 311,000 USD). In addition the research group received an unrestricted unconditional research grant of 15,550 USD and a donation of 100 PICO dressing kits from Smith and Nephew in 2013.

ALF (Agreement on medical education and research) funding has been granted for the time period 2019 - 2022 but has not yet been defined monetarily.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and above
* Elective vascular surgery
* Inguinal incision (transverse or longitudinal)
* Capable of understanding the study information and giving written informed consent

Exclusion Criteria:

* Emergency surgery
* Ongoing infection in inguinal area
Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes

The purpose of this study is to address whether inactive individuals with prediabetes who take part in the Small Steps for Big Changes program, which is a 3-week supervised exercise and lifestyle change program with brief counseling, will be more adherent to regular exercise one year after program completion compared to before they took part in the program.

The study is a one-group repeated measures design and the primary outcome is exercise adherence at 12 months post the 3-week supervised exercise program. There is no randomization of individuals to conditions. Exercise adherence will be measured using self-report physical activity (using the Godin leisure time exercise questionnaire) and a subsample will also wear tri-axial accelerometers to measure total time spent in moderate-to-vigorous physical activity assessed over 7 days. Secondary outcomes include physical fitness, haemoglobin A1C, quality of life, self-regulatory efficacy, anthropometrics, diet and exercise-related cognitive errors.

The 3-week lifestyle program includes six sessions with a lifestyle coach and exercise sessions performed at home. These sessions will focus on regular healthy lifestyle that includes walking (or exercise of any kind) at least three times per week and will highlight simple dietary strategies that are linked to reduced risk of T2D. The 3-week supervised exercise program includes brief exercise counseling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercise and a healthy diet. At the conclusion of the three-week program, participants will be asked to continue exercising a minimum of three times per week for twelve months on their own.

Eligibility Criteria:
Inclusion Criteria:

* ability to speak and read English
* BMI between 25-40 kg/m2 (as measured by body mass and height self-reporting),
* blood pressure of \<160/99 mm Hg assessed according to CHEP guidelines,
* not diagnosed with type 2 diabetes
* no prior history of cardiovascular disease
* not on hormone replacement therapy
* Cardiovascular medications (e.g., statins) will be allowed if the participant is on stable therapy (6 months on same dose).

Exclusion Criteria, if subjects:

* take glucose-lowering medications that have changed within the past 6 months;
* report any explicit contraindications to exercise (e.g., musculoskeletal injury, chest pain during exercise)
* report having had a heart attack or stroke in the past;
* report that they are pregnant or plan on becoming pregnant over the next 12 months;
* have uncontrolled major depression;
* have bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity which a physician has not cleared them for to exercise;
* report that a physician has not cleared their participant for exercise.
Loop-tipped Guidewire in Selective Biliary Cannulation

1. Background

   * Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel.
   * The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels.
2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
3. Design

   - Prospective randomized trial.
4. Setting:

   - Tertiary-care medical center
5. Patients

   - This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
7. Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.


Eligibility Criteria:
Inclusion Criteria:

* age \> 19 and ability to consent
* no evidence of significant cardiopulmonary or medical comorbidities precluding participation

Exclusion Criteria:

* Known gastroduodenal anatomic abnormalities
* Coagulation disorders (international normalized ratio \> 1.5 or platelet count \< 50000 cells/cubic millimeter)
* Prior gastric surgery,endoscopic retrograde cholangiopancreatography
* Pregnancy
Treatment of Androgenetic Alopecia in Males and Females

The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy system configured in a novel product called the TopHat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of androgenetic alopecia
* Fitzpatrick Skin Phototypes I-IV
* Norwood-Hamilton IIa to V for males and Ludwig I or II for females
* Active hair loss within the last 12 months
* Willingness to refrain from using all other hair growth products or treatments
* In overall general good health as determined by the physician investigator

Exclusion Criteria:

* Photosensitivity to laser light and non-laser LED light operating at 655nms.
* Malignancy in the target treatment area
* Other forms of alopecia of the head
* Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously effects the scalp
* Unwillingness to remove hair replacement products during the therapy sessions
* Using any medications deemed to inhibit hair growth as determined by the physician investigator
Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is evaluating kidney damage in patients receiving cisplatin and ifosfamide for solid tumors.

OBJECTIVES:

Primary

* Identify and evaluate the early biomarkers of renal toxicity in patients with solid tumors treated with cisplatin and ifosfamide.

Secondary

* Correlate the modification of biomarker studies and blood concentrations of cisplatin.

OUTLINE: Patients receive standard chemotherapy comprising cisplatin and/or ifosfamide.

Blood and urine samples are collected on days 1 and 2 (or day 3 if receiving ifosfamide only) during the first 3 courses. Samples are analyzed to determine plasma concentrations of residual cisplatin and to obtain urinary-protein profiles to measure renal toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a solid tumor

  * Any location allowed
  * Metastatic disease allowed
* Planned treatment comprising cisplatin and/or ifosfamide as standard chemotherapy

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Life expectancy \> 3 months
* Creatinine clearance ≥ 60 mL/min
* Must be available for follow up
* Not pregnant or nursing
* Not under guardianship or in prison

Exclusion criteria:

* Prior drug-related nephrotoxicity
* Acute, uncontrolled urinary infection or \> 48-hours
* Pre-existing hemorrhagic cystitis
* Weak bladder
* Bilateral obstruction of urinary tract
* Insufficient, severe bone marrow hypoplasia
* Cardiorespiratory condition contraindicating hyperhydration
* Hearing impairment
* Hypersensitivity to cisplatin or products containing platinum
* Major psychiatric condition (severe depression, psychosis, dementia)

PRIOR CONCURRENT THERAPY:

* No prior yellow fever vaccine, live attenuated vaccine, or phenytoin
* No concurrent participation in another biomedical study
Wound Assessment Using Spectral Imaging US

During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments.

Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Subject has an ulcer, or slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes.
* The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study.
* The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy).
* Subject understands and is willing to participate in the clinical study and can comply with required visits.

Exclusion Criteria:

* Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
* Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
* Eligible DFU has associated untreated acute osteomyelitis or active infection
* Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), or cytotoxic chemotherapy.
* Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.