cyrilzakka/clinical-trials huggingface dataset:
EUS-guided PSE in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension

This study aims to evaluate the efficiency of EUS-guided combination therapy (EUS-guided PSE + EUS-guided treatment of varices) to EUS-guided treatment of varices alone in cirrhotic patients with portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.

Partial splenic embolization (PSE) was developed in the purpose of managing two common complications of portal hypertension including variceal bleeding and hypersplenism. The procedure is normally performed by clinicians engaged in interventional radiology via a transcatheter embolization method as the successful embolization of the selected splenic arteries results in devascularization of a focal lesion followed by splenic infarction and subsequently reducing the splenic contribution to the portal blood flow. Our previous case study suggests implanting coil in a branch of splenic artery under the endoscopic ultrasound (EUS) -guidance followed by the glue injection was an alternative PSE procedure to control hypersplenism. Recent advance has also heightened the therapeutic aspect of EUS in managing varices. We have established the novel approach to manage varices and hypersplenism at the same time by combining EUS-guided PSE and EUS-guided treatment of varices. This study aims to evaluate the efficiency of EUS-guided combination therapy (EUS-guided PSE + EUS-guided treatment of varices) to EUS-guided treatment of varices alone in cirrhotic patients with portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.

Eligibility Criteria:
Inclusion Criteria:

* At the risk of gastroesophageal variceal hemorrhage; Acute gastroesophageal variceal hemorrhage; Hematemesis and/or melena resulted from gastroesophageal variceal hemorrhage of liver cirrhosis in the past.
* Hypersplenism is indicated by either abdominal ultrasound or CT image showing splenic enlargement or splenomegaly and CBC test showing deficiency of one or more blood cell lines.
* Consent form must be signed by patients or their guardians before entering the test.

Exclusion Criteria:

* History of liver surgery or spleen surgery and liver cancer
* Coagulopathy (INR \> 1.5) or having been taken oral anticoagulation agents such as aspirin, warfarin, etc. in the past week.
* Existence of gastrointestinal endoscopic therapy contraindication; Hemorrhagic shock has not be corrected; Hepatic encephalopathy; Moderate to severe ascites, Poor liver function (Child - Pugh class C).
* Severe cardiorespiratory dysfunction, including sinus bradycardia, bronchial asthma, chronic obstructive pulmonary disease, heart failure, and atrioventricular block
* Pregnant women and nursing mothers.
* Absence of informed consent
The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis

Background: In the present study, we aimed to evaluate the effect of regular Schroth exercises on pulmonary functions in adolescent idiopathic scoliosis (AIS) patients who use rigid braces and perform Schroth exercises regularly.

Objective: The main purpose of this study, is to investigate the effects of Schroth exercises on pulmonary functions in adolescents who use rigid braces and perform Schroth exercises regularly.

Methods: Twenty-four patients with AIS were included in the study. The patients who wore rigid braces and performed the SSE therapy constituted the "Brace\&Exercise" (N=12), and the patients who wore full-time rigid braces but did not perform exercise constituted the "Brace Group" (N=12) of the study. The effects of Schroth exercises on pulmonary functions were measured at the beginning of treatment and the 8th week of the treatment.

Keywords: Adolescent, idiopathic scoliosis, conservative treatment, brace, respiratory function, Schroth exercises.


Eligibility Criteria:
Inclusion Criteria:

* 10-16 years,
* 25-45 Cobb degree,
* Brace and exercise treatment prescribed by the physician
* Participation in the study was approved by the family/caregiver

Exclusion Criteria:

* Chronic respiratory diseases,
* Professional athletes,
* Did not perform the exercises regularly
* Did not compliance the brace
Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.

ASTER is a multi-part study that aims to prospectively establish evidence for the implementation of aromatherapy as complementary therapy within cancer care in the Singapore context. ASTER 2 study evaluates how extracts from Asian aromatic plants with familiar aromas introduced as inhalation therapy can alleviate distress in breast cancer patients scheduled to undergo radiotherapy (RT).

On the day of CT Simulation, a research coordinator from the team will obtain consent from the eligible patients. Patient related outcomes will be collected from the consented patients. Study team will meet the patient 2 weeks later, on the day of their first radiotherapy session. Patient will be given an hour before the radiotherapy session begin. During this time distress score will be assessed, blood pressure and pulse rate will be measured, and saliva sample be collected. Patients will then be provided with the Inhaler stick containing 2 drops of either carrier oil (placebo), or Asian plant extract blend (intervention), which will be prepared prior to the study recruitment.

Patient will be instructed to hold the inhaler stick at about 8 cm (a hand fist's distance) away from their nose, to take up to 3 sniffs. This will be repeated with every 5 minutes of interval for 20 minutes of duration. After completion of the inhalation procedure, anxiety \& distress score will be assessed, blood pressure and pulse rate will be measured, and saliva sample be collected.

A total of 300 breast cancer patients scheduled to undergo radiotherapy for the first time will be recruited in a randomized double-blind, 2-arm study: 150 patients in a Placebo-Control-Group, 150 patients in the Aromatherapy-Intervention-Group.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 21 years old and above
2. Confirmed diagnosis of breast cancer of any stage
3. Scheduled to undergo radiotherapy for the first time
4. Capable of providing informed consent

Exclusion Criteria:

1. Physically or mentally incapable of providing verbal/written consent
2. Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations
3. Airway hypersensitivity to fragrances, paint fumes or turpentine
4. Taking medications for anxiety (e.g. benzodiazepines) before radiotherapy
5. Pregnant, breastfeeding, or intending to conceive during study period
Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral temporomandibular pain for more than one month.
* Older than eighteen.
* No previous treatment to temporomandibular pain in the last 3 months.
* Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Exclusion Criteria:

* Patients with cervical or cranial trauma or whiplash.
* Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
* Diagnosed of any vascular or metabolic disease.
* Previous cervical or temporomandibular surgery.
* Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.
Argipressin's Influence on Blood Loss During Hepatic Resection

Infusion of Argipressin during hepatic resection surgery may reduce blood loss. It may also reduce transfusion requirements, and mitigate the perioperative inflammatory response compared to placebo. Subjects will be randomized to infusion of Argipressin or placebo during surgery. Blood loss, transfusion requirements, surgical data including length of stay in hsopital, inflammatory markers and markers of renal- intestinal- and cardiac injury will be assessed. Two sub-studies has been added; one for evaluation of coagulation function, and one for assessment of pain scores and morphine consumption.

Hepatic resection is a major surgical intervention with high risk of substantial blood loss. The surgical means to reduce blood loss may impair perfusion and induce intestinal congestion. If blood flow to the liver can be influenced by pharmacological means, blood loss and transfusion requirements may be reduced. Moreover, the inflammatory system is involved in cancer development, and the anti-inflammatory properties of Argipressin may decrease the inflammatory response after hepatic surgery.

Argipressin is an endogenous substance, and part of the body's response to stress and trauma. Argipressin affects V1-receptors to produce vasoconstriction. It is also involved in inflammatory reactions and affects platelets.

Patients will be stratified according to planned type of surgery (open/laparoscopic) and planned extent of resection, and randomized to etiher infusion of Argipressin or placebo (normal saline) during surgery. In all other aspects, the participants will be treated according to the institution protocol for hepatic resection. The study drug will be started as soon as the central line is placed, and discontinued at the end of surgery. Hemodynamic data will be collected during surgery, and blood and urine-samples will be obtained during and after surgery for analysis of inflammatory markers and markers of organ injury.

Eligibility Criteria:
Inclusion Criteria:

1. Participant planned for hepatic resection (open or laparoscopic, regardless of indication for surgery).
2. Age ≥18 years.
3. ASA class I-III.
4. Signed informed consent form

Exclusion Criteria:

1. Participant does not understand the given information, and/ or cannot give written informed consent.
2. Simultaneous operation of tumor with other localization, or surgery for superficial single hepatic tumor less than 2 cm, expected to be of short duration and with minimal blood loss.
3. Terminal kidney failure (estimated preoperative GFR\< 15 ml/min)
4. Pregnancy or lactation.
5. Known allergy to Empressin®.
6. Patient included in other interventional study, interacting with the endpoints in the present study, or previous randomization in this study.
7. Hyponatremia (S-Na \< 130 mmol/L)
8. Patient considered ineligible for other surgical or medical reason.
9. Present infection. Patients with systemic inflammatory disease, inflammatory bowel disease or preoperative corticosteroid treatment will not be eligible for the subgroups where cytokines and interleukins are investigated.
Four-week Breathing Interventions on Gut Symptoms, Heart Rate Variability, and Psychological Measures in Runners

Recent research has suggested that stress and anxiety levels are associated with gastrointestinal (GI) symptoms in endurance athletes (runners, cyclists, triathletes). Yet, there has been limited attempt to evaluate whether GI symptoms during running can be mitigated by interventions designed to reduce stress and anxiety. Thus, this study will evaluate the effects of four-week slow deep breathing and mindful breath counting interventions on subjective and objective measures of stress/anxiety and GI symptoms in runners with mild-to-high anxiety and that are prone to GI symptoms during runs.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Run at least 15 miles per week
* Access to internet
* Access to a smart phone that is compatible with iOS or Android applications
* Score at least a 5 on the GAD-7
* Report to have experienced GI symptoms "sometimes", "often" or "always" during runs in the previous month.
* If on a psychotropic medication, must be on a stable dose for the past 3 months.
* Live within the contiguous United States

Exclusion Criteria:

* Younger than 18 years
* Run less than 15 miles per week
* Do not have access to the internet
* Do not have access to a smart phone that is compatible with iOS or Android applications
* Score less than 5 on the GAD-7
* Report to have "never" or "rarely" experienced GI symptoms during runs in the previous month
* Are being prescribed a psychotropic medication and have not had a stable dose for at least three months.
* Do not live within the contiguous United States
Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance

The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.

The secondary objectives of this study are to compare the following between the two techniques:

* the success rate of the establishment of a central venous catheter
* the success rate of establishment of a central venous catheter at the first attempt at venipuncture
* for non-failures (eg, a catheter is placed in the first four trys), time to cannulation
* the presence / absence of the following complications:
* arterial puncture (yes / no)
* pneumothorax (yes / no)
* hemothorax (yes / no)
* hematoma (yes / no)
* nerve injury (yes / no)
* aberrant course (yes / no)

The reasons catheter placement failures will also be described.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 24 hours of follow-up
* Patient requiring the establishment of a central venous catheter

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Patient has a body mass index \< 15 or \> 40
* Congenital or acquired anatomical deformity (radiation therapy, trauma, surgery) of the axillary and/or subclavian regions
* Bleeding disorder (platelets \< 50,000, prothrombine \< 50%, activated cephaline time \> 2 times the control value)
* Severe hypoxemia defined by a ratio PaO2 / FIO2 \< 100
* Infection of the puncture area
* Known thrombosis of the subclavian or axillary veins
* Scheduled length of hospitalization less than 24 hours
* Agitated or non-cooperative patient
* The patient has already been included in this study
* subclavian and axillary veins are not simultaneously echogenic on one or both sides (left and right).
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).


Eligibility Criteria:
Inclusion Criteria:

* Male patients
* Age from 0 years
* With the diagnosis of severe congenital haemophilia A (FVIII≤1%)
* History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients:
* Patients of 12 years or above: 100 exposures days (ED) or more
* Patients below 12 years: 50 exposure days (ED) or more

Exclusion Criteria:

* Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory
* Known history of FVIII inhibitors
Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department

Laceration repair can cause significant anxiety in children. As open wounds account for 21-25% of injuries in children presenting to the emergency department, the management of anxiety is of great importance. Anxiety can often lead to poor patient cooperation and the use of potentially excessive physical restraint. High rates of procedural anxiety have also been correlated with increased rates of negative behaviours after discharge.

The current standard of care for suture closure of lacerations throughout most of Canada is to provide local analgesia only. The literature has therefore focused on finding anxiolytic adjuncts to local analgesia.

Midazolam is an ideal adjunct due to its fast onset and short duration of action with an excellent safety profile. The advantages of the IN route are less pain on administration when compared to the IV and IM routes, and increased acceptability compared to the rectal route in older children. Oral midazolam also has poor palatability.

While the onset of INM at 5-10 minutes, and duration of 20-40 minutes make it an ideal candidate for anxiolysis in the ED its use has been limited by the common side effect of nasal irritation, burning and lacrimation when it is administered in its droplet form. The recent development of mucosal atomization devices (MAD) has resolved this issue by delivering 30-μ particles to the nasal mucosa.

Previous studies investigating the use of INM for laceration repair in the pediatric ED have demonstrated that INM is safe but most used non-validated measurement tools to assess anxiety and facilitation. Only one of these studies used atomized INM, retrospectively examining safety as the primary outcome. The authors reported an excellent safety profile for INM using the mucosal atomization device MAD-300 (Wolfe Tory Medical Inc.). The use of atomized INM for anxiolysis during pediatric laceration repair has not been evaluated prospectively.

Most studies have focused on preschool aged children (\<6 years). While studies have demonstrated that the prevalence of procedural anxiety is higher in younger children, up to 51% of children age 7-12 years experience high levels of procedural distress. The effectiveness of INM in the pre-adolescent age group is, therefore, yet to be determined.

It is hypothesized that INM will reduce anxiety in children age 2-12 years undergoing laceration repair and will facilitate the successful completion of suturing by the physician.


Eligibility Criteria:
Inclusion Criteria:

* children 2-12 years requiring laceration repair using suturing and use of injected lidocaine

Exclusion Criteria:

* Administration in ER of analgesia or sedation other than acetaminophen or ibuprofen prior to enrolment
* ASA of III or greater
* Multi-system trauma
* Severe neurologic impairment or non-verbal autism, known allergy/hypersensitivity to lidocaine or midazolam
* Parent/guardian does not speak one of French or English
* No parent/guardian present during procedure
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion

Exclusion Criteria:

* previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
* Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
* neovascularization on the disc or elsewhere or rubeosis
Daily Adaptive Radiation Therapy: An Individualized Approach for Stage III Lung Cancer

This is a prospective multi-center randomized clinical trial designed to demonstrate that daily online adaptive radiotherapy with concomitant chemotherapy for stage III non-small cell lung cancer (NSCLC) will result in decreased acute respiratory and esophageal toxicity compared with non-adaptive radiotherapy with concomitant chemotherapy. The timepoint for this assessment will be 3 months following the end of radiotherapy and will use the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Histologically confirmed NSCLC
3. Clinical stage IIIA-IIIB (AJCC v8) disease who are either:

   1. Patients classified as non-operable by the treatment team
   2. Patients who refuse surgery
4. Clinical stage IIIC due to contralateral mediastinal lymph node involvement only (e.g., no contralateral hilar or any supraclavicular/cervical lymph node metastases). Mediastinal stations 2R and 4R are considered contralateral for patients whose primary tumor is within the left lung. Mediastinal stations 2L, 4L, 5, and 6 are considered contralateral for patients whose primary tumor is in the right lung.
5. Completed evaluation for metastatic disease with no distant metastases identified. Evaluation must include the following:

   1. History and physical examination within 30 days prior to enrollment.
   2. Whole body FDG PET-CT for staging within 60 days prior to enrollment
   3. Brain MRI or contrast enhanced CT within 60 days prior to enrollment.
6. ECOG performance status 0-2 and deemed clinically fit for chemoradiotherapy.
7. Age ≥18 years (or at least the local age of consent)
8. Patients must have normal organ and marrow function.
9. Serum creatinine ≤1.5 mg/dL within 60 days prior to enrollment.
10. Measurable disease must be present.
11. Negative urine or serum pregnancy test within 14 days prior to enrollment for women of childbearing potential.

Exclusion Criteria:

1. Contralateral hilar or any supraclavicular/cervical lymph nodes.
2. Baseline grade ≥3 dyspnea, or cough, or dysphagia.
3. Prior invasive non-skin malignancy unless disease free for a minimum of 3 years.
4. History of prior RT to the thorax.
5. Severe imaging artifact that, in the view of the local investigator, would preclude accurate identification of the thoracic anatomy and tumor targets on the cone beam CT (e.g., artifact created implanted cardiac device in proximity to the targets).
6. Evidence of malignant pleural effusion, defined as either FDG PET avidity within effusion fluid or presence of malignant cells identified by cytology of thoracentesis fluid.
7. Severe active chronic obstructive pulmonary disease or respiratory illness other than NSCLC precluding study therapy.
8. Hospitalization for chronic obstructive pulmonary disease or respiratory illness other than NSCLC within 1 year prior to study enrollment.
9. Women of childbearing potential and sexually active women not willing or able to use contraception.
Segmentectomy vs Lobectomy

Actual indications for stage Ia NSCLC patients suggest lobectomy and lymphadenectomy. On the other hand, recent studies reported non-inferiority of segmentectomy in case of nodule \< 2cm or with ground glass appearance at computed tomography.

However, most of these studies did not report specifical analysis on kind of segmentectomy (single or multiple) and kind of lobectomy. Moreover, a specific study on solid nodules only is still missing.

For these reasons, the effectiveness of segmentectomy instead lobectomy for every kind of segment or tumor is still to be defined.

Aim of this study is to analyze survival outcome in patients underwent single or multiple segmentectomy compared to lobectomy in stage I non small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma or squamous cell carcinoma
* cStage cIA with or without nodal upstaging
* lymphoadenectomy
* age \> 18 years old
* Radical resection
* anatomical resection (lobectomy or segmentectomy)
* PET CT done

Exclusion Criteria:

* Nodal or distant metastasis confirmed before surgery
* Pure solid GGO
* Follow up \< 12 months
* Bilobectomy/pneumonectomy
* Trans fissure tumor
* Multiple lung tumors