cyrilzakka/clinical-trials huggingface dataset:
The Effects of Dexmedetomidine to Postoperative Awakening and Extubation-related Changes in Blood Pressure

The postoperative removal of intubation tube induces a noticeable sympathic response and increase of blood pressure. The risk of complications is especially elevated with the patients having cardiac surgery. Though sedation inhibits the sympathetic responses to extubation, according to the current protocol the propofol infusion has to be discontinued well before extubation because of its inhibitory effects on breathing centers.

Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its characteristic that it does not have the paralyzing effect on breathing. The aim of our study is to work out whether dexmedetomidine-extended propofol sedation over the extubation diminishes the aforementioned harmful effects of the extubation procedure.

Study design is prospective double-blinded randomized study. The investigators compare two groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first group receives dexmedetomidine infusion and the other receives placebo infusion after the end of propofol infusion.

The specific goal of the study is to figure what haemodynamic - mostly blood pressure related - changes can be observed when the postoperatively cut propofol infusion is continued with dexmedetomidine over the extubation procedure.

Our hypothesis is that by using dexmedetomidine supplemented sedation the normally notifiable peak in blood pressure may be avoided.

The study will be carried out completely in Cardiac ICU in Tampere University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patient has to be scheduled for aortic valve surgery OR previous AND coronary artery bypass
* Patient has to be 60 to 90 years of age

Exclusion Criteria:

* If a patient is unable to give informed concent to participate the study
* If a patient is allergic or otherwise hypersensitive to the drug used in the study
* If the patient has either insufficient kidney or insufficient liver function
Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors

The primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent and signed by the patient
* Age ≥ 18 years
* Breast tumor for which the therapeutic indication for surgery has from the outset: breast surgery (conservative or radical) associated with a conventional axillary dissection
* Proof of infiltrating ductal carcinoma histology
* No known metastasis
* No cons-indication to anesthesia.

Exclusion criteria:

* History of neoadjuvant therapy
* Patients with invasive lobular carcinoma
* Indication of the use of sentinel node (if invasive carcinoma uni-centric, ≤ 2 cm in diameter, without palpable lymphadenopathy (N0))
* Diabetes is not controlled by conventional treatment (blood glucose\> 1.8 g / l)
* Inability to capital
* Patients who are pregnant or nursing or of childbearing potential and not using adequate contraception
* Persons deprived of their liberty
* Major subject of a measure of legal protection or unable to consent
* Refusal to participate
Addition of Pyridoxine to Prednisolone in Infantile Spasms

Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of hypsarrhythmia. When all 3 components are present, the eponym "West syndrome" is commonly used. West syndrome is a catastrophic epileptic encephalopathy. It does not respond well to standard anti-epileptic drugs. Hormonal therapy is the mainstay in the treatment of infantile spasms. This includes adreno-cortico trophic hormone (ACTH) and oral steroids. Variable dose of prednisolone used in the treatment. Oral prednisolone used in usual dose (2mg/kg) has been shown to be less effective as compared to ACTH. High dose prednisolone (4mg/kg) has been used in the treatment of infantile spasms, which has been shown to be as effective as ACTH. Pyridoxine has been used as first line treatment in Japan, however there is paucity of data on the efficacy of combination of pyridoxine with hormonal therapy. There are no studies comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the treatment of infantile spasms. Therefore the study has been planned to see whether the addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms improves the efficacy in terms of spasm cessation.


Eligibility Criteria:
Inclusion Criteria:

1. Age in 3months-3years.
2. Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants.

   -

Exclusion Criteria:

1. Children with active systemic illness
2. Children with evidence of active tuberculosis
3. Severe Acute Malnutrition (standard deviation scores below median weight for height)
4. Children with recurrent illness/chronic systemic illness
5. Prior treatment of pyridoxine, steroid, or ACTH.

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Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea

OBJECTIVES

To train and test a mathematical model to predict complete concentric collapse at the level of the palate (CCCp, primary) and other sites of upper airway collapse (secondary) during drug-induced sleep endoscopy (DISE) using the data captured during a diagnostic polysomnography (PSG).

HYPOTHESIS

The site, pattern and degree of upper airway collapse is associated with distinct flow features as captured during a baseline PSG.

STUDY DESIGN

Retrospective trial.

STUDY POPULATION

200 patients with moderate to severe obstructive sleep apnea (OSA, AHI ≥ 15/h) who underwent both a DISE and a diagnostic PSG at the Antwerp University Hospital (UZA) between January 2018 and December 2020.

OUTCOME MEASURES:

Raw data as captured during a diagnostic PSG, including electroencephalography (EEG), flow, electrocardiography (ECG), electromyography (EMG), oxygen desaturation and breathing effort.

SAMPLE SIZE / DATA ANALYSIS

Data of 200 patients will be retrospectively included into this study protocol. Different machine learning techniques will be adopted to select features, train the model and test the model.

TIME SCHEDULE

January 30, 2021 - November 30, 2021


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Diagnosis with symptomatic moderate to severe OSA (AHI ≥ 15/h).
* Underwent DISE at UZA as part of the clinical pathway for non-continuous positive airway pressure (CPAP) therapies
* Underwent a baseline diagnostic PSG at UZA max 2 years before DISE

Exclusion Criteria:

* Medication use related to sleeping disorders
* Central Sleep Apnea Syndrome.
* Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, periodic leg movements, narcolepsy).
* Seizure disorder.
* Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
* Pregnancy
* \<4 h of data recording during the baseline PSG night
16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer

Breast cancer (BC) is the most common cancer diagnosis among women and the incidence is increasing. Prognosis and treatment are dependent on the expression of estrogen receptors (ER) in the tumor. ER status is determined by immunohistochemistry (IHC) on biopsy tissue. The ER expression can change over time and be heterogeneous.

The IHC score on ER expression is subjective and can lead to intra and inter observer variability. A new computer image analysis software that can give the exact percentage of colored tumor cells on sectional tumor cuts has been developed.

It is also possible to quantify the ER expression non invasive by using the tracer 16α-18F-flour-17β-estradiol (FES) and in vivo positron emission tomography (PET) scans. FES-PET/CT has a high background activity in the liver which complicates the visualization of liver metastases. Theoretically, a new whole body parametric scan method makes it possible to distinguish background activity from uptake in liver metastases.

Malignant tumors often have an increased perfusion, and previous studies have found that tumors with low metabolism relative to blood flow have the longest disease free survival (DFS). To the best of our knowledge, no previous studies have examined the correlation between ER expression and blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known disseminated breast cancer
* Metastatic ER+ HER2- breast cancer with metastases in the liver, at least two separate liver foci visualised on CT
* Diagnostic CT scan done in connection with clinical control
* Treatment with aromatase inhibitors, and potential additional treatment
* Postmenopausal

Exclusion Criteria:

* Treatment with Tamoxifen or Fulvestrant completed within 5 weeks prior to FES-PET/CT
* ER- metastases
* Life expectancy under three months
* Claustrophobia
* Any pain which makes it impossible to lie in the scanner for 90 minutes
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
* Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
* HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits
* Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
* Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
* Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
* Agreement to use contraception
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.

Exclusion Criteria:

* Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Laboratory values outside of the protocol-defined ranges.
* Further exclusion criteria apply.
Effect of Transform Burn on Weight Loss

This study was undertaken to explore the effects of a Thermogenic Composition (TC) composed of dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel extract, coleus (Coleus forskholi) root extract, and african mango (Irvingia gabonensis) seed extract to support body composition, weight management, and improve parameters related to energy, hunger, and satiety on healthy adult women and men over a 12-week interval.


Eligibility Criteria:
Inclusion Criteria:

* Individuals could participate who were at least 18 years old and not smokers.
* Not currently taking a dietary supplement or prescription for weight loss.
* Exercising volunteers were asked to maintain their regimen consistently throughout the course of the 12-week study and caffeine drinking volunteers maintained their caffeine intake consistently throughout the course of the 12-week study.

Exclusion Criteria:

* Participants were not allowed to participate if they were pregnant or planning to become pregnant in the following 12 weeks, or lactating.
* Individuals were not allowed to participate if they were taking any stimulant medications.
Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor \[human\]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor \[human\]) in routine clinical practice and as a data source for post-marketing investigations.

The Icatibant Outcome Survey (IOS) is a multicenter, prospective, observational study for participants treated with Firazyr (icatibant) and/or Cinryze (C1 inhibitor \[human\]) in countries where it is currently approved. The entry of participants in the Icatibant Outcome Survey (IOS) is at the discretion of the physician and the participant and is not a pre-requisite for prescribing Firazyr (icatibant) or Cinryze (C1 inhibitor \[human\]).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of at least 1 of the following:

   * Hereditary angioedema (HAE) type I or II
   * HAE with normal C1 inhibitor
   * ACE-I-induced angioedema
   * Non-histaminergic idiopathic angioedema
   * Acquired angioedema.
2. Signed and dated written informed consent from the participant or, for participants aged less than(\<)18 years (or as per local regulation, such as \<16 years in the United Kingdom \[UK\]), parent and/or participants legally authorized representative (LAR), and assent of the minor where applicable.
3. At sites only participating in the drug registry, participants must have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]).
4. Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]) will only use the respective product in accordance with the product label.

Exclusion Criteria:

1. Participants enrolled in clinical trials where the product is blinded or where the product under investigation is for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema.
2. Participants enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema. An exception applies to participants enrolled in the Shire lanadelumab ENABLE study.
Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study

The site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. Transradial access (TRA) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (RAO) that limits the radial artery for future needs. Distal radial access (dTRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dTRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort. This study aims to reveal the feasibility and safety of dTRA and routine TRA procedures in acute coronary syndrome patients. The primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (MACEs) in the two groups. Investigators conduct this retrospected analysis to demonstrate the difference of the two procedure of Cannulation.


Eligibility Criteria:
Inclusion Criteria:

* presence of a pulse in the snuffbox

Exclusion Criteria:

* Absence of pulse
* Ultrasound indication of arterial occlusion or severe calcification
* Severe forearm artery malformation
* Patients with severe liver and renal failure, or abnormal coagulation function
* Established cardiogenic shock
* History of previous coronary artery bypass grafting and radial artery use.
* Raynaud's disease in the medical history
Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA

The present study aims to collect data regarding the history of the disease, previous and current treatments, and the clinical status of Dravet patients during the 3 months prior to stiripentol initiation, the first 3 months on stiripentol and the last 3 months on stiripentol (irrespective of stiripentol discontinuation).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Dravet syndrome
* Treated with stiripentol for a minimum of 3 months in routine practice

Exclusion Criteria:

* NA
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

The prospective clinical trial "PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes" aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response.

The prospective clinical trial "PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes" aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response. Patients with histologically confirmed PDA are enrolled at primary diagnosis and prior to oncological or surgical treatment. Rectal and buccal microbiome swabs as well as detailed clinical records are obtained from all patients. Following DNA extraction, both 16S rRNA and metagenomic sequencing will be performed using ONT sequencing platform. All data and clinical records are centrally stored, visualized and integrated via tranSMART and SEEK platforms.

Eligibility Criteria:
Inclusion Criteria:

- Patients with pancreatic mass suspicious of pancreatic ductal adenocarcinoma

Exclusion Criteria:

* \< 18 years
* patients that cannot give informed consent
* pregnant and breastfeeding women
Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?

The purpose of this study is to determine if tailored letters sent to diabetic patients will improve care of diabetes.

Diabetes care in the US is less than optimal. Some authors have found that targeted patient letters are also an effective tool to improve outcomes when they are part of a comprehensive disease management plan. Local patient satisfaction surveys had revealed that many patients had sub-optimal understanding of diabetes measures and of the importance of controlling these measures to reduce diabetic complications. We wondered if tailored patient letters and enclosed lab orders when due might increase patient awareness of diabetes measures and increase patient engagement.We hypothesized that the addition of targeted patient letters with enclosed lab orders to an ongoing performance improvement program would further improve diabetes care.

We conducted a randomized controlled study of tailored patient letters and diabetes lab orders at our two resident-based clinics.

Eligibility Criteria:
Inclusion Criteria:

* All active patients age 18 to 75 years with a diagnosis of diabetes mellitus were eligible.
* An active patient was defined as one having an ICD-9 code on the active problem list identifying the patient as diabetic, and a progress note in the EMR associated with an office visit within the prior 12 months.

Exclusion Criteria:

* None
Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients

Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed.

This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver, and renal function
* Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
* Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
* Measurable disease with obstruction into the airway
* Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
* Patients undergo recanalization procedure of tumor during bronchoscopy
* Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization

Exclusion Criteria:

* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
* Uncontrolled infection
* Presence or recent history of any systemic disorder or conditions, such as:

  * uncontrolled hypertension
  * type 1 diabetes
  * severe pulmonary hypertension
  * acute kidney injury
  * stroke (within the last 6 month)
  * myocardial infarction (within the last 3 months)
* Individuals with neurological, mental or psychiatric disorders
* Concurrent participation in another study involving investigational drugs or investigational medical devices
* Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
* Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media
* Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion Criteria
* Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation
* Any intraoperative complications that per the investigator's judgment increase the risk to the patient.