cyrilzakka/clinical-trials huggingface dataset:
Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

It is known that perioperative hypothermia can influence the postoperative outcome negatively.

The most important complications are cardiac, increased blood loss with need for transfusion and a significantly increased wound infection rate.

The thermal redistribution after the induction of anesthesia is on of the reasons for perioperative hypothermia. Another reason is negative heat balance during surgery.

Further negative side effects of hypothermia are an increase of blood viscosity and thus a higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding.

The aim of the study is to evaluate if patients with a perioperative active thermal management during an interventional minimal invasive valve replacement have a significantly higher body temperature at the end of the operation than patients without an active thermal management. Secondary outcome variables are complication rates, length of mechanical ventilation and length of ICU treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients, who need an interventional minimal invasive valve replacement
* Age ≥ 18 years
* scheduled general anesthesia during intervention
* no participation on another interventional study
* signed informed consent

Exclusion Criteria:

* pregnant or breast feeding women
* non-elective intervention
* conversion to HLM
* implantation of IABP
* pre-existing decubitus
* patients who are not able to sign informed consent
EuroPainClinics® Study IV (Prospective Observational Study)

In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive therapy should be examined in (approximately 150) adult patients with low back pain positive for facet joint pain component.

Facet joint pain encompasses a significant portion of possible sources of pain in patients with vertebrogenic algic syndrome. A typical symptom is intermittent radiation of pain in the back and legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root, which innervates a facet joint. Confirmation of the source of pain involves using a local anaesthetic to block the medial branches of several vertebral areas. If, through this test, the facet joints are determined to be the source of pain the patient's condition is indicated for radiofrequency ablation of the nerve branches.

EuroPainClinics® Study IV (EPCS IV) is a prospective observational comparative study that will use pain scales to analyse changes in the neurological status of nerves of patients who undergo the minimally invasive procedure: radiofrequency nerve ablation and cryoablation of the lumber facet joints.

The study aims to investigate documented clinical results of the neurological conditions of patients, to compare pain scales and the use of analgesics over a number of time periods: prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure. The data will be subsequently statistically analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo Endoscopic rhizotomy therapy

Exclusion Criteria:

* No
Gastric Pathophysiology in Diabetes

This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated.

For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.


Eligibility Criteria:
Inclusion Criteria (diabetic group):

* Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years

Exclusion Criteria (diabetic group):

* Diabetes mellitus type II being treated with a diet only
* Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization
* Concomitant treatment with more than one prokinetic agent
* Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
* Previous esophageal or major gastric surgery (e.g. esophageal myotomy, esophagectomy, antireflux surgery, Billroth I or II gastric resection, gastric pull-through, pyloromyotomy, pyloroplasty, gastric electrical stimulation)
* Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
* Severe coagulopathy
* Esophageal or gastric varices and /or portal gastropathy
* Advanced liver cirrhosis
* Pregnancy or puerperium
* Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment
* The presence of a rumination syndrome or eating disorders (anorexia nervosa, bulimia). In case of doubts, a psychiatric examination will be performed.
* Systemic connective tissue disorder
* Inability to obtain informed consent
* Any other condition, which in the opinion of the investigator would interfere with study requirements
Cognitive Appraisals and Team Performance Under Stress in Simulated Trauma Care

Medical teams work in demanding situations that are often uncertain, changeable and require accurate decision-making, skilled movement and coordinated action. How teams perform matters for patient outcomes. In addition to medical expertise, how individuals and the team collectively respond and manage the psychological stress of the situation has a significant impact on performance. One approach, which attempts to explain the facilitating and debilitating effects of stress on performance is the biopsychosocial model of challenge and threat. A challenge state occurs when perceived personal resources meet or exceed the situation's demands, whereas threat occurs when demands exceed resources. Challenge states have been consistently associated with improved performance in a range of environments and activities, including medical settings. In a recent study conducted during a national simulation-based training event for residents (the SIMCUP Italia 2018) it was found that a high level of resources is associated with better performance until demands become very high. The present study builds on previous work to explore how challenge and threat states are linked to performance. It includes a more recently developed and robust measure of demands and resource appraisals. In addition, secondary aims include the exploration of how psychological variables, specifically cognitive anxiety, somatic anxiety, self-confidence and social identity (connection with other members of the medical team) are linked to challenge and threat and performance. Understanding the psychological determinants of performance in critical care can provide the basis for individual and team-based interventions to improve critical care team performance.


Eligibility Criteria:
Inclusion Criteria:

* Learners of the European Trauma Course in Italy

Exclusion Criteria:

* Age \< 18 years
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects

A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects


Eligibility Criteria:
General Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male (Part A and B) and female subjects (Part B) aged between 18 and 55 years (inclusive) at Screening.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
* Male subjects with a partner who might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use a highly effective method of contraception.

Inclusion Criteria for Part B:

* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a highly effective method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner.
* Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.

General Exclusion Criteria:

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.

Exclusion Criteria for the ADME evaluation (Part A) only:

* Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed workers, as defined in the relevant Ionising Radiation Regulations, must not participate in the study.
* Participation in any study involving administration of any 14C radiolabeled compound within the 12 months prior to Screening.

Exclusion Criteria for Part B:

- Pregnant or lactating women.
The Effect of Theraworx Foam in Carpal Tunnel Syndrome

Participation will be for approximately 21 days (3 study visits,1 week apart with allowance for scheduling conflicts). A topical (or placebo) foam alone or with a splint will be used. Demographic and symptom information will be obtained. At each visit 3 questionnaires (BCT, CTS-6, and DASH) will be completed and an ultrasound of the wrist (median nerve) will be done to document any change in symptoms and/or in the size of the nerve. Random assignment will be to one of 4 groups: foam or placebo with or without a night splint. We will provide instruction on how to apply the foam, whether or not and how to wear the splint, and return visits.

The PI will identify potential participants from his clinical practice. Evaluation of symptoms will be by exam, questionnaires, and ultrasound of the median nerve. These will document baseline/change in the size of the median nerve and improvement in function/symptoms. The questionnaires are 1.) Boston Carpal Tunnel (BCT). 2.) Carpal Tunnel-6 (CTS-6); and 3.) Disabilities of the Arm, Shoulder and Hand (DASH). These will be used to document a baseline and change (if any) in nerve size and hand symptoms, over a 2 week time frame, that are common in carpal tunnel syndrome (including numbness, pain, tingling, and/or decreased function).

1. The Boston Carpal Tunnel is a 19 question tool that assesses function (8 items) and symptom severity (11 items). Score range is from 0 to 95 with a high number indicating more severe/worsening symptoms and lower number less severe/improving symptoms.
2. The CTS-6 is a six item tool that combines reported symptoms with a physical exam of the hand. Scores range from 0 to 26 with a higher score reflecting increased severity.
3. The DASH is a 30 item tool with each scored 1 to 5. Scores can range from 0 to 150 and the higher the score the worse the symptoms/disability.

Treatment groups are as follows:1.) Theraworx foam alone; 2.) Theraworx foam with night time splint; 3.) Placebo foam alone; 4.) Placebo foam with night time splint. The active ingredient in Theraworx foam is magnesium sulfate and will not be in the placebo foam. Instructions on how to apply the foam, whether or not and how to wear the splint, and return visits will be provided. If in a group that requires night time splinting, the subject must wear the splint only at night and for a minimum of 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Carpal Tunnel Syndrome
* Age 18 years or older
* Interest in non-surgical treatment of carpal tunnel syndrome

Exclusion Criteria:

* Prior carpal tunnel release
* Non-English speaking
* Skin lesions/rashes on hand being treated
* Current use of topical anti-inflammatory medication
* Other diagnoses that would impact results (determined by PI)
Reliable Hypertension Diagnosis Based on 24 ABPM

24 h blood pressure monitoring can help to define which is the optimal timing and frequency of measurements

Hypertension is a common condition in modern society. As blood pressure fluctuates with time, a single blood pressure measurement is useless to diagnose hypertension. Nevertheless, a questionable not well-defined number of measurements still is often used for this purpose. Diagnosis and therapeutic control of hypertension are therefore suboptimal. This study's objective is to determine the number and timing of measurements needed to give a trustworthy approximation of an individual's average blood pressure. Therefore, 24 h ambulatory blood pressure measurements were retrospectively analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 70 per cent of valid measurements

Exclusion Criteria:

* none
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).
* Available tumor tissue for central review of HER2 status.
* Planned surgical resection of breast tumor.
* Planned neoadjuvant chemotherapy.
* Documentation of HER2 gene amplification or overexpression.
* Ipsilateral, measurable tumor longest diameter \> 2 cm.
* Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).
* ECOG performance status of 0 or 1.
* Adequate bone marrow, hepatic and renal functions.
* Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.
* Effective contraception as defined by protocol.

Key Exclusion Criteria:

* Investigational therapy within 2 months of first dose of study drug.
* Bilateral breast cancer.
* Inflammatory breast cancer
* Metastases.
* Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.
* Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.
* Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.
* Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.
* Pre-existing clinically significant Grade 2 peripheral neuropathy.
* Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).
* Severe dyspnea at rest requiring oxygen therapy.
* Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C.
* Current pregnancy or breastfeeding.
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.
PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)

The aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus corticosteroid) administered via Dry Powder Inhaler (DPI) compared to new users of pressurized Metered Dose Inhaler (pMDI).

Data from clinical practice from different European data sources will be collected. The baseline hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.

Non-interventional, multi-country cohort study to assess the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (COPD), exposed to inhaled fixed triple therapy BDP/FF/GB via DPI (drug of interest) or pMDI (comparator).

The study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different European data sources in the following countries: United Kingdom, Germany, The Netherlands, Denmark, Sweden, Norway and Finland.

Patients in the two exposure groups of this Post Authorisation Safety Study (PASS) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. The pre-defined hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COPD
* 40 years or older
* Availability of baseline information for a minimum of 12 months before the index date
* New users of fixed triple therapy BDP/FF/GB via DPI or pMDI

Exclusion Criteria:

* Single or multi-inhaler triple therapy in the previous 90 days before the index date
* Hospitalization due to cardiovascular causes in the previous 30 days before the index date.
The Comparation of Lateral Sagittal Infraclavicular and Costoclavicular Block

In this study, the investigators aimed to compare the block dynamics and characteristics of the two approaches while providing effective analgesia and safe anesthesia of the Ultrasound-guided Lateral sagittal Infraclavicular and costoclavicular approach in Brachial plexus blocks.

Participants between the ages of 18-70 with the American Society of Anesthesiology (ASA) score I-II-III will be included in the study. All participants will be evaluated preoperatively and information will be given about the anesthetic method to be applied. Demographic data and ASA scores of the participants will be recorded.

All of the participants included in the study will be taken to the regional anesthesia application room in the operating room approximately 1 hour before the operation. After standard anesthesia monitoring (electrocardiography, pulsoximetry, non-invasive blood pressure), all participants will be given an iv vascular access with a 20 or 22 G cannula from the arm that will not be operated.

All blocks will be made using portable US machine and echogenic block needle.

For all blocks, 20 ml of a mixture of 0.25% bupivacaine, 1% lidocaine will be used.

An overall (average) sensory and motor score was also calculated for every participants and at each time point assessed by averaging the VRS sensory or motor scores of all the 4 nerves will be tested preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 to 3
* 18-70 age
* hand , wrist , forearm and elbow surgery

Exclusion Criteria:

* refusal to participate,
* pregnancy,
* body mass index of 30 kg/m2 or greater
* history of allergy to local anesthetic drugs
* prior surgery over the infraclavicular fossa,
* preexisting neurological deficit
* coagulopathy
* infection over infraclavicular fossa.
Accuracy and Reliability of GSA for Remnant Liver Function

Preoperative evaluation of future remnant liver function is critical for patients undergoing hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening postoperative hepatic failure, and its underestimation can lead to a lost opportunity for potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has been estimated preoperatively using computed tomography (CT) volumetry. CT can provide precise anatomical information, and the remnant liver volume, measured by CT volumetry, has been reported to be an effective predictor of hepatic dysfunction after hepatectomy. However, the indirect estimation of liver function by CT volumetry is reliable only when the function is assumed to be homogenous over the whole liver.

99mTc-galactosyl human serum albumin (99mTc-GSA) single-photon emission CT (SPECT) was developed to facilitate investigations of regional hepatic function. A disadvantage of conventional 99mTc-GSA SPECT was poor anatomical resolution, and this newly developed SPECT has a tremendously improved anatomical resolution owing to the fusion of CT and 99mTc-GSA SPECT. Recent reports have indicated that accurate regional function, based on precise anatomical information, could be evaluated using this technique.

Eligibility Criteria:
Inclusion Criteria:

* All eligible patients were those surgically treated for hepato-biliary diseases.

Exclusion Criteria:

* Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth

The purpose of this study is to assess the efficacy of a novel telehealth-based intervention to reduce tobacco use among LGBTQ+ people.

After being informed about potential risks and screened into the study, patients will be randomized into the treatment or control group. Control group participants will complete 7 sessions based on quit.gov smoking cessation planning. Intervention participants will complete 7 sessions of individualized asynchronous telehealth sessions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Live in Greater Austin
* Identify as LGBTQ+
* Current smokers
* High speed internet access

Exclusion Criteria:

* Exceed screener cutoff for suicide risk
* Exceed screener cutoff for borderline personality disorder
* Report current active substance use other than tobacco that interferes with functioning
Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training

The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant. The investigators hypothesize that active participants will improve their CRM skills more than observer participants.

This will be a prospective randomized controlled study. Participants will be randomized to one of two groups with stratification according to their level of training: the active group and the observer group. Each participant of the active group will be paired with one of the participants from the observer group. The active participant will manage individually a simulated crisis scenario (pretest) while the paired observer participant will observe the scenario from outside the simulation room using a video transmission system. Immediately after, both participants will be debriefed by a trained instructor focused on CRM principles. The same active and observer participants will then individually manage another simulated crisis scenario (post-test). Two independent raters, blinded to the study design and to the randomization groups, will review the videos of all scenarios in a random order and rate each participant on their CRM performance using a global rating scale (GRS).

Eligibility Criteria:
Inclusion Criteria:

* emergency medicine residents from the University of Ottawa