cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery

The objective of this research proposal is to find out whether comparing the two different anaesthetic maintenance techniques (Propofol vs volatile anaesthetics) in adult patients undergoing heart surgery is practical for the anaesthetist treating the patients and whether it is feasible for the research team to recruit patients and follow them up after the operation.

All patients undergoing heart bypass surgery are given anaesthetics during the operation. There are two types of anaesthetic commonly given to patients undergoing heart bypass surgery.

Propofol is an anaesthetic that is delivered into the patient's vein. Other anaesthetics which are inhaled include Isoflurane, Sevoflurane and Desflurane and these are called volatile anaesthetics. Preliminary studies over the past ten years suggests that maintenance of general anaesthesia using only volatile anaesthetics has the potential to improve health outcomes after bypass surgery, when compared with propofol.

Volatile anaesthetics have been shown to protect the heart, the kidneys and the brain, however results of studies have been inconclusive. Currently both volatile anaesthetics and propofol are used equally in clinical practice in the UK.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male and female) aged 18 years and above
* Written informed consent to participate
* Patients undergoing Coronary Artery Bypass Graft (CABG) surgery on Cardiopulmonary bypass (CPB) with or without valve surgery
* Additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 5 or higher

Exclusion Criteria:

* Pregnant or lactating women
* Allergy to propofol
* Previous diagnosis or suspected malignant hyperthermia
* Patients with a known sensitivity to any of the IMPs or other halogenated anaesthetics
* Concomitant therapy with glibenclamide or nicorandil (medications that may interfere with preconditioning)
* Inclusion in another clinical trial of an investigational medicinal product within the last 3 months.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in South Korea

This is a National, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment from hospital in Korea in order to assess the level of adherence of subjects receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter, longitudinal, observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

To assess the level of adherence of subjects receiving SAIZEN via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN via easypod™
* To identify adherence subject profiling
* To assess the impact of adherence on Insulin-like growth factor 1 (IGF-1) (i.e. above, below or within normal ranges)
* Temporal profile of IGF-1 and IGFBP-3 levels

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristics (SmPC)
* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the Summary of Product Characteristics (SmPC)
* Use of an investigational drug or participation in an interventional clinical study
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia

This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.

Study AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants originally randomized to receive placebo in the double-blind feeder study AZES and switched to LY3314814 at the start of study AZFD did not "catch up" on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants originally randomized to receive LY3314814 in the double-blind feeder study.

Eligibility Criteria:
Inclusion Criteria:

* Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.

Exclusion Criteria:

* Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO

The purpose of this study is to describe the regional and global tumor hypoxia in head-and-neck cancer during percutaneous radiation therapy


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed head-and-neck cancer not curable by surgery
* Karnofsky \> 70%
* tumor volume and localisation allow curative radiotherapy
* written consent

Exclusion Criteria:

* metastases
* earlier radiation therapy of head and neck
* pregnancy
* secondary malignancy excluding dermal carcinoma and Tis-carcinoma of cervix uteri
* psychiatric impairment
Early Intensive Physical Therapy in Subarachnoid Hemorrhage

This study will investigate the safety and feasibility of early intensive physical therapy for patients diagnosed with subarachnoid hemorrhage. Intervention will begin in the neurological Intensive Care Unit (ICU) and continue for 30 days or hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed by CT scan or MRI with subarachnoid hemorrhage and admitted to the neurological ICU \>48 hours.

Exclusion Criteria:

* Significant language barrier that would limit the ability to participate in the physical therapy program
* Severe baseline physical or cognitive impairment that would impair their ability to participate in the protocol
* Patients whose vital signs are outside the accepted starting and stopping criteria outlined below:

  1. intracranial pressure ≤ 15 mm Hg
  2. Cerebral perfusion pressure \>50 or \<70 mm Hg
  3. Mean arterial pressure ≥ 80 and ≤ 110
  4. Heart rate ≥40 and \<140 bpm
  5. Pulse oximetry \>88%
TRIAD Project: Qualitative Study of Adolescent Depression and Smoking

It has been shown in the adult literature that smoking is related to depression and visa versa. Not much is known about how this relationship is started or if one perhaps leads to the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet criteria for major depression and who smoke. They are interviewed along with their parent. Questions center around their view of depression and their history of depression as well as questions around their smoking as well as the interrelationships between the two. Transcripts are made of the interview and are being analyzed for themes.


Eligibility Criteria:
Inclusion Criteria:

* 12-19 years old
* Major depression
* Smoke cigarettes
* Lives with parents
* No confidentiality issues related to smoking

Exclusion Criteria:

* Non English speaking
* Suicidal ideation
* Pregnant
The Effect of Two Different Tourniquet Techniques on Peripheral IV Access Success Rates

The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.


Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients
* 18 years old or older
* who receive peripheral IV access

Exclusion Criteria:

* Patients under the age of 18
* prison inmates
* pregnant patients
* patients who are unable to give informed consent
* critically ill patients who need emergent IV access as defined by the Emergency Medicine consultant of record for the patient
Acute Sodium Bicarbonate Supplementation in Athletes

The purpose of this study is to verify the effect of acute sodium bicarbonate (SB) and placebo (PLA) supplementation on buffering potential kinetics, physical capacity, discipline-specific performance as well as concentration of diagnostically significant blood biochemical indices in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Effective muscle work is conditioned by maintaining the proper range of muscles pH, regulated by buffering systems, in which the main role is played by bicarbonates (HCO3-). For this reason, sodium bicarbonate (SB) is often proposed as an ergogenic agent, especially during high-intensity efforts. Until now the major limitation to SB supplementation has been the gastrointestinal (GI) side effects. There is also a lack of data of the individual SB-induced changes of buffering potential kinetics and its actual connection with physical capacity and discipline-specific performance. Therefore, this study aims to examine the effect of acute, different-dose SB ingestion on buffering potential kinetics, physical capacity, discipline-specific performance as well as changes of diagnostically significant blood biochemical indices concentration in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate,
* a current medical clearance to practice sports,
* training experience: at least 2 years,
* minimum of 4 workout sessions (in the discipline covered by the study) a week.

Exclusion Criteria:

* current injury,
* any health-related contraindication,
* declared general feeling of being unwell,
* unwilling to follow the study protocol.
Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery

The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. During different phases, all patients received a Passive Leg Raising (PLR) maneuver for preload status evaluation using the PICCO system, a Lung Recruitment Maneuver (LRM) and an echographic evaluation of the right cardiac function. 20 patients were analyzed. Incomplete Lung Recruitment Maneuver (LRM) can predict fluid responsiveness at phase 1, pre-operatively, with a sensitivity of 0.57 and specificity of 0.62. Performance of an incomplete Magnetic Resonance Angiography (MRA) to predict right cardiac dysfunction based on TAPSE post-operatively provides a sensitivity and specificity of respectively 0.33 and 0.17 Tolerance to a stepwise lung recruitment maneuver can not be used to evaluate reliably the preload responsiveness and guide fluid therapy except pre-operatively. The use of a lung recruitment maneuver can be a promising method for right cardiac dysfunction screening but further studies need to be done with different echographic tools for right cardiac dysfunction evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving an elective or urgent cardiac surgery with or without extracorporeal circulation under general anesthesia, under protective mechanical ventilation, monitored by invasive arterial blood pressure and pulse contour analysis (PICCO system) for cardiac output measurement and central venous pressure

Exclusion Criteria:

* Left ventricular ejection fraction ≤ 30%
* heart arrhythmia, pulmonary hypertension (SPAP \> 35 mmHg)
* right heart failure (TAPSE \< 16 mm, S' at lateral tricuspid valve \< 10 cm/sec)
* lower limbs obstructive arteriopathy (stage IIb, III and IV)
* severe and very severe chronic obstructive pulmonary disease (COPD)
* pneumothorax and extreme weights (BMI \< 35 kg/m2).
Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)

This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.

Studies comparing two-stage implant-based breast reconstruction with immediate one-stage implant-based breast reconstruction have inconsistent results and investigators find that there is a lack of high quality evidence focusing on comparing one-stage and two-stage implant-based breast reconstruction with TiLoop®Bra.

This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra in breast cancer patients.

The hypothesis is that one step method is not inferior to two step method in implant based breast reconstruction following skin-sparing and/or Nipple-sparing mastectomy using TiLoop® Bra.

The current study is a randomized multicenter, open labeled, prospective, controlled study.

Participants were enrolled at six hospitals in different places of China. All participants will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.

Based on earlier experience, investigators calculated that the surgical complication rate was approximately 30 percent in the one-stage group and 25 percent in the two-stage group. Consider a dropout rate of 5%, a total of 450 patients, with 225 in each group, are needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological proven invasive breast cancer or ductal carcinoma in situ;
* Clinical T1-T2 disease with no distant metastasis;
* Patient with clinical N0 status;
* Intent to receive NSM or SSM and implant based breast reconstruction;
* Signed consent to participate.

Exclusion Criteria:

* Patient with severe breast ptosis;
* Patient received ipsilateral breast reduction or enlargement;
* Locally advanced stage patients who received neoadjuvant chemotherapy or hormone therapy;
* Patients enrolled in other clinical trial which may as influence the outcome;
* Patients received neo-adjuvant therapy and will receive radiotherapy.
* History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
* Patients of pregnancy or lactation.
Mechanisms Underlying Abnormal Ambulatory BP Patterns

To understand the mechanism(s) underlying sodium-dependent blood pressure control, and to determine the consequences thereof.

BACKGROUND:

The blood pressure of a significant percentage of the hypertensive population, and the normotensive population at a high risk for the development of hypertension (Blacks and older individuals), is sodium (salt)-dependent. That is to say, increasing the intake of salt will increase blood pressure in these individuals; conversely, and more importantly, decreasing the intake of salt will reduce blood pressure.

DESIGN NARRATIVE:

The investigators believed that the mechanisms responsible for sodium-dependent blood pressure were only indirectly linked to race, sex, and age. Their research was consistent with the hypothesis that sodium-dependent blood pressure control resulted from decreased responsiveness of the renal and adrenal blood pressure regulatory systems. This produced abnormal daily blood pressure patterns, with reduced fluctuation resulting in extended periods of increased blood pressure. The increased cardiovascular load led to the early development of cardiovascular and renal disease, including hypertension. They tested this hypothesis by identifying 'high risk' and 'normal risk' subjects based on renal responses to sodium restriction. The subjects were equal numbers of healthy males and females, Blacks and whites, between the ages of 55-70 years. Using an innovative approach, they then examined the influence of risk status on 24-hour patterns of blood pressure, hormonal activity, and sodium handling. Finally, they determined the clinical significance of the profiles by examining changes in cardiac and renal status at a two-year follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.
* Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).
* Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
* Cohort D Only: Diagnosis of type 2 diabetes
* Cohort D Only: Use of GLP-1R agonist for at least 90 days
* Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3

Exclusion Criteria:

* Main Study Only: Weight loss \> 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.
* Type 1 diabetes or uncontrolled Type 2 diabetes
* Cohort D Only: Weight loss \> 5% in the 90 days prior to screening
* Cohort D Only: Presence of cirrhosis on liver biopsy

Other inclusion and exclusion criteria may apply
Effect of Instrument-assisted Soft Tissue Mobilization Versus Myofascial Release in Treatment of Mechanical Neck Pain

Mechanical neck pain has become a major health problem recently, affecting around one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years causing pain and functional deficits. No study has been conducted before to investigate the effect of Instrument assisted soft tissue mobilization (IASTM) with mechanical neck pain on university students involved in distance learning.

Mechanical neck pain is a major social and economic burden. It showed a one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years. Treatment of neck pain is costly in terms of utilization of health care services, disability, compensation payments and lost work productivity. With the increasing prevalence of pain and disability associated with musculoskeletal impairments, it is essential to identify the most efficacious interventions to maximize patient outcomes and decrease the societal burden.

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age will be between 18-25 years old.
2. Subjects with mechanical neck pain localized to cervical and periscapular region.
3. Subjects with at least one trigger point in the upper trapezius and/or levator scapulae muscles
4. Subjects should report mechanical neck pain of at least 30 mm on a visual analogue scale (VAS). The scale is ranged from 0 mm (no pain) to 100 mm (worst imaginable pain).
5. Subjects who use computers daily for at least two hours and are involved in distance learning for at least three months.

Exclusion Criteria:

1. Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases.
2. Sensory problems at mid or upper back
3. A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication
4. History of head and upper trunk trauma or surgery.
5. Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency.
Hepatitis C Screening Alerts

The objective of this study is to evaluate whether alerts that identify patients without hepatitis C infection to healthcare providers and clinic staff can increase the uptake of screening for hepatitis C. A period of time without alerts will be compared to a period of time with alerts.

An estimated 2.4 million people in the United States were living with hepatitis C virus (HCV) infection during the period of 2013-2016. There were 4,798 new cases of acute HCV infection reported to the Centers for Disease Control (CDC) in 2020, but under ascertainment and underreporting of cases suggests that this number is less than 10% of all new HCV infections; as such, there were an estimated 66,700 new cases in 2020.

One-time screening is recommended by both the CDC and the United States Preventive Services Task Force for asymptomatic adults (aged ≥18 years and 18-79 years, respectively). The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America additionally recommends annual testing for people who inject drugs and for HIV-infected men who have sex with men. Unfortunately, HCV screening rates remain low. The objective of this before and after study is to evaluate if an HCV screening algorithm, disseminated as risk score alerts in the CHORUS™ Disease Management and Clinical Considerations Report to healthcare providers and clinic staff, increases the uptake of HCV screening among patients who are HCV screening-eligible (i.e., not known to have current or prior HCV infection).

Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* In care at an AIDS Healthcare Foundation Healthcare Center
* HCV screening eligible

Individuals who are HCV screening eligible include:

* HCV unknown: Never received an HCV antibody, RNA, or genotype test
* Previously HCV negative, high-risk for HCV infection: HIV-infected men who have sex with men or people who inject drugs with ≥ 1 prior negative HCV antibody or RNA test(s) who have not been screened in the prior 12 months

Exclusion Criteria:

* \<18 years of age
* Diagnosed HCV infection (i.e., reactive HCV antibody, detectable HCV RNA test, or HCV genotype test)

Individuals with diagnosed HCV infection include:

* Acute HCV infection, untreated or in treatment
* Chronic HCV infection, untreated or in treatment
* Spontaneous clearance of prior HCV infection
* Sustained virologic response after direct acting antiviral therapy for prior HCV infection
* Treatment failure after direct acting antiviral therapy for prior HCV infection