cyrilzakka/clinical-trials huggingface dataset:
A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants

This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.

This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).

Eligibility Criteria:
Inclusion Criteria:

* Satisfactory medical assessment.
* Participants must have had vaccination against pneumococcus (Pneumovax 23 \[PPSV23\]) at least 28 days, and maximally 4 years prior to Day 1.
* Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
* Body weight within 50 to 90 kg, inclusive, and body mass index (BMI) within the range of 18 to 24.9 kg/m\^2, inclusive.
* Must be willing to follow protocol-specified contraception guidance during the study and for up to 3 months after last dose of study drug.

Exclusion Criteria:

* Current/recurrent diseases or relevant medical history.
* Known exposure to therapeutic proteins, such as monoclonal antibodies, including marketed drugs prior to dosing.
* Participants who have prior exposure to ALXN1830.
* Exposure to more than 4 new (small molecule) investigational compounds within 12 months prior to dosing.
* Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
* Presence of hepatitis B surface antigen (HBsAg) at Screening.
* Positive hepatitis C antibody test result at Screening.
* Positive human immunodeficiency virus (HIV) antibody test at Screening.
* Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies
Follow-Up After Surgical Treatment of Peri-implantitis

The objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (SPIT) programme was followed.

The patients enrolled in this prospective study all received surgical treatment for peri-implantitis at one of 2 treatment centres (specialist periodontal practice, Molndal and Gothenburg, Public Dental Health Services, Region Vastra Gotaland, Sweden) and were enrolled between October 2010 and December 2013.). All were treated by experienced periodontists.

Details of the peri-implantitis treatment protocol have been described in a previous publication reporting on the 12-month clinical and radiographic treatment outcomes, registered at ClinicalTrials.gov (NCT01857804) and approved by the Regional Ethical Committee, Gothenburg, Sweden (Dnr. 654-10).

Eligibility Criteria:
Inclusion Criteria:

* all patients who received surgical treatment for peri-implantitis for 3 years ago

Exclusion Criteria:

-
Development of a Multimodal Index to Improve the Predictive Value of Success in Weaning From Mechanical Ventilation

Weaning from mechanical ventilation (MV) is a complex process in which patients are liberated from the ventilator. Prolongued weaning and weaning failure, defined as the need for reintubation, have different adverse effects, including prolongation of MV, intensive care unit (ICU) and hospital stay, and are also associated with increased incidence of ventilator-associated pneumonia and high mortality. The rate of weaning failure is high, even when the classic extubation criteria are met, so it is necessary to improve scores that allow predicting and determining the ideal time for MV withdrawal.

The aim of this study is to design a new multimodal index to predict and optimize weaning results in a personalized way, based on the use and interpretation of data derived from continuous monitoring of critically ill patients. The new multimodal index, in addition to classical respiratory parameters, will include parameters related to patient-ventilator interaction (asynchronies), diaphragmatic function, cardiovascular status and autonomic nervous system function (ANS).

The investigators have designed a prospective observational study that will include 126 critical patients from a medical-surgical ICU that meet the classical criteria for weaning. The management of the patients, as well as the weaning process, will be carried out following the usual protocol. In addition to the classical weaning predictor data, data on the patient-ventilator interaction and the function of the autonomic nervous system will be collected by means of specific software (BetterCare). Cardiovascular and diaphragmatic function will be evaluated using ultrasound. Based on the advanced analysis of data from different devices collected throughout the mechanical ventilation period, it will be designed a "personalized" weaning score that should improve the accuracy of the decision-making process and therefore reduce morbidity and mortality. Additional benefits would include lowering health care costs without increasing adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with MV\> 24 hours.
* Patients with orotracheal tube.
* Patients who meet the classic criteria of weaning from the MV defined as:

Improvement or resolution of the cause required for MV. PaO2\> 60mmHg with FiO2≤0.4 and PEEP ≤8cm H2O. Glasgow Coma Score\> 10 Temperature \<38 ° C. Hemoglobin\> 8g / dL No need for vasoactive drugs or at doses \<5μg / kg / min Obtaining informed consent.

Exclusion Criteria:

* Tracheostomy patients.
* Patients with neurological pathology with involvement of the brainstem.
A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants

The main purpose of this study is to determine the effect of selpercatinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with selpercatinib in healthy participants. This study will last up to approximately 26 days excluding screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participant must be Caucasian
* Body mass index (BMI) within the range of 19.0 to 32.0 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have known allergies to selpercatinib-related compounds or any components of the formulation of selpercatinib, or or rosuvastatin
* • Have a significant previous or current history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product
* Have used or are intending to use over-the-counter or prescription medication, including dietary supplements and herbal medications, within 14 days prior to dosing
From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests

Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation.

The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation.

DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.


Eligibility Criteria:
Group 1:

Inclusion Criteria:

* Unexplained abdominal pain 12 months after elective cholecystectomy

Exclusion Criteria:

* Immunosuppressive treatment (NSAID excepted)
* Anticoagulant treatment

Group 2:

Inclusion Criteria:

* No pain 12 months after elective cholecystectomy

Exclusion Criteria:

* Immunosuppressive treatment (NSAID excepted)
* Anticoagulant treatment

Group 3:

Inclusion Criteria:

* Elective operation in spinal anesthesia or
* Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected

Exclusion Criteria:

* Acute or chronic pain condition
* Immunosuppressive treatment (NSAID excepted)
* Previous abdominal operation
Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).

Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF.

A common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF.

The investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.

Eligibility Criteria:
Inclusion criteria:

* Age 18 to 80 (inclusive)
* Patients with symptomatic advanced persistent AF, defined as:
* AF which does not spontaneously terminate and requires medical intervention (antiarrhythmics or DCCV) to terminate, AND
* Recurs following cardioversion, AND
* Is associated with evidence of left atrial cardiopathy, defined as at least mild left atrial enlargement on imaging (echo, CT or MRI) as defined by standard values (for example British Society of Echocardiography or European equivalent) - in the event of uncertainty, Principal Investigator discretion is allowed.

Exclusion Criteria

* Any previous catheter (or surgical) ablation for AF (previous ablation for atrial flutter or focal atrial tachycardias are allowable)
* An indwelling atrial septal defect occluder device or anatomical structure that pre-vents free access to the left atrium
* Severe left ventricular systolic dysfunction (ejection fraction less than 35%)
* Recent stroke/transient ischaemic attack within 3 months
* Inability, unwillingness or absolute contraindication to taking an oral anticoagulant medication
* Severe kidney function impairment (eGFR less than 30ml/min/1.73m2)
* Morbid obesity with a body mass index ≥40
* Extreme frailty (a score of 7,8 or 9 on the Rockwood Clinical Frailty Scale)
* Severe valvular heart disease of any kind as assessed by the investigator, with or without a prosthetic valve in place
* Pregnancy
Physical Activity Measured Through Accelerometers and Its Association With Endothelial Function in Young Patients With Fontan Physiology

This study will be a cross sectional assessment of physical activity as measured through accelerometers and its association with endothelial function of children with Fontan circulation and healthy age and gender matched controls who are followed at the University of Alberta - Stollery Children's hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Children with Fontan physiology between the ages 24 months to 18 years at the Stollery Children's Hospital
2. Informed written consent obtained prior to enrolment
3. At least 6 months post Fontan procedure

Exclusion Criteria:

1. Patient hospitalized within the previous 2 weeks
2. Patient unable to ambulate independently
3. Underwent coarctation of the aorta repair using a subclavian flap.
Cardiorespiratory Responses to Treadmill Running at Different Slopes

The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. The investigators hypothesized that maximal oxygen uptake will be lower in downhill running. The investigators also anticipate attenuated cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or uphill running performed at similar velocity but not when the comparison is done at similar metabolic power.


Eligibility Criteria:
Inclusion Criteria:

* to be a well-trained runner with a VO2max \> à 55 ml/kg/min
* nonsmoker or stopped smoking for 5 years
* BMI \< 25
* affiliation to the social health insurance scheme
* signing an informed consent form.

Exclusion criteria:

* impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, ...);
* subject under the protection of justice
* subject under guardianship or curatorship
* contraindication to the practice of physical and sport activities
* lower limbs musculotendinous or articular problems
* respiratory, cardiovascular or metabolic pathology
* drug treatment in progress and impossibility to stop it within 7 days before the beginning of the study
Electrophysiology in Congenital Cataract After Lensectomy and Anterior

In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and b-wave and PhNR related parameters was evaluated.

Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E).

electroretinography and photopic negative response are performed to each patient.The research was to evaluate the relationship between the best corrected visionn and the related parameters of a- and b-wave and PhNR .

Eligibility Criteria:
Inclusion Criteria:

* phakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation

Exclusion Criteria:

* patients with mild cataracts do not require surgery
Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.

FAMES involves three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the Diagnostic and Statistical Manual of Mental Disorders 5TH Edition (DSM-5) Cultural Formulation Interview (CFI).

The overarching objective of this study is to assess the feasibility and acceptability of a brief provider-led FAmily Engagement Motivational Strategy (FAMES) and its accompanying implementation toolkit. The investigators will also preliminary examine whether FAMES improves family engagement and retention in treatment, and motivation.

A total of 50 participants with a loved one enrolled in CSC program for FEP will be recruited from five CSC programs in Washington State to take part in a non-randomized stepped-wedge pilot trial. Each CSC program will represent a cluster and serve as its own control. A two-month implementation transition period will occur at each CSC program and during which providers will be introduced to the intervention using the implementation toolkits and trained to conduct FAMES. A 12-month open cohort design will be utilized to recruit approximately 50 family members during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older;
2. One family member (e.g., parent, guardian, aunt, uncle, spouse, grandparent, sibling, close friend) of an individual enrolled in a Washington State CSC program; and
3. Received no more than 6 months of services

Exclusion Criteria:
Clinical Trial for Vespa Amino Acid Mixture (VAAM®)

ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then followed by the generation of lactic acid. However, this process can only be maintained for a short time, approximately one minute, because the accumulation of lactic acid in the muscles may affect muscle performance. The efficiency of lactic acid metabolism is one of the most important reasons for endurance improvement. The purpose of this study was to evaluate the impacts of the daily ingestion of a commercially available Vespa amino acid mixture (VAAM®) beverage on blood parameters that are related to fatigue, muscle damage and immunity in healthy, young athletes during middle-distance running exercises. VAAM® contains 17 types of amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive required speed and strength running tests.

The subjects were instructed to maintain their usual dietary habits in addition to drinking VAAM® (two cans every day) for 10 weeks. In detail, on the 6 days/week of supervised running tests, participants were instructed to consume one drink before their warm-up exercise and the other drink while running. During their sessions and without supervision (1 day/week), participants were also instructed to consume one drink in the morning after breakfast and the other drink in the evening after dinner.

The subjects were divided into three groups for the running tests: 3 males were assigned to group 1, which involved training for the 1500-meter race; 2 males were assigned to group 2, which involved training for the 800-meter race; and 1 male and 3 females were assigned to group 3, which involved training for the 400-meter race. The running exercises began with a 45 min warm-up (including jogging, leg stretching, etc.) followed by running their specific races. The experimental procedure was conducted 6 days/week for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Athletes from 16 to 18 years old;
* Subjects underwent a physical examination before enrollment and showed no sign of illness or malaise.

Exclusion Criteria:

* Subjects were smokers or ergogenic aid users;
* Subjects had any metabolic, cardiovascular, renal, or liver diseases;
* Subjects had psychiatric disorders.
Study of Economic Circumstances, Service Utilization, and Service Needs Among Older Colon Cancer Patients

The purpose of this study is to learn more about the social and financial impact of colon cancer for older patients. We want to know how cancer has affected the patient financially and socially, and to know if the patient has resource needs that have gone unmet. By doing this study, we hope to learn about resources that can reduce the financial burden from cancer.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Newly diagnosed stage II-III colon cancer
* Receiving chemotherapy and at least 4-6 months into chemotherapy treatment, or have received chemotherapy and no more than 7 months post-treatment
* Sufficient cognitive capacity as determined by investigator or consenting professional
* Able to speak English or Spanish
* Able to provide informed consent

Exclusion Criteria:

* N/A
Epirubicin and Thalidomide in Treating Patients With Liver Cancer

RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with thalidomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide in treating patients who have unresectable or metastatic liver cancer.

OBJECTIVES:

* Determine the antitumor activity of epirubicin and thalidomide in patients with locally unresectable or metastatic hepatocellular carcinoma.
* Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive epirubicin on days 1, 8, and 15 and thalidomide on days 1-21. Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 12 patients per year will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of hepatocellular carcinoma

  * Locally unresectable or metastatic disease
* Measurable disease
* No clinically apparent CNS metastases
* No carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* ECOG 0-2

Life expectancy

* At least 12 weeks

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 75,000/mm\^3

Hepatic

* SGOT no greater than 5 times upper limit of normal
* Bilirubin no greater than 3.0 mg/dL
* INR no greater than 1.5\*
* Albumin at least 2.0 g/dL NOTE: \*Not required for patients receiving full anticoagulation with warfarin for deep vein thrombosis or pulmonary embolism

Renal

* Creatinine no greater than 2.0 mg/dL

Cardiovascular

* No myocardial infarction within the past 6 months
* LVEF normal by echocardiogram or MUGA

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Willing and able to participate in the System for Thalidomide Education and Prescribing Safety (STEPS) program
* No uncontrolled serious medical or psychiatric illness
* No other concurrent uncontrolled malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No more than 1 prior chemotherapy regimen for hepatocellular carcinoma
* No prior chemoembolization to the liver

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* More than 2 weeks since prior major surgery