cyrilzakka/clinical-trials huggingface dataset:
Neuroanatomical and Functional Changes in Response to an Intensive Balance Training

The purpose of this study is to determine whether intensive slackline training improves spatial orientation abilities, balancing skills and causes neuroplasticity in related brain cortical regions.


Eligibility Criteria:
Inclusion Criteria:

* No previous slacklining or related experience, 18-30 years of age, good or corrected to good vision

Exclusion Criteria:

* Musculoskeletal and nervous system injuries/diseases that significantly reduce one's ability to perform slacklining training, systemic diseases (cardiovascular, gastrointestinal, metabolic...)
DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

This study aims to evaluate the efficacy and safety of traditional Chinese medicine DaZhu Rhodiola Rosea Capsule for treatment of coronary artery disease by observing angina symptoms, exercise capacity, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years old
* Coronary heart disease with grade Ⅱ or Ⅲ stable or unstable angina (≥ 2 times per week), or residual angina-like symptoms 1 month to 1 year post percutaneous coronary intervention (PCI) or 3 months to 1 year post coronary artery bypass surgery (CABG)
* Written informed consent

Exclusion Criteria:

* Acute myocardial infarction within 1 month before admission
* Patients who plan to undergo revascularization in the next 3 months
* Congestive heart failure, acute myocarditis or pericarditis, thrombophlebitis, pulmonary embolism, or severe neurosis within 3 months prior to admission
* Patients with uncontrolled high blood pressure (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg), severe cardiopulmonary insufficiency (cardiac function grade Ⅲ, Ⅳ or left ventricular ejection fraction (LVEF) \< 40%), severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, degree Ⅱ type Ⅱ and degree Ⅲ atrioventricular block, etc.)
* Severe liver, kidney and hematopoietic system dysfunction or psychosis (serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the normal upper limit, or serum creatinine \> 1.5 times the normal upper limit)
* History of bleeding or treatment with warfarin
* Implanted pacemakers
* Pregnant or lactating women
* Allergic to study drugs
* Legal disability (blindness, deafness, dumbness, intellectual disability, mental disability, physical disability)
* Patients who participated in other clinical trials within 3 months
VIrtual STudy in Achondroplasia for the US (VISTA)

This is an observational study of individuals with achondroplasia in the United States. The primary study population consists of pediatric individuals treated and untreated with VOXZOGO™. Study enrollment started in February 2023. The projected total duration of the study is approximately 5 years at minimum from start of study recruitment in February 2023, with the duration of individual prospective follow-up differing depending on the time of enrollment. The study duration may be extended based on decisions by the study sponsor.

Data will be collected in two formats for the primary pediatric study population:

1. Participant-mediated access to electronic health records(including medical imaging, when available) which will enable retrospective and prospective collection of secondary data reflecting real-life treatment use and clinical care. .
2. Primary data collection of Clinical Outcome Assessments (COAs) and questionnaire data.

Data will be collected in the following format for the adult cohort:

- Participant-mediated access to electronic health records (including medical imaging, when available) which will enable retrospective and prospective collection of secondary data reflecting real-life treatment use and clinical care.

The primary study population will include approximately 150 pediatric individuals with achondroplasia regardless of their treatment status with VOXZOGO™. Individuals may change status from untreated to treated during the prospective period of the study (or vice versa) however they will only be counted once, based on their treated status at the point of enrollment.

The secondary study population will include 20 adolescent and adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of achondroplasia
* Age at time of enrollment:

Primary Pediatric Cohort: ≤13 years old Secondary Adolescent and Adult Cohort: ≥14 years old

* Receiving medical care in the United States
* Complete PicnicHealth's onboarding process, including signing informed consent and authorization for medical record retrieval

Exclusion Criteria:

* Lack of any medical records
Comprehensive HIV and Harm Prevention Via Telehealth

The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* able to speak English or Spanish
* willing and able to sign informed consent, provide locator information and medical records release
* non-reactive result on rapid HIV test
* use of SSP to exchange syringes 2 times in the past 3 months
* planning to stay in the area for 12 months

Exclusion Criteria:

* reactive HIV test
* currently on medications for opioid use disorder (MOUD) by urine drug screen
* currently on PrEP by self-report
* Principal or site investigator discretion
* currently in prison or jail
* current enrollment in Clinical Trials Network 121
* receipt of tele-harm reduction in previous 3 months
* signs or symptoms of acute HIV infection
Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in male and female participants with performance anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent.
* Sufficiently fluent in English to participate in the trial.
* Male and female patients aged 18-70 years (inclusive).

Exclusion Criteria:

* Lifetime history of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders or obsessive-compulsive disorder.
* Current or planned pregnancy or nursing during the trial period.
* A positive test for substances of abuse.
Effect of scFOS on Increase in Stool Frequency in Constipated People

The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

This randomized, placebo-controlled, double-blind study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

Eligibility Criteria:
Inclusion Criteria:

* functional constipation according to ROME III criteria with 3 or less than 3 stools per week
* BMI between 18 and 32kg/m², limits included
* Subjects who do not usually eat high-fibre foods
* Subjects who do not usually consume foods siad "reduced in sugars" or "light"
* Subjects who do not consume regularly pre- and probiotics in the form of dietary supplements

Exclusion Criteria:

* subjects presenting Irritable bowel syndrome
* history of chronic GI disorders: crohn disease, ulcerative colitis,....
* treatments likely to influence GI sensitivity or motility (laxative, neuroleptics,...)
* Antibiotic therapy in progress or in the past 8 weeks
* medical history with impact on the study objectives as defined by investigator
* known food allergy to one of the compounds of the study product
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.


Eligibility Criteria:
Inclusion criteria:

* Written informed consent must be obtained before any assessment is performed.
* Males and females ages 40 to 80 years
* Smoking history of at least 10 pack-years
* Diagnosis of COPD according to GOLD guidelines (GOLD, 2010), with a post-bronchodilator FEV¬1 \< 80% predicted and FEV1/FVC ratio \< 0.70
* BMI \<20 kg/m2 or skeletal muscle mass index by DXA \< 7.25 kg/m2 for men or \<5.45 kg/m2 for women.
* In general stable health, including managed COPD, by past medical history, physical examination, vital signs at baseline as determined by the investigator.

Exclusion criteria:

* Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or breathless when dressing)
* Plans for lung transplantation or lung reduction surgery within four months of enrollment
* Patients participating in a formal pulmonary rehabilitation program within 3 months of dosing
* History of malignancy of any organ system (other than excised non-melanomatous carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, chronic kidney disease (estimated GFR \< 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus, etc.
* Inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency
* Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, metformin, etc.
* Hemoglobin concentration below 11.0 g/dL at screening.
* Liver disease or liver injury.
* Use of other investigational drugs at the time of enrollment, or within 30 days and for any other limitation of participation in an investigational trial based on local regulations.
* Women of child-bearing potential.

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia

The aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypothermia in obese and non obese women under target controlled infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* women
* 18-65 years old
* gynecologic
* obesity

Exclusion Criteria:

* fever
* endocrine disease
* hypertension
* vasoactive drugs
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP

This is a prospective interventional study to assess laboratory testing which will identify the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent selection for patients with community acquired-pneumonia (CAP).

Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to Empiric therapy in patients with viral pneumonia

The study will be conducted at five academic medical university sites with 7 hospitals. Empiric therapy is defined as selection of antibiotic therapy based on the 2007 ATS-IDSA guidelines in which broad-spectrum antibiotics are recommended, and microbial cause is uncertain

Eligibility Criteria:
Inclusion Criteria:

● Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU).

The definition of CAP is as follows:

* Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician - but has to be confirmed by board certified radiologist for inclusion in the study).
* At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever \> 380C, abnormal chest auscultation, WBC \> 12,000 cells/mL.
* Able to provide informed consent
* Read, signed, and dated informed consent document
* Available for follow-up for the planned duration of the study

Exclusion Criteria:

* Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone \> 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents.
* Patients residing in long-term care facilities
ACL Reconstruction with a New Generation of LARS Artificial Ligament

This clinical investigation is intended to demonstrate the safety of the new generation of LARS ligaments and compare this new generation (grafted ligament) of artificial ligament to the LARS current artificial ligament (non-grafted ligament) which is CE marked since 1997, in case of ACL injury. The new generation of LARS artificial ligament is expected to improve physiological response by enhancing fibroblast proliferation, fibroblast organization and collagen type I \& III secretion. This physiological response leads to a better osseo-integration of the ligaments. Therefore, the study is expected to demonstrate the investigational device safety and biomechanical improvements.

Forty subjects over 40 years old with acute ACL injury will be included. A follow-up program is planned over 1 year per subject (days 7, 15, 30, 60, 90, 180, 365) based on physical therapy, biological analysis and biomechanical measurements.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the grafted ligament
* Subject provides written informed consent approved by the Ethics Committee prior to any clinical investigation related procedure
* Subject must agree to undergo all clinical investigation plan - required clinical follow-up visits
* Subject must agree not to participate in any other clinical investigation for a period of 1 year following the procedure
* Male and female subjects over 40 years old
* MRI positive for full acute ACL injury
* Arthrometric evaluation (KT1000) with a side-to-side difference greater than 3 mm
* Symptomatic subjects with no previous knee injury
* Subjects without concomitant pathologies (fracture, infections, immunodepression, HIV, HCV) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
* I and II degree chondral lesions

Exclusion Criteria:

* Subjects under 40 years old
* III and IV degree chondral lesions
* Associated ligament injuries
* Meniscus suture (e.g. hndle bucket meniscal tears) that compromise the rehabilitation program
* History for sepsis
* Subjects with concomitant pathologies (fracture, infections, immunodepression, HIV, HCV,) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol
* Previous knee injuries
* Septic arthritis
* Infected tissues
* Pregnancy
* Overweighed, obese subject (\>100kg)
* History of metabolic bone disease
* Inflammatory joint disease
* Known neoplastic disease
* Medical treatment (e.g steroid)
* HIV positive subject
* Hepatitis positive subject
* Allergy to Titanium, PET, Ugurol, Gentamicin, Polystyrene Sulfonate, other medication
Handoffs and Transitions in Critical Care

The HATRICC study will use mixed methods to implement a standardized process for operating room to intensive care unit handoffs that is accepted and sustainably used by perioperative clinicians.

BACKGROUND: Operating room to intensive care unit handoffs are high-risk events for critically ill patients. Studies in selected patient populations show that standardizing operating room to intensive care unit handoffs improves information exchange and decreases errors. To adapt these findings to mixed surgical populations, the investigators propose to study the implementation of a standardized operating room to intensive care unit handoff process in two intensive care units currently without an existing standard process. METHODS/DESIGN: The Handoffs and Transitions in Critical Care (HATRICC) study is a hybrid effectiveness-implementation trial of operating room to intensive care unit handoffs. The investigators will use mixed methods to conduct a needs assessment of the current handoff process, adapt published handoff processes, and implement a new standardized handoff process in two academic intensive care units. Needs assessment - The investigators will use nonparticipant observation to observe the current handoff process. Focus groups, interviews, and surveys of clinicians will elicit participants' impressions about the current process. Adaptation and implementation - The investigators will adapt published standardized handoff processes using the needs assessment findings. The investigators will use small group simulation to test the new process' feasibility. After simulation, the investigators will incorporate the new handoff process into the clinical work of all providers in the study units. Evaluation - Using the same methods employed in the needs assessment phase, the investigators will evaluate use of the new handoff process. Data analysis - The primary effectiveness outcome is the number of information omissions per handoff episode as compared to the pre-intervention period. Additional intervention outcomes include patient intensive care unit length of stay and intensive care unit mortality. The primary implementation outcome is acceptability of the new process. Additional implementation outcomes include feasibility, fidelity and sustainability. DISCUSSION: The HATRICC study will examine the effectiveness and implementation of a standardized operating room to intensive care unit handoff process. Findings from this study have the potential to improve healthcare communication and outcomes for critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* All clinicians caring for patients being transferred from the operating room to intensive care unit.

Exclusion Criteria:

* None.
The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease

The purpose of this clinical research study is to determine if a specific genetic allele is involved with the development of agitation in patients with late-onset Alzheimer's Disease (AD). The study will compare the results of genetic testing between two groups: individuals with late-onset AD who show signs of agitation and individuals with late-onset AD who do not show signs of agitation.

Agitation and other behavioral disturbances are a main cause in the need for increasing levels of care for the patient with Alzheimer's disease (AD). And while the pathology of dementia has been studied in great detail, the etiology is considered multi-factorial. The hypothesis behind this clinical study is that the presence of the apo lipoprotein E4 (APO E4) allele will serve to predict which patients with late on-set AD are at greater risk to develop agitation.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are at least 65 years of age
* Meet the DSM-IV-TR criteria for late-onset Alzheimer's Disease (AD)

Exclusion Criteria:

* Unable to provide informed consent or do not have a legally acceptable caregiver and/or representative present or available to enter into the informed consent process on the study subject's behalf
* Diagnosis of a non-Alzheimer's type of dementia
* Determined by the Principal Investigator (or his designee) that the study subject would be unsuitable for study participation
Use of Probiotics to Prevent Influenza

The goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection.

The goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection. The investigators will determine whether it is feasible to enroll residents and randomize them to a daily course of probiotics or placebo and monitor for influenza and other respiratory tract infections. In addition, the investigators will asses the feasibility of obtaining a nasal specimen for evaluation of the upper respiratory microbiome, measure antimicrobials, and deterioration in functional status. All aspects of the proposed trial will be assessed, including enrollment, randomization, respiratory infection surveillance, methods for outcome assessment, and event rates. The investigators will test the use of our data collection forms and data management strategy and will generate date to derive an appropriate sample size.

Eligibility Criteria:
Inclusion Criteria:

* nursing home residents, 65 years of age or older, in the Hamilton ON area

Exclusion Criteria:

* residents who are immunosuppressed (steroids or other immunosuppressives), have a hematologic malignancy, structural heart disease, gastroesophageal or intestinal injury and those are at increased risk of an endovascular infection will be excluded
Laryngeal Mask Position in Magnetic Resonance Imaging in Children

The aim of the trial is to obtain and to describe the position of the laryngeal mask during elective magnetic resonance imaging in paediatric patient. The radiologic findings will be compared to the clinical performance of the laryngeal mask.

Properly inserted laryngeal mask (LMA) with good clinical performance can be misplaced (on radiological imaging) but with not know effect on clinical practice. The percentage of the misplaced LMAs are relatively high, but the exact number in paediatric population is currently not clear. The aim of this prospective observational cohort study is to describe the percentage of misplaced LMAs during elective magnetic resonance imaging (MRI) in paediatric patient. After approval of the local ethical committee all elective paediatric patients in study interval (10/2016-3/2017) indicated for elective MRI of the brain or elective MRI of the brain and cervical spine will be included to the trial. Demographic characteristics - age, weight, comorbidities, anesthesia management - education of anesthesiologist, type of LMA, number of insertion attempts, clinical performance of the LMA, presence/absence of leak, the peak inspiratory pressure (mechanical ventilation), volume of air in cuff, complications during anesthesia and LMA soil after extraction - blood, saliva, mucus, gastric content. The clinical performance will be compared to the LMA position on MRI - position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae, displacement of the epiglottis, distance between proximal LMA cuff and vocal cords, distance between distal LMA cuff and vocal cords.

Eligibility Criteria:
Inclusion Criteria:

* paediatric patient undergoing elective MRI scanning - brain and/or brain and cervical spine
* laryngeal mask inserted for airway management during anesthesia
* age between 29 days and 19 years

Exclusion Criteria:

* outside the age limit
* laryngeal mask contraindication - gastroesophageal reflux disease, ileus, full stomach, impairment of the haemodynamics