cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Respiratory Monitoring During SBT

Spontaneous breathing trials (SBTs) assess readiness for extubation, yet the use of conventional parameters used to establish weaning success may be elusive, especially in high-risk patients. Currently, non-invasive techniques allow comprehensive bedside assessment of advanced respiratory mechanics, including metrics of respiratory system compliance (CRS), respiratory muscle effort (POCC) and respiratory drive intensity (P0.1). This study investigates whether these measurements during SBT may improve the prediction of extubation outcomes


Eligibility Criteria:
To be eligible, patients had to meet all of the following criteria:

1. Age ≥ 18 years.
2. The presence of ≥ 1 among the following factors to define the high-risk for re-intubation: age older than 65 years; heart failure as the primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease (COPD); an Acute Physiology and Chronic Health Evaluation II (APACHE II) score higher than 12 on extubation day; body mass index of more than 30; inadequate cough reflex or suctioning \>2 times within 8 hours before extubation; prolonged use of invasive ventilation (≥ 7 days from the first SBT); more than 2 comorbidities categorized based on the Charlson Comorbidity Index.
3. Deemed ready to be weaned from the ventilator, based on the following criteria: (a) invasive mechanical ventilation for more than 48 hours, including at least 12 hours of pressure support ventilation with PEEP ≤ 8 cmH2O and pressure support ≤ 10 cmH2O; (b) Improvement of the condition leading to intubation; (c) patient making inspiratory effort; (d) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within normal range (7.30 - 7.50); (e) Glasgow Coma Score higher than 13; (f) a core temperature below 38°C; (g) Richmond agitation and sedation scale between -1 and +1.

Eligibility required readiness for scheduled extubation after successfully completing a 30-minute SBT in the pressure-support mode (7 cmH₂O)

SBT success was defined by the following criteria \[19\]: (a) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within the normal range (7.30 - 7.50); (b) respiratory rate \< 35/min; (c) spontaneous tidal volume higher than 5 ml of predicted body weight (PBW); (d) a ratio of respiratory rate to tidal volume (i.e. the rapid shallow breathing index, RSBI) \< 105/min per liter; (e) systolic blood pressure between 90 and 160 mmHg and heart rate \< 140/min, with or without low doses of vasopressors (\< 0.5 mcg/kg/min). Exclusion criteria were tracheostomy, patients undergoing withdrawal of life-sustaining treatments, known neuromuscular diseases.
HYPOXI for Women With Lipedema

The proposed study is for women with lipedema, a painful fat disorder where fat cannot be lost from the legs and hips with diet and exercise. The study will compare the use of the specialized exercise equipment called HYPOXI, which is like a bike but you lie down and air circulates around the participant's legs like a vacuum with pressure increasing and decreasing in cycles over time. The goal of the study is to see if using a HYPOXI bike compared to a regular recumbent (sit down) bike helps women with lipedema lose weight. The women with lipedema in the study will have the option to use a whole-body suit that works like a pump and was designed to improve blood circulation in the body. The body suit is called Dermology and can be used before the HYPOXI exercise equipment but will be optional for the women in the study. The study is 16 weeks long for 20 women with lipedema. Ten women with lipedema will exercise with HYPOXI for 8 weeks then switch to a recumbent bike for the second 8 weeks. The other 10 women will exercise on a recumbent bike for 8 weeks then switch to HYPOXI for 8 weeks in the second half of the study. Baseline, mid-study, and end of study data will be collected including measurements of body composition and shape, a blood draw at the beginning, middle and end, and questionnaires. This study will be listed on clinicaltrials.gov for more information.


Eligibility Criteria:
Inclusion Criteria

* Female
* 18-65 years of age
* Lipedema any stage
* Weight \< 300 lbs.
* Able to participate for 4 months
* Self-reported weight stable
* Able to use Hypoxi equipment \& recumbent bike
* Able to undergo baseline, mid- and end-study in Tucson.

Exclusion Criteria

* Hip width \> 30 inches (76.2 cm)
* Waist width \> 46 inches
* Pregnancy
* Use of weight loss medication within 3 months of the study
* History of myocardial infarction
* New York Heart Association Functional Class II or above congestive heart failure
* Sustained tachycardia above calculated maximum heart rate limit
Using Technology to Address Disparities and Promote Healthcare Equity in Type 1 Diabetes Registry

This study is being done to see if using technology, with the help of a Patient Navigator, can help address disparities, improve outcomes, and promote healthcare equity in type 1 diabetes.

Patients with T1D require an individualized care plan with ongoing education and support. A recent qualitative study of young adults with T1D and end-stage renal disease revealed that childhood environment, education, socio-economic status, and other determinants contributed to disengagement from treatment regimens and the development of microvascular complications early in life1. Providing participants with real-time CGMS will inform daily decision making.

This is an interventional study using prescribed real-time CGMS together with feedback and support from a Patient Navigator in patients with T1D. The aims of this study include the following.

Aim 1: To incorporate real-time CGMS and patient navigation support into the care of adolescent and adult patients with T1D and one of the following: 1.) two or more hospitalizations for DKA in the last five years or 2.) two or more hemoglobin A1c values over 10% in the last two years.

Aim 2: To collect information from participants regarding health outcomes, experiences with health care, and changes, if any, in diabetes self-management practices, diabetes distress, and diabetes health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 14 to 64 years
* Clinical diagnosis of type 1 diabetes (T1D)
* Two or more hospitalizations with diabetic ketoacidosis (DKA) within the past 5 years or hemoglobin A1c greater than 10% on two or more laboratory samples in the last 2 years.
* Informed Consent
* Has a CGMS or a prescription for a CGMS as part of their clinical care as part of their clinical care

Exclusion Criteria:

* Inability or unwillingness to share CGMS data with the study team
Gustatory Evoked-related Potentials in Humans

Taste perception plays an important role in maintaining nutritional balance. Gustatory evoked potentials (GEP) can be detected in response to an intermittent stimulation of the gustatory receptors by a primary flavour. GEP are non invaisve, painless and safe.

The aims were to establish a reliable recording of GEP in Humans and to determine physiological variations of the gustatory evoked cerebral activity, by recording gustatory evoked potentials in different physiological situations (different intensities of taste solutions, after feeding or fasting, with different taste...). Healthy volunteers were included in this study. GEP were recorded in 9 cortical sites by EEG sensors (10/20 system), in front of the primary and the secondary gustatory cerebral areas, referenced against ear lobes.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* non smoker

Exclusion Criteria:

* diabetes mellitus
* treatment interfering with taste
* history or current neurological problem
Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum

This is an amendment to study posting NCT00970060. Based on preliminary results from that study is was determined there needs to be a follow-up exercise intervention study. This study has two additional aims than the original study. The objectives are to determine is a prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness positively impact people with diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-70
* Type 2 diabetes
* Peripheral neuropathy

Exclusion Criteria:

* serious cardiac pathology such as recent myocardial infarction or heart surgery, uncontrolled cardiac arryhthmia, hypertrophic cardiomyopathy symptomatic aortic stenosis or heart failure, unstable angina, acute pulmonary embolus or myocarditis, conduction abnormalities, or mitral valve prolapse
* serious musculoskeletal problems that would limit ability to exercise
* skin conditions, circulatory insufficiency, or open wounds in the leg that would interfere with healing from the biopsy
* open wounds on the weight bearing surface of the feet
* not able to ambulate independently
* stroke or other central nervous system pathology
* stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic)
* lidocaine allergy
* anticipated difficulty with blood clotting due to Coumadin(Warfarin) use or blood clotting disorder
* body weight \> 450 lbs
* inadequate cognition and communication abilities, defined as \< 24 on the Mini Mental Status Exam (MMSE)
* pregnant or planning on becoming pregnant in the 18 weeks following enrollment
Project RESIST: Evaluating the Effects of Anti-smoking Inoculation Messages Among Young Adult Sexual Minority Women

Project RESIST is an R01 study funded by NCI focused on determining the effects of using culturally tailored inoculation approaches to increase resilience to tobacco marketing influences among young adult sexual minority women ages 18-30 and incorporates critical stakeholder inputs that support later adoption and implementation. The study team is utilizing formative research to design and pre-test anti-smoking messages and two national longitudinal online survey experiments.

This study will recruit 3000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1500) and not current smokers (n = 1500). The study will determine the effects of varying the dose (single vs. multiple), and latency (immediate vs. delayed) of showing participants inoculation anti-smoking messages on smoking and quitting intentions. The study team hypothesize that the multiple exposures (vs. single), and delayed exposure (vs. immediate) will be associated with increased resistance to marketing, reduced smoking intention, and increased quitting intention. The study team will further explore the mechanisms of inoculation effects through emotions, beliefs, and attitudes towards tobacco companies. Participants will be asked to complete a baseline survey and then will receive an anti-smoking message in varying dosages based on the condition they are assigned with a control group receiving no message. Participants will then see a pro-smoking or threat message immediately, one week, or one month late, depending on the condition they were assigned.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-30
* Woman
* Identifies as a sexual minority (any sexual orientation other than heterosexual)
* Lives in the United States
* Able to take surveys in English

Exclusion Criteria:

* Under 18 or older than 30
* Men
* Heterosexual
* Lives outside the United States
* Unable to take the survey in English
COVID-19 Vaccine Response in Chronic Respiratory Conditions

The investigators will assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) in adults and children including patients with chronic medical conditions.

HYPOTHESES

1. Patients with chronic respiratory diseases will have a lower antibody response to SARS-CoV-2 virus after vaccination and shorter durability of the response than control subjects without chronic disorders.
2. Patients on corticosteroids and other immunomodulator medications for chronic medical disorders will have a lower antibody response to SARS-CoV-2 after vaccination and shorter durability of the response than subjects with chronic disorders who are not being treated with corticosteroids and immunomodulator medications.

SPECIFIC AIMS

1. Enroll up to 1,000 patients receiving a SARS-CoV-2 vaccination (initial or subsequent vaccinations) in an observational study to determine vaccine antibody response and durability.

   1. Obtain blood samples to measure antibody assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) .
   2. Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities.
   3. Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections.

3. Determine the clinical features and gene expression of patients who are less responsive (have lower antibody levels and shorter duration of antibody response) to SARS-CoV-2 vaccinations.

STUDY DESIGN Patient population - up to 1,000.

Consisting of patients in the following groups:

1. Controls - who are NOT in any of the groups listed below.
2. Previous COVID infection
3. Asthma receiving immunomodulator medications
4. Asthma receiving chronic oral steroids
5. Asthma - NOT receiving immunomodulator medications or chronic oral steroids
6. Chronic Obstructive Pulmonary Disease (COPD)
7. Rheumatoid Arthritis receiving immunomodulator medications
8. Rheumatoid Arthritis NOT receiving immunomodulator medications
9. Interstitial lung disease
10. Cancer patients receiving chemotherapy
11. Bronchiectasis
12. Cystic fibrosis

Eligibility Criteria:
Inclusion Criteria:

* Receipt of a SARS-CoV-2 vaccination

Exclusion Criteria:

* None
Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy
* Age 3-8 years
* Spastic diplegic/ hemiplegic CP
* Ankle dorsiflexion 5-10 degrees
* GMFCS level 1-3
* Modified Ashworth's scale level 1+ - 3

Exclusion Criteria:

* Congenital foot deformities
* Cognitive impairments
* Secondary orthopedic, auditory and severe visual impairments
* Unwilling patients or parents
* Recent surgical interventions
T2000 in Essential Tremor - Open Label Continuation

This study will evaluate the safety and efficacy of T2000 when used to treat patients with moderate to severe essential tremor over an 18 month period.

Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's disease. The medications that are currently used to treat ET work in a small proportion of patients and provide only partial improvement in symptoms. Use of these current medications is also limited by side-effects in many patients.

T2000 is a medication currently under development for the treatment of essential tremor. Although T2000 is a new medication, it belongs to a class of medications that has been used for many years for the treatment of a variety of medical conditions. In previous studies, T2000 appeared to be effective in controlling symptoms of ET and some patients with severe ET had major improvements in tremor. In some patients T2000 was well tolerated for periods up to 5 months and the minimal side-effects seen were those that would be expected for medications in this class.

The current study will evaluate the safety and efficacy of T2000 in patients with moderate to severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day, followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 18 months. Patient's tremor and neurological examination will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

Patients will be enrolled following completion of a dose escalation trial (such as T2000-0533)

* Confirmed essential tremor by NIH criteria
* Significant functional activity limitation due to ET
* Patients who have failed, are inadequately treated or cannot tolerate alternative treatments for ET as well as treatment naïve patients who have considered but declined alternative treatment

Exclusion Criteria:

* Patients adequately controlled without side effects on a current ET treatment
* Pregnant patients or patients who may become pregnant during the study
* Patients with other medical conditions that may cause tremor, such as Parkinson's disease or active hyperthyroidism
* Patients taking medications that might produce tremor or interfere with the evaluation of tremor such as CNS-stimulants or beta-blockers
* Patients who must take medications that alter liver metabolism as well as patients with liver disease or coagulation disorders
* Patients with seizure disorders
* Patients with a history of allergy or hypersensitivity reaction to barbiturates or other related medications, such as phenobarbital or phenytoin
* Patient with significant general medical or clinical laboratory abnormalities
Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

In this 48-week, randomized, double-masked, multicenter, active controlled study, consenting patients will be randomized in a 1:1 ratio to one of the two treatment arms and attend 14 planned visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at Screening
* BCVA score between 23 and 65 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/50 to 20/320), at screening and baseline
* DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ≥ 320 µm on SD-OCT

Exclusion Criteria:

* High risk or advanced proliferative diabetic retinopathy in the study eye as per reading Center
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg)
* Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye in the last 3 months prior randomization
* Stroke or myocardial infarction during the 6-month period prior to baseline
* Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg Other protocol-specified inclusion/exclusion criteria may apply
Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation

To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.


Eligibility Criteria:
Inclusion Criteria:

* Premature ejaculation as defined by DSM-IV

Exclusion Criteria:

* History of erectile dysfunction
Ankle-Brachial Index Estimating Cardiac Complications After Surgery

Introduction: Patients undergoing noncardiac surgery are at increased risk of cardiovascular complications. The development of methods that can accurately predict the occurrence of these events is of critical importance and large studies have been published with this purpose. Based on these studies, several algorithms have been proposed to predict of cardiovascular events postoperatively. However, quantification of this risk is often difficult to measure, especially in those patients with subclinical disease, not always detected in routine evaluation. The ankle brachial index (ABI) has proved a valuable tool in the quantification of cardiovascular risk, and perhaps the most promising when compared with other methods. It is easy, cheap, fast and feasible in office care, with a great acceptance between patients and small intra and inter observer variability. Despite strong evidence of the utility of ABI as a tool in assessing cardiovascular risk, there are no data about the use of ABI in other patients referred for non vascular surgery, which constitutes the majority of operations performed worldwide.

Objectives: To evaluate the use of ABI as a predictor of cardiovascular events in patients undergoing non-cardiac and non-vascular surgery and its applicability as a tool in the reclassification of patient risk groups established by guidelines for perioperative evaluation.

Methods: 300 moderate to high risk patients referred for non-vascular and non-cardiac will be included. Data about risk factors, signs and symptoms, physical examination and treatment used will be collected before surgery. The ABI will be measured and the patient will be monitored for 30 days to the detection of cardiovascular events: death from any cardiovascular causes, unstable angina, nonfatal myocardial infarction, isolated elevation of troponin, decompensated heart failure, cardiogenic shock, stop nonfatal heart failure, pulmonary edema, stroke and lower limb ischemia. Postoperative electrocardiogram, total creatine kinase, MB fraction and troponin I will be measured daily until 3º day and whenever clinically indicated.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older, moderate to high risk by Revised Cardiac Risk and the Modified Cardiac Risk Index undergoing non-cardiac and non-vascular surgery will be referred for the study.

Exclusion Criteria:

* Patients with atrial fibrillation, aortic regurgitation, low risk of cardiovascular complications by the Revised Cardiac Risk and the Modified Cardiac Risk Index and those referred for vascular or cardiac surgery.