cyrilzakka/clinical-trials huggingface dataset:
Lighting Intervention for Cancer-related Fatigue

Fatigue is a major problem for cancer patients, and one that can persist long after treatment ends. Recent work has demonstrated that light therapy may mitigate or reduce fatigue levels in both cancer patients and cancer survivors. This protocol seeks to assess how lighting interventions distributed through a mobile app affect fatigue, sleep, and quality of life across three populations of cancer patients: breast cancer and prostate cancer, and patients who have undergone autologous hematopoietic stem cell transplant (HSCT). Participants will be randomized 1:1 to either the interventional SYNC app or to a control app.


Eligibility Criteria:
Inclusion Criteria

* Must own an iPhone 6s or later (with iOS 14 or later or willing to update to iOS 14+) and be willing to complete surveys on it, per the protocol.
* Sleep aid usage will be allowed as long as the patient has been on a stable dose for at least 4 weeks prior to enrollment and agrees to continue the same dose during the study.
* A response of at least 4 on a 10 point scale (with 0 = not fatigued at all and 10 = extremely fatigued) to the question "How fatigued did you feel in the past week?"
* Breast cancer population: Diagnosed with stage 1-3 breast cancer in the last 10 years, without metastatic disease. Chemotherapy or radiation therapy, if indicated, must have been completed at least 3 months prior to enrollment. Concomitant anti-HER2 therapy and/or anti-endocrine therapy is permitted.
* Prostate cancer population: Undergoing androgen deprivation therapy (ADT) for at least three months and are anticipated to remain on ADT for the duration of the trial. Concomitant additional anti-androgen therapy (e.g., enzalutamide) is permitted.
* Autologous HSCT population: Participants must be from the University of Michigan Blood and Marrow Transplant Program.

Exclusion Criteria

* The patient cannot be undergoing chemotherapy at the time of enrollment, but post transplant maintenance therapy that begins after enrollment is allowed.
* The patient must have no evidence of disease progression or recurrence. Specifically for the prostate cancer population, the patient must have no evidence of disease progression on their current ADT regimen at the time of enrollment.
* The patient must not be a night shift worker, where night shift is defined as working a significant number of hours (i.e. more than half) between the hours of 11PM and 6AM on a regular basis.
EzPAP Therapy Versus Non-invasive Ventilation Therapy

This study compared EzPAP and noninvasive treatments of hypercapnic COPD attacks.

In this study, the effectiveness of NIV and EzPAP treatments was compared in patients admitted to the emergency department due to hypercapnic COPD exacerbation. Blood gas was taken at the 4th and 24th hours of treatment to evaluate the effectiveness.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Chronic obstructive pulmonary disease Dyspnea

Exclusion Criteria:

Cardiac failure Dead
New Version Pulmicort Turbuhaler USA Adults

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
* To enter the run in period, subjects were also required to have the following:
* A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
* At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

Exclusion Criteria:

* Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
* Use of steroid tablets or injections during the month (28 days) prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
* Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to the study. Subject must not smoke or have smoked within 6 months of the study.
Effect of Cabergoline on Weight and Glucose Tolerance

The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine receptor agonist, on body weight and blood glucose in healthy obese adults.

This is a randomized double-blind placebo controlled study. Twenty subjects each will be randomly assigned either placebo or cabergoline for 16 weeks.

The effect of treatment on body weight and blood glucose and insulin levels will be compared in the treatment versus the placebo arm.


Eligibility Criteria:
Inclusion Criteria:

* age 18 - 55 years
* BMI 30 -40

Exclusion Criteria:

* diabetes,
* clinically significant medical condition,
* use of medications that effect blood glucose or body weight
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation

Prospective, multicenter, randomized trial.

Patients with severe native aortic valve regurgitation (AR) who have symptoms, impaired LVEF (≤55%) or left ventricular enlargement have the indications for surgery. According to data from the Euro Heart Survey, only 21.8% with LVEF 30-50% and 2.7% with LVEF \<30% were referred for surgical aortic valve replacement (SAVR) among patients with severe native aortic regurgitation. Advanced age and comorbidities were often considered as main reasons to refuse SAVR. The annual mortality of untreated patients with severe AR is 10-20%. Pure native AR is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation (TAVR) because the specific anatomical features can preclude adequate valve implantation. Several small, retrospective studies showed that off-label use of TAVR appears to be a feasible treatment choice for AR patients at high risk for SAVR. The present study aims to investigate the use of TAVR in AR patients.

Eligibility Criteria:
Inclusion Criteria:

1. Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) \> 65mm or left ventricular end-systolic dimension (LVESD) \> 50mm;
2. Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm;
3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
4. STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:

   1. Severe aorta calcification or active ascending aorta atherosclerotic plaque
   2. History of mediastinum radiotherapy
   3. Past mediastinitis
   4. Presence of unobstructed coronary bypass implants
   5. Previous more than two cardiothoracic surgeries
   6. Liver cirrhosis
   7. Other surgical risk factors

Exclusion Criteria:

1. Age \< 60 years old;
2. Ascending aorta diameter \>45mm;
3. Coronary multi-vessel disease (SYNTAX score \>32);
4. Life expectancy \<1 year;
5. Left ventricular ejection fraction \<30%;
6. Acute myocardial infarction within 30 days;
7. Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);
8. Other situations judged by the researcher as unsuitable for participating in the study.
Menstrual Cycle Symptom Tracking

This study will provide menstrual cycle symptom information from women over the course of three menstrual cycles to determine whether there are any noticeable physiological changes that can be related to stage of the menstrual cycle or onset of menstruation.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 years and over
* Regular menstrual cycles
* Owns a compatible smart phone i.e. iPhones® and AndroidTM phones equipped with Bluetooth® 4.0/BLE
* Willing to use their own smartphone for the duration of this study and to download and install the study app
* Willing to give informed consent

Exclusion Criteria:

* Currently trying to conceive
* Currently or recently pregnant or breastfeeding
* Taking any treatment which may affect the menstrual cycle (e.g. contraceptive pill, fertility medications or hormone replacement therapy)
* Taking or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)
* Has abnormal liver or kidney function
* Taking antibiotics containing tetracycline
* Taking clomiphene citrate or other ovulation induction drugs
Inguinal and Axillary LN Size Distribution

Recently, intralymphatic allergen-specific immunotherapy (ILIT) showed promising treatment outcomes for allergic rhinoconjunctivitis. However, the normal size distribution of superficial lymph nodes (LNs) on the trunk that are potential target LNs for ILIT has not been evaluated.

The objective of this study is to investigate the distribution of LN size in inguinal and axillary area.

In this study, the long-axis diameters of the largest LNs in the inguinal and axillary areas were retrospectively measured in subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes from September 2022 to November 2022.

Eligibility Criteria:
Inclusion Criteria:

* subjects who underwent chest and abdominopelvic computed tomography on the same day for health screening purposes

Exclusion Criteria:

* Malignancy
* Follow-up less than 1-year
Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly

The objective of this trial is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in elderly population living in a nursing home. In addition, it will be evaluated if the probiotic strain have some effect on the immune response generated by the Covid-19 vaccine inthis population.

The working hypothesis is that the administration of a Lactobacillus strain improves the immune response in the elderly population, improving the immune response to a possible COVID-19 infection. The strain would act as an adjuvant that contributes to developing an effective response against the virus, and therefore there are fewer infectious symptoms due to this virus or, if it appears, it occurs in a milder way among the subjects who take the probiotic strain. Also,the investigators hypothesizes that the administration of the Lactobacillus may improve the immune response generated by the Covid-19 vaccine in this elderly population.

Eligibility Criteria:
Inclusion Criteria:

1. Person over 60 years of age.
2. Intern in residence for the elderly.
3. Sign informed consent.

Exclusion Criteria:

1. Person who at some previous time has tested positive for detection of COVID-19 by PCR or serology.
2. Person who at the time of starting the intervention presents symptoms compatible with COVID-19.
3. Person with concomitant disease type HIV, transplant, active cancer or other type of active immunosuppression.
One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers

The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.

The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.

Eligibility Criteria:
Inclusion Criteria:

1. Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
2. Subject is \>18 years of age.
3. Subject's BMI \> 35.

Exclusion Criteria:

1. Subject \< 18 years of age.
2. Subject's BMI \< 35.
Shanghai High Myopia Study for Adults

High myopia retinopathy has become the first cause of irreversible blindness and severe visual impairment in Chinese adults, in order to avoid the blind and visual impairment caused by high myopia retinopathy, it is very necessary to research the mechanism of early visual impairment to prevent and control damages. Our recent research found that the decreasing of macular retina vascular density and subfoveal choroidal thickness, the increasing of Beta Zone area in optic atrophy and the rising of glycosylated hemoglobin in high myopia patients were significantly related to visual impairment, which suggested that the source of visual impairment was the abnormal structure changes surrounding optic and fovea, but so far there is no related study. We will conduct a 5 years prospective cohort study in the population of 2420 high myopia and controls which have established in college student population, working population and aged more than 50 years old population, using the latest OCT-A and SS-OCT to measure macular retina vascular density, subfoveal choroidal thickness, Beta Zone area in optic atrophy, combined with the semiparametric mixed effects model, we will analysis the prediction index between fundus structure parameters, blood biochemical index and individual characteristics prediction to explore the public health management mode of early prevention and treatment during high myopia population.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old; spherical equivalent refraction ≤-6.00D;

Exclusion Criteria:

* a history of ocular or systemic diseases including congenital cataract and glaucoma; previous intraocular or refractive surgery;other evidence of retinal pathology
Cost Assessment of Videolaryngoscopy Compared to Direct Laryncoscopy in a Large Academic Center

Cost, both direct and indirect, assessment of videolaryngoscopy, specifically the McGrath, compared to direct laryncoscopy in a large academic center.


Eligibility Criteria:
Data were obtained on all endotracheal intubations where the Anesthesiology service was assigned to staff a surgical case requiring tracheal intubation during general anesthesia. Data were also obtained for tracheal intubations outside the operating room (ICUs, Trauma, patient wards) when Anesthesiology personnel were requested which did not include the Emergency Department

Electronic patients' medical records spanning a two-year period (July 1, 2019 to June 30, 2021)
ILLUMENATE EU Randomized Clinical Trial

This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
* Rutherford clinical category 2, 3 or 4
* Male or non-pregnant female at least 18 years

Exclusion Criteria:

* Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries
* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
* Known intolerance of study medications, paclitaxel or contrast agent
* Active participation in another investigational device or drug study
the Effect Site Equilibration Time of Propofol is Age Dependant

This study obtains an effect site model for White (Modified Marsh) pharmacokinetic propofol model. The plasma effect-site rate constant (ke0) obtained is affected by age.

In the Target Controlled Infusion pumps the first order plasma-effect-site steady-state rate constant (ke0) links the pharmacokinetics (PK) and pharmacodynamics (PD) for a given drug and it is used to predict the course of the effect and to calculate a theoretical drug concentration at the effect site. The PK model for propofol recently published by White et al. (derived from the Marsh model used by the Diprifusor®) include covariate as age and gender to describe the pharmacokinetics but does not incorporate a ke0.

Methods: 45 healthy adult patients will be scheduled for elective surgery with standard monitoring and BIS XP (Aspect) will received a White PK model-driven plasma target controlled infusion of propofol ( 12 ugml-1 or 10 ugml-1 over 65 years) to be reached in 4 min. After reaching the target, the infusion will be stopped obtaining a complete effect curve upon patient awakening. Calculated plasma concentration and EEG data were stored every one second. Loss (LOC) and recovery (ROC) of consciousness were assessed and recorded. The dynamic relationship between propofol Ce and its effect as measured by BIS will be modeled with an inhibitory Emax model using a population PK/PD approach with NONMEM V.

the Study take around 12 min.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2

Exclusion Criteria:

* less than 70% or more than 130% ideal body mass index,
* neurologic disorders,
* pregnancy,
* psychoactive medication intake during last 48 hours
Quality of Life in Patients Having a Prosthetic Joint Infection

Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy handicap and sometimes to the life threatening. These are devastating diseases whose diagnosis is difficult. They are known to be associated with high mortality rates (5%) and significant morbidities responsible for functional sequelae (40% of patients) with an individual cost (prolonged hospitalization, altered quality of life) and societal (work stoppage, partial or total disability, temporary or permanent) extremely high.

These bone and joint infections have a significant impact on the quality of life of those affected who, in addition to their infection, are reduced in their autonomy and often need to be taken care of outside their home, sometimes away from home.

To the knowledge of investigators, there are few studies on the measurement of quality of life in patients with osteoarticular infection.

The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint infection (IPA) on prosthesis during their medical care in the department of Infectious and Tropical Diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patient having prosthetic joint infection
* Patient who did not object to participate in the study
* Patients over 18 years of age

Exclusion Criteria:

* Patient with additional psychological or psychiatric support outside the service.
* Patient benefiting from a system of legal protection (safeguard of justice, guardianship, curatorship)
* Patient participating in another study on measuring quality of life
* Patients with cognitive impairment to understand the questionnaire
* Impossibility of giving the patient informed information
* Patients with no infection diseases follow up at the CROIX ROUSSE hospital
* Patients with amputation as initial surgery for infection management
A Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. This study is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented, incurable, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable.
* Evaluable or measurable disease
* Life expectancy \>= 12 weeks
* Adequate hematologic and organ function within 14 days before initiation of GDC-0068
* Documented willingness to use an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for both men and women while participating in the study

Exclusion Criteria:

* History of Type 1 or 2 diabetes mellitus requiring regular medication
* Grade \> 2 hypercholesterolemia or hypertriglyceridemia
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Leptomeningeal disease as the only manifestation of the current malignancy
* Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for \>= 3 months