cyrilzakka/clinical-trials huggingface dataset:
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates

Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive .

The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective).

secondary objective).


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> or = 18 years old)
* Ongoing on conventional oxygen therapy with peripheral oxygen saturation (SpO2) between 88 and 100% with the usual oximeter
* SpO2 \< 92% ambient air with the usual oximeter

Exclusion Criteria:

* No SpO2 signal with with the usual oximeter
* False nails or nail polish
* Severe anemia documented on last blood count during current hospitalization (haemoglobin (Hb) \< 80g/L)
* Oxygen flow \> 6 L/min
The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration, both acutely and after 1 month of use.

Two smokers groups matched for age and sex will be assessed:

1. a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase
2. a group of 30 current smokers with no diagnosed cardiovascular disease who will be using the I quit ordinary smoking (IQOS) for 1 month.

In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards all 60 smokers will be randomized to smoke either a normal cigarette or IQOS and the after 60 minute washout period these subjects will be crossed over to the altenate mode of smoking (IQOS or normal cigarette respectively).

After the completion of the acute phase all 60 smokers will start the use of IQOS for one month.

In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal cigarette or IQOS. The chronic phase measurements will be performed 1 month after use IQOS. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment.

In both phases the investigators will assess: a) the aortic pulse wave velocity (PWV) and augmentation index (AIx) by Arteriograph and Complior; b) the perfusion boundary region of the sublingual arterial microvessels using Sideview, Darkfield imaging (Microscan, Glycocheck); c) the exhaled carbon monoxide (CO) level (parts per million -ppm) as a smoking status marker; d) the vital signs; e) an electrocardiogram; and f) plasma levels of C- reactive protein (CRP), transforming growth factor-b (TGF-b), lipoprotein associated phospholipase A2 (LP- LPA2), tumor necrosis factor- α (TNF-α), interleukins 6 and 10 (IL-6 and -10), procollagen propeptide type III (PIIINP), matrix metalloproteinase 2 and 9 (MMP-2 and -9), and macrophage-colony stimulating factor (MCSF), malondialdehyde (MDA) and protein carbonyls (PCs).

Eligibility Criteria:
Inclusion Criteria:

* Active conventional cigarette smoker

Exclusion Criteria:

* Health condition adversely affected by smoking
* History or presence of cardiovascular disease
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2

This study, involves the implementation and evaluation of a Monday-focused, individually tailored mobile health application to assist overweight or obese adults who would like to achieve a healthful weight. The goal was to evaluate the application of a Monday-focused delivery system for the M-TRIMM2 intervention on participants who worked or lived in areas in or adjacent to Johns Hopkins East Baltimore medical campus.Targeting mobile messaging occurred at strategic intervals throughout each week, with the intent of prompting participants to renew their health resolutions each Monday combined with lifestyle behavioral education.

The specific aims of this research project are to:

1. Develop a targeted delivery system for mobile health messages which focused on improving physical activity and diet, and setting healthy resolutions each week.
2. Deliver the M-TRIMM intervention, which encourages healthy behavior and the weekly renewal of health resolutions.
3. Evaluate the effectiveness of this intervention on individuals' weight loss, self-efficacy, and motivation to sustain changes in lifestyle behaviors.
4. Assess the benefit of receiving the message content only (in a paper document), versus a scheduled weekly delivery via mobile messaging.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 and \<71
* BMI \> 25
* having a phone that was capable of receiving text-messages and being willing to receive text-messages

Exclusion Criteria:

* age \<18 or ≥ 71
* BMI ≤ 25
* not having a phone that was capable of receiving text-messages or not being willing to receive text-messages
The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy

Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years
* Undergoing percutaneous coronary intervention for angina or acute coronary syndrome.
* Calcific coronary disease requiring rotational atherectomy

Exclusion Criteria:

* Pre-existing pacemaker or implantable cardioverter defibrillator.
* Mobitz II heart block or complete heart block.
Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Macular edema involving the center of the macula demonstrated on OCT
* Clear ocular media
* Untreated patients
* Older than 45 years
* BCVA of the fellow eye at least 20/100

Exclusion Criteria:

* Renal diabetic disease, uncontrolled hypertension or stroke history
* Other ocular disease
* Ocular surgery excepting uncomplicated phacoemulsification
* History of photocoagulation (panretinal or focal)
* History of another intravitreal treatment (like triamcinolone)
Criticality, Working Memory, and Effort

The project examines electroencephalography, MRI, and behavioral measures indexing flexibility (critical state dynamics) in the brain when healthy young adults do demanding cognitive tasks, and in response to transcranial magnetic stimulation.

The healthy human brain is a complex, dynamical system which is hypothesized to lie near a phase transition at rest - at the boundary between order and chaos. Proximity to this critical point is functionally adaptive as it affords maximal flexibility, dynamic range, and information handling capacity, with implications for working memory function. Divergence from this critical point has become correlated with diverse forms of psychopathology and neuropathy suggesting that distance from a critical point is both a potential biomarker of disorder and also a target for intervention in disordered brains. The Investigators have further hypothesized that subjective cognitive effort is a reflection of sub-criticality induced by engagement with demanding tasks.

A key control parameter determining distance from criticality in a resting brain is hypothesized to be the balance of cortical excitation to inhibition (the "E/I balance"). Transcranial magnetic stimulation is a widely used experimental and clinical tool for neuromodulation and theta-burst stimulation (TBS) protocols are thought to modulate the E/I balance. Here the Investigators test whether cortical dynamics can be systematically modulated away from the critical point with continuous theta-burst stimulation (cTBS), which is thought to decrease the E/I balance, and thereby impact on working memory function and subjective cognitive effort during performance of the working memory tasks.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study and availability for the duration of the study
3. Males and females; Ages 18-45
4. Healthy, neurologically normal with no diagnosed mental or physical illness
5. Willingness to adhere to the MRI and two session stimulation protocol
6. Fluent in English
7. Normal or corrected to normal vision
8. At least twelve years of education (high school equivalent)
9. Right-handed

Exclusion Criteria:

1. Ongoing drug or alcohol abuse
2. Diagnosed psychiatric or mental illness
3. Currently taking psychoactive medication
4. Prior brain injury
5. Metal in body
6. History of seizures or diagnosis of epilepsy
7. Claustrophobia
8. Pregnant or possibly pregnant
9. Younger than 18 or older than 45
10. Use of medications which potentially lower the usage threshold
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks

According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases. Among Chinese breast cancer patients, approximately 60% are hormone receptor (HR) positive, and 80% have early-stage breast cancer. For HR-positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer patients, the first peak of recurrence is about 2-3 years after surgery, especially for patients with high-risk clinical and/or pathological features. Therefore, adjuvant therapy is essential to reduce recurrence during this period.

Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil (5-Fu) in vivo. Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer. Therefore, we assumed that additional capecitabine may reduce the reccurence of breast cancer in patients with high-risk factors.

This trial is an open, single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-70 years.
* Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as positive cells \>1%) and HER2 negative (defined as HER2 immunohistochemistry 2+ or less and FISH negative).
* Definition of high-risk factors: 4 or more positive axillary lymph nodes; 1-3 positive axillary lymph nodes with primary tumor ≥ 5 cm or histologic grade 3 or ki67 ≥ 20%; or residual lesions despite neoadjuvant chemotherapy.
* No prior treatment for present breast cancer onset.
* ECOG physical status score 0 to 1
* Hematological examination before treatment should meet: white blood cell count (WBC) ≥ 4.0×10\^9/L, neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet count (PLT) ≥ 100×10\^9/L; hemoglobin (Hb) ≥ 90g/L; AST (sGOT), ALT (sGPT) ≤ 1.5 times the normal value upper limit, creatinine ≤ 1.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value.
* No serious impairment of heart, liver, kidney and other important organ functions.

Exclusion Criteria:

* Unwilling or unable to use an acceptable method of contraception for up to and including 8 weeks after the final dose of the test drug.
* Women during pregnancy and breastfeeding after pregnancy.
* Women with proven distant metastases of breast cancer.
* Patients with proven sensory or motor nerve disease.
* Definite cardiovascular disease, severe co-morbidity or active infection, including known HIV infection.
* Patients who need long-term anticoagulant drugs for cardiovascular or thrombotic diseases.
* History of other tumors.
* Allergic to the study drug or its excipients, etc.
Effect of Contrast Medium on Optic Nerve Sheath Diameter

One method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. There is no study whether equal volume of contrast medium injection has any increasing effect of optic nerve sheath diameter.

This study is designed to measure the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.

Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve sheath diameter. This study was designed to examine the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer
* gallbladder

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain lesion
Effect of Laser Puncture Versus Ultraviolet Radiation on Women With Polycystic Ovarian Syndrome

Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided into three groups. For three months, group (A) will receive laser puncture (3 sessions per week), along with a metformin supplementation, group (B) will receive ultraviolet radiation (3 sessions per week), along with a metformin supplementation, while group (C) will receive only metformin supplementation. The follicular size will be measured using ultrasound, while, female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood analysis

Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided into three groups. For three months, group (A) will receive laser puncture (3 sessions per week), along with a metformin supplementation, group (B) will receive ultraviolet radiation (3 sessions per week), along with a metformin supplementation, while group (C) will receive only metformin supplementation. The follicular size will be measured using ultrasound, while, female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood analysis

Eligibility Criteria:
Inclusion Criteria:

* Obese nulli gravid PCOS women
* BMI 30-40 kg/m2

Exclusion Criteria:

* hyperprolactinemia
* BMI \> 40 kg/m2 Endocrinological disorders such as thyroid disease, Cushing's syndrome, Coagulopathy
* Recent use of oral contraceptive pills
* Recent use of any photosensitizing medications, such as aspirin, tetracycline, chlorothiazide, or psoralen suspicious of neoplasms
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.

This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury. The investigators hypothesize that this stimulation can revive spared function in the spinal cord of individuals who are clinically paralyzed, but who have some remaining connections between the brain and spinal cord. Our research has demonstrated that modifying the activation state of the spinal cord or awakening the spinal cord can benefit people with paralysis years after a spinal cord injury. This method and device have not yet been approved by the FDA for the treatment of paralysis and are under investigation. This study if successful will help provide further evidence that could be use to gain FDA approval.

Eligibility Criteria:
Inclusion Criteria: ASIA C

* Spinal cord injury 1 or more years prior
* Non progressive SCI at C7 or higher
* Half of key muscles below neurological level having a motor score of less than 2/5
* Ability to commit to home exercises and 12 week participation
* Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities
* Not dependent on ventilation support
* No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with upper extremity rehabilitation or testing activities
* No clinically significant depression or ongoing drug abuse
* Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 12 week study period
* No current anti-spasticity regimen
* Must not have received botox injections in the prior six months
* Be unable to use upper extremity for functional tasks

Exclusion Criteria:

* Pregnancy
* No functional segmental reflexes below the lesion
The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women

Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate the potential efficacy of a mobile phone based physical activity intervention in 30 physically inactive pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* pregnant, gestational week (10-20 weeks)
* pre-pregnancy BMI ≥ 18.5 kg•m2
* physically inactive at work and during leisure time
* intent to be physically active
* access to a home telephone or a mobile phone
* have a personal computer access
* ability to communicate (speak and read) in English.

Exclusion Criteria:

* known medical or obstetric complication that restricts physical activity
* history of eating disorders
* current participation in lifestyle modification programs
* history of bariatric surgery.
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma

This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.

In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;
2. Age ≥60 years old;
3. The expected survival time is more than 3 months;
4. ECOG score is 0-2;
5. Those who voluntarily participate in the study and sign the informed consent;
6. Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) \>1×10\^9/L Total platelet count (PLT)≥35×10\^9/L;
7. left ventricular ejection fraction \> 45%.

Exclusion Criteria:

1. High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;
2. Those who have graft versus host disease and need to use immunosuppressive agents;
3. Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);
4. Active hepatitis B or C virus, HIV or other untreated active infected persons;
5. Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;
6. Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.