cyrilzakka/clinical-trials huggingface dataset:
Monitoring Exhaled Propofol to Individualize General Anesthesia

This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath, blood and drug effect in volunteers undergoing general anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model for propofol in exhaled breath.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age

  * Written informed consent
  * Ability and willingness to give written informed consent
  * American Society of Anesthesiologists (ASA) risk score I

Exclusion Criteria:

* Volunteers ASA physical status II - III
* Pregnancy
* Volunteers with history of neurological disease or stroke
* Volunteers with a history of recreational drug abuse
* Volunteers with a history of alcohol abuse
* Smokers
* Anesthesia within 6 months
* Known drug allergies
* History of adverse events during general anesthesia
Zinc Supplement Before or With Food in Generally Healthy Men

The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement

This research is a dietary intervention study designed to evaluate the effect of the food consumption timing on the absorption of zinc supplement.

The main objective is to measure plasma zinc in generally healthy male subjects, who will consume zinc supplement with food or 30-min before food for 2-weeks.

In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

* willing to stop supplementation 4 weeks prior to start of the study
* has an operative understanding of English
* no plans to move from the area during the study period
* regularly eat breakfast

Exclusion Criteria:

* Chronic or acute metabolic disease
* smoker or user of nicotine products
* history of alcohol abuse, or use of illicit drugs (incl marijuana)
* Is underweight or overweight, body mass index (BMI) \< 18 or \> 30 kg/m2
Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.

To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 12 years or older
* History of persistent bronchial asthma for at least 6 months
* Documented use of bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening
* At screening, FEV1 60 to 90% of predicted. Reversibility of FEV1 by at least 12% post-bronchodilator
* Be able to use oral inhalers
* Non-smokers

Exclusion Criteria:

* History of life-threatening asthma
* Other pulmonary diseases
* URI within 4 weeks before screening
* Use of systemic steroids within 6 months before screening. Use of inhaled steroids within 30 days before screening. More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening
* Pregnant or breast-feeding females
* Females of child-bearing potential not using adequate means of birth control
* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease
* Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results
* History of drug or alcohol abuse
* Treatment with any investigational product within 30 days prior to study entry
Identifying Patterns in the Breath of Individuals With Breast Cancer

The goal of this observational collection protocol is to develop a machine learning model capable of differentiating between the breath profiles of individuals with breast cancer and those without breast cancer.

The purpose of this collection protocol is:

* To further develop Breathe BioMedical's technology and machine learning algorithms to detect breast cancer in women with dense breast tissue.
* To identify patterns of compounds that are either over- or under-represented in the breath of women with breast cancer compared to the breath of women without breast cancer.
* To assess performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.
* To pool and analyze de-identified data from this, previous, and future breath analysis studies.

Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.

Women with mammogram-confirmed dense breast tissues undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results.


Eligibility Criteria:
Inclusion Criteria:

* Female (sex as assigned at birth);
* Aged 40 - 74 years;
* Mammography confirmed dense breast tissue (BI-RADS density score of C or D);
* Scheduled for standard of care biopsy or MRI;
* Fluent in language of consent (English, Spanish, or French);
* Ability to give informed consent;
* Able to provide a breath sample.

Exclusion Criteria:

* Mammography confirmed fatty breast tissue (BI-RADS A or B);
* Prior history of breast cancer;
* Previous surgical biopsy or surgical excision of breast cancer in the past six months;
* History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year;
* Acute respiratory infection and/or symptoms in the past seven days;
* MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery

The study aims to evaluate whether preoperative albumin supplementation in pediatric patients with hypoalbuminemia undergoing cardiac surgery can reduce inflammatory responses and prevent acute kidney injury (AKI) following cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass
* Preoperative serum albumin level of 4.0 g/dL or lower

Exclusion Criteria:

* abnormal preoperative creatinine level
* history of dialysis
* liver dysfunction
* diabetes
* history of hypersensitivity to albumin
* coagulation disorders
Dose of Labeled Cholesterol for Kinetics: A Pilot Study

This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics.


Eligibility Criteria:
Inclusion Criteria:

• Healthy men and women ages 18 - 50

Exclusion Criteria:

* Cardiovascular disease
* Metabolic disease
* Hematologic disorder
* Liver or kidney disease
* phenylketonuria
* Currently taking lipid lowering medications or any other drugs that could affect lipid metabolism
Virtual Human Technology for Patients With Chronic Pain

The experimental study compares three virtual human interviews of patients with chronic musculoskeletal pain: Emotional disclosure and brain, emotional disclosure only, basic information control. Effects on attitudes and clinical outcomes at 1-month follow-up are assessed.

Emotional disclosure about stressors and other private experiences has been found to be helpful for some people with chronic musculoskeletal pain. Also, helping patients understand the role of the brain in pain has been helpful. We have developed a virtual human interviewer to help patients talk about their pain and their lives. We will conduct an experimental study to compare the effects of several different types of VH interviews. Patients with chronic pain will be randomized to receive one of three VH interviews: emotional disclosure and brain education; emotional disclosure alone; or a control basic pain interview. Patients will be assessed at baseline and 1-month follow-up on a range of attitudinal and clinical measures to determine how these different interviews affect outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Chronic musculoskeletal Pain

Exclusion Criteria:

* Non-English speaking
Market Penetration of Laser Therapy in Venous Surgery: Ziekenhuis Oost-Limburg - Ziekenhuis Maas En Kempen Center Experience

The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).


Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patient must sign and date the informed consent form prior to treatment.
3. Presence of unilateral or bilateral primary or recurrent symptomatic varicose veins (CEAP grade ≥ C2).
4. Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).

Exclusion Criteria:

1. Current deep vein thrombosis.
2. Acute superficial thrombosis.
3. Pregnancy.
4. Coagulopathy or bleeding disorders.
5. Contraindications to the use of general or regional anesthesia.
Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer

This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in breast cancer

This is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both groups. Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy. Primary and secondary study findings and adverse events will be thoroughly evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
2. Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
3. Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
4. Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of
5. Patients with adjuvant chemotherapy or combined targeted therapy.
6. Life expectancy of at least 6 months.
7. No other uncontrolled benign diseases at the time of recruitment.
8. All patients must have complete clinical medical records.
9. Willingness to voluntarily sign an informed consent form.

Exclusion Criteria:

1. History of invasive breast cancer.
2. Prior systemic treatment for the treatment or prevention of breast cancer.
3. Known allergic reactions to vitamin D or calcium compounds.
4. Comorbidities that may affect vitamin D or calcium balance or bone health.
5. Vitamin D or calcium supplementation in the past 3 months.
6. Presence of other tumors.
7. Pregnant or lactating women.
8. Individuals who do not wish to participate in the study.
Feasibility Study: Heavy Water Tissue Labeling Protocol

Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in tissue treated with the Ulthera® System compared to control tissue.

This study is a prospective, single-center, blinded, non-randomized clinical trial. Two subjects who have chosen to have a surgical facelift procedure and agree to drink heavy water for tissue labeling, will be enrolled. Subjects will consume heavy water and collect saliva specimens over the course of the study period, following a specific heavy water labeling protocol. Two weeks after starting the heavy water protocol, subjects will return to the study site to receive one Ultherapy® treatment to the pre-auricular region on one side of the face. The contra-lateral pre-auricular region will serve as a control. Following Ultherapy® treatment, subjects will continue to follow the heavy water protocol for 4 more weeks. Subjects will then return to the study site to undergo resection of the treated and control tissue for analysis during their planned rhytidectomy procedure. Subjects will send in saliva samples on a weekly basis to allow for confirmation that they are drinking the heavy water.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 30 to 65 years scheduled for rhytidectomy.
* Subject in good health.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control.
* Absence of physical or psychological conditions unacceptable to the investigator.
* Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
* Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Severe or cystic acne on the area to be treated.
* Presence of a metal stent or implant in the facial area to be treated.
* Inability to understand the protocol or to give informed consent.
* Microdermabrasion, or prescription level glycolic acid treatments to the submental area within two weeks prior to study participation or during the study.
* Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area to be treated.
* BMI equal to or greater than 30.
A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years

The primary aim of this study is to evaluate the effect of using Tysabri on changes in the brain using MRI and on disease progression in patients with relapsing-remitting Multiple Sclerosis over 5 years.

This is a prospective, observational, single-blinded, longitudinal study of natalizumab effect on brain atrophy development and disability progression in multiple sclerosis patients over 5 years, which will evaluate originally treated patients with natalizumab who participated in a prospective 1- and 2-year VWMTR study. (Zivadinov et al., 2011b) All subjects will be assessed at 5-year follow-up with the same clinical examinations and will obtain 1.5T MRI examination on the same scanner that did not undergo any upgrade changes in the period of 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Participation in natalizumab 1-year follow-up study
* Participants were aged 18-65
* Have clinically definite MS according to the Polman criteria of either RR or RSP disease type
* EDSS scores ≤6.5
* disease duration \<30 years
* normal kidney function (creatinine clearance \>59 mL/min)
* started therapy either with natalizumab or IM interferon beta-1a (IFNβ-1a)
* Signed informed consent
* Normal kidney functioning (creatinine clearance \>59)
* None of the exclusion criteria

Exclusion Criteria:

* A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to 5-year follow-up visit
* Nursing mothers or pregnant women who will need to undergo 5-year follow-up MRI
* Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
* Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

The conventional sonography is frequently used to detect incidental focal liver lesions because of its availability, innocuity and low cost. Nevertheless, sensibility and specificity of conventional sonography does not exceed 70% for tumoral affections. Consequently the interest of this practice must be reconsidered by studying its ratio cost/diagnosis contribution.

These limitations of conventional sonography have led to the use of other imaging modalities and invasive or costly procedures such as computed tomography (CT), magnetic resonance imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or cirrhotic liver in a neoplastic context or not, without inconvenience for the patient.

The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance and catch of load cost, in the characterization of focal liver lesions detected but not characterized by CT or conventional sonography.


Eligibility Criteria:
Inclusion Criteria:

* Target focal liver lesion of size lower than 10 cm and higher than 5 mm detected by conventional ultrasonography

Exclusion Criteria:

* Patients with acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: myocardial infarction, recent coronary artery intervention, acute cardiac failure (within last month), acute endocarditis and prosthetic valves.
* Pregnant and lactating women
Correlation Between Brain Structure and Activity and Spontaneous Recovery of Motor Function Following Brain Ischemic Stroke

The investigator aims to find a correlation between brain structure and activity and spontaneous recovery of motor function following brain ischemic stroke by Analysis of MRI scans. The research includes stroke patients and healthy patients (control group).

The recovery process, especially the recovery of motor functions after an ischemic stroke, differs from one person to another. In recent years, there is more evidence of spontaneous biological recovery (SBR), which is independent of training or rehabilitation-induced recovery, throughout the post-stroke subacute phase. However, the neural basis associated with motor function in this recovery phase remains unknown. We believe that the research results may help to explain the neural mechanism which promotes or inhibits recovery.

Eligibility Criteria:
Inclusion Criteria:

1. age between 21 years old and 80 years old
2. admission to the hospital 2-14 days after a first ischemic stroke, confirmed by CT, MRI or neurological report
3. residual unilateral upper extremity weakness
4. ability to give informed consent and understand the tasks involved.

Exclusion Criteria:

1. younger than 21 years old or older than 80 years old
2. cognitive impairment, as seen by a score of \<20/30 on the Montreal Cognitive Assessment (MoCA)
3. history of a physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease)
4. contraindication to transcranial magnetic stimulation (TMS), such as deep brain stimulators or skull defect, presence of other metal devices or objects in the head, or a pacemaker
5. inability to sit in a chair and perform upper limb exercises for one hour at a time
6. inability to lie down in the MRI scanner for an hour
7. participation in another upper extremity rehabilitative therapy study during the study period
8. terminal illness
9. social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow-up assessments
10. pregnancy
11. severe visuospatial neglect, as seen by a score of \<44/54 on the Star Cancellation Test.
Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR

The purpose of this study is to determine whether cetuximab is effective in the treatment of locally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR.

Patients with locally advanced or metastatic squamous cell carcinoma (SCC) of the skin are often bad responders to conventional chemotherapy included cisplatin.

The investigation of the EGFR expression may allow identifying new molecular targets for novel therapeutic strategies in patients with locally advanced or metastatic SCC of the skin.

Several publications in the literature for primary lesions and one publication for metastatic lesions showed that EGFR was expressed in 80-90% of SCC of the skin. Immunohistochemistry studies performed at the Gustave Roussy Institute confirm these data: they found an over-expression of EGFR in 90% of patients with metastatic disease. These results are in favor of the investigation of cetuximab in patients with locally advanced or metastatic SCC of the skin expressing EGFR.

Cetuximab is a monoclonal antibody targeted against EGFR administered weekly by intravenous route; it may be prescribed as out hospital to patients with locally advanced or metastatic SCC of the skin expressing EGFR.

Due to the low occurrence of locally advanced or metastatic SCC of the skin, a multicenter trial will be required.

Eligibility Criteria:
Inclusion Criteria:

* Histological SCC of the skin expressing (IHC) moderately or highly the EGFR (++ and +++, on a semi-quantitative scale).
* Locally advanced or metastatic SCC of the skin not suitable for local surgery with documented progression.
* Presence of at least one measurable target lesion by RECIST criteria.
* At least one lesion accessible to biopsies.
* ECOG Performance status \< 2.
* Life expectancy \> 3 months.
* Age \> 18 years.
* Normal hematological (Neutrophils \> 1.5x109 cells/l, platelets \> 100x109 cells/l), hepatic (bilirubin \< 1.5 times the upper limit of the normal range (ULN); alkaline phosphatase and transaminases \< 5 x UNL in case of hepatic metastases or \< 2.5 x UNL in absence of hepatic metastases) and renal (serum creatinine \< 150 micromol/L) functions.
* Written informed consent.
* In case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator.

Exclusion Criteria:

* Prior chemotherapy
* Prior radiotherapy \< 1 month.
* Prior therapy with agent targeting EGFR
* Unstable systemic diseases or active uncontrolled infections.
* Patients (male and female) not using effective contraception if of reproductive potential.
* Females pregnant or lactating. Women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.