cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between 18 to 55 years of age
* Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
* History of being a nonsmoker for at least 1 year Other inclusions apply.

Exclusion Criteria:

* Presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease
* Known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months
* Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day-1 until the end of the study Other exclusions apply.
Endoscopic Breast Surgery in Treating Patients With Breast Cancer

RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.

PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer or prophylactic mastectomy requiring axillary nodal staging
* Breast disease (e.g., fibroadenoma, ADH)
* Ability to read and/or comprehend consent form and questionnaires
* Ability to follow-up per protocol
* Not pregnant or breastfeeding

Exclusion Criteria:

* Pregnant or breastfeeding
* Evidence of chest wall or skin\* involvement
* NOTE: \*may be endoscopy-assisted
Volatilomic Approaches for the Study of CFTR Modulators (VOLATIL-CF)

This study relies on the hypotheses that (1) exhaled breath is intimately correlated to the patient's lung condition and that (2)the composition of exhaled breath , i.e. the VOCs profile, will be significantly modified from the first days of treatment by CFTR modulators in a or pauci/symptomatic patients such as young children under 12 years old. The non-invasive and longitudinal collection and analysis of exhaled breath may reveal modifications in signaling pathways impacted by these treatments on the very short term. This study is a single-center pilot study.

This is a single-center prospective cohort study that plans to include 20 children with cystic fibrosis aged 6 to 12 years old who will initiate Kaftrio® in early 2023.

The children will be monitored for one month; three visits are planned as part of routine care (before initiation of treatment, in the course of the first week and after one month of treatment) during which exhaled breath collection and analysis will also be performed. Access to clinical data collected throughout routine follow-up of these children (analysis of induced sputum, urine and blood, sweat test, respiratory function tests) will be granted upon patient/parent authorization.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cystic fibrosis initiating Kaftrio® treatment.
* Patients and holders of parental authority not opposing participation in this research.
* Patients affiliated to a Health Insurance system or beneficiaries. Exclusion Criteria
* Patients deprived of liberty or under guardianship.
* Pregnant or breastfeeding patients.
* Lung transplanted patients.
The Angioshield Study Feasibility II

Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.

The study is designed to investigate the feasibility of using an applied support (Angioshield) to a saphenous vein to be used in Coronary Artery Bypass Surgery. It is a feasibility to determine safety prior to launching a larger pivotal study. The primary endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit. The secondary endpoints, long term safety and patency, will be assessed by recording and reporting of adverse events and graft patency (via serial CT angiograms) at the 30, 90, and 365 day follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

Subject will be eligible for inclusion in the investigation if he/she:

1. is between the ages of 18 and 80 years of age, inclusive
2. requires CABG surgery due to atherosclerotic coronary artery disease with minimum of two SVGs, one used to bypass a stenosis in the main Right Coronary artery and one used to bypass a stenosis in the Circumflex artery territory
3. is able to give their informed written consent
4. is willing and able to complete all follow-up visits and procedures
5. is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery
6. has adequate saphenous veins
7. Is a candidate for transcatheter therapy, PCI

Exclusion Criteria:

Subject will be excluded from participation in the investigation if he/she:

1. is currently enrolled in another clinical investigation
2. is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
3. is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
4. history of a hypercoagulable state
5. has had an acute MI within the last 21 days
6. has had a previous CABG
7. requires emergency surgery
8. has a left ventricular ejection fraction (LVEF) less than 35 %
9. has a target vessel stenosis of less than 75%
10. has a transmural infarct of the target artery territory
11. has a serum creatinine greater than 1.5 mg/dL
12. is having concomitant -surgery of any kind
13. has had previous saphenectomy (See inclusion)
14. has saphenous vein sizes incompatible with treatment range (i.e., \<3.5 mm or \>5 mm inner diameter)
15. limb Ischemia or non-healing ulcer
16. has moderate to severe COPD defined as FEV 1 of less than 1 liter
17. has had a CVA in last 90 days
18. has diffuse disease in target vessel with an inadequate anastomotic touchdown site
Vaginal Electrical Stimulation Versus Neuromodulation

This prospective study compares quality of life measures of patients with refractory overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation (Group A) and sacral nerve stimulation (Group B).

The specific aims are:

1. To characterize patient symptom bother score, quality of life, and body image scores in patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.

- Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of life, patient symptoms, and body image questionnaires.

All participants will have a standardized intake history which will include age, weight, history of prior treatment for incontinence, medication list, obstetric and gynecologic history, medical history, and surgical history, as well as a complete review of systems. The physical examination will include vital signs (including BMI), genitourinary exam, including Pelvic Organ Prolapse Quantification (POPQ), and neurologic exam. All patients will undergo spontaneous uroflowmetry, urine dipstick from catheterized specimen, multichannel urodynamics, and 3-day voiding diary. Measurement of post-void residual will also be obtained. Completion of the UDI-69, King's Health Questionnaire10, and the Modified Body Image Perception Scale (MBIS) will also be part of the initial visit 11,12.

All participants taking anticholinergics will undergo a 2 week flush-out period prior to the intake assessment. After the intake assessment, the provider will determine which treatment option is appropriate to the participant, and they will then be assigned to one of the two treatment arms: Group A will use vaginal electrical stimulation using the Empi Intravaginal Stimulation Unit Minnova (Empi, St. Paul, MN, USA) and participants in Group B will receive sacral neuromodulation using InterStim (Medtronic, Minneapolis, MN, USA).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory OAB (+/- UUI)\*
* Female Gender
* Eligible for both treatment interventions
* Available for 8 weeks of follow-up
* Able to complete study assessments
* Must discontinue anticholinergics within 2 weeks of intervention

Exclusion Criteria:

* Age \< 21
* Pregnancy
* Stage 3 or 4 pelvic organ prolapse
* Current use of anticholinergics
* Urinary tract infection
* Undergoing concurrent treatment for pelvic organ prolapse
* Unstable or serious cardiac arrhythmia
* Implanted pacemaker
* Postvoid residual \> 100ml
* Unstable seizure disorder
* Dementia or inability to follow instructions
Helsinki Declaration on Patient Safety

In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the investigators would like to ask medical colleagues in the region to participate in an anonymous German online survey on patient safety.

The investigators want to investigate the implementation and establishment of measures on patient safety, that anaesthesiologists utilize to fulfill their obligations.

The Declaration builds on earlier statements about safety and quality of care. It represents a shared European opinion of what currently is both worth doing and practical to improve patient safety in anaesthesiology in 2010. The Declaration recommends practical steps that all anaesthesiologists who are not already using them should include in their own practice. These are relatively straightforward and where they are currently being used have a track record of improving patient safety. All European anaesthesiology institutions are expected to support the World Health Organization(WHO) 'Safe Surgery Saves Lives' initiative including the "Safe Surgery Checklist". The Declaration was endorsed by European Board of Anaesthesiology (EBA) and the European Society of Anaesthesiology (ESA). It was officially launched at the Euroanaesthesia congress in Helsinki in June 2010 and was subsequently signed by several representatives of European anaesthesiology and different additional stakeholders (WHO, World Federation of Societies of Anaesthesiologists (WFSA), European Patients Federation (EPF)).

In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the investigators would like to ask medical colleagues in the region to participate in an anonymous German online survey on patient safety.

The investigators want to investigate the implementation and establishment of measures on patient safety, that anaesthesiologists utilize to fulfill their obligations under the perspective of the Declaration.

Eligibility Criteria:
Inclusion Criteria:

Members of the innovation alliance Berlin-Brandenburg (INABBRA)
Hispanic and White Women's Cardiovascular Health

To elucidate the influence of ethnicity and socioeconomic status (SES) on women's cardiovascular health, using recently completed risk factor and mortality data from the Stanford Five-City Project.

DESIGN NARRATIVE:

Two data sets were used to evaluate the specific aims: (1) survey risk factor data (e.g., blood pressure, cholesterol, blood lipids, smoking, etc.) on over 4500 girls and women; and (2) surveillance mortality data on over 1800 women.

Eligibility Criteria:
No eligibility criteria
Aesthetic Performance of an Injective Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen

The objective of this study was to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" technique) in woman aged 40-65 years with mild-moderate skin flaccidity and roughness of the abdomen and inner arms.


Eligibility Criteria:
Inclusion Criteria:

* female sex;
* age 40-65 years;
* 3-4 abdomen and inner arm roughness/laxity grade according to a clinical reference scale;
* asking for abdomen and inner arms laxity and roughness restoration;
* available and able to return to the study site for the post-procedural follow-up examinations;
* accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the body;
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
* accepting to sign the informed consent form.

Exclusion Criteria:

* Pregnancy;
* lactation;
* smokers;
* alcohol or drug abusers;
* subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the 1st aesthetic procedure) and at T1 (1 month after the 1st injection treatment execution, before the 2nd aesthetic procedure);
* Body Mass Index (BMI) variation (± 1) during the study period;
* performing skin treatments for abdominal and brachial zone aesthetic correction (carboxytherapy injections, body lifting, laser, infrared light, bipolar radiofrequency, vacuum and mechanical massage) in the 6 months prior to the study start;
* aesthetic surgical procedure on abdominal and brachial zone in the past;
* change in the normal habits regarding food, physical activity, cosmetic products and cleansing for the body during the month preceding the test;
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study currently or during the previous 6 months.
* Dermatitis;
* presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* recurrent facial/labial herpes;
* clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
* Diabetes;
* endocrine disease;
* hepatic disorder;
* renal disorder;
* cardiac disorder;
* pulmonary disease;
* cancer;
* neurological or psychological disease;
* inflammatory/immunosuppressive disease;
* drug allergy.
* Anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
* using of drugs able to influence the test results in the investigator opinion.
Effect of PEP'C-R on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70

The primary purpose of the protocol is to determine the effects of a new program of PEP'C "PEP'C with constant load and intermittent recovery" (PEP'C-R) on endurance parameters of older seniors.

The study hypothesis: the investigators propose that PEP'C-R training offers a significant improvement in endurance parameters for older seniors.

The secondary objectives are to determine the effects of PEP'C-R on maximal cardio-respiratory function, FMD (Flow-mediated dilation), PWV (pulse wave velocity), systolic and diastolic heart function, body composition (measured by impedance), biological, functional and cognitive functioning and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Low physical activity determined using the questionnaire IPAQ in METs (\<3).
* Informed about the results of examinations performed at screening visit.
* Subject able to understand the purpose, procedures and risks of the study and give written informed consent.

Exclusion Criteria:

* Contraindications to perform the cardiac stress test and PEP'C-R (Musculoskeletal limitations, Unstabilized heart Failure with chest pain on exertion under maximal medical therapy, ventricular and supraventricular disorders, Acute coronary syndrome within \<1 month, Unstabilized respiratory failure or oxygen-dependent)
* Abnormality shown at the cardiac stress test : clinical abnormality (chest pain), electric abnormality (found on ECG), abnormal blood pressure, abnormality of the ventilatory system (bronchospasm, hypoxemia,...)
* Cognitive impairment which exclude PEP'C-R training.
* Current Cancer chemotherapy.
* Visual Impairment which exclude PEP'C-R training.
* Presence of fibromyalgia.
* Subject treated with beta-blockers and other negative chronotropic molecules.
* Acute infection at the time of inclusion.
* Dependent patient.
Intraarticular Injection of Infliximab

Intra-articular (IA) injection of medication is a common procedure in the management of joint disorders. In particular, the procedure is effective in the treatment of inflammatory conditions, with long acting corticosteroids most commonly used. These agents have been shown to reduce the signs and symptoms of inflammation, expressed primarily in the synovium of the joint, and are probably capable of slowing the progression of damage to joint cartilage and bone in some of these inflammatory conditions. Arthritis that is refractory to IA corticosteroid injections may respond to surgical, chemical, or, radioisotope synovectomy, procedures in which the inflamed synovial tissue is eradicated. It has been noted that infliximab, a monoclonal antibody directed to Tumor Necrosis Factor (TNF) - α, has high affinity for the TNF-α rich inflamed synovium. Recently, clinical benefit from IA injections of infliximab has been reported in some cases that were refractory to IA injections of corticosteroids. Similarly, the effectiveness of IA infliximab in suppression of joint inflammation has also been demonstrated in patients who could not receive systemic therapy with infliximab. These reports examined the effect of a single injection of infliximab100 mg injected into a large inflamed joint or 2 IA injections 24 hours apart.

We propose to further evaluate the use of IA infliximab in patients with intractable knee monoarthritis, explore the optimal mode of its employment, and assess the degree of infliximab systemic absorption from the IA injection. In a pilot study 40 knees will be evaluated, 20 injected with infliximab and 20 injected with a corticosteroid comparator reflecting the current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Have non-infectious monoarthritis of the knee and with inadequate response to IA injection of corticosteroids, at least 3 months before enrollment.

or

* Have oligo or polyarthritis controlled by disease modifying agents (DMARDs) but with residual 1-2 inflamed joints, one of which is a knee with inadequate response to IA injection of corticosteroids within 3 months
* Have negative PPD skin test.
* Have no evidence of TB on chest x-ray.
* Be negative for HBsAg and HCV.
* No evidence of infectious arthritis

Exclusion Criteria:

* Known allergy to infliximab.
* Known allergy to lidocaine.
* Pregnant.
* Female patients with childbearing potential who do not practice effective methods of contraception.
* Suffer from a chronic infection.
* On systemic anti TNF-α or other biologic agents
The Conflicts of Ethics and Law on Patient's Surrogate

This study is a prospective cross-sectional survey study. The investigators developed self-administrated questionnaire and recruit 120 physicians in two hospitals and 60 lawyers from some law firms to this study.

To realize and compare the opinions of physicians and lawyers about controversial decision-making of surrogate.

This study provides three real scenarios regarding dilemma between ethics and law when patient's surrogate may not represent patient's best interest：1. Parents ask physician resect their mentally handicapped daughter's uterus. 2. A son refuse physician's suggestion of surgical treatment for his mother, instead, wishes donating his mother's kidney to his son. 3. A mother decides to give up treatment for her son's head injury because of his rebel behavior before.

T-test, ANOVA and Logistic Regression will be used to analyze in this study.

Eligibility Criteria:
Inclusion Criteria:

* resident
* visiting Staff
* chief resident

Exclusion Criteria:

* intern
* clerk
Neoadjuvant Chemoimmunotherapy in Stage IIIA- N2IIIB Non-small Cell Lung Cancer

to explore the impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world


Eligibility Criteria:
Inclusion Criteria:

* Confirmed as primary lung cancer through cytology or histological examination;

  * ECOG score of 0 or 1; ③ 18 years old or above;

    * Received imaging examination, with a preliminary clinical staging of stage III;

      * Received genetic testing and tested negative for EGFR mutations, ALK or ROS-1 fusion; ⑥ Accepting preoperative neoadjuvant immunotherapy combined with chemotherapy; ⑦ Receive surgical treatment after completion of neoadjuvant therapy; ⑧ The postoperative specimens were sent to the pathology department of our hospital for pathological testing, and a complete pathological report is available.

Exclusion Criteria:

* Patients with combined small cell lung cancer; ② Patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders;

  * Accept other neoadjuvant treatments; ④ Patients participating in any clinical trial.
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)


Eligibility Criteria:
Inclusion Criteria:

* Objective disease progression
* Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)

Exclusion Criteria:

* Infection requiring IV antibiotics
* Treatment with anticancer interventions within 14 days prior to enrollment
* Any medical condition which could compromise the study's objectives (discretion from sponsor)