cyrilzakka/clinical-trials huggingface dataset:
Trial for Harm Reduction With Incentives & Vaping E-cigarettes

The purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ENDS) provisions and contingent incentives (CI) on smoking in individuals with overweight/obesity who smoke cigarettes (SWO). All participants will be provided information on the comparative risk of ENDS relative to cigarette smoking, and a randomized group of participants will be provided ENDS provisions for 6 weeks. All participants will complete breath samples for 28 days to measure their exhaled carbon monoxide and will either receive fixed incentives for sample completion or receive varying incentives contingent on their carbon monoxide levels. Researchers will compare groups to understand the effect of each condition on smoking-related behavior.

Individuals with overweight/obesity who smoke cigarettes (SWO) have greatly increased risks of metabolic, cardiac, and pulmonary diseases due to the synergistic effects of tobacco and obesity. Switching to electronic nicotine delivery systems (ENDS) may decrease the risk of negative health outcomes and be a promising approach for SWO. The purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ENDS) provisions and contingent incentives (CI) on individuals with overweight/obesity who smoke cigarettes (SWO). The primary aim of this study is to examine the effect of ENDS provision on smoking and the effect of the provision of CI provision on smoking. The secondary aims are to assess the effects of ENDS and CI provision on exhaled carbon monoxide (CO), cigarette dependence, intention to quit smoking, and quitting self-efficacy, and to determine whether any changes in weight occurred secondary to the use of ENDS. Evidence of the efficacy of switching to ENDS and the use of CI could be utilized in healthcare settings to reduce the risk of morbidity and mortality among smokers with obesity.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25 kg/m2
* smoked ≥ 5 cigarettes/day during the past year
* 21 or older
* exhaled CO of \> 6 ppm at Baseline
* willing to use ENDs for 6 weeks
* daily access to a Bluetooth-enabled smartphone/tablet

Exclusion Criteria:

* planning to set a smoking quit date in the next 30 days
* receiving smoking cessation treatment of any kind in the past 30 days
* currently using ENDS \> 4 day per month
* hospitalized for mental illness in past 30 days
* heart-related event (e.g., heart attack, severe angina) in past 30 days
* resides with another person enrolled in the study
* pregnant, nursing, or planning to become pregnant in the next 6 months.
Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes.

In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design.

This study is exploratory and there is no pre-specified hypothesis to be tested.

The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including subjective effects and related behavioral assessments, as well as human puffing topography (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and product use. Safety will be assessed throughout the study.

The aim is to evaluate if P4M3 Gen 2.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for current adult smokers who would otherwise continue smoking cigarettes.

Eligibility Criteria:
Inclusion Criteria:

* Subject has signed the ICF and is able to understand the information provided in the ICF.
* Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
* Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission.
* Subject does not plan to quit smoking cigarettes or using other nicotine or tobacco containing products in the next 3 months.
* Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.

Exclusion Criteria:

* As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
* Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
* BMI \< 18.5 kg/m2 or \> 35.0 kg/m2.
* Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer), which has an impact on CYP2A6 activity.
* Subject has a positive serology test for HIV 1/2, Hepatitis B or Hepatitis C.
* Subject has a history of alcohol abuse that could interfere with the subject's participation in study.
* Subject has a positive urine drug test.
* Subject has a positive alcohol breath test.
* Subject has participated in another clinical study within 30 days prior to the Screening Visit.
* Subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) or is breastfeeding.
* For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
Social Safety Learning in the Brain Oxytocin System

The investigators are conducting this research study to examine whether oxytocin enhances social safety learning (learning safety through the experience of another individual) in people with social anxiety disorder (SAD) compared to healthy volunteers. Oxytocin is a hormone that can also act as a chemical messenger in the brain. Oxytocin plays a role in a number of functions, including responding to fear and social interactions. In this study, the investigators would like to compare the effects of oxytocin and placebo nasal sprays in adults with SAD and healthy adults. This research study will compare an oxytocin nasal spray to a placebo nasal spray. About 120 people will take part in this research study, all at the University of Washington (UW).

The goal of the current study is to examine the potential role of oxytocin in enhancing social learning in SAD. The investigators' primary hypothesis is that vicarious extinction learning will contribute to safety learning and that oxytocin will potentiate vicarious extinction learning in patients with SAD, compared to healthy controls (HC). The investigators will directly test the effect of intranasal oxytocin and matching placebo on the brain mechanisms underlying vicarious extinction learning using a novel task. 60 adults with SAD and 60 healthy control participants will perform a task that involves three phases: (i) a standard social fear acquisition procedure while in a mock scanner, followed by (ii) a vicarious extinction and (iii) fear reinstatement test procedure, while being scanned during functional magnetic resonance imaging (fMRI). Participants will receive oxytocin or placebo prior to the extinction phase. The investigators will also measure skin conductance responses as an index of learning in each phase.

Eligibility Criteria:
Inclusion Criteria:

For Clinical Sample

* Men and women age 18-45
* Women must be having regular menstrual cycles and not be taking oral contraception
* Primary diagnosis of social anxiety disorder

For Healthy Sample

* Men and women age 18-45
* Women must be having regular menstrual cycles and not be taking oral contraception
* No current or lifetime history of psychiatric, neurological, or medical disorders

Exclusion Criteria:

For All Groups

* Pregnancy or breastfeeding
* Positive urine drug screening test result
* History of nasal pathology
* Current use of any psychotropic medication or steroids
* Active substance use disorder within the past 6 months
* History of serious medical illnesses or untreated endocrine diseases
* History of head injury, neurological disorder, or neurosurgical procedure
* Positive magnetic resonance (MR) screen

For Clinical Sample

* Lifetime diagnoses of mania or psychotic disorder based on the Diagnostic and Statistical Manual (DSM- 5th ed)
* Acute suicidal ideation

For Healthy Sample

* Lifetime DSM-5 diagnosis of any medical, neurological, or psychiatric illness
Effect of Hybrid Simulation Method on Advanced Life Support Application of Nursing Students

The use of simulation in nursing education is an effective way to provide professional skills and enrich learning experiences while protecting patient safety. When the literature is examined, it is seen that simulation is frequently used in advanced life support training. The aim of the study is to examine the effects of advanced life support training in adults, which will be carried out with high-reality simulator/model simulation, web-based simulation and hybrid simulation methods, on the knowledge and skills of nursing students. It has been determined that training provided with hybrid simulation contributes to the professional development of students by creating individualized and interactive learning environments, and that students can more easily transfer the knowledge they have acquired in the educational environment to clinical practice. As a hybrid simulation method in the study; It is planned to use a combination of high-reality simulator/model, which has been proven to be effective in the development of psychomotor skills, and the web-based simulation method, which is effective in creating permanent learning by allowing students to repeat more. In the literature; It has been stated that the level of knowledge and skills gradually decreases after 6-10 weeks of advanced/basic life training. It is anticipated that the web-based simulation method will be effective in providing permanent learning as it gives learners the opportunity to repeat during/after the training. Based on these assumptions, it is planned to develop an adult advanced life support training program consisting of theory and practice, in which the development of students' professional skills is supported through hybrid simulation applications, and the students are provided with the opportunity to repeat. Since the study tests 3 different interventions, it is anticipated that it will lay the groundwork for subsequent studies and provide comprehensive information about simulation-based education practices.


Eligibility Criteria:
Inclusion Criteria:

* To complete first aid, internal medicine nursing, surgical nursing courses,
* Volunteering to participate in the research.
* Having experienced the simulation application before

Exclusion Criteria:

* Fail the specified courses (taking FF)
* Not having taken first aid course/training before
* Not having experienced the simulation application before.

Disqualification criteria:

* Being absent for more than 20% of the theoretical part of the planned advanced life support training
* Not participating in the laboratory applications of the planned advanced life support training
* Not having completed the planned web-based simulation application
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)

The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR, known as the "usual prosthesis".

The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life, bringing it closer to that of asymptomatic people.

This is a prospective, multicenter, randomized, cross-over study. The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Amputee at or above knee level
* Person fitted for more than 3 months with a microprocessor-controlled knee support phase and oscillating phase, in accordance with the conditions for reimbursement set out in the LPPR.
* Person with a level of activity according to the International Classification of of Functioning, Disability and Health greater than or equal to d4602 (moving around outside the house and other buildings)
* Person able to understand simple commands, to read and write, and to give their informed consent
* Person who has given informed consent
* Person affiliated to a social security scheme

Exclusion Criteria:

* Minor
* Person of full age subject to a legal protection measure or unable to express consent
* Pregnant or breast-feeding women
* Persons with bilateral amputations
* Person with a neurological or orthopedic pathology with major repercussions on locomotion
* Persons with a ground/knee height of less than 43.5 cm or more than 55 cm
* Persons weighing more than 125 kg
* Foot size less than 24 cm or greater than 30 cm
* Person with a hip disarticulation
* Person without an emergency walking solution
* Person with a suspension fitting with vacuum pump
* Person planning a trip outside Europe or unable to return in less than 24 hours (in case of device failure) for the duration of the protocol.
Mirena Extension Trial

The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding \[HMB\]) and safety will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or for contraception and heavy menstrual bleeding. The duration of use of the current Mirena has to be at least 4 years 6 months at the start of screening phase but not more than 5 years at visit 2 and the woman is willing to continue with its use and has a continuing need for contraception.
* Normal or clinically insignificant cervical smear not requiring further follow up

Exclusion Criteria:

* Menopausal symptoms with Follicle-stimulating hormone\>30 mIU/ml
* Pregnancy or suspicion of pregnancy
* Uterine bleeding of unknown etiology
* Untreated acute cervicitis or vaginitis or other lower genital tract infections
* Increased susceptibility to pelvic infection
* Acute pelvic inflammatory disease (PID) or a history of PID unless successfully treated and which, in the investigator's opinion, has not negatively affected subject's fertility
* Congenital or acquired uterine anomaly if it distorts the uterine cavity
* History of, diagnosed or suspected genital or other malignancy and untreated cervical dysplasia
* Any active acute liver disease or liver tumor (benign or malignant)
* Clinically significant endometrial polyp(s)
Study on the Dynamic Changes of Metabolic Biomarkers and Their Prognostic Relationship in Ovarian Cancer

Ovarian cancer is a highly lethal gynecological malignancy, often diagnosed at an advanced stage, with high rates of recurrence within 1-2 years after frontline treatment. Current guidelines recommend monitoring tumor markers CA125 and HE4 for disease progression, but these markers may not detect recurrence or disease progression when their levels are below the detection limit. Therefore, there is a need to identify new prognostic biomarkers and monitor their dynamic changes for effective risk stratification and personalized treatment in patients with ovarian cancer

Ovarian Cancer is the deadliest gynecological malignancy, with over 70% of patients being diagnosed at advanced stages, and more than 70% experiencing recurrence within 1-2 years after frontline treatment. The recommended tumor biomarkers for monitoring ovarian cancer progression, CA125 and HE4, still pose the risk of recurrence and disease progression when their levels are below the detection limit. Therefore, it is of paramount importance to search for new prognostic monitoring biomarkers for ovarian cancer in order to stratify the prognosis and implement personalized treatment, ultimately improving patient outcomes. Previous research and literature have indicated that metabolic biomarkers can directly reflect the biochemical changes, physiological status, and disease progression in cancer patients. In comparison to studying the relationship between metabolite expression levels at a single time point and disease prognosis, the dynamic changes in metabolite trajectories with multiple time points can better reflect the dynamic patterns of disease progression throughout the entire cancer cycle, providing more prognostic information for patients with ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years;
* Pathological diagnosis of high-grade serous ovarian cancer;
* Newly diagnosed ovarian cancer case without prior neoadjuvant therapy.

Exclusion Criteria:

* Non-primary (recurrent) patients;
* Ovarian cancer patients who have not undergone surgical treatment;
* Patients with a history of other malignancies.
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

Subjects will receive 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks, plus cisplatin administered 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (Investigator's choice).

All subjects will be assessed twice weekly for Oral Mucositis (OM) per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT).

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
2. Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
3. Patients who have had prior surgery may be eligible,
4. Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).
5. Age 18 years or older
6. ECOG performance status ≤ 2
7. Adequate hematologic function
8. Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN

Exclusion Criteria:

1. Metastatic disease
2. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
3. Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
4. Planned concurrent chemotherapy other than single agent cisplatin
5. Receiving any approved or investigational anti-cancer agent
6. Concurrent participation in another interventional clinical study
7. Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
8. Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
9. Malignant tumors other than head and neck cancer (HNC) within the last 5 years
10. Active infectious disease excluding oral candidiasis
11. Presence of oral mucositis at baseline.
12. Known history of human immunodeficiency virus (HIV) or active hepatitis B/C
13. Female patients who are pregnant or breastfeeding
14. Known allergies or intolerance to cisplatin and similar platinum-containing compounds
15. Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating Investigator, create a risk for a precipitous decrease in blood pressure.
A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers

The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg

Exclusion Criteria:

- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Analysis of HPV and Biomarkers Present in the Biological Fluids of Patients Suffering From Head and Neck Cancer as a Non-invasive Strategy for Detecting Recurrence

Multicenter, non-interventional, retrospective/prospective biological study on patients affected by head and neck tumors, for which the collection and use of tissue samples, blood and saliva for the detection of HPV-DNA/RNA and miRNA.

For each patient they will come collected tissue, blood and saliva samples. In particular, as regards tissue collection, tumor and neighboring tissues will be used healthy specimens taken during surgical removal, according to clinical practice.

The fresh tissues thus collected will be stored in RNA-later before freezing at - 80°C.

Furthermore, blood and saliva samples will be taken at different times, in particular:

i) the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the patient's follow-up (FU): every 3 months for the first 2 years and every 6 months for the following 3 years.

The samples will then be used to carry out nucleic acid extraction, the DNA will instead be used to detect the presence of HPV.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patients suffering from squamous cell tumors of the oral cavity, pharynx or larynx
* Surgical patients with HNSCC primary tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery.
* Availability of material (tissue) and follow-up data for at least one year (retrospective part)
* Written informed consent (prospective part/patients in follow-up

Exclusion Criteria:

* Presence of distant metastases at the time of diagnosis
* Previous head and neck cancer+
* Second cancer under treatment or follow-up for less than 5 years