cyrilzakka/clinical-trials huggingface dataset:
In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus

In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Comparisons:

A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.

D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.

Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers, 18 to 50 years of age.
* Habitual use of \> 7 portions snus daily since minimum 1 year.
* Healthy according to the health declaration and interview.
* Written informed consent given.

Exclusion Criteria:

* Concurrent participation in another clinical trial.
* History of allergy.
* History of allergy.
Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease

The purpose of this study is to show that the use of low volume iso-osmolar non-ionic radio contrast medium (30 cc) in a thoracic CT Scanning procedure in a selected group of patients with chronic kidney disease (CKD) will avoid contrast induced nephropathy (CIN) in comparison to a similar group of patients with CKD who receive no contrast medium..

The use of radio contrast medium enhances the image quality of CT scans. However, contrast CT is avoided in patients with CKD for fear of contrast-induced nephropathy. The current standard of care for these patients is CT without contrast. Taking advantage of fast scanning capabilities of modern CT scanners (64-Multi-Detector CT), the current investigators have developed a method to use low volume iso-osmolar non-ionic radio contrast medium (30 cc) which can be used in a selected group of adult patients with mild to moderate stable CKD (eGFR 16-60 ml/min/m\^2 for at least 12 months), who require thoracic CT imaging for diagnostic purposes. Up to 100 patients who meet the inclusion/exclusion criteria will be randomized to standard care (no-contrast, 50 controls) or low volume contrast CT (50 intervention group). The peak increase of serum creatinine levels within 72 hours after the CT procedure will be measured as an outcome variable for comparison between the two groups, as well as a safety monitoring variable in the intervention group (25% increase is the upper threshold).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented stable Chronic Kidney Disease (CKD) defined as a stable eGFR 16-60 ml/min/m\^2 for ≥ 12 months; and
* Referred to CT scanning procedure to evaluate pulmonary embolism, pulmonary malignancy, acute aortic syndromes, or renal artery stenosis.

Exclusion Criteria:

* CKD Stages 1, 2 and 5
* Stage 3-4 congestive heart failure (CHF)
* Irregular supraventricular tachycardia
* Allergic to iodinated Radio Contrast Medium (RCM)
* Allergic to Mucomyst
* Pregnancy
* Evidence of acute renal failure (ARF)
* Serum bicarbonate either less than 20 meq/L or greater than 35 meq/L
* Hydration with a bicarbonate solution is contraindicated or considered unsafe by the subject's caring physicians
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome

The primary objective is to determine if meals of different fat and fiber content affect postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our hypothesis is that a high-fiber meal will have a greater reduction in testosterone composition compared with a high-fat meal.

The study participants are 15 women with PCOS between the ages of 19-40. All participants must be in good health, non-smokers, and not pregnant or lactating. For three days prior to both study visits, participants follow a standard 2,000 calorie meal plan of approximately 30% fat, 55% carbohydrate and 15% protein. On the morning of the two study visits, participants arrive at the General Clinical Research Center at 0700 h. A venicatheter is inserted into an antecubital vein for collection of blood samples and the catheter is kept open with saline. A baseline blood sample is taken for measurement of estradiol, progesterone, glucose, insulin, testosterone, and sex hormone binding globulin (SHBG). Participants are then served the test meal and asked to consume it within 15 minutes. The high-fat, low-fiber and low-fat, high-fiber meals are isocaloric and are 62% and 6% fat, 24% and 81% carbohydrate, and have 1g and 26.8g of fiber, respectively. After each meal, a blood sample is taken at 30 minutes and every hour for six hours for measurement of testosterone, SHBG, glucose and insulin. During this time participants remain comfortably seated or reclined. After the last blood draw, the catheter was removed and participants are given a complementary meal.

Eligibility Criteria:
Inclusion Criteria:

* Chronic oligo/anovulation - intermenstrual periods of ≥ 45 days or ≤ 8 menses per year.
* Hyperandrogenemia - elevated total testosterone or free androgen index (ratio of testosterone/SHBG x 100). To participate in the study, women must have total testosterone \>50 ng/dL or a free androgen index \>1.5
* In good general health

Exclusion Criteria:

* Currently pregnant or lactating
* Use of confounding medications such as oral contraceptives or other hormonal medication, lipid lowering medications or insulin sensitizing agents such as metformin or the glitazones.
* Tobacco use
* Alcohol consumption of more than two drinks per day
* Unusual meal patterns (including no breakfast, breakfast before 6 am or breakfast after 10am.
* Untreated hyperprolactinaemia (Prolactin \>25ng/ml)
* Uncontrolled hypothyroidism
* History of blood clotting disorder
* Diagnosis of anemia at baseline visit
* Presence or history of diabetes mellitus
* Existence of an organic intra cranial lesion such as a pituitary tumor.
* Presence or history of coronary artery disease
A Study to Evaluate EDP 938 Regimens in Children With RSV

A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.

Eligibility Criteria:
Inclusion Criteria:

* Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 days to \<6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born ≥29 weeks of gestation to be eligible.
* Subjects diagnosed with RSV infection
* Subjects with signs of an acute respiratory illness with onset ≤7 days for Part 1 and ≤5 days for Part 2 before the time of signing the ICF
* In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

Exclusion Criteria:

* Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
* Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
* Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
* Receiving chronic oxygen therapy at home before admission
* Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age
* In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.
A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism

The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of \[14C\] SHR6508.


Eligibility Criteria:
Inclusion Criteria:

1. Be able and willing to provide a written informed consent form.
2. Male subjects and postmenopausal women.
3. Meet the Body Mass Index (BMI) standard.

Exclusion Criteria:

1. Subjects with a history of cardiovascular diseases.
2. Subjects with gastrointestinal diseases.
3. Subjects with a history of surgery.
4. Subjects with a history of blood loss.
5. Abnormal blood pressure.
6. Be allergic to a drug ingredient or component.
7. Subject with a history of alcohol abuse and drug abuse
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease
* Confirmation of hormone receptor (HR) positive disease status
* Amenable to receive endocrine therapy
* Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer
* Postmenopausal woman ≥ 18 years old

Exclusion Criteria:

* HR-unknown or HR-negative disease
* Not amenable to endocrine therapy
* Central nervous system metastasis
Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.

Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation

A side effect of some volatile anesthetics, such as isoflurane and desflurane, is enhanced automaticity, accounting for secondary atrial pacemakers. Volatile anesthetics also have varying effects on the AV node and His-Pukinje system. These agents also prolong the QT interval and, for this reason, volatile anesthetics as a group have at times been avoided for atrial fibrillation ablation due to the fear that they may affect the efficacy of the ablation and increase recurrence. However, sevoflurane does not have the effects shown for other volatile anesthetics cardiac conduction. At this point there has not been a study comparing propofol, a non volatile anesthetic typically used in these cases, to sevoflurane, a volatile anesthetic, to determine if volatile anesthetics should be avoided during these procedures. This study will challenge the existing belief that sevoflurane increases the length of time to ablate atrial fibrillation and also decreases the efficacy of the ablation.

Eligibility Criteria:
Inclusion Criteria:

* have paroxysmal atrial fibrillation
* undergoing their first ablation.

Exclusion Criteria:

* none
Effect of Lowering IOP in Glaucoma Suspects With HM

Currently, whether and when intraocular pressure (IOP) lowering medication should be used in glaucoma suspects with high myopia (HM) is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the incidence of glaucoma suspect progression in HM eyes.

HM is associated with increased prevalence of glaucoma. However, accurate diagnosis of glaucoma in HM is a challenge. More and more viewpoints had been raised that HM eyes with optic disc head damage or/and visual field (VF) defects should been classified as glaucoma suspects.

IOP is the only modifiable parameter in glaucoma and glaucoma suspect patients. However, the decision to begin treatment to lower IOP in the glaucoma suspect patient is complex, especially for glaucoma suspects with HM. There are lack of guideline and consensus of treatment choices. Therefore, it is necessary to investigate the effect of medically IOP lowering on the progression of glaucoma suspects with HM.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 35 and 65 years.
2. Diagnosed with high myopia (spherical equivalent ≤ -8.00 diopters or axial length ≥ 26.5 mm).
3. Diagnosed with glaucoma suspect, which cannot be explained by myopic macular changes, or other retinal and neurologic condition.
4. IOP ≥ 12 mmHg and ≤ 24mmHg on at least 2 visits, as measured by Goldmann applanation tonometry.
5. An open anterior chamber angle as based upon gonioscopy.
6. Best corrected visual acuity (BCVA) ≥ 6/12.

Exclusion Criteria:

1. Allergy to prostaglandins.
2. Advanced VF loss (MD worse than 16 dB) or a threat to fixation (sensitivity 10 dB or worse affecting either or both test points closest to the point of fixation in the upper hemifield and at either or both of the corresponding test points in the lower hemifield) in either eye.
3. Previous IOP-lowering surgery in the study eye (i.e. trabeculectomy, Ahmed glaucoma valve implantation, any laser trabeculoplasty).
4. Previous cataract surgery in the study eye.
5. Previous corneal refractive surgery in the study eye.
6. Clinically significant or progressive retinal disease such as proliferative diabetic retinopathy, retinal detachment, central retinal vein occlusion, or retinitis pigmentosa in the study eye.
7. Chronic, recurrent or severe inflammatory eye disease in the study eye (from screening), such as chronic or recurrent uveitis.
8. Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, or monophtalmia.
9. Need for ocular surgery/laser or anticipated need for cataract surgery that would influence the ophthalmological parameters measured in this study during the study period.
10. Other serious systemic diseases (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases).
11. Pregnant or nursing women.
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study

The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers.

Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be repeated.

Primary outcome parameter is Lamotrigine AUC before and after coadministration of paracetamol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy no medication use
* Informed consent

Exclusion Criteria:

* Allergy to paracetamol or lamotrigine
Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial

The purpose of this study is to determine the effectiveness of a program to improve habits in a population with cardiovascular disease, comparing two different educational techniques (cognitive behavioral therapy group vs. informational workshops).


Eligibility Criteria:
Inclusion Criteria:

* Patients who live in the catchment area of the health centers participating in the trial or that have their primary care physician in these centers.

or

* Patients with a diagnosis of coronary heart disease, and / or transluminal angioplasty and / or coronary artery bypass grafting (CABG). These diagnoses must have occurred longer than six months from the time of inclusion.

or

* Patients with a diagnosis of cerebrovascular accident (CVA), transient ischemic attack (TIA), carotid endarterectomy and / or carotid angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion.

or

* Patients with peripheral arterial disease with or without intermittent claudication, revascularization surgery, bypass placement of arterial and / or peripheral arterial angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion.

and

* Sedentary persons, defined as less than 90 minutes per week of moderate aerobic physical activity in their daily life (leisure, travel or work).

Exclusion Criteria:

- Patients on chronic home monitoring and / or institutionalized before admission or living in a tertiary institution.

or

* Moderate or severe limitation on functional capacity and / or mobility. or
* Patients with dementia. or
* Patients diagnosed with psychiatric illnesses that compromise patient autonomy. or
* Life expectancy less than 1 year. or
* Patients who do not want to take part in the program. or
* Patients who are participating in another research protocol at recruitment. or
* Patients with a diagnosis of intracranial hemorrhage secondary to aneurysmal rupture.
Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion

According to the figures for the last three years collected from the Indian Ocean Regional Health Observatory, it appears to be about twice as many voluntary terminations of pregnancy on the island of Reunion compared with France metropolitain region.

Furthermore, the overseas section in 2002, which looked at violence against women of all types in three different spheres of life (the marital sphere, the workplace and public spaces), tends to show a much higher incidence of sexual violence than in metropolitain France.

This trend seems to be confirmed by the overseas section of the VIRAGE survey started in 2018 on the island.

Furthermore, data found in a qualitative study conducted in Ile de France in 2013 seems to demonstrate a more frequent use of abortion among patients who are victims of sexual violence.

Thus, thiçs study will consist in evaluating the impact of sexual violence on the incidence of voluntary termination of pregnancy in Reunion Island.


Eligibility Criteria:
Inclusion Criteria:

- Adult patient coming for an abortion request at the CHU SUD and NORD, at the GHER and at the CEPS for the CHOR (Reunion Island)

Exclusion Criteria:

* Patient coming to the above-mentioned centres for a "post-abortion" consultation.
* \<18 years
* Patient who does not speak French.
* Illiterate patient.
* Patient who has already completed the questionnaire.
* Patient refusing to participate in the study.
Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

The purpose of this study is to assess the effectiveness of RaPID/BSI by testing its performance compared to blood cultures collected prospectively from consented subjects.


Eligibility Criteria:
Inclusion Criteria:

* Determined to have a positive blood culture.

Exclusion Criteria:

-
Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study

A randomised controlled trial that will compare the effects of a brief benefit -finding writing intervention with an active control condition on quality of life and psychological health among informal caregivers.

A double-blind, randomized controlled parallel group study design with an equal 1:1 allocation ratio will be employed. This study will compare the effect of a brief benefit finding writing intervention with a control condition among caregivers. Caregivers currently caring for people with mental and physical disabilities will be randomised into a two-week, a) a benefit writing group or b) a control writing group. Caregivers will complete self-report measures relating to their care-recipient and themselves (e.g., illness type, and sociodemographics) and psychometric measures of benefit finding (primary outcome), psychological distress and quality of life(secondary outcomes). These will be assessed via online software at baseline, immediate post-test and at 3 month follow-up. Additionally, expectations and fidelity indices will be assessed and qualitative commentary on participation experiences gathered.

Eligibility Criteria:
Inclusion Criteria:

* Must be over the age of 18
* Must identify as caring for a family member, friend or relative
* Must be living in Ireland

Exclusion Criteria:

* If the person cared for is living in institutional care
Psychedelic Virtual Reality

The purpose of this study is to evaluate a novel VRP.

The primary objective of this study is to determine whether the subjective experience of a novel VRP (DeepDream) will be comparable to a standard dose of psychedelics. This study also looks to compare the subjective experience of DeepDream VRP to other available VR modalities developed to mimic psychedelic subjective experience along with assessing the incidence of VRP adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* No history or current DSM-V diagnosis

Exclusion Criteria:

* Unstable medical conditions
Single Cell Sequencing Analysis of Thymoma

The purpose of this study is to understand how genetics play a role in thymoma. Intratumoral heterogeneity is among the greatest challenges in precision cancer therapy. However, developments in high-throughput single-cell RNA sequencing (scRNA-seq) may now provide the statistical power to dissect the diverse cellular populations of tumors. This study aims to find out how it affects genetic and protein expression in patients with malignant thymoma, compared to Benign thymoma, at a single-cell level using a flow cytometry and RNA-sequencing protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with thymoma
* Ability to provide written consent and comply with the protocol
* At least 18 years of age

Exclusion Criteria:

* Patients undergoing thymoma treatment
* Patients with previous malignancy
* Known HIV positive status.
* Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
One-Stage Exchange for Chronically Infected Total Hip Arthroplasty

The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure.

The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure


Eligibility Criteria:
Inclusion Criteria:

* Chronically infected total hip Arthroplasty
* One-stage exchange procedure operated on at the investigators institution between January 1, 2007 and November 30, 2010

Exclusion Criteria:

* Patient refused to participate