cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Short-term Safety and Use Patterns of an Electronic Nicotine Delivery System

Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes have gained in popularity over the last several years. The technology used to manufacture ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content, e-liquids and flavorings. Only in the last few years have researchers begun to examine the health risks and benefits, nicotine blood levels, patterns of use, likability, and craving and withdrawal relief of ENDS. These studies have shown great variability in nicotine delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS brands among tobacco cigarette smokers.

This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is a single use unit that resembles a traditional cigarette and delivers approximately 150 puffs. The cartridge inside contains 26 milligrams of nicotine.

Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns for cigarettes and NJOY King ENDS during a one-week period in which they can use each freely.

The study includes three visits to the clinic spaced approximately one week apart. Subjects who pass the screening visit will return to the clinic for Visit 2 in which they will sample the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one week later. They will be instructed to use as many or as few as they like during the week. Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of abstinence from any form of nicotine in order to assure that they have no nicotine left in their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4) craving for cigarettes and nicotine withdrawal symptoms will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy cigarette smokers
2. Not trying or planning to quit
3. \>10 factory-produced cigarettes/day for previous year
4. Breath carbon monoxide level of \>10 ppm at screening

Exclusion Criteria:

1. Pregnancy or lactation
2. Abuse of drugs other than tobacco
3. Use of any prescription psychoactive medications within 14 days
4. Use of ENDS within 14 days
5. Use of any nicotine replacement within 30 days
Comparing Montiroing Cardiac Index by Transpulmonary Thermodilution and Transesophageal Echocardiography During Liver Transplantation

Liver transplantation poses challenges due to hemodynamic changes throughout different surgical phases. Monitoring devices are essential for therapeutic adjustments. Transpulmonary thermodilution and transesophageal echocardiography are commonly used, but thermodilution may have limitations depending on the surgery.

This study aims to compare cardiac index variations between thermodilution and transesophageal echocardiography during liver transplantation. Patients undergo monitoring with both techniques. Measurements are recorded and reported at multiple time points.


Eligibility Criteria:
Inclusion Criteria:

* liver transplantation
* adults

Exclusion Criteria:

* - Oesophageal varice ligation \< 14 days
* Mediastinal radiotherapy
* Femoral bypass
* Severe lower extremity artery disease
Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis

A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cystic fibrosis
* Over 6 years old
* FEV1 over than 30%
* Must be able to perform a spirometry
* Must be able to perform induced sputum
* Must tolerate the maximum dose of 10 ml hypertonic saline
* No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study
* No treatment with hypertonic saline in the 2 weeks before

Exclusion Criteria:

* No clinical diagnosis of Cystic Fibrosis
* No tolerance of 10 ml of hypertonic saline
* Positive pregnancy test
* No tolerance of Beta2-agonist
* Treatment with corticosteroids
* FEV1 \< 30%
* Liver and/or lung transplantation
* Oxygen treatment
* Hospital admission within the 4 previous weeks
* Oral or intravenous antibiotic treatment within the 2 previous weeks
* Smokers
* Pulmonary colonisation with Burkholderia cepacia complex
Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level

This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.

This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)

Eligibility Criteria:
Inclusion Criteria:

* Age 19-70 years with Triglyceride 120-200 mg/dL

Exclusion Criteria:

* Lipid lowering agent within past 6 months
* Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Persons with significant hypersensitivity reactions to ginseng and red ginseng
* Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
* Those who have received antipsychotic medication within 2 months before screening
* Those with a history of alcoholism or substance abuse
* Those who participated in other clinical trials within 2 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients Hospitalized for COVID-19

To better understand the role of inflammation in COVID-19, we established the Michigan Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently enrolled over 1500 adult patients (≥18 years) with severe COVID-19 admitted at the University of Michigan. The purpose of M2C2 is to define the in-hospital course of these patients and understand the role of inflammation as a determinant of organ injury and outcomes in COVID-19.

The Michigan Medicine COVID-19 Cohort is a prospective observational cohort study of patients hospitalized specifically for COVID-19 at the University of Michigan Health System in Ann Arbor. Medical records of all consecutive patients with a positive SARS-CoV-2 are reviewed, and patients with confirmed SARS-CoV-2 infection but not primarily admitted for COVID-19 were excluded.

Biologic samples of patients enrolled in M2C2 were collected, and clinical characteristics including in-hospital outcomes were characterized in detail.

Biomarkers measured include, but not be limited to, soluble urokinase plasminogen activator receptor (suPAR), high sensitive C reactive protein (hs-CRP), brain natriuretic protein (BNP), high sensitive troponin T (hsTnT), interleukin 6 (IL-6), osteopontin, a2-antiplasmin.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS-CoV-2 infection
* Hospitalized primarily for the treatment of COVID-19

Exclusion Criteria:

* SARS-CoV-2 positive but hospitalized for non-COVID-19 reasons
A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must provide written informed consent.
* Male and female outpatients and inpatients aged: ≥19
* Patients BMI shoule be ≤ 30

Exclusion Criteria:

* Patients with past history within last 12 months or current episode of severe constipation
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* Known phenylketonuria.
* Clinically relevant findings on physical examination based on the Investigator's judgment.
Improving Quality of Life for Veterans Undergoing Interferon Treatment

The purpose of this study is to evaluate a group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus. It is hypothesized that the cognitive behavioral therapy (CBT) condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status.

The purpose of the proposed pilot study is to evaluate a rehabilitative cognitive-behavioral group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus (HCV). The specific objectives of the proposed pilot study are: 1) develop study methods and materials; 2) evaluate study feasibility; and 3) assess the efficacy of a cognitive-behavioral group therapy approach and a telehealth approach as compared to care as usual in a randomized design. Participants will be 45 patients (15 participants in each condition) from the VA Boston Healthcare System who are undergoing interferon treatment for HCV. Assessment will occur at pre-treatment, post-treatment, and 3-month follow-up. Assessments will measure key areas, including adherence, quality of life, and psychological distress. Analyses will examine study feasibility and the effects of the treatment condition. It is hypothesized that the CBT condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status. This treatment approach addresses initiatives by the National VHA Hepatitis C Program by optimizing the care of veterans experiencing the devastating side effects of interferon treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hepatitis C.
* Must be on the interferon treatment
* Need to have access to telephone.

Exclusion Criteria:

* Life threatening or acute illness
* Current alcohol or substance abuse or dependence
* Individuals already receiving psychological interventions specifically to manage the side effects of the IFN treatment.
Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability, widespread pressure pain sensitivity, and cervicokinethesia in patients with mechanical neck pain.

Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability and cervicokinethesia in patients with mechanical neck pain. Patients will receive cervical spine manipulation in either right or left side of the neck and will be assessed on pain intensity, neck-related disability, widespread pressure pain sensitivity, and cervicokinethesia by an assessor blinded to the allocation group.

Eligibility Criteria:
Inclusion Criteria:

- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.

Exclusion Criteria:

* any contraindication to manipulation, e.g., positive extension-rotation test;
* whiplash injury;
* previous cervical surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone spinal manipulative therapy in the previous 6 months;
* less than 18 or greater than 65 years of age.
Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

The objectives of the current project aim to determine whether a more controlled amplification method or a visual administration has an effect on hearing impaired older individuals' cognitive test scores.

Aim 1 is to create a visually administered condition of a cognitive test and to validate this condition in comparison to the auditory administration. Data will be collected from younger individuals with normal hearing. Each younger individual is tested using both visual and auditory condition and the scores are compared across the two conditions. It is anticipated that the scores will not be significantly different between the two conditions.

Aim 2 is to examine the test condition effect on cognitive testing results in older individuals with hearing loss. The three test conditions include auditory unamplified, auditory amplified, and visual. Each older individual will be tested using two different test conditions. It is predicted the auditory amplified and visual administrations will alleviate the cognitive load associated with hearing difficulty and lead to improved performance on the test.

Eligibility Criteria:
Inclusion Criteria:

* Have sensorineural hearing loss
* Have normal or corrected-to-normal vision

Exclusion Criteria:

* Have conductive hearing loss;
* Have history of otologic or neurologic disorders
* Have dementia
* Non-native speakers of English
CLI and FAR for Intraoperative Margin Assessment

This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.

The intraoperative LightPath images will be used to inform the operating surgeon about potentially detectable cancer at the margins of the excised specimen in an attempt to achieve better guided cancer surgery and complete tumour excision with clear resection margins. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a cavity shaving of the corresponding margin, provided more tissue can be taken. Subsequent LightPath® imaging of the cavity shaving will inform the operating surgeon on the margin status of the shaving. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a further cavity shave of the corresponding margin, provided more tissue can be taken.

The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results.

A positive margin on histology will be defined as

* Invasive carcinoma: positive: \<1mm; negative ≥1mm
* Ductal carcinoma in situ (DCIS) (if present): positive: \<2mm; negative ≥2mm.

Eligibility Criteria:
Inclusion Criteria:

* • Female subjects ≥18 years of age with a diagnosis of invasive breast cancer scheduled to undergo BCS

  * Subjects who are able to give voluntary, written informed consent to participate in this study
  * Subjects who are able to understand this study and are willing to complete all the study assessments
  * Female subjects of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotrophin (β-HCG) qualitative analysis) or must have had a history of a surgical sterilisation or must give history of no menses in the past twelve months.

Exclusion Criteria:

* Subjects who have had surgery to the ipsilateral breast in the past 12 months
* Subjects who have had radiotherapy to the ipsilateral breast
* Subjects who have a known hypersensitivity to 18F-FDG
* Subjects who are pregnant or lactating
* Subjects who have an existing medical condition that would compromise their participation in the study
Clinical Performance of Posterior Composite Tooth Fillings in Adults

The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.

In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.

Eligibility Criteria:
Inclusion Criteria:

* be older than 18 years of age
* have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings
* both study teeth must be vital (tested with cold)
* both study fillings must be visible on the cheek-side of the tooth.

Exclusion Criteria:

* do not meet all inclusion criteria
* are under active orthodontic treatment
* have severe medical complications
* have dry mouth
* have chronic gum disease or poor oral hygiene
* are unavailable for long term recall (minimum of 2 years required)
* cannot tolerate the rubber dam
* have an unstable tooth contacts
* have severe bruxing or clenching, or are in need of jaw joint therapy
* are pregnant or breastfeeding.
Acute Kidney Injury After Cardiac Surgery

The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery.

Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk in patients without underlying kidney disease are lacking. Renal functional reserve (RFR) can be used to measure the capacity of the kidney to increase glomerular filtration rate under conditions of physiological stress and may serve as a functional marker that assesses susceptibility to injury.

The investigators seek to determine whether a reduced preoperative RFR predicts postoperative AKI in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery. All centres will measure RFR with creatinine clearance, except University Hospital Giessen where in addition iohexol plasma-clearance will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects older than 18 years
2. Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
3. Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
4. Subjects who signed informed consent forms

Exclusion Criteria:

1. Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
2. Chronic kidney disease ≥ stage III (KDIGO)
3. Subjects undergoing transcatheter aortic valve implantation (TAVI)
4. Pregnancy
5. Solitary kidney
6. Diabetes mellitus type 1
7. Recent cardiac arrest (within last 3 months)
8. Liver failure or cirrhosis
9. Total parenteral nutrition
10. Hemoglobin \<11 g/dl
11. Sepsis
12. History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
13. Transplant donor or recipient
14. Active autoimmune disease with renal involvement
15. Rhabdomyolysis
16. Prostate hypertrophy with International Prostate Symptom Score ≥20
17. Active neoplasm
18. Decompensated heart failure / inability to pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers minimum 2 days before protein load
19. Known iodine allergy (exclusion criteria only for those centres who use iohexol plasma clearance for determination of GFR)
20. TSH \<0.3 µU/l (exclusion criteria only for those centres who use iohexol)
21. Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load
22. Subjects who received NSAIDs within 48 hours before the protein load
Prescribe to Save Lives

The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. This study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage HIV physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.


Eligibility Criteria:
Inclusion Criteria:

Clinicians and staff of HIV practice sites that:

* Receive Ryan White Funding;
* Treat adults with HIV;
* Have 3 or more prescribing clinicians;
* Have an electronic medical record (EMR) with an electronic medication list.

Exclusion Criteria:

* Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded
Comparison of Three Robotic Platforms for Hysterectomy

Hysterectomy is the most common procedure in gynaecology after a cesarean section. In recent years, the laparoscopic approach has become preferred given the different advantages over the traditional laparotomic approach, and both conventional laparoscopy and robotic-assisted laparoscopy have become the standard approach for hysterectomy. To date, robotic-assisted laparoscopic hysterectomy has been performed using one robotic platform and only recently, two new robotic platforms have been introduced in clinical practice. Although all three are registered for human use and available for clinical practice, there are currently not enough clinical experiences and data in the literature to evaluate the efficacy, safety and relationship between cost and efficacy of the new platforms available for the robotic-assisted laparoscopic hysterectomy. For this reason, the investigators will conduct an exploratory clinical study on a Post Market Clinical Follow up (PMCF) medical device aimed at performing a preliminary assessment of the global performance of the ITL procedure implemented using the three robotic platforms currently available.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective total laparoscopic hysterectomy surgery
* Age \> 18 years
* Signature of the informed consent

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients who are candidates for hysterectomy for a non-gynaecological indication
* Patients undergoing previous radiation therapy
* Patients unable to express adequate informed consent to participate in the study