cyrilzakka/clinical-trials huggingface dataset:
Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.

This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.

Eligibility Criteria:
Inclusion Criteria:

* healthy, male and female subjects aged between 18 and 65 years old.
* normal body weight.
* normal ECG, vital signs and lab tests.
* normal kidney function
* agree to use acceptable contraceptive methods required.
* capable of giving written informed consent.

Exclusion Criteria:

* positive blood alcohol or urine drug test.
* positive hepatitis B/C and HIV
* donation of more than 450 mL blood within the 56 days.
* sensitivity to gabapentin
* pregnant or lactating females
* smoker
* certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
* history of seizure
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System

Collect and evaluate the long term safety data.

The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has given written study Informed Consent for participation prior to any study procedures.
2. Subject is ≥ 18 years of age or legal age in host country at time of consent.
3. Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve

Exclusion Criteria:

1. Subject currently participating in another investigational device or drug study.
2. Subject is unable or unwilling to return for the required follow-up visits.
Doppler Indices to Predict Spinal Hypotension During Cesarean Section

Spinal anesthesia is safe and advisable anesthetic during cesarean section, despite that spinal induced hypotension is a common associated problem. Therefore early recognition of these critical events should take high priority to avoid serious consequences. in this regards several parameters were available to detect spinal hypotension but non is satisfactory till now. Researchers of this study aimed to evaluated the diagnostic accuracy of femoral artery Doppler to predict hypotension


Eligibility Criteria:
Inclusion Criteria:

* ASA II
* singleton pregnancy
* full term

Exclusion Criteria:

* vascular disease
* contraindication to spinal anesthesia
* inability to obtain adequate Doppler
Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device

This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.

The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up.

The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults subjects (≥18 years old).
* Subject implanted with FHK ASYMETRIQUE prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
* Subject who received an information form and is willing to participate in the study.

Exclusion Criteria:

* Contraindications described in the instructions for use
* Usual surgical contraindications
* Patients objecting to participate in this study
* Subject who is not able to express his/her non-opposition
Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers

The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.

The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 30 years
* Smoke at least 100 cigarettes in their lifetime
* Now smoke cigarettes on all or some days
* Reside in the Washington, DC metro area
* Willing to send and receive text messages on a personal mobile phone

Exclusion Criteria:

* No additional exclusion criteria
Fish Oil for Cognitive Function, Sleep Quality, and Bone Density

The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. This ancillary study is being conducted among PNMD participants and will examine whether fish oil supplements affect A) cognitive function, B) sleep quality, and C) bone mineral density. Cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants. The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone density.


Eligibility Criteria:
Inclusion Criteria:

1) diagnosed type 2 diabetes according to WHO diagnostic criteria or those on the use of diabetic medications; 2) between 40 and 75 years old (postmenopausal women); 3) have never used n-3 PUFA supplements before or have stopped using them for more than six months.

Exclusion Criteria:

1) type 1 diabetes; 2) coronary heart disease, stroke, cancer, hepatic or kidney disease; 3) pregnancy or lactation; 4) allergy to fish; 5) have participated in other clinical trials in the last three months.
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine

Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.

Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa

Eligibility Criteria:
Inclusion criteria:

* Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.

Exclusion criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
* Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.

The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations

This study is a preliminary device safety and performance evaluation in healthy adult volunteers (ages 18-55 years).

Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:

* Upper deltoid with the side-load ID adapter
* Upper deltoid with the autodisable (AD) ID adapter
* Suprascapular (behind the shoulder) with the side-load ID adapter
* Suprascapular with the AD ID adapter
* Forearm with the side-load ID adapter
* Forearm with the AD ID adapter

Intradermal administration of each injection will be assessed:

* The liquid remaining on the surface of the skin will be blotted with absorbent paper and the amount of liquid present will be recorded.
* The formation of an intradermal wheal will be observed, and the diameter of the wheal measured using a ruler or similar measurement tool.
* A photo of the injection site will be taken.

Injections will be assessed for safety by observation of injection sites for any local adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Female and male participants ages 18 to 55 years.
* Healthy enough to participate in the clinical trial per site investigator assessment.
* Healthy skin on the upper deltoid, suprascapular, and forearm regions (both sides of the body).
* Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
* Literate in English.
* Available by telephone 48 hours after the study visit.

Exclusion Criteria:

- Skin abnormalities on upper deltoid, suprascapular, and forearm regions of either side of the body (scars, rash, infection), tattoo at the injection site, or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
Mindful Steps: Promoting Physical Activity

This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD OR clinical diagnosis of HF syndrome (New York Heart Association Class 1-3)
* Able to participate in an exercise program
* Have an active email account and access to a computer with internet connection

Exclusion Criteria:

* COPD or HF exacerbation in the previous month
* Inability to ambulate
* Clinical signs of unstable cardiovascular disease
* Hypoxemia during 6MWT
* Inability to collect at least 7 of 14 days of baseline step counts
* Current participation in a cardiac or pulmonary rehabilitation program.
Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy

The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and change in patient with ectopic pregnancy who needs to surgical treatment.

Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be included in the study. This is an observational study.The plasma Vascular Endothelial Growth Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.

This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board. This study will be completed with 30 patients with ectopic pregnancy. An intervenous cannula will be centrifuged for 15 minutes at 1000 g within 30 minutes of collection. Aliquots of plasma will be added to eppendorf tubes and stored at -20°C.

Plasma Vascular Endothelial Growth Factor levels will be measured using a Human VEGF-A Platinum ELISA kit (bioscience company, Catalog No: 00122, Santa Clara, California, USA). All assays will be performed according to the manufacturer's instructions. The test kit sensitivity is 2.5 pg/ml. Intracycle variability is %4-6, intercycle variability is %8-10.

Eligibility Criteria:
Inclusion Criteria:

* Patients who suspected ectopic pregnancy

Exclusion Criteria:

* hemodynamically unstable patient
* healthy pregnancy (a healthy increase in ß HCG)
* missed abortion
* incomplete abortion
* The patient who need immediate surgical treatment
Pars Plana Vitrecromy in Patients Aged 85 Years and Above

We reviewed the records of 120 consecutive patients (male and female), aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in the center until December 2015.

We reviewed the records of 120 consecutive patients (male and female), aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in the center until December 2015. We will be measuring visual acuity, intra-ocular pressure, demographics (age, gender), indication for surgery, ocular co-morbidities, surgical parameters (time of surgery, type of anesthesia - general or local, type of suture), and intraoperative and postoperative complications.

Primary outcome - visual acuity will be measured at base line, after 1 week, 1 month, 3 months, 6 months / last follow up (until December 2015). visual acuity will be determined by a standardized chart test (Snellen chart). For statistical analysis, all VA values were converted to logMAR scale. According to Holladay and the University of Freiburg study group results, blindness was set at 0.00125/2.9 (decimal/logMAR), light perception at 0.0025/2.6, hand movements at 0.005/2.3 and counting fingers at 0.014/1.85. Data will be analyzed using SPSS software. A p-value of 0.05 will be considered statistically significant and t-tests analysis will be used to compare between means.

Secondary outcomes - demographics, Indication for surgery, ocular co morbidities will be measured at baseline. Surgical parameters and intraoperative complications will be measured at 1 week. Postoperative complications will be measured during follow up after 1 week, 1 month, 3 months, 6 months / last follow up (until December 2015).

Complications will be measured by examination of intraocular pressure, slit-lamp and fundus (Ophthalmoscopic Exam).

Eligibility Criteria:
Inclusion Criteria:

Patients aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013

Exclusion Criteria:

ANy other
HIV-DNA Dynamics in HIV Monoinfected or HIV/HCV Coinfected Patients

New markers of viral activity are now under investigation. Aim of the study is to investigate the efficacy of new antiretroviral drugs by monitoring HIV-DNA dynamics in HIV-positive population. In HIV/HCV coinfected population, the study of HIV reservoir dynamics and the analysis of the prevalence of HCV resistance-associated mutations will help clinicians to improve the management of coinfected patients.

New markers of viral activity are now under investigation. Besides HIV-RNA and CD4 cells count, HIV-DNA is an emerging marker of viral reservoir, that seems to be associated with the risk of HIV-related diseases, especially in HCV coinfected patients. New antiretroviral drugs, particularly integrase inhibitors, are expected to decrease residual viremia and, consequently, viral reservoir. Monitoring of HIV-DNA dynamics during antiretroviral treatment could lead to a better management of HIV infected population.

Also, the role of HCV in influencing HIV natural history requires careful monitoring. In particular, with a broader use of direct acting antiretroviral, the analysis of prevalence of HCV resistance associated mutation will be more and more important to manage patients with treatment failure.

Eligibility Criteria:
Inclusion Criteria:

* Persons ≥ 18 years-old;
* Signing an informed consent to study participation and data treatment;
* HIV-positive patients, beginning a new antiretroviral treatment patients or with clinically relevant events;
* HCV-positive patients beginning an antiviral treatment with DAA.

Exclusion Criteria:

* Patient's deny
* Clinical contraindications to blood sample withdrawal
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke

Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≤ 6 months
* Fugl-Meyer Assessment score ≥ 19
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* Severe upper extremity pain that could interfere with rehabilitation therapy
* Neurological disorders other than stroke that can cause motor deficits
* Uncontrolled severe medical conditions.
Cerebral Microemboli in Venoarterial ECMO Patients

Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes.

In venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated ME are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. Although patient exposure to cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral ME in patients undergoing ECMO therapy.

The primary study goal of this study is to determine the load and nature of cerebral ME in critically ill patients under va-ECMO support. We also aim to compare the results to measurements in healthy subjects und intensive care unit (ICU) patients without extracorporeal support to get a better impression on the relevance of ME generation during ECMO support.

The addition of ICU patients was made according to reviewer suggestions after an initial submission to a medical journal.

Eligibility Criteria:
Inclusion Criteria (for patients):

* Intensive care patients with cardiac or respiratory failure under va-ECMO therapy
* Age \> 18 yrs.
* Signed informed consent

Exclusion Criteria:

* use of any other extracorporeal device including venovenous (vv) ECMO
* continuous renal replacement therapy
* medical history of severe mitral or aortic stenosis
* medical history of severe mitral or aortic regurgitation
* medical history of carotid stenosis \> 70 %
* septicaemia
* medical history of vascular dementia or Alzheimer's disease
* inclusion in an other clinical study
* gravidity
* allergy against materials of one of the medical device used in the study
Dyadic Psychological Stress Among Lung Cancer Patient-caregiver Dyads

A lung cancer diagnosis has a huge impact on the psychological well-being of both patients and family caregivers. However, the current psychological stress status among dyads remains unclear. The investigators aimed to determine the prevalence of anxiety and depression and identify the factors that influence patients with lung cancer and their caregivers. The investigators will conduct a cross-sectional study of 254 dyads of lung cancer patients and family caregivers from four tertiary hospitals in Hunan Province, China from January 2021 to June 2021. Besides, the investigators used several instruments to collect data on depression, anxiety, illness perception, mindfulness, self-compassion, and dyadic coping. The independent samples t-test, analysis of one-way variance, Spearman's correlation analysis, and multiple linear regression analysis were employed. The results will recommend oncology nurses promptly screen high-risk patient-caregiver dyads who may suffer from severe psychological stress and provide them with targeted psychosocial interventions.


Eligibility Criteria:
Inclusion Criteria:

* As for patients: aged≥18 years; hospitalized patients with lung cancer diagnosed by pathological section or cytology; and relatively stable condition, conscious, and able to express their willingness correctly.
* As for caregivers: aged ≥18 years; a primary caregiver with a cumulative caregiving time of more than 33 hours; and a family member of the patient with lung cancer, such as spouse, children, parents, or other relatives.

Exclusion Criteria:

* As for patients: people with a combination of other cancers or serious life-threatening diseases; the presence of audiological disorders or previous mental or cognitive disorders, such as anxiety disorder, or depression disorder; and receiving mental disorder treatments.
* As for caregivers: formal caregivers with employment relationships, such as nannies; the presence of audiological disorders or previous mental disorders or cognitive disorders, such as anxiety disorder, depression disorder; and receiving mental disorder treatments.
Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis

This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT), will be performed at baseline and again \~4 weeks after treatment with study drug. We will also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before each time the MMTT/OGTT are performed. Several hormones that may affect the way the body regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine has on the hormones measured during the OGTT and MMTT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CF between 13 and \<21 yrs old
* Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
* No history of CFRD

Exclusion Criteria:

* Insulin use in the last two months
* Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
* History of pancreatitis in the last 12 months
* Skin rashes or conditions that may affect CGM placement and wear
* Pregnancy or intent on becoming pregnant
* Patients on growth hormone therapy
* Renal insufficiency with creatinine clearance \<50 ml/min (based on Schwartz formula)