cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease

The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.

The high anxiety levels that children may experience during the preoperative period may be associated with negative medical, psychological, and social consequences. To reduce this stress, and to facilitate separation from parents and the induction of anesthesia, children are often given a sedative prior to undergoing a procedure. Dexmedetomidine is a highly selective a2-adrenergic receptor agonist with sedative, anxiolytic, and analgesic properties. While off-label in its use, the administration of dexmedetomidine by the intranasal route has become a popular and effective technique for sedation in children because it is non-invasive, easy to administer, well tolerated, and relatively fast in onset. Despite this, little consistent data have been published on its onset time, duration of action, or optimal dose. The only available pharmacokinetic (PK) data on dexmedetomidine in pediatric patients is in children who were administered IV dexmedetomidine. We are proposing a prospective open-label inter-subject cohort dose-escalation pharmacokinetic study to obtain peak dexmedetomidine drug concentration level in plasma and the corresponding time point following intranasal administration in the pediatric patient with cardiac disease.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects age ≥1 mo to ≤6 yo.
2. Subjects must have congenital heart disease.
3. American Society of Anesthesiology (ASA) Physical Status 1-3.
4. Subjects scheduled for elective cardiac interventional or diagnostic catheterization anticipated to last ≥ 3hours.
5. Subjects spontaneously ventilating with a natural airway scheduled for elective cardiac interventional or diagnostic catheterization anticipated to last ≥ 2 hours.
6. Subjects must have reliable intravascular access from which to draw blood samples.

Exclusion Criteria:

1. History of allergic reaction or sensitivity to dexmedetomidine.
2. Nasal pathology preventing the administration of drug.
3. Patients that are on maintenance medications that could inhibit or induce the CYP2A6 enzyme.
4. Cardiac conduction abnormalities defined as second or third degree heart block or pacemaker dependence.
5. Bradycardia, defined by age, upon arrival in the preoperative care area.
6. Hepatic dysfunction defined as a history of hepatic dysfunction AND an Alanine Aminotransferase (ALT) value greater than 2 times normal in the 6 months prior to study drug administration.
7. The subject has received dexmedetomidine or clonidine within 1 week of the study date.
8. BMI \>30.
9. Patients previously enrolled in this study.
10. Any investigational drug use within 30 days prior to enrollment.
11. Wards will not be eligible.
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.


Eligibility Criteria:
Inclusion Criteria: - Diagnosis of rheumatoid arthritis

* RA subjects
* 18 years or older
* Currently taking etanercept in pre-filled syringes for at least 4 weeks
* Subjects must give written informed consent
* Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
* Subject is pregnant or breast feeding
* Significant concurrent medical diseases
Extended Follow-Up of Participants in Preventive HIV Vaccine Studies in Uganda

Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study, were halted because people who received the vaccine were more likely to become infected with HIV. Why this vaccine failed is still being researched, but one reason may be related to the recombinant Adenovirus type 5 (rAd5) virus vector used in the vaccine. Two trials of another HIV preventive vaccine that used a rAd5 virus vector were conducted in Uganda. This study will obtain follow-up safety information on participants in those trials.

Two previous trials of an HIV preventive vaccine, referred to as the MRK rAd5 vaccine, were halted because people receiving the vaccine were at greater risk of HIV infection. The MRK rAd5 vaccine delivered parts of HIV inside a recombinant Ad5 (rAd5) virus vector, which is a modified version of a common virus that does not usually cause serious disease. Analyses of these trials found that the increased risk of HIV infection was seen only in male participants who already had detectable antibodies to Adenovirus type 5 (Ad5).

A different HIV preventive vaccine developed by the Vaccine Research Center (VRC) at the U.S. National Institutes of Health (NIH) also uses a rAd5 virus vector. Although this vaccine, referred to as VRC Ad5, uses a rAd5 virus vector, it is structured and delivered differently than the MRK rAd5 vaccine. In two trials in Uganda it has shown no serious side effects. This study will perform safety follow-ups on participants in these two trials, RV 156A/WRAIR 1078A and RV 172/WRAIR 1218. Participants who received either the vaccine or the placebo will be recruited in order to compare health and HIV status.

Participants in this study will complete eight clinic visits over 1 year and 2 weeks. Four visits will be completed at baseline and after 4, 8, and 12 months. During these visits, participants will be checked for health changes and complete a blood draw. As part of the blood tests performed, participants will be tested for HIV. Every 2 weeks after the four visits mentioned (on Days 14, 134, 254, and 374), participants will return to the clinic to receive the results of their HIV tests. On all eight visits, participants will also receive HIV risk reduction counseling.

Eligibility Criteria:
Inclusion Criteria:

* Participated in either of the following studies: (1) RV 156A/WRAIR 1078A, or (2) RV 172/WRAIR 1218
* Able to provide informed consent

Exclusion Criteria:

* Incapacitating illness precluding clinic visits
Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

The primary objective of this study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate distal subungual onychomycosis (DSO).

The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females 18 - 75 years of age
2. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail
3. Positive culture for dermatophytes
4. Signed written informed consent

Exclusion Criteria:

1. Proximal subungual onychomycosis
2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm)
3. Target toenail thickness more than 3 mm
4. "Spike" of onychomycosis extending to eponychium of the target toenail
5. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
6. Other conditions than DSO known to cause abnormal nail appearance
7. Presence of toenail infection other than dermatophytes
8. Previous target toenail surgery with any residual disfigurement
9. Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before screening/Visit 1
10. Systemic use of antifungal treatment within 6 months before screening/ Visit 1
11. Severe moccasin tinea pedis
12. Signs of severe peripheral circulatory insufficiency
13. Uncontrolled diabetes mellitus
14. Known immunodeficiency
15. Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2
16. Known allergy to any of the tested treatment products
17. A positive pregnancy test indicating pregnancy in a woman of childbearing potential at Baseline/ Visit 2
18. Females who are pregnant or breastfeeding
19. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who are of childbearing potential and are not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial
20. Patients previously randomized in this study
21. History of, or current drug or alcohol abuse
22. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient's ability to completely understand the consequences of consent is missing
23. Close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor's company
24. Patients who are institutionalized because of legal or regulatory order
25. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
Evaluation of Length of Stay After TF-TAVI

Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented.

While earlier data showed prolonged length of stay after TF-TAVI \[10.5 ± 8.1 days in the FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time period of 2007 to 2012. More contemporary data from other centers has been published showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus.

Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. Rouen University Hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. Moreover, in a prospective study, Rouen University Hospital recently shown that early discharge afterelective TF-TAVI with SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. Factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. But currently, there are no guidelines for the length of stay after a TF-TAVI.


Eligibility Criteria:
Inclusion Criteria:

* Stable patients with severe symptomatic aortic stenosis
* Patient undergoing planned TF-TAVI with the SAPIEN-3 prosthesis,
* TF-TAVI using a minimalist approach of local anesthesia and conscious sedation

Exclusion Criteria:

* The use of other (than Edwards SAPIEN-3 or XT) transcatheter aortic valve devices.
* TF-TAVI requiring general anesthesia or surgical cut-down.
* TF-TAVI performed in unstable patients or on an urgent/emergent basis.
* Non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc).
* Discharge back home impossible (including transfer in another hospital)
* Programmed transfer to another hospital
Single Dose Adductor Canal Block vs SPANK Block for TKA

This is a prospective, randomized control trial to compare SPANK block combined with adductor canal block to adductor canal block alone in treatment of post-operative pain after total knee arthroplasty. The primary outcome is pain control, which will be measured throughout the post-operative course using morphine equivalents of opioid analgesics used during the first 24 hours after surgery. Secondary outcomes include pain scores recorded at 4, 8, 12, 16, 20, and 24 hours post-operatively, cumulative pain score, incidence of post-operative nausea and vomiting, and extent of motor blockade. The study will aid in answering the question of whether SPANK block is an effective adjunct in preventing pain and decreasing opioid requirement after TKA.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 40 and 80 years old undergoing total knee arthroplasty amenable to peripheral nerve block for perioperative analgesia.
* BMI \<45
* ASA class III or less

Exclusion Criteria:

* Inability to sign consent form
* Allergy to medications used in the study
* Repeat surgery
* History of seizure disorder
* Simultaneous bilateral TKA
* History of substance abuse
* BMI \>45
* Opioid consumption of greater or equal to 30mg morphine equivalents per day
* Age \<40 or \>80 years old
* ASA IV or greater
* Inability to use a PCA
* Inability to access the intrathecal space
* Infection at the site of injection (either for spinal or PNB)
* INR greater than or equal to 1.4
Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects or men with ED aged 25 - 64
* Baseline sperm conc. of \> 20 mio / ml- Normal World Health Organization A+B+C sperm mortality \> 50%- Normal sperm morphology (WHO, 1992 manual criteria) \> 30% and - 1.0 mL ejaculate volume at each of the 3 analyses during the screening phase.

Exclusion Criteria:

* Presence of any psychological or physiological abnormalities that in the opinion of the Investigator would significantly impair sexual performance or ability to provide semen samples according to the protocol- Spinal cord injury
* History of surgical prostatectomy
* Other exclusion criteria apply according to US Product Information
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.


Eligibility Criteria:
Inclusion Criteria:

* One of the following diagnoses and candidacy for SAIZEN® therapy:

A) GHD: documented pre-established diagnosis of GHD with a growth hormone (GH) peak response of \<10 microgram per liter (mcg/L) with 2 GH stimulation tests, without priming with oestradiol.

B) Turner syndrome: documented pre-established diagnosis by karyotype.

* Prepubertal status according to Tanner Pre-established history of normal thyroid function or adequate substitution for at least 3 months.
* Weight for stature within the population specific normal range (\>5th and \<95th percentiles) for gender Willingness and ability to comply with the protocol for the duration of the study.
* Parent's or guardian's written informed consent, given before any study related procedure that is not part of the subject's normal medical care, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given.

Exclusion Criteria:

* Acquired GHD due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and history of irradiation or cranial surgery
* Previous treatment with GH, growth hormone-releasing hormone (GHRH), anabolic steroids or any treatment affecting growth.
* Previous treatment with corticosteroids, except in case of topical or inhaled corticosteroid administration for atopic disease. Corticosteroids for hormonal substitution are also allowed if the condition and the treatment regimen have been stable for at least 3 months.
* Severe associated pathology affecting growth such as malnutrition, malabsorption, or bone dysplasia.
* Chronic severe kidney disease.
* Chronic severe liver disease.
* Chronic infectious disease.
* Acute or severe illness during the previous 6 months.
* Significant concomitant illness that would interfere with participation or assessment in this study.
* Active malignancy (except non-melanomatous skin malignancies that have undergone surgical excision and/or biopsy, diagnosis and treatment to resolution)
* History or active Idiopathic intra-cranial hypertension (benign intracranial hypertension or pseudo-tumor cerebri).
* Diabetes Mellitus type I \& II.
* Any autoimmune disease.
* Previous screening failure in this study.
* Use of an investigational drug or participation in another clinical study within the last three months.
Nutritional Intervention in Hip Fracture Patients

Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Nutritional intervention starting soon after hospital admission might reduce complication rate and total length-of-stay by improving nutritional and functional status. Research questions are:

1. Does nutritional intervention reduce total length-of-stay?
2. Is nutritional intervention cost-effective?
3. Can nutritional screening contribute to targeting of nutritional intervention, and thereby reduce costs without loss of effectiveness?

Patients randomized to the intervention group will receive oral nutritional supplements (protein and energy enriched) and regular dietetic counselling during hospitalisation and after discharge at patients' homes for 3 months. Patients in the control group will receive usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6 months after inclusion.


Eligibility Criteria:
Inclusion Criteria:

* Admission to one of the participating hospitals because of a proximal femur fracture
* Age 55 years and older

Exclusion Criteria:

* Periprosthetic or pathologic fracture
* Diseases of bone metabolism, e.g. Paget, primary/secondary bone tumors, hyperparathyroidism, M. Kahler
* Life expectation of less than one year due to underlying disease (e.g. cancer)
* Presence of dementia or other severely impaired cognitive function
* Inability to communicate in Dutch language
* Nutritional intervention prior to admission
* Patients who are bedridden
* Patients who are too ill or for any other reason not able to participate adequately in follow-up
Metabolic Dynamics During Physical Activity

The aim of this study is to systematically Analyse the metabolome in capillary blood of healthy men and women at rest and during defined standardized physical activity under normobaric normoxia or hypoxia with a specific focus on metabolites and metabolic pattern related to energy metabolism. The metabolome analyses in capillary blood could give us also or more detailed insight into erythrocyte metabolic physiology because it is known for a longer time that the primary metabolism of the erythrocyte reflects its Oxygen Saturation via the glycolytic metabolites / intermediates pattern.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* written informed consent

Exclusion Criteria:

* known cardio-vascular, lung, metabolic, endocrine, hematologic, kidney or neurologic diseases
* pregnancy, lactating period
* unability to understand study content and aims and to give written informed consent
Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.

Polycystic ovarian syndrome (PCOS) is characterized by elevated androgens such as testosterone. Clinical studies suggest that ketogenic diets lower the levels of androgens. The ketone 3-hydroxybutyrate (3-OHB) may play an important role in these effects and the main purpose of this study is to investigate whether a 3-OHB supplement acutely improves the hormonal and metabolic status in women with PCOS.

Polycystic ovary syndrome (PCOS) affects 5-18% of women and is characterized by the presence of two of three of the Rotterdam criteria: Hyperandrogenism (clinical or biochemical), irregular menstrual cycles, and polycystic ovary morphology, after exclusion of other conditions that mimic PCOS. PCOS is associated with elevated levels of luteinizing hormone (LH) and unaltered levels of the follicle stimulating hormone (FSH), which leads to the characteristic hyperandrogenism (high levels of testosterone), oligo- or anovulation, and a large number of premature follicles in the ovarian. Insulin resistance causes hyperinsulinemia that decreases sex hormone binding globulin (SHBG) levels and stimulates androgen production (e.g., elevated concentrations of testosterone). Ketogenic diets are characterized by a diet low in carbohydrates, and has shown beneficial effects on weight and hormonal status in women with PCOS. Whether these improvements are mediated by ketones (e.g., 3-hydroxybutyrate, 3-OHB) or other effects related to this diet is unknown. The main purpose of this study is to investigate whether a 3-OHB supplement acutely improves the hormonal and metabolic status in women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* PCOS diagnosis
* age \>18 years

Exclusion Criteria:

* Medications affecting sex hormones (e.g. contraceptives, dopamine agonists, etc) or glucose metabolism (e.g. saxenda).
* Anemia (Hgb \< 6.0 mM)
* Practicing ketogenic diets (e.g., low-carb diet, fasting regimes)
* Inability to understand Danish or English
* Diabetes
* Ongoing cancer or other acute/chronic serious diseases (PI will determine)
The Impact of a Redesigned Handout for Robotic Sacrocolpopexy on Patient Preoperative Preparedness and Satisfaction

The goal of this clinical trial is to learn if a new preoperative handout for patients undergoing robotic sacrocolpopexy will improve patient sense of preparedness and satisfaction in comparison to the previously used handout. The main questions it aims to answer are:

* Does the new preoperative handout for patients undergoing robotic sacrocolpopexy improve patient preparedness and satisfaction?
* Will the new preoperative handout for patients undergoing robotic sacrocolpopexy impact postoperative queries in the form of phone calls and messages to the clinic?

Participants will:

* Receive routine counseling regarding robotic sacrocolpopexy from their surgeon
* Be randomized to the new or old preoperative handout
* Undergo robotic sacrocolpopexy
* Complete a questionnaire at their 4 week postoperative follow up visit regarding their sense of preparedness for surgery and overall satisfaction


Eligibility Criteria:
Inclusion Criteria:

* women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures.

Exclusion Criteria:

* patients unable to provide informed consent, those undergoing other concomitant major abdominal surgeries, patients less than 18 years old, pregnant patients, non-English speaking patients, and patients planning postoperative follow up at an outside facility.