cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects

The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
* Women who are not of childbearing potential

Exclusion Criteria:

* Women of childbearing potential
* Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
* Gastrointestinal disease that may impact the absorption of study drug
* History of any chronic respiratory disease (asthma, COPD)
Training of the Inspiratory Musculature in the Improvement of Inspiratory Strength and Muscle Recovery in Soccer Players

Soccer requires the activation of aerobic and anaerobic metabolism. The increase of the ventilatory demand stimulates the increase of the neural impulse to the respiratory muscles, increasing the mechanical power of the inspiratory muscles.

The main objective of the study is to assess the effectiveness in the improvement of the strength of the inspiratory muscles and the muscular recovery with the Powerbreathe® device in semi-professional soccer players.

Randomized double-blind clinical study with follow-up period. 36 semi-professional soccer players from the province of Soria will be randomly distributed to the study groups: experimental (inspiratory muscle training with 50% resistance) and control (10% resistance training). The dependent variables will be: aerobic and anaerobic sports performance (Cooper's 12-Minute Run Test and Repeated Sprint Ability), blood lactate concentration (Lactate Scout®), and lung function using the ergo-respiratory parameters (maximum inspiratory pressure, expiratory pressure maximum, forced vital capacity and forced expiratory volume in 1 second). The sample distribution will be calculated using the Kolmogorov-Smirnov test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.

It is intended to observe improvement in inspiratory strength levels, decrease in blood lactate concentration and an increase in aerobic and anaerobic sports performance.


Eligibility Criteria:
Inclusion Criteria:

* Football players
* Male
* With an age range of 18 to 35 years
* Which currently compete in the category of Spanish third division nationally.

Exclusion Criteria:

* Subjects who have some type of injury that prevents them from practicing sports at the time of study
* With medical diagnosis of respiratory pathology
* That are not able to overcome the respiratory resistance of the device
* Have not signed the informed consent document.
Coiling of Echogenic Sciatic Nerve Perineurial Catheters with Integral Stylet

Coiling of perineurial catheters under the sciatic nerve and examination of catheters position through ultrasound imaging 36 hours postoperatively.

To assess procedural effectiveness of the preferred coiling technique (method B), a pilot study was performed. Straight perineural catheters with coiled distal ends behind the sciatic nerve were examined in 25 patients who had sustained tibia fractures.

Patients were placed in the lateral position (with the injured leg uppermost) and a US-guided sciatic nerve block was performed under aseptic conditions. The sciatic nerve was visualized at the upper third of the posterior thigh (short axis view) and a Tuohy needle (21 G × 10 mm, SonoLong/NanoLine, PAJUNK, Germany) was inserted in a lateral to medial direction. The needle was placed underneath the sciatic nerve and 10 ml of ropivacaine (0.1%) were injected. A perineural catheter (with retracted integral stylet by 6 cm) (SonoLong Sono, PAJUNK, Germany) was then threaded through the needle tip and coiled behind the sciatic nerve. Confirmation of correct catheter tip placement was defined as adequate spread and contact of ropivacaine injectate (3 ml, 0.1%) with the sciatic nerve (Figure 2C). If the distribution of the local anaesthetic (LA) could not be visualized on the first infusion, 2 additional injections were performed until the distribution was clearly seen. If LA spread could not be visually confirmed, or if, when confirmed, LA did not come in contact with the sciatic nerve, the case was excluded.

Subcutaneous tunneling (4 cm long) and placement of a transparent adhesive dressing were used to secure the catheter. All sciatic nerve blocks were followed by an adductor canal block (10 ml of ropivacaine 0.5%) and general anaesthesia. A continuous infusion of ropivacaine (8-12 ml, 0.1%) was commenced and a combination of oxycodone 5 mg with paracetamol 325 mg was provided on an as-needed basis after surgery.

All nerve blocks were assessed and data were collected in the post-anaesthetic care unit, and every 12 hours thereafter until 36 hours postoperatively from members of acute pain service (APS) team not participating in the study.

Eligibility Criteria:
Inclusion Criteria: Orthopaedic patients with Tibia fractures

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Exclusion Criteria:

* Patients with infection in the sub gluteal region.
* Allergies to local aesthetics
* Patients refusal to consent for the nerve block
* Neurological disorders
* Pregnancy
Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery

In patients undergoing coronary artery bypass surgery, the relationship between neurocognitive changes seen in the early period and brain-induced neurotrophic factor serum levels will be investigated.

Although postoperative cognitive dysfunction (POKD) is the most common neurological complication in patients undergoing coronary artery bypass grafting (CABG) surgery, its pathophysiology is still not fully understood. However, the quality of this dysfunction has not been properly measured. In addition to clinical tests, biomarkers are often used to detect the presence of POKD. In this study, it was aimed to evaluate the relationship between intraoperative and postoperative brain-derived neurotrophic factor serum levels and POKD in patients undergoing CABG surgery.

This prospective observational study is planned to include 30 adult patients aged 40-90 years. Patients with stroke history, neurodegenerative disease, seizure history, alcohol use, general anxiety, hearing deficit, unilateral carotid artery stenosis greater than 70%, and carotid artery bilateral stenosis greater than 50% will be excluded from the study.

This study aimed to determine perioperative changes in serum brain-derived neurotrophic factor levels in patients undergoing CABG surgery.

Eligibility Criteria:
Inclusion Criteria:

* At Least Primary School Graduates,
* Not Using Drugs That May Affect Cognitive Functions,
* No Alcohol Substance Use,
* Without Psychiatric And Neurological Diseases

Exclusion Criteria:

* Uneducated Patients,
* Drug Users Who May Affect Cognitive Functions (Antipsychotic, Antidepressant),
* Have Alcohol And Substance Use Disorders,
* Those With A History Of Central Nervous System Disease That May Cause Cognitive Dysfunction (Such As Stroke, Neurodegenerative Disease, Seizure, General Anxiety),
* Hearing Deficit,
* Patients With Unilateral Carotid Artery Stenosis Greater Than 70% And Bilateral Stenosis Greater than 50% Carotid Artery
The Impact of Enhanced, Demand-side Sanitation and Hygiene Promotion on Sustained Behavior Change and Health in Ethiopia

This study is a two-year evaluation investigating the impacts of an enhanced, demand-side sanitation and hygiene intervention on sustainable adoption of improved water, sanitation, and hygiene (WASH) practices and mental well-being.

This study utilizes a cluster randomized, controlled trial design to examine the impacts of an enhanced, demand-side sanitation and hygiene intervention on behavior change and health in Amhara, Ethiopia. The study will test hypotheses set out in the investigation team's theory of change through the measurement and evaluation of process indicators, intermediate and shorter-term behavioral outcomes, and longer-term behavioral and health impacts, including mental well-being.

The study aims to: (1) identify ways in which WASH-related behavior change components preventive for neglected tropical diseases (NTDs) can be mainstreamed into the government-led Health Extension Program; (2) document the effectiveness of an enhanced demand-side sanitation and hygiene intervention; (3) investigate whether changes in personal hygiene, sanitation, and water behaviors are sustained; (4) document the cost-effectiveness of integrated WASH-related NTD-preventive behavior change promotion; and (5) assess whether collective efficacy and water security modify intervention effectiveness.

Eligibility Criteria:
Inclusion criteria:

* Households residing in kebeles in select woredas of Amhara National Regional State
* Households with at least one adult (18 years of age or older) who provides consent to serve as the survey respondent
* Households with at least one child aged 1-9 years (at baseline) living in the household and consenting to enrollment in the study, including study staff observation of children, specifically their faces and hands

Exclusion criteria:

* Households that refuse to provide consent to enroll in the study or have one adult consent to serve as the survey respondent
* Households that are repeatedly vacant or do not have an appropriate member of the household home to serve as the household's respondent (capable adult 18 years or older) after three attempts within the course of one day (for study enrollment and baseline)
* Households that do not have a household member aged 0-5 years of age (at baseline) living in the household
Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients

Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations (pancreas, lungs, brain and stomach), including risk factors are not always identified.

Advanced stage cancer (= metastatic) is most often incurable with the exception of germ cell tumors. Palliative care is then most often offered. Palliative care favors the patient's quality of life as a whole (medical, physical, psychological and social).

The symptoms most often reported by patients are: pain, fatigue, decreased appetite, nausea, and are directly related to phenomena such as cachexia, loss of autonomy and deterioration of psychological state, resulting in decreased overall survival. Chemotherapies and targeted therapies (immunotherapy, hormonal therapy, participation in a clinical trial) can provide a benefit in quality of life and survival only in the early phase (little benefit in the terminal phase).

Other prognostic factors can impact the quality of life and overall survival in these situations: sarcopenia and disorders of nutritional status (obesity, undernutrition).

The study of sarcopenia by CT scan of patients in a palliative situation is still too scarce. Sarcopenia is an often underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.

The study of the prevalence of sarcopenia by CT scan would confirm its prognostic impact in a palliative situation.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years old,
* patient with solid cancer diagnosed with metastatic disease,
* having had a biological assessment and a CT scan in the month preceding the medical consultation,
* and whose prognosis is considered palliative

Exclusion Criteria:

* age \<18 years old,
* adults under guardianship measure,
* pregnancy or breastfeeding in progress,
* malignant hemopathies,
* metastatic germ cell tumors,
* non-metastatic disease
Internet-based Rehabilitation Aftercare Focusing on Physical Activity Promotion in Persons With COPD

The aim of the study is to evaluate a 12-week internet-based rehabilitation aftercare program with an emphasis on physical activity promotion for persons with COPD. The program starts directly after an inpatient pulmonary rehabilitation program. It includes monitoring and promotion of physical activity, progressive resistance and endurance training, education through online learning modules and continuous support from a therapist.


Eligibility Criteria:
Inclusion Criteria:

* Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications A-D and stages 1-4.
* Internet access at home
* owning a smartphone with the operating system Android or iOS
* basic computer and internet skills (e. g. using web browser)
* ability to operate a smartphone (especially to install mobile applications)
* ability to read, write and comprehend as well as communicate electronically

Exclusion Criteria:

* severe concomitant disease, which will affect the ability to be physically active more than COPD for example, cancer or severe cardiac, neurological, orthopaedic or metabolic comorbidities)
* cognitive impairment that hampers study implementation
* Lack of ability to speak German
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include pediatric patients, between the ages of 2 and 21 years, with CKD stages 2-4 (GFR 15-90 ml/min/1.73m2).

Exclusion Criteria:

* Exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(OH)vitamin D or 1,25dihydroxyvitamin D, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.
The Impact of Vaping Ethanol in the Evaluation of Impairment

The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.


Eligibility Criteria:
Inclusion Criteria:

* Individuals must be e-cigarette users who are 21-65, willing to provide informed consent, attend the lab sessions as needed. Participants must agree to use designated products according to study protocol.

Exclusion Criteria:

* Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem

This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.


Eligibility Criteria:
Inclusion Criteria:

* Patient signed an IRB, study specific informed patient consent.
* Patient is a male or non-pregnant female age 18 years or older at the time of study device implantation.
* Patient has primary diagnosis of non-inflammatory degenerative joint disease.
* Patient is a candidate for primary cementless total hip replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) \> 40 Kg/m2.
* Patient has an active or suspected infection at the time of device implantation.
* Patient is immunologically suppressed.
* Patient requires revision surgery of a previously implanted total hip replacement.
* Patient has a known sensitivity to device materials.
Methadone in Pediatric Anesthesiology II

Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).

Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.

Eligibility Criteria:
Inclusion Criteria.

* Age 11-18 years
* Undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated postop inpatient stay of \> 3 days
* Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria.

* History of or known liver or kidney disease.
* Females who are pregnant or nursing.
* Children with developmental delay
* Children undergoing surgery for scoliosis of musculoskeletal origin
Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.

Polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation.

The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive patients with atrial fibrillation assigned for the totally thoracoscopic left atrial appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The registry has no limit of the number of patient included. Patients will be followed up with transoesophageal echocardiography at 6-12 months to assess the durability of left atrial appendage (LAA) oclusion and collect the informations about possible adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Lone atrial fibrillation
* Previous stroke or systemic thromboembolic complications
* High risk of thromboembolic complications assessed with CHA2DS2-VASc Score \>2
* High bleeding risk assessed with HASBLED score =\> 2.
* Contraindications to oral anticoagulation
* Complications of the oral anticoagulation
* Acceptable surgical candidate, including use of general anaesthesia

Exclusion Criteria:

* Patient refusal
* Significant valve disease or coronary multi-vessel artery lesions requiring surgery
* Stroke/cerebrovascular accident (CVA) within previous 30 days
* Critical preoperative state

Intra-Operative Exclusion Criteria

* Presence of thrombus in the left atrium or LAA as documented on intra-operative transesophageal echocardiography
* LAA tissue with significant adhesions (as evaluated by the surgeon) carries AtriClip placement overly risky.
Effects of a Probiotics on the Health of Normal Young Males

The important role played by the GI tract microflora on the metabolic health of an individual are increasingly recognized. In this respect, the initial studies of Metchinkoff that suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora have evolved into the concept of "probiotics". Probiotics are living microorganisms that bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).

Here the investigators will study, in normal young male volunteers, the potential to modulate post-prandial metabolic and inflammatory responses by the administration of a yoghourt containing the probiotic Lactobacillus rhamnosus (LGG).

This is a prospective, randomized, double-blind and cross-over study designed to evaluate the potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic and inflammatory response of normale healthy individuals.

After a wash out period during which volunteers will have to follow a diet devoid of all milk or milk-derived products, they will receive, in random order, either a daily dose of the probiotic, or a daily dose of acidified milk (control) for a total of three consecutive weeks. At the end of each of these period, they will be submitted to a day of investigation, during which their metabolic and inflammatory profile will be studied following the ingestion of a standard test meal. The potential for the probiotic to modulate the metabolic and inflammatory parameters will be evaluated.

The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).

Eligibility Criteria:
Inclusion Criteria:

* Normal male with normal BMI (18.5-25 kg/m2)
* non smoker
* stable physical activity

Exclusion Criteria:

* Food intolerance (ceoliac disease, lactose intolerance, food allergies)
* Particular regimen (vegetarian...)
* Chronic disease (any)
* Elevated blood pressure
* Regular drug treatment
* Antibiotics treatement in the preceding six months
* \>4 hrs/week of physical activity