cyrilzakka/clinical-trials huggingface dataset:
Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis

The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).


Eligibility Criteria:
Inclusion Criteria:

* Infant of less than 18 months old
* infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\\or crépitants in a viral context (head cold and\\or cough and\\or fever and\\or notion of contage)
* Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
* absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
* signature of the Informed consent
* Membership in a national insurance

Exclusion Criteria:

* Refusal of the parents to participate in the study
* 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
* signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
* histories of bronchiolitis or asthma of the infant
* cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
* child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.
Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial

To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.

Women presenting with a preterm singleton pregnancy between 28.0 and 36.6 weeks of gestation with cephalic lie and a medical indication for induction of labor will be approached for this study. The patient/provider must be attempting induction with the goal of vaginal delivery. Women with ruptured membranes, suspected intrauterine infection, prior uterine scar, fetal demise, or a fetal anomaly will be excluded. Women that agree to the study will be randomized to 2 groups: the "early amniotomy" group and the "late amniotomy" group.

Women in the early amniotomy group will undergo artificial rupture of membranes (AROM) prior to reaching cervical dilation of 4 cm. Women in the late amniotomy group may not undergo AROM until they reach cervical dilation of greater than 4 cm or they have been on an oxytocin drip for greater than 10 hours with no cervical change. It is possible that a woman in the late amniotomy group will not undergo AROM at all.

The primary outcome under consideration is time in labor. Secondary outcomes include rates of chorioamnionitis, postpartum endometritis, mode of delivery, and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Preterm singleton pregnancy between 28.0 and 36.6 completed weeks of gestation
* Fetus in the cephalic position
* Intent to induce labor for vaginal delivery
* If cervical ripening is planned, patient must be enrolled within an hour of initiation of ripening. If no ripening is planned, enrollment must be complete prior to starting induction.

Exclusion Criteria:

* Preterm premature rupture of membranes (PPROM)
* Fever or suspected chorioamnionitis prior to start of IOL
* Prior uterine scar
* Infection with HIV/Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) or an active Herpes Simplex Virus (HSV) infection
* Intrauterine fetal demise
* Major fetal anomaly
* Cervical dilation \> 4 cm
Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy

The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).

An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.

Eligibility Criteria:
Inclusion Criteria:

* patient's age ≥65years
* prostate cancer
* robot-assisted laparoscopic radical prostatectomy (RALP)

Exclusion Criteria:

* inability to obtain written informed consent
* history of significant liver, renal or pulmonary diseases
* current smoking
* chronic or acute alcoholism
* known or suspected neuromuscular disorders
* family history of malignant hyperthermia
* any pre-existing coagulopathy
* abnormal blood coagulation tests (including prothrombin time \<70%; activated partial thromboplastin time \>38 seconds and INR \>1.20) or preoperative anticoagulant therapies
* BMI ≥30 Kg/m2
* known allergy or hypersensitivity to the drugs used in the study
* planned postoperative admission to intensive care unit.
* moderate neuromuscular block (TOF 1-3) at the end of surgery
Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement

The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).

The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment.

See statistical analysis plan available under "Links" for further description of the study.

Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.

It is recommended both nationally and internationally that the treatment of knee OA should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement. If this non-surgical treatment is ineffective surgical treatment, especially surgery with insertion of total knee replacement (TKR), may be indicated. There are effects of both non-surgical treatment and TKR, but no studies exist, which examine the effect of surgery with insertion of TKR in addition to the recommended non-surgical treatment of knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Knee-OA detected by x-ray (Kellgren \& Lawrence grade 2 or greater)
* Considered a candidate for TKR by the orthopedic surgeon.
* The participant is \> 18 years of age.
* The participant can provide relevant and adequate, informed consent.

Exclusion Criteria:

* Bilateral simultaneous TKR
* Revision of prior TKR, unicompartmental knee arthroplasty or high tibial osteotomy
* Rheumatoid arthritis
* Mean VAS \> 60mm on a 0-100mm scale
* Investigator considers that the mental condition of the participant does not allow participation.
* The participant must not be pregnant or plan pregnancy during the study.
* Inability to comply with the protocol;.
* Inadequacy in written and spoken Danish.
Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]

Acne is a chronic inflammatory disease of the pilo-sebaceous unit with a multi-factorial etiology. It is one of the most frequent cutaneous diseases, affecting more than eighty percent of the population at some point in their lives .

Endocrine factors especially androgens and steroids are one of multiple factors provoked to be involved in pathogenesis of acne . Thyroid hormones have steroid like action that have many regulatory functions in many body organ functions including skin and pilosebaceous unit. Furthermore, subtle thyroid dysfunction was shown to have a role in many disease conditions.

Thyroid hormone action on sebaceous glands is unclear. In hypothyroid states, sebocytes exhibit reduced rates of secretion that increases with thyroxine administration .

Most of studies about thyroid dysfunction in acne patients focused on adult acne population especially females and searched for presence or absence of associating anti-thyroid antibodies with controversial results .

Some other studies were concerned with the impact of acne treatments as tetracycline, isotretinoin or radiotherapy on thyroid pathologies and dysfunction .

Global Acne Severity Scale (GAGS) is a simple, accurate, fast method for the determination of severity of acne, and it requires no special equipment and is relatively cost-effective. Its personal and interpersonal differences is low and it was first used by Doshi and his colleagues in 1997 in USA .

To the best of knowledge, little is published about thyroid dysfunction in acne female patients of different age categories and correlating thyroid function with other important patient and acne variables as body mass index (BMI) , age (starting from 16 years) , acne type, severity and duration.

Eligibility Criteria:
Inclusion Criteria:

* Patient with acne vulgaris from females only with different ages (starting from 16 years) , BMI groups.

Exclusion Criteria:

* Female patients with clinically diagnosed thyroid disease.
* Female patients receiving isotretinoin or minocycline in the last 6 months
* Female patients who were subject to radiotherapy or surgery in neck region.
Preoperative Subclinical DVT Screening in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy.

Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate for radical cystectomy.

60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex within 1 week preoperative to radical cystectomy

Eligibility Criteria:
Inclusion Criteria:

* any age
* Any sex
* Muscle invasive bladder cancer local advanced patients candidate for radical cystectomy

Exclusion Criteria:

* Unfit patients
* any contraindication for surgery
* obese
* coagulopathy
* bedridden
Brain Representation of Acquisition in Humans of Motor-Sensory Skills

Interactions between the perceptual and motor systems are fundamental to the performance of complex motor tasks and are at the heart of the fine motor control required for the production of complex sounds such as speech production or playing a musical instrument. In such situations, the brain must learn to generate relevant motor commands to a sound-producing system with fixed physical characteristics, such as the vocal tract or a musical instrument.

No study has yet been able to directly test the dynamic aspect of this sensorimotor learning in an acoustic production task with fine motor control.

The Adolphe de Rothschild Foundation Hospital takes care of patients requiring awake surgery. During these procedures, a direct cortical recording, called electro-corticography, is performed in order to better delineate the tumor or epileptogenic resection area. Reference recordings are made in healthy areas at a distance from the lesion site making it possible to record normal brain activity.

In this case, we would propose to the patient to use a tool similar to the theremin (a musical instrument the size of a golf ball whose displacement in space modulates the frequency and the harmonics of a sound). The patient should therefore learn in order to create relevant motor patterns.


Eligibility Criteria:
Inclusion Criteria:

* Benefiting from an intracranial brain recording during a programmed surgery in awake condition.

Exclusion Criteria:

* Patient with complete deafness
* Patient with a disorder or impairment that does not allow him/her to perform the experimental task according to the investigator's judgment
Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer

This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.

The purpose of this trial is to study the clinical effects of increasing the weekly fraction number for locally advanced head and neck cancers by a multi-institutional prospective randomised trial. The primary endpoint is to clarify whether a six fraction per week protocol has a greater effect on the survival, as compared to the conventional five fraction per week protocol.

Eligibility Criteria:
Inclusion Criteria:

* Head and Neck Cancer

Exclusion Criteria:

* Unable to give an informed consent
Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin

Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. Treatment of neuropathic pain often requires a combination of pain medications due to the complex nature of neuropathic pain and frequent inadequate response to drug treatment. Common drugs used concomitantly with tramadol are SNRI antidepressant duloxetine and anticonvulsants such as pregabalin. Both tramadol and duloxetine have serotonergic effects and duloxetine has also a potential to inhibit metabolism of tramadol. The objective of the study is to investigate the pharmacokinetics and pharmacodynamic interaction of oral tramadol with duloxetine and pregabalin in patients with chronic neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy. All subjects will receive tramadol and duloxetine or tramadol and pregabalin in a randomized double-blind order. Primary end point is O-desmethyltramadol concentration.


Eligibility Criteria:
Inclusion Criteria:

* Chronic (≥ 6 months) neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy
* Pain intensity ≥ 4 on a numerical scale of 0-10
* Informed consent

Exclusion Criteria:

* Clinically significant abnormalities in laboratory screening
* Pregnancy
* Depression
* Use of strong opioids (morphine, oxycodone, fentanyl, hydromorphone, methadone)
* A previous history of intolerance or allergy to the study drugs or to related compounds and additives
* Existing or history of seizures, haematological disorders, clinically significant renal, hepatic, respiratory, cardiac or psychiatric disease, dementia, drug allergy
* Previous or present alcoholism, drug abuse, psychological or other emotional problems or cognitive impairment that are likely to invalidate informed consent or limit the ability of the subject to comply with protocol requirements
* Concomitant drug therapy known to cause significant enzyme induction or inhibition of CYP 1A2, 2D6, 3A4, 2B6, drugs metabolised by CYP2D6 enzyme, antidepressants, MAO-inhibitors, non-steroidal anti-inflammatory analgesics.
SUMCO Metabolic Syndrome Project

Physical activity is considered important in prevention and treatment of obesity and metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated with the development of metabolic syndrome. However, scarce evidence exists regarding the influence of physical activity intensity and genotype on metabolic syndrome in people with obesity. The investigators examine physical activity using an uniaxial accelerometer, as well as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who were employees in silicon wafer manufacture and participated in a health checkup.


Eligibility Criteria:
Inclusion Criteria:

* healthy people and individuals with obesity and metabolic syndrome

Exclusion Criteria:

-
Education vs Education Plus Intervention in HIV/HCV Diagnosis (DRIVE 03)

Objectives: A targeted HIV testing strategy (TTS) through an HIV risk of exposure and indicator conditions (RE\&IC) questionnaire resulted in same rate of new HIV infection diagnosis (NHID), coverage and even reduced costs compared with a universal non targeted (Non TSS) HIV testing strategy in a prior study (DRIVE 01). To compare number of New HIV/HCV Infection Diagnoses (NHID HIV/HCV) and costs two HIV/HCV testing programs in the Primary Health Care: an educational and support only initiative to enhance HIV /HCV testing (EDSUP) or EDSUP plus a resourced external program (DRIVE 03).

Methodology: Prospective, randomized 1:1, clustered, crossover study, in one Health Care Area of Madrid, Spain, comparing the implementation of two HIV testing programs, EDSUP only vs. EDSUP plus DRIVE 03 program in 4 Primary Care Centers (PCC´s). People randomized to EDSUP plus DRIVE 03 program, non HIV infected, between 18-65 years, attending to any of the 4 PCC´s, not previously included in the study will be offered to participate. HIV testing program will be evaluated by measuring absolute number of new diagnosed infections (NDI) HIV/HCV and costs. Other outcomes considered will be people assigned and offered to participate, number of HIV tests performed, coverage (HIV /HCV tests/assigned population ratio), and rate of NDI HIV/HCV per ‰ tests performed. Six months prior to randomization main outcome variables will be recorded in the 4 PPC´s. Before randomization, EDSUP will be equally implemented in the 4 PCC´s. After randomization, first six months, DRIVE 03 program will be implemented in 2 PCC´s and in the other 2 observation of interest variables will be conducted. After first 6 month study period, PCC´s will be crossover to the opposite arm of randomization. DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all study procedures. For NDI HIV/HCV, molecular epidemiology, delayed diagnosis, retention in care, HIV/HCV treatment and control/eradication will be also monitored.


Eligibility Criteria:
Inclusion Criteria:

* Have attended to one of the PCC´s randomized to DRIVE 03 HIV testing program,
* Be 18-70 years
* Have understood, accept and sign the written informed consent, and in case of inability, it will be signed by the legal representative.

Exclusion Criteria:

* A prior HIV diagnosis,
* have already been included in the DRIVE 03 study,
* inability to understand the Spanish language.
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age" to allow a follow-up period to Month 126.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents and preadolescents with no prior sexual history

Exclusion Criteria:

* Subjects with compromised immune system or have a history of severe allergic reaction
A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia (OP-724-H201)

This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.

This is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. A follow up visit will be conducted 4 weeks after the last administration.

Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included.

Eligibility Criteria:
Key Inclusion Criteria

* Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):

  1. Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA \< 200 copies/mL and CD4 positive T lymphocyte count \>= 200 cells/µL at screening).
  2. Regarding HCV, patients who had passed \>= 12 months after achieving SVR at registration.
* Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).
* Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:

  1. Liver stiffness measurement by FibroScan is \>= 12.5 kPa (Fibrosis stage F4) at screening.
  2. Abdominal CT scan shows changes in liver shape and/or portal hypertension.
* Patients with Performance Status 0-2.

Key Exclusion Criteria

* Patients with liver cirrhosis of which cause is not HCV or unknown.
* Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
* Patients with complication or history of malignant tumor (within 3 years before registration).
* Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
* Patients with active AIDS-indicator disease that require treatment.
Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.


Eligibility Criteria:
Inclusion Criteria:

* History consistent with type 1 diabetes
* At least 18 years of age
* Available and capable of following the protocol instructions provided by the healthcare professional
* Signed and dated informed consent form

Exclusion Criteria:

* Pregnancy
* Type 2, gestational, or secondary diabetes
* Known allergy to medical grade adhesives
* Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
* Seizure disorder
* Myocardial ischemia
* History of stroke
* Severe hypoglycemia unawareness
* Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety