cyrilzakka/clinical-trials huggingface dataset:
Nurse Anesthesist Assessment of Patient Preoperative Anxiety

Preoperative anxiety is a major concern for patients who undergo surgery. To accurately identify anxious patient is therefore crucial to improve perioperative patient care. Preoperative anxiety remain highly difficult to quantify in current practice. Many patient fail to express their anxiety and the assessment of the level of anxiety is mainly based on heteroevaluation by caregivers. Nurse anesthetists provide closed support to patient prior to the induction of anesthesia. The aim of the study is to assess whether nurse anesthetist accurately assess patient preoperative anxiety from arrival to the operating room to the induction of anesthesia.

EVALANXI is a single-center prospective observational study. The main objective of the study is to assess whether the assessment of preoperative anxiety by nurse anesthetist (hetero-assessment) accurately estimate the level of anxiety reported by the patient from arrival to the operating room to the induction of anesthesia (self-assessment).

Eligibility Criteria:
Patient Inclusion Criteria:

* Age \> 18 years old
* Patients with ASA 1, ASA 2 ou ASA 3
* Patients undergoing planned surgery with general anesthesia

Patient Exclusion Criteria:

* Age \<18
* Refusal, inability to oral consent
* Cardio-thoracic surgery or emergency surgery
* Patient with dementia, medically diagnosed psychiatric disorder, inability to answer questions

Nurse anesthetist Inclusion Criteria:

* Nurse anesthesis in charge of the corresponding patient

Nurse anesthetist Exclusion Criteria:

* Assessment of the preoperative anxiety of a previously included patient
Influence of Triflusal on Cognitive Functions in Healthy Subjects

The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in healthy participants.

Randomised, placebo controlled, double blind, cross-over design

Primary study outcomes are:

Performance in picturial and verbal memory tasks.

Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and motivation.

Once daily oral administration of placebo mannitol for 7 days in a cross-over trial with a washout period of at least 14 days between the two periods. Each participant will take triflusal as well as placebo

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male or female
* Normotensive
* BMI between 20 and 27 kg/m2
* Aged between 18 and 40 years
* Native or fluent German-speaking
* Caucasian
* Female practicing safe contraception

Exclusion Criteria:

* Acute or chronic psychiatric or somatic disorder
* Any contraindication against aspirin or other NSAIDS
* History of coagulation disease
* History of gastrointestinal disease
* Laboratory exclusion criteria: values of blood count, blood chemistry and coagulation status outside normal range
* Pathological ECG
* Pregnancy, breast-feeding
Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.

Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later.

We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.

Eligibility Criteria:
Inclusion Criteria:

* Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).

Exclusion Criteria:

* 1. Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (\< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc.
* 2. Simplified Bishop score must be \<6 and cervical dilation \<2 cm.
* 3. Women must be able to give informed consent.
* 4. Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive.
* 5. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects

This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled ETD001in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males and females using suitable methods of contraception, or females of non-childbearing potential
* Consent to study participation
* Body weight ≥ 50 kg and body mass index 19 - 30 kg/m2
* Vital sign assessments within the normal ranges
* Healthy as determined following physical and laboratory examinations at screening visit
* Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value

Exclusion Criteria:

* Acute or chronic illness detected at the screening visit
* Respiratory tract infection within 4 weeks of the screening visit
* Use of prescribed or OTC medication within 14 days of the screening visit
* History of regular alcohol use over the recommended limits within 6 months of screening, or history/evidence of alcohol or drug abuse
* Smoker or use of tobacco products within 6 months of screening
* Abnormal blood or urine laboratory test results at screening
* Recent participation (within 3 months) in another clinical trial
* Current, or history of, allergy that may be contraindicated
European Registry of Patients With Infantile-onset Spinal Muscular Atrophy

IO-SMA-Registry is a prospective, longitudinal and observational study which objective is to collect prospectively information on longevity, psychomotor development and respiratory function of patients with infantile-onset spinal muscular atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Spinal Muscular Atrophy diagnosed in childhood (before 18 months) and genetically confirmed.
* For patients with SMA type 1: Never acquired independent sitting position (more than 30 seconds, without hand support or any external support)
* For patients with SMA type 2 or 3: Patient treated with a market approved treatment for SMA or with a treatment in an expanded access program
* Any age
* Patients over 18 years of age or parent(s)/legal guardian(s) of patients \< 18 years of age not opposed to data collection for research purposes

Exclusion Criteria:

* None
Pathomechanism of MicroRNA-29 in Shoulder Stiffness

The team integrates experimental analyses of clinical and basic medicine and transgenic mice models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue homeostasis that alleviates tissue stiffness and maintains function.

Aims of first: The team will evaluate the associations among the mR-29a, miR-29b, miR-29c expression in subacromial bursa and subacromial fluid, incidence of shoulder stiffness, Constant scores, and VAS.

Aims of second: The team will isolate primary myofibroblast from subacromial bursa tissue as in vitro models and investigate the molecular events in the IL-1β modulation of miR-29a expression and the molecular mechanism underlying miR-29a inhibition of fibrotic matrix accumulation and apoptotic reactions in myofibroblast cultures.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 80 years
* receiving surgery for open acromioplasty

Exclusion Criteria:

* shoulder disorders caused by traumatic fracture
* previous surgery
* osteoarthritis
* malignant disorders
* hepatic disorders
* renal disorders
Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children

The purpose of this study is to investigate the impact of a beverage containing carbohydrate powder fortified with micronutrients on agility, speed, and power in school going children


Eligibility Criteria:
Inclusion Criteria:

* Informed consent by participant's parents or legally accepted representative
* Good general health
* Non anemic children (Hb≥12 g/dl)
* Academy/development level athlete (at least 3 activity sessions per week, for a minimum of 2 hours of activity in each session e.g. hockey, football, team sports)

Exclusion Criteria:

* Child in care
* Allergy/Intolerance to study materials
* History of cardiovascular disorder, respiratory diseases, diabetes mellitus, serious infection/injuries/surgeries (within past 3 months)
* Participation in any nutritional study in past 1 year
* Substance abuse
* Children on any kind of medication in past 1 month of screening
A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)

This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.


Eligibility Criteria:
Inclusion Criteria:

* Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.

Exclusion Criteria:

* Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
Long-term Follow-up of HALT-C Sustained Virological Responders

The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial is a multicenter clinical trial conducted to assess the effects of long-term antiviral drug therapy on the progression of liver disease in patients who have advanced chronic hepatitis C and have not responded to prior therapies. Chronic hepatitis C is a long-lasting viral infection affecting the liver that may lead to permanent liver damage and cirrhosis (replacement of healthy liver cells by scar tissue). If left untreated, a proportion of patients with chronic hepatitis C will be at risk for complications of liver disease. The drug therapy in the HALT-C trial was designed to clear the hepatitis C virus from the patient s system in order to prevent or mitigate these potential complications. The purpose of this research is to determine if patients with chronic hepatitis C who experienced clearance of hepatitis C virus (known as a sustained virologic response, or SVR) during the HALT-C trial have developed any complications of their liver disease.

This study will include 180 subjects who participated in the initial phase of the HALT-C trial and experienced an SVR. The participants will visit the National Institutes of Health for an in-person study visit.

During the visit, patients will have blood drawn for lab tests to monitor the progress of their liver disease, and may be asked to undergo an ultrasound examination of the liver to detect any abnormalities that may be attributed to liver cancer. Patients will also answer questions about their medical history particularly any outcomes or events related to their hepatitis C that have occurred since the HALT-C trial and may be asked to sign a release of information to allow researchers to obtain medical records from other clinics or physicians where they have received treatment.

...

Subjects who have achieved a sustained virologic response during their participation in the multicentered HALT-C clinical trial for treatment of chronic hepatitis C are being invited to return for a single clinic visit to assess whether any decompensation events (e.g. ascites, varicela hemorrhage, hepatic encephalopathy) or hepatocellular cancer has occurred. Subjects able and willing to return to the NIH will undergo standard clinical examinations, questionnaires and an ultrasound examination of the liver, to assess the status of their hepatitis C. Data will be pooled from all of the 10 clinical centers, analyzed and compared to an age and gender matched control group of nonresponder subjects who participated in the HALT-C Trial. A data coordinating center (New England Research Institutes) will conduct the data analysis. This will be a descriptive natural history study.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients who developed a virological response at week 20 of the HALT-C study.

EXCLUSION CRITERIA:

None
Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors

The purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.

The primary objective of the study was to assess the safety and tolerability of multiple subcutaneous injections of BAY1093884 (anti-TFPI monoclonal antibody, immunoglobulin G2, IgG2) in patients with hemophilia A or B with or without inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Male severe hemophilic patients with undetectable FVIII activity \<1% or FIX activity \<2%, with or without inhibitors (any titer) are eligible.
* Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
* Age ≥18 years.
* Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening.
* For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.
* For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing ITI.

Exclusion Criteria:

* History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
* History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.
* Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).
* History of cardiac, coronary and/or arterial peripheral atherosclerotic disease
* Platelet count \<100,000/μL.
* Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of \<200/mm\^3
POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)

Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment


Eligibility Criteria:
Inclusion Criteria:

* Clinical history of SAR known and treated since 2 years.
* Positive skin prick test (wheal \> 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to grass pollen (less than 1 year).
* Minimum mean T5SS of 8 during the baseline period.

Exclusion Criteria:

* Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
* Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids
Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients After Intensity Modulated Radiotherapy

This is an observational cohort study to investigate the incidence of radiation-induced otitis media, changes in tubal function and hearing in newly diagnosed nasopharyngeal carcinoma patients without metastasis at multiple time points from baseline to 1 year after radiotherapy.

Patients with newly diagnosed non-metastatic nasopharyngeal carcinoma (AJCC 8th) will be recruited. The incidence of radiation-induced otitis media, eustachian tube function and hearing level in nasopharyngeal carcinoma patients will be prospectively evaluated by magnetic resonance imaging, otoscope, pure tone audiometry, acoustic immittance test and the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) before treatment and serially up to 1 year after radiotherapy. The quality of life of patients will be evaluated before treatment and serially up to 1 year after radiotherapy. The incidence of radiation-induced otitis media, the changes of eustachian tube function and hearing level, together with the influencing factors, in nasopharyngeal carcinoma patients after induction chemotherapy and concurrent chemoradiotherapy will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70, regardless of sex.
* ECOG (Eastern Cooperative Oncology Group) score: 0-1.
* Patients must sign informed consent and be willing, and well understood the objective and procedure of this study.
* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I-IVa (according to the 8th American Joint Committee on Cancer \[AJCC\] edition.
* No radiotherapy or chemotherapy was administered before enrollment.
* Expected survival time ≥ 6 months.

Exclusion Criteria:

* Women in pregnancy or lactation.
* Patients with significantly lower heart, liver, lung, kidney, bone marrow function and other severe medical condition.
* Prior to radiotherapy, there is a clear underlying disease of the eustachian tube or other ear diseases.
* Patients with otitis media before radiotherapy and have no improvement at the end of radiotherapy.
* Patients with history of middle ear, nasal or nasopharyngeal surgery on the affected side.
* Patients combined with congenital cleft palate and other craniofacial abnormalities.
* Patients with histologically confirmed keratinizing nasopharyngeal carcinoma, type of WHO I.
* Patients with recurrence and distant metastasis.
* Patients with radiotherapy or chemotherapy before.
* Age \< 18 or age \> 70.
* Patients who changed their initial treatment regimen during the observation period due to disease progression (including tumor residual after radiotherapy, tumor recurrence, and new distant metastases).
A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)

This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily clinical practice and will evaluate the dose reduction of glucocorticoids once low disease activity is achieved in patients with rheumatoid arthritis tre ated with GC and background RoActemra/Actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. In the non-interventional phase, the use of GC in daily clinical Belgian practice will be evaluated and described. This period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for the secondary interventional phase. In the interventional phase, a systematic GC dose reductio n schedule will be evaluated in patients having achieved low disease activity wh ile receiving the same background therapy with RoActemra/Actemra 8 mg/kg. Methyl prednisolone will be given from a starting dose of \>/= 1 mg to \</=20 mg orally d aily and will be tapered down. The anticipated study duration is up to 13 months


Eligibility Criteria:
Inclusion Criteria:

Non-interventional phase

* Adult patients, \>/=18 years of age
* Moderate to severe active rheumatoid arthritis defined as Disease Activity Score using 28-joint count (DAS28) \>/=5.1
* Patients with inadequate clinical response to a current treatment with 2 or more non-biologic disease-modifying anti-rheumatic drugs (DMARDs), one of them being methotrexate (MTX) optimally administered during a period of more than 3 months or inadequate response to a current anti-TNF therapy
* Current use of oral glucocorticoids started at least 4 weeks prior to enrolment Interventional phase
* Patients enrolled in the non-interventional phase
* Patients with low disease activity defined as DAS28 \</=3.2 at Visit 2
* Use of oral glucocorticoids with methylprednisolone equivalent dose of \>/=1mg and \</=20mg/day at Visit 2

Exclusion Criteria:

Non-interventional \& interventional phase

* Rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis
* Prior history or current inflammatory joint disease other than rheumatoid arthritis (e.g. gout)
PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site

PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site: A Non-Inferiority Trial

A prospective single-blind study, where the evaluator is blinded to the treatment. Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.

3 days after surgery the patients will be asked to complete a VAS questionnaire. A week and 2 weeks after surgery, patients will have their dressing changed as in the first treatment, and will answer VAS(9) and bluebelle(10) questionnaires. The wound will be photographed again for follow-up. Three weeks, 6 weeks and 3 months after surgery the scar in the donor area will be evaluated. The photographs will be shown to the blinded evaluator, to evaluate wound healing by epithelialization estimation.

Eligibility Criteria:
Inclusion Criteria:

- Patients with a small burn (2-20% TBSA), who require skin grafting.

Exclusion Criteria:

* Patients younger than 18 years
* Patients refusing hospitalization
* Patients with heavily infected wounds, which are the probable cause of bacteremia or sepsis.
* Patients with diabetes mellitus or peripheral vascular disease
* Patients under treatment of steroids or other immunosuppressing agents
* Patients with infectious diseases, i.e., HIV, HCV or HBV.
* Patients who are smokers.
* Patients with a known allergy to the dressing.
* Female patients who are pregnant or nursing, psychiatric patients and soldiers.