cyrilzakka/clinical-trials huggingface dataset:
S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation

Evaluate efficacy and safety of Indobufen v. Aspirin in preventing thromboembolic events in patients at high risk of CV events such as patients suffering from nonrheumatic atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus

Exclusion Criteria:

* Clinically relevant organ disease
* creatinine clearance \< 30 ml/min
* gastric or duodenal ulcer
* severe anaemia or poliglobulia
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment


Eligibility Criteria:
Inclusion Criteria:

1. Aged 12 years and older inclusive of either sex.
2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)
3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

Exclusion Criteria:

1. Pregnant or lactating women.
2. Plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period.
3. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
5. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
6. Subjects with an active pulmonary disorder or infection.
7. Subjects with posterior subcapsular cataracts or glaucoma
Placebo and Active Controlled Study to Compare the Antipyretic Efficacy of Aspirin® in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin

This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo (comparator medication without an active substance). Despite of its common use for fever treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin are sparse. Therefore, the purpose of this study is to collect such data.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female patients 18 to 65 years of age
* Acute uncomplicated febrile URTI suspected to be of viral origin and present not more than 5 days
* Symptoms of a viral URTI
* Oral temperature \>/= 38.5 °C to \</= 40°C

Exclusion Criteria:

* Patients with physical findings consistent with the diagnosis of pneumonia, otitis media, bacterial sinusitis or any other bacterial infection of the respiratory tract requiring antibiotics or other therapeutic intervention by a physician
* Current antibiotic treatment or pre-treatment with antibiotic agents during the last week
* History or presence of asthma or hypersensitivity to ASA, salicylates, paracetamol, or other non-steroidal anti-inflammatory drugs; peptic ulceration or gastric bleeding; hemorrhagic diathesis; hepatic and/or renal dysfunction; Gilbert's disease; Quincke's edema
* Any other acute or chronic disease which in the opinion f the investigator could interfere with the patient's health and well-being during the conduct of the study or which could interfere with the evaluation of data generated from this subject
* Any conditions possibly interfering with the gastro-intestinal absorption of the study medication
* Pregnant or lactating women. All women of childbearing age were to undergo a pregnancy test before start of the study
A Cluster-RCT of SHS Among Primary School Students

This is a school- and family-based prospective trial among Primary/Grade 2-4 (P2-4) students in randomly selected 12 schools in Hong Kong. This study will assess the intervention effects on children's exposure to environmental tobacco smoke (including SHS and THS at home, SHS at home from neighbours and SHS outside home), children's SHS-related knowledge and attitude, intention to smoke, respiratory symptoms, parents' smoking cessation, and family happiness.

Around 12 primary schools in Hong Kong will be randomly selected and recruited and the 3 grades (P2-4) in each of the recruited schools will be randomly allocated to intervention or control arms. After the consenting process and baseline survey, we will conduct a 3-month intervention and then 2-month boosters which include 8 worksheets, around 15 online question quizzes and 30 WhatsApp messages. After 3-month and 6-month follow-up periods, we will assess the differences of children's exposure to environmental tobacco smoke (including SHS and THS at home, SHS at home from neighbours and SHS outside home), children's SHS-related knowledge and attitude, intention to smoke, respiratory symptoms, parents' smoking cessation, and family happiness. According to the results of baseline survey, we will also invite all the students exposed to SHS at home to provide their hair samples before intervention and at the 6th month in order to obtain objective results (hair nicotine measurements).

Aims of this study: (1) To reduce children's exposure to environmental tobacco smoke. (2) To reduce objectively measured exposure to tobacco smoke (hair nicotine) among children who are exposed to SHS at home at baseline. (6-month, laboratory test). (3) To promote SHS-related knowledge and attitudes, and avoidance of SHS among children. (4) To reduce children's intention to smoke. (5) To reduce children's respiratory symptoms. (6) To promote smoking cessation (past 7 days) of parents. (child report) (7) To promote children's perception of family happiness.

Eligibility Criteria:
We will invite all P2-4 students from 12 schools randomly selected from the 100 schools (which watched the performance by Hong Kong Council on Smoking and Health) to participate in this cluster RCT, as they are able to understand simple questionnaires and other self-help intervention materials, yet remain very receptive to intervention activities from our experience.

Inclusion criteria for hair nicotine test:

1) exposed to secondhand smoke at home from smokers inside home in any of the past 7 days; 2) living with at least 1 smoker; 3) Never smoking or using e-cigarettes.
Weightbearing After High Tibial Osteotomy

In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies.

The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.

In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.

However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.

Different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery.

Results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing.

The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20 kg) for 6 weeks, and unrestricted weight-bearing.

The investigation is performed as a randomised prospective clinical trial including 20 patients with a planned 2 years follow-up period.

Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.

Routine standing x-rays is performed. Stability of the osteotomy is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
* Varus deformity

Exclusion Criteria:

* Prednisolone treatment.
* NSAID treatment.
* BMI \> or = 35.
* Previous surgery in lateral knee compartment.
* Secondary Arthrosis following fracture(s) of the tibial condyle(s).
* Lack of informed consent.
* Correction \>12,5 mm
* Peroperative displaced fracture of lateral bony hinge.
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period

Patients will receive the study drug (SENS-401 or placebo) in the form of tablets by mouth, twice a day (3 tablets in the morning and 3 tablets in the evening), during the first 4 weeks after randomization.

SENS-401 is an investigational medicinal product. It belongs to a family of drugs known as "5 HT3 antagonist".

Eligibility Criteria:
The main criteria for inclusion:

* Male or female aged at least 18 years old
* Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden sensorineural hearing loss.
* Patients with sudden hearing loss with onset within 96 hours prior to prior to first study drug intake.
* Patients under highly effective contraception

The main criteria for exclusion:

* Bilateral idiopathic hearing loss
* Fluctuating hearing loss
* History of asymmetric hearing (\>20 dB difference between ears) to the best knowledge of the patient
* Severe hearing loss (\>90 dB) associated with unilateral (ipsilateral) complete vestibular loss.
* History of Ménière's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma), otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, or barotrauma
* Previous SSNHL in the affected ear within the past 6 weeks
* Complete loss of peripheral vestibular function on the affected side
* Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 6 weeks (except oral corticosteroids)
* Any ongoing or planned concomitant medication for the treatment of tinnitus until 6 weeks after administration.
* Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) at the current time or in the past 6 months or planned in the coming 3 months.
* Acute or chronic otitis media or otitis externa terminated less than 7 days
* Prior ear surgery of any kind (except ventilating tubes), or cochlear implants
* Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular, respiratory, neurological (except vertigo or tinnitus), hematological, renal, dermatological or psychiatric disease or substance abuse
* Neurological disorders including stroke, demyelinating disease, brain stem or cerebellar dysfunction within the last 3 months.
* Treatment with any investigational agent within 4 weeks or any past treatment with azasetron or with 5-HT3 antagonists, or any prior or planned treatment by antidepressant treatment containing serotoninergic agents.
* Patients with either a history of significant arrhythmia, or a history of conditions known to increase the proarrhythmic risk (e.g., congestive heart failure, long QT Syndrome, hypokalemia etc...).
Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC

To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS.

The objectives of this study are to assess the effectiveness and safety of Osimertinib combined with chemotherapy in a real-world setting in patients with locally advanced or metastatic, EGFR mutation-positive NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed.
* Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation.
* EGFR sensitive mutation-positive (Ex19del and/or 21 L858R)
* WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks.
* Patients who receive Osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (For patients who received prior chemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months).
* Patients with asymptomatic CNS metastases or patients who have completed definitive therapy, are not on steroids and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids are allowed.
* Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.

Exclusion Criteria:

* Spinal cord compression and symptomatic brain metastases
* Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc
* Any banned substance in label
Comparison of Ways to Prepare Patients for Decisions About Joint Replacement Surgery

Ministries of Health consider wait lists for total joint replacement a top priority. Research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. When decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option. The primary study objective is to evaluate the effect of patient decision aids (PtDAs) on total wait times (wait times for surgical consultation, plus wait times for surgery) when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility. Major secondary objectives include determining (a) the effect of PtDAs on surgery rates within two years, (b) the effect of PtDAs on decision quality, and (c) cost-effectiveness of PtDAs for total joint arthroplasty.

This was not indicated as required.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for surgical consultation for hip or knee osteoarthritis
* WOMAC and HKPT scores indicate that pain and functional criteria are rated as moderate or severe, or there is radiographic evidence of joint damage

Exclusion Criteria:

* Patients with inflammatory arthritis
* Patients who have had previous TJA
* Patients unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier
Predictors of HFNC Failure in Patients With AHRF Using Echocardiography Parameters

Right ventricular dysfunction (RVD) and right ventricular-pulmonary arterial (RV-PA) uncoupling detected by transthoracic echocardiography (TTE) in acute respiratory distress syndrome (ARDS) are associated with poor survival. Early detection of RVD and RV-PA uncoupling in patients with acute hypoxemic respiratory failure (AHRF) may be indicative of worsening and decompensating pulmonary condition which may require escalation of respiratory support. The use of TTE parameters in predicting high-flow nasal cannula (HFNC) failure has not been previously studied. The objective of this study is to identify predictors of HFNC failure by TTE and to compare its performance with the well-established ROX index.


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18; AND
* Acute hypoxemic respiratory failure (AHRF), defined by respiratory rate of greater than 25 breaths per minute and a ratio of the PaO2 to the fraction of inspired oxygen (PaO2 / FiO2) of less than 300, and use of accessory muscles of respiration or paradoxical abdominal motion; AND
* Required ventilatory support with high-flow nasal cannula (HFNC)

Exclusion Criteria:

* Patients suffering from hypercapnic respiratory failure; OR
* AHRF secondary to conditions that are indicated for non-invasive ventilation (NIV) (e.g. acute exacerbation of COPD, cardiogenic pulmonary edema); OR
* Use of NIV or invasive mechanical ventilation (IMV) prior to HFNC initiation; OR
* Patients with imminent need for endotracheal intubation and invasive mechanical ventilation (IMV); OR
* Patients with known or suspected diaphragm paralysis; OR
* Pregnancy; OR
* Patients with abdominal compartment syndrome; OR
* Use of HFNC for more than 12 hours prior to ICU admission; OR
* Patients with suboptimal echocardiographic image quality for data processing; OR
Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW

There is a need for better visualization of polyps during surveillance endoscopy in patients with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the determination of the optimal tracer dose.


Eligibility Criteria:
Inclusion Criteria:

* Patients with genetically or clinically proven Familial Adenomatous Polyposis. Genetically proven: Adenomatous Polyposis Coli (APC)-mutation identified. Clinically proven: more than 100 colorectal polyps at diagnosis
* Age 18 to 70 years
* Written informed consent
* Adequate potential for follow-up

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Proctocolectomy
* MutYH mutation
* Concurrent uncontrolled medical conditions
* Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre-menopausal women with intact reproductive organs and women less than two years after menopause.
Minimal Versus Conventional Exposure in Unicompartmental Knee Arthroplasty

The purpose of this study is to determine whether Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.

Postoperative pain is often moderate to severe following unicompartmental knee arthroplasty. In order to reduce postoperative pain and improve mobilization the minimal invasive technique was developed. After a 8-10 cm skin incision, a medial parapatellar capsule incision in made. The rectus tendon or the vastus medialis are not incised and the patella is not everted.

In recent years The Local Infiltration Analgesia (LIA) technique has been developed to reduce postoperative pain. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.

The aim of this study is to investigate if Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for unicompartmental knee arthroplasty
* Aged 20-80 yrs
* ASA physical status I-III and mobility indicating normal postoperative mobilization

Exclusion Criteria:

* Known allergy or intolerance to local anesthetics, ASA or NSAID
* Serious liver-, heart- or renal decease
* Rheumatoid arthritis
* Chronic pain or bleeding disorder
PECS and Parasternal Block for Breast Surgery

Propose to evaluate efficacy of association between US guide parasternal block and pectorals nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple mastectomy).

All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will be observed.

All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine 0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.

During surgery patients receive light sedation with continuous infusion of propofol

Will be observed:

Additional local anesthetic infiltration from surgeon. Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.

Eventual side effects such as nausea/vomiting.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years;
* ASA score I - II - III;
* undergoing elective medial quadrantectomy breast surgery;
* undergoing elective mastectomy not reconstruction breast surgery;
* signed informed consent;

Exclusion Criteria:

* chronic therapy with opioids/ antidepressants;
* urgent/emergent surgery;
* postoperative transfer to the intensive care unit;
* known allergy to any drug medication;
* local skin infection;
* epilepsy;
* alcohol or drug abuse;
Observational Study of Ultravist in Patients Requiring CECT

It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen or pelvis.

Exclusion Criteria:

* There is no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics