cyrilzakka/clinical-trials huggingface dataset:
Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes

Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT). The endovascular recanalization and stenting technique has become the gold standard treatment for medically resistant and disabling PTS.

Stent thrombosis is a significant complication of this procedure; the risk factors for thrombosis are poorly understood.

Monitoring the patency of the stent is a key component in maintaining clinical success.

Doppler ultrasound is the first-line diagnostic tool for monitoring patients with venous stents, and has the potential to allow accurate assessment of venous stent obstruction.

Absence of validated morphological and hemodynamic echodoppler criteria for the follow-up of these stents.

• Main objective: Clinical and hemodynamic results of venous recanalisations by stenting in the chronic phase

• Secondary objective (s):

* External validation of hemodynamic criteria proposed in the literature to detect venous stent obstruction
* Risk factors for venous stent restenosis


Eligibility Criteria:
Inclusion Criteria:

- Disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.

Exclusion Criteria:

* Inability to consent
* Age \<18 years old
* Life expectancy \<3 months
* Incomplete medical records
* Lost in follow up
Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses

3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

The rationale behind this feasibility study is to show that accessing and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in patients suffering from symptoms attributable to sinusitis is feasible; This is an essential step in the development of a system that will later allow visualization, sampling, and treatment of the sinuses via the natural sinus ostium during the patient's first office visit in a minimally invasive manner while enabling treatment by lavage, and minimizing radiation exposure, antibiotic use, multiple office visits, and cost.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient indicated for primary FESS procedure by the ear, nose and throat (ENT) specialist
* Patient age: adult (\>18 years old)
* Patients in general good health in the opinion of the investigator as determined by medical history physical examination
* A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent

Exclusion Criteria:

* A patient with nasal polyposis
* A patient indicated for tumor excision
* Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
* Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)
* Pregnancy
* Patients with previous FESS surgery
Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy

CIPN is induced by neurotoxic chemotherapeutic agents and manifests with sensory and/or motor deficits. It is associated with significant disability and poor recovery. Common symptoms include pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control and insecure gait. The purpose of the study is to compare effects of sensory vibrations training to conventional aerobic and strenght exercise on neurophatic symptoms related to chemotherapy treatment.

Aim: To (a) compare the effects of WBV exercise compared to regular cardiovascular and resistance exercise (CAR) on the primary outcome of (a) CIPN symptoms and secondary outcomes of (b) balance, physical function, and quality of life.

Based on previous pilot study findings, we hypothesize that WBV exercise compared to CAR will reduce relevant symptoms to a larger degree, such as the loss of peripheral deep sensitivity, pain, weakened or absent reflexes and loss of balance control (aim a) and that patients will experience an improvement in physical function and quality of life (aim b).

The study employs a prospective, multicenter, two-armed, randomized controlled design. Study participants will be informed about the study procedure and sign a written informed consent. Patients will then be assigned randomly either to the WBV group or the CAR group. Patients allocated to the WBV group receive a defined WBV exercise program twice a week in addition to their usual treatment. Patients in conventional aerobic and resistance exercise (CAR) group will receive a defined exercise program twice a week in addition to their usual treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with breast cancer, aged 18-80 years,
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2,
* completed chemotherapy in the past 3 months. Experiencing symptoms of CIPN

Exclusion Criteria:

* pre-existing neuropathy of other cause (eg, diabetes),
* given contraindications for WBV including instable bone metastases and severe cardiovascular disease.
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures


Eligibility Criteria:
Inclusion Criteria:

* Outpatients ≥ 50 kg (110 lb) of weight
* A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures
* Uncontrolled partial seizures despite having been treated with at least two different AEDs within the last 2 years prior to screening.
* Treated with a stable dose of 1-2 AEDs
* At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.
* No 28-day seizure-free period during the 8 weeks preceding randomization
* Positive biomarker screening

Exclusion Criteria:

* Presence of only non-motor simple partial seizures
* History of psychogenic seizures
* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;
* Previous history of Lennox-Gastaut syndrome
* Pregnant or nursing (lactating) women
* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply
Bioavailability and Metabolism of Voriconazole in Relation to Its Modulation by the CYP2C19 Genetic Polymorphism

The purposes of this study are:

* To determine the absolute bioavailability of voriconazole after a single oral dose (400 mg voriconazole \[VFEND brand\]) in comparison to intravenous (i.v.) administration (400 mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole \[VRC\]) in healthy individuals stratified according to the three predominant CYP2C19 genotypes
* To investigate the possible pathways of metabolism and their modulation according to genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.

As CYPs are mainly involved in VRC metabolism it is likely that also gut wall metabolism by CYPs occurs. However, no substantial first pass metabolism of VRC has been reported. In humans the VRC metabolism has not been studied systematically. It is therefore important to assess VRC metabolism on its own and in addition the influence of CYP2C19 genetic polymorphisms on the formation of the different VRC metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Good state of health (physically and mentally)

Exclusion Criteria:

* Any regular drug treatment within the last two months except for oral contraceptives in female participants
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport system enzymes within a period of less than 10 times the respective elimination half-life
* Any acute or chronic illness or clinically relevant findings in the pre-study examination
* Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Smoking (regular or irregular)
* Excessive alcohol drinking (more than approximately 30 g alcohol per day)
* Positive drug screening or known or admitted drug abuse
Effect of Exercise Training on Breastmilk Composition

The aim of this trial is to investigate whether regular endurance exercise during the lactation period will influence breastmilk composition among individuals with overweight/obesity, and secondarily to assess if such changes impact the growth and health of the infants.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 years or older
* Body mass index ≥ 25 kg/m2 pre-pregnancy and/or BMI ≥ 28 kg/m2 postpartum
* Given birth to a singleton term (after 37 weeks + 0 days) baby
* 6-7 weeks postpartum at time of inclusion
* Exclusively breastfeeding the baby (no other foods are given) and intend to continue this practice for ≥ 8 weeks at inclusion
* Understands oral and written Norwegian

Exclusion Criteria:

* On-going pregnancy
* Known type 1 or type 2 diabetes
* Known cardiovascular disease
* High intensity exercise more than twice weekly the last three months before inclusion and/or an intention to start regular endurance training within the next 8 weeks at baseline
LASER: Real Life Antithrombotic Stent Evaluation Registry

LASER is designed to gather data about ischemic an bleeding complications for a period of 12 months after a PCI with the aim to optimize the therapy of these patients.

The LASER Registry will collect data from unselected patients on how the problem of stents on the background of full anticoagulation is approached by the investigators. On the collected data the LASER registry will

* document the frequently used treatment modalities how patients requiring stents on the background of full anticoagulation with Vitamin K Antagonists are currently managed
* will document the associated cardiac event rates with each currently used treatment strategy
* will document the associated bleeding rates with each currently used treatment strategy

With these data available, the LASER Registry will allow

* to define an optimised treatment regimen for the treatment of patients on full anticoagulation with Vitamin K Antagonists receiving one or more coronary stents
* to allow the appropriate sample size calculation for the design of a subsequent randomised comparison of continuous triple anticoagulation versus this optimised treatment regimen in such patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant symptomatic coronary artery disease (stable angina class II or more (CCS) , unstable angina, NSTEMI, or STEMI) and who for this reason do undergo percutaneous coronary revascularization with one or more drug eluting stent(s) (DES) or bare metal stent(s)
* Patients requiring Vitamin K Antagonists based full anticoagulation therapy (target INR 2-4,5) for any clinical indication
* Age: \>18 years; no upper age limit
* Informed consent has been obtained that the patient agrees to be fol-lowed up for up to one year

Exclusion Criteria:

* Patients who have been treated with a combined anticoagulant \& antiplatelet therapy within the previous two months
* Overt or constant occult bleeding that cannot adequately be treated (proton pump inhibitors, H2-blockers e.g.)
* Any contraindication to the use of thienopyridines
* Any contraindication to the use of aspirin
* Severe liver or kidney disease
* Any reason that creates sufficient doubts that follow-up can be obtained with reasonable efforts
* Any other reason that in the eye of the investigator makes the patient unsuitable for the participation in the registry
* For female patients only: pregnant or not on oral contraceptives or child bearing potential
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

This is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
2. LDL-C ≥2.6mmol/L at the screening visit
3. Body weight ≥40 kg
4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.

Exclusion Criteria:

1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%)
2. eGFR \<30ml/min/1.73m2 at the screening visit
3. CK \>5times ULN at the screening visit
Effect of Parcetamol in Headach

Tension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (two to 14 headaches per month), and chronic TTH (15 headache days a month or more). Paracetamol (acetaminophen) is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.Objectives To assess the efficacy and safety of paracetamol for the acute treatment of frequent episodic TTH in adults.

Headaches are a commonly reported problem in community-based surveys worldwide. The lifetime prevalence of headache is estimated to be greater than 90% , and the annual prevalence rate is estimated to be 46% in the general adult population . Variations in reported prevalence may result from differences in study design, population, inclusion or exclusion of cases of infrequent episodic TTH, overlap with probable migraine, cultural and environmental differences, or even genetic factors . TTH is more common than migraine, a finding replicated across the work.

The management of people with headaches is largely neglected , and may be fragmented by the involvement of clinicians from different medical specialities (neurology; ear, nose and throat; ophthalmology; psychiatry). Because headache is rarely life-threatening and headache pain is generally mild to moderate in intensity, people often self medicate and do not seek formal care from health services .

Headache can be either primary (no underlying cause) or secondary (due to other systemic or local causes) . TTH belongs to the group of primary headaches and is seen in nearly one-third of people experiencing headaches; the large number of people affected imposes a significant burden on the healthcare system. Generally, episodes of TTH are mild to moderate in intensity, and self limiting, but in a small group of people they may be more severe and disabling . People with longer lasting or more severe headaches may seek help in a clinical setting, but the majority of people do not do so, resulting often in inadequate and inappropriate management .

Eligibility Criteria:
Inclusion Criteria:

* both sex
* 18 years old to 65 years
* free ct brain

Exclusion Criteria:

* migrane
* any brain pathology
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.


Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects meet the diagnosis of SAR which has been prevalent for at least 2 years, and: standard treatment regimen for SAR was ineffective or subjective symptom control was unsatisfactory in the subject; positive test for at least one allergen associated with the development of SAR; pre-baseline symptom episodes of ≥ 4 days/week and a baseline TNSS of ≥ 6 points.
2. Consent to highly effective contraception

Key Exclusion Criteria:

1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening；
2. It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period.
3. Patients with asthma requiring stable use of inhaled controlled medications;
4. Previous or current malignant tumor within 5 years prior to screening;
5. Presence of other acute or chronic diseases or abnormal laboratory tests at the time of screening that, in the investigator's assessment, may have a more serious impact on the efficacy or safety assessment of the subject;
6. Live/live attenuated vaccine within 3 months prior to baseline;
7. Subjects with very limited outdoor activity during the daytime, as inferred from their regular daily routine;
8. Unwillingness or inability to comply with the permitted and prohibited medication/treatment specifications of the study, inability to meet the pre-randomization drug elution cycle specified in the protocol;
9. Women who are pregnant or breastfeeding;
10. History of alcohol or drug abuse within 3 months prior to screening.
Memantine - Communication Study

The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient at least 50 years of age and at least 8 years of education.
* The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks.
* Current diagnosis of probable Alzheimer's disease consistent with NINCDS- ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
* Mini Mental State Examination (MMSE) total score is less than 20
* Patients treated with any acetylcholinesterase inhibitor (AChEI) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months.

Exclusion Criteria:

* Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease
* History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose.
* Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
* Modified Hachinski Ischemia score greater than 4 at screening.
* Current evidence of clinically significant systemic disease
* Known or suspected history of alcoholism or drug abuse within the past 10 years.
* Previous treatment with memantine or participation in an investigational study with memantine.
Evaluation of Intraocular Pressure Following a Vitreoretinal Surgery Using Goldmann Applanation Tonometry, Icare and Accupen

The goal of this prospective controlled study is to measure the reliability of two intraocular pressure (IOP)-measuring instruments in comparison to the gold standard, Goldmann applanation tonometry (GAT) following vitreo-retinal surgery. The main question the current study aims to answer is: are Icare and Accupen as accurate as GAT in measuring IOP one day post eye surgery?

Participants in this study will have their IOP measured by the three different instruments one day post-surgery.

Goldmann applanation tonometry (GAT), used since 1948, is the reference technique for measuring intraocular pressure (IOP) in both healthy patients and those suffering from glaucoma or other eye disorders. However, the use of GAT requires the topical application of fluorescein, local anesthesia, and direct contact with the cornea. In addition to its lack of portability, these characteristics of GAT quickly led clinicians to try to find simpler, less cumbersome, but just as reliable techniques to measure IOP. Among the techniques developed to potentially replace GAT, two portable techniques are particularly easy to use: rebound tonometry (Icare) and portable applanation tonometry (Accupen). Before these techniques are universally and interchangeably used with GAT, their reliability and accuracy must be measured. The majority of studies have evaluated these techniques in glaucomatous or healthy eyes, presenting mixed but promising results. However, only one recent study has evaluated the validity of the two techniques (Icare and TonoPen) in a post-operative context of vitreo-retinal surgery. More data is therefore necessary to come to a definitive conclusion regarding the reliability of Icare and Accupen.

The objective of this study is therefore to determine whether the IOP measured by Accupen and/or Icare is as accurate as that taken by GAT in patients who have undergone vitreo-retinal surgery.

To answer this question, this project will be a prospective controlled study of 67 patients who have undergone vitreo-retinal surgery and who will have their intraocular pressure taken 1 day post-operatively by the 3 instruments mentioned above, in a randomized order. At their 1-day post-operative visit, an ocular medical history will be taken, including the preoperative diagnosis and the type of surgery performed. A resident in ophthalmology at Laval University, will take a series of 2 intraocular pressures with these 3 devices: GAT, Icare, and Accupen and will average for each group.

The project research hypothesis would be that the taking of intraocular pressure by Icare and/or Accupen is as valid as that taken by Goldman's applanation tonometry.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Received a vitreoretinal surgery

Exclusion Criteria:

* Corneal dystrophy
* Corneal surgery (penetrating keratoplasty, DSAEK/DMEK less than 6 months, radial keratotomy)
* Irregular corneal surface
* Active corneal ulcer
* Active epithelial deficit
* Central corneal scarring
* A history of scleral buckle
Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.


Eligibility Criteria:
Inclusion Criteria:

* Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit)
* Established history of COPD as diagnosed by a physician
* Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit
* Ability to read, comprehend, and record information in the English language

Exclusion Criteria:

* Currently active asthma (receiving asthma therapy and or having asthma symptoms)
* Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit
* Previous lung surgery
* Other respiratory disorders other than COPD
* Current alcohol, illegal drug, or solvent abuse
* Females with a positive urine pregnancy test at the study visit