cyrilzakka/clinical-trials huggingface dataset:
Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms

The goal of this clinical trial is to determine the most effective timing for clipping in adults with ruptured intracranial aneurysms. It will also assess the safety of performing the surgery at different times of early period after the aneurysm has ruptured. The main questions it aims to answer are:

1. Does ultra-early surgical intervention ( less than 24 hours of rupture) improve survival rates compared to delayed surgery (24 to 72 hours after rupture)?
2. What are the complication rates associated with early versus delayed surgical intervention?

Researchers will compare clipping in ultra-early period to surgery in early period to see if timing affects the outcomes for treating ruptured intracranial aneurysms.

Participants will:

* Be randomly assigned to undergo surgical clipping either within 24 hours of rupture or between 24 hours to 72 hours after the rupture.
* Visit the clinic for follow-up assessments at 1 month, 3 months, 6 months, and 12 months post-surgery.
* Keep a diary of their symptoms, neurological function, and any complications they experience post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* aneurysmal subarachnoid hemorrhage
* patient eligible for surgical clipping
* patients with informed consent for inclusion into the study

Exclusion Criteria:

* patients admitted and treated \>72 h after subarachnoid hemorrhage onset
* patients with severe comorbidities
* patients with multiple aneurysms
Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers

The most frequent reason for failure of laminate veneers made of glass ceramics (feldspathic, leucite based and lithium silicate based ceramics) was fracture of the ceramic, Therefore, ceramic materials that have higher fracture resistance, especially for patients suffering from abnormal occlusion, are needed.

IPS Empress CAD is a leucite glass-ceramic of the SiO2-Al2-O3-K2O material systems with leucite crystal ranging from 5 to 10 µm in size. The leucite crystals increase the material strength and interferes with crack propagation, while the fracture energy is absorbed by the crystalline phase. The resistance and flexural strength (160 Mpa) is improved by the difference in the coefficient of thermal expansion between the glass phase and the crystalline phase and the cooling process following sintering phase.

CELTRA DUO: is a new generation of glass ceramic material. With the aid of a new manufacturing process, the glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic (ZLS). The material is characterized by a unique homogenous structure with fine grains that provides excellent material quality and consistency, high strength properties and long term performance. In addition, the material offers satisfying processing characteristics which can be milled and polished easily. After milling the restorations are shaded correctly shaded, with no need for crystallization step 10. The milled restorations have a flexural strength of 210 MPa. After stain and glaze firing the restoration will exhibit a flexural strength up to 370 MPa.

Eligibility Criteria:
Inclusion Criteria:

* All subjects are required to be

  1. From 18-50 years old, be able to read and sign the informed consent document.
  2. Physically and psychologically able to tolerate conventional restorative procedures
  3. have no active periodontal or pulpal diseases, have teeth with good restorations
  4. Patients with teeth problems indicated for laminate veneer:

     1. Discoloration
     2. Fracture not involving more than 50% enamel loss
     3. Mild malposition
     4. Diastema
     5. Enamel fluorosis
     6. Stained or defective restorations
  5. Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* 1. Patients in the growth stage with partially erupted teeth 2. Patient with fractured teeth of more than 50% enamel loss 3. Patients with poor oral hygiene and motivation 4. Pregnant women's 5. Patient with post and core endodontically treated teeth 6. Psychiatric problems or unrealistic expectations 7. Lack of opposite occluding dentition in the area intended for restoration 8. Patients involved in contact sports 9. Teeth with deep discoloration
Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.


Eligibility Criteria:
Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR Rheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake of at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration Exclusion Criteria:

* Current RA functional status class IV according to the ACR 1991 revised criteria •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply
Impact of Decision Aids in Urogynecology

To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.

The investigators will enroll patients seeing a specialist to discuss treatment of pelvic organ prolapse, overactive bladder and stress urinary incontinence in this pilot study. The study will evaluate the feasibility and acceptability of three decision aids designed to promote shared decision making conversations for these three condition. The investigators use a quasi-experimental design in which the investigators first enroll patients in the control arm and measure their outcomes. Then, the investigators enroll patients into the intervention arm and measure their outcomes. The investigators estimate that it will take about one month to recruit the control arm and one month to recruit the intervention arm. Patients will be surveyed after the clinic visit with a specialist and surveys will assess patients' knowledge, treatment preferences, shared decision making, decisional conflict and acceptability of the tool. A clinician survey will be administered and completed after each patient visit, that details how the physician felt about the length of the visit, how informed the patient was, and how far along they may be with their decision.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-95 years only
* English speaking
* Pelvic organ prolapse defined by noticeable (to the patient) vaginal bulging
* Symptoms of stress urinary incontinence (cough, sneeze, laugh, exercise)
* Presenting for initial consultation for either of the above symptoms

Exclusion Criteria:

* Primary complaint is not vaginal bulging or stress urinary incontinence
* Prior surgery for pelvic organ prolapse or any incontinence procedure
A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.


Eligibility Criteria:
Inclusion Criteria:

* Male or female diagnosed with FECD.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye.
Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis

It will be done a prospective Study involving 38 patients with lumbar stenosis. A magnetic resonance (MR) imaging study and a electromyographic study will be done previously and 3 months after the epiduroscopy to confirm radiologic or neurophysiological changes.

During the technic it will be used different instruments, an endoscope developed for its use in the epidural space (Resascope), a Fogarty balloon (Resaloon) to dilate the space near the epidural recess where it will be try to decrease the ligamentum flavum using the Resaflex, an instrument with Quantum Molecular Resonance for tissue coablation, in order to get less symptomatic lumbar stenosis.

The investigators will compare qualitative and quantitative variables at baseline and 1, 3, 6, ant 12 months after the epiduroscopy.

The investigators perform the Interventional Endoscopic Spinal Surgical (IESS) ,with the different instruments mentioned above. The Resaflex wich use Quantum Molecular Resonance, through combination of different frequencies in the range of the radio-frequency, emit quantum in resonance and produce lesion and coagulation; The objective is to reach the ligamentum flavum doing lesions to diminish the stenosis caused by hypertrophic ligamentum over all in the recess area near the radicular nerve.

To increase the security of the procedure the investigators introduce for the first time , neurophysiological monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patient with indication for epiduroscopy in the usual clinical practice
* Neurogenic claudication
* Lumbar pain for more than 6 months
* Numerical rating scale \>6
* No response with medical treatment
* No response with other interventional treatment: epidurolysis

Exclusion Criteria:

* Psychiatric disorders
* Opioid addiction
* Acute organic disease
* Severe chronic organic disease
* Vasculo-cerebral disease
* Coagulation alterations
* Ofthalmologic disease
* Allergic
* Infections
* Impossibility to understand the procedure
Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

The purpose is to determine diagnostic performances of flat panel dual energy arthrography and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as reference the results of surgery performed 6 months after arthrography.

Secondary purposes are:

* To describe the level of concordance of each technique with the indication for surgery
* To study inter-technique concordance with kappa coefficient
* To study the relationship between density differential between 2 acquisitions and grey level on subtraction, i.e. subtraction quality according to metal

Hip arthroplasty has become one of the most performed orthopedic procedures. Actual average lifetime of total hip prosthesis is approximately 15 years. Some complications are inevitable. Total hip prosthesis imaging, performed to search for a complication or wear, is difficult and depends on many techniques. Subtracted arthrography is a good technique but its access is limited because it needs an angiography room.

In this study patients undergo standard arthrography, dual energy arthrography, arthro-tomosynthesis and arthro-tomography.

Eligibility Criteria:
Inclusion Criteria:

* Patients sent for arthro-tomography of painful prosthesis, without contraindications to arthrography or injection of contrast agent
* Aware and cooperative
* Signed informed consent
* Affiliation to social security

Exclusion Criteria:

* Any contraindication to arthrography or injection of contrast agent
* Pregnant or possibly pregnant women
* Patient under guardianship
* Refusal or impossibility of informed consent
Evaluation of the Effect of a Combination of Plants to Regulate Mood

The aim of this study is to confirm by a randomized double-blind controlled study the interest of a combination of saffron (Saffr'Activ®) and scutellaria (Scutell'up®) on the regulation of mood.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man, aged of 18 to 75 years;
* Participant presenting a depressive episode, according to the DSM-5 definition;
* Participant presenting a BDI ≥ 14 and ≤ 28 at the inclusion, corresponding to mild to moderate symptoms;
* Participant with a recent episode of depression (less than 2 years), not managed by antidepressant or psychotherapeutic treatment;
* Participant with a current depressive disorder not requiring, in the investigator's opinion, the initiation of antidepressant medication;
* Provision of signed and dated informed consent form;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* French speaker.

Exclusion Criteria:

* Participant with a depressive disorder of another nature or any other mental pathology (schizophrenia, bipolarity, addiction to alcohol or drugs...);
* Participant at risk of suicide (determined by the Investigator, or HAMD item 3 score \> 2) or having made a suicide attempt in the last 5 years;
* Participant with depression for more than 2 years;
* Participant undergoing psychotropic treatment (current or in the month prior to inclusion) (neuroleptic, anxiolytic, hypnotic);
* Participant with a serious health problem for which the Investigator considers that it is not in the participant's interest to participate in the study;
* Participant using products containing piperine or millpertuis, or having a known effect on mood within the last 4 weeks;
* Pregnant or breastfeeding women, or those planning to become pregnant within the next 8 weeks;
* Participant with an allergy or contraindication to any component of the study drug;
* Participant unable to understand study information (mental or linguistic disability);
* Participant who is participating or has participated in the previous month in another clinical trial.
Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects

A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI : 20.0 - 28.0 kg/m2 willingness to sign the written informed consent form(ICF)

Exclusion Criteria:

* Evidence of clinically relevant pathology within 30 days prior to drug administration History of relevant drug and/or food allergies
A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection

Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.

Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent.

Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery

Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.

Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.

Other Outcome Measures:

1. efficacy:

   * 1 year success rate of treatment
   * 1 year patency rate of branch stent
2. safety:

   * in-hospital mortality
   * complication rate of neural system
   * 1 year dissection or stent related mortality


Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 80, male or unpregnant female
* diagnosed as aortic dissection
* proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA
* good compliance with the instructions and cooperate with follow-up
* voluntarily signed the informed consent form

Exclusion Criteria:

* Pregnant female
* no appropriate vessel approaches
* patients with connective tissue diseases (such as Marfan syndrome)
* allergic to nitinol or contrast medium
* bad compliance with the instructions and follow-up
* estimated remaining life is less than 12 months
Peri-neural Electrical Dry Needling Migraine Treatment Study

This study seeks to determine the effectiveness of a specific treatment protocol using dry needling with perineural electrical stimulation in comparison to standard treatment in physical therapy for patients with migraine headaches. This will be a randomized cross-over study in which participants will be in the first arm of the study, have a washout period, then cross over to the other arm of the study.

From current understanding of migraine pathophysiology, the investigators know that it involves excitability of the trigeminovascular system. Intercranial vasculature containing nociceptor innervation consists of unmyelinated (c-fibers) and thinly myelinated (a-delta fibers ) axons which hold vasoactive neuropeptides including substance P and (CGRP) calcitonin gene related peptide. When a migraine occurs, there is a cortical spreading depolarization, which on a molecular level involves a release of ATP, glutamate, potassium, hydrogen ions, glia or vascular cells, and CGRP and nitric oxide by activated perivascular nerves. These substances, including CGRP diffuse to come in contact with nociceptors causing neurogenic inflammation (vasodilation), thus propagating a headache.

Electrical perineural dry needling causes the release of substance-P and CGRG predominantly from non-neural structures, facilitating a negative feedback loop to neural and neuroactive components of the target tissue. This causes a lowering of the levels of CGRP which in turn decreases the inflammatory component thought to play a role in migraine headaches.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 to 100 years old
* Acute or chronic manifestation of migraine headaches or prior diagnosis of migraine headache.
* Numeric pain rating of 3/10 (where 0= no pain and 10= worst pain)

Exclusion Criteria:

* History of epilepsy
* Needle-phobia
* Unstable psychological status
* Compromised immune system
* Metallic allergy
* Having not eaten within the past 3 hours
* Inability to lie in prone, or side-lying
* Pregnant or trying to become pregnant
* Inability to consent or understand English.
* Prisoners
Right Ventricular Haemodynamic Evaluation and Response to Treatment

Mono-center Study to evaluate different multimodal functional parameter of the right ventricle in PAH-patients

Mono-center-study tu evaluate functional parameters in cardiac MRI, conductance catheter (pressure-volume-loops), echocardiography and right heart catheter in PAH patients and to compare different multimodal parameters

Eligibility Criteria:
Inclusion Criteria:

* PH Nizza group 1 and patients without pulmonary hypertension after having the right heart catheter on clinical grounds
* ability to sign informed consent
* male and female between 18 to 85 years
* haemodynamic criteria:

  * Pulmonary vascular resistance (PVR) \> 240 dyn x sec x cm-5
  * Mean Pulmonary artery pressure (mPAP) ≥ 25 mmHg for PAH patients
* normal haemodynamic in controls
* therapy-naive or at least since two months stabil therapy with approved drugs for PAH (Sildenafil, Tadalafil, Macitentan, Ambrisentan, Bosentan, Iloprost, Treprostinil, Riociguat).

Exclusion Criteria:

* therapy with positive inotropic drugs (dobutamin etc.)
* missing informed consent
* pregnancy or lactation
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria

Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters" let protein get into the kidney.

FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney failure is dialysis or kidney transplant.

Proteinuria means too much protein came through the kidneys into the urine.

If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS. This kind of FSGS is very hard to treat.

This study will test Acthar in patients with this condition who have not responded to other treatments. It primarily investigates how well the therapy is tolerated by the patients and how well they respond to this treatment.


Eligibility Criteria:
Inclusion Criteria

Potential participants must meet the following summary criteria for inclusion in the study:

* Is male or non-pregnant, non-lactating female
* Has primary FSGS, is nephrotic and did not achieve at least partial proteinuria response with prior therapy
* Has been treated with an angiotensin converting enzyme inhibitor or receptor blocker (or have documented intolerance), for at least 4 weeks before screening
* Has blood pressure no higher than 150/90 mmHg
* Meets all other inclusion criteria detailed in the protocol

Exclusion Criteria

Potential participants will not be eligible for the the study if they meet the following summary criteria:

* Has hepatitis B or C, tuberculosis, or other contraindication listed on the United States (US) Prescribing Information for Acthar
* Has Type 1 or Type 2 diabetes mellitus or any clinically significant infection
* Has received specific treatments at exclusionary time points per protocol
* Has been involved in a therapeutic drug/device trial (other than for FSGS) within 4 weeks before screening
* Meets any other exclusion criteria detailed in the protocol
* Has any other condition that might, per protocol or in the opinion of the investigator, compromise:

  1. the safety and well-being of the participant or their offspring
  2. the safety of study staff
  3. analysis of results