cyrilzakka/clinical-trials huggingface dataset:
Prediction of WMH in Migraine Using a BOLD-CVR Map

Brain white matter hyperintensities (WMHs) are prevalent in migraineurs, of which the mechanism is still unclear. The investigators aimed to test the spatial association between areas with reduced cerebrovascular reactivity (CVR) to hypercapnic stimuli and consequent development of WMHs.

A whole-brain map of CVR will be created in patients with migraine and normal controls. Hypercapnic stimuli for CVR will be delivered by prospective end-tidal CO2 targeting device. Hemodynamic responses will be determined by BOLD signal changes using fMRI. WMHs will be determined by high-resolution 3D FLAIR imaging. Patients and controls will undergo serial MRIs with 1 year interval. Associations between areas of reduced CVR and consequent WMH development will be tested in both patients and controls.

Eligibility Criteria:
Inclusion Criteria:

1. Migraineurs(patients) :

   * age 18-50 years
   * migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta)
   * migraine duration \> 6 months
   * episodic migraine feature headache (\< 15 attacks/m)
   * not any preventive medications for migraine
2. Control:

   * age 18-50 years
   * no headache disorder requiring painkillers within the past year
   * no more than moderate intensity of headache within the past year
   * no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta

Exclusion criteria:

* chronic migraine within last month (≥15 attacks/m)
* medication overuse headache as defined by ICHD-3 beta
* other comorbid disease that may affect vascular function (Hypertension, diabetes, hyperlipidemia, cerebral infarction, smoking etc)
* can not breath 20 L for 1 minute because of basal cardiopulmonary disease (chronic obstructive pulmonary disease, heart failure etc)
* a disease that can be exacerbated by elevated PCO2 in blood (Interstitial lung disease, amyotrophic lateral sclerosis etc)
* predicted to be unable to write the headache diary due to cognitive decline
* contraindications to MRI
* pregnancy
* refusal to informed consent
Xenograft and Posterior Mandibular Socket Filling

The aim of this study is to evaluate the volume of madibular bone after placement of a xenograft in a fresh extraction socket in human. The surgery protocol is flapless, and the teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3 walls intact and the buccal wall at 80% . This study will include 35 patients.

Primary objective :

Estimate the percentage of loss of bone volume and the percentage thickness loss of the buccal and palatal cortical for patients who underwent bone volume preservation technology and conservation of the vestibular cortical by guided bone regeneration using a material slow absorption in the molar areas and premolar.

Secondary objectives:

Compare the percentage of loss of bone volume and the percentage loss of thickness of the buccal and palatal cortical patients who underwent a preservation technique, the upgrading data of mandibular posterior region without fillers described in the literature.

Methods :

After tooth extraction of a premolar or molar in mandibular flapless technique, guided bone regeneration is carried out. The cell is filled by a slow absorption material (Xenograft common use). The regeneration space is maintained by a resorbable membrane. To protect the membrane without tissue motion (technical flapless) placing a three-dimensional collagen matrix graft substitute gingival (Muccograft®) will be used. A CBCT preoperative be performed to verify the integrity of cortical and measure the height and width of the residual cavity. caliper measurements at the foot will also be performed during surgery in order to integrate also the thickness of the bone tables and gingival thickness.

After healing of the graft, the pre-implant scan performed at six months postoperatively will measure the height and width of the grafted cell, to compare measurements and evaluate the dynamics of alveolar resorption

Eligibility Criteria:
Inclusion criteria general

* with a unit or avulsion and ROG including 2 adjacent teeth maximum premolars
* aged 18 to 75
* has given its no objection to participate in research Inclusion criteria patient
* Patients can meet the demands of implant treatment (attendance, hygiene)
* Patients showing no indication against-General to surgery

Exclusion criteria patient

• Patient with against-indication for implant treatment. Whether for medical reasons against showing the pre and implant surgery, or local reasons a total loss of vestibular cortical unstabilized periodontal disease or aesthetic cons-indication.

Exclusion criteria general

* Inability to maintain a good level of oral hygiene and good cooperation.
* Higher tobacco consumption has 10cig / day
* Acute dental infection
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation

This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with \<3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period.

The objectives of this study are:

* To assess the efficacy of YKP10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation.
* To determine the safety and tolerability of YKP10811 once daily in subjects with chronic idiopathic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet modified Rome II criteria for Chronic Constipation.
* Patients who are male or female, 18 to 65 years of age inclusive.
* At Visit 3, patients must have \< 3 CSBMs per week and ≤ 5 SBMs per week during the 2-week baseline period.

Exclusion Criteria:

* Patients who meet Rome II criteria for Irritable Bowel Syndrome (IBS-C).
* Patients with constipation that is drug-induced, or secondary to endocrine, metabolic or, surgery.
* Patients with a clinically significant diseases that would limit the patient's ability to complete and/or participate in the study, including gastrointestinal disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal function (GFR of \< 55mL/minute/1.73m2), uncontrolled pulmonary diseases (including asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or cerebrovascular accident within 6 months prior to screening) or significant neurological diseases.
* Patients with a history of inflammatory bowel disease.
* Patients with a history of cancer (other than basal cell or squamous cell carcinoma of the skin completely excised) unless the malignancy has been in complete remission for at least 5 years prior to screening.
* Patients who started a special diet and/or an intense physical workout program within 30 days prior to the beginning of the baseline period or who are intending to substantially modify their dietary habits at any time during the study (patients on a stable, continuous regimen of fiber therapy for at least 30 days prior to the pretreatment baseline period are allowed to continue that therapy, provided that they continue at a constant dose throughout the study.
* Patients with a history of clinically significant hypersensitivity or allergy (facial swelling, hives, breathing difficulty, Stevens-Johnson syndrome etc), in response to any medication, either prescription or nonprescription including an investigational drug, dietary supplement, or herbal medicine.
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People with Upper Extremity Nerve Lacerations.

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.

NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.

Eligibility Criteria:
Inclusion Criteria:

* The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
* The subject is between eighteen (18) and eighty (80) years of age.
* The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.

Exclusion Criteria:

* Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
* Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
* Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
* Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity.
* The subject's injury is a result of a suicide attempt or self- harm.
* The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
* The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
* The subject is pregnant or breastfeeding.
* The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.
Magnetic Resonance Imaging Studies of Motor and Thought Processes

Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). MRI is especially useful when studying the brain, because it can provide information about certain brain functions. In addition, MRI is much better than standard X-rays at showing areas of the brain close to the skull and detecting changes in the brain associated with neurological diseases. In this study researchers will use MRI to gather information about the processes that control human movement and sensory processing.

The purpose of the study is to investigate how the brain is activated when remembering, thinking, or recognizing objects. Researchers would like to determine what happens to brain functions when patients have trouble remembering, thinking, or recognizing objects following the start of disorders in the brain and nervous system. In addition, this study will investigate the processes of motor control in healthy volunteers and patients with disease.

The main purpose of the studies presented in this protocol is to investigate the physiology of motor control in health as well as the pathophysiological modifications taking place during disease. Patients and normal volunteers will be scanned at rest and during different tasks, either while making repetitive movements or undergoing sensory stimulation. These studies should provide new insight concerning the processes that control human movement and sensory processing. The studies described in this protocol will be conducted by systems operating on 1.5 Tesla up to 4 Tesla, including a system at 3 Tesla which is going to be installed in near future.

Eligibility Criteria:
Patients with movement disorder and normal volunteers.
Skeletal Health in Bariatric Surgery Patients

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

While highly effective both RYGB and SG may lead to increased bone resorption, decreased bone mass, and increased risk of some fractures. Very few studies have compared the effects of the RYGB and the SG on changes skeletal health and findings have been inconsistent. Furthermore, few studies have investigated the short- or long-term consequences of bariatric surgery on bone mineral density in pre- and post-menopausal women. To what extent and how bariatric surgery impacts the skeleton largely remains undetermined. Because estrogen is protective against osteoporosis and fractures, the majority of fractures occur in postmenopausal women. It is important that women have higher rates of obesity (38.3%) compared to men (34.3%) and that ≥67% of bariatric patients are women. Therefore, women may be at a significantly increased risk of developing osteoporosis. These data may help establish clinical guidelines to assess, maintain, and promote skeletal health in the preoperative and postoperative care of bariatric patients; and it may help to determine the appropriate bariatric procedure for women at risk of osteoporosis and fractures.

Eligibility Criteria:
Inclusion Criteria:

* Adult females ≥ 19 years scheduled to undergo bariatric surgery (Roux en Y Gastric Bypass or Gastric Sleeve Surgery)
* Class II (BMI 35-39.9 kg/m2).
* Class III obesity (BMI ≥ 40 kg/m2).
* Scheduled to undergo bariatric surgery with the ability to provide informed consent.

Exclusion Criteria:

* Patients with a history of thyroid disorders, thyroidectomy and levothyroxine use.
* Patients with a history of known osteoporosis, steroid-induced osteoporosis, current or previous use of medications for osteoporosis.
* Patients with a history of gastrointestinal malabsorption.
* Patients with a history of renal diseases.
* Patients with a history of current or previous use of corticosteroids.
* Patients who have used tobacco products within a year of study enrollment.
* Patients with surgically-induced menopause e.g. bilateral salpingo-oophorectomy.
* Patients with a history of breast cancer, who have had or are currently on hormonal therapy or anti-hormonal therapy.
Vascular Access for Hemodialysis and Inflammation

The aim of the present study was to investigate patients free of active infection and/or thrombosis to assess if the type of vascular access (AVF, AVG, TCC), could influence:

1. the levels of serological markers of inflammation (CRP, IL-6, TNF-a);
2. the degree of expression on monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.
3. the amount of monocytic cells expressing a senescent phenotype (CD14 and CD32).

Patients with AVF assumed ticlopidine 250 mg/die, patients with TCC and AVG assumed warfarin to maintain target INR between 1.8 and 2.5.

Six wash out consecutive sessions were carried out before starting the study with Fresenius FX8 Helyxone® , for patients who underwent HD, or with FX 80 Helyxone®, for patients who underwent hemodiafiltration (HDF). After the wash out period, fresh whole blood and serum samples were drawn on starting dialysis, during the midweek HD session for 4 consecutive weeks. For each patient the mean value of the 4 blood samples was considered. All patients continued HD or HDF with FX8 or FX 80 Helyxone® during the whole study period.In order to estimate the normal ranges of the parameters that we evaluated, 60 anonymous healthy volunteers were also submitted to the same assays.

Eligibility Criteria:
Inclusion Criteria:

* All the patients recruited for the study were infection and thrombosis free from almost 6 months.
* No patients included had autoimmune disease, hepatic failure, diabetes or malignancy.
* Patients were not administered ACE inhibitors, angiotensin receptor antagonists, antiinflammatory or immunosuppressive drugs.
* All the patients had residual GFR \< 5 ml/min.
* The vascular access considered were placed from at least 6 months.

Exclusion Criteria:

* Patients with recirculating vascular access \> 10% were excluded from the study.
* Patients with acute cardiovascular accident in the last 15 days before starting the study.
Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization by Botulinum Toxin Injections. Study of Facial Symmetry Before and After Botulinum Toxin Injections on the Face of Patients Suffering From Sequellar Peripheral Facial Paralysis

"This is a prospective, single-center study. The main objective of our study will be to objectively evaluate the improvement of facial symmetry after botulinum toxin injection on the face in patients suffering from sequelae of peripheral facial paralysis. A secondary objective will be to assess the utility of 3D photography and stereophotogrammetry to detect and quantify facial changes relevant to this type of treatment. The number of patients included in the study is expected to be 15 at minimum. Our study will rely on 3D photographs taken with the Vectra H2 Imaging System camera device (Canfield Scientific, Inc., Fairfield, New Jersey), which will be captured before and 3 weeks to 1 month after botulinum toxin injection into the facial muscles. Various analyses of static and dynamic symmetry will be performed using the Vectra software: bi-pupillary line angle / bi-commissural line angle, superposition of healthy and pathological sides followed by RMS (root mean square) calculation, analysis of pre- and post-injection skin displacement vectors.

The results of these analyses will allow conclusions to be drawn regarding the objective efficacy of botulinum toxin injections for facial symmetrization in patients with peripheral facial paralysis, as well as to adapt injection patterns based on the severity of facial paralysis."


Eligibility Criteria:
Inclusion Criteria:

-Patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France at Head and Neck Institute, Nice, France.

Exclusion Criteria:

* History of corrective surgery for facial palsy, significant facial surgery, neurodegenerative diseases, the presence of skin imperfections or facial tumors that would impede a rigorous analysis of wrinkles and facial movements.
The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)

Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the classic LMA and the air-Q SP.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-75 of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

* Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial

The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

The trial is a prospective, international, multi-centre, randomised (1:1), double-blind, parallel group comparison conducted for investigating the efficacy and safety of tenecteplase and placebo in patients with cardiac arrest of presumed cardiac origin.

Approximately 1300 patients (two groups of 650 patients; tenecteplase or matching placebo) suffering from witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, who are treated with ALS-CPR will be randomised at approximately 40 study centres. Randomisation is done immediately after insertion of an IV line is established. Study drug application, as a single IV bolus over 5-10 seconds, should be done immediately after the first vasopressor application during the ALS-CPR procedure.

PCI facilities will be required at all participating sites, i.e. hospitals receiving patients.

Study Hypothesis:

The primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of 30-day survival (30daysurv).

Comparison(s):

Group A (experimental; fibrinolytic treatment) Tenecteplase, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.

Group B (reference) Placebo, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.

Eligibility Criteria:
Patients, indicated for pre-hospital ALS-CPR procedures\* must fulfil the following inclusion criteria:

* Age at least 18 years (known or estimated; no upper limit)
* Out-of-hospital cardiac arrest of presumed cardiac origin (including recurrent cardiac arrest(s) after initial ROSC)
* Witnessed (by eye and/or ear) cardiac arrest
* BLS-CPR started within 10 min of onset (known or estimated time) and may be performed for up to 10 min, followed by ALS-CPR - or ALS-CPR started within 10 min of onset (known or estimated time)

Subjects who meet any of the following criteria will be excluded from randomisation into the study:

* In-hospital cardiac arrest
* Cardiac arrest of presumed non-cardiac origin (e.g., drug overdose, carbon monoxide poisoning, drowning, hypothermia, exsanguination, electrocution, asphyxia, hypoxia, trauma, cerebrovascular accident)
* Obvious significant internal bleeding
* Known neurological impairment
* Known coagulation disorder
* Known pregnancy
* Known current participation in any other clinical study
* Known hypersensitivity to study medication
* Institutionalised subjects (e.g., prisoner)
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects

This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men ages of 19 and 55 years old, inclusive
* weighs at least 132 lbs

Exclusion Criteria:

* Clinically significant comorbid disease
* History of substance abuse
* Hemoglobin less than 12.0 g/dl