cyrilzakka/clinical-trials huggingface dataset:
"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes

Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.

Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Estimated remaining duration of mechanical ventilation for more than two days
* patient alert and calm
* Surrogate decision maker's consent

Exclusion Criteria:

* Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
* Clinical instability for any reason
* Contraindications for continuing intensive care treatment
* Patient under tutelage
* Age \< 18 years
* Pregnancy
* No French health insurance
Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis

The purpose of this study is to determine the safety and efficacy of FX006 in bursal injections and to assess the patient's impression to change in their chronic pain, following treatment.


Eligibility Criteria:
Inclusion Criteria:

* Written consent to participate in the study
* Symptoms consistent with greater trochanteric bursitis for greater than or equal to 3 months prior to screening (patient reported is acceptable)
* Pain in hip for greater than 15 days over the last month (as reported by the patient).
* Hip bursitis as determined by clinical examination and clinical features. Where Magnetic Resonance Imaging (MRI) data is available, it will be used to confirm the bursitis diagnosis. Also, pain relief in subjects that have been treated with bursal injections containing an anesthetic (such as ropivacaine) is in itself indicative of bursitis.
* Body mass index (BMI) less than or equal to 40 kg/m2
* Ambulatory and in good general health
* Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
* Willing to abstain from use of protocol-restricted medications during the study

Exclusion Criteria:

* Hip Arthroplasty
* Hip osteoarthritis, iliopsoas bursitis, reactive arthritis,rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
* History of local infection around the bursa.
* Lack of pain relief with the intrabursal treatments containing an anesthetic
* Intra-bursal treatment of any bursa with any of the following agents within three (3) months of screening: any corticosteroid preparation (investigational or marketed, including FX006); and/or six (6) months for any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
* Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
* Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of screening.
* Females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive
A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial

Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible.

However the results of surgery are generally disapointing in most large series.The exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortality.The extent of surgery and particularly the development of systematic lymphadenectomy(D2)has been credited in Japan for the improved outcome in patients with gastric cancer.

Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in terms of overall survival,disease free survival and loco regional recurrence and also post operative morbidity and mortality following both these procedures,this study has been undertaken.

In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will also be removed according to internationally accepted guidelines and also include resection of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto its attachment to hepatoduodenal ligament.

Currently both these procedures are widely practised worldwide and there is no definite evidence showing the superiority of one procedure over the other.Neither is any of these procedures experimental.

We are doing this trial to see whether one of these procedures is superior to the other.


Eligibility Criteria:
Inclusion Criteria:Patients with biopsy/frozen section proven adenocarcinoma of stomach.

* Preoperative clinical examination and imaging indicating operable disease.
* Intraoperative exploration indicating operability i.e. no peritoneal deposits,no evidence of para aortic lymphadenopathy,no direct involvement of contiguous organs
* Surgical plan for distal/proximal/total gastrectomy

Exclusion Criteria:Patients with low performance score

* Staging investigations or intraoperative exploration indicating inoperable disease
* Patients medically unfit for major surgery
* Patients who have been given preoperative chemotherapy/chemoradiation.
* Patients with gastroesophageal junction tumours
* Patients unreliable for follow up
* Patients above the age of 70 years
* Past history of malignancy
Early Detection of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies

Chemotherapy-induced peripheral neuropathy (CIPN) is a common, but not well understood complication to treatment with chemotherapy. In this study the investigators will investigate a novel method for early detection of CIPN and compare it to other methods in patients treated for haematological cancers.

Haematological malignancies can be treated with chemotherapy if the patient tolerates the treatment. However, many patients develop complications during treatment including chemotherapy-induced peripheral neuropathy (CIPN) and/or impaired memory. Even though it is a well-known complication, no gold standard for CIPN assessment is known. Besides chemotherapy reduction or cessation, there is so far no sufficient prevention or treatment, therefore early detection and intervention is crucial.

The main purpose of this study is to find a reliable test for chemotherapy-induced peripheral neuropathy (CIPN) in order to predict early signs of CIPN. All included patients has to be scheduled for treatment with vincristine, bortezomib or lenalidomide regardless of haematological malignancy. Neuropathy and cognitive impairment will be tested at baseline (prior to treatment with chemotherapy), before each treatment course, 1 month after treatment and finally 1 year after onset of chemotherapy. CIPN will be examined by different methods: Clinician-based assessment, objective neurophysiological parameters and patient-reported outcome. A novel test using Perception Threshold Tracking (PTT), developed at Aalborg University, is included in the study. The test investigates the nerve excitability in both large and small fiber nerve fibers using two different electrodes. Blood samples will be collected, stored, and analyzed for deficiencies correlated to neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age ≥ 18 years
* Scheduled for treatment with Vincristine (R-CHOP, CHOP, R-CHOEP, CHOEP, R-CVP, CVP or simi-lar), Bortezomib (VCD, MPV, VRD or similar) or Lenalidomide (VRD, len-dex or similar) regardless of type of haematological malignancy
* Not started chemotherapy treatment before enrollment (pretreatment with steroids is allowed)
* Associated to Department of Haematology, Aalborg University Hospital during the project period
* Signed informed consent form
* Able to read and speak Danish

Exclusion Criteria:

* Known vitamin B12 deficiency and treated with either oral or intramuscular vitamin B12 within the last year
* Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.)
* Known severe skin disease
* Pregnancy or breastfeeding
* Inability to understand or comply with instructions
Home Respiratory Polygraphy in Childhood Sleep Apnea-Hypopnea Syndrome (CHILDSLEEP).

The aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.

Methods: Children referred with suspected OSAS will be evaluated during one year performing home respiratory polygraphy in all cases. PSG will be chosen in patients with concomitant pathology or according to medical criteria, or complemented with HRP in doubtful cases. Clinical and anthropometric data, severity, technical quality and treatment will be obtained. Patients will be divided in two groups (HRP vs PSG) and compared, and the accuracy from HRP to establish a therapeutic decision it wil calculated. The investigator's hypothesis is that PSG should be recommended only for complex or doubtful cases.


Eligibility Criteria:
Inclusion Criteria:

* Sleep apnea suspicion

Exclusion Criteria:

* Other sleep conditions
* Non valid home respiratory polygraphy and non valid polysomnography in the same patient
* Non informated consent
Efficacy of Nalmefene in Patients With Alcohol Dependence

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.

Eligibility Criteria:
Inclusion Criteria:

In- and outpatients who:

* had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
* had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
* had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

* had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
* had an antisocial personality disorder
* had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
* had a history of delirium tremens or alcohol withdrawal seizures
* reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
* reported current or recent treatment with antipsychotics or antidepressants
* was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of epilepsy
* Subject having at least 1 seizure (any type) during the 3 weeks before first visit
* Stable dosing of 1-3 concomitant antiepileptic drugs

Exclusion Criteria:

* Pregnant or nursing females
* Concomitant use of Levetiracetam
* Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
* History of status epilepticus
* Clinically significant acute or chronic illness, underlying disease or medication condition
* History of suicide attempt
Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.

The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in people with a brief psychotic disorder, especially positive symptoms.

The secondary objectives would be to assess the effect of EMC on metacognition (cognitive distortions and deficits in theory of mind), psychosocial functioning and quality of life, neuropsychological functioning and gender, as well as determine the changes produced by EMC in the insight of each session and the maintenance of the effects of EMC program at six months of treatment.

The study is a randomized clinical trial in which a group will receive the Meta-Cognitive Training (EMC) and a control group will receive a journal workshop.

The evaluator will be blind to the group that owns the patients included. The total simple will be of 122 people with a psychotic disorder, less than 5 years of evolution and a score at or above 3 on the PANSS during the last year. Patients should be attended in one of the next services: Parc Sanitari Sant Joan de Déu, Corporació Sanitària Parc Taulí, Hospital de la Santa Creu i Sant Pau, Hospital Clínic de Valencia, Centre d´Higiene Mental de les Corts, Institut d´Assitència Sanitària Girona, Servicio Andaluz de Granada, Málaga y Jaén. The assessment was performed at baseline, at the end of treatment and six month follow-up.

The assessment includes: psychopathology and insight ( PANSS, PSYRATS, PDI, GAF, BDI, BCIS, Sumd), meta-cognition (jumping to conclusions, IPSAQ, TCI), neuropsychology (WCST, TMT, CPT-II, TAVEC, WAIS) and social functioning and quality of life (EFS, DAS-SV, SLDS). The insight will be assessed at the final of each session (BCIS). The treatment and control group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group. The EMC group material is translated and validated in Spanish by investigators of the team.

The primary analysis variable is the difference between the scores of experimental and control group in the symptoms scales (especially positive). Secondary outcomes will change in other assessments of social functioning, metacognition (cognitive distortions and theory of mind) and neuropsychological variables. Were analyzed using regression and ANCOVA methods with SPSS 19.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified.
* Less than 5 years of evolution.
* Score at or above 4 on the PANSS during the last year (delusions, grandiosity, suspiciousness).

Exclusion Criteria:

* Neurological disorder which impairs cognition.
* Intellectual Disability.
* Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).
Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.

There is some evidence that paravertebral analgesia is similar to epidural analgesia in efficacy but superior in maintenance of blood pressure. This is a double blind, randomized control trial comparing paravertebral catheters to epidural catheters for the management of post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural catheter as well as a surgically placed paravertebral catheter. Patients will also receive PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes will be measured during the first five postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* Open thoracotomy
* Age \> 18 yo
* Able to use a patient controlled analgesia device

Exclusion Criteria:

* Previous thoracotomy
* Previous spine surgery
* Chronic pain condition
* Ongoing narcotic use
* Prior narcotic abuse
* Active chest infection
* Chest trauma
* Anticoagulation
* Other contraindication to epidural catheter placement
* Allergy to local anesthetic or narcotic
Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

The purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.

This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group (each group of participants will be treated at the same time), multi-center (when more than one hospital or medical school team work on a medical research study) study. All eligible participants will be randomly assigned to receive either a combination of loperamide hydrochloride and simethicone or loperamide hydrochloride. The study includes Screening Visit (from -24 to 0 hours), Baseline Visit (at 0 hour) and Concluding Visit (within 48 to 96 hours following the start of the trial). The timing of each bowel movement, stool characteristics and the degree and duration of abdominal discomfort caused by gastrointestinal gas accumulation will be recorded for each participant for 48 hours after the first trial drug administration. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial
* Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container)
* Participant's most recently produced stool must be unformed stool
* Participant must give a positive answer to the following question: "Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour"
* Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal

Exclusion Criteria:

* Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis
* Participant shows an axillary temperature greater than (\>) 38.2 degrees Celsius (C) or an oral temperature \> 38.6 degrees C
* Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at \> 3 per high power field
* Participant shows a sitting systolic blood pressure less than (\<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure \< 60 mmHg
* Participant is unable to take medication orally or tolerate oral rehydration
A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44

Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining) will be compared by the three contrast agents.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender at least 18 years at the time of signing the informed consent.
* Having a clinical indication for CT-examination of the abdomen

Exclusion Criteria:

* IV administration of iodine is contraindicated
* Known allergy to egg albumen
* Clinical suspicion, according to medical record, of fistula formation and/or leakage
* Referral indication of small bowel disease(s)
* Having known manifest thyrotoxicosis
* Having known phenylketonuria
* Having known Glucose-6-phosphatase deficiency
A Novel Strategy For Personalized Long-Term Dual Antiplatelet Therapy (RAPID EXTEND PILOT STUDY)

In patients with heart attacks, the current standard of care is to restore blood flow through percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens up blockages. Following PCI, standard preventative drug treatment includes the use of dual antiplatelet therapy (DAPT) using both aspirin and a platelet P2Y12 receptor inhibitor (Ticagrelor 90 mg twice a day or Clopidogrel 75 mg once a day) for one year to prevent clotting that can result in additional heart attacks, sudden clotting of stents or death.

New studies have shown that there is a benefit to continuing DAPT beyond this one year mark. Longer-term DAPT has been shown to reduce ischemic events (heart attack, stroke) but increase the risk of bleeding. Present guidelines state that the decision to continue DAPT beyond the one year mark should be made on an individualized basis.

The present study is a "pilot study" that seeks to compare Long-Term use of Ticagrelor (LTT) versus a Personalized Approach (PA). We will be recruiting patients who have been stable (free of ischemic or bleeding outcomes) on DAPT for 1 year after initial presentation with a heart attack.

The PA group will use a modified DAPT score based on patient demographics to decide whether treatment is warranted. Patient will also undergo bedside genetic testing to identify potential at-risk genes. Those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel.

The present study will determine whether a personalized approach will decrease bleeding versus an approach of universal ticagrelor use.

The hypothesis is that patients receiving a personalized strategy will have a decreased risk of bleeding.


Eligibility Criteria:
Inclusion Criteria:

* non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) at presentation for index PCI who have successfully completed \>1-year follow-up of RAPID MANAGE or TAILOR-PCI trials without having incurred an ischemic or bleeding outcome while on DAPT
* Patients with DAPT interruption after 1 year will be eligible, if within 3 years of index MI

Patients must also have 1 of the following atherothrombotic risk enrichment criteria:

* age ≥ 65 years
* diabetes
* 2nd prior MI (\> 1 year ago)
* multi-vessel coronary disease
* Creatinine Clearance \< 60mL/min

Exclusion Criteria:

Patients will be excluded from the study if they:

* refuse consent
* are \> 3 years post MI
* are deemed to require a P2Y12 inhibitor
* require oral anticoagulation
* have a history of stroke, transient ischemic attack (TIA) or intracranial bleed
* have had a recent GI bleed or major surgery
* have a life expectancy of \< 1 year
* have a platelet count \< 100,000/μl
* have a bleeding diathesis
* have hematocrit \< 30% or \> 52%
* are on dialysis or have severe liver disease
* are at risk for bradycardia