cyrilzakka/clinical-trials huggingface dataset:
Multisystem and Autonomic Complications of NMD on Long-term NIV

This exploratory observational study evaluates autonomic function using measures including heart rate variability in adults with childhood-onset neuromuscular and neurological disorders (NMD) who use non-invasive ventilation (NIV) as part of their long-term care. Autonomic function will be correlated with measures of symptom burden, disease severity and complications.

Childhood-onset neuromuscular and neurological disorders (NMD) are a diverse group of rare conditions in which muscle function is significantly impaired. Due to progress in NMD management over recent decades, particularly the use of non-invasive ventilation (NIV) to treat chronic respiratory failure, many individuals are surviving into adulthood and even middle age. However, older individuals are developing potentially fatal complications related to the heart e.g. sudden cardiac death, gastrointestinal (GI) tract and increasing dependence on NIV.

Previous studies largely in children and adolescents suggest individuals with NMD may develop problems of the autonomic nervous system (ANS), a network of nerves vital to controlling the body's short-term responses to internal and external stimuli. It is likely some complications of NMD are related to ANS abnormalities.

This will be an exploratory observational study using a cross-sectional design in which non-invasive tools will be used to evaluate autonomic function during wake and sleep. Individuals over 16 years of age with a confirmed NMD diagnosis will be recruited. Derived parameters of autonomic function including heart rate variability will be compared to values from an exploratory reference group of age- and sex-matched healthy adults. Autonomic function will also be correlated to measures of symptom burden, complications, quality of life and disease severity. Qualitative methods will be used to further evaluate the experience and perceptions of adults with NMD in making decisions about their personal and medical care, which become more complex with increasing age and disease severity.

Eligibility Criteria:
Inclusion Criteria:

Patient group:

* Age ≥16 years
* Confirmed diagnosis of childhood-onset NMD
* Able and willing to provide informed consent
* Requires non-invasive ventilation on an intermittent or continuous basis to manage respiratory failure

Reference group:

* Age ≥16 years
* No significant co-morbidities
* Not on any regular medications
* Able and willing to provide informed consent

Exclusion Criteria:

* Inability to travel to hospital site
* Clinical instability or acute deterioration requiring hospitalisation or changes to medication in the previous 4 weeks
* A female of child-bearing potential who is pregnant or intends to become pregnant during study involvement
A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin

A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic, or recurrent AGC
2. Previous use of fluoropyrimidine as palliative chemotherapy. Concurrent use of platinum is permitted. Patient with recurred disease within 6 months after the end of adjuvant therapy can participate to this trial.
3. Documented HER2 expression status.
4. Radiologically proven progression of disease.
5. Age \> 20 years
6. ECOG PS 0 - 2
7. Life expectancy more than 3 months
8. Adequate organ function for treatment including liver, kidney and bone marrow (absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 100,000/ul, AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement, Total serum bilirubin ≤ 2.0 mg/dL)
9. Written informed consent

Exclusion Criteria:

1. Prior administration of taxane or anthracycline as palliative chemotherapy. If those agents were used as adjuvant or neoadjuvant aim, at least 6 months should be passed.
2. Uncontrolled medical comorbidities Congestive heart failure (NYHA class III or IV) Recent (within 6 months) unstable angina or myocardial infarct Clinically significant cardiac arrhythmia LVEF \< 45% Liver cirrhosis (Child-Pugh class B or C) Interstitial pneumonia Psychiatric illness/social situations that would limit compliance with study requirements
3. Active CNS metastasis not controllable with radiation or steroid
4. Concurrent administration of systemic chemotherapy or radiotherapy. Palliative radiotherapy for pain control more than 2 weeks ago is acceptable.
5. Pregnant or lactating women.
6. Peripheral neuropathy G3\~4.
7. Metachronous malignancy other than adequately treated CIN of uterine cervix, basal cell or squamous cell carcinoma of the skin.
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)

This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.


Eligibility Criteria:
Inclusion Criteria:

* Must have relapsing MS
* Must have lifetime tetanus vaccination
* Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection

Exclusion Criteria:

* Patients with a type of MS that is not relapsing
* Patients with history of chronic immune disease
* Certain cancers
* Diabetic patients with certain eye disorders
* Patients who are on certain immunosuppressive medications or heart medications
* Patients with certain heart conditions
* Patients with certain lung conditions
* Patients who have already received the 2010/2011 seasonal influenza vaccine

Other protocol-defined inclusion/exclusion criteria may apply
AI-Driven Cognitive Digital Therapeutics for Dementia Management

The study would investigate the effect of a cognitive digital therapeutics system. The intervention group would receive three digital therapeutics sessions per week for 8 weeks, while the control group would receive usual care. Evaluations would be done at baseline, week 8, and week 16.


Eligibility Criteria:
Inclusion Criteria:

1. Age at least 50 years old.
2. Clinical Dementia Rating from 0.5-1
3. Physician diagnosed mild neurocognitive disorder or dementia (according to ICD-11 diagnostic criteria)

Exclusion Criteria:

1. Mini-mental state examination score below 18
2. If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 4 weeks prior to Baseline.
3. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's mild neurocognitive disorder or dementia.
4. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
5. Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant.
6. Geriatric Depression Scale (GDS) score greater than or equal to 10 at Screening.
7. Participants who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm.
Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients

A low endothelial count with endothelial pump dysfunction can contribute to corneal stromal hydration and loss of vision that can only be reversed by corneal transplantation,so this research proposed to detect any corneal endothelial changes related to DM , its duration and control of diabetes.

- To establish any correlation between endothelial changes , and the duration of diabetes, hemoglobin A1c (HbA1c) by using specular microscope to do morphological examination of corneal endothelial cells, makes the measurement of mean cell density (MCD), measurement of coefficient of variation (CV) in the cell size as well as hexagonal appearance of the cell. These parameters provide the functional status index of the corneal endothelial layer .

Eligibility Criteria:
Inclusion Criteria:

* - Diabetic patient type 2
* Elderly patients above 40 years old

Exclusion Criteria:

* - Patients with any of the following conditions have been omitted from the study included a past medical history of ocular trauma, corneal or intraocular inflammation, the use of systemic drugs that could affect endothelial cells, evidence of endothelial disease during a slit-lamp examination, previous ocular surgery (including cataract surgery), increased intraocular pressure, corneal opacity, or retinal photocoagulation procedures.
* non of the inclusion criteria patients
The Impact of Pecs Blocks on Postmastectomy Pain Syndrome

The aim of the present study is to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms

Breast cancer is the commonest type of malignancy in women. Chronic postoperative neuropathic pain may appear either in the early postoperative period or at a later stage, usually 3-6 months post-operatively. Chronic post-operative pain syndrome of any magnitude usually involves 19-57% of patients that have undergone any kind of surgical procedure, while 5% of them experience intense symptoms. Risk factors for developing post-mastectomy pain syndrome include younger age, increased Body mass Index (BMI), psychological profile, co-existence of other painful conditions, pre-operative radiotherapy/chemotherapy, type of surgical procedure and anaesthesia, persistent acute postoperative pain, etc. Consequently, chronic post mastectomy pain syndrome results in significant psychosomatic sequelae with variable social impacts for the female patients.

The aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms.

During the preoperative visit, the women will be informed about the study and will be instructed to the use of the pain numeric rating scale (NRS) graded from 0 to 10. Standardized anesthesia will be administered. All patients will receive 1000 mg of paracetamol and 0.07 mg/ Kg of morphine intraoperatively. In the Post-Anesthesia Care Unit (PACU), patients will receive additional morphine boluses on request, until NRS score is lesser or equal than 4. Postoperative nausea and vomiting will be treated with ondansetron 4 mg iv. After discharge from PACU, patients will receive a combination of paracetamol 1 gr/6h and im pethidine 75 mg on request, as per hospital protocol.

Numerical rating scores (NRS) at rest and movement will be measured at 6h, 12h and 24h postoperatively. Additionally, the time to first request for analgesia after surgery will be noted.

All patients will also be evaluated 3 and 6 months after surgery with the use of NRS at rest and movement and additionally, via the use of Douleur Neuropathique (DN4) questionnaire for the occurence of neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-III patients
* Breast cancer patients
* Patients who receive operative treatment

Exclusion Criteria:

* inability to consent to the study due to language barriers or cognitive dysfunction -
* skin infection at the puncture site
* contraindication to paracetamol administration
* known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers
Peripheral Primitive Fibromatosis

It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral primitive fibromatosis
* Adults patients
* Peripheral primitive fibromatosis proved by biopsy
* Peripheral primitive fibromatosis R2 resected for which monitoring is decided
* MRI realized before inclusion
* Patient information and informed consent signed

Exclusion Criteria:

* Local recur
* Head and neck topography
* Primitive fibromatosis R0 or R1 resected
* Specific medical treatment of fibromatosis
* Patient already included in an other clinical trial with an experimental molecule
* Persons deprived of liberty
* Impossibility to submit to the trial's medical follow-up for psychological, geographical or socials reasons
* Previous history of cancer
* Counter indication to the realization of an MRI
Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block

The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided infraclavicular brachial plexus block. However this technique is less popular because brachial plexus at the infraclavicular level runs deeper compared to its course proximally, often give rise to impaired needle visualisation due to its steep angle of needle trajectory to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to improve needle visibility. This approach proved feasible from our case series hence the investigators would like to compare it with the conventional method in this study

This study compared the conventional lateral and posterior approach parasagittal in-plane ultrasound guided infraclavicular brachial plexus block for upper limb surgery. A cadaveric study was also performed to complement the findings.

After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre (IRB reference no. 949.14 dated 17 October 2012), 46 patients undergoing upper limb surgery were prospectively recruited and randomized. A cadaveric dissection was also performed.

DESIGN: Prospective randomized study

SETTING: Single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia; November 2012 to October 2013

INTERVENTION: Ultrasound guided, lateral or posterior parasagittal in-plane infraclavicular brachial plexus blocks were performed on patients, depending on randomization. All blocks were performed using 21G x 4 inch Stimuplex A (B Braun Medical) without nerve stimulation plus SonoSite M-Turbo with HFL38x/ 13-6 MHz linear transducer probe. A 25-ml local anaesthetic admixture \[Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)\] were injected to all patients. A total volume of normal saline 0.9% 25ml mixed with methylene blue (0.2ml) was used for cadaveric study.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I - III
* Body Mass Index (BMI) between 20 and 35 kg/m2
* Surgery of the forearm, wrist, or hand

Exclusion Criteria:

* Inability to give consent to the study
* Pre-existing neuropathy
* Infection at the site of puncture, skin ulcer
* Coagulopathy
* Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax
* Allergy to amides local anaesthetics
Evaluation of the Benefits of Glucose Drinks During Childbirth

Fear of full stomach when emergency general anaesthesia is required is the origin of fastening when giving birth. This behaviour does not warranty perfect security for the general anaesthesia. In addition, well being for women and new born is affected. Giving birth is finally compared to a sportive competition with high-energy needs. As Intravenous energy intake is not regulated by physiologic digestion, it can induce metabolic disorders for the mother that can be amplified for the foetus.

Oral glucose drinks could offer some benefits:

* gastric acidity would be decreased without significant increase in volumes.
* energy intake would further more active and more efficiency labour
* an increase in foetus well being

However, it has never been shown yet that such behaviour could offer those benefits. Also, it seems that there is not more vomiting, but most of the studies compared oral glucose intake to waterborne intake with the same volumes The expected efficacy is a reduction in labour duration and a reduction in percentage of extraction. Previous studies said that the lack of statistical power due to small number of subjects caused the absence of statistical significant relationship.

In addition, even though newborn have less acidosis, there is no clinical relationship proven.

The investigators propose a randomised multicentre study to assess efficacy of oral glucose drinks in comparison to traditional fastening when giving birth.

Main objective is to significantly reduce instrumental extraction rates. 5400 women will be included in the study in 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 yrs
* Entering for childbirth
* Informed written consent

Exclusion Criteria:

* more of 8 cm of dilatation
* Caesarean section planned
* natural delivery non-indicated
* pre-partum hemostasis troubles
* salicylic acid or anticoagulant treatment
* pre-eclampsia or HELLP syndrome
* diabetic neuropsy with troubles in gastric emptying
* IMC \> 40 at the end of pregnancy
* understanding of the information
* under guardianship
Effects of Non-invasive Ventilation on Rehabilitation Outcome in COPD-patients

The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of COPD in stages GOLD III/ IV
* receiving optimized medical treatment and long term oxygen therapy if needed
* patients consent to participate in this trial
* no treatment with NIV in the last 4 weeks
* treatment with NIV in the last 4 weeks due to an acute exacerbation

Exclusion Criteria:

* treatment with NIV in the last 4 weeks (except due to an acute exacerbation)
* Intolerance to perform NIV
* Acute exacerbation at baseline or during PR
* Hypercapnia \> pCO2 55mmHg
* Inability to perform a 6 minute walking test
Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
* No prior systemic therapy for RCC with the following exception:

  1. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

     * Karnofsky Performance Status (KPS) of at least 70%
     * Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
     * Tumor tissue \[formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition\] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration \[FNA\] and bone metastases samples are not acceptable for submission)

Exclusion Criteria:

* Any history of or current central nervous system (CNS) metastases. Baseline imaging of the brain is required within 28 days prior to randomization
* Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)
* Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
* Any condition requiring systemic treatment with corticosteroids (\>10 mg daily Prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \>10 mg daily Prednisone equivalents are permitted in the absence of active autoimmune disease