cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD

This is a phase 2B multicenter, randomized, double-blind, placebo-controlled, parallel group dose finding study to evaluate the safety, tolerability and efficacy of PQ912, an inhibitor of the glutaminyl cyclase enzyme, in 250 subjects with mild cognitive impairment and mild dementia due to Alzheimer 's Disease.

In the parallel group dose finding part of the study the first 90 subjects will be randomized 1:1:1 between PQ912 300 mg BID, 600 mg BID, and placebo. When the 90th patient has completed the week 24 treatment visit, the DSMB will decide on the dose of PQ912 to be continued. The decision is based on safety findings only, no efficacy data will be considered. After the DSMB has reached a decision on the dose to be continued, all subjects randomized to receive PQ912 will be reallocated to this dose (1:1). The duration of Subjects participation in the study is either 48, 60, 72, 84 or 96 weeks of treatment (depending on time of randomization). Subjects recruited early into the study will be kept on treatment for 96 weeks or until the regular, scheduled study visit which is closest to the scheduled week 48 visit of the last subject recruited in the study, whichever comes first.

Eligibility Criteria:
Main Inclusion Criteria:

* Positive CSF AD biomarker signature according to the AA-NIA criteria
* Clinical syndrome of MCI or mild dementia according to the AA-NIA Research Framework
* A cognitive impairment in the WAIS IV Coding Test of at least 0.5 standard deviation below the normative data
* Adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the investigator
* Meeting the completion and performance criteria for the CogState NTB
* Outpatient with study partner capable of accompanying the subject on all applicable clinic visits

Main Exclusion Criteria:

* Significant neurological or psychiatric disorders, other than AD, that may affect cognition.
* Atypical clinical presentations of MCI due to AD or mild dementia due to AD, such as the visual variant of AD (including posterior cortical atrophy), frontal variant or the language variant (including logopenic aphasia).
* Moderate and severe dementia with a Mini-Mental State Examination score (MMSE) below 20.
* Current presence of a clinically important major psychiatric disorder (e.g. major depressive disorder) as defined by DSM-5 criteria, or symptom(s) (e.g. hallucinations) that could affect the subject's ability to complete the study.
* History of clinically evident stroke.
* History of seizures within the last two years prior to the screening visit.
* Myocardial infarction within the last six months prior to screening.
* History of uncontrolled hypertension (in the opinion of the investigator) within six months prior to screening.
* Contraindication to lumbar puncture and MRI
Relationship Between Muscle Mass and Muscle Relaxation Time

Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. The purpose of this study is to find relationship between muscle mass and muscle relaxation time.

Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. Until now, dose of rocuronium has been judged by patient's weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find relationship between muscle mass and muscle relaxation time. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.

Eligibility Criteria:
Inclusion Criteria:

* All patient who undergo general anesthesia.
* Male; weight 70-75kg , height 170-175cm
* Female; weight 53-58kg , height 158-163cm

Exclusion Criteria:

* Liver and kidney disease
* Any types of muscle disorder.
* Metal materials or pacemaker in body
Simultaneous Recording of Cognitive and Motor Functions After Stroke

Aim: To assess whether a cognitively demanding dual-task has greater impact on manual dexterity in chronic stroke patients than in healthy subjects.

Methods: A visuomotor force-tracking task, combining grip force and oculomotor recordings, will be applied in chronic stroke patients with mild-moderate hemiparesis without clinical cognitive impairments and in age-comparable healthy subjects. The dual-task includes avoiding visual distractors and mental addition of numbers. Dual-task effect is calculated as difference in force control accuracy (dual minus single-task) and as difference in saccade rate (addition of numbers minus visual distractors).


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* First symptomatic stroke more than 3 months ago
* Box and blocks test score \< 52
* Mini Mental State Examination Test \> 25

Exclusion Criteria:

* Psychiatric disease
* Risk of Pregnancy
* History of previous stroke
* Disability that may interfere with the performance of tasks
Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide

Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.

Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant.

Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 26 and 36 weeks
* intubated for respiratory distress syndrome

Exclusion Criteria:

* cardiac defects,
* hemodynamically significant patent ductusarteriosus,
* congenital pneumonia,
* early sepsis
* unstable infants in need of inotropic support.
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma

Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2.

Phase 1 (ATLL expansion part): Evaluate the safety of ASTX660 at RD in patients with r/r ATLL.

Phase 2 : Evaluate the efficacy of ASTX660 at RD in patients with r/r PTCL.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with T-cell lymphoma with histological diagnosis based on WHO classification (2017)
2. Patients with evaluable lesions.
3. Patients with ECOG PS score of 0 or 1.
4. Patients with adequate organ functions as shown below.

   * AST and ALT ≤ 2.0 × ULN (≤ 3.0 × ULN if liver infiltration is present)
   * Total bilirubin ≤ 1.5 × ULN
   * ANC ≥ 1,000/mm3 (≥ 750/mm3 if bone marrow infiltration is present)
   * Platelet count 50,000/mm3 (25,000/mm3 if bone marrow infiltration is present)
   * Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
   * Amylase and lipase ≤ 1.0 × ULN

Exclusion Criteria:

1. Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals
2. Patients with heart disease that meets the followings:

   1. LVEF of \< 50% by echocardiography or MUGA scan
   2. Congestive heart failure (NYHA classification III or IV)
   3. Uncontrolled heart disease including unstable angina pectoris or hypertension considered to require hospitalization within last 3 months (90 days)
   4. Complete left bundle branch block, III degree (complete) atrioventricular block, use of pacemaker, history or complication of poorly controlled arrhythmia requiring treatment
   5. History or complication of long QT syndrome
   6. History or complication of ventricular arrhythmia requiring active treatment
   7. Corrected QT interval of ≥ 470 msec based on 12-lead ECG performed at the screening
   8. Concern on increased cardiac risk by participating in the study based on medical judgment
3. Patients receiving the following treatment for the primary disease prior to the initial dose of study drug

   1. Chemotherapy or radiotherapy within last 3 weeks
   2. Skin directed therapy including local treatment or phototherapy within last 3 weeks
   3. Treatment with monoclonal antibody within last 4 weeks
   4. Treatment with other study drugs or study treatment within last 3 weeks or 5 half-lives, whichever is longer
4. Patients with prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 14 weeks prior to the day of initial dose of study drug
5. Patients who have received corticosteroids at a dose exceeding a prednisone equivalent dose of 10 mg/day within 3 weeks prior to the initial dose of study drug.
6. Patients with Inadequately controlled diabetes mellitus
The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State

There will be formed of groups for application of vibration methods on the lungs: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device; the method of oscillating PEP therapy using Acapella DH Green; the method of hardware stimulation of cough with a mechanical insufflator-aspirator Comfort Cough Plus (Comfortable cough Plus). As a control group, classical manual chest massage with percussion and verbal stimulation of cough against the background of chest compressions with a total duration of 15 minutes will be used

The patient signs an informed consent to participate in the study after 10-12 hours tracheal extubation and transfer of the patient to spontaneous respiration. The application of one or another method of influence is carried out by the method of random sampling (the envelope method). Next, a session is conducted using one of the methods of vibrational respiratory therapy. We are exploring the gas composition of arterial blood is examined, spirometry, and the respiratory rate is measured after 20 minutes of the procedure. Further, respiratory therapy sessions are repeated 3 times a day for three days

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 years to 80 years inclusive.
2. Performed cardiac surgery in IC conditions.
3. The patient's consent to participate in this study.

Exclusion Criteria:

1. Lack of productive contact with the patient
2. Any disorder in the central nervous system in the perioperative period (acute cerebrovascular accident, coma, posthypoxic encephalopathy), being on a ventilator.
3. Unstable hemodynamics or hemodynamically significant rhythm disturbances
4. Shocks of various etiologies
5. Inability to provide respiratory protection, high risk of aspiration
6. Refusal of the patient to participate in this study
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors

This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).


Eligibility Criteria:
Inclusion Criteria:

* performance status ECOG-WHO ≤ 1
* histologically proved neuroendocrine tumor with Ki67 \< or = 10%, metastatic or locally advanced without surgery possibility
* at least one measurable lesion based on RECIST criteria version 1.1
* signed written informed consent

Exclusion Criteria:

* previous treatment with interferon or cyclophosphamide
* treatment by immunosuppressive drugs
* diabetes complicated by coronary artery disease or vasculopathy
* severe respiratory failure, chronic respiratory failure, COPD
* history of severe heart failure
* severe renal or hepatic impairment
* diabetes complicated with coronary artery disease or vasculopathy
* alcoholism unweaned
* uncontrolled epilepsy and/or achievement of the central nervous system functions
* history of severe depressive syndrome
* presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide
* decompensated liver cirrhosis
* severe myelosuppression
* psoriasis and sarcoidosis
* active disease condition or uncontrolled infection
* association with the yellow fever vaccine
* association with phenytoin in prophylaxis
* hypersensitivity against interferon or cyclophosphamide
* prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 3 years
* pregnancy, breast-feeding or absence of adequate contraception for fertile patients
* patients under guardianship, curatorship or under the protection of justice
Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery

Exploring the reorganization (plasticity) of neuroanatomic networks associated with language and memory in patients with left (or dominant hemisphere) temporal lobe epilepsy using functional MRI (fMRI)

The purpose of this study is to explore the reorganization of neuroanatomic networks associated with language and memory in adult patients with temporal lobe epilepsy (ELT). By using functional MRI, patients will be examined before and after surgery. Cerebral plasticity, defined in terms of intrinsic variables such as the topography of the activated regions, will be explored according to some extrinsic factors such as the age at onset of crises (before or after 5-6 years), whether or not Hippocampal sclerosis, hemispheric predominance of language (left or right).

Eligibility Criteria:
Inclusion Criteria:

* epileptic patients
* medical exam before inclusion
* social security affiliation
* Pharmaco-resistant epilepsy

Exclusion Criteria:

* MRI contraindication
* pregnant women
* breastfeeding mothers
* person under tutorship
Premedication Gastric Ultrasound

The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 patients aged 0-18 years of scheduled for elective surgery under general anesthesia.

Exclusion Criteria:

* Patients who are not adhere to institutional fasting guidelines.
The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia

The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.

Research Question/Hypothesis

The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.

Objectives

The primary objective of this study is to compare the pain rating scale from an exposure group (digit block injection with the aid MVS) and the control group (traditional injection).

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 18 and 65 who are willing and able to consent and who require the use of local anesthetic digit block to both sides of a finger for the treatment of wounds, injuries, infections, or laceration of the fingers.

Exclusion Criteria:

* Allergy to any type of local anesthetic.
* Inability to Consent.
* Inability to complete a numeric pain scale.
* Clinical appearance or clinical evidence of intoxication.
* Significant compromising conditions such as major trauma and severe respiratory distress.
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone

Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized

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

Inclusion Criteria:

* Unresectable Stage III or Stage IV melanoma
* Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
* Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
* Normal liver function tests

Exclusion Criteria:

* Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
* Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
* Autoimmune disease
Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls

The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2 diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain insight in some mechanisms behind the association between inflammation and insulin resistance.

Numerous studies have shown an association between low-grade inflammation and insulin-resistance in type 2 diabetics. It is also well-known that septic patients often develop insulin-resistance. The pathogenetic mechanisms behind the association between inflammation and insulin-resistance is not fully understood.

In this study we create an experimental inflammation by giving E. coli endotoxin 0,3 ng/kg iv to type 2 diabetics and healthy controls. Muscle biopsies are taken at 0, 2, 4 and 6 hours after injection, while fat biopsies are taken 0, 2, 4, 6 and 8 hours after endotoxin. mRNA for adiponectin, leptin, PPAR-gamma, PGC-1, PAI-1 and cytokines in tissue is later measured by RT-PCR.

Blood samples are drawn on an hourly basis until 8 hours after endotoxin injection for common biochemical analyses including white blood cell count. Plasma is spared and later analyzed for cytokines, PAI-1 and VCAM-1/ICAM-1.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Type 2 diabetes

Exclusion Criteria:

* Heart failure
* Lung disease
* Anti-coagulation treatment
Myopic Optic Neuropathy in Chinese High Myopia Population

This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population.

Global prevalence of high myopia brings about markedly increasing of blinding complications as myopic optic neuropathy (MON) and glaucoma. It was estimated that there were 163 million people who have high myopia in 2000, and the population with high myopia would increase to almost one billion (9.8% of the world population) worldwide by 2050.

Glaucoma is the leading cause of irreversible blindness worldwide while it is difficult to distinguish glaucoma among MON in high myopia eyes. However, there lack longitudinal study to illustrate the natural course interpreting the distribution and natural history of MON.

In view of the above problems, this is a longitudinal registry cohort study to observe the long-term changes of structural and functional parameters of MON in high myopia, and to investigate the natural course and associted risk factors that influence the progression in a Chinese adult population.

Eligibility Criteria:
Inclusion Criteria

* Age ≥18 years
* Equivalent spherical ≤-6D or axial length ≥26.5mm
* Best corrected visual acuity ≥ 6/12

Exclusion Criteria

* Unwilling or unable to give consent, or unable to return for scheduled protocol visits.
* Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease.
* Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, VF test or monophthalmia.
* Need for ocular surgery/laser or anticipated need for cataract surgery during the study period.
* Other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases);
* Pregnant or nursing women
Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery

This study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and need surgery will be part of the study. Some patients will get the usual information from their doctor, while others will also watch a video that explains the surgery in a simple and clear way. The study will check if the video helps patients feel more confident about their decision, lowers anxiety, and helps them remember important information about their surgery. Patients will answer surveys before surgery, after surgery, and 3 months later.


Eligibility Criteria:
Inclusion Criteria Fluent in English

* English is Primary Language
* ≥18 years old at time of consent
* Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication

Exclusion Criteria:

* History of prior thyroid surgery
* Previously consented for thyroid surgery
Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea

Upper airway resistance during sleep can present with a range of symptoms from simple snoring (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or collapse leads to reduction or cessation in airflow during sleep, and is associated with loud snoring.

The investigators hypothesized that regular singing exercises could strengthen pharyngeal muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus quality of life in patients with all forms of snoring.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years old or over
* history of simple snoring or sleep apnoea with RDI 10-40

Exclusion Criteria:

* severe sleep apnoea RDI \>40
* morbid obesity BMI \> 40
* unable to provide written informed consent