cyrilzakka/clinical-trials huggingface dataset:
Caffeine Use in the Management of Preterm Infants

This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

This study is a randomized, double-blinded, placebo-controlled trial. Infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. Initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. Oral feedings will be advanced by a standardized 5 step oral feeding protocol. The time it takes to achieve full oral feeds between the treatment and control groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

• Infants born at equal to or less than 32 weeks and 0 days gestational age AND

* Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment.
* Off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation).
* On caffeine and meet criteria to discontinue caffeine.
* No significant cardiopulmonary events for at least 5 days (apnea \> 20 seconds, apnea with heart rate (HR) \< 80 beats per minute (bpm), HR \< 80 bpm with desaturation \< 85% or color change).

Exclusion Criteria:

* Infants with critical congenital heart disease.
* Infants with neuromuscular conditions affecting respiration.
* Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding.
* Infants with major genetic disorders.
* Infants with anatomic anomalies that will hinder oral feeding.
* Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day).
* Infants who develop necrotizing enterocolitis after enrollment.
* Failure to obtain consent or declined by parents.
Tourniquet Application on Total Knee Arthroplasty

This is a randomized controlled trial designed to research the effects of different tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty, and to guide early postoperative recovery.

Sixty participants undergoing unilateral TKA would be recruited in this study. On one side, the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later(after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. On the other side the tourniquet would be inflated immediately before incision and deflated at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes. The postoperative pain, limb swelling , the score of surgical field, blood pressure during the operation, blood loss, operating time, transfusion rate, deep vein thrombosis (DVT) incidence and clinical outcomes would be monitored for comparison.

Eligibility Criteria:
Inclusion Criteria:

* American Society of anesthesiologists Grade 1-3 Patients
* Undergoing unilateral total knee arthroplasty under general anesthesia
* Should be treated with tourniquet

Exclusion Criteria:

* Tourniquet inflation time is less than 1h, greater than 1.5h
* Abnormal coagulation function
* BMI \< 20kg/m2 or \> 35kg/m2
* History of cerebral infarction
* History of Peripheral vascular disease
* Anemia (hemoglobin\<90g/L)
* Systolic blood pressure (SBP) ≥ 170mmHg
* Pregnant blood glucose \> 10mmol/L or HbA1c \> 8.5% of diabetic patients
* History of chronic narcotic use
* Participate in other clinical trials at the same time
* Asked to withdraw from the trial
Gabapentin for the Treatment of Neuroleptic-Induced Tremor

We will attempt to establish whether gabapentin as compared with placebo will reduce the severity of tremors caused by the use of antipsychotic medications. Baseline severity of tremor will be measured using both clinical ratings and ratings obtained with an instrument designed to measure tremor, giving more objective evidence of tremor frequency and severity.

We propose to enroll 40 veterans with antipsychotic induced tremor in this RCT of gabapentin. Baseline measurements will be obtained with the tremor section of the UPDRS, the Simpson-Angus Scale, the ESRS, AIMS, and the Barnes Akathisia SScale. The Tremorometer, an instrument designed to quantatatively measure frequency, amplitude, and tremor power will be used for baseline and subsequent assessments. Demographic data will be collected. Diagnoses will be established with the SCID. Appropriate lab studies with an EKG will be done at baseline and at study end. Patients will be randomized to gabapentin or placebo and assessed on a blinded basis. Effectiveness of the blind will be assessed at study end. Gabapentin will be started at 300 mg/day and tapered up to a maximum of 1800 mg/day. The SF36 will be used to assess quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Veterans 18 and older with an observable tremor judged to be caused by exposure to antipsychotics

Exclusion Criteria:

* Concomitant use of other anticonvulsants, L-Dopa, cocaine, amphetamines, or other tremorogenic agents excepting SSRIs, TCAs.
* Current suicidality, severe psychosis, inability to sign informed consent or to cooperate with study procedures.
* Current use of gabapentin or exposure to gabapentin in the past 2 years.
* Women who are pregnant, or not using adequate birth control.
Randomized Trial to Evaluate the Usefulness of Mental Health e-Learning

In this proposal, the investigators plan to study the impact of In this proposal, we plan to study the impact of e-learning on mental health literacy and stigma related to anxiety and depression. Participants will be randomized to one of four groups - Depression e-Learning A, Depression e-Learning B, Anxiety e-Learning A, and Anxiety e-Learning B. All participants will be given access to all e-learning at the conclusion of the study.


Eligibility Criteria:
Inclusion Criteria:

* Live in Canada
* 45 years of age and over
* Good command of the English language
* Access to email and high speed internet
* Comfortable using email and internet

Exclusion Criteria:

* Lives outside of Canada
* Not 45 years of age or over
* Does not speak English,
* Does not have access to email or high speed internet
* Is not comfortable using email of internet
Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.

Researchers will review data from the Eovist MRI and compare the scan with previous MRI exams the patient had with the same or other contrast agents.

To determine the efficacy of Eovist contrast agent in producing MRI images of the liver. We will monitor patients for any unusual symptoms (adverse events) when the contrast is given.

Patients are asked to hold their breath during an MRI scan. Eovist may interfere with the "breath hold" which could result in more breathing artifacts (based on a qualitative scale) on arterial images when the patients are given Eovist vs. other contrast agents.

Eligibility Criteria:
Inclusion Criteria:

1. You have had a scheduled MRI(magnetic resonance imaging) scan using the contrast agent EOVIST.
2. Male and females 21 years of age or older.

Exclusion Criteria:

1. Does not have a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants).
2. Pregnancy
Spa Therapy in Knee Osteoarthritis (OA): Nancy-thermal

Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another.

The main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement at 6 months, defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis.

The secondary objectives are:

1. To compare the efficacy of the 2 protocols at 3 months.
2. To determine the evolution of quality of life and medical care consumption
3. To describe postural abnormalities
4. To determine predictive factors to a favourable response at 3 and 6 months

This is a monocentric randomised non inferiority trial comparing 2 spa therapy protocols in symptomatic knee OA.

In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. In the second group, the same 4 treatments are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.

Data will be collected at inclusion, 3 and 6 weeks and 3 and 6 months.

Eligibility Criteria:
Inclusion criteria are:

* both gender
* uni or bilateral symptomatic knee OA
* pain VAS \> 3 on a 0-10 scale)
* fulfilling ACR criteria for knee OA
* Kellgren and Lawrence stage 2 or over on standard radiograph

Non inclusion criteria are:

* severe comorbidity
* isolated femoro-patellar knee OA
* total knee replacement surgery expected during the next year
* other joint disease
* a contraindication or intolerance to any aspect of spa treatment (immune deficiency, evolving cardiovascular conditions, cancer, infection),
* spa treatment within the previous 12 months
* knee injection within the past month for corticosteroids and within the past 3 months for hyaluronic acids
* osteoarthritis (SYSADOA) change in the past 3 months
* massages, physiotherapy or acupuncture in the past month
* Patients will not be allowed to modify their non-steroidal antiinflammatory drug (NSAID) or their analgesic drug within the past 5 days and in the previous 12 h respectively.
The Influence of Applying Additional Weight on Crouch Gait in Children With Spastic Cerebral Palsy

The purpose of this study was to investigate the effectiveness of applying additional weight in the improvement of the crouch gait pattern in children with spastic cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

The children who participated in the study, aged 12 - 15 years old, were diagnosed with spastic cerebral palsy, level III according to the classification of the GMFCS.

Exclusion Criteria:

From the study, they were excluded:

1. children who have received botulinum toxin injection up to 3 months before,
2. children who have had selective rhizotomy surgery up to 1 year before,
3. children who have a baclofen pump,
4. children with uncontrolled epilepsy,
5. children with cognitive deficits who cannot follow verbal instructions.
Bitter Tastants and Reflux

Recently the relationship between intragastric pressure (IGP) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act as a trigger for reflux. It has been demonstrated that bitter administration leads to a smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of TLESRs and reflux events in healthy volunteers. Additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. Therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of TLESRs, via a change in gastric tone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* Age between 18 and 65
* Written informed consent

Exclusion Criteria:

* A history of any upper GI symptoms or GI surgery;
* Psychological disorders;
* Concomitant use of other medication or treatments except for oral contraceptives;
* Use of medication altering esophageal or GI motility;
* Pregnant or nursing women.
Body Awareness in Adults With Obesity

The goal of this observational study is to examine the level of body awareness in individuals with obesity and investigate the parameters associated with body awareness. In addition, compare these parameters with healthy subjects with normal weight. The main questions it aims to answer are:

* How is body awareness affected compared to healthy individuals?
* Is physical activity level, dynamic balance, proprioception, and reaction time related to body awareness in individuals with obesity?
* Is there any difference between obese and normal-weight individuals in terms of physical activity level, dynamic balance, proprioception, and reaction time?


Eligibility Criteria:
Inclusion Criteria:

* Adults with obesity ((BMI) ≥ 30 kg/m2) aged 18-65 years, who did not receive obesity-related treatment 6 months before the study
* Healthy adults with normal weight (BMI: 18.5-24.9 kg/m2).

Exclusion Criteria:

* Musculoskeletal, neurological, and rheumatological disorders (fractures, sprains or strains, spine surgery, advanced respiratory or orthopaedic problems),
* Malignancy and pregnancy within the last 12 months, which might interfere with evaluations
Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients

Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.

The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral Leriche-Fontaine stage-II PAD
2. Both sexes
3. Aged 50 to 60 years
4. Outpatients
5. Clinically stable
6. Sedentary
7. Not participating in any physical activity last 3 months

Exclusion Criteria:

1. Walking disorders related to orthopedic or neuromuscular disease
2. Renal insufficiency requiring dialysis (Renal diseases)
3. Known and documented myopathy
4. Progressive cancer
5. Associated progressive disease causing a deterioration in general health
6. Participation in another research protocol
7. Skin disorder making it impossible to use TENS
8. Absolute contraindication to physical activity
9. Presence of a pacemaker/defibrillator
Investigation of the Perception of Protein Fortified Foods and Beverages

This study aims to investigate whether protein fortification of foods and beverages causes mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.

1. To investigate, by using protein fortified foods and beverages, whether mucoadhesion to the oral cavity is greater for older adults compared to younger adults and determine whether it is related to salivary flow rate.
2. To determine whether protein fortification of foods and beverages causes mouthdrying and whether perception and acceptance are influenced by age and individual differences in saliva flow.

These aims will be investigated using two different models: a liquid model using whey protein and a solid model using protein fortified biscuits and cakes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years or over 65 years
* Self reported as healthy (no specific disease states)

Exclusion Criteria:

* Cognitively impaired
* Allergies or intolerances that include coeliac disease, lactose or gluten intolerance
* Diabetic
* Had oral surgery
* Had stroke
* Smoker
Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)

Evaluate the long-term safety of amifampridine phosphate in patients with MuSK antibody positive and AChR antibody positive myasthenia gravis.

The Primary objective :

To characterize the long-term safety and tolerability of amifampridine phosphate in patients with MG

The Secondary Objective:

To assess the clinical efficacy of amifampridine phosphate over time in patients with MG based on change in Myasthenia Gravis Activities of Daily Living Score (MG-ADL)

This was a long-term extension study for subjects who participated in Protocol MSK-002 where the efficacy and safety of amifampridine was evaluated in subjects diagnosed with MuSK MG or AChR-MG. The optimal dose and schedule for amifampridine from the end of the Run-in Period from Study MSK-002 was initially used for each patient. The Investigator could adjust the dose of amifampridine during the course of the trial, in order to optimize neuromuscular benefit for the patient. Clinic visits for safety assessment and for evaluation of MG-ADL were made at Months 3, 6, 9, 12, 15, 21, 27, 33 and 39. Additional visits could occur at the discretion of the Investigator.

The Original protocol (12 Nov 2017) included analysis of MG-ADL change over time, however, Statistical Analysis Plan (SAP), dated 21 Feb 2023, removed the analysis of MG-ADL score change over time.

Eligibility Criteria:
Inclusion Criteria

1. Participated in the MSK-002 study
2. Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures.
3. Female patients of childbearing potential must have a negative pregnancy test (urine human chorionic gonadotropin \[HCG\] at the end of MSK-002 study); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment.
4. Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires.

Individuals who met any of the exclusion criteria in the original protocol or those listed below are not eligible to participate in the study:

1. Epilepsy and currently on medication.
2. Clinically significant abnormalities in 12 lead ECG, in the opinion of the Investigator.
3. Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study.
4. Intolerable amifampridine-related side effects
5. Treatment with an investigational drug (other than amifampridine) or device while participating in this study.
6. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient.
Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System

Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.

This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.


Eligibility Criteria:
Inclusion Criteria:

* preterm newborns born between 26-34 weeks of gestational age

Exclusion Criteria:

* infants infected,
* suffering from neurological disorders,
* serious heart, respiratory, digestive or metabolic diseases;
* infants born from mothers aged less than 18 years old or deprived of their parental rights
The Cognitive Resilience Study

The purpose of this study is to test whether two new cognitive "stress tests" may help distinguish between people at lower or higher genetic risk of Alzheimer's Disease. The investigators are trying to understand how these cognitive "stress tests" work in people who have not been diagnosed with Alzheimer's Disease and are not exhibiting symptoms of Alzheimer's Disease. Study subjects will undergo testing of memory and executive function during functional magnetic resonance image (fMRI) of the brain and also during a walking test.

The objective is to establish the feasibility and evaluate the role of two novel tests of cognitive resilience for use in identification of early Alzheimer's Disease. The investigators hypothesize that exposure to the controlled stressor of increased cognitive task demand will evoke measurable phenotypes of poor resilience, which will be associated with Alzheimer's Disease risk. The study will include 30 volunteer participants from the Duke Alzheimer's Disease Prevention Registry (ADPR). The ADPR cohort has been characterized according to genetic risk based on genotype at loci associated with Alzheimer's Disease. The investigators will recruit a sample from the ADPR that includes 15 people in the "genetic high risk" group and 15 people, matched by age, in the "genetic low risk" group. Investigators and experimenters are masked to the genetic profile of all participants. All participants will undergo two cognitive stress test protocols. Both protocols include memory and executive function components, one done during functional MRI and one while ambulating on a force sensor mat. Both cognitive stress tests are minimal risk; the primary risk of this study is loss of confidentiality. Genetic testing is not performed as part of this protocol; the sampling strategy will make use of prior genetic testing results, which are not revealed to the primary investigators. In addition to determining whether scores on the two novel tests statistically differ by AD risk groups, the project will establish the tests' feasibility and characteristics for use in future study.

Eligibility Criteria:
Inclusion Criteria:

* Able to walk 2 minutes without assistive device or assistance from another person
* Cognitive function within normal limits

Exclusion Criteria:

* Unable to undergo MRI
* Left handed
* Red/Green Color Blind
* Severe vision impairments
* Diagnosis of Alzheimer's Disease or other dementia/memory problem