cyrilzakka/clinical-trials huggingface dataset:
GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography

The GLEAM study aims at assessing the potential of electrical impedance tomography (EIT) for noninvasive glucose measurement.

Within the GLEAM study, paired samples of EIT and blood glucose measurements will be collected in individuals with type 1 diabetes during standardized euglycemia, hypoglycemia and hyperglycemia. These samples will be used to assess the potential of EIT for noninvasive glucose measurement and/or dysglycemia detection.

Eligibility Criteria:
Inclusion Criteria:

* Written, informed consent
* Type 1 Diabetes mellitus as defined by WHO for at least 6 months
* Aged 18 - 60 years
* HbA1c ≤ 9.0 %
* Insulin treatment with good knowledge of insulin self-management
* Use of a continuous (CGM) or flash glucose monitoring system (FGM)
* Native language German or Swiss German

Exclusion Criteria:

* Incapacity to give informed consent
* Contraindications to insulin aspart (NovoRapid®)
* Known allergies to adhesives of the EIT device (e.g., gel electrodes)
* Pregnancy, breast-feeding or lack of safe contraception
* Active heart, lung, liver, gastrointestinal, renal or psychiatric disease
* Patients with implantable electronic devices (e.g., pacemaker or implantable cardioverter defibrillator (ICD)) or thoracic metal implants
* Epilepsy or history of seizure
* Active drug or alcohol abuse
* Chronic neurological or ear-nose-and-throat (ENT) disease influencing voice or history of voice disorder
* Thoracic or back deformities
* Body mass index (BMI) \>35.0 kg/m2
* Open wounds, burns, or rashes on the upper thorax
* Active smoking
* Medication known to interfere with voice or to induce listlessness (e.g., opioids, benzodiazepines, etc.)
Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients

The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings


Eligibility Criteria:
Inclusion Criteria:

1. Adults 19 years of age or older
2. CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
3. Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
4. Those (or his / her legal guardian) who have agreed in writing to participate in the survey

Exclusion Criteria:

1. Patients with contraindications to receive Nephoxil

   * Patients with hypersensitivity to the active substance or to any of the excipients
   * Patients with hypophosphatemia
   * Patients with abnormal iron metabolism or symptoms of excessive iron (e.g. hemochromatosis)
2. Patients who intend to use this drug for non-approved indications
3. Patients who participated in pre-market clinical trials with Nephoxil
4. Patients who took this drug before the starting day of this survey
Effect of Acupuncture on Postoperative Nausea and Vomiting

The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients ASA I-II scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patient's refusal
* Patients with history of carpal tunnel syndrome or eczema at P6 point
* Pregnant patients
* Female patients in a phase of the menstrual cycle other than premenstrual, nausea and vomiting within 24 hours before anaesthesia
* Known allergy to anti-inflammatory drugs, opioids and ondansetron.
* Patients with a pre-existing chronic pain disorder or with a gastrointestinal disease.
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.

The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Average of 1-4 breakthrough pain episodes per day
* Opioid tolerant
* Histologically documented diagnosis of a malignant solid tumor or hematological malignancy

Exclusion Criteria:

* Primary breakthrough pain is not related to cancer in any way
* Opioid or fentanyl intolerance
* Chronic obstructive pulmonary disease (COPD) or heart disease
* Sleep apnea or active brain metastases with increased cranial pressure
Concurrent Assessment of Skeletal Muscle Mass and Synthesis/Breakdown in Old Age

This study involves minimally-invasive techniques to measure muscle mass, muscle protein breakdown and synthesis simultaneously in older age.

Most people will have noticed that with age people become frail. This is principally due to wasting of skeletal muscle known as "sarcopenia". Crucially, sarcopenia is more than just a symptom of weakness and poor functional capacity; it exposes people to an increased risk of falls and fractures, impacting quality of life, independence, health status and ultimately lifespan. Muscles represent the largest organ in the body, making up over 50% of total body weight. Most people know that skeletal muscles are important for movement and to support the skeleton, but not everyone is aware of how important muscles are for whole-body health. For example, muscles represent a vast protein store containing amino acids (the building blocks of protein) which can be broken down in times of fasting, infection and disease in order to provide energy to help other vital organs. Because of the detrimental effects on health, and the associated health costs, sarcopenia is of grave concern. Therefore, there is a significant clinical need to pre-identify at-risk older individuals who have low muscle mass so that they can be offered an intervention (of diet, exercise or drug-based) before they suffer any of the potential problems outlined above. Current techniques for measuring whole-body muscle mass, including MRI and CT are time-consuming, expensive and in huge demand in hospital settings, meaning that muscle wasting conditions such as sarcopenia often go undiagnosed. In this project we propose a potential solution to this problem by developing a diagnostic of sarcopenia that requires only a single drink and subsequent urine collection. In addition, throughout this project we aim to explore the mechanisms underlying muscle wasting by assessing the muscle of those with low and 'normal' muscle mass.

Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteers of normal body mass index (BMI \<35 kg/m2), aged 65-85 years

Exclusion Criteria:

* A BMI \> 35 kg/m2
* Active cardiovascular disease:

  o angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
* Cerebrovascular disease:

  o previous stroke, aneurysm (large vessel or intracranial), epilepsy
* Respiratory disease including:

  o pulmonary hypertension, COPD
* Metabolic disease:

  o hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
* Active inflammatory bowel or renal disease
* Malignancy
* Recent steroid treatment (within 6 months) or hormone replacement therapy
* Clotting dysfunction
Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia

Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the drug has been used for so long, its precise mechanism of action remains elusive. The aim of this study was to characterise the metabolic changes induced by 8 week treatment with Niacin in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. In order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.

24 patients will be included in a double blind placebo controlled cross-over 8 week study comparing placebo to Niaspan (a long release formulation of niacin). In order to prevent any drop out linked to the flushing side effect of niacin, patient will take aspirin (300mg) prior to treatment throughout the study duration. The study will include at start and end of each arm, a full lipoproteins quantification as well as a measure of enzymes involved in lipid metabolism. On day 42 and 56 of each period, after an administration of either placebo or 500mg of immediate release niacin respectively, changes in plasma free fatty acid levels will be measured for 8hours in order to assess potential loss of activity of niacin over time upon chronic treatment with niaspan. Half of the patient will have an exploration of their glucose metabolism using hyperinsulinic clamp technique, whereas in the other half a metabolic turnover study using stable isotopes will focus on their lipoproteins, triglycerides and cholesterol handling. These explorations will be done at the end of each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference \> 94cm
* Triglyceride concentration between 150mg/dL and 400mg/dL
* HDL-c \< 60mg/dL
* Body mass index: 27 to 35 kg/m²

Exclusion Criteria:

* cancer
* diabetes mellitus
* hepatic, renal or digestive disorder
* hypertension
* chronic medical treatment interfering on lipids parameters
Comparison of Efficacy Between Suggestion Method During Video EEG Recording by Verbal Suggestion in Isolation and Verbal Suggestion Along With Cotton Swab or Tuning Fork for Inducing the Paroxysmal Event in Children Aged 5 to 18 Years With Suspected Psychogenic Nonepileptic Events

In this study we are going to compare efficacy between suggestion method during video EEG recording by verbal suggestion in isolation and verbal suggestion along with cotton swab or tuning fork for inducing the paroxysmal event in children aged 5 to 18 years with suspected psychogenic nonepileptic events. Still there is paucity of data regarding the optimum method for video EEG by suggestion for psychogenic nonepileptic events. We are planning to recruit 25 children aged 5 to 18 years in each of the three arms after taking informed consent from the guardian and then they will be subjected to video EEG by any one of the three suggestion methods.


Eligibility Criteria:
Inclusion Criteria: Children between 5 and 18 years of age with suspected diagnosis of psychogenic nonepileptic events -

Exclusion Criteria: Children with paroxysmal events, who will be later diagnosed as having epilepsy or movement disorder

-
A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIR-2482 compared to placebo in preventing influenza A illness in healthy adults 18 to \<65 years of age without pre-existing risk factors for serious complications from influenza infection.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to \< 65 years of age, at time of randomization
* Participants must be in good health, determined from medical history and no clinically significant findings from physical examination, 12-lead electrocardiogram (ECG), vital signs, and laboratory values

Exclusion Criteria:

* History or clinical evidence of conditions considered high risk for developing influenza-related complications
* History of confirmed influenza infection within 3 months prior to randomization.
* Febrile illness with or without respiratory symptoms
* History of malignancy within 5 years or participant is under evaluation for malignancy.
* Any condition or receipt of any medication contraindicating IM injection, as judged by the investigator.
* History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis
* Participant has a clinically significant medical condition, physical exam finding, or abnormal laboratory result.
* Prior or planned receipt of any influenza vaccine for the upcoming season.
* Received any investigational agent within 90 days or within 5 half-lives of the investigational agent.
Corrected Flow Time in the Carotid Artery as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume in the Intensive Care Unit

The purpose of this study is to evaluate predictability of carotid corrected flow time for fluid responsiveness in mechanically ventilated patients with low tidal volume in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with age more than 19
2. Undergoing postoperative mechanical ventilation with low tidal volume
3. Clinically diagnosed with hypovolemic status
4. If one of follow criteria is satisfied 1) Systolic blood pressure \<90mmHg 2) Mean arterial pressure(MBP)\<70mmHg or fall more than 20% from baseline 3) Heart rate \>100bpm 4) Urine output \<0.5mg/kg/hr more than 1 hour 5) Arterial lactate \>2mmol/L 6) Capillary refilling time \>3secs

Exclusion Criteria:

1. Body mass index \<40 or \>15 kg/m2
2. Medical history of carotid artery stenosis \>50% or diagnosed while examination
3. Cardiac arrhythmia other than normal sinus rhythm
4. Moderate or severe valvular heart disease, intracardiac shunt, heart failure, pulmonary hypertension
5. Moderate or severe chronic obstructive pulmonary disease
6. Increased intracranial pressure
7. Using vasopressor
8. Pregnancy
Application of the Recommendations of the SPLIF (French Society of Infectious Pathology) in a Geriatric Population on the Duration of Treatment for Bacterial Pneumonia

Pneumopathy is the leading cause of death from infectious disease in the elderly. Prior to 2021, the recommended duration of antibiotic therapy for pneumonia, in adults, was 7 days.

Two theses have shown that these recommendations were poorly applied in geriatric services. Indeed, the duration of treatment exceeded 7 days, and less than 30% of antibiotic antibiotic treatments were re-evaluated at 72 hours.

In 2021, the SPLIF ( published new recommendations reducing this duration to 5 days in the event of clinical improvement observed on the 3rd day of treatment. These new recommendations are based on studies, in which the average age of participants was 65 years. However, the average age of patients in geriatric short-stay departments is 84.7 years.

In addition, the geriatric population is characterized by immunosenescence, pulmonary vulnerability and undernutrition, raising questions about the validity of these recommendations in the geriatric population.

The investigators offer a monocentric, retrospective, observational study of the geriatric hospital Casanova to assess the application of SPLIF recommendations in the geriatric population.


Eligibility Criteria:
Inclusion Criteria:

* All patient treated for bacterial/community/nosocomial pneumonia who stayed in the geriatric short-stay at Casanova's Hospital between January 2, 2023 and April 30, 2023

Exclusion Criteria:

* HIV Positif
* Immunosupressed patient
* Complicated pneumonia (abcess, pleuropneumonia)
3D Ballistocardiography in Microgravity

3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2 missions on a single astronaut. The results from this experiment have been published in the literature: the influence of respiration have been demonstrated and the signal processing methodology for the reconstruction of the displacement in one cardiac cycle have been developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained microgravity experiment onboard the Russian segment of ISS has been initiated. To be integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity before implemented on ISS.

The aim of the present parabolic flight study is to serve as a feasibility demonstrator and test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test whether the sensitivity of the developed 3D-BCG sensor is appropriate


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Whose 4 chamber view of the heart during a breath hold is easy to get during a routine cardiac echocardiography (M-Mode - apical view).
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Difficulty to obtain a clear echocardiography.
* Pregnant women
Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy

Study Design: This is a within-subjects crossover design. Subjects will participate in the procedures twice, once under each condition (active vs. sham stimulation). The order of conditions will be counter-balanced across subjects. Stimulation will target ventral inferior frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome measures will be acquired at the beginning and end of a semester of standard speech-language therapy.

Baseline Behavioral Assessment: Medical and neurological history will be taken. Western Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered. Narrative will be elicited (Cinderella story). Some of these procedures will be videorecorded for later transcription. Subjects will also complete a pre-tDCS safety screening questionnaire.

tDCS: Participants will undergo placement of 2 tDCS electrodes. For all subjects, the anodal electrode will be placed at the following locations (EEG 10-20 system):

(i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)

The cathodal electrode will be placed at the second site:

(ii) over right frontal pole (Fp2)

Two types of stimulation will be given, an active condition and a sham condition. In the sham condition, stimulation is ramped up over the first 30 seconds (as in the active condition), but then discontinued. This gives the physical perception of stimulation without the modulatory effects.

Stimulation will be delivered by a tDCS device with the following parameters for intensity and duration:

* Intensity: 2 mA
* Duration: 20 minutes

tDCS will be provided for the first 20 minutes of each aphasia therapy session provided at the LSU Speech-Language-Hearing Clinic. The therapy sessions last for one hour and are provided twice weekly for 8 weeks over the course of an academic semester (fall and spring).

Post-Therapy/Stimulation Assessment: Western Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered as before therapy. Cinderella narrative will again be elicited. Some of these procedures will again be videorecorded for later transcription. A tDCS sensations survey will also be completed at the final assessment to determine the effectiveness of blinding.

Eligibility Criteria:
Inclusion Criteria:

* Single, unilateral stroke resulting in aphasia
* Competency to provide written informed consent
* Ability to participate in standard aphasia therapy

Exclusion Criteria:

* Serious psychological condition
* Serious neurological condition, other than stroke
* Serious medical condition
* Pregnancy
* History of seizures
* Presence of electronic or metal implants (e.g., pacemaker, vagal nerve stimulator, etc.).
Effects of Marijuana on Symptoms of OCD

The purpose of this pilot research study is to test whether certain components of the marijuana plant, known as "cannabinoids", may help to reduce symptoms in patients with OCD. Specifically, patients enrolled in the study will smoke marijuana containing different concentrations of 2 different cannabinoids, THC and CBD. Both of these agents act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Neither compound is currently FDA-approved for treating OCD.

Prior research suggests that certain areas of the brain are receptive to chemicals like those found in the cannabis (marijuana) plant, known as cannabinoids, and that these regions may be involved in anxiety disorders and OCD. More recent data shows that synthetic drugs that target these systems may be helpful in conditions related to OCD like anxiety disorders and Tourette's syndrome. Thus, these substances could also possibly be useful to treat OCD symptoms. However, to date there has been little research regarding the role of cannabinoids in OCD.

The purpose of this study is to examine the effects of different cannabinoids on OCD symptoms in humans. To accomplish this in a laboratory setting, patients with OCD who are also occasional cannabis users will receive different combinations of two of the most well-studied cannabinoids, delta-9-tetrahydrocannabinol (THC, the main psychoactive component in cannabis) and cannabidiol (CBD, another component of the cannabis plant). We will then measure acute effects on OCD symptoms, anxiety, intoxication, and cardiovascular outcomes (i.e. blood pressure and heart rate).

Eligibility Criteria:
Inclusion Criteria:

* Age 21-55
* Physically healthy
* Diagnosed with OCD
* Current marijuana user
* Women of childbearing potential must be using an effective form of birth control
* Not currently taking psychotropic medications
* Ability to provide informed consent

Exclusion Criteria:

* History of any significant medical condition that may increase the risk of participation
* Females who are pregnant or nursing
* If female, not pregnant
* Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation
* Current substance use disorder
* Severe depression or positive urine toxicology (other than THC) at screening, or any adverse reaction to a cannabinoid
* Patients who are seeking treatment for substance abuse
* Patients who are planning to begin a course of cognitive-behavioral therapy within 8 weeks of beginning the study