cyrilzakka/clinical-trials huggingface dataset:
Metabolic Impact of Fat Digestion

In this study, the investigators are interested in investigating how the emulsification state and amount of fat in a meal can modify the kinetics of postprandial lipemia and inflammatory outcomes (including endotoxemia) in obese vs lean subjects.

10 lean and 10 obese volunteers will come 3 times (\>3 weeks apart) at the investigation center to receive a standard breakfast containing milk fat (10 g non emulsified, or 40 g non emulsified, or 40 g finely emulsified). 13C triglyceride stable isotopes will allow to follow the metabolic fate of fatty acids and calculate lipid oxidation by breath test. Blood sampling throughout digestion will allow to measure metabolic, lipid and inflammation parameters. Stool will be analysed to determine lipid losses in faeces and to phenotype microbiota.


Eligibility Criteria:
Inclusion Criteria:

* No smokers
* BMI 18 to 35 kg/m2
* Moderate physical activity
* Safety subject during medical consultation

Exclusion Criteria:

* Medical history which may affect lipid metabolism and gut microflora (renal -cardiovascular -hepatic- endocrine-inflammatory diseases)
* Drug use that could affect lipid metabolism and gut microflora (steroids, antilipemic agent, anorectic, antibiotic)
* Inflammatory or infectious disease in the last three month
* C Reactive Protein \> 20
* Prebiotic or probiotic high consumers (several times a day)
* Eating disorder
* Claustrophobic subjects
Testosterone for Peripheral Vascular Disease

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus.
2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
3. Peripheral vascular disease as defined by

   * previous diagnosis by a specialist vascular surgeon OR
   * ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
5. Ability to give written informed consent after verbal and written explanation in the English language.
6. Ability to comply with all study requirements.

Exclusion Criteria:

1. Current or previous breast cancer.
2. Current or previous prostate cancer.
3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
4. Severe symptoms of benign prostatic hypertrophy ('prostatism')
5. Treatment with testosterone in the 3 months prior to the trial.
6. Investigational drug treatment in the 3 months prior to the trial.
A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea

The goal of this study is to evaluate the feasibility of a decentralized clinical trial in South Korea. The main questions it aims to answer are:

* Does decentralized elements feasible in Korea?
* Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients with functional dyspepsia?

The trial aims to evaluate decentralized elements in South Korea, including clinical laboratory testing using local laboratories, medication adherence assessment using wearable devices, analysis of self-kit specimens, delivery and tracking of investigational medication, real-time remote interview of subjects and e-consent acquisition.

Mastic gum is registered with the Ministry of Food and Drug Safety in South Korea as a dietary supplement for gastric health, and the study aims to explore the effect on the gastrointestinal symptoms and composition of the stool microbiome.

Eligibility Criteria:
1) Inclusion Criteria

1. Adults aged 19 to 75 years old at the time of consent.
2. The sum of the intensity and frequency score of the six major symptoms (epigastric pain, early satiety, postprandial fullness, bloating, belching and nausea) of the self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) is 12 or more.

2) Exclusion Criteria

1. Those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, bloody stools) that may suggest a malignant disease of the gastrointestinal tract.
2. Subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic esophagitis.
3. Have or have had clinically significant hepatic, renal, neurologic, respiratory, endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease.
4. Pregnant or lactating women
5. Have or have had a history of clinically significant hypersensitivity to the dietary supplement to be administered.
6. Aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal range on screening tests
7. Subjects who are expected to take other medications within the study period that may affect the evaluation of the effectiveness of the study substance (gastrointestinal motility promoters, acid secretagogues, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, anticholinergics, erythromycin, corticosteroids, antidepressants, etc.
8. Those deemed by the investigator to be unsuitable for participation in the clinical trial due to other reasons.
A Comparison of Learning Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration

Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced attention, impaired cognition and perception, usually resulting from general physical conditions. Delirium contributes to longer hospital length of stay, increased mortality, increased healthcare costs, and long-term cognitive and functional impairment. However, it is often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a time-efficient, flexible and convenient training method, making it suitable for a large organization like Siriraj hospital where there is a large employee turnover rate. So the investigators want to compare the passing rate between the e-learning group and the traditional learning group.

Primary objective: Compare the passing rate between the e-learning group and the traditional learning group

Secondary objectives: Assess the trainees' satisfaction and problems associated with e-learning implementation, Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions

Eligibility Criteria:
Inclusion Criteria:

* ICU nurse
* general ward nurse
* private ward nurses
* nurse anesthetists

Exclusion Criteria:

* Previous exposure to CAM-ICU
* Inability to complete the training courses
* Inability to complete the required 3 simulated patient scenarios
Safety of RG2077 in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system attacks and destroys the cells that cover and protect nerves. This study will test the safety of a new drug called RG2077 that is designed to treat MS. The study will not determine whether RG2077 is effective in treating MS, only whether it is safe to use in patients with MS.

Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and decrease accumulation of lesions on MRI.

Effective treatment of autoimmune disorders is likely to arise not from improved immunosuppression, but from improved understanding of the normal mechanisms that generate and maintain self-tolerance. RG2077 may block a T cell costimulation pathway central to the pathophysiology of MS. A total of 20 patients with MS will be enrolled in this study. Each patient participates in the study for 4 months.

The dose-escalation portion of this study evaluated the safety of a single infusion of RG2077 (CTLA4-IgG4m) in 16 patients with MS and is now complete. Patients who participated in the single infusion portion of the study were assigned to one of four groups. Each group received a different dose of RG2077. The second portion of the study will evaluate the safety of 4 doses of RG2077 in 4 additional patients. In the multiple infusion portion of the study, all patients will receive the same dose of RG2077. Patients will be monitored for possible side effects of RG2077.

Eligibility Criteria:
Inclusion Criteria

* Confirmed diagnosis of MS, defined as an MRI consistent with MS plus two separate clinical events, or one clinical event and MRI consistent with demyelination plus a second MRI demonstrating new lesions
* Have declined all FDA approved therapies for MS
Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis

The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants:

* healthy volunteers
* patients with early Parkinson's disease
* patients with incipient Lewy body disease.

To this end, the results obtained from taste evoked potentials in each of the 3 groups of participants will be compared with each other and with different nutritional, motor and cognitive data.

This study could reveal a difference in cortical processing of gustatory sensory information between patients who have had idiopathic Parkinson's disease progressing for 3 years or less, and patients who have had Lewy body disease progressing for 3 years or less. Indeed, a modification of taste evoked potentials (in terms of latencies) proportional to the degree of cerebral degeneration could be observed.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

* Person who has given written consent
* Adult
* Enrolled in the national register of healthy volunteers
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* No cognitive complaints and normal neurological assessment

Patients with idiopathic Parkinson's disease:

* Person who has given written consent
* Adult
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for established or probable IPD

Patients with Lewy body disease:

* Person who has given written consent
* Adult
* Fasting \> 2 hours prior to PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for probable or possible LBD

Exclusion Criteria:

* Non-affiliated to national health insurance
* Person under legal protection (curatorship, guardianship)
* Person subject to a court order
* Pregnant, parturient or breast-feeding women
* Major unable to give consent
* MMSE score \< 15 and/or MoCA \< 10
* Known infection with COVID-19 in the 6 months prior to inclusion
* Active smoker (\> 4 cigarettes per day on a regular basis)
* Subject with pacemaker (contraindication for bioelectrical impedancemetry)
* Diabetic (type 1 or type 2)
* Taking medication (in progress at the time of the study) that interferes with gustation
Preoperative Evaluation of Airway

Evaluation of airway markers of patients who have undergone obesity surgery.

The investigators evaluated the airway parameters recorded preoperatively for patients with BMI\> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.

Eligibility Criteria:
Inclusion Criteria:

1. BMI\>30kg/m2
2. 18\<age \<65
3. elective surgery planned
4. ASA II-III

Exclusion Criteria:

1. BMI\<30kg/m2
2. 18\>age \>65
3. ASA IV
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops

A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.

Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7.

Statistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18-40 years old, regardless of gender;
2. Plan TPRK for myopia and/or myopic astigmatism, meet the indications for TPRK, and set the ablation diameter of the optical zone at 6.0-6.5 mm;
3. Schirmer test I ≥10mm/5min;

Exclusion Criteria:

1. prior corneal refractive surgery or keratoplasty;
2. Contraindications to TPRK surgery, including severe ocular surface disease that may affect the corneal epithelium, active ocular inflammation, moderate to severe dry eye, keratoconus or other types of corneal ectasia, thin corneas, severe lesions of ocular appendages (such as eyelid defects, deformations, etc.), glaucoma, cataract that affects vision, History of systemic immune diseases (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.);
3. incomplete eyelid closure;
4. corneal degeneration, corneal stroma or endothelial damage or malnutrition;
A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers

New treatments for persistent DFU have emerged, among which are the bioengineered skin substitutes, extracellular matrix proteins products, matrix metalloproteinases modulators, and growth factor therapy. Platelet rich plasma (PRP) gel has been used for stimulating wound healing since the last decade of the 20th century. This randomized trial was conducted to assess the role of PRP in gel form as a treatment for clean non-healing diabetic foot ulcer in comparison to regular dressing with saline as a control.


Eligibility Criteria:
Inclusion Criteria:

* adult patients of both sexes aging below 70 years with non-infected chronic foot ulcer confined to one anatomical site. Chronicity was defined as non-healing ulcer for twelve or more weeks

Exclusion Criteria:

* Patients with chronic limb ischemia.
* Evidence of osteomyelitis in the affected foot
* Exposed tendons, ligaments or bones at the base of ulcer
* Patients who received radiotherapy or chemotherapy at time of study or within 3 months of its beginning.
* Patients having low peripheral platelet count, low serum albumin level or low hemoglobin level
Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.

To compare the efficiency and maternal and fetal tolerance of two techniques of amnioreduction used in cases of symptomatic second and third trimester polyhydramnios: syringe manual aspiration technique (S group) and continuous suction technique (C group) set to - 250 mmHg

Polyhydramnios is defined as more than 2 liters of amniotic fluid. Ultrasound diagnosis is made either by measurement of a deepest vertical pocket exceeding 8 cm, or by use of an amniotic fluid index (AFI) exceeding 25 cm. Potential complications of polyhydramnios are preterm labor, premature rupture of membranes, altered utero-placental perfusion, and maternal discomfort.

Amniodrainage has become an established technique to improve maternal comfort and reduce the risks of severe polyhydramnios in both singleton and twin pregnancies, decreasing uterine contractility, as well as over-stretching of membranes and uterus. It also acts on the pathological processes of twin to twin transfusion syndrome.

Several techniques are used to reduce symptomatic polyhydramnios. Passive gravitational drainage is long, does not allow to evacuate larger amounts of amniotic fluid and continuous maternal and fetal monitoring is difficult. The standard syringe technique is often a source of discomfort for both the patient and the operator. Continuous aspiration is faster and limits patient's discomfort.

The aim of this study was to compare the efficiency and maternal and fetal tolerance of these two latter techniques of amnioreduction.

A preliminary study permitted to assess the depression value created at the tip of the needle during amniodrainage: the syringe aspiration technique showed large depression variations from 0 to - 300 millimeters of mercury (mmHg). The continuous wall suction was thus chosen to be set to - 250 mmHg: depression at the needle's tip didn't vary during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (AFI\>25cm)
* Single or twin pregnancies

Exclusion Criteria:

* Multiple pregnancy (more than 3 fetuses)
* Maternal history of placental abruptio
* Fetus with IUGR
* Pregnancy complicated with pre-eclampsia
* Unability to give informed consent
Clotting With Different Dialyzer Membranes

Primary Objective:

The purpose of this study is to measure the amount of convection achieved with two different haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration treatment.

This is a prospective observational cohort pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodiafiltration treatments in a dialysis centre. Information on the study will be disseminated to the Royal Free consultant nephrologists at the dialysis centre with primary responsibility for the individual patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years and older up to 80 years
* Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
* Able to provide written informed consent obtained

Exclusion Criteria:

* Patients scheduled for a kidney transplant
* Patients taking concomitant systemic anticoagulants
* Patients with known prothrombotic or bleeding disorders
* Patients with abnormal platelet counts
* Patients unable to provide written informed consent
* Patients not fulfilling inclusion criteria
PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)

The investigators evaluated whether it was possible to improve the measurement of memory, attention, and executive function in patients who have suffered traumatic brain injury through the use of computer-based testing.

Note: the original design of the study was altered due to failure to recruit sufficient numbers of patients who were willing to undergo prolonged cognitive training.

Here we describe a series of computer-based tests that were used to evaluate memory, attention, and executive function in large groups of control subjects and in patients with chronic mild and moderate/severe TBI. This extensive battery of neuropsychological tests (NPTs) and subjective rating scale measures were obtained at study entry from the TBI cohort. NPT and rating scale data were compared to those obtained from control subjects to characterize the cognitive deficits following mild, moderate and severe TBI. .

Normative data were obtained by regressing the influences of age, education, and computer use on scores to create normed z-scores on different NPTs,. We hypothesized that patient with TBI would show deficits on tests of memory, attention, and executive function relative to their predicted z-scores (based on the aforementioned regression functions) and that deficits would be more pronounced in patients with severe TBI than in patients with mild TBI.

Eligibility Criteria:
Inclusion Criteria:

Control subjects were required to meet the following inclusion criteria:

* (a) fluency in the English language
* (b) no current or prior history of bipolar disorder, mania, or schizophrenia
* (c) no current substance abuse
* (d) no concurrent history of neurologic disease known to affect cognitive functioning
* (e) on a stable dosage of any required medication
* (f) auditory functioning sufficient to understanding normal conversational speech and visual acuity normal or corrected to 20/40 or better

Exclusion criteria:

* History of TBI

Exclusion Criteria for TBI patients:

* TBI patients had to meet the same inclusion criteria as the controls with the exception that they were required to have a history of TBI. They also had to be in the chronic phase, i.e., 1-4 yrs post-injury.
* Exclusion criteria:

  * current substance abuse
  * current psychiatric diagnosis other than PTSD
Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder

The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview using the K-SADS-E adult ADHD module
* Patients with a CGI Global Severity (GS) score ≥4 (moderate impairment)
* The Patient provided written informed consent.
* Non-lactating women of childbearing potential that used adequate contraception (i.e. the use of oral contraceptives and practising a double-barrier form of birth control) and had a negative pregnancy test at screening. Women of no childbearing potential who had been postmenopausal for less than 2 years must have a negative pregnancy test at screening.

Exclusion Criteria:

* Any clinically unstable medical condition
* Clinically significant abnormal baseline laboratory values
* Mental retardation
* Organic brain disorders
* Non-febrile seizure disorder
* Patients with a history of an eating disorder including anorexia or bulimia nervosa
* Psychotic disorder of any type
* Patients with a HAM-D (17 item) \>15
* Patients currently (within the past 6 months) known to abuse or to be dependent on any drug, including alcohol or a positive urine drug screen for cocaine, heroin, or marijuana
* Treatment with stimulants was prohibited within 1 week prior to randomisation
* Treatment with antipsychotics/neuroleptics was prohibited for 8 weeks prior to randomisation
* Treatment with monoamine oxidase inhibitors was prohibited for 8 weeks prior to randomisation
* Treatment with tricyclic antidepressants, histamines and selective serotonin reuptake inhibitors was prohibited for 4 weeks (fluoxetine for 6 weeks) prior to randomisation
* Treatment with benzodiazepines, anticonvulsants (for behaviour) and lithium for 2 weeks prior to randomisation
* Patients with a history of bipolar disorder
* Patients using any concurrent medication for the treatment of ADHD
* Patients that had previously participated in a NS2359 study
* Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
* Patients with a history of positive human immunodeficiency virus (HIV) test.