cyrilzakka/clinical-trials huggingface dataset:
Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects

Assessment of retinal vessel calibers combined with bidirectional Fourier domain optical coherence tomography (FDOCT) for measurement of retinal blood velocities is a new and sophisticated method for assessing retinal blood flow in humans. The valid measurement of retinal blood flow is of significant importance, because it is known that major ophthalmic diseases are associated with alterations in blood flow.

As such, retinal vascular occlusive diseases represent a major cause of visual impairment and blindness. The prevalence of the disease is between 0.7 and 1.6%. Compression of the retinal veins at arterio-venous (AV) crossings plays an important role in the development of branch retinal vein occlusion (BRVO). The mechanical narrowing of the vessel lumen is supposed to be the mechanism behind this fact. The present study should elucidate how BRVO influences retinal blood flow at retinal vessel crossings in comparison to healthy control subjects. Retinal blood flow at retinal bifurcations will also be assessed. In addition, a fundus image will be taken to assess retinal oxygen saturation.

For the first time we use a combination of a dynamic vessel analyzer (DVA) with bidirectional Fourier domain optical coherence tomography (FDOCT) to assess retinal blood flow. Whereas the DVA provides information concerning retinal vessel caliber, FDOCT provides laser Doppler information in addition to conventional optical coherence tomography, allowing the observation of blood flow dynamics simultaneously.

In the present study we hypothesize that the DVA in combination with FDOCT is a suitable new tool for the assessment of blood flow in healthy subjects and in patients with BRVO.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for healthy subjects

* Men and women aged over 18 yrs
* Nonsmokers
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 Dpt.

Inclusion criteria for patients with BRVO

* Age ≥ 18a
* Patients with branch retinal vein occlusion with a history of 3 to 9 months in one eye
* No history of BRVO in the fellow eye
* Temporal inferior or superior vein occlusion
* Ametropia \< 6 Dpt

Exclusion Criteria:

Any of the following will exclude a healthy subject from the study:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy
* Any abnormalities preventing reliable measurements as judged by the investigator

Any of the following will exclude a patient with BRVO from the study:

* Presence of intraocular pathology other than branch retinal vein occlusion
* Blood donation during the previous 3 weeks
* Clinical trial in the 3 week preceding the study
* Pregnancy
* Any abnormalities preventing reliable measurements as judged by the investigator
Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis

The prevalence of Sjogren's syndrome (SS) in rheumatoid arthritis (RA) patients varies from 3.5 to 31%. Between 30% and 90% of patients with (RA) have dry eye and/or mouth syndrome. To date, no studies have assessed whether RA patients have echostructural changes in their salivary glands suggestive of SS and the factors associated with these changes.The aim of this study is to investigate if there are changes in the echostructure of the salivary glands of RA patients, especially in patients with dry syndrome.

The EchoPR study is an exploratory pathophysiology, cross-sectional, case-control study.

The aim is to study the echo-structure of the salivary glands of patients with RA ( group of 70 patients), in comparison to patients with SS (suspected of strong alteration of the echo-structure)(group of 70 patients) and patients with sicca, asthenia, polyalgia syndrome (SAPS)(group of 70 patients).

After a standard consultation with the rheumatologist, patients in each group will have an salivary gland ultrasound to assess the homogeneity of the echostructure of the parotid and submandibular salivary glands. A salivary flow measurement for 15 minutes and a Schirmer test to determine tear secretion for 5 minutes are also performed. All of these tests are performed during a single visit, so the total study time for the patient is one hour. Patient recruitment is expected to last 1 year.

Eligibility Criteria:
Inclusion Criteria:

Patient, male or female, over 18 years of age, followed in the Rheumatology Department of the Clermont-Ferrand University Hospital, capable of giving informed consent to participate in the research.

* For RA subjects: Diagnosis of rheumatoid arthritis meeting the ACR/EULAR 2010 classification criteria.
* For SS subjects: Diagnosis of primary Sjögren's syndrome meeting the ACR/EULAR 2016 criteria.
* For SAPS subjects: Patients with dry syndrome not meeting the criteria for SS

Exclusion Criteria:

* Not covered by social security
* Minors or adults under the protection of the law or under the protection of justice.
* Pregnant or breastfeeding women
* Refusal to participate
* Interference with results or classification bias: secondary causes of dry syndrome: Previous radiotherapy of the face and neck, AIDS, Hepatitis C, Sarcoidosis, Amyloidosis, Hyper-IgG4 syndrome
Treatment of Natural Killer/T Cell Lymphoma-I/II

The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage I/II Natural Killer (NK)/T Cell Lymphoma.

Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage I/II NK/T cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months
* Histological confirmed NK/T cell lymphoma
* None of chemotherapy or radiotherapy has been previously used
* None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups )
* At least one measurable lesion
* None of other serious diseases, cardiopulmonary function is normal
* Pregnancy test of women at reproductive age must be negative
* Patients could be followed up
* None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
* volunteers who signed informed consent.

Exclusion Criteria:

* Disagreement on blood sample collection
* Patients allergic of any of drug in this regimen or with metabolic disorder
* Pregnant or lactating women
* Serious medical illness likely to interfere with participation
* Serious infection
* Primitive or secondary tumors of central nervous system
* Chemotherapy or radiotherapy contraindication
* The evidence of CNS metastasis
* History of peripheral nervous disorder or dysphrenia
* patients participating in other clinical trials
* patients taking other antitumor drugs
* patients estimated to be unsuitable by investigator
Increased Tea Consumption is Associated With a Decreased Risk of Renal Stone Disease in a Taiwanese Population

The objective of the this study was to examine the amount and duration of tea consumption in relation to the risk of renal stone disease.

Previous studies have investigated the association between tea consumption and renal stone disease, but the results are still unclear. Besides, the impact of the duration of tea consumption has not yet been investigated in the aforementioned studies. The present study was conducted as a retrospective research to investigate the relationship between both tea consumption amount and time and renal stone disease. Information on tea consumption was obtained by four closed-ended questions in questionnaires, and the diagnosis of renal stones was established on the results of abdominal sonography.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old

Exclusion Criteria:

* individuals with a history of hyperuricemia or gout at baseline, findings of abdominal ultrasound showing transplant kidney, only one kidney, or gouty nephropathy, or missing data
NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation

The study seeks to investigate the neurological effects caused by Covid-19 in children and adolescents in the 6-16 age group. To do this, neuropsychological scales, an EEG and an MRI were used.


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 years and 16 years and 11 months
* Symptomatology compatible with long neurological COVID, specifically: persistence or appearance of new neurological signs/symptoms (e.g. fatigue, headache, sleep disturbance, cognitive dysfunction, memory difficulties, emotional or mood disorders, vertigo cognitive dysfunction, memory difficulties, emotional or mood disorders, dizziness, dysautonomia, movement disorders movement disorders, ataxia, tremor, epilepsy, muscle weakness, myalgia, hyposmia, hypogeusia hearing loss or tinnitus and/or sensorimotor deficits such as hypoesthesia, dysesthesia) after three months after established SARS-CoV-2 infection, as well as persistence of these symptoms for at least two months, in the absence of a clear aetiology.
* Signature of the appropriate Informed Consent by caregiver(s) and patient(s)

Exclusion Criteria:

* Poor knowledge of the Italian language or other limitation of verbal communication that compromises the subject's ability to perform neuropsychological tests
* Need for sedation to perform brain MRI 7 Tesla
* Neurological or neuropsychiatric disorder diagnosed prior to COVID-19 diagnosis
* Caregiver's failure to sign consent
Cortisol Diurnal Variation and the Risk for Developing Post Traumatic Stress Disorder

The purpose of this study is to examine a possible link between the time of day of exposure to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and biological correlates will also be examined from this perspective.


Eligibility Criteria:
Inclusion Criteria:

1. Persons 21-65 years old, who have been exposed to an event meeting the following DSM-IV criterion for Acute Stress Disorder:

   Criteria A.1 and A.2 At least one of Criteria B1-5A.1
2. Who provide written, informed consent to participate in the study.

Exclusion Criteria:

1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment;
2. Head injury involving confusion, loss of consciousness, or amnesia;
3. Medical conditions such as extreme obesity, psoriasis, herpes, Cushing's syndrome, current infectious disease, current viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, and heart failure. Persons taking medications that can interfere with the HPA axis (e.g.,steroids, betablockers,indomethacin) will be excluded;
4. Weight below 45 or above 120 kg.
5. Pregnancy (in suggestive cases, a pregnancy test will be performed);
6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
7. Overt psychopathology, intoxication, or under the influence of substances.
8. Evidence or history of schizophrenia, bipolar, other psychotic condition;
9. Prior history of PTSD;
10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
11. Assessed serious suicide risk. -
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

This is a 60 week study including a double-blind phase followed by an open-label phase.


Eligibility Criteria:
Inclusion Criteria:

* Frequent migraine (\>=15 headache days per month)
* \>=4 distinct headache episodes lasting \>=4 hours
* \>=50% of baseline headache days migraine/probable migraine days

Exclusion Criteria:

* Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
* Any medical condition that puts the patient at increased risk with exposure to BOTOX
* Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
* Use of prophylactic headache medication within 28 days prior to week -4
* Unremitting headache lasting continuously throughout the 4-week baseline period
* Known or suspected TMD
* Diagnosis of fibromyalgia
* Beck depression inventory score \>24 at week-4
* Psychiatric problems that may have interfered with study participation
Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome

Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and UV exposure. A 14-week trial with 50 women aged 45-65 will test if polyphenol-rich pulses improve skin health by affecting these factors. Using a white rice control diet, the study will measure skin parameters and analyze correlations with changes in lipids and microbiome, potentially proving the benefits of pulses.

Human skin is the largest organ in the body. The slow deterioration of skin appearance and its barrier function are the most prominent signs of human ageing. Cutaneous factors (microbiome and lipids) have immediate and direct impacts on skin health and functions. Intrinsic factors (oxidative stress and inflammation) and extrinsic ones (mostly UV irritation due to sun exposure) affect the skin chronically. Our preliminary research showed that six weeks of cranberry juice intake improved part of women's skin health parameters and decreased oxidative stress. Its activities on the skin correlated with changes in skin microbiome and epidermal lipids. Pulses, especially lentils and beans, are rich sources of polyphenols and fibers. However, there is no clinical evidence on whether adding a serving of cooked mixed pulses with high polyphenol content (lentils, red kidney bean, black beans, and pinto beans) to the diet affects skin health and the underlying causes of skin aging. Women make over 90% of the decisions on food purchases for their families. Skin health is a major concern for women because skin aging becomes visibly noticeable after age 30. The investigators hypothesize that polyphenol-rich pulses improve skin health by reshaping the cutaneous microbiome and lipids and suppressing inflammation and oxidative stress. This hypothesis will be tested in a 14-week clinical trial in 50 women aged 45-65 using a randomized controlled parallel design. The control diet will be formulated using white rice to match the calories and macronutrients of mixed pulses.

Eligibility Criteria:
Inclusion Criteria:

* BMI (18.5-29.9)
* Body weight ≥110 pounds
* Fitzpatrick skin type 2 and 3.

Exclusion Criteria:

* pregnancy
* breast-feeding
* impaired fasting glucose
* frequent alcohol use
* history of skin cancer
* sunbathing and the use of tanning bed, intake of vitamin/mineral supplements
* habitual high intake of fruits (≥ 2 cups daily)
* intake of medication that might influence the outcome of the study
Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.

Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and inhibition of 1,25-OH vitamin D).

There are no published studies on the role of FGF23 in undernourished anorexic adolescents taking oral phosphorus supplements.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged from 11 to 17
* Follow-up or hospitalisation for anorexia
* Overt undernutrition (clinical signs of undernutrition, body mass index and the Waterlow index)
* Social security coverage

Exclusion Criteria:

* Known pre-existing renal disorders
* Known constitutional disorders of phosphate-calcium metabolism
* Adult patients, legal guardianship, incarceration
Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mortality. The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella species, and Escherichia coli O157:H7. This study will evaluate the performance of the assays and the platform in clinical conditions with non-expert users. It will provide important data on the performance of DEC for at least one target pathogen, an understanding of the potential impact of different sample types on device performance, and human factors associated with instrument interface in the field.


Eligibility Criteria:
Inclusion Criteria:

* Have 3 or greater liquid stools in the past 24 hours.
* Provide written informed consent from at least one parent in the case of children under 18 years of age.
* Provide written informed consent for those participants above 18 years of age.
* Provide assent in the case of children 10 years of age or greater.

Exclusion Criteria:

* Previously enrolled in the study.
* Parents are unwilling or unable to provide written informed consent.
* Report using antibiotics in the last 30 days.
* Adolescent (\<18 years old) parent of a child already enrolled in the study.
The Effect of Using Mobile Applications for Improving Oral Hygiene

The study aims to investigate the effect of the use of mobile phone application sending reminders to patients with orthodontic fixed appliances on oral hygiene.

Subjects were randomized into two groups, the first group received a mobile application that sends active reminders notifications of oral hygiene. The second group received verbal oral hygiene instructions during their regular visits to the orthodontics clinics.

Eligibility Criteria:
Inclusion Criteria:

1. Participants were having orthodontic fixed appliance treatment.
2. Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
3. Participants were willing to comply with given oral hygiene instructions.
Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).


Eligibility Criteria:
Inclusion Criteria:

Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).

Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections.

Exclusion Criteria:

Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial.

Patients with endocarditis, osteomyelitis, meningitis, CNS infections.
Prehospital TEE in Cardiac Arrest

This study shall investigate the feasibility of prehospital performed trans-esophageal echocardiography in out of hospital cardiac arrest.

The investigators will include ten patients undergoing advanced life support in this study and determine if it is possible to acquire adequate trans-esophageal images within 10 minutes after arrival of the study team on scene.

Out of hospital cardiac arrest (OOHCA) remains a leading cause of death in Austria.

Current guidelines recommend to address potentially reversible causes for OOHCA early to improve survival and some of these causes can be recognized using echocardiography. The usefulness of trans-thoracic echocardiography during OOHCA seems to be limited as image acquisition may prolong now flow time and image quality is variable. These limitations might be overcome with trans-esophageal echocardiography.

The investigators will investigate the feasibility of prehospital performed trans-esophageal echocardiography in ten OOHCA patients undergoing advanced life support.

In addition to routine care by paramedics and emergency physicians, a dedicated expert in emergency ultrasound will perform trans-esophageal echocardiography in these patients.

Primary outcome parameter: Is it possible to obtain trans-esophageal images of the heart within 10 minutes after arrival of the study team?

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing advanced life support for out of hospital cardiac arrest

Exclusion Criteria:

* patients who should undergo rapid transport to the hospital with ongoing CPR (ECMO candidates, pregnant, trauma, obvious reversible which can be treated in hospital only)
* known esophageal pathology contraindicating TEE
* no definite secure airway present (endotracheal intubation, tracheostomy)