cyrilzakka/clinical-trials huggingface dataset:
Pre-engraftment Cytomegalovirus DNAemia

Cytomegalovirus (CMV) DNAemia occurs frequently in allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients.Both high-level and persistent virus DNAemia are known risk factors for CMV end-organ disease and perhaps non-relapse mortality. CMV DNAemia is usually documented after engraftment, but it may occur before. The virological features and clinical consequences of these latter early-onset episodes remain largely unexplored. The U.S. Food and Drug Administration (FDA) has recently approved letermovir for prophylaxis of CMV infection and disease in adult CMV-seropositive allo-HSCT recipients (PREVYMIS™, Merck \& Co., New Jersey, USA). In accordance with the design of the phase III, double-blind trial the drug may be administered as early as the day of transplant and no later than 28 days post-transplant. Nevertheless, the timing of drug inception should be contingent on the clinical impact of very early episodes of CMV DNAemia. In a recent work from our group (single-center study) we found that a total 38 out of the 197 patients in our series developed CMV DNAemia before engraftment (cumulative incidence (CI), 19%; 95% CI, 10-30.3%). Nine episodes of CMV DNAemia were detected prior to the time of donor progenitor cell infusion. A greater number of post-engraftment episodes required preemptive antiviral therapy compared with pre-engraftment episodes (62.5% vs 44.7%; P=0.05). The cellular content of the donor progenitor cell infusion and transplant characteristics of patients did not differ between patients with pre- or post-engraftment CMV DNAemia. The cumulative incidence of overall mortality by days 100 and 365, aGvHD by day 100 and relapse by day 365 were not significantly different between patients with pre-engraftment or post-engraftment CMV DNAemia. Our study was limited by the retrospective and single-center design and the scarce number of pre-engraftment CMV DNAemia episodes included; therefore, the results may not be extrapolated to other transplantation centers or patient cohorts. Further retrospective and prospective studies are thus required to validate the data presented herein.

Episodes of CMV DNAemia developing prior to engraftment (pre-CMV DNAemia), which usually occur between the third and fourth week after allo-HSCT, may conceivably have a different course from episodes emerging after engraftment once patients have begun to expand donor-derived T cells (post-CMV DNAemia). Thus, whether the precise timing of Letermovir treatment initiation should matter will ultimately depend on the impact of CMV DNAemia episodes developing prior to engraftment on clinical outcomes. There is limited information available on this topic. Here, we conducted a retrospective multicenter, non-interventional study to further address this issue.

Eligibility Criteria:
Inclusion Criteria:

* Recipients \>18 years old
* CMV seropositive recipients and/or donors
* First allo-HSCT (T cell replete)
* CMV DNA load monitoring by real-time PCR

Exclusion Criteria:

* Recipients \< 18 years
* CMV seronegative donors and recipients.
* No CMV DNA load monitoring
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics

We believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like preparations. In addition to the benefits associated with the consumption of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense food.

More specifically, the rationale for this Phase I study is to determine safety of our drink and comply with the FDA's recommendations pertaining to an IND application, we will conduct a phase I safety study.

We hypothesize that BB-12 is safe in healthy adults ages 18 and over.


Eligibility Criteria:
Inclusion Criteria:

* Ability to speak and write English or Spanish
* Refrigerator for proper storage of drink
* Telephone access
* Enrollment must take place within 24 hours of starting antibiotics
* Treatment with a penicillin class antibiotic regimen for 10 days for an upper respiratory infection;

The following is a list of inclusive antibiotics:

1. Amoxicillin
2. Augmentin (amoxicillin/clavulanate)
3. Ancef (cefazolin)
4. Cefadroxil
5. Cephalexin
6. Cephradine
7. Duricef (cefadroxil)
8. Keflex (cephalexin)
9. Kefzol (cefazolin)
10. Velosef (cephradine)
11. Ceclor (cefaclor)
12. Cefotan
13. Cefoxitin
14. Ceftin (cefuroxime)
15. Cefzil (cefprozil)
16. Lorabid (loracarbef)
17. Mefoxin (Cefoxitin)
18. Zinacef (cefuroxime)
19. Omnicef (cefdinir)
20. Suprax (cefixime)
21. Dicloxacillin
22. Pen-Vee K (penicillin)

    * Antibiotic prescribed at least twice a day
    * Outpatients

Exclusion Criteria:

* Chronic conditions, such as diabetes or asthma, that require daily medication
* Allergy to strawberry
* Active diarrhea
* Allergy to penicillin class antibiotic
* Any other medicines used except prescribed antibiotic and anti-pyretic medicines
* Allergy to any of the following medications

  1. Tetracycline
  2. Erythromycin
  3. Trimethoprim
  4. Ciprofloxacin
* Lactose intolerance.
* During baseline physical exam, any of the following will be grounds for exclusion; systolic blood pressure\>140, systolic blood pressure \<90, diastolic \>90, oxygen saturation \<98%, pulse rate \>100, pulse rate \<55 and respiratory rate \>17. These include all vital signs that fall outside of the "normal" range, including Grade 1 through Grade 4.
The Effects of Mood on Cerebral Perfusion

Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the effects of a different mood state (neutral, positive and negative mood), induced using subjects own memories, on both global and regional cerebral perfusion, measured with arterial spin labeling.


Eligibility Criteria:
Inclusion Criteria:

* Healthy university students
* between 18 and 30 years old

Exclusion Criteria:

* No informed consent
* Not using hormonal contraception
* MRI-contraindications
* Claustrophobia
* Pregnancy
* Chronic diseases and chronic medication use
Exergame Study for Family Caregivers

The goal of this study is to examine Go\&Grow as a social exergame intervention to increase physical activity and social support, to promote well-being in family caregivers, and to test social support and physical activity as mechanisms for the effects of the intervention.

The study is a 2-week baseline and 6-week intervention aimed at comparing the feasibility and efficacy of an exergame (Go\&Grow without social contact components) and a social exergame (full version of Go\&Grow) in promoting physical activity, social support, and well-being in family caregivers. The study also seeks to test social support and physical activity as mechanisms for the relationships between condition (exergame non-social vs social exergame) and wellbeing. Participants will be randomly assigned using a random assignment generator to either the control condition (exergame non-social) or the treatment condition (social exergame) on a rolling basis. Participants from both conditions will be reminded daily via app-based notifications during the intervention period to wear their Fitbit and to play the game.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are caregivers for a family member (e.g., relative, spouse, friend) who is 65 years or older and is either frail, has a disability, or has at least one chronic illness
* 40 years or older
* Own an Android smartphone with Google play store/internet access
* Able to walk for at least 20 minutes at a time
* Comfortable wearing a fitness tracker for the duration of the study
* Familiar with smartphone app usages
* Comfortable with using the study-related app for the duration of the study

Exclusion Criteria:

* Had a recent (within the past 6 months) cardiovascular event or fall.
* Currently participating in any other physical activity study/intervention
* Currently own or use a Fitbit or other activity tracking watches
* Knows someone who is participating or has participated in the study
* Currently physically active (exercise regularly 3 times a week or more for at least 30 minutes)
* More than 2 errors on the Short Portable Mental Status Questionnaire (Pfeiffer, 1975).
Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

The management of cerebral palsy is complex and requires a multidisciplinary approach. Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function.

the current study is designed to assess the effectiveness of Selective dorsal rhizotomy on motor function in ambulant children with spastic diplegia. therefore, A convenient sample of ambulant children with spastic diplegia will be allocated to two groups of equal numbers (control and experimental)

Eligibility Criteria:
Inclusion Criteria:

* CP, spastic diplegia
* 4-8 years of age
* The ability to walk with or without assistive devices typically on Level II-III on Gross Motor Function Classification System
* At least six months after the last Botulinum toxin A injection in the lower extremities
* Average intelligent quotient according to medical records for active participation
* Good trunk control with good antigravity strength of lower extremity on clinical examination.

Exclusionary criteria

* Ankle clonus; exaggerated deep tendon reflex in the legs
* Babinski sign
* Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
* Moderate to severe signs of dystonia, athetosis or ataxia.
Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and the optimal time for blood sampling


Eligibility Criteria:
Inclusion Criteria:

The subjects to be enrolled are healthy volunteers, defined as follows:

* Healthy men or women between 18 and 30 years old
* Non-smokers
* Fit for work
* Having given informed consent and signed the form

Exclusion Criteria:

* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, hypervitaminosis A, psychic disorder etc.).
* Treatment with other drug that might interfere with the evaluation of the safety of the test drug
* Known hypersensitivity to any of the ingredients of the study drug
* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
* Drug and alcohol abuse
* Participation in another trial
* Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are not medical objections)
* Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study
DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
2. Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
3. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit
4. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level \>18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response. -

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
3. Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea)
5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
7. Subjects who have an abnormal sleep schedule or work at night.
8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
The Effect of Alcoholic-carrier Solutions Within Devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers

The study objective is to determine the effect of the ethanolic solutions inhaled from the Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4 of ethanol) on the breath alcohol measurements in healthy volunteers.

Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open, randomized, four-way-cross-over design is chosen. The randomization is balanced and stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoker volunteers without dental prothesis
* 18 to 45 years old, male or female
* No clinically significant abnormal conditions at the screening visit. A clinically significant disease is defined as one, which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study or the subjects ability to participate in the study
* Volunteer with gamma-glutamyl-transferase (GGT) level \< 32 IU/L
* Volunteer is able to sign informed consent in accordance with Good Clinical Practice and local legislation
* Volunteers is able to be trained in the performance of technically satisfactory pulmonary function tests
* Volunteer is able to be trained in the correct use HFA-MDI, Respimat® and Ethylometer
* Affiliated to the National Social Security System

Exclusion Criteria:

* Subjects who are already taking other investigational drugs or who have taken part in another trial during the past month
* Consumption of alcoholic beverage within 12 hours prior to observation period
* Breast feeding or pregnant female or female with no medically approved contraception method (oral contraceptive, intra uterine device)
* Subjects who have a known intolerance or hypersensitivity to aerosolized containing products and/or to any of the HFA-MDI or Respimat® excipient
* Volunteer with history of drug abuse and/or alcoholism
* Intensive exercise one week prior to the study
* Major exposure to dust, smoke or pollution one week prior to the study
* Subjects with an upper or lower respiratory tract infection within the previous four weeks to screening. This is to insure no reduced alcohol absorption by mucus
* Current psychiatric disorders
* Previous inclusion in the randomized period of this study
* Subjects on concomitant medications
Escitalopram (Lexapro) for the Treatment of Postpartum Depression

The purpose of this study is to determine whether women with postpartum major depressive disorder (MDD) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 to 45 years old
* Subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth
* Subjects must present within six months of childbirth
* MADRS score \>15
* BAI score \>10
* Subjects will be able to be treated on an outpatient basis
* Subjects will be able to provide written informed consent

Exclusion Criteria:

* Subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)
* Suicidal ideation with active plan or intent, as determined by the investigator
* Presence of psychotic symptoms or homicidal ideation
* History of mania or hypomania
* Pregnant or breastfeeding
* Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator
* Active alcohol/substance abuse currently or within the past year
* Abnormal TSH, severe anemia, or uncontrolled hypertension
Effect of Magnesium Sulphate on the Intracranial Pressure of Preeclamptic Patients

It had been shown that high percentage of severe preeclampsia patients got a high cerebral perfusion pressure (CPP) due to abnormal autoregulation of cerebral blood vessels with associated endothelial dysfunction and disrupted blood brain barrier. Moreover, patients with high CPP is more likely to present with headache compared to other patients with normal CPP.In this particular scenario, use of magnesium sulphate is associated with marked reduction of CPP and. hence prevention of cerebral damage.This hypothesis was confirmed by new magnetic resonance techniques that demonstrated brain edema in eclampsia/ severe preeclampsia patient mostly due to vasogenic edema and less commonly attributed to cytotoxic edema.

Changes in the optic nerve sheath diameter (ONSD) mirrors the changes in the Intracranial pressure(ICP), subsequently when the intracranial pressure increases the optic nerve sheath diameter (ONDS) also increases.

The aim of this study is to determine the effect Magnesium sulphate infusion on intracranial pressure, in patients presented with severe preeclampsia by measuring changes in the ONSD using ultrasound examination.

30 obstetric patients admitted to the HDU in Corniche Hospital for treatment of severe preeclampsia. Patients with the following criteria will be excluded from the current work: Patients undergone cranial or eye surgeries, Patients with known intracranial pathology, Patients suffering from glaucoma or any other eye pathology that prevent clear identification of the optic nerve, and Patients on drugs that may affect the cerebrospinal fluid \[based on operator decision\].

In this prospective pilot study, patients who will fulfill the inclusion criteria will be recruited at the time of admission in HDU by the investigators. The ONDS will be measured before the commencement of Magnesium sulphate infusion, 1hr after finishing the loading dose, 6 and 24 hrs after infusion started. Patients will be in supine position with the head of the bed less than 20 degrees. High frequency (7.5 MHz) linear probe will be used; it will be placed gently over both closed eye after liberal application of sterile gel, the patient will be instructed to look forward to align the optic nerve directly opposite to the probe. The ONSD will be measured 3mm behind the optic disc in both the sagittal and transverse planes and an average will be calculated and recorded. In the absence of complete visualization of the optic disc, the largest viewed diameter will be taken as the maximal ONSD. Hemodynamic variables \& oxygen saturation will be recorded at the same times.

Eligibility Criteria:
Inclusion Criteria:

* obstetric patients admitted to the HDU at Corniche Hospital for treatment of severe preeclampsia

Exclusion Criteria:

* (1) Patients undergone cranial or eye surgeries, (2) Patients with known intracranial pathology, (3) Patients suffering from glaucoma or any other eye pathology that prevent clear identification of the optic nerve, (4) Patients on drugs that may affect the cerebrospinal fluid
Clinical Value of Plasma Humanin in Acute Kidney Injury

The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI Researchers will compare humanin concentration in healthy people to see if humanin can be a novel marker for predicting AKI

Acute Kidney Injury (AKI) is a clinically critical condition manifested by a sharp decline in kidney function, with approximately 13.3 million people diagnosed with AKI each year in hospital worldwide and associated with 1.7 million deaths. According to global multi-center research data, the total incidence of AKI in hospital is as high as 21%, and the incidence of acute kidney injury in hospitalized patients in China is 0.99%\~11.6%. AKI increases the risk of long-term chronic kidney disease (CKD) and end-stage renal disease (ESRD), and has a very high long-term mortality rate. The diagnosis of AKI is mainly based on blood creatinine or urine output, and the current KDIGO criteria are used, but blood creatinine is a very insensitive indicator, so in the past 20 years, scholars have been exploring biological markers that are more sensitive than blood creatinine and urine output. Humanin is a mitochondrial polypeptide containing 24 amino acids. It was first identified in Alzheimer's disease patients in 2001. Studies have shown that Humanin has a strong mitochondrial protective effect in neurodegenerative diseases, cardiovascular diseases, diabetes, male infertility, cancer and other diseases, and its mechanism may be related to anti-apoptosis, anti-inflammation, regulation of autophagy and maintenance of mitochondrial homeostasis, because Humanin can function through autocrine, paracrine or endocrine forms, so it can be detected in the blood. Studies have shown that Humanin expression in serum or plasma of patients with diabetes and coronary heart disease is declined. In our previous study, the investigators found that Humanin was elevated in plasma in a mouse model of AKI with sepsis.

The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age, male or female；
* Patients with AKI: Patients with acute kidney injury who meet the definition of KDIGO guidelines；
* Control group: from healthy physical examination population, physical examination blood routine, urine routine, liver function, kidney function, glycated hemoglobin and other indicators are normal；
* The patient's baseline medical record data is complete, including liver and kidney function, urine protein level, blood creatinine value, etc；
* Consent to enrollment and sign informed consent；

Exclusion Criteria:

* Age\< 18 years；
* Baseline data were missing