cyrilzakka/clinical-trials huggingface dataset:
Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)

Acute kidney failure remains one of the most challenging entities to diagnose in clinical medicine, especially in the field of intensive care. The diagnosis of acute kidney injury is based solely on urine output and serum creatinine, both of which could also be influenced by other factors. A more sensitive and faster diagnostic option would not only be desirable but of utmost clinical importance. Therefore, the investigators aim to identify Neuronal Guidance Proteins (NGPs) as potential biomarkers for the identification and early detection of AKI with this investigation. This investigation aims to identify the possibility of diagnosing acute kidney injury, the subsequent validation of a potential biomarker will then have to take place in a multicenter study approach: Data in preclinical mouse models suggest that SEMA7A as one of the NGPs could be valuable as a biomarker, the study now aims to attempt a preliminary survey in humans and measure various NGPs.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery
* written consent

Exclusion Criteria:

* no written consent possible
* Polytrauma, severe burns
* Immunosuppression
* Pregnancy
* Diagnosis of Hepatitis B, Hepatitis C, and/or HIV
* Sepsis
* Pre-existing kidney damage
VGR Accelerated TMS Treatment for Depression

Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well documented method for treatment of depression.

The aim of the study is to assess the effect of an accelerated iTBS protocol compared to a routine iTBS protocol. In the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days).

Participants (n = 146) will be recruited among patients referred to iTBS and randomized to treatment. Participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. A psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. Patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
* MADRS-S \>= 20
* unchanged medication last month
* unchanged psychological treatment last month
* admitted to psychiatric ward last month
* no ECT or TMS last six months
* provision of signed informed consent form
* indication for TMS is depression

Exclusion Criteria:

* addiction (illicit drugs or alcohol)
* pregnancy
* epilepsy
* conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil
* implanted device that is activated or controlled in any way by physiological signals
* implanted mediation pumps
* intracardiac lines, even when removed
* regular use of benzodiazepines
* any condition that seriously increases the risk of non-compliance or loss of follow-up
Systemic Lupus Erythematosus Exercise Program

This pilot study is a randomized controlled trial to assess the effect of an individualized supervised exercise program in patients with systemic lupus erythematosus (SLE) compared to treatment-as-usual (TAU).

The aim of this study is to evaluate the effect of a 12-week individualized exercise program in subjects with SLE in comparison to treatment-as-usual therapy. Several previous studies showed that exercise leads to various benefits in treating SLE, including enhanced aerobic capacity, reduced symptoms of depression and fatigue. Moreover, it has been shown that exercise is well tolerated and does not impair disease activity in SLE negatively. Here, the effects of an individual internet-based exercise therapy for 12 weeks will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Positive ANA-titer (≥ 1:80) or Anti-dsDNA (≥ 200 IU/ml) or Highly avid-dsDNA autoantibody (≥ 30 IU/ml)
* Stable immunosuppressive therapy more than 30 days before beginning of the study with steroid (0-20 mg/day) or other immunosuppressive medication like Hydroxchloroquin, Chloroquin, Azathioprin, Methotrexat, Mycophenolatmofetil, Cyclosporin, Belimumab, Rituximab

Exclusion Criteria:

* Pregnancy, Active lupus nephritits, Physical activity more than two times a week
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3

The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit.

Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.

The infants will remain in the study as long as the Neosense measuring system is used


Eligibility Criteria:
Inclusion Criteria:

Sick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:

* The infant needs invasive measurement of blood pressure.
* The infant needs repetitive sampling of blood.
* The infant needs prolonged infusion(s) \&gt; 2 days.
* The infant needs infusion of vessel irritating and potentially vessel harming solutions.
* The infant is born extremely preterm (before 28+0 weeks gestational age).
* A newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% Fraction of inspired oxygen (FiO2)).
* The infant is undergoing therapeutic hypothermia following asphyxia \&#34;oxygen deficiency at birth\&#34;).
* The infant has a severe infection/sepsis.

Also:

• Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).

Exclusion Criteria:

* Gastroschisis
* Omphalocele
* Peritonitis
* Necrotizing enterocolitis
* Omphalitis
* The infant has a severe infection/sepsis
* Expected MRI investigation within the 7 first days after birth
* The infants birth weight is below 750 g
* The infant is born before week 25+0
* Local vascular compromise in lower limbs or buttocks area, or portal venous hypertension
The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis

Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis

Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.

Eligibility Criteria:
Inclusion Criteria:

1. Patients clinically diagnosed with bacterial vaginosis, should meet the following criteria: vaginal Gram stain integration score (Nugent score) ≥7 points
2. Female patients aged 18 to 55 years old.
3. Patients signed the Informed Consent Form(ICF).

Exclusion Criteria:

1. Patients with vulvovaginitis caused by other infectional reasons such as vaginitis vulvovaginal candidiasis, trichomoniasis vaginitis.
2. Patients received systemic or vaginal antimicrobial therapy in a week before enrolled.
3. Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy.
4. Pregnant or lactating patients.
5. Menopausal women.

   Menopause definition: perimenopausal women stop menstruations for a year.
6. Women with diabetes.
7. Dependent on alcohol and could not prohibit during the study period.
8. Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases.
9. Women allergic to metronidazole, clindamycin.
10. With poor compliance.
Skincare Products and Environmental Health

The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils.

After being informed about the study and privacy, parents will give informed consent and complete the APICHS (Aromatic Plant Ingredient \& Child Health Survey), a validated measurement tool for determining exposure to plant-based ingredients in pediatric personal care products.

Eligibility Criteria:
Inclusion Criteria:

* Parent of child aged 2-15 living in the United States

Exclusion Criteria:

* none
Intravenous Magnesium in Wheezy Bronchitis

In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always satisfactory.

The purpose of this trial is to investigate the effectiveness of iv-magnesium in the treatment of moderate or severe bronchial obstruction associated with viral infection in small children.

The study population will include the children attending the Pediatric Emergency Department of Oulu University Hospital because of respiratory infection and bronchial obstruction that is not relieved with conventional treatment. After written consent from the parents, the children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points and length of hospital stay.

The sample size is 64 children at the age of 6 months to 4 years.

If iv-magnesium is effective in relieving viral infection associated bronchial obstruction, that would be an important addition to the treatment of this common disease.

In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always satisfactory.

Intravenous infusion of magnesium sulfate has been proven to be efficacious and safe for the treatment of acute asthma attacks in adults and school-aged children. The purpose of this trial is to investigate the effectiveness of iv-magnesium in the treatment of moderate or severe bronchial obstruction associated with viral infection in small children.

The study population will include the children attending the Pediatric Emergency Department of Oulu University Hospital because of respiratory infection and bronchial obstruction that is not relieved with conventional treatment. After written consent from the parents, the children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points and length of hospital stay.

The sample size is 64 children at the age of 6 months to 4 years.

If iv-magnesium is effective in relieving viral infection associated bronchial obstruction, that would be an important addition to the treatment of this common disease.

Eligibility Criteria:
Inclusion Criteria:

* age 0.5 - 4 years
* wheezy bronchitis
* RDAI \> 6 after conventional treatment

Exclusion Criteria:

* prematurity
* congenital heart disease
* immune deficiency
Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate

Preoperative use of finastride will decrease the amount of perioperative blood loss during and after TURP

The effect of finastride on decreasing the amount of perioperative blood loss during and after TURP is dose dependent

Finastride will decrease microvascular density in prostate tissue and this effect is dose dependent


Eligibility Criteria:
Inclusion Criteria:

* Patients with BPH that require TURP

Exclusion Criteria:

* Previous prostate surgery
* Prostate Cancer
* Coagulopathy
* The use of NSAIDs, Anticoagulants, Antiplatelet drugs
* CRF/ESRD
Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects

The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (\>4 weeks) in subjects with acromegaly in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥ 18 years
* Diagnosed with acromegaly
* Receiving treatment with ATG 120 mg at extended dosing intervals (\> 4 weeks) for at least six months before the study visit.
* Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available.
* Able to sign the informed consent form for study participation.

Exclusion Criteria:

* Received radiation therapy treatment in the last six months.
* Active participation in another clinical study.
* Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form.
* Pregnancy or breastfeeding for female patients.
* No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months.
The Contraceptive Choice Project

The purpose of this project is to remove barriers to obtaining contraceptive methods, including the most effective and expensive methods. The study seeks to remove the financial and knowledge barriers and promote the most effective contraceptive methods to reduce unintended pregnancy rates at the population level.


Eligibility Criteria:
Inclusion Criteria:

1. 14-45 years of age
2. Primary residency in St. Louis City or County
3. Does not desire pregnancy during the next 1 year
4. Desires reversible contraception
5. Sexually active with a man within the past 6 months or intend to have sex with a man in the next 6 months
6. Is not currently using a contraceptive method, has begun using a new contraceptive method within the last 4 weeks, or is a current contraceptive method user who wants to switch to a NEW contraceptive method immediately
7. Willing and able to undergo informed consent
8. Willing to comply with study protocol and 2-year follow-up schedule
9. Not currently pregnant, or meets one of the following criteria:

   1. Currently pregnant, undergoing medical or surgical termination of pregnancy, and planning for post-abortion contraception
   2. Currently pregnant with an abnormal pregnancy (miscarriage or ectopic pregnancy), undergoing medical or surgical management, and planning for post-pregnancy contraception
   3. Currently pregnant, estimated gestational age of 36 weeks or greater, and planning for post-partum contraception.

Exclusion Criteria:

1. History of hysterectomy or sterilization
2. Current participation in another research study that would interfere with the conduct of this study
Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements

The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* APPI within 28 days of primary TKR
* Acute hematogenous infection within 4 weeks of symptoms

Exclusion Criteria:

* Exposed prosthesis
* Infection occuring in revised joints
* Poly articular infections
* have allergies to tobramycin or Vancomycin
* previous chronic infections in or around any ipsilateral extremity trauma or implants
a 3.0T Magnetic Resonance Imaging Study

Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex; the neural degenerations could be identified through the whole visual tract, which suggests the central nerve system may play a vital role in the progression of glaucoma. The investigators used MRI to investigate changes of visual pathway in vivo.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma diagnosed on the basis of glaucomatous optic disc cupping ratio (in particular, thinning of the inferior and/or superior rim, cup-to-disc ratio asymmetry of \>0.2)
* matching glaucomatous visual field defects (European Glaucoma Society (2008) Perimetry )

Exclusion Criteria:

* optic neuropathy
* neurological disorder
* other diseases and use of systemic medications which affect optic nerve or the visual ﬁeld underwent complete eye examination and visual-field testing.
Impact of Resveratrol on Brain Function and Structure

The study will investigate whether resveratrol could provide positive effects on memory and brain structures and functions in healthy elderly participants.

Cell and animal studies postulated various beneficial effects of resveratrol, ranging from a reduction of inflammatory processes and the treatment of cancer to the prevention of cardiovascular diseases and stroke. With regard to cognitive decline, rodent models for Alzheimer's disease (AD) showed improved learning and decelerated hippocampal neurodegeneration after intake of resveratrol.

Animal and first human studies provided evidence that resveratrol might serve as an easy, cost-effective option to develop novel prevention and treatment strategies against age-associated cognitive decline. To test this hypothesis, the researchers study general brain structure and function on healthy older individuals (\> 60years old).

Eligibility Criteria:
Inclusion Criteria:

* subjects who are healthy or with subjective memory complaints
* older than 60 years old
* normal to overweight participants (BMI: 22-40 kg/sqm)

Exclusion Criteria:

* dementia
* Psychiatric diseases
* severe untreated internal diseases
* diabetes
* younger than 60 years
* BMI \< 22 or \>40
Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)

There was no evidence to suggest that a shortened fluid fast results in an increased risk of aspiration, regurgitation or related morbidity compared with the standard 'nil by mouth from midnight' fasting policy. However, there is no available data regarding the safety and efficacy of fasting approach in patients undergoing cardiac implantable electronic device (CIED) procedures. The aim of this study is to demonstrate that a non-fasting protocol is non-inferior in regard to safety to a fasting protocol (current practice) in patients undergoing cardiac device implantation procedures


Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years undergoing elective implantation or generator exchange of cardiac implantable electronic devices

Exclusion Criteria:

* Patients presenting with an acute unstable condition (bradycardia \< 30/min or temporary pacing wire)
* Patients scheduled for deep sedation
* Patients with increased intra-abdominal pressure (severe intra-abdominal tumors, severe ascites, very severe obesity: BMI\>40 kg/m2).
Evaluation of Visual Outcomes After Myopic LASIK

The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and high order aberrations induced by different laser technologies and to evaluate differences in aberrometer technology. We hypothesized that there will not be differences among conventional or wavefront guided treatments.

The aim of the study was to evaluate and compare visual outcomes, contrast sensitivity, glare testing and induction of high order aberrations by different laser technologies and to evaluate differences in aberrometer technology.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Candidates for bilateral LASIK
* Myopic range: 0.00 to -7.00 D
* Astigmatism: 0.00 to -5.00 D

Exclusion Criteria:

* Pupil size greater than 8mm diameter, infrared measurement
* thin corneas (preoperatively calculated minimal residual bed \< 250 um)
* irregular astigmatism
* asymmetric astigmatism
* unstable refraction
* other criteria that preclude the patient to undergo LASIK
Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.

COPD is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling. Periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity, mortality and health care utilization. Currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations.

Macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD. We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD. If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of COPD
* Clinically stable for 6 weeks
* Able to Swallow Tablets

Exclusion Criteria:

* Clinically significant respiratory disease other than COPD
* Women of child bearing age
* Patients receiving existing Medication which may interact adversely with trial drug
* History of clinically significant liver disease
Vitamin D Supplementation for the Prevention of Cardiovascular Risk

Hypovitaminosis D is highly prevalent in the general population, particularly in obese individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it has been reported that individuals with low vitamin D levels are at increased risk for cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of these lifestyle interventions. The purpose of this study is to assess whether vitamin D supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile of overweight/obese subjects to a greater extent than diet alone.


Eligibility Criteria:
Inclusion Criteria:

* BMI≥25 kg/m2

Exclusion Criteria:

* Diabetes mellitus
* Chronic kidney disease
* Liver disease
* Cholestasis
* Cancer
* Chronic bowel disease
* Primary or secondary hyperparathyroidism
* Treatment with drugs that may affect insulin sensitivity, weight or calcium/vitamin D metabolism
* Laxative abuse
* Changes \>10% of usual body weight in the previous 6 months
* Alcohol or illicit drug abuse
* Pregnancy