cyrilzakka/clinical-trials huggingface dataset:
Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma

In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation solution will be investigated in subjects with mild bronchial asthma. This dose-finding study will estimate the minimum effective dose and will assess the safe dosage, in terms of the quantity given to patients. The results will be compared to baseline measurements. The results regarding Sputum measurements will be compared to measurements after placebo administration.

Based on the anti-inflammatory effects of inhaled Ectoin® shown in previous animal studies, this trial aims to investigate the effects in terms of a reduction of the unspecific bronchial hyperresponsiveness (BHR) to Methacholine challenge test on subjects with mild bronchial asthma. In addition, measurements of exhaled nitric oxide level as an indicator of bronchial inflammation will be investigated.

This study will focus primarily on safety and dose finding in 12 to 18 subjects with mild bronchial asthma.

After a screening visit, subjects will be treated with placebo, followed by increasing doses of Ectoin® (low, medium and high dose). All doses of Ectoin® inhalation solution and placebo will be administered for 5 - 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 - 65 years)
* FEV1 ≥ 80% of predicted for patient's normal value pre bronchodilator (according to European Coal and Steel Community reference values)
* Positive Methacholine challenge test (PD20 ≤ 0.5 mg)
* A general practitioner or consultant diagnosed mild bronchial asthma
* Non or ex smoker (for more than 6 months, pack years (PY) ≤ 5)

Exclusion Criteria:

* Pregnant or lactating females
* Participation in another clinical study in the previous month
* Severe concomitant disease which may have an impact on the study participation
* Hypersensibility against Ectoin®
* Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (Inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit).
* Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, etc.)
* Upper and lower airway respiratory infection within 4 weeks prior to study start
Creon After Pancreatic Surgery

This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA


Eligibility Criteria:
Inclusion Criteria

Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:

* Direct or indirect pancreatic function test (except stool fat excretion) and
* Steatorrhoea: stool fat \> 15 g/day (using van de Kamer method)
* Proven chronic pancreatitis
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria

* Subjects in an unstable situation (catabolic) after pancreatic surgery
* Ileus or acute abdomen
* Current excessive intake of alcohol or drug abuse
* Hypersensitivity vs porcine proteins / pancreatin
* Subjects taking digestive enzyme preparations have to stop them before start of the run-in period
Vitamin D Supplementation in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.

SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).

Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.

Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.

SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).

Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.

Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.

Objective : To evaluate the cellular immune response after vitamin D supplementation in patients with SLE.

Methods : This is an open prospective trial. SLE patients with hypovitaminosis D (\< 30 ng/mL) receive vitamin D supplementation. 100 000 UI of cholecalciferol per week for 4 weeks then 100 000 UI of cholecalciferol per month for 6 months will be administered. All patients are followed after the beginning of vitamin D supplementation at month 2 and month 6.

End points :

1. Clinical and biological tolerance: Absence of hypercalcemia or lithiasis during and after vitamin D supplementation.
2. Immunologic follow-up of T cells and B cells homeostasis (including Treg and Th17) and gene expression profile in PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation.
3. Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI) during and after vitamin D supplementation.

Schedule : Duration of patients' inclusion period is estimated 3

Eligibility Criteria:
Inclusion Criteria:

* Systemic lupus erythematosus
* Age \> 18 years
* Serum vitamin D levels \[25(OH)D\] \< 30 ng/mL
* Low to moderate active disease without modification of associated treatments

Exclusion Criteria:

* Pregnancy
* Serum 25(OH)D levels \> 30 ng/mL
* Flare requiring modification of treatments
Study of the ONS "Nutrinidrink With Dietary Fiber" Use Effect on Some Health Indicators in Children With Cerebral Palsy

The goal of this low-interventional study was to study the effect of additional nutritional support with ONS "Nutrinidrink with dietary fiber" on the anthropometric parameters of patients and the dynamics of gastrointestinal symptoms in patients with cerebral palsy. Among the additional objectives were to study the quality of life, metabolic parameters and the dynamics of some functional parameters of patients. Possible adverse events were also studied and described.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cerebral palsy, spastic and hyperkinetic forms;
* Class of cerebral palsy GMFCS 2-3;
* Z-score BMI ≤ -1;
* The patient's ability to safely swallow liquid food;
* Availability of informed consent signed by the patient's legal representative for inclusion in the study and processing of personal data.

Exclusion Criteria:

* Individual intolerance to the investigational product components;
* Galactosemia;
* Allergy to cow's milk proteins and other food intolerances;
* Participation in another clinical study currently or in the past 30 days;
* Any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study.
* Deterioration of the patient's condition requiring his transfer to enteral or parenteral nutrition;
* Transfer of a patient to another hospital;
* Complications that could be caused by the investigational product (diarrhea, nausea, vomiting, allergies, etc.);
* Withdrawal for a safety reason
* Refusal of the patient (his legal representative) from further participation in the study and withdrawal of informed consent to participate in the study and the processing of personal data. At the same time, the exclusion of a patient from the study should not affect the nature of his therapy
Genotyping Analysis of Acute Lymphoblastic Leukemia

Identification of alterations potentially involved in the complex mechanisms of leukemogenesis and at the identification and validation of novel biological factors which may serve as predictors of drug-response and drug-resistance or which may be suitable for targeted therapy.

The investigators will use several approach to identify common genetic variations: single-nucleotide polymorphisms (SNPs), genomic insertions and deletions, and genetic copy number variations (CNVs), interchromosomal translocations, loss of heterozygosity (LOH), and uniparental disomy (UPD), Epigenetic changes, such as silencing of gene expression via DNA hypermethylation, that can also influence drug effects, and aberrant methylation of CpG islands is a common feature of cancer cells. Over the years, methods of cytogenetic analysis evolved and became part of routine laboratory testing, providing valuable diagnostic and prognostic information in hematologic disorders. The recently developed single nucleotide polymorphism (SNP) arrays offer the ability to define simultaneously the copy number changes and loss of heterozygosity (LOH) events occurring in a tumor, at high resolution and throughout the genome. In addition to information on copy number changes, SNP arrays allow us to investigate the impact of a high number of SNPs on drug response and toxicity This molecular integrated approach will lead to the identification of alterations potentially involved in the complex mechanisms of leukemogenesis and at the identification and validation of novel biological factors which may serve as predictors of drug-response and drug-resistance or which may be suitable for targeted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Acute Lymphoblastic Leukemia of any subtype OR Lymphoid blast crisis Chronic Myeloid Leukemia
* Age \> 18 years
* Available data set of clinical data for review (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular results if available as routinely performed during diagnosis procedures)

Inclusion Criteria:

* No written informed consent
* No DNA samples available
Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn

The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.


Eligibility Criteria:
Inclusion Criteria:

* gestation week \> 37 ve Na \>150 mg/dl
* Dehydration

Exclusion Criteria:

* Sepsis
* Intracranial Haemorrhagia
* Congenital Cardiac Diseases
Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)

To investigate the treatment effect of Stanford Neuromodulation Therapy (SNT) on patients with Non-suicidal Self-injury (NSSI) and the underlying neural mechanism.

This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of SNT among patients with NSSI.

80 patients with NSSI diagnosed by DSM-5 were recruited from the Second Hospital of Anhui Medical University. After meeting the inclusion criteria and obtaining informed consent, All the participants were randomized (1:1) into two groups: SNT group and rTMS group.

Before the treatment, the Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) was obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(Hamilton depression/anxiety scale, Health Questionnaire-15) and magnetic resonance imaging (MRI) scan in multimodalities.

For SNT group, the treatment was performed once a day for 5 consecutive days. A Brainsight neuronavigation system was used to position the TMS coil over the individualized stimulation target at each session. Ten sessions of iTBS were delivered daily, for a total of 18,000 pulses per day. Stimulation was delivered at 90% of resting motor threshold (rMT).

For rTMS group, the treatment was also performed once a day for 5 consecutive days. Two sessions of rTMS were delivered daily. Each rTMS session comprised 100 trains of 4s duration at 10 Hz with inter-train intervals of 26 s (i.e., 4000 pulses per session). Stimulation was delivered at 90% of rMT.

In the second day after the last treatment, all the tests and MRI were reassessed. Patients were instructed to focus their answers on the past 1 week.

The clinical symptom and cognition of participants were followed in one week and one month after the last treatment.

Eligibility Criteria:
Inclusion Criteria:

* the patients were diagnosed by 2 or more senior clinical psychiatrists, meeting DSM-V criteria, and having 1 or more non-suicidal self-injurious behaviors in the last 6 months
* 12-18 years of age
* The medicine has not changed in the 4 weeks prior to or after this study, and if it has to be changed, the treatment medication is required to be at a subtherapeutic dosage level

Exclusion Criteria:

* the patients has suicidal ideation, or have committed suicidal behavior
* T1 or T2 weighted phase magnetic resonance images show focal brain lesions
* patients had neurological disorders such as epilepsy, or serious physical illnesses
* patients had history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months
* patiens had received radial cranial electrical stimulation or magnetic stimulation treatment in the last 3 months, or received electroconvulsive therapy in the last 6 months
* patients had previous significant head trauma or with EEG abnormality in the last 1 month
* body-mounted devices unsuitable for treatment, such as pacemakers, artificial valves and other metal implants.
Risk Stratification for Patients Presenting With Acute Pulmonary Embolism (PE)

Hypothesis: Increases in CRP, trop T, and BNP values will correlate significantly with right heart failure on echocardiogram and with mortality, ICU stay, hospital stay, and escalations in care.

1. Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure on echocardiogram.
2. Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care.
3. Compare each test's correlation with clinical outcomes to the others, to determine which test provides the best risk ratio.
4. Compare each trop T value's correlation with echo findings and clinical outcomes to determine the optimal time to draw trop T levels on a patient presenting with acute PE.
5. These tests will not be used in an attempt to establish a diagnosis of PE.

Purpose: This study will help us to determine whether laboratory tests used to evaluate cardiac function and blood flow (troponin T (trop T), C-reactive protein (CRP), and brain-natriuretic peptide (BNP)) correlate with findings on echocardiogram and with meaningful clinical outcomes when patients present with acute pulmonary embolism (PE). We will be studying these tests for prognostic purposes only, in patients with an established diagnosis of PE.

Research design: Prospective cohort study Methodology: Patients diagnosed with acute PE (see exclusion and inclusion criteria below) will be offered enrollment in the study. Once enrolled, he/she will then have a trans-thoracic echocardiogram (TTE) performed by a member of the cardiology service who will not be aware of the patient's clinical status, co-morbidities, or lab results (other than knowing that the patient has been diagnosed with acute PE). The patient will then have trop T, CRP, and BNP levels drawn (or added to laboratory tests that have already been drawn), which will be ordered by a member of the research team. CRP and BNP will be drawn only once, while trop T levels will be drawn every 4 hours for the first 24 hours, and every 8 hours from 24 to 48 hours. The primary team managing the patients will be privy to both the additional laboratory values ordered by the research team and the results of the TTE.

Each patient will be followed for the remainder of their hospital stay by a member of the research team. The following outcomes will be recorded: deaths, length of ICU stay, length of hospital stay, and escalations in care (pressor support, cardiopulmonary resuscitation (CPR), administration of thrombolytics, mechanical ventilation, ICU transfer).

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Acute PE (diagnosed by pulmonary angiogram, Computed tomography using the DVT/PE protocol, Ventilation/Perfusion (V/Q) scan read as high probability by the radiologist, or (+) lower extremity Doppler ultrasound with symptoms consistent with PE)

Exclusion Criteria:

* Hemodynamic instability (BP \< 90/60, IV pressor support) on admission
* Acute respiratory failure on admission
* Treatment with thrombolytic therapy prior to enrollment
Hydrolized Protein Formula for Premature Infants

Premature infants fed with a protein hydrolyzed formula will have better tolerance needing shorter time to achieve full feeds when compared to those fed with an intact protein formula.

The study formula is a 100% whey protein partially hydrolyzed (vs 60/40 Whey:Casein ratio of regular premature formulas) Because the tolerance and availability of breast milk is not predictable at the time of enrollment all the eligible premature infants will be randomized and assigned to the study or control group. Infants will receive formula, either because breast milk is not available or because indicated by the attending physician and switched to formula, They will be fed, depending of the group to what they are assigned, with either the PH formula for the study group or regular premature formula for the control group.

Randomization and blinding All eligible infants with parental consent will be randomized to either the study group to receive protein hydrolyzed formula (PH group) or to the control group to receive standard premature formula. Randomization will be stratified by 2 birth weight categories (500-1000 g and 1001-1500 g). The purpose of such stratification is to avoid imbalance between groups for factors that may influence outcome and is based on the different morbidity in different birth weight categories.

Masked randomization will be performed in a way that avoids the possibility of knowledge of treatment assignment at the time that eligibility is assessed and consent is sought. Only the person in charge of preparing the control or study formula will be aware of the infant's assignment group. Caregivers will remain masked to treatment group.

Study population Preterm newborns admitted to the neonatal intensive care unit with a birth weight 500-1500 g and who survive more than 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight between 500 -1500g and \< 32 weeks GA who survive more than 3 days.
* Has not yet started enteral full feeds.
* Study explained and parent/caregiver demonstrating understanding of the given information.
* Informed consent signed.

Exclusion Criteria:

* Chromosomal anomalies.
* Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia).
* Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention.
* Parental refusal.
* Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies aimed to accelerate feeds and or improve tolerance.
Abdominal Free Air After Surgery

The aim of this study is to evaluate if the presence of abdominal free air on a plain chest radiograph predicts gastrointestinal perforation. We aimed to enroll all patients undergoing abdominal surgery reporting major symptoms and signs suggestive of gastrointestinal perforation (abdominal pain, leukocytosis, fever) within the third postoperative day.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal surgery and major symptoms and signs suggestive of gastrointestinal perforation within the third postoperative day.

Exclusion Criteria:

* inability to consent to the study, age ≤18 yr, certain or probable pregnancy, inability to remain in upright position for more than 10 minutes.
Barriers for the Uptake of LaparoScopic Hysterectomy

Hysterectomy (surgical removal of the uterus) is the most common major gynaecological operation in women in developed countries. In Queensland, 6000 women require a hysterectomy for irregular periods, benign tumours or pelvic pain every year. Surgical approaches to surgical removal of the uterus (womb) include Laparoscopic Hysterectomy (LH), Vaginal Hysterectomy (VH) and Abdominal Hysterectomy through an abdominal incision (AH).

It is widely accepted that LH and VH are less invasive surgical procedures, cause less bleeding, surgical complications and pain and are associated with quicker recovery from surgery than the more invasive AH. In a clinical trial comparing LH and AH we recently demonstrated that LH outperforms AH with regards to cost effectiveness causing less total health-services cost than AH.

Implementation of LH in Queensland could save $9.8 million every year. Despite the evidence for LH and VH, 2600 hysterectomies (43%) are still performed through an open, abdominal incision. In brief, a common but outdated operation is still performed regularly causing not only unnecessary pain, surgical adverse events and longer hospital stay but also increased healthcare costs.

This study will assess reasons why a significant number of gynaecologists and patients prefer AH over LH (Barriers to the uptake of laparoscopic hysterectomy). We will survey specialist gynaecologists as well as patients who have had a hysterectomy for different health reasons. Based on the information from the survey the investigators will develop an intervention to increase the rate of laparoscopic hysterectomies in Queensland and pilot test it.


Eligibility Criteria:
Inclusion Criteria:

* Obstetricians and Gynaecologists or Women who have had a hysterectomy in the previous 2 years

Exclusion Criteria:

* Women who have had a hysterectomy more than 2 years ago
* Women who had a hysterectomy for cancerous conditions