cyrilzakka/clinical-trials huggingface dataset:
Xiamen Registry of Pregnant Women and Offspring (REPRESENT)

To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking to three other platforms, i.e. Residents Healthcare Management Platform, Primary Healthcare Management Platform, and Electronic Healthcare Records (EHR) Platform, which had been developed since 2006. The registry documented information and events about pregnant women from registration at their first trimester to postpartum, and includes the childhood follow up records. The registry not only enables longitudinal follow up of pregnant women and their offspring, but also expands the scope of database from pre-pregnancy exposures to long-term outcomes by data linkage.

During the past 11 years (January 2008 to March 2019), the REPRESENT has accumulated data concerning more than 700 thousands pregnancies. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The disease categories and codes are standardized according to the International Classification of Diseases 10th Revision (ICD-10). The whole process of data access, data extraction, data processing and data analysis was conducted through an internal-only accessible server at Xiamen Health and Medical Big Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement and should obtain approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.

Exclusion Criteria:

* None.
Skeletal Muscle and Adipose Tissue Study

The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.

Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion or intermittent bolus.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic scoliosis
* Planned posterior spinal fusion surgery (PSFS)
* Age: 12-20 years old
* American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels
* No known allergy to cefazolin

Exclusion Criteria:

* Known allergy to cefazolin
* Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle
* Known renal or hepatic insufficiency or failure
Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention

As mental disorders constitute a core health care challenge of the 21th century, increased research efforts on preventive interventions are indispensable. In the field of clinical psychology, indicated preventive interventions targeted to those with initial symptomatology appear particularly promising. Applied relaxation (AR) is a well-established intervention technique proven to effectively reduce tension/distress, anxiety and depressive symptoms in the context of treatment of a wide variety of manifest mental disorders as well as somatic illnesses. However, it has not been studied so far whether AR as indicated preventive intervention in subjects with initial symptomatology but no full-threshold mental disorder yet is capable to prevent a further symptom escalation. This randomized controlled trial in subjects with elevated tension/distress, anxiety or depressive symptomatology aims to investigate whether an AR intervention (10 sessions à 60 min) can (a) effectively reduce present psychopathological symptoms as well as (b) prevent a further symptom progression to full-threshold DSM-5 mental disorders. Putative mediators (physiological, emotional, cognitive and behavioral changes including heart rate and heart rate variability, hair and salivary cortisol secretion, affectivity, self-efficacy, internal locus of control and cognitive / behavioral coping) and moderators (sex, age, symptom severity at baseline and homework adherence during the intervention course) of the intervention/preventive efficacy will be additionally studied. Predictor and outcome measures will be assessed both conventionally (via personal interview, questionnaires and physiological measures during the respective main assessment) and with ecological momentary assessments (EMA, applied via smart phone over a 1-week interval following the respective main assessment) in everyday life.


Eligibility Criteria:
Inclusion criteria are as follows: at least mild symptoms of tension/distress, anxiety or depression (DASS-21 score of 8 or higher on tension/stress, of 4 or higher on anxiety, and of 5 or higher on depression)

Exclusion criteria are as follows: (1) a 12-month diagnosis of any mental disorder, (2) lifetime psychotic symptoms, (3) current psychological or psychopharmacological intervention, (4) acute suicidality
Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease

The purpose of the study is to determine whether a diuretic drug called amiloride is capable of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients with kidney disease. Our hypothesis states that amiloride is capable of reducing blood pressure in these patients and thus decrease the cardiovascular risk associated with diabetic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Negative pregnancy test at inclusion and taking contraceptive medication
* One group with diabetic nephropathy and overt proteinuria
* One normoalbuminuric group without nephropathy
* Creatinine clearance \> 40 ml/min

Exclusion Criteria:

* Type 2 diabetes
* Receiving amiloride, glucocorticoids, aldosterone or spironolactone
* Clinically relevant organic or systemic disease including malignancy
Oxidative Stress and Iron Overload in Patient With Abnormal Haemoglobinopathy

The effects of iron overload and oxidative stress and dyslipidemia on glucose level and thyroid function in patients with abnormal hemoglobinopathy. 2- Evaluation of MDA level as a marker of oxidative stress.

Severe anemia due to defect in the synthesis of hemoglobin and hemolysis can endanger the life of β- thalassemia major (β-TM) patients and sickle cell anemia; therefore, the span and patient's quality of life is highly dependent on regular blood transfusion. Nonetheless, blood transfusion causes iron accumulation in the patients. Excess iron deposits in vital organs, such as liver, heart and endocrine glands, result in their malfunction. Endocrinopathies account as one of the most common iron overload complications. Oxidative stress is a major mechanism contributing to the progression of the disease in TDT. Iron overload enhances oxidative stress in patients with TDT. Iron is recognized to be a catalyst in developing reactive oxygen species (ROS).

MDA is an eosinophilic enol compound that reacts with the structural and functional cellular protein to generate toxic lipoxidation end product destined for cellular damage of the affected organs. It is used as a sensitive biomarker for oxidative stress. Disturbances in serum lipids and carbohydrates homoeostasis as well as OS were documented in β-TM and sickle cell anemia. Increase in serum levels total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and decrease in high-density lipoprotein cholesterol (HDL-C) are the well-known causative factors and predictors of CHD development and endocrine abnormality

Eligibility Criteria:
Inclusion Criteria:

- age 18 and above.

-patients diagnosed according to physical examination and results of laboratory tests as beta thalassemia major. -patient under gradual blood transfusion and iron chelating therapy. -Gender and age matched healthy controls with normal serum lipid, glucose level and thyroid function will enrolled in this study as the control group

Exclusion Criteria:

* age under 18 years.
* patient diagnosed with DM or those taking pharmacological agents such as steroids, insulin and lipid lowering drugs
Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.

The aim of this study is to assess the maternal psychological implication of the novel coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women over the age of 18 that present in labour (vaginal delivery or caesarean section)

Exclusion Criteria:

* psychiatric disorders
* drug abuse
* not eligible to read and write in Greek
PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).

Tonsillectomy is performed in response to cases of repeated occurrence of acute tonsillitis or adenoiditis, obstructive sleep apnea, nasal airway obstruction, snoring, or peritonsillar abscess.

The PEAK PlasmaBlade uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing tonsillectomy.

Two study sites were granted approval for this prospective randomized study. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent for themselves (adults) or for their child prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for tonsillectomy or tonsillectomy and adenoidectomy (TnA).

Eligibility Criteria:
Inclusion Criteria:

1. Children \& adolescents: Age 3-17; Adults: 18 and older
2. Physically healthy, stable weight
3. Requiring tonsillectomy and adenoidectomy per widely accepted indications
4. For adults, subject must understand the nature of the procedure and provide written informed consent.
5. For children and adolescents age 7 to 17, subject must understand the nature of the procedure and be able to give verbal assent prior to the procedure. In addition, parent or guardian must provide written informed consent.
6. For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent.
7. Subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets.

Exclusion Criteria:

1. Children: Age 2 and under
2. Bleeding disorder
3. Peritonsillar abscess
4. Requiring concomitant uvulopalatopharyngoplasty (UPPP)
5. Anticoagulation therapy which cannot be discontinued
6. Unable to follow instructions or complete follow-up
7. Currently taking any medication known to affect healing
8. Currently enrolled in another investigational device or drug trial
Diabetic Foot Ulcers Microbiome and Pathogen Identification

This research is being done because people with diabetes have reduced healing capacity and prone to develop infections of foot wounds. This can be problematic because wounds that become infected may result in amputation and more severe complications. New evidence suggests that a better understanding of the microbiome of wounds (e.g., bacterial presence) may provide information about wound healing and provide an earlier opportunity to identify an individual who may be prone to develop diabetic foot infection in their wound.

Therefore, the purpose of this study is to evaluate the role of the microbiome of the diabetic foot ulcer in development of infection and wound healing. Once the role of the microbiome is confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible.


Eligibility Criteria:
Inclusion Criteria:

* DFU patients with diabetes mellitus
* Have a hemoglobin A1c\[HbA1c\] of 12% or less as measured within the last 6 months
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Pregnant or lactating
* Uncontrolled blood glucose as demonstrated by by a HbA1c of greater than 12%
* Bilateral wound or ulcer
* Current infection of Coronavirus (COVID-19)
* Unable to provide informed consent or are unwilling to participate.
DNA Changes That Affect Vitamin D Metabolism in Patients With Colorectal Cancer Receiving Vitamin D Supplements

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying changes in DNA that affect vitamin D metabolism in patients with colorectal cancer receiving vitamin D supplements.

OBJECTIVES:

* To identify CYP24 single nucleotide polymorphisms (SNPs) using peripheral blood mononuclear cell genomic DNA from patients with colorectal cancer receiving cholecalciferol supplementation.
* To evaluate the effects of these CYP24 SNPs on baseline serum vitamin D_3 metabolites (25-D_3, 24,25-D_3, and 1,25-D_3), and parathyroid hormone levels (PTH).
* To evaluate the effects of these CYP24 SNPs on serum vitamin D_3 metabolites and PTH levels during cholecalciferol treatment.
* To examine CYP24 splicing, protein expression, and enzyme activity at baseline and during cholecalciferol treatment.
* To determine the relationship, if any, between serum cholecalciferol pharmacokinetic parameters and CYP24 SNPs, splicing variants, and enzyme activity.

OUTLINE: Patients receive oral cholecalciferol 2000 IU once daily for 1 year. Patients without response to vitamin D supplementation (serum 25-D_3 level \< 32 ng/mL) by 6 months will have their cholecalciferol dose increased to 4000 IU once daily.

Blood is collected at baseline and on days 14, 30, 60, 90, 180, 270, and 360. Peripheral blood mononuclear cells for CYP24 genotyping, protein expression, enzyme activity, and splicing variants are analyzed by polymerase chain reaction (PCR), western blot, high performance liquid chromatography, and reverse transcriptase PCR, respectively. Serum is analyzed for vitamin D_3 metabolite levels (by radioimmunoassay), calcium (to monitor for hypercalcemia), and parathyroid hormone assays (to measure vitamin D effect).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prior or current documented diagnosis of colorectal cancer

  * All stages
* 25OH-D3 level \< 50 ng/mL

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 6 months
* Serum creatinine \< 2.0 mg/dL
* Serum bilirubin \< 2.0 mg/dL
* No prior or current hypercalcemia (defined as albumin corrected serum calcium \< 10.2 mg/dL)
* No known contraindication for vitamin D supplementation
* No genitourinary stones within the past 5 years
* No severe comorbid conditions such as uncompensated heart failure or active infection

PRIOR CONCURRENT THERAPY:

* No supplemental vitamin D beyond what is provided through the study
* At least 2 months since prior vitamin D supplementation exceeding 800 International Units (IU)

  * Nondietary vitamin D supplements should not have exceeded 800 IU/day within the past 2 months
A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female subjects following administration of single rising doses and administration of multiple rising doses.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male or female (of non-child-bearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 65 years (inclusive)
3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
2. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.

Further exclusion criteria apply.
Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders
* Age ≥ 18 years old
* Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
* Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
* OSDI scale: 13-30
* VAS scale: 2-7
* Ocular tests in both eyes:
* Corneal staining with fluorescein. Oxford scale \> 0
* Tear Breakup Time Test: (BUT) \< 10 seconds
* Schirmer test with anaesthesia \< 10 mm/5min

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test.
* Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study.
* Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
* Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
* Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
* Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
* Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
* Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
* Previous history of drug hypersensitivity.
* Use of contact lenses
* Case history of drug or alcohol abuse or dependence.
* Relevant abnormal laboratory results as judged by the investigator
* Previous refractive surgery
* Participation in a clinical trial within 2 months before the enrolment visit
* Relevant ocular pathology judged by the investigator.
Safety and Efficacy of Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Pancreatic cancer is 5th leading cause of cancer-related death in Korea. It has a dismal prognosis with very low 5-year survival rate, about 5%. Only 10% of pancreatic cancer patients is diagnosed in operable status. So, most of patients could not be treated with curative resection.

Locally advanced pancreatic cancer (LAPC) is defined by defined as surgically unresectable due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but have no evidence of distant metastases. In LAPC patients, systemic chemotherapy with/without radiotherapy was used as a standard therapy, but therapeutic response was very poor. Only less than 30% of patients showed treatment response, and median survival of LAPC patient was only 9 months. Thus, more effective treatment modality is needed for LAPC patients.

Irreversible electroporation (IRE) is a soft tissue ablation technique using ultra short but strong electrical fields to create permanent and hence lethal nanopores in the cell membrane, to disrupt the cellular homeostasis. IRE does not cause thermally induced necrosis and has tissue selectivity, so adjacent tissue or vascular structures can be preserved.

Several clinical trials using IRE were performed to liver, kidney or lung cancer patients. We will operate IRE procedure to LAPC patients who were previously received standard therapy but showed no response, using NanoKnife IRE device. We will investigate treatment response and safety of IRE.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed pancreatic cancer patients
* Locally advanced pancreatic cancer patients. Vascular encasement by tumor was noted in radiological evaluation (CT, MRI or PET-CT)
* Older than 19 years old and younger than 70 years old
* Previously treated with systemic chemotherapy or chemoradiotherapy due to locally advanced pancreatic cancer.

Exclusion Criteria:

* Patients with life-threatening systemic disease.
* Metastatic or borderline-resectable pancreatic cancer patients
* Patients with seizure history
* Patients with arrythmia or heart failure
* Recent history of myocardial infarction (within 1 year)
* Patients who have implantable electronic devices. (e.g. pacemaker, defibrillator)
* Patients who have metal devices (e.g. metal stent) around tumor.
* Coagulopathy patients.
Muscle Strength and Total Knee Replacement

Purposes: To compare knee extensor muscle strength, physical function and self-reported function before and after total knee replacement with healthy age-matched controls. To describe changes in knee extensor muscle strength up to one year after surgery. To study the relationship between changes in knee extensor muscle strength and changes in physical function, self-reported function and physical activity level and the relationship between changes in knee extensor muscle strength and satisfaction.

Methods: A prospective observational study and comparison with controls. 50-55 individuals aged 65 or older, scheduled for total knee arthroplasty will be recruited to the study group. Measurement of study group 0-2 weeks before surgery and 3, 6 and 12 months following surgery. Comparison with 50-55 healthy age-matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for total knee replacement on the basis of osteoarthritis of the knee
* Expected rehabilitation in a primary care setting

Exclusion Criteria:

* Difficulties reading or speaking Swedish
* Revision surgery
* Rehabilitation in other settings than primary care
Adult Follow-up of Preventive Study With Brief Smoking Intervention for Adolescents

The purpose of this study was to see whether a brief intervention given in adolescence has an effect on smoking in adulthood. The investigators also wanted to clarify the significance of some known psychosocial risk factors of smoking in adulthood.


Eligibility Criteria:
Inclusion Criteria:

* Born on 1979.
* Living in Vaasa, Pietarsaari, Kokkola or Seinäjoki at school age.

Exclusion Criteria:

* Other year of birth.