cyrilzakka/clinical-trials huggingface dataset:
Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test

The study will determine the performance of the Infinium HD Test.

* The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population.
* The secondary objective of the study is to determine the background number of chromosomal abnormalities per person in the general population based on the resolution of the Infinium HD Test.


Eligibility Criteria:
Method Comparison - Sample Inclusion Criteria

The following are criteria for inclusion of extracted genomic DNA samples in the method comparison sample pool:

1. Sample is from a patient referred for post-natal cytogenetic testing.
2. Sample gender is known.
3. Sample quantity available for testing is ≥ 1 microgram of genomic DNA at a concentration of 60-80 nanograms per microliter (60-80ng/µl).
4. Sample is extracted genomic DNA from EDTA or heparin-anticoagulated whole blood.
5. Sample has been stored at 2 to 8°C or -15 to -25°C for no greater than three years from the date of extraction.
6. Sample has been tested by a reference method. Acceptable reference methods include karyotype, FISH, qPCR, MLPA, and methylation analysis.

Method Comparison - Sample Exclusion Criteria

1. Sample is from a patient not referred for post-natal cytogenetic testing.
2. Sample is from a patient referred for cytogenetic oncology testing.
3. Sample quantity \< 1 microgram of genomic DNA or less than 60 nanograms per microliter (60ng/µl).
4. Sample was improperly stored or was extracted from a sample that was improperly stored.
5. Sample was tested by an Illumina array during standard of care testing.

Clinical Specificity - Sample Inclusion Criteria

The following are criteria for inclusion of extracted genomic DNA samples in the clinical specificity sample pool:

1. Sample gender is known.
2. Sample is from a patient not referred for post-natal cytogenetic testing.
3. Sample quantity available for testing is ≥ 1 microgram of genomic DNA at a concentration of at least 60-80 nanograms per microliter (60-80ng/µl).
4. Sample is extracted genomic DNA from EDTA or heparin-anticoagulated whole blood.
5. Sample has been stored at 2 to 8°C or -15 to -25°C for no greater than three years from the date of extraction.

Clinical Specificity - Sample Exclusion Criteria

1. Sample is from a patient referred for post-natal cytogenetic testing.
2. Sample quantity \< 1 microgram of genomic DNA or less than 60 nanograms per microliter (60ng/µl).
3. Sample was improperly stored or was extracted from a sample that was improperly stored.
Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study

After vaginal delivery, all of the participants will evaluate by using Edinburg depression scale and venous blood sample will obtain. Postpartum depression will consider the result of scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin level will compare between depressed and nondepressed women.


Eligibility Criteria:
Inclusion Criteria:

* All women who gave birth

Exclusion Criteria:

* women with previously diagnosed depression and any psychiatric disorders
* women with previously take antidepressan and antipshycothic
* women giving birth to children with anomalies
* women with undertake surgery for peripartum hemorrhage
An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application

The aim of our study is to investigate the effect of providing patients access to their electronic medical records Via the IPC Connect Application on their A Survey will be proposed to all outpatients with a solid or hematologic malignancy who will attend an appointement at Institut Paoli Calmettes clinic.

Data will be collected during a 1-month period. The auto-questionnaire will be composed of 31 questions addressed to all patients, 17 questions will be specifically addressed to patients using IPC connect application and 7 questions will be addressed to patients who do not use the application.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman, age\> 18 Years
* Solid tumor or hematologic malignancy
* Patient attending an appointment at Institut Paoli Calmettes
* Non-opposition

Exclusion Criteria:

* emergency, Vulnerable person or unable to provide informed consent
* First appointment at Institut Paoli Calmettes
Percutaneous Gelled Alcohol Sclerotherapy for Aggressive Angiomas: Evaluation of Feasibility, Safety, and Efficacy

The investigators aimed to evaluate efficacy and safety of a non-surgical protocol treatment combining transarterial embolization and percutaneous radiopaque gelled ethanol (RGE) sclerotherapy in a first procedure, then followed by vertebroplasty in a second procedure, to treat aggressive vertebral hemangioma patients in tertiary hospital. Exclusion criteria were age \<18-years old and any association with neurological deficit.


Eligibility Criteria:
Inclusion Criteria:

* Every patients treated by gelled alcohol sclerotherapy for aggressive angiomas, in the University Hospital of Saint-Etienne.

Exclusion Criteria:

* Patients no treated by gelled alcohol sclerotherapy.
HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients

HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level HBsAg.

Low replicative chronic HBV infection patients with low Level HBsAg were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA\<2000 IU/mL and HBsAg levels ≤1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy.

After giving informed consent, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.

In this study, treatment endpoint was HBsAg loss(\<0.05 IU/mL) and anti-HBs positive(\>10 milli-International unit(mIU)/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels.

Eligibility Criteria:
Inclusion Criteria:

1. Hepatitis B surface antigen (HBsAg) positive and \<1000 IU/mL.
2. Hepatitis B surface antibody (HBsAb) negative.
3. Hepatitis B e antigen (HBeAg) negative.
4. Hepatitis B virus DNA \<2000 IU/mL.
5. Absence of previous antiviral therapy.

Exclusion Criteria:

1. Patients with active alcohol and/or drugs consumption.
2. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
3. Patients with other factors causing liver diseases.
4. Pregnant and lactating women.
5. Patients with concomitant HIV infection or congenital immune deficiency diseases.
6. Patients with diabetes, autoimmune diseases.
7. Patients with important organ dysfunctions.
8. Patients with mental illness.
9. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
10. Patients who can't come back to clinic for follow-up on schedule.
Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers

The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between ≥19 and ≤30 kg/m2.

Exclusion Criteria:

* A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease
* Use of drugs that induce the liver drug metabolising enzymes within 4 weeks before first PET
tDCS in Patients With Disorders of Consciousness

test

Neurostimulation techniques such as deep brain stimulation (DBS) and spinal cord stimulation (SCS) have been used to treat DOC. Although these techniques have been shown to increase patient response, there are still some limitations. For example, DBS requires craniotomy and may increase the risk of intracranial hemorrhage and infection. In addition, the complexity and cost of these technologies also limit their potential applications.

Eligibility Criteria:
Inclusion Criteria:

Patients with DOC: VS and MCS (the cause of unification is: traumatic brain injury, the course of more than 1 month, not more than 1 year ; age 18-65; Past history without a mental disorder; No previous alcohol or substance abuse; No epilepsy or frequent spontaneous movement; No benzodiazepines; No moderate or severe hydrocephalus, All patients were right handed.

Exclusion Criteria:

Exclusion of organic heart disease, such as sinus bradycardia, arrhythmia; exclusion of patients with intracranial metal devices, pacemakers or any other device.
HSP-glomerulonephritis Trial: MP vs CyA

No curative treatment of severe HSP nephritis is known.

Apart from corticosteroids, immunosuppressive drugs, such as azathioprine and cyclophosphamide, have been used to treat severe HSP nephritis.Limited patient series treated with these drugs have been described, but there are no reports of controlled trials.

Cyclosporine A have been used to treat corticosteroid-resistant or corticosteroid-dependent nephrosis. (11) Cyclosporine A has also been used to treat HSP nephritis, but as far as we know, there are no publications reporting such trials.

The aim of the study is to compare MP pulses and cyclosporine A for their efficacy in the treatment of HSP nephritis.

The efficacy of the two treatments will be assessed on the basis of the duration of nephrosis/nephritis, the maintenance of renal function and the renal biopsy findings.

Using a prospective, randomised, open-labelled design, MP pulse treatment and cyclosporine A treatment will be compared for their efficacy in the treatment of severe HSP glomerulonephritis.

The trial will be a national multi-centre trial that involves all Finnish university hospitals, a few Finnish central hospitals.

The HSP patients with crescent HSP glomerulonephritis (ISKDC class III or IV) diagnosed by renal biopsy or with a renal biopsy finding of ISKDC class II + a distinct nephrotic syndrome will be included. Most of the patients will be recruited from a series collected by the same authors to study the prevention of HSP nephritis (see Effect of prednisone treatment on the symptoms of HSP disease and the development of glomerulonephritis).

The patients will be randomised to receive either MP pulses i.v. or cyclosporine A p.o. The MP pulses will consist of three doses of methylprednisolone 30 mg/kg i.v. given over a period of one week in hospital. On the intermediate days and for a month after the MP pulses, the patients will be given prednisone 30 mg/m2/day p.o., after which the prednisone medication will be gradually tapered over 3 months. The patients randomised into the cyclosporine A group will receive an initial dose of 5 mg/kg/day, after which the dosage will be titrated to an optimal therapeutic level by monitoring the B-Cya concentration. The cyclosporine A treatment will be continued for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* On the basis of a renal biopsy, the patient has been diagnosed for crescentic HSP glomerulonephritis of ISKDC grade III or IV or HSP glomerulonephritis of ISKDC grade II + a definite nephrotic syndrome (proteinuria \> 40 mg/m2/h).

Exclusion Criteria:

* The child is on regular medication known to interact with cyclosporine. Such medication includes cisapride, phenytoin, phenobarbital, carbamazepine, digoxin and anti-inflammatory pain medication.
Superficial and Cutaneous Fungal Infections Among Drug-users in Northeast Region of Iran

The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran

There were two groups with overall members of 1436. Statistically, the investigators have used "Likelihood ratio " and " Exact's Fisher" tests.

Eligibility Criteria:
Inclusion Criteria:

* Suspected fungal lesions

Exclusion Criteria:

* non use of local or edible anti-fungal drugs and not taking bath within the last 48 hours of testing
Fetuin A Association in Periodontal Disease and Diabetes Mellitus

Aim: The aim of the current study was to compare and correlate gingival crevicular fluid (GCF) fetuin-A levels and high sensitivity C-reactive protein (hs-CRP) levels in non-diabetic periodontitis patients and type 2 diabetic periodontitis patients with healthy subjects and revealing its possible role in diagnosis of periodontal disease.

Methodology: Forty-five periodontitis stage III patients categorized into 3 groups according to whether having type II diabetes mellitus or not were compared to systemically and periodontally healthy participants in this investigation. Clinical parameters for all groups were recorded. Assessment of GCF levels of fetuin A and hs-CRP were done to all enrolled participants utilizing an enzyme linked immune-sorbent assay (ELISA) kit. Receiver operating characteristic (ROC) curve was performed to reveal sensitivity, specificity, predictive value and diagnostic accuracy of the markers used.


Eligibility Criteria:
Inclusion Criteria:

* both gender periodontitis stage III

Exclusion Criteria:

1. Smoking,
2. Systemic diseases (except DM in group B),
3. Periodontitis patients having periodontal treatment recently (past 6 months),
4. Pregnancy, lactation, contraceptive pills,
5. Anti-inflammatory/ immunosuppressive drugs.
The Effect of Web-based Mindfulness-based Stress Reduction Program on Pregnant Women

Pregnancy is a period in which physiological and psychological changes are experienced and discomforts related to these changes are observed, and comfort is affected for the pregnant. However, fetal health concern refers to the concern of the expectant mother about the health of her developing fetus. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.

Women experience intense physiological, psychological and social changes during pregnancy and postpartum period. Pregnancy and postpartum period can be a difficult process for some women due to biological and environmental factors. Mindfulness-based approaches have been used in solving both physical and mental problems in pregnant women and very positive results have been obtained. The aim of this study, which is carried out to determine the effect of mindfulness on prenatal comfort and fetal anxiety levels in pregnant women, is aimed at creating intervention programs compatible with the antenatal period and contributing to the improvement of pregnancy outcomes. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the

Eligibility Criteria:
Inclusion Criteria:

* Not having any diagnosed psychiatric disease,
* Literate,
* Using a smart phone,
* With internet access
* Having a headset accessory for phone calls,
* Pregnant women who voluntarily agreed to participate in the study

Exclusion Criteria:

* Filling in the questionnaire form incompletely,
* Pregnant women with communication barriers and mental disabilities
CNS Correlates of Extended Sleep Restriction

Chronic sleep restriction is ubiquitous in both the general population and the military. The deleterious effects of sleep loss on human alertness and cognitive performance have been documented in numerous studies dating back to the nineteenth century. Over the past decade, evidence has emerged indicating that chronic sleep restriction may also precipitate deleterious, long lasting neuropathological changes in the brain. The purpose of this study is to determine neuropathological effects of sleep restriction and identify physiological mechanisms that correlate with sleep loss-induced performance impairment.


Eligibility Criteria:
* Ages 18 to 39 (inclusive)
* A body mass index (BMI) below 30.
* Weigh at least 140 lbs
* Females must not be pregnant or nursing, and must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
* No history of sleeping problems such as insomnia or sleep apnea.
* Test negative for alcohol, nicotine, illegal drugs, and not take certain medications.
* Must not excessively consume alcohol or caffeine.
* Active duty and Federal employees must be on leave during participation.
* No history of heart disease (high blood pressure), neurologic disorder (such as seizures of epilepsy), liver disease, kidney disease, or metabolic disorder or diabetes.
* No history of underlying acute or chronic pulmonary disease requiring daily inhaler use.
Effect of Targeted Education for Atrial Fibrillation Patients

The aim of this study is to evaluate the effect of targeted in-person and online education on cardiovascular outcomes of AF patients (inpatient and outpatient), compared with standard care. Several other parameters (i.e. knowledge level, quality of life, symptom burden, self-care capabilities, adherence to oral anticoagulation, and an evaluation of the educational efforts) will be studied. Cost-effectiveness and cost-utility will also be investigated.

The main research hypothesis is that individualized education based on the knowledge gaps measured with the JAKQ (Jessa Atrial fibrillation Knowledge Questionnaire) in each individual patient (called 'targeted education') is superior when compared to current AF care, both from an efficacy perspective (evaluated by different outcome measures) and from a cost-effectiveness perspective.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,...)
3. Patients who are capable to sign the informed consent.

Exclusion Criteria:

1. Not able to speak and read Dutch
2. Cognitive impaired (e.g. severe dementia)
3. Life expectancy is estimated to be less than 1 year.
4. Ongoing participation in another clinical trial.
5. Pregnant women
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate \[GFR\] 44-15 ml/min/1.73m2)
* Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level \< 30 ng/mL
* Corrected serum calcium \< 10.2 mg/dL
* Serum phosphate \< 4.6 mg/dL
* Serum albumin \> 3.0 g/dL
* Body mass index \< 40 kg/m2
* Ability to give informed consent

Exclusion Criteria:

* Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Expected to undergo living related kidney transplant in next 6 months
* Pregnant, breastfeeding, or unwilling to use adequate birth control
* History of severe liver disease
* Nephrotic range proteinuria (\> 3.5 gm/day)
* Use of active vitamin D analogs within 30 days of randomization
GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake

The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.

The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.

Eligibility Criteria:
Inclusion criteria:

* Caucasian men
* Age between 18 and 70 years
* Body mass index (BMI) between 25 and 40 kg/m2
* Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mM (\<8.5 %)
* In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
* Informed consent

Exclusion criteria

* Anaemia (haemoglobin outside normal range)
* Any current or prior gastrointestinal disease that may interfere with the endpoint variables
* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \> 2 times normal values) or history of hepatobiliary disorder.
* Nephropathy (serum creatinine above normal range and/or albuminuria).
* Anorexia, bulimia or binge eating disorder
* Allergy or intolerance to ingredients included in the standardised meals
* Tobacco smoking
* Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
* Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
* Any physical or psychological condition that the investigator feels would interfere with trial participation