cyrilzakka/clinical-trials huggingface dataset:
More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease

A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. Many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. Currently, many children with permanent kidney failure only receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than their healthy counterparts. Survival for these children has not improved over the last 20 years. These data indicate that the current dialysis treatment strategy is unacceptable.

This research project will study if more frequent dialysis, performed 5 days per week, will improve the health of children with permanent kidney failure compared to the current treatment strategy. Children will be treated with both traditional and more frequent dialysis schedules to measure improvements in their health and well being.


Eligibility Criteria:
Inclusion Criteria:

* Current outpatient ESRD pediatric patients, 3-21 years old, receiving in-center chronic HD.
* Patients have to be on chronic HD for at least 2 months before eligibility

Exclusion Criteria:

* Patients with a scheduled (with a specific transplant date) kidney transplant in the next 6 months
* Patients scheduled to be switched to peritoneal dialysis in the next 6 months
* Patients currently receiving \>3 days per week of hemodialysis
* Patients currently receiving \>12 hours per week of hemodialysis
* Anyone \<3 years of age would be excluded from the study, so our minimum anticipated patient weight would be about 11 kg
* Patients \>21 years of age at enrollment
* Patients receiving concomitant peritoneal dialysis
* Patients with \<2 months on chronic HD
* Patients with a temporary or femoral dialysis catheter
* Patients who are not hypertensive (both not on blood pressure medication and with a SBP \<95th percentile for age, sex, and height)
* Patients enrolled in an investigational drug trial involving blood pressure medication or any other clinical trial potentially affecting the primary outcome of the study

Patients listed for a deceased donor transplant will not be excluded.
Evaluation of U-AKIpredTM for Predicting AKI in Critically Ill Patients Within 12 Hours: a Multicenter Prospective Cohort Study

The goal of our study is to evaluate U-AKIpredTM for predicting AKI in critically ill patients within 12 h by the multicenter prospective cohorts. AKI was diagnosed by Kidney Disease Improving Global Outcomes (KDIGO) criteria. We designed five aspects including the overall fitting effecience evaluation, calibration curve, quantifying calibration performance, quantifying discrimination performance, quantifying clinical utility to evaluate the external validation model.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients who stayed in ICU for over 24 h;
* patients older than 18 years of age.

Exclusion Criteria:

* patients who admitted in ICU had been diagnosed acute kidney injury;
* patients who admitted in ICU had been diagnosed acute kidney disease;
* patients who admitted in ICU had been diagnosed chronic kidney disease;
* patients who admitted in ICU had performed kidney dialysis;
* patients who admitted in ICU had performed kidney transplantation;
* Pregnant women.
Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation

Working hypothesis and aims: The aim of our study is to investigate whether vitamin D deficiency could cause increased thrombin generation and a hypercoagulable state healthy volunteers.

Methods:

In total 400 healthy volunteers are planned for inclusion in this trial. After signing an informed consent two blood samples will be obtained from each participant.

Expected results: invastigator expect to find that volunteers with vitamin D deficiency will have thrombin generation curve compatible with hypercoagulable state and returning to normal after treatment with vitamin D


Eligibility Criteria:
Inclusion Criteria: age \>18 healthy naive to drug treatment -

Exclusion Criteria:

no exc criteria

-
Aspirin Resistance and Stroke Risk: Platelet Function Analysis in Patients With Ischemic Events

The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.

Atherothrombotic disease is a leading killer of adults throughout the world. The current mainstay for the prevention of ischemic vascular events is the use of aspirin Antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, TIA, or at high risk for the development of cerebrovascular disease. Numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. The purpose of this study is to perform serial platelet function assays (PFAs) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering ASA as a dose adjusted medication using PFA. The long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be taking Aspirin or Plavix
* Patient must have had a stroke, TIA or cerebrovascular disease

Exclusion Criteria:

-None
Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan

The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world Japanese clinical practice. The secondary objective of the study is to compare LoS of patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial fibrillation. Other objectives are (1) to compare the in-hospital direct and indirect-related costs between dabigatran and warfarin, and (2) to compare the rates of patients directly discharged at home after the index hospitalization between dabigatran and warfarin.


Eligibility Criteria:
Inclusion criteria:

1. Hospitalized patients among patients having a visit record with a confirmed diagnosis of NVAF (ICD-10 Code: I48) and prescribed dabigatran or warfarin in the hospitalization period

Exclusion criteria:

1. Having a record with a diagnosis of atrial flutter, valvular atrial fibrillation or postoperative atrial fibrillation diagnosis as standard disease name during the study period.
2. Having a record with a diagnosis of rheumatic atrial fibrillation (ICD-10 code I05 to I09 \[chronic rheumatic atrial fibrillation\])or mechanical-valvular atrial fibrillation (ICD-10 code T820 \[artificial cardiac valve mechanical complication\]) during the study period.
3. Having a record with a confirmed diagnosis of cancer (ICD-10 code C00-C97 \[malignant neoplasm\]) during the study period.
4. Having a record of dialysis (class J038 artificial kidney) during the study period.
5. Having a record of dabigatran use for a purpose other than prevention of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients.
6. Having a record of dabigatran or warfarin before the hospitalization
7. Having a record of new diagnosis of atrial fibrillation after the initiation of dabigatran or warfarin treatment in the hospitalization period.
Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction

This is a clinical study on patients who have been prescribed opioids (narcotic pain relievers) for the treatment of pain, to determine what genetic factors influence outcome of treatment. Procedures include: an initial telephone prescreening, completion of a number of questionnaires, and a blood draw to determine genetic factors. Participants will take part in a one-time clinic visit, during which all procedures will be completed.

The investigators hypothesize that several classes of genes, including genes in opioid, pain, and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed nondependent subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older.
* Subject is willing and able to speak, read, and write in English and comply with all study procedures.
* Subject is willing and able to voluntarily sign and date an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB), prior to the conduct of any study-specific procedures.
* Subject has been prescribed opioids for the treatment of pain for at least 6 months at the time of the study.

Cases:

* Subject has a diagnosis of current prescription opioid dependence (confirmed by the MINI).
* Subject had no history of dependence on alcohol or illicit or prescription drugs, including opioids, prior to prescription opioid exposure for the treatment of chronic pain. Patients who have abused these substances but have not met criteria for dependence (confirmed by the MINI and/or medical history) will be included.

Controls:

* Subject's prescribing physician has reported absence of significant problematic behavior with respect to prescription opioids or other substances while under the physician's care.
* Subject has a negative urine drug screen for alcohol, illicit drugs, and nonprescribed controlled substances at screening.
* Subject has no current or past substance abuse or dependence (confirmed by the MINI and medical history).

Exclusion Criteria:

* Subject has any condition that poses undo study-related risk, or that interferes with assessment.
* Subject is not willing to have blood drawn or has any condition that in the investigators' opinion precludes having blood drawn.
The Effect of Training Given by Whatsapp Application on Mamography Health Beliefs and Behaviors

It is known that the healing process of breast cancer is accelerated thanks to the early diagnosis and effective treatment. Mammography screening is an important diagnostic method in the early diagnosis of breast cancer. It is thought that the education to be given according to the Health Belief Model will make important contributions to developing a positive attitude in breast cancer screenings and regular mammography.

The research will consist of women who have previously applied to Erzurum Cancer Early Diagnosis, Screening and Education Center, had mammography taken, and whose phone records are available, whose appointment has been made since December 2022, and who meet the screening selection criteria. Women who have had a mammography appointment from KETEM and have not taken it yet, request their phone information. After the women were searched one by one to identify those who fit their characteristics and volunteers, they would leave the simple random experiment control elements. During the searches, all women will be invited to KETEM to have a mammogram again. The experimental group will send educational content through the WhatsApp application once a week, and will also answer questions and provide individual counseling. A total of 8 weeks of intervention will be implemented, the first 6 weeks of training will be provided with training presentations and the last 2 weeks of training video will be sent. Feedback will be received after the training presentations are followed through the WhatsApp application where they are read. The control group will not take any action and will be invited to KETEM for mammography. Pre-test and post-analysis phone access will be collected. At the end of the training, he will have the final examinations applied after 3 months. The number of women who participated in the study will be determined by examining the KETEM records of mammography.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 40-69,
* Be woman,
* Not having been diagnosed with breast cancer,
* Not to be pregnant, lactating or puerperal,
* Absence of a mental illness
* At least 2 years have passed since the last mammogram,
* Being able to use the WhatsApp application

Exclusion Criteria:

* Having had problems with breast cancer before,
* Having a mammogram at regular intervals,
* Having had breast-conserving surgery for any purpose.
Safety Study of AZD5672 in Renally Impaired Subjects

The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent.
* Females should not be of childbearing potential
* Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.

Exclusion Criteria:

* Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin \>20mg once daily, medications that prolong QT/QTc interval
* Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)
* Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases

The molecular mechanisms of action of photo(chemo)therapy in skin diseases are investigated in this study. The phototherapeutic modalities employed include UVB (ultraviolet B), UVA (ultraviolet A), PUVA (psoralen+UVA) and/or extracorporeal photochemotherapy (photopheresis). The study will address whether and how photo(chemo)therapy affects specific biologic pathways in different skin disorders and search for predictive biomarkers.

This study is performed in order to investigate the molecular mechanisms of action of photo(chemo)therapy in skin diseases, including psoriasis, cutaneous T-cell lymphoma, other lymphoproliferative disorders of the skin, eczema, lichen planus, prurigo/pruritus, polymorphic light eruption, mastocytosis, graft-versus-host disease, vitiligo and other photo(chemo)therapy-responsive diseases. Twenty patients will be enrolled per diagnosis group. The phototherapeutic modalities administered will be UVB, UVA, PUVA and/or extracorporeal photochemotherapy (photopheresis). The severity of disease and clinical response to treatment will be assessed with scores including dermatological quality of life (DLQI) and disease-specific scores such as PASI (psoriasis area and severity index), mSWAT (modified severity-weighted assessment tool), SCORAD (scoring atopic dermatitis), scleroderma score and/or different visual analog scale (VAS) scores for pruritus. The effect of treatment on a variety of laboratory endpoints will be investigated in blood samples and optionally also skin samples. Those endpoints include among others the regulation of cytokines/chemokines, immune function, clonality of immune cells, vitamin D, and serum lipids. The study will address whether and how photo(chemo)therapy affects specific biologic pathways in the different disorders and determine whether predictive biomarkers for therapeutic response exist.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Skin disorder to be treated with photo(chemo)therapy

Exclusion Criteria:

* Pregnancy and breastfeeding
* Poor general health status
Comparative Evaluation of Herbal and Allopathic Drugs for the Treatment of Chronic Diarrhea

Revival of significance and the emergent market of herbal medicinal products necessitate strong commitment by the stakeholders to safeguard the end users. The variability in the concentrations of constituents of plant material, coupled with the variety of extraction techniques and processing steps used by different manufacturers, results in distinct inconsistency in the quality of herbal products. The present study will be directed to a polyherbal formulation Entoban which integrates an outstanding blend of herbs that have been used for decades to eradicate microorganisms and worms from gastrointestinal tract. It is the combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus infectoria and Helicteres isora. The current study would target the chemical assessment, pharmacological and comparative clinical evaluation of Entoban to assure its safety and efficacy.

The study will be adopted to compare the efficacy, tolerability, and safety of Entoban using Metronidazole DS as a comparator. The study was carried out in XYZ hospital from Jan 2015 to Dec 2015. The participants will be selected on the basis of inclusion and exclusive criteria.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults between the age of 18-60 years who were suffering from diarrhea of presumed infectious origin and willing to participate were eligible for inclusion in the study.

Exclusion Criteria:

* Exclusion criteria were the presence of chronic
* Iatrogenic, or bloody diarrhea, having received antibiotic treatment for other medical or surgical problems
* Having a history of renal or hepatic dysfunction
* Having a concomitant infection.
* Patients receiving treatment with an anti-diarrheal drug in the five days prior to the study were also excluded.
* Pregnant or lactating women and women planning pregnancy were also ineligible for study participation.
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)

The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia.

Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic primary insomnia

The investigator will evaluate whether there are other reasons why a patient may not participate.
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)

The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.


Eligibility Criteria:
Inclusion Criteria:

* Apnea hypopnea index ≥ 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram
* Sleep efficiency reported on CPAP titration night PSG should be \> 78%
* Diagnosis of moderate to severe obstructive sleep apnea (AHI ≥15) or central/complex sleep apnea
* On stable CPAP or APAP \[Automatic Positive Airway Pressure\] therapy, with compliant use averaging 4 or more hours nightly
* Age 21-75 years
* Predominately central sleep apnea for up to 10 subjects only
* Willingness to give written informed consent and ability to adhere to visit schedule

Exclusion Criteria:

Diagnosis of mild sleep apnea

* CPAP naïve patients
* Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD \[Chronic Obstructive Pulmonary Disease\] or psychiatric illness
* Allergies to mask materials
* Evidence of another primary sleep disorder
* Evidence of arousing periodic limb movements during titration
* Contraindications as listed on product labeling
* Pregnant
* Currently diagnosed with depression if symptomatic
* Deemed medically unsuitable by investigator
* Evidence of any type of infection or treatment of an infectious condition during the period of research participation
* Have a bi-level requirement, or prescribed a bi-level therapy device
* CPAP pressure \>15cmH2O
* Subjects with tracheotomy
* Uncontrolled hypertension
* Require supplemental oxygen
* Stimulants, major tranquillizers or antipsychotics
* Restless Leg Syndrome or Periodic Leg Movement Index of \> 5 per hour
Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even though outcomes are good, they need lifelong follow-up because of a higher risk for cardiovascular diseases. Studies have shown that patients with CHD are not active enough and that a substantial amount of patients is overweight. Hence preventive strategies and education should not only focus on the heart problem, but also on a healthy lifestyle including physical activity. Recently a new guideline introduced exercise prescription based on the absence/presence of certain key elements. However, a number of important questions remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport' program for adults with CHD, based on this new guideline, will be investigated. This study is a randomized controlled trial that investigates the effects of the program on daily physical activity, exercise capacity, quality of life and exercise self-efficacy both in short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by using a new exercise-testing protocol that looks simultaneously to all body parts that are involved during exercise. Ultimately, our findings will result in the implementation of the guideline in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* adolescents and adults with congenital heart disease
* 16 to 65 years

Exclusion Criteria:

* congenital rhythm or conduction disorders
* isolated congenital coronary artery anomalies
* pregnancy
* being listed for heart transplantation
* inability to perform standard physical activities due to mental/physical disability.
Sitagliptin in Cystic Fibrosis-Related Diabetes

The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.

To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.

Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older
* Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy

Exclusion Criteria:

* Age under 19 years
* Use of basal insulin therapy
* Creatinine Clearance \< 50 mL/min
* Active cystic fibrosis exacerbation
* Pregnancy
* Women of child-bearing age not using effective contraception
* Current or prior use of DPPIV inhibitor