cyrilzakka/clinical-trials huggingface dataset:
Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes

To study antihypertensive efficacy of 12 weeks of Losartan based therapy Resilo (Losartan) and Resilo-H (Losartan+ Hydrochlorothiazide) in uncontrolled hypertensive and diabetic hypertensive patients.

200 hundred Subjects will be treated with a dose escalation regimen to achieve a target blood pressure. Subjects with mild hypertension at baseline will be started with losartan 50 mgs and those with severe hypertension will be started with losartan H 100/25. After 6 weeks they will titrated if goal blood pressure not achieved. For Mild hypertensive group this will be with losartan H 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime. Subjects with mild hypertension and diabetes at baseline will be started with losartan H 50/12.5 mg and those with severe hypertension with diabetes will be started with losartan H 100/25. After 6 weeks they will be titrated if goal blood pressure not achieved. For Mild hypertensive-diabetic group this will be with Resilo H 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime.

Target Blood Pressure is systolic \< 140 mmhg and diastolic \< 90 mmHg if age \< 60 years and systolic \< 150 mmHg and diastolic \< 90 mmHg if age \>60 years.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign Informed Consent Form.
* Patients of either sex above 18 years of age.
* Patients not previously diagnosed with hypertension and with sitting blood pressure \> 140/90 mmHg on two readings 15 minutes apart.
* Newly diagnosed hypertensive patients.
* Hypertensive patients on other antihypertensive therapies but not at goal
* Diabetes defined as patient on insulin therapy or oral diabetic therapy or fasting blood glucose on screening \> 7 mmol/L

Exclusion Criteria:

* Patients with history of allergic reaction to any angiotensin II antagonist or a thiazide diuretic
* Patients with history suggestive secondary hypertension
* Patients who have taken Resilo or Resilo-H or other losartan based treatment in past three months of study inclusion.
* Patients with chronic renal failure or who on screening has serum creatinine \>150 µmol/L
* Patients who is participating concurrently in another clinical trial.
Non-significant Risk Study of a Cochlear Implant Headpiece

This study aims to evaluate a cochlear implant headpiece.

The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.

Eligibility Criteria:
Inclusion Criteria:

* Pre- or post-lingually deafened.
* Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.
* Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.
* Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study
* Be able to remove their own headpiece
* Have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study
* Capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent

Exclusion Criteria:

* Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.
Turkish Version of Modified Child Dental Anxiety Scale

Background: The faces version of the Modified Child Dental Anxiety Scale (MCDASf) is less time consuming and an easy to understand tool for measuring dental anxiety. The aim of this study was to develop the Turkish version of MCDASf and to analyze its validity and reliability.

The internal consistency reliability was determined by calculating Cronbach's alpha (n=300). Intraclass correlation coefficients (ICCs) were calculated for test-retest reliability (n=67). Construct validity was determined by comparing with the Venham Picture Test (VPT). The factor structure was examined using exploratory factor analysis (EFA). Confirmatory factor analysis (CFA) was used for the dimensionality. The cut-off points of the Turkish version of MCDASf were plotted using a receiver operating characteristic (ROC) curve.

Eligibility Criteria:
Inclusion Criteria:

* aged between 6-12 years, intellectual sufficiency to complete the questionnaire, and voluntariness to take part in the study. Also, only children whose parents were willing to participate were included

Exclusion Criteria:

* Children who had mental or physical disorders, cooperation problems or dental pain were excluded from the study.
Trigeminal Evoked Responses to Improve Rhizotomy

Trigeminal neuralgia (TGN) is a debilitating pain syndrome where electrical, shock- like jolts of pain affect the face. Trigeminal somatosensory evoked potentials (TSEPs) provide a promising modality for measuring the trigeminal sensory and nociceptive pathway by using peripheral stimulation of the trigeminal nerve (on the skin) and measuring low latency evoked potentials on the scalp (contralateral sensory cortex). While TSEPs have been measured in the past, it is not clear if implementing TSEPs into a routine neurosurgical rhizotomy procedure will be feasible. This is a prospective cohort study examining the feasibility of routinely performing TSEPs during rhizotomies for TGN.


Eligibility Criteria:
Inclusion Criteria:

* Adults of 18 years or older
* Scheduled to undergo percutaneous rhizotomy for facial pain

Exclusion Criteria:

* For TGN: Facial pain of unclear origin (i.e. not clearly TGN pain) or Rhizotomy procedure canceled
* For Healthy control: Diagnosis or history of facial pain such as TMD or TGN, History of migraine, History of any functional pain disorder: fibromyalgia, IBS, CRPS or Recent chronic pain (within last month)
Frequency and Risk Factors of Acute Myeloid Leukemia

1. to assess the frequency of acute myeloid leukemia at clinical Haematology unit of Assiute university hospital
2. to study correlations of known risk factors and if there are new risk factors participate in increasing frequency of acute myeloid leukemia

Acute myeloid leukaemia (AML) is a rare heterogeneous disease comprising a group of hematopoietic neoplasms originating from the excessive clonal proliferation of myeloid pre- cursor cells \[1\]. Diagnosis of AML is based on morphological diagnosis with proliferation of blast cells ≥ 20% of bone marrow cells, flow cytometric analysis and cytogenetic abnormalities, including the t(8;21)(q22;q22), t(15;17) (q22;q12) and inv (16)(p13.1;q22) which are associated with longer remission and survival, while alterations of chromosomes 5, 7, complex karyotype and 11q23 are associated with poor response to therapy and shorter overall survival \[2\] The etiological agent and pathogenesis of AML are not entirely clear, only few AML cases can be accurately classified through traditional cellular morphological classification \[3\]It is the most common acute leukaemia in adults. It accounts for 1.3% of new cancer patients in the United States, in 2018\[ 4\] Some factors are well documented to increase the risk of some types of leukemia such as benzene exposure and ionizing radiation \[5\] increased frequency of acute myeloid leukemia has been noticed at Haematology unit so the aim of the study to assess the the frequency of acute myeloid leukemia and to evaluate the risk factors for it .

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria

Exclusion Criteria:

* Patients with other types of leukemia
A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography

To evaluate the safety and performance of an innovative artificial intelligence based Computer-Aided Diagnosis(CAD) system for diabetic retinography, Retinal images of patients with diabetes mellitus or diabetic retinopathy(DR) were collected retrospectively. All images were graded by a retinal specialists expert panel and the CAD device using the International Clinical Diabetic Retinopathy severity scale criteria. Investigator responsible for DR grading by CAD system is blinded to the DR grading results from the expert panel. Finally, DR grading results of the CAD system and experts were compared using sensitivity and specificity.

1. Retinal images were collected retrospectively according to the following inclusion/exclusion criterion:

   Inclusion Criterion:

   Clinical history of diabetes mellitus or diabetic retinopathy; Fully Gradable Images; around 45° field which covers optic disc and macula; complete patient identification information;

   Exclusion Criterion:

   incomplete patient identification information;
2. DR grading by expert panel At first, retinal images are graded by three experts independently, then they met for a consensus meeting to discuss cases without initial agreement. If they can't achieve consensus, a final decision is made by the principal investigator. Experts give a grading of both DR and Diabetic Macular Edema (DME) for each image according to the International Clinical Diabetic Retinopathy severity scale criteria and hard exudates around optic disc.
3. Blinding and DR grading by CAD system Before DR grading by CAD system, a randomized identification(ID) is assigned to each retinal image, which ensures that investigator responsible for CAD system operation is masked to the expert panel grading result. Both DR and DME grading is generated by the CAD system and the results are exported.
4. Unblinding Finally, all data are unblinded and results of the CAD system are compared to the results of human grading, which is considered the gold standard, using measures as sensitivity and specificity;

Eligibility Criteria:
Inclusion Criteria:

* Clinical history of diabetes mellitus or diabetic retinopathy;
* Fully Gradable Images;
* around 45° field which covers optic disc and macula;
* complete patient identification information;

Exclusion Criteria:

* incomplete patient identification information
Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea

The purpose of this study is to investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. The effect is evaluated on blood pressure levels, particularly nocturnal blood pressure, both central and peripheral, and renal function, including the kidneys treatment of salt and water.

Hypothesis:

1. Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during the day more accurately than peripheral 24-h blood pressure measuring because the measurement is painless and does not interfere with the patient activities during the daytime or nighttime sleep.
2. Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
3. The renal tubular function relating to the treatment of water and sodium is abnormal in patients with OSA with increased tubular absorption of water via the U-aquaporin 2 (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during treatment with CPAP.

4 Quality of life is improved during treatment with CPAP.

Approximately 30 patients with chronic kidney disease and obstructive sleep apnea in moderate to severe degree is examined with central and peripheral 24-h blood pressure monitoring, 1 night home polygraphy to determine the degree of sleep apnea, blood and urine samples to determine levels of u-AQP2, u-ENAC, plasma renin concentration (PRC), s-angiotensin II (p-angII), p-aldosterone, p-vasopressin (p-avp) and p-endothelin, before the start treatment with CPAP for sleep apnea.

After 3 month of treatment all the above described is repeated to determine effects of CPAP treatment on blood pressure levels during the day, changes i apnea hypopnea index (AHI) and the kidneys treatment of salt and water.

Eligibility Criteria:
Inclusion Criteria:

* renal insufficiency (CKD stage III + IV), estimated glomerular filtration rate (eGFR) 15-59 ml/min/1.73 m2
* Obstructive sleep apnea, AHI\> 15 (moderate to severe)
* both men and women
* 18-80 years

Exclusion Criteria:

* lack of desire to participate
* malignant disease
* Abuse of drugs or alcohol
* pregnant and lactating
* incompensated heart failure
* atrial fibrillation
* liver disease (alanine aminotransferase\> 200)
* Severe chronic obstructive lung disease (Forced expiratory volume in 1 second \<50% predicted)
Intralipid Versus SMOFlipid in HPN Patients

This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.

Primary aim is to assess the impact to direct bilirubin.

Secondary aims will be to assess impact to other liver function studies, metabolic parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.

Eligibility Criteria:
Inclusion Criteria:

* Newly initiated Mayo Clinic HPN patient
* Able to provide informed consent
* Anticipated duration of HPN greater than 3 months,
* Infusion company is able to provide Smoflipid

Exclusion Criteria:

* Age less than 18 years
* Pregnant and lactating women
* Failure to provide consent
* Patients with underlying liver dysfunction (defined as liver function studies equal to or more than 2 times upper limit of normal) or pathology as determined by primary investigator
* Patients with active malignancy
* Patients who are deemed to be on HPN for less than three months
* Patients who have previous proven addiction and dependence to alcohol/ heavy alcohol AND consumption/active use reported during last 12 months.
* Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients in Smoflipid
* Patients who will not be managed by the Mayo Clinic HPN team
* Patients who have active infection (as determined by the clinician) at the time of enrollment.
* Patients who have received Smoflipid greater than 4 weeks in the last 12 months prior to enrollment.
* Patients who have been on TPN greater than 4 weeks in the last 12 months prior to enrollment.
* Enrolled in another interventional study.
* Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides more than 1,000 mg/dL.
A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist

The purpose of the study is to assess safety and tolerability of prostacyclin receptor agonist formulation in treatment period 1 and with different formulation of prostacyclin receptor agonist in treatment period 2.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise, healthy as deemed by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECG) performed at Screening and Day -1 of oral treatment period
* Otherwise, healthy medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter square (kg/m\^2) (inclusive) and body weight not less than 50 kilograms (kg) at screening
* All female participants must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

Exclusion Criteria:

* Known allergies, hypersensitivity, anaphylaxis, or intolerance to prostacyclin receptor agonist or drugs of the same class, or any excipient (including poloxamer and polysorbate) of the drug formulation(s)
* Clinically significant abnormal physical examination, vital signs, or 12-lead ECG (QTc greater than or equal to \[\>=\]450 milliseconds \[msec\] for men and \>=460 msec for women. QT corrected according to Bazett's formula \[QTcB\]) as assessed by the Investigator at Screening or Day -1 of oral treatment period
* History of malignancy within 3 years before screening (exceptions are squamous and basal cell carcinomas of the skin
* Positive serologic testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (hBsAg), hepatitis C virus (HCV), active coronavirus disease 2019 (COVID-19) infection
* A history of repeated (more than once over the last 30 days) fainting due to cardiac cause, collapse, syncope, orthostatic hypotension, or vasovagal reactions
Chemotherapy of NSCLC With or Without Icotinib

Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing completely resection of EGRF mutation-positive NSCLC
* Staging ⅠB (with high risk factor) to ⅢA
* PS = 0 or 1
* Adequate hematological, biochemical and organ functions

Exclusion Criteria:

* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating
Pilot Study of Human Tear Proteins

The significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film from diseased and non-diseased patients. This pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* able to cooperate with tear sample collection
* provide written informed consent

Exclusion Criteria:

* special populations (children, pregnant or lactating females, prisoners, etc)
* refusal to sign sudy consent
Study Using Citrate to Replace Heparin in Babies Requiring Extracorporeal Membrane Oxygenation (ECMO)

The purpose of this study is to determine the safety and efficacy of citrate to provide anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of providing ECMO circuit anticoagulation is the use of heparin which also anticoagulates the patient and increases the risk of patient bleeding.

Extracorporeal membrane oxygenation (ECMO) is a form of extended heart/lung bypass support that has been used to treat more than 650 patients over 20 years at Vanderbilt. Over 29,000 patients have been treated worldwide. Bleeding is the most common complication during ECMO because of systemic anticoagulation with heparin. It is most commonly seen in patients following surgery either preceding or while on ECMO support. Regional citrate anticoagulation for hemodialysis was first introduced in 1961. It is the ideal alternative to heparin in patients who are at increased risk for bleeding. It permits effective anticoagulation across the extracorporeal circuit without impacting the patient's systemic coagulation. Citrate functions by binding free calcium, thereby inhibiting coagulation in both the intrinsic and extrinsic coagulation pathways. The purpose of this study is to evaluate the use of citrate as a regional anticoagulant in the ECMO circuit in high risk infants less than one year of age.

Eligibility Criteria:
Inclusion Criteria:

* Infant less than one year of age and less than 6 kg
* Informed consent obtained from parent
* One or more of the following diagnoses:
* Post-op congenital heart surgery
* Congenital diaphragmatic hernia
* Sepsis with coagulopathy not corrected prior to ECMO
* Other newborn diagnosis with Grade I or II IVH
* Infant requires/is on ECMO

Exclusion Criteria:

* Consent denied or unobtainable
* Age greater than one year
* Weight greater than 6 kg
* Gestational age less than 34 weeks
CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage

Ovarian stimulation for the induction of multifollicular growth by gonadotrophins represents an important part of In Vitro Fertilization (IVF). However, the use of these drugs can be associated with side effects, from which the most common is the Ovarian Hyperstimulation Syndrome (OHSS). Stimulation with gonadotrophins in a Gonadotropin-releasing hormone (GnRH) antagonist cycle rather than a GnRH agonist cycle reduces significantly the risk of OHSS. During stimulation, the best predictor of severe OHSS is the number of follicles \>10mm on the day of triggering final oocyte maturation, with the threshold at ≥16 follicles. When this occurs, final oocyte maturation can be induced with a GnRH agonist, reducing further the risk the syndrome. To perform a fresh embryo transfer, 1500 IU human Chorionic Gonadotropin (hCG) can be administered on the day of oocyte retrieval for the luteal support. However, with this procedure there are still some cases of OHSS. To overcome this, it is suggested to combine GnRH agonist triggering with a freeze-all embryos strategy and perform embryo replacement in subsequent frozen-thawed embryo transfer (FET) cycles. Different cryopreservation strategies are been performed according to the procedure of each fertility center, such as cryopreservation at 2 pronuclear (2PN), cleavage or blastocyst stage. The aim of this study is to determine the optimal strategy for the freeze-all cycles and particularly the optimal day for freezing, thawing and transferring the embryos. The hypothesis is that there will increased cumulative live birth rates per started cycle in blastocyst compared to cleavage stage FET cycles.


Eligibility Criteria:
Inclusion Criteria:

* Patients \<40 years old
* Indication for In Vitro Fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI)
* No more than 2 previous failed IVF/ICSI cycles
* Stimulation in GnRH antagonist cycle
* Presence of ≥16 follicles of \>10mm on the day of triggering of final oocyte maturation
* GnRH agonist trigger (triptorelin 0.2mg)

Exclusion Criteria:

* Cycles with testicular sperm extraction
* Preimplantation genetic diagnosis
* Patients with uterine malformations
* Patients with infectious diseases