cyrilzakka/clinical-trials huggingface dataset:
EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.

Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes and it is responsible for the morbidity of both mother and child. The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).

We have three groups; the first group consisted of pregnant volunteers with GDM. The second group consisted of healthy pregnant participants. The third group consisted of healthy, non-pregnant women at the reproductive age. Macular, choroid and retinal nerve fiber layer (RNFL) thicknesses were evaluated in patients with GDM and comparisons were made among GDM, healthy pregnant and healthy non-pregnant subjects for these parameters by using optic cohorence tomography.

Eligibility Criteria:
Inclusion Criteria:

Singleton pregnancies Pregnancies between 26-28 weeks of gestation Gestational Diabetes

Exclusion Criteria:

* ocular surgery ocular trauma glaucoma cystoid macular edema macular degeneration optic atrophy
Effect of the Pigment-free Optical Zone Diameter of Decorative Tinted Soft Contact Lenses on Visual Function

Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters.


Eligibility Criteria:
Inclusion Criteria:

* normal subject
* aged above 20 years old

Exclusion Criteria:

* subject who had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease,
* patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.
Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection

Currently, paracetamol, ibuprofen and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of fever . The objective of the study is compare the efficacy of intravenous ibuprofen and paracetamol in the treatment of patients with upper respiratory tract infections presenting with fever in the emergency department

This is the randomized double blinded clinical trial to compare the efficacy of these two drugs in this clinical setting. A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital Study personnel (emergency physicians and emergency service nurses) were trained before the study. When intravenous drugs (Paracetamol and İbuprofen) was being recommended, an eligibility checklist was completed by the attending physician. patients who presented to the emergency department with upper respiratory tract infection and had a temperature above 38.0 ° C were measured by a fever gauge included into the study First Group: 1000 mg of paracetamol ( parol 10mg/ml solution Mefar, Turkey) intravenous (IV) was given 100 patients

Second Group:

Ibuprofen 400 mg ( intrafen 400mg/4ml solution -Gen ilaç san., Turkey) intravenous (IV) was given 100 patients which determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms). Patients in both groups received two types of medication in a similarmanner, thus ensuring double blind.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have fever for less than five days
* At least 1 upper respiratory tract infection (URTI) symptom according URTI questionare

Exclusion Criteria:

* Patients use anti-pyretic last 4 hours
* To be Pregnancy and breast-feeding Patients of childbearing age who are not using a birth control method
* Patients with an allergy trait (paracetamol and Ibuprofen) Illiterates
* Hemodynamically unstable patients
* Patients with renal transplantation
* Patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency
* Patients with non-controlled hypertension
* Patients with a history of cerebrovascular disease
* Patients with severe liver, kidney,pulmonary and cardiac heart failure
* Patients use antibiotics last 7 days
* Patients with Wolff-Parkinson-White syndrome or accompanying arrhythmias associated with conductive stimulus delivery in the heart
* Patients with vision problems
Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD

The aim of this study is to identify families with ADPKD , characterize the phenotype and screen for mutations in known genes (PKD1 and PKD2, and then HNF1b and UMOD in PKD1 PKD2 negative carriers).

Genome wide analysis will be performed in families without mutations identified.

* Inclusion of ADPKD patients in 20 different centers of Nephrology in the Western part of France
* Characterization of the Phenotype
* Collect DNA sample
* Analysis of PKD1 and PKD2 genes first
* Analysis of HNFIb and UMOD for PKD1 and PKD2 negative patients
* Recruitment of affected and non-affected relatives of PKD1 and PKD2 negative ADPKD patients
* Identify new genes involved in ADPKD using exome sequencing in PKD1 and PKD2 negative pedigrees

Eligibility Criteria:
Inclusion Criteria for the proband :

* Patients with a diagnosis of ADPKD
* Written Informed Consent
* Affiliated or benefiting from a national insurance

Inclusion Criteria of the relatives (affected or non affected) :

* Relatives with a diagnosis of ADPKD (ADPKD relatives)
* And Relatives over age 30 for whom the diagnosis of ADPKD has been discarded (non ADPKD relatives) with renal ultrasonography performed after age 30.
* Written Informed consent
* Affiliated or benefiting from a national insurance

Exclusion Criteria for the Probands:

* Subjects unable to provide written informed consent
* Previous Molecular analysis of PKD1 and PKD2 genes with identification of the pathogenic mutation

Exclusion criteria for the Relatives:

* Subjects unable to provide written informed consent
* Age under 30 for the "non-affected" relatives
Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

This multicenter, prospective cohort study will evaluate whether Robotic-Assisted total knee arthroplasty (RATKA) with a Medial Congruent implant is a successful method to improve implant alignment, insert thickness accuracy, and patient satisfaction, compared to a conventional TKA (cTKA) Medial Pivot technique. It aims to assess and compare clinical and functional outcomes in patients with severe knee osteoarthritis at 3, 6, and 12 months.

This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as \>2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.

Eligibility Criteria:
Inclusion Criteria:

Patients with severe osteoarthritis (greater than III Ahlback)

Exclusion Criteria:

Patients who refuse participation in the study Low-grade osteoarthritis
Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.

The aim of this observational pilot study is to determine whether intolerance of carotid occlusion during carotid artery stenting can be predicted with preprocedural transcranial Doppler evaluation.

Carotid artery stenting procedures are increasingly performed with devices that involve endovascular clamping of the common carotid artery, thus exposing the ipsilateral hemisphere to hypoperfusion. Approximately 5% of patients do not tolerate the clamp and are in increased risk of periprocedural cerebrovascular complication such as transient ischemic attack or stroke. To date, there is no method available that could be used to predict the risk of occlusion intolerance. The aim of this study is to determine whether preprocedural evaluation with transcranial Doppler ultrasonography can be effective in prediction of occlusion intolerance.

Eligibility Criteria:
Inclusion Criteria:

* Either \>50% symptomatic carotid artery stenosis (transient ischemic attack or ischemic stroke within 6 months before procedure) or \>70% asymptomatic carotid artery stenosis eligible for carotid artery stenting with proximal flow arrest protection
* Signed informed consent

Exclusion Criteria:

* Disagreement to be included in the study
* Inadequate acoustic window for transcranial Doppler ultrasound monitoring
* Carotid occlusion
* Significant extracranial artery stenosis (\>50%) other than target artery
* Inability to hold breath for sufficient time (approximately 30s)
Phase Angle and Mortality in Patients With Cirrhosis

A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

Malnutrition is a frequent complication of cirrhosis, and it has been associated with a more severe disease and decompensating events. Despite its relevance, there is no gold standard for nutritional assessment in cirrhosis, and intrinsic pathophysiologic changes make biochemical markers and traditional methods used to evaluate malnutrition unreliable. Phase angle (PhA) obtained from bioelectrical impedance has been successfully used as a nutritional marker in several diseases such as chronic renal failure, cancer, and HIV, where it has been associated with prolonged in-hospital stay and mortality. In cirrhosis, research linking malnutrition to increased mortality has yielded conflicting results, likely due to the lack of a gold standard. A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old ambulatory patients Diagnosis of liver cirrhosis

Exclusion Criteria:

* Acute or chronic liver failure heart failure hepatocellular carcinoma pregnancy acute infections
Sun Protection Factor Assay

To evaluate the Sun protection factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unbambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
Myomectomy During CS: A Retrospective Cohort Study

To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery

Exclusion Criteria:

* Antepartum hemorrhage
* Blood diseases or bleeding tendencies.
* Medical conditions complicating pregnancy.
* Performed another surgical procedure at CS other than myomectomy.
SITELINE 2 Polyurethane

The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.

This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol
* Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atrium and the right ventricle
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
* Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals
* A life expectancy of more than 180 days

Exclusion Criteria:

* Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
* Have surgically uncorrected primary valvular heart disease
* Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously)
* Requiring ICD therapy
* Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug
* Enrolled in any concurrent study, including drug investigation, without Guidant written approval, that may confound the results of this study
* Women who are pregnant or plan to become pregnant
Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response

This is a monocentric, randomized controlled, open-label, 2x2 cross-over study. The main objective of the study is to Evaluate the efficacy of Nestle YIYANG TangLv milk powder in lowering the Post Prandial Glucose Response (PPGR) of a high carbohydrate meal when consumed with the meal.

This is an acute, monocentric, open label, randomized, 2-arm, cross-over, clinical trial in 30 subjects of Chinese Han ethnicity. Subjects will receive the two different interventions in a randomized order. This study will assess the efficacy of the investigational product after a single consumption. Day before (V1 and V3) the intervention visits (V2 and V4) the subjects will be admitted at the investigational site for an overnight stay where they will consume a standardized dinner. V2 and V3 will be followed by a wash-out period of 3 days. The two arms are:

Arm 1: skimmed milk (control) Arm 2: Nestle YIYANG TangLv milk powder

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign written informed consent prior to trial entry
2. Deemed able to comply with study protocol for 2-3 weeks
3. Male or female aged 45-75 years (inclusive 45 and 75)
4. HbA1c test results \< 6.5% at Visit 1 (Admission 1)
5. Waist circumference ≤90 cm in males and ≤ 85 cm in females
6. Chinese Han ethnic group
7. BMI \>18.5 and \<28 kg/m2

Exclusion Criteria:

1. Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician (psychiatric illness, asthma or chronic lung disease requiring long term medications or oxygen, diabetes mellitus, chronic infective disease, including tuberculosis, hepatitis B and C, and HIV)
2. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments
3. Known food allergy in particular cow's milk protein allergy (CMPA), lactose and /or soy intolerance or known hypersensitivity/intolerance to any other ingredients in the study product
4. Known substance abuse or alcohol user exceeds following intake, alcohol intake \> 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer
5. Consumption of tobacco products, smoking or chewing tobacco
6. History of significant organ dysfunction or disease
7. Subjects with refractory hypertension, and patients with hypertension who are taking antihypertensive drugs (beta-blockers, thiazide diuretics, etc.) that may affect blood glucose metabolism
8. Females currently on hormonal therapy including post-menopausal hormone replacement therapy (PRT) or have been on PRT treatment in the past two months before study participation
9. Known autoimmune and/or genetic disease
10. Known chronic diarrhea or gastrointestinal discomfort
11. Known endocrine and metabolic diseases under drug treatment (e.g., pituitary tumors, thyrotoxicosis due to various causes, Cushing's syndrome etc.)
12. Subjects on systemic corticosteroids, glucocorticoids, or cyclosporine A
13. Recent blood donation (\<8 weeks)
14. Pregnant or lactating women
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
* Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening
* BMI \> 20.0 kg/m2 at the enrollment visit
* Males and Females, age ≥18 years old at time of screening visit
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
* Women must not be breastfeeding

Exclusion Criteria:

* Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus
* History of diabetic ketoacidosis
* Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit

  * Myocardial infarction
  * Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft \[(CABG)\]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty \[(PTCA)\])
  * Unstable angina
  * Unstable congestive heart failure (CHF)
  * Transient ischemic attack (TIA) or significant cerebrovascular disease
  * Unstable or previously undiagnosed arrhythmia
  * Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%
* Renal Disease
* Hepatic Diseases
* Hematological and Oncological Disease/Conditions
* Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women
* Abnormal Free T4
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 or Type 2 diabetes mellitus
* Meet the per protocol criteria of diabetic gastroparesis
* Compliance with diary
* Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

* Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
* Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)
* Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
* History of gastrointestinal disorders that may be similar to gastroparesis
* Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation

Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.


Eligibility Criteria:
Inclusion Criteria:

* core biopsy with diagnosis of breast cancer
* start of neo-adjuvant chemotherapy

Exclusion Criteria:

* magnetic resonance imaging incompatibility