cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of mμSORS for Non-invasive Blood Glucose Detection in Non-diabetic Subjects

This is a single-center, open-label, prospective study. Blood glucose is measured at different time points during oral glucose tolerance test and hypoglucose clamp test in healthy subjects, using both venous plasma and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS). Venous plasma glucose was set as gold standard. The two measurements were collected synchronously so as to calculate the mean absolute relative difference (MARD) and the consensus error grid (CEG). Accuracy of non-invasive blood glucose testing by mμSORS will be in-depth validated specifically in the 3-10 mmol/l glucose range.

In order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμSORS technology specifically in the 3-10 mmol/l glucose range, this study will conduct oral glucose tolerance tests and hypoglucose clamp tests on healthy subjects at different time points during the tests. In oral glucose tolerance tests, there will be 9 points as follows: 0-min and post glucose-load 30-min, 60-min, 90-min, 120-min, 150-min, 180-min, 210-min and 240-min. While in hypoglucose clamp tests, blood glucose will be set at around 3.0-4.0mmol/l for about 1.5-2.0 hours, blood glucose will be detected every 10 minutes.

Eligibility Criteria:
Inclusion Criteria :

* Male or female.
* Aged\>=18 years for OGTT participants or aged between 20 and 40 years for hypoglucose clamp tests participants.
* Fasting blood glucose (FPG) \< 6.1 mmol/L and glycated hemoglobin (HbA1c) \< 5.7% during the screening period.
* There are no scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
* Confirmed as healthy based on the results of physical examination, medical history, vital signs and clinical laboratory tests.
* Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.

Exclusion Criteria :

* With diabetes history.
* Any history of serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry or metabolic abnormality, or any other disease that can interfere with the test results, which the investigator considers significant.
* Alcohol dependency or drug abuse.
* Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial).
* Those who have used any drugs that affect blood glucose levels (such as insulin, oral hypoglycemic drugs, steroid hormones, thyroxine, etc.) within 28 days before screening;
* Pregnancy or lactation period.
* Difficulty in venous blood collection or fainting of needles or blood.
* Other circumstances that the investigator considers inappropriate to participate in the study.
RadConnect Communication Application

The aim is to evaluate the impact of an innovative asynchronous communication application on the number of calls from technologists to radiologists. Even though it is paramount that radiologists be accessible and available to other healthcare workers in the enterprise, frequent interruptions have negative impact on productivity and well-being. A novel communication app was developed that streamlines communication between technologists and radiologists: RadConnect.


Eligibility Criteria:
Inclusion Criteria:

* Individuals that are employed by LUMC
* Individuals that are radiologists, radiology fellows, radiology residents, radiology technologists, doctor assistants, physician assistants or other support personnel in the Department of Radiology that raise managing image acquisition related questions.
* Individuals that consent to participating in the study.
* Individuals scheduled to work at locations at Sending Extensions, Receiving Extensions and Control Extensions.

Exclusion Criteria:

* Individuals not able to understand or not willing to sign the informed consent form.
* Individuals that indicate that they do no comprehend RadConnect and/or its intended use after two educational sessions.
* Individuals not able to not willing to comply with the intended use of RadConnect.
Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women.

Randomized, prospective, monocentric, open-label comparative study with two parallel groups (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in reducing placental insufficiency during pregnancy in pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and
* Age ≤ 45 years and
* Single and confirmed pregnancy and
* Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) \< 3rd percentile and / or
* In utero fetal death (IUFD) history \> 12 weeks of amenorrhea (WA) and / or
* Central Retroplacental hematoma (RPH) history \< 34 WA and / or
* History of severe preeclampsia \< 34 WA and
* Informed consent, written and obtained

Exclusion Criteria:

* Age \<18 years or
* Age \> 45 years or
* Multiple pregnancy or
* Pregnancy \> 7 WA or
* Positive immunological assessment or
* Known history of Thromboembolic diseases, Hemorrhagic diseases, Systemic Lupus Erythematosus (SLE), Heparin-induced thrombocythemia (HIT), Suspicion of thrombophilia (burdened history) or an episode of Deep Vein Thrombosis (DVT) or
* Anticoagulation required or
* Thrombocythaemia \< 100,000 plq / µl or
* Weight \> 100 kg or
* Osteoporosis or
* Known allergy to the study products or
* Inability to ensure injections' administration or
* Family history of DVT before 40 years of age or
A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects

Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception.
* Is willing and able to comply with restrictions related to food, drink and medications.
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures.

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters.
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  * the safety or well-being of the participant or study staff.
  * the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); the analysis of results.
Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis

The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with between 20 and 80 years scheduled for aortic valve replacement alone or combined surgery including aortic valve replacement due to severe aortic valve stenosis

Exclusion Criteria:

* Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
* patients who are considering surgery for coronary artery disease or who have a stenosis\> 70%
* hemodynamically unstable patients undergoing emergency surgery or patients with intra-aortic balloon pump insertion
* patients unable to make their own decisions, illiterate, foreigners
* epilepsy
* severe metabolic acidosis
* pulmonary edema
* history of myocardial infarction
* elevation of total bilirubin or AST / ALT
* Patients higher than normal, weighing more than 80 kg
* with evidence of infection
* pregnant and lactating women
Procalcitonin and Threatened Premature Delivery

Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of AP in case of MAP.

The purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 year
* Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with a measurement of the crown-rump length
* hospitalization for preterm labor between 24 and 36 weeks of gestation
* Intact membranes,
* not opposed to participate in the study

Exclusion Criteria:

* Pregnancy uncertain term (no early ultrasound)
* Pregnancy combining a condition that can interfere with the assays performed,
* Uterine malformation known
* Multiple pregnancy,
* Premature rupture of membranes,
* Chrorio-amnionitis,
* Fetal malformation known
* Strapping
* GB\> 15000 and CRP\> 10 mg / L,
* No affiliation to a social security scheme.
* Woman with a measure of legal protection
Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography

the aim of this study is to assess the impact of duration of DM on OCTA parameters in diabetic patients without clinical Diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Age : Above 40 years old
2. Type of DM: Type 2.
3. Fundus examination: no macular edema or other signs of clinical retinopathy

Exclusion Criteria:

1. Age : below 40 years old
2. Ocular history : any history of significant ocular injury or disease that could affect the retinal microvasculature such as retinal vascular occlusion, glaucoma, or vitreo-macular disease, as such conditions have also been noted to show sub-clinical OCTA changes \[13, 14\].
3. Fundus examination: macular edema or any other signs of clinical retinopathy
A Correlative Study of Biomarkers of Resistance in Patients With Castrate Resistant Prostate Cancer Treated With Abiraterone

Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate treatment, particularly at the time of progression. Biomarkers may also help identify pathways to resistance of abiraterone acetate treatment. The most practical way of approaching this question is to explore surrogate biomarkers of prostate cancer including quantification of pharmacodynamic endocrine biomarkers.

Goals of this study include:

* Explore which circulating endocrine markers or endocrine related markers have the best potential to predict clinical response to abiraterone acetate in CRPC patients
* Explore the utility of microRNA, circulating DNA and exosome analyses in complementing the previous objective

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent. Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. If subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel
* Be suitable for receiving treatment with abiraterone acetate and prednisone
* Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Patients may not receive any other investigational agent or dose escalation of abiraterone acetate during study participation
* Patient consents to comply to treatment with abiraterone acetate as directed by their physician

Exclusion Criteria:

* Taking a dose of abiraterone acetate other than 1g daily or lack of compliance to daily dosing of abiraterone acetate and prednisone
* Patients receiving spironolactone or any other steroidogenic compounds in excess of the associated prednisone 5mg bid are excluded due to the potential for androgen receptor agonism
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)

The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed and maintained during 4 weeks.


Eligibility Criteria:
Inclusion criteria:

1. Male or female aged between 20 and 64 years old.
2. Patients diagnosed with partial seizure (including secondarily generalized seizure).
3. Patients who have at least 3 counts of partial seizures during the previous 4 weeks prior to observation start and no seizure-free for 21 days during 8 weeks before the treatment start based on medical records. Simple partial seizure without motor signs will not be counted.
4. Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.
5. Patients treated with stable doses of up to three AEDs. Only one cytochrome

   P450 (CYP) 3A4 inducer shown below will be allowed for concomitant use:
   * Carbamazepine
   * Phenytoin
   * Phenobarbital
   * Primidone
6. Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.

Exclusion criteria:

1. Patients with present or a history of Lennox-Gastaut syndrome.
2. Patients with present generalized seizures (e.g., absence, myoclonic).
3. Patients with a history of status epilepticus within 1 year.
4. Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.
5. Patients with a history of psychogenic seizure.
6. Patients who underwent surgical operation for epilepsy within 2 years.
7. Patients using rescue benzodiazepines at least twice in a 4-week duration within 8 weeks (if 1 or 2 doses over 24-hour period considered one-time rescue).
8. Patients whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at enrollment in observation period exceeds 1.5-fold the upper limit of normal (ULN), but those whose ALT or AST are constantly higher than ULN, they can enroll if ALT or AST remain in 3-fold the ULN.
9. Patients with significant active hematological disease; white blood cell (WBC) count \</=2500/uL or neutrophil count \</=1000 uL.
10. Patients on anti-psychotics or who have psychotic disorder and/or psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of suicidal attempt within 2 years.
11. Patients who operate heavy equipment or drive should not be recruited into the study.
Temporomandibular Joint Eminence Augmentation Using Titanium Ring Inlay: A New Surgical Technique

To evaluate the efficacy of titanium ring inlay in ESS technique in Temporomandibular joint eminence augmentation

Background:Temporomandibular joint (TMJ) disorders affect approximately 5-12% of the population, with eminence augmentation being a challenging surgical intervention. Current techniques using autogenous grafts or alloplastic materials present limitations including donor site morbidity, resorption, and implant failure. This study evaluates a novel titanium ring inlay technique for TMJ eminence augmentation, which may offer improved stability, osseointegration, and functional outcomes.

Patients and Methods: A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee, Faculty of Dentistry, Sinai University OMS 01-04-024; . Titanium ring inlay procedure was performed to Temporomandibular joint eminence augmentation. Preoperative and postoperative assessments included pain levels (VAS pain), maximum mouth opening (MMO), Clicking during mouth opening, Headach presence, tinnitus and subjective patient feedback.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed TMJ dysfunction requiring eminence augmentation
* Failed conservative management (≥3 months)
* Adequate bone stock for inlay placement
* Willingness to comply with follow-up protocol

Exclusion Criteria:

* Systemic conditions contraindicating surgery
* Active TMJ infection
* Previous TMJ surgery
* Pregnancy
* Neuromuscular disorders-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants

This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are age 12 to \<18 years at the time of randomization
* Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)
* International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
* Significant proteinuria defined by a UPCR above \> 0.5 based on a first-morning void (FMV) collection at screening
* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.

Exclusion Criteria:

* Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
* Sclerosis in \>50% of glomeruli on renal biopsy
* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
* Presence of rapidly progressive glomerulonephritis
* Pure Class V LN
* Intolerance or contraindication to study therapies
* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization
* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders
* History of serious recurrent or chronic infection
* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years
* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation
* Currently active alcohol or drug abuse or history of alcohol or drug abuse
Dolastatin 10 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Hormone Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.

OBJECTIVES: I. Determine the objective response rate in patients with hormone refractory prostate cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Hormone refractory metastatic prostate cancer (stage D1 or D2) with no greater than 3 prior endocrine manipulations PSA level increased on 3 consecutive measurements at least 2 weeks apart PSA at least 10 ng/mL (not required if measurable disease)

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Hemoglobin at least 8 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: No other serious medical illness No serious infection No other prior malignancy within the past 5 years except nonmelanoma skin cancer or any in situ carcinoma

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Concurrent LHRH-agonist therapy allowed without antiandrogens At least 4 weeks since prior flutamide and nilutamide At least 6 weeks since prior bicalutamide At least 4 weeks since other prior hormone therapy including steroids Radiotherapy: At least 4 weeks since prior radiation therapy and recovered No prior strontium Surgery: Recovered from prior surgery
Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

Endoscopic thyroidectomy has been used to treat thyroid diseases in China. However, whether this technique is rational to treat thyroid carcinoma is still in controversy. The diagnosis of thyroid carcinoma is predominantly made according to intra-operative frozen section pathological examination in China. In this research, the investigators want to compare clinical index (blood loss, operation duration, number of lymph nodes dissected, complication rates, etc) between patients underwent endoscopic thyroidectomy ( total thyroidectomy) and those underwent conversion to open procedure. The investigators want to evaluate the technical feasibility of endoscopic thyroidectomy for treating thyroid carcinoma.

intra-operative diagnosis of thyroid carcinoma is usually considered the indication of conversion to open surgery. with accumulation of experience of endoscopic thyroidectomy, the investigators want to evaluate the technical feasibility, completeness and safety of endoscopic thyroidectomy.

Eligibility Criteria:
Inclusion Criteria:

* lesion diameter less than 1 cm by ultrasound

Exclusion Criteria:

* frozen section diagnosis indicates benign lesion