cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Serum Pentraxin 3 and High Sensitive CRP in Female Patients With Gestational Diabetes Mellitus in Second Trimester of Pregnancy

1. To assess the value of serum Pentraxin-3 and high sensitive CRP in females with normal pregnancy and females with gestational diabetes mellitus in second trimester of pregnancy.
2. To study correlations between serum Pentraxin-3 and High sensitive CRP in gestational diabetes.

Gestational diabetes mellitus (GDM) refers to abnormal glucose metabolism that occurs or is discovered during pregnancy, it can cause multiple poor outcomes and increase maternal and child prevalence and mortality.

GDM can increase the risk of type 2 diabetes mellitus (T2DM) and cardiovascular diseases in pregnant women, and the risk of metabolic disorders in their offspring is high, so it's called a disease that affects two generations.(1) The relationship between maternal hyperglycemia and fetal macrosomia together with other complications has been confirmed.(2) Women with GDM have a higher long-term risk of type 2 diabetes mellitus.(3) Pentraxin 3 (PTX3) and high sensitive CRP are both the acute phase proteins belonging to the pentraxin family but with different biological characteristics, CRP belongs to the short PTX, which is an acute phase protein synthesized by the hepatocytes when the body is stimulated by microbial invasion or tissue damage.(4) PTX3 is a long-chain PTX protein. A variety of tissue cells can produce PTX3 under the stimulation of pro-inflammatory factors, including the endothelial cells, fibroblasts, monocytes, adipocytes, etc.(5,6) There is one study(Changes of serum pentraxin-3 and hypersensitive CRP levels during pregnancy and their relationship with gestational diabetes mellitus , 2019) , that has come to PTX3 and hs-CRP may be related to the pathogenesis of GDM, and they are significantly increased in the second trimester, which provides a new idea for early prevention and treatment of GDM .

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women.
2. Diagnosed GDM. 3Gestational age \>20weeks

Exclusion Criteria:

1. Women with pregestational diabetes .
2. Women with chronic diseases.
3. Twin pregnancy.
Clinical Evaluation of the STANDARD™ Q Malaria/CRP Duo Test

The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available C-Reactive Protein (CRP) test kit run on a laboratory machine as a reference test for CRP.


Eligibility Criteria:
Inclusion Criteria:

* clinically suspected malaria on the basis of fever or history of fever in the previous 72 h
* age ≥ 5 years, (iii) having been informed of the study and signed a written consent form

Exclusion Criteria:

* signs of severe malaria or other severe disease
* patients not fulfilling the inclusion criteria.
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC

The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.

ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no regimen has been proved to be more effective while less toxicity than ECF regimen. Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical setting in advanced colorectal cancer. It presents a better toxicity profile than cisplatin. Recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion 5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response rates and median overall survival times while resulting in lower rates of grade 3-4 adverse events. Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin and a short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate whether the EOF5 regimen is less toxicity while is comparable effective as ECF regimen.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG performance scale ≤2
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Adequate hepatic, renal, heart, and hematologic functions (platelets \>80×109/L, neutrophil\>2.0×109/L, serum creatinine ≤1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
* Uncontrolled significant comorbid conditions and previous radiotherapy
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized. The usefulness of this therapy in the outpatient setting is unproven. This pilot study will test the feasibility of using this therapy in the outpatient setting and its effects on sleep.

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure. HNHF-O2 may be beneficial in patients with COPD and chronic impairments in gas exchange, both hypoxemia as well as hypercapnia. HNHF-O2 may decrease work of breathing, reduce dyspnea, improve airway humidification, and potentially stabilize or reduce carbon dioxide levels. However, there is limited data showing the chronic effects of HNHF-O2 in patients with hypercapnic respiratory failure, specifically those discharged to home following hospitalization for an acute exacerbation. Data that demonstrates that HNHF-O2 is well tolerated, and stabilizes or improves gas exchange long term in patients with COPD is lacking. Similarly, data that demonstrates that this therapeutic regimen is feasible to provide to patients in the home environment are lacking. This is an open-labeled pilot study of thirty patients to determine the safety and feasibility of using the device in the outpatient management of patients with COPD. A subset of ten patients will have serial sleep studies to determine the effects, if any, on sleep.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the hospital for an acute exacerbation of COPD within the past 12 weeks
* have COPD as the primary diagnosis
* have smoked \> 10 pack years.
* receiving supplemental oxygen as part of their usual clinical care.
* willing to give informed consent

Exclusion Criteria:

* upper airway or nasal problems that prohibit the use of high flow oxygen
* current use (≤ 4 weeks of study entry) of any PAP-therapy (e.g., CPAP or NPPV)
* sleep apnea as follows: STOPBang scores ≥ 5 or STOPBang score ≥ 2 plus BMI \> 35 kg/m2; or Berlin questionnaire scores suggesting high likelihood of sleep apnea with increased risk of sleep-related accident (e.g., occupation as a commercial driver or pilot);
* excessive daytime sleepiness (i.e., either of High (\>15) score on the Epworth Sleepiness Scale or "fall asleep" accident or "near miss" accident in prior 12 months).
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.

The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 20 and 80 years
2. Patients with a diagnosis of restless legs syndrome (RLS) according to the following diagnosis criteria of National institute of health (NIH)/International restless legs syndrome study group (IRLSSG):

   1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
   2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
   3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
   4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
3. Patients with a total score larger than 15 on the IRLS at Visit 2

Exclusion Criteria:

1. Premenopausal women who meet any of the following 1) to 3) 1) Patients who are pregnant or possibly pregnant 2) Patients who are lactating 3) Patients who wish to become pregnant during the study period
2. Patients who cannot take adequate contraceptive measures
3. Patients with a history of akathisia induced by neuroleptics
4. Patients with diabetes mellitus requiring insulin therapy
5. Patients who are judged to have microcytic anaemia by the investigator or sub-investigator
6. Patients with a history or signs of peripheral neuropathy, myelopathy, multiple sclerosis, Parkinson's disease or other neurological diseases that may result in the occurrence of secondary RLS in the physical function tests or neurological tests
7. Patients with other sleep disorders such as abnormal behaviour during Rapid eye movement (REM) sleep, narcolepsy and sleep apnoea syndrome (patients with an apnoea-hypopnoea index (AHI) exceeding 15 determined by polysomnography at the relevant trial site or those with loud snoring at least 5 nights/week and an experience of respiratory arrest during sleep or excessive daytime sleepiness)
A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

Cohort study according to national regulatory guidelines: Non-interventional, observational cohort study. Pair-matched comparison with patients chosen from historical series.

To evaluate the clinical and technical success as well as the safety and feasibility of the E-XL aortic stent used in complicated type B aortic dissection in addition to a classic stentgraft in a single procedure.


Eligibility Criteria:
The clinical records of the patients mus support the following criteria:

* Age \> 18 years
* Type B dissection with expanding false lumen eligible for endovascular treatment which occured within 90 days prior to implantation
* The endovascular treatment may be associated with a complementary surgical operation
* The total diameter of the dissected aortic segment should not surpass 6cm, and have increased between 0.5 and 1cm within 1 month, prior to implantation
* Visceral arteries involvement, i.e. perfusion of side branches via true or false lumen of type B dissection
* Aortic kinking \< 90°
* The patient must be available for the appropriate follow-up times for the duration of the study
* Informed consent from patient or authorized relative

The data of whose patients clinical records confirm one of the following conditions will not be considered in this study:

* Patients with a contraindication as indicated in the instruction for use
* Patients with chronic thrombocytopenia or ongoing anticoagulation
* Patients with renal failure and/or creatinine \>2.4mg/dl immediately before the intervention
* Patients in whom the false lumen is completely thrombosed
* Patients with ongoing infection
* Patients with ongoing cancer
* Patients who are enrolled in a clinical study
* Aortic landing zone diameter over 40 mm
* Potentially emboligenic iliac and aortic atheroma lesions
* Associated pathology with life expectancy of less than 24 months
* Unstable infectious syndrome
High Resolution Manometry for Swallowing

This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.

The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Healthy Volunteer
* No clinical evidence of dysphagia

Exclusion Criteria:

* History of prior dysphagia
* Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus)
* Known gastrointestinal malignancy
* Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers)
* Previous esophageal or gastric surgery
* Significant cardiac or respiratory disease
* Pregnancy (a pregnancy test will be performed in women of child-bearing potential)
The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer

Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically.

The idea of using single cone obturation is not novel historically, silver points were used in conjunction with various sealers. It has the advantages of being simple, is easy to learn, quick and does not require any complicated armamentarium or devices. Furthermore, unlike lateral or vertical compaction no force is used, therefore minimizing the risks of dentinal cracks. Recently single cone obturation in combination with bioceramic sealers has been advocated as an alternative obturation technique and is rapidly gaining popularity among dentists. Some studies have demonstrated that the amount of the overall porosity of the single cone fillings is comparable to other techniques.

Eligibility Criteria:
Inclusion Criteria:

patients with symptoms of irreversible pulpitis without apical periodontitis related to the maxillary first premolar ranging from 20 to 40 years old and with separate roots were selected from patients referred to the diagnosis clinic, Faculty of dental medicine Al-Azhar University, Cairo, Boys branch.

Exclusion Criteria:

1. Patients with any systemic disorders.
2. Pregnancy.
3. teeth with positive response to palpation test
4. Non vital teeth.
5. Teeth with positive response to percussion test.
6. Teeth with mobility of grade II or III.
7. teeth with probing depth more than 3 mm.
8. Teeth with abnormal morphology.
9. Teeth with root curvatures more than 20 degree (according to Schneider's method).
10. Teeth with internal or external root resorption.
11. Teeth with vertical root fracture.
12. Teeth with open apices.
13. Teeth with any root canal type other than type I.
14. Patients with (VDS) test with score 4 or less. 15- teeth with fused roots or single root.
Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (not of childbearing potential) participants as determined by medical and surgical history and assessments
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
* Normal kidney function at screening

Exclusion Criteria:

* History of chronic headaches (eg, migraines, cluster headaches), defined as occurring 15 days or more a month, over the previous 3 months
* History of headaches related to caffeine withdrawal, including energy drinks
* History of syncope, orthostatic instability, or recurrent dizziness

Other protocol defined inclusion and exclusion criteria could apply
DANHEART (H-HeFT and Met-HeFT)

The present study is testing in a combined design to types of drugs in patients with chronic heart failure: 1) Hydralazine in combination with isosorbide dinitrate (BiDil) and 2) Metformin hydrochloride. The study is double blind, placebo controlled.

1. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure.
2. The second hypothesis is that treatment of underlying insulin resistance/ type 2 diabetes with metformin in heart failure patients with moderately to severely reduced LVEF can reduce mortality and cardiovascular hospitalizations. Among secondary endpoints are reduction in new-onset diabetes in heart failure patients with insulin resistance and diabetes risk profile and patient safety.


Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria for both H-HeFT and Met-HeFT

* Patients with chronic heart failure
* NYHA-class II, III or IV
* LVEF \</= 40% within 12 months prior to screening. The echocardiography should (i) be performed after uptitration in heart failure medication and (ii) LVEF from the most recently performed echocardiographic study should be used and (iii) LVEF must not be measured during rapid atrial fibrillation, i.e. heart rate \>110/min) and (iiii) the echocardiography should be performed at least 3 months after CRT-implantation.
* Patients should be uptitrated to recommended or maximally tolerated dose of ACE-I/ARB/ARNI (unless contraindicated) and beta-blocker (unless contraindicated). If indicated, an aldosterone receptor antagonist should be given (unless contraindicated).
* A CRT device should be implanted, if indicated and accepted by the patient and patients with a CRT device should be treated for \> 3 months.
* Implantation of an ICD unit should be planned or already done, if indicated and accepted by the patient. The patient can be included in the study before a planned ICD implantation has been performed.
* Informed consent

Specific inclusion criteria for only H-HeFT:

* Systolic blood pressure ≥100 mmHg
* NT-proBNP \> 350 pg/ml or BNP \> 80 pg/ml (in patients treated with ARNI, NT-proBNP must be used)

Specific inclusion criteria for only Met-HeFT:

Patients must have a diagnosis of type 2 diabetes or insulin resistance or diabetes risk. This includes 1 or more of any of the following:

* A previous diagnosis of type 2 diabetes at any time without Metformin treatment during the last 3 months
* HbA1c ≥ 5.5 % (≥ 37 mmol/mol) within 12 months prior to screening
* Fasting P-glucose ≥ 5.6 mmol/l within 12 months prior to screening (measured when the patient in stable condition / has no intercurrent illness)
* Body mass index ≥ 30 kg/m2
* If oral glucose tolerance testing (OGTT) has been performed at any time prior to randomization: 2 hour P-glucose ≥ 7.8 mmol/l
* In addition, patients in Met-HeFT must have eGFR ≥ 35 ml/min (MDRD)

Patients are randomized through an internet based randomization module. Patients can be allocated to a) both H-HeFT and Met-HeFT or to b) only H-HeFT or to c) only Met-HeFT.
Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)

This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

1. Of either gender, aged \>=19
2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
3. Chronic Atopic Dermatitis that has been present for at least 3 years
4. EASI\>=12 at screening and baseline visit
5. IGA\>=3, SCORAD index\>=25, BSA \>=10% of AD involvement at screegning and baseline visit
6. Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks
7. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects with medical history or surgery/procedure history
2. Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
3. Subjects who need prohibited medication during clinical period
4. Pregnant, breast-feeding women or women who plan to become pregnant during this study
5. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
6. Any other condition which the investigator judges would make patient unsuitable for study participation
Evaluation of Bay 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma

Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin's Lymphoma.


Eligibility Criteria:
Inclusion Criteria: - Measurable disease as defined by the presence of at least one measurable lesion - Failed at least one prior therapy or has achieved remission but has progressed or relapsed within 6 months of therapy - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and kidney function Exclusion Criteria: - Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - Others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation