cyrilzakka/clinical-trials huggingface dataset:
Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension
* Clinical diagnosis of type 2 diabetes or impaired glucose tolerance

Exclusion Criteria:

* History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
* Taking calcium channel blocker for the purpose of angina pectoris
* Reduced ejection fraction (\< 40%)
* Second- or third-degree of atrioventricular block
* Severe hypertension (\> 200/110 mmHg) or secondary hypertension
* History of stroke in the recent 6 months
* Serum creatinine \> 2.5 mg/dl
* Estimated survival duration less than 3 years due to other conditions
* Pregnant woman or possibly pregnant woman
A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy

This study is a multi-site, retrospective chart review to determine the effect of Neevo® or NeevoDHA® (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical food indicated for the dietary management of women under a doctor's care who face high risk pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize folic acid. Data will be collected from existing patient charts of subjects administered Neevo® or NeevoDHA® daily compared to subjects administered a prenatal vitamin daily.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant females, age 21-39, who received either Neevo®/NeevoDHA® or another standard prenatal vitamin (Prenatal vitamins must contain ≤1 mg folic acid, 27-35mg iron, and ≤12mcg vitamin B12).
* Clinical diagnosis of pregnancy must have been made at ≤12 weeks of Pregnancy, and delivery must have occurred on or after January 1, 2008 and on or before March 31, 2010
* Subjects must have been compliant in taking Neevo®/NeevoDHA® or other prenatal vitamin

Exclusion Criteria:

* Subjects should not have taken Prenate®, Prenate®DHA, or Prenate® Elite, which are L-methylfolate-containing prenatal vitamins.
* The following supplements within 2 months of diagnosis of pregnancy: B12 injection; \> 35mg Iron; \> 1.2 mg of folate; or a L-methylfolate product that is not a prenatal vitamin such as Life Extension methylfolate, Prothera methylfolate, Thorne 5-MTHF, Metanx®, Deplin®, Cerefolin®, or CerefolinNAC®
* History of leukemia or any anemia other than iron deficiency anemia or;
* Taking any iron supplement (in addition to the prenatal vitamin) prior to Week 22
Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU

VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two mechanical ventilators during non-invasive ventilation for patient suffering from respiratory acidosis.

This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation valve.

Patient will be randomized before the first NIV session lasting 2 hours. After a two hours wash-out, a second NIV treatment will be delivered with the other ventilator for duration of 2 hours.

Arterial blood samples will be collected at the beginning and the end of each session of NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Dioxide carbon arterial pressure \> 60 mmHg
* Blood acidity (pH) \<7.36

Exclusion Criteria:-Patient age under 18

* Pregnant woman
* Cognitive disorder (other than the one induced by hypercapnia)
* Acute intoxication with morphine or benzodiazepines
* Patient already equipped prior to admission with a home NIV or Continuous Positive Airway Pressure (CPAP) device
* All contraindications to NIV already described in the French Consensus Conference on NIV, from 2006.
Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia

The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration.

Design: split-mouth design AND parallel-arm design

Local anesthesia is commonly used in oral health care and intra-mucosal infiltration anesthesia is most commonly used by practitioners. Anesthesia may cause children a great deal of anxiety because of the fear of the injection. The latter can be painful if the product is delivered too quickly in the mucosa. Recent developments in the techniques and anesthesia systems allow reducing pain during the injection. In particular, computerized systems (electronically assisted local anesthesia) allow a slow injection limiting pressure. Moreover, these systems look like a pen which prevents the negative impression of the image related to the syringe metal. The intraosseous electronically-assisted anesthesia could be an interesting alternative to conventional infiltration anesthesia by making the act less stressful but also less painful for the child.

Eligibility Criteria:
Inclusion Criteria:

* split-mouth randomized controlled trial: patients with at least two first permanent molars requiring the same treatment with anesthesia
* parallel-arm radnomized controlled trial: patients with first permanent molar requiring treatment with anesthesia
* vital pulp
* patient did not take any pain medication 48 hours before randomization
* non-opposition of the child and two holders of parental participation in the study
* Treatments can be conservative treatment or endodontic treatment limited to pulpotomy.

Exclusion Criteria:

* Patients with periodontal disease (periodontal pockets or tooth mobility) or radiological defects (necrosis, furcation or periapical radiolucency)
* Disabled or autistic patients
* Patients with cancer, heart disease or sickle cell anemia
Different Squatting Modes in the Rehabilitation of Patellofemoral Pain Syndrome

This study take 84 patients with Patellofemoral Pain Syndrome in Peking University Third Hospital during January to September in 2023 as subjects, aiming to explore the efficacy and intervention effects of three different static squat modes including straight leg raise, wall squat, direct squat and wall squat assisted by elastic bands for patients with PFPS, in order to providing theoretical basis and effective guidance for future home rehabilitation of patients with PFPS combined with mobile health.

Background：Static squat has been widely used in the treatments of patellofemoral pain syndrome (PFPS), but no study has assessed which static squat modes is more effective .This study aimed to compare the effects of three different static squat modes on patients with patellofemoral pain syndrome .

Methods：Investigators included 84 patients with patellofemoral pain syndrome, a 6-week training period using a mobile phone app with angle recognition function, patients were devided into 4 groups based on different static squat modes. Kujala score, Lysholm score, VAS-W score, VAS-U score,thigh circumference, peak torque of knee extension, and peak torque of knee flexion on the affected side were used to assess efficacy.Two-way ANOVA was conducted to determine the differences within and between groups.Paired-samples t-test was used for intergroup comparisons, and one-way ANOVA was applied for intergroup comparisons. Chi-square tests were performed on categorical data.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of PFPS.

  * Age between 20 and 45 years (to reduce the risk of suffer from patellofemoral joint bone joint)

    * Have no other treatments before the experiment.

      * Sign the informed consent form.

Exclusion Criteria:

* Patients with a history of knee surgery.

  * With other lower limb injuries such as meniscus tear, bursitis, ligament injury, patellar tendon injury, joint degeneration, etc.

    * With a history of dislocation and subluxation of patellofemoral joint.

      * With cardiovascular vessels, lung, kidney and other important organs.

        * Not available to use mobile phone APP
Oral Side Effects of COVID-19 Vaccine

This study is a multicenter cross-sectional survey-based study conducted in four European countries (Czech Republic, Germany, Slovak Republic, and Turkey). An online questionnaire will be utilized to collect data from volunteer subjects following the STROBE reporting guidelines of cross-sectional studies.

The primary objective of this multicentre cross-sectional survey-based study is to estimate the prevalence of oral side effects of COVID-19 vaccine in the short term.

The secondary objectives are:

* to identify the risk factors of COVID-19 vaccine oral side effects in the short term.
* to evaluate the relationship between oral side effects and other inflammatory side effects of COVID-19 vaccine in the short term.

The target population is healthcare workers as they are identified among the priority groups of COVID-19 vaccine deployment plans in the EU/EEA and the UK. One more reason to select the healthcare workers among different groups of the population, their higher awareness about the possible vaccine-related oral side-effects so that more accurate and reliable results can be obtained.

A self-administered questionnaire will be developed, and its content validity will be tested using a panel of experts. The test re-test reliability of the questionnaire will be tested by 30 volunteers (10 Czech, 10 Turkish, 10 German) to achieve at least a Cronbach's alpha of 0.70. The questionnaire will be available in five languages; Czech, English, German, Slovak and Turkish. Dual forward translation and expert panels will produce equivalent Czech, German, Slovak and Turkish versions of the questionnaire.

The questionnaire will be composed of multiple-choice items divided into four main categories; a) demographic data including gender, age, location of practice, profession, and experience, b) medical anamnesis including medical comorbidities, medications, and recent oral symptoms, c) COVID-19 related anamnesis including vaccination date, previous infection, and exposure to infected cases, and d) vaccine side effects including inflammatory symptoms, cutaneous symptoms, and oral symptoms. (Annex 1)

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers who received COVID-19 vaccine during the last 30 days.
* Participating subjects should be at least 18-year-old and able to give their informed consent independently.

Exclusion Criteria:

* The healthcare workers who did not receive the COVID-19 vaccine recently.
* Non-healthcare workers who received the COVID-19 vaccine recently.
Prospective Evaluation of Biomarkers Variability in Knee Prosthetic Surgery

Bone quality is an important factor influencing the outcome of total knee replacement (TKR) surgery. Therefore, assessing bone quality preoperatively could help the surgeon in the choice of the most appropriate prosthetic implant.

The primary goal of this study is to measure serum and tissue levels of some proteins involved in bone remodelling.

Aseptic implant loosening after TKR causes knee pain, reduces knee function and may require revision surgery.

Several proteins have been identified, which are involved in bone metabolism and remodelling; variations in serum levels of some of these proteins after TKR loosening have also been described.

However, preoperative identification of risk factors for aseptic loosening remains a challenge.

An observational study is conducted to evaluate how levels of the following serum biomarkers vary after TKR:

* osteoprotegerin (OPG)
* receptor activator of nuclear factor kappa-B (RANK)
* receptor activator of nuclear factor kappa-B ligand (RANK-L)
* sclerostin
* cathepsin K

To avoid bias caused by inflammatory states, C reactive protein (CRP), interleukin 1 (IL-1), interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) levels and erythrocyte sedimentation rate (ESR) will be measured.

Secondary goals are to evaluate the mRNA expression of OPG, RANK-L, cathepsin K and sclerostin on tibial bone biopsies and to study if changes in serum biomarkers levels after surgery are associated with:

* clinical outcomes
* periprosthetic bone density
* variation of two bone reabsorption markers, the postoperative change of which has already been described in details: type 1 collagen cross-linked C-terminal telopeptide (CTP1) and type 1 procollagen N-terminal telopeptide (P1NP).

One day before surgery, after having signed informed consent, patients will undergo a vertebral and femoral dual-energy X-ray absorptiometry (DEXA) scan and blood samples will be collected.

During surgery a tibial biopsy will be collected. Between 4 and 7 days postoperatively and 3, 6 and 12 months after surgery patients will again undergo periprosthetic DEXA scans and blood samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40, \<80
* Indication for TKR
* Surgical indication for PFC Sigma®, posterior stabilized, mobile bearing TKR
* Patients signed written informed consent

Exclusion Criteria:

* Age \> 80, \< 40
* TKR revision surgery
* Fixed knee deformities greater than 15° in varus, valgus, flexion or tibial slope.
* Knee ankylosis
* Paget's disease
* Hyperparathyroidism
* Patient treated with: bisphosphonates, strontium ranelate, selective estrogen receptor modulators for osteoporosis, calcitonin, denosumab.
* Informed consent not accepted
* Serious comorbidity
* Active infections
* Pregnant or breastfeeding women
Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults

Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large amount of research indicates EGCG (amongst other catechins) is responsible for most of the potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa \& Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects including modulation of cell survival and cell cycle genes (Levites et al 2002).

Although there have been several human studies looking at the bioavailability of EGCG when administered in varying doses, there have been no studies that have specifically investigated the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical activity (EEG) and behavioural effects of EGCG. A randomised, double-blind, placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day participants will attend a screening/training visit where relevant exclusion criteria will be assessed including any food sensitivities. They will also complete a caffeine consumption questionnaire in order to control for potential caffeine withdrawal effects as a result of restrictions of the study.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* aged 18-35
* either caffeine consumers (consume more than 150mg caffeine per day) or non-consumers (consume less than 44mg caffeine per day).

Exclusion Criteria:

* smoke or consume any tobacco products
* not proficient in English language
* pregnant (or seeking to become pregnant)
* taking recreational, over the counter/prescription medication (including the contraceptive pill), and/or dietary/herbal supplements
* have food allergies or sensitivities
* have history of/current head trauma, learning difficulties , ADHD, migraines or any gastric problems
Effect of Aging on Haemostasis Parameters

Aging is an independent risk factor, without any clear explanation. The primary aim of the study is to depict the effect of aging on the coagulation fibrinolysis parameters and microparticles.

Patients older than 40, without any acute disease and not receiving any antiaggregant and anticoagulant therapy will be included in the study. Blood tests will be performed for coagulation, fibrinolysis and microparticles measurement.

Eligibility Criteria:
Inclusion Criteria:

* age \<40 2 groups : 1 : no history of VTE 2 : history of VTE

Exclusion Criteria:

* antiaggregant or anticoagulant therapy at curative dose
* arterial or thrombotic event in the last month
Natural History Study in Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD

SHIELD HD is an international, multisite, prospective, longitudinal cohort natural history study to assess the natural history of HD and its biomarkers that are associated with modulation of the number of cytosine-adenine-guanine (CAG) repeats in the mutant Huntingtin (HTT) gene.

Approximately 60 patients will be enrolled into the study and followed for up to 24 months at clinical sites in North America and Europe.

The results of this study will inform assessments for a future interventional treatment trial.

The rationale for this study is to obtain longitudinal information related to Somatic Instability and DNA damage response genes in HDGECs at various stages of the disease. Established assessments of disease progression will also be recorded.

Eligibility Criteria:
Key Inclusion Criteria

Patients who meet all of the following criteria will be eligible to participate in the study:

1. Capacity to comprehend the study objectives and procedures
2. Documentation of genetically confirmed disease by direct DNA testing, defined as a CAG repeat length ≥39 in the HTT gene
3. Ability to undergo and tolerate MRI scans
4. Ability to tolerate blood draws and lumbar punctures

Key Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participation in the study:

1. Any conditions, including severe chorea and dementia, that would prevent either writing or performing pen and paper, tablet, or computer based tasks as determined by the Investigator
2. Treatment with an investigational drug within 30 days prior to screening or within 5 half lives of the investigational drug, whichever is longer
3. History of gene therapy or cell transplantation or any other experimental brain surgery
Evolutionary Aspects of Polydistrict Atherosclerosis

Atherosclerosis is a systemic, multifocal disease that represents the leading cause of death in Western countries. The risk factors contributing to its distribution, extent and progression in different organs (i.e., the heart, brain or limbs) and different segments (large and small vessels) are not identical. The present study analyses data the evolutionary aspects of polydistrict atherosclerosis by analysing the possible role of morphological factors, biomolecular and genetic in the progression of atherosclerotic lesions and the development of major and/or minor acute cardiovascular events.

For this purpose, will be recalled to follow-up all 320 patients already enrolled in the previous protocol of Research in the period between 1 March 2014 and 28 February 2015 at the Department of Internal Medicine, Catholic University of Rome.

The subjects will undergo a new clinical evaluation, with particular interest to the onset of major cardiovascular events (myocardial infarction, stroke, death for all causes) and major adverse events to the lower limbs (critical ischemia of the lower limbs requiring revascularization or amputation) in the follow-up period, and a ultrasonographic examination of carotid arteries and arteries of lower limb districts at the Service of Angiology, Catholic University of Rome.

The study employed a new semiquantitative ultrasonographic score (ultrasonographic lower limb atherosclerosis (ULLA) score), that enables a complete evaluation of the entire lower limb atherosclerotic burden and has already been shown to be associated with major cardiovascular risk factors.

Therefore, the aims of this study are:

* to assess the association between functional, morphological, biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events (MACE) and major adverse events to the lower limbs (MALE);
* to analyse the morphological progression of atherosclerotic disease in its different localizations and the possible determining factors in such progression with a 10-year follow-up ultrasound study.


Eligibility Criteria:
Inclusion Criteria:

* Follow-up of n.320 subjects previously enrolled in the period between 1 March 2014 and 28 February 2015 in the previous Research Protocol at the Department of Internal Medicine, Catholic University of Rome.

Exclusion Criteria:

* Acute diseases;
* Age \< 18 years;
* Inclusion in another clinical trial;
* Impossibility of follow-up (homeless, residence abroad)
Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to observe quality of life and treatment side effects in patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and Yangzhengxiaoji capsule.


Eligibility Criteria:
Inclusion criteria:

1. Histology and/or cytology confirmed stage Ⅳ NSCLC patients;
2. With at least one measurable solid tumor (RECIST standard version 1.1): tumor \>=10 mm in diameter on CT or MRI images, or lymph node \>=15 mm in diameter on CT or MRI images;
3. Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival \> 3 months;
4. Age: 18-70 years;
5. Normal organ function:

   Bone marrow: neutrophils (ANC) count\>=1.5×10\^9/L, Platelets count\>=100×10\^9/L, hemoglobin\>=90g/L；Renal function, serum creatinine\<=1.5 mg/dl, and/or creatinine clearance or\>=60 ml/min; Liver function: total serum bilirubin levels \<= 1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT)\<=2.5 times the ULN, if abnormal liver function caused by the underlying malignancy, the AST and ALT \>=5 times ULN;
6. For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms;
7. Informed consent.

Exclusion criteria:

1. Clinically significant hepatic dysfunction: AST or ALT \> 2.5 times the ULN, total serum bilirubin levels \> 1.5 times the ULN; clinically significant renal insufficiency: serum creatinine \> 1.5 times the ULN;
2. Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure, unstable angina, myocardial infarction, coronary revascularization six months before randomization;
3. Spleen resection or combined with other severe hematopoietic system diseases;
4. Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe gastrointestinal ulcers;
5. History or present with other cancer, except for non melanoma skin cancer, cervical cancer in situ and other cured cancer for at least 5 years;
6. Mental illness, without legal capacity or limited capacity;
7. Pregnancy, lactation or patients with pregnancy plan;
8. Participated in other clinical trail in the past 1 months or participating in other trail now;
9. Other unsuitable condition decided by the investigator.