cyrilzakka/clinical-trials huggingface dataset:
Cardiometabolic Risk of Obese Subjects: Cross-sectional Study

experimental study with analysis on tissues. This study aims to study cardiometabolic risk from a genetic, clinical, instrumental and laboratory point of view in a population of subjects with obesity.

Compared to normal clinical practice, if you decide to participate in the study you will be asked to:

1. allow the collection of an additional study-specific amount of blood as part of a blood sample already provided for by clinical practice during the dietetic visit; The sample will be used to perform the genetic and laboratory analyses required by the study.
2. Undergo an additional study-specific visit within one month of the dietetic visit. will be subjected to the measurement of the degree of vascular aging and the evaluation of the health of his/her arteries, through non-invasive examinations.

Eligibility Criteria:
Inclusion Criteria:

* • Age \> 18 years

  * BMI \> 30 Kg/m2
  * In primary prevention for cardiovascular disease
  * Ability to communicate, make themselves understood and adhere to study-specific procedures
  * Willingness to participate in the study and obtain informed consent

Exclusion Criteria:

* Patients already enrolled by the Research Units involved in the enrolment
* Glycated hemoglobin level \> 55 mmol/L
* Patients suffering from obesity secondary to endocrinological diseases or iatrogenic causes
* Patients with heterozygous Familial Hypercholesterolemia (Dutch Lipid Score - DLS\>8)
* Patients suffering from hypercholesterolemia secondary to lipid or iatrogenic extra-metabolic pathologies
* Patients suffering from systemic inflammatory or oncological diseases
* Patients on active treatment with GLP-1 analogues
* Pregnancy and breastfeeding
* Any medical or surgical condition that makes the patient's adherence to the study protocol complex or inconsistent.
Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
* Adnexal tenderness on bimanual vaginal examination,
* Temperature \> 38.0°C; - Elevated C-reactive protein value (CRP);
* Signed PIC/IC

Exclusion Criteria:

* Pregnancy
* Abnormal lab values
24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the synthetic prostaglandins most commonly used to achieve cervical ripening and labour induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical) or as a controlled-release intravaginal pessary. The controlled-release pessary has some potential advantages: a single application is required; the insert is easily administered and can be removed as soon as labour starts or if complications ensue. Studies comparing the dinoprostone vaginal insert to other prostaglandin formulations have shown variable results, probably influenced by drug administration regimens, indications for induction, and cervical conditions of the women. The purpose of this study is to assess the efficacy of the induction of labour using dinoprostone in patients with an unfavourable cervix, and to compare the efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal dinoprostone gel.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks

Exclusion Criteria:

* premature rupture of the membranes, history of a previous caesarean section,
* maternal clinical contraindications to the administration of prostaglandins,
* fetal malpresentation
Glycemic Response Testing

The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18-75 years of age
* Subject has a body mass index (BMI) ≥ 20.0 and \< 35 kg/m² at screening (visit 1).
* Subject has normal fasting serum glucose (\<7.0mmol/L capillary corresponding to whole blood glucose \<6.3mmol/L).
* Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

-
Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS)

This research is a clinical trial with a Randomized Controlled Trial (RCT) design. The purpose is to identify the effect of intravenous thiamine administration compared to normal saline placebo on glucagon levels and ROS levels in patients undergoing general anesthesia surgery

Surgery may increase postoperative cortisol and blood glucose levels. Changes in normal metabolic patterns due to surgery stimulate gluconeogenesis, glycogenolysis, proteolysis, lipolysis, and cytogenesis. These result in hyperglycemia and ketosis conditions. Surgery and anesthesia lead to an immunosuppressive effect. Increased secretion of proinflammatory cytokines may also occur after the surgery.

Besides an increase in cortisol levels, surgery can also increase cytokine response and ROS production in patients who have undergone surgery under general anesthesia after 72 hours. ROS production can also be a useful indicator in assessing the severity of surgical trauma.

In surgical procedures, there is an acute increase in reactive oxidative stress (ROS). This occurs when ischemia is followed by reperfusion. ROS can trigger tissue injury seen in transplantation (liver and heart), the release of aortic clamps during abdominal and thoracic aortic surgery, the release of limb tourniquets during orthopedic surgery, and reperfusion during and after cardiopulmonary bypass. There is a thiamine deficiency in 20% of patients treated in the intensive care unit (ICU). Thiamine deficiency is a source of lactic acidosis that does not seem in severe sepsis and septic shock. An imbalance between the formation and removal of free radicals causes a pathological condition called oxidative stress. However, the human body uses antioxidants to suppress these free radicals. One of the antioxidants that can reduce oxidative stress is thiamine. Previous studies proved this finding. Thiamine has also been able to significantly prevent the expression of inflammatory cytokines and chemokines, depending on NF-B induced by thromboxane and PGI2 synthase.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years who undergo surgery under general anesthesia
* ASA physical statuses 1 and 2
* Sepsis

Exclusion Criteria:

* Refuse to participate
* Diabetes mellitus, experience shock sepsis or lactic acidosis
* Have a history of hypersensitivity (allergy) to thiamine
* Thiamine deficiency
* Take immunomodulatory drugs, antiplatelet or anticoagulants surgery duration \> 6 hours, and thiamin regularly
* They experience massive bleeding and receive blood transfusions preoperatively, intraoperatively, or postoperatively
Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum

Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy.

The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.

The investigator will include 35 children under 12 years old with OME and who need tympanostomy or tube placement under general anesthesia. Middle ear effusion will be collected, divided in two and frozen.

The investigator will perform ELISA tests to measure the level of MMP2 MMP9 MMP7 et TIMP2 (inhibitor of MMPs). The investigator want to compare the level of MMPs between healthy eardrum and atrophic membrane.

Clinical data will be collected such as age, gender, chronicity of the OME, quality of the eardrum and middle ear effusion type to see if there is any difference when MMPs level is higher.

Eligibility Criteria:
Inclusion Criteria:

- every children under 12 yo operated on in Gui de Chauliac Hospital

Exclusion criteria:

- when effusion is not possible to collect (too thick or amount of fluid not enough)

Collection of both MEE on each ear when OME is bilateral. We will perform the tests on only one ear. The other one will be kept in case of technical issue. A random draw will establish which ear will be tested.
Caduet in an Untreated Subject Population

The purpose of this study is to determine if Caduet will lower blood pressure to \<140/90 mmHg and lower LDL Cholesterol to \<100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.
* SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL

Exclusion Criteria:

* Subjects with a history of MI, angina, coronary artery bypass or intra-coronary interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.
* Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood glucose \> 126 mg/dL at the Screening visit.
Breastfeeding Preterm Infants - The Efficacy of Internet-based Peer Support

This study examines if the internet-based peer support has an effect on the breastfeeding attitude or the duration of breastfeeding in preterm infants and their mothers compared with mothers with routine care. The factors associated with the initiation of breastfeeding in the neonatal intensive care unit will be determined. In addition, the perceptions of the mothers of preterm infants about their needs and problems when breastfeeding their preterm infants are described.


Eligibility Criteria:
Inclusion Criteria:

* Mothers giving birth before full 35 gestational weeks in a study hospital

Exclusion Criteria:

* The mother not able to speak Finnish
* The infant's condition is critical (based on the paediatrician),
* The mother has a syndrome or illness preventing breastfeeding
Role of Curcumin in Paclitaxel Induced PN

Paclitaxel induced peripheral neuropathy is the most common and serious side effect associated with Paclitaxel treatment in breast cancer patients receiving Paclitaxel.

The efficacy of antioxidant molecules as neuroprotective strategies to preventing the development of peripheral neuropathy has been investigated in preclinical and clinical studies. Vitamin E and Glutathione have been explored as adjuvant therapies to preventing taxane-induced peripheral neuropathy. Other tested neuroprotective treatments with limited success include amifostine, glutamine and acetyl l-carnitine. Curcumin's antioxidant capacity is similar to other potent antioxidants, such as trolox (a vitamin E analog). Curcumin inhibits lipid peroxidation in different tissues, regulates intracellular levels of antioxidant enzymes (e.g., catalase, glutathione peroxidase and superoxide dismutase) and is an effective intracellular reactive oxygen species (ROS) scavenger.

The investigators are going to investigate the neuroprotective effect of Curcumin against Paclitaxel induced peripheral neuropathy.

The work is a prospective, randomized, open label controlled study. A total of 90 breast cancer female patients will be enrolled in the study. Eligible patients will simply be randomized using random allocation generator, after the end of anthracycline adjuvant therapy to one of two groups, Group I: will receive paclitaxel regimen plus 2g of curcumin Group II: will receive paclitaxel regimen only.

The cases involved in the study will be recruited from Ain Shams Teaching Hospital.

All patients presenting to the department were assessed for eligibility according to certain inclusion and exclusion criteria.

Details of the research steps that the subscriber will be exposed to:

* Base line evaluation then alignment in either intervention or control group either for taking the interventional drug or standard of care in control group.
* Blood samples will be collected at baseline.
* Patient will be given a weekly supply of the medication and will be asked to take his prescribed dose daily.
* Every week all patients will be asked about their symptoms and if they experience any adverse drug reaction.
* Patients will receive the interventional drug until the last paclitaxel dose will be taken.
* After 3 months, another full clinical examination and blood sample will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of early stage breast cancer with age \> 18 years.
* Performance status of the patients based on Eastern Cooperative Oncology Group (ECOG) from 0 to 2.
* Patients must receive paclitaxel 80 mg/m2 weekly or 175 mg/m2 every 3 weeks for 12 weeks.
* Patients clinical parameters should be (ANC ≥ 1500/mm3). Platelet count 100,000/mm3) (serum total bilirubin \< 1.5 mg/dl) and (creatinine \< 1.5 mg/dl).

Exclusion Criteria:

* Patients they had any signs and symptoms of clinical neuropathy.
* Diabetes mellitus
* Patients receiving vitamin supplementation including vitamin B1, B6 and B12
* Patients receiving antidepressants, anticoagulants, opioids or anticonvulsants
* Patients had a hypersensitivity to curcumin.
Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients

Double blinded Clinical trial to test efficacy of Quetiapine versus placebo in reducing postoperative delirium in high risk surgical patients after three days of treatment.

This study evaluates postoperative delirium in high risk surgical patients to know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 65 years-old patients who will be undergoing major surgery (noncardiac) and having an equal or greater score of 5 on the scale Delphi.
* Age: 70-79 years: 1 point; ≥80 years: 2 points.
* Physical activity: need for assistance, not self-sufficient: 2 point.
* Alcoholism: 1 point.
* Hearing Impaired: 1 point.
* History of delirium: 2 points.
* Emergency surgery: 1 point.
* No laparoscopic surgery: 2 points.
* Admission critical Units: 3 points.
* Value of C-reactive protein (CRP) ≥ 10 milligrams (mg) / decilitre (dL): 1 point

Exclusion Criteria:

* Allergy to quetiapine.
* Patients with a score less than 5 on the Delphi scale.
* Diagnosis of delirium at admission.
* Cardiological diseases: QTc ≥ 460 millisecond (msec) in men, ≥ 470 msec in women, recent myocardial infarction or cardiac decompensation, 2-3° degree atrioventricular block or history of torsades de pointes arrhythmias or ventricular arrhythmias, bradycardia...
* Hypokalemia ≤ 3 milliequivalent (mEq) / Potassium chloride (KCl).
* History of drug use.
* Patients on Antipsychotic or antidopaminergic treatment (chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, paliperidone, amisulpride).
* Parkinson's disease.
* Test MINIMENTAL ≤ 24.
* Corps or vascular dementia Levi.
* Hypokinetic movement disorder.
* History of neuroleptic malignant syndrome.
* Central Anticholinergic Syndrome.
* Epilepsy.
* Patients with a wight less than 50 or greater than 200 kg (kilograms).
A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients

The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.

A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults, age ≥ 40 years old.
* Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
* At least 10 pack years of smoking.

Exclusion Criteria:

* Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
* Unable to follow commands (cognitive impairment).
* Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
* Live in an area that does not have cellular service (Verizon).
Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery

The trial aims to evaulate the possiblity that use of virtual reality spectacles will affect post operative pain in total knee arthroplasty patients. The trial is a single center open label design. Patients will be randomized into two arm study comparing the effect of the use of virtual reality spectacles on pain levels and analgesic consumption in the perioperative period. The controls shall receive standard post operative care. The endpoints are VAS levels and analgesic use.

Evaluation Procedure This is a single center, interventional, randomized, unblinded two arm study assessing pain and analgesic use in post knee arthroplasty patients. The randomization ratio is 2:1 intervention to control. Both groups will receive routine post operative care. The intervention group will be treated with virtual reality spectacles. The control group will receive routine post operative care. Pain levels will be assessed using VAS and analgesic use.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee arthroplasty gender indifferent, aged over 18 years old
* Patient with ability to see in three dimensions

Exclusion Criteria:

* Inability to comply with the study protocol
* Single eye vision
* Blindness
Clinical Trial of Donepezil Between the Naive Group and the Switching Group

To compare the clinical efficacy of donepezil between the naive group and the switching group.

The purposes of this study are:

1. to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil
2. to help to clinicians in choosing the best treatment

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
2. Korean version Mini-Mental State Examination scores between 10 and 26
3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
4. Clinically active cerebrovascular disease; History of seizure disorder
5. Other physical conditions that required acute treatment.
A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=45 years of age
* Patients admitted to the hospital for acute coronary syndrome (ACS)
* Patients receiving guideline-based medical and dietary management of dyslipidemia

Exclusion Criteria:

* Symptomatic congestive heart failure (NYHA Class III or IV)
* Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
* Uncontrolled hypertension
* Uncontrolled diabetes
* Severe anemia
* Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)
Connect ME: Improving Social Connectedness

To assess the reach and effectiveness of a behavioral activation intervention for older adults experiencing low social connectedness by Area Agency on Aging Staff.


Eligibility Criteria:
Inclusion Criteria:

* Older adults (age\>60) will be enrolled because they are the target population served by the home-delivered meals program and the target sample for this study.

Exclusion Criteria:

* Clinically significant depression (Patient Health Questionnaire; PHQ-9 ≥ 10) or active suicide risk (Columbia Suicide Severity Rating Scale; C-SSRS), or Cognitive Impairment (Blessed Orientation-Memory-Concentration Test\>9)
* Clients who score 1 or greater on question 9 of the PHQ-9 will be further assessed for suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Clients will meet exclusion criteria for a positive response to any item
* We will exclude older adults with uncorrectable hearing or vision impairment rendering them unable to use the tele-conferencing equipment.
* Those who cannot speak English and have impaired decision-making capacity
* Adults unable to consent will be excluded
* Individuals who are not yet adults (infants, children, teenagers) will be excluded
* Pregnant women will be excluded
* Prisoners will be excluded