cyrilzakka/clinical-trials huggingface dataset:
Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome

Observational, prospective, monocentric study conducted in the cardiac surgery department about biological markers to predict the short-term outcome of heart surgery patients.

At present, there are no biological markers to predict the short-term outcome of heart surgery patients. Redox balance, determined by the interaction between oxidants and reducers in tissues, is an essential parameter in the regulation of cellular functions. Cardiac surgery with extracorporeal circulation (CEC) induces major disturbances in this balance. In preliminary work, it was observed that the redox potential (Eg) varied with the introduction of CEC, and a persistent imbalance appeared to correlate with post-operative complications. It is believed that Eg potential could be a new biomarker of the post-operative outcome of major surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years of age Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting.

Patients able to understand the protocol; Patients able to express non-opposition to participating in the study Patients affiliated to a social security system or equivalent.

Exclusion Criteria:

Emergency surgery patients. Pregnant or breast-feeding women. Patients deprived of their freedom or under legal protective measures.
Esomeprazole (NEXIUM) vs. Surgery

The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* Subjects considered suitable for surgical treatment and long-term management of esomeprazole.
* History of chronic reflux esophagitis or symptomatic GERD

Exclusion Criteria:

* History of esophageal, gastric, or duodenal surgery predicted to influence negatively on subsequent treatment within the study.
* Contraindication to the study drug.
* Pregnancy, lactating or of child-bearing potential.
Vitamin D Influence on Oocyte Donation

Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin D, ovarian reserve and ovarian response to controlled stimulation in egg donors.

Design: Retrospective study. Setting: University affiliated private IVF center. Intervention: Serum analysis of vitamin D, bioavailable vitamin D, antimullerian hormone (AMH), antral follicular count (AFC), reproductive outcome of oocytes recipients Main outcome measure: AMH, AFC, number of oocytes retrieved and number of mature oocytes, pregnancy and implantation rate of donated oocytes'recipients.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian race,
* between 18 and 34 years of age,
* all donors had normal menstrual cycles of 26-34 days,
* normal weight range (BMI 18- 25 Kg/m2),
* normal uterus and ovaries on transvaginal ultrasound (no signs of polycystic ovarian syndrome), and
* an antral follicle count (AFC) \>10,
* normal karyotype

Exclusion Criteria:

* current or past exposure to radiation or hazardous chemical substances,
* history of drug use,
* family history of hereditary chromosomal diseases,
* sexually transmitted diseases
Tolerance and Development of Healthy, Term Infants

To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants;
* Age 0-8 days of age;
* Exclusively formula fed;
* No use of vitamin/mineral supplements.

Exclusion Criteria:

* Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.
The Effect of East-West Collaborative Medicine on Chronic Cervical Pain

The purpose of this study is to assess the effect of East-West collaborative medicine on chronic cervical pain.

Design: This is a randomized, controlled study.

Participants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups.

Intervention: Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks

Eligibility Criteria:
Inclusion Criteria:

- presence of Chronic neck pain

Exclusion Criteria:

* Cancer
* Spinal infection
* ankylosing spondylosis
* myelopathy
* moderate hypertension or more
* serious mental disease
* other skeletomuscular disease
* history of operation or acupuncture treatment about spinal disease
Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate in patients who initially survive an in-hospital cardiac arrest. Patients who are successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical ventilation in the intensive care unit will be enrolled, and will get either thiamine or placebo. Their oxygen consumption and lactate will be measured at serial time points and compared between groups. The investigators' hypothesis is that thiamine will help restore the body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in oxygen consumption and a decrease in lactate.

In-hospital cardiac arrest often leads to shock and organ failure, and low oxygen consumption and high lactate are associated with worse outcome. Thiamine is a B vitamin necessary to maintain the body's ability to use oxygen effectively, and the investigators have found that many patients are thiamine deficient after cardiac arrest. The investigators have also found that thiamine can decrease lactate in thiamine-deficient patients who are critically ill. Patients in this study will be randomized to receive either thiamine or placebo every 12 hours for 2 days after surviving an in-hospital cardiac arrest. The investigators will measure oxygen consumption continuously during that time with a monitor attached to the ventilator tubing, and will also measure lactate and other lab values at several time points.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age \> 18 years)
* Cardiac arrest occurring while admitted to the hospital, with sustained (\>20 minutes) return of spontaneous circulation (ROSC)
* Mechanically ventilated at the time of enrollment
* Within 12 hours of cardiac arrest event

Exclusion Criteria:

* Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
* Comfort measures only or anticipated withdrawal of support within 24 hours
* Severe agitation
* Protected populations (pregnant women, prisoners)
Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients

This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease

Caries and periodontitis are infectious diseases that can eventually lead to the loss of the dental organ. The masticatory deficit engendered will have repercussions on the general state of the subject and on his quality of life (pains, difficulties of feeding which can cause nutritional deficiencies ...). The systematic review of the literature, despite low levels of evidence, shows that there is an influence of Parkinson's disease on oral health. Our goal is therefore to determine the impact of implementing appropriate oral hygiene measures on improving the quality of life of patients with Parkinson's disease.

This is a 40-patient, interventional, preliminary study that will rely on indicators of oral health status (DMF, Periodontal Index, presence of pathogenic bacteria), as well as a questionnaire measuring impact of oral conditions on patient well-being (OHIP-14). These data will be collected before and after the implementation of the hygiene measures, within a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient with Parkinson disease
* Able to give written informed consent
* Affiliated to French health care system

Exclusion Criteria:

* Patient under tutorship and curatorship
* Pregnant women
* Patient wearing subtotal or total dental prosthesis
* Antibiotic treatment or antiseptic mouthwashes in the month prior to sampling
* Patient with less than 6 teeth distributed on maxilla and mandible
Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer

The purpose of this study is to evaluate the response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.

Since 1982,cancer has been the leading cause of death in Taiwan. In particular,gastric cancer is the fourth leading cause of death in male cancer patients and the sixth for female patients in 2000,accounting for an estimated 2,374 deaths. In recent years, the treatment of gastric cancer patients has gradually been improving due to advances in early diagnosis and surgical techniques. Although chemotherapy and radiation therapy have been used in either the adjuvant or palliative setting, their values are still limited due to their unacceptable toxicity or inadequate efficiency.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease
3. Patients with at least one measurable lesion
4. ECOG performance status of 0,1 or 2
5. Patients with no prior chemotherapy and radiotherapy for metastatic disease (patients who have received and completed prior adjuvant chemotherapy at least 6 months prior to study enrollment may be enrolled into the study, prior taxane chemotherapy should be excluded)
6. Patients with physiological functions (bone marrow, heart, liver, kidney, etc.) meeting the following criteria: WBC \>4000/mm3, ANC \>1500/mm3, PLT \>100,000/mm3, Hb \>9.0g/dL, ALT\<3 times the ULN (\<5 times the ULN for liver metastasis cases), Total bilirubin \<1.5mg/dL, Creatinine \<the upper limit of normal
7. Accessible for treatment and follow-up
8. Give written informed consent
9. Women of child bearing potential must have a negative plasma or urine pregnancy test within 72 hours prior to start of the study medication

Exclusion Criteria:

1. Patients who received surgery within 14 days prior to enrollment
2. Patients with CNS metastasis
3. History of hypersensitivity related to the administration of polyoxyethylated-castor-oil (cremophor EL)-containing preparation (e.g. cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin preparation for injection,etc.)
4. Patients with a history of severe hypersensitivity
5. Active infectious symptoms
6. Patients with active gastrointestinal bleeding, intestinal obstruction or other situation that dose not allow oral intake of medication
7. Patients with ascites that adversely affects performance status
8. Pre-existing CTC Grade 2 or greater neuropathy (motor or sensory)
9. Pregnant or nursing females
10. Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug
Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

Delirium is a common postoperative complication in the elderly, often caused by multiple factors. It is defined as an acute neuropsychiatric disorder characterized by fluctuating disturbances in attention, awareness, and cognition. Postoperative delirium occurs in 17-61% of the major surgical procedures. It may be associated with cognitive decline, decreased functional independence, increased risk of dementia, caregiver burden, health care costs, morbidity, and mortality. Therefore, delirium is a possibly disastrous condition and is both a huge burden on a patient's health and on the health care system in general.

Over the last few decades, numerous risk factors for delirium have been identified, emphasizing the importance of delirium prevention in patients undergoing surgery. It has already been identified as a state that may be associated with serious complications such as prolonged ICU and hospital stays, decreased quality of life, and increased mortality ). Previous studies on delirium pointed out old age and other factors as important predisposing factors. on the health care system in general. Extensive research on reducing the incidence of delirium has been conducted using both pharmacological and non-pharmacological preventive measures in the acute setting. As evidence recommending or opposing specific drugs for the prevention of postoperative delirium remains insufficient and the international guidelines can only recommend perioperative pharmacologic adjustments ("American Geriatrics Society Abstracted Clinical Practice Guideline for Postoperative Delirium in Older Adults," 2015) . Consequently, the challenge of developing reliable hospital algorithms for delirium prevention and treatment remains unresolved. Furthermore, there is a link between postoperative delirium and two biomarkers, cortisol and C- Reactive Protein (CRP), which have previously been linked to delirium but whose significance is unknown.

Eligibility Criteria:
Inclusion Criteria:

* 1- Patients aged ≥ 65 years. 2- Scheduled for visceral, orthopedic, vascular, obstetric, urology, or plastic surgery.

Exclusion Criteria:

* 1- Delirium upon hospital admission or development of delirium prior to surgery stated by family members.

  2- Mini-Mental State Examination (MMSE) score \< 24 points 3- Delirium Observation Scale (DOS) ≥4 points 4- preoperative neurological diseases affecting cognitive function (such as vascular dementia) 5- High risk for postoperative treatment in the intensive care unit (ICU) 6- Known to have dexmedetomidine and or ketamine intolerance. 7- Lack of cooperation or communication. 8- Parkinson's disease, parkinsonism, intake of dopaminergic drugs (levodopa, dopamine agonists) 9- Epilepsy. 10- Patients on steroid therapy 11- severe liver and renal insufficiency
Efficacy of SLN Block for Chronic Cough

This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age \>18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.


Eligibility Criteria:
Inclusion Criteria:

* History consistent with neurogenic cough
* Exclusion of other etiologies (see exclusion criteria)
* Age ≥ 18

Exclusion Criteria:

* Current neuromodulating medication use
* Untreated other etiologies of cough:

Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI \> 13 or RFS \>11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)
Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity

The purpose of this study is to gain insight into the side-effects of statin consumption, and assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse these changes. The investigators' prior research has shown that epicatechin can improve skeletal muscle structure and mitochondrial (which gives us energy) structure.

Patient Inclusion Criteria:

1. Must be between 30-75 years of age.
2. Must have a VO2max greater than 18 ml/kg/min(non-sedentary individuals).
3. Subjects with LDL\>100mg/dL (or on drug treatment)
4. Subjects without a prior cerebrovascular event (example: stroke)
5. Subjects without a prior cardiovascular event (example: heart attack)

Patient Exclusion Criteria:

1. Liver, thyroid, or kidney disease.
2. Currently taking drugs that interfere with statin metabolism (calcium channel blockers, colchicine etc.).
3. Acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, COPD, anemia, diabetes, psychiatric illness.
4. Non-smokers, prior smokers, or illicit drug users with abstinence \>1 year.
5. Subjects taking blood thinners (Coumadin, xarelto, pradaxa, Plavix, effient, apixiban, etc) will be excluded. If subjects are taking aspirin for routine prevention they will be asked to hold aspirin for 7 days prior to biopsy. Routine prevention means that the patients are taking aspirin to reduce their risks, but do not have established cardiovascular disease.
6. History of previous knee surgery and active history of knee pain or neuromuscular disease are exclusions as they are known to affect muscle structure and function.

The study will be a double blind placebo controlled study where subjects will be randomized to either of two groups:

1. Simvastatin 40 mg + placebo once daily (statin only group) for 3 months
2. Simvastatin 40 mg + Epi 50 mg once daily (statin + Epi group) for 3 months

Eligibility Criteria:
Patient Inclusion Criteria:

* Must be between 30-75 years of age
* LDL\>100mg/dL (or on drug treatment)
* VO2 max greater than 25 ml/kg/min

Patient Exclusion Criteria:

* Liver or kidney disease
* Currently taking drugs that interfere with statin metabolism
* Currently taking blood thinners
* Acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, COPD, anemia, psychiatric illness, insulin-dependent diabetes
* smokers or illicit drug users
* adverse cardiovascular event (ex: heart attack)
* history of knee surgery or active history of knee pain
Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication

This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion


Eligibility Criteria:
Inclusion Criteria:

* After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.
* The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

* Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.
* Subjects who were previously enrolled in this study.
* Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.
Erector Spinae Plane Block vs Transforaminal Epidural Injection

Lumbar disc herniation is the main cause of low back pain and radicular leg pain. Steroids administered to the epidural area reduce the inflammatory response and pain by inhibiting the synthesis of proinflammatory agents. Epidural steroid injections are used in the treatment of lumbosacral radicular pain with various techniques including fluoroscopy-guided transforaminal and interlaminar injection.

Ultrasound-guided erector spina plan block (ESPB) was first described in 2016 and has been used for postoperative analgesia in many surgeries including thoracic and lumbar dermatomes. The distribution of local anesthesia in the ESPB from the paravertebral area to the transforaminal and epidural space has been shown in studies.

The aim of this study was to compare the efficacy of ultrasound-guided ESPB and fluoroscopic guided transforaminal epidural steroid injection in chronic discogenic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Patients with unilateral radicular pain and low back pain persisting despite medical treatment.

Exclusion Criteria:

* Spinal cord disease or spinal mechanical instability,
* Previous low back surgery,
* More than two levels of lumbar disc hernia,
* Allergic to local anesthetic drugs to be used,
* Use of oral anticoagulants,
* Uncontrolled diabetes mellitus type I and II
Clinical Study to Evaluate the Short Time Efficacy of AP Green Tea Extract Affer High Fat, High Carbohydrate Diet

The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (\< 30 kg/m2) and fasting glucose level of \> 100 mg/dL after high-fat/high-carbohydrate meal.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 19 years or over
* BMI \< 30 kg/m2
* Fasting glucose level \> 100 mg/dL (who is not under medication)
* Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives

Exclusion Criteria:

* At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication
* Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
* Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis
* In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion
Oxytocin and Non-verbal Communication

In this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.

Using Liu et al.'s (2012) dataset, the investigators seek to observe whether the administration of oxytocin modifies non-verbal communication with a stranger.

This dataset involves a conversation between two strangers that took place 45 minutes after drug administration. While Liu et al. coded the video for markers of interpersonal distance (physical distance, eye contact, conversational intimacy), the investigators seek to analyse oxytocin's effects on non-verbal communication of affiliative and sexual cues (e.g., smiles, lip puckers). Based on findings that oxytocin's effects depend on context, the investigators will explore these relationships as a function of the conversational context (where participants converse with each other using low-, medium-, and high-intimacy topics, or in an unstructured conversation).

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* pregnant;
* history of epilepsy, severe depression, severe anxiety, or psychosis;
* smoking more than 15 cigarettes a day;
* addicted to illegal substances.