cyrilzakka/clinical-trials huggingface dataset:
Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

Due to various causes, such as brain impairment, environment changes, anxious,et al. patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In chinese traditional medicine, acupuncture can improve the quality of sleep in patients with sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients with heart operations.

60 patients are divided into three groups. control group: no any intervention; experiment group 1: acupuncture are used in patients before cardiac operation; experiment group 2: acupuncture are used through all the course in hospital.

before operation, before discharge, one month after operation, two month after operation, the quality of sleep are evaluated. and comparisons will be made in three groups.

Eligibility Criteria:
Inclusion Criteria:

* aging:18yr--65yr
* cardiopulmonary bypass
* NYHA ≤II and EF≥50%
* not illiterate person

Exclusion Criteria:

* neurological disease,mentality disorder
* abuse of alcohol
* long history of smoking
* sleep disorder before admitting to hospital
Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke

The primary purpose of this study is to investigate the effectiveness of Ginkgo Diterpene Lactone Meglumine (GDLM) for patients with acute ischemic stroke (AIS) in real-world settings.

The randomized controlled trial (RCT) of GDLM for the treatment of AIS was published in JAMA Network Open, titled "Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial." This study provided valuable insights into the efficacy and safety of GDLM in improving functional recovery for patients with AIS. However, the generalizability of these findings to real-world medical settings remains unclear, as the trial was conducted under controlled conditions that may not fully reflect routine clinical practice. To address this gap, we will conduct this study to further explore the effectiveness of GDLM in a real medical environment. Using routine clinical care data for real-world evidence, we aim to investigate the treatment's impact on a broader and more diverse patient population. This approach will allow us to better understand the practical application of GDLM in everyday clinical settings, including its potential benefits and challenges when used outside the confines of a RCT.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years, regardless of gender
* within 48 hours of stroke onset of ischemic stroke
* patient or their legally authorized representative (LAR) has signed informed consent or legally authorized oral consent with documentation

Exclusion Criteria:

* mRS score of 2 or more prior to onset
* total hospital stay less than 7 days
* use of other ginkgo-derived preparations except GDLM
* current or planned participation in any other interventional clinical trials
* inability to comply with study procedures due to documented psychiatric disorders or severe cognitive impairment
Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?

Acetaminophen is the first drug involved in voluntary drug poisoning. According to the studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver failure, and this poisoning is responsible of 10 percent of liver transplants each year in these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly correlated with factors predisposing socio-economic field are an important issue, including the speed and appropriateness of care are key factors both in terms of reducing morbidity mortality in socio-economic terms for the community.A nomogram defines a statistical threshold from which the blood concentration of paracetamol has a significant risk of liver toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a toxic dose, but there is no consensus on whether or not to repeat this dosage during the treatment, as the first result is beyond the threshold or not.The administration of the antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a protocol that can vary in different services.In the absence of clear guidelines, the question of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the curve, and thus enable the return home of the patient's somatic point of view (excluding psychiatric care when is voluntary drug intoxication), with consequences in terms of costs (hospital days) and duration of treatment?


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Having taken a single dose of acetaminophen
* With a supposed ingested dose over 4 grams

Exclusion Criteria:

* Patients treated with N-Acetyl
* Cysteine before their admissions in the participating units
* With repeted ingested doses
* Pregnant and nursing wifes
* Patients unable to give their consent to the study
Effects of Lactose on Fecal Microflora

The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those who cannot(LNP)digest lactose. This division may help modify disease risks according to geographic population distribution. At least some of the putative mechanism of risk modification may relate to an effect of undigested lactose on lower intestinal bacteria. The effect may provide for support of beneficial microbes. The amount of lactose reaching the colon is made easier in LNP than LP subjects who have to consume larger amounts to have meaningful spillover into the lower bowel.The current study examines whether there are quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk sugar)between these 2 different phenotypic populations. Finding of differences would lend support to the notion that for some diseases LP and LNP subjects face different risks even in an area of uniform disease risk if they consume lactose (found in dairy foods).

The primary end point is comparison of 4 groups of specific bacteria between LP and LNP participants before and after 2 weeks of lactose(in powder form mixed in water) consumption. Classification is based on genetic analysis and secondarily on breath hydrogen results. Results are compared within groups.

The secondary outcome is comparison of 4 groups of bacteria between LP and LNP subjects against each group of stool samples obtained on the first visit. Results are obtained between groups.

Additional information and other secondary outcomes are to evaluate any relationship between diet intake and the 4 groups of bacteria on the first visit

Another outcome will be to compare within groups any effect of lactose consumption on insulin and glucose levels within the 2 groups.

Healthy volunteers between the ages of 18 and 49 are recruited.

1. Each participant fills a lactose targetting diet questionnaire(3 day recall).
2. A 50g lactose challenge tets is administered,breath hydrogen and symptoms are recorded for 4.5hrs.
3. Blood is drawn for analysis of lactase genetic status.
4. A stool sample is collected(10-15g)and analysed fo total anaerobes, enterococci, bifidobacteria and lactobacilli.
5. All subjects are withdrawn from dairy foods(calcium replacement suggested in diet) for 2 weeks and are aked to return to repeat parts 2 and 4.
6. A voluntary segment has glucose and insulin measured for 4 hrs via an indwelling venous catheter.
7. Subjects are asked to consume 50g lactose in divided doses for 2 further weeks
8. At the end they return and repeat sections 2 and 4 for the third time.
9. Participants who volunteered to have glucose and insulin measured repeat this segment of the study as well.

Eligibility Criteria:
Inclusion Criteria:

* 18-49 yr old male or female.
* Healthy except may take chronic thyroid or hypertension medication.

Exclusion Criteria:

* Pregnancy
* Antibiotics in last 6 weeks
* Any active illness.
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
* Adequate bone marrow, renal, and hepatic function
* Patients must be entered no more than twelve weeks postoperatively

Exclusion Criteria:

* Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
* Stage IV or suboptimally debulked disease following primary cytoreductive surgery
* Patients who have received prior radiotherapy or chemotherapy.
Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea

Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.


Eligibility Criteria:
Inclusion Criteria:

1. Female aged 18-50 years
2. Menstrual pain rated at least 6/10 on a 0 (no pain) to 10 (worst pain possible) NRS for all menstrual cycles in the previous 6 months
3. Regular menstrual cycles over the past year (at least 9 in the previous 12 months)
4. Self-reported menstrual cycle averaging 22-35 days
5. Access to a smartphone and email, and willing/able to receive text messages
6. Able to read and understand English
7. Ability and willingness to provide written informed consent.

Exclusion Criteria:

1. Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
2. Variable levels of menstrual pain in the previous 6 months
3. Self-reported symptoms consistent with a chronic pain condition (e.g., pain in any body area lasting longer than 3 months) or previous diagnosis of a chronic pain condition
4. Currently pregnant or breastfeeding
5. History of pelvic inflammatory disease or sexually transmitted disease
6. Acute illness or injury that would potentially impact pain task performance (e.g., fever, flu symptoms) or that affect sensitivity of the extremities (e.g., Reynaud's disease)
7. Allergy to naproxen or having a health condition that contradicts use of naproxen or affects naproxen metabolism (e.g., kidney disease)
8. History of high blood pressure or anemia (due to possible complications from NSAID use).
Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients

Most cancer-related deaths are caused by distant metastases, which are tumour cells that have escaped from a primary tumour and passed into the bloodstream to colonize a new organ. In this context, communication between tumour and stromal cells is essential. Indeed, tumor cells interact with cells in the tumor microenvironment and are able to modify them to their advantage. Both extracellular vesicles (EVs) and exosomes are heterogeneous populations of small vesicles present in the tumor microenvironment and in body fluids that have recently emerged as powerful mediators involved in this communication and their transport in fluids. Tumor cells release large quantities of exosomes containing tumor markers, which can then spread to distant locations.

The exosomes are of endosomal origin. They are composed of proteins, lipids, RNA and DNA, and they circulate in the bloodstream. They can be internalized by specific distant cells and thus deliver a functional message. It has recently been shown that tumor exosomes containing pro-metastatic factors form pre-metastatic niches, before the tumor cells actually arrive, while determining the metastatic organotropism of tumors. These properties are now opening up new avenues of research in tumor biomarkers. In recent years, several studies have highlighted different markers contained specifically in exosomes derived from cancer cells. Consequently, exosomes are considered as potential reservoirs of tumor biomarkers that could be clinically useful for the non-invasive diagnosis of cancer, with the advantage of being performed by liquid biopsy. The study of microRNA (miRNA) is of particular interest. Indeed, miRNAs are small non-coding RNAs (between 21 and 25 nucleotides) involved in the regulation of gene expression and which are frequently deregulated in cancer. Several studies underline that the variation of free miRNAs in the blood is correlated with the progression of the disease, particularly in colon cancer. However, the stability of free miRNAs is controversial. Therefore, exosomes represent a very advantageous means of transporting miRNAs in the blood, as they are able to protect miRNAs from degradation by RNAase.

The hypothesis of the project is that circulating exosomes derived from tumours contain markers including specific miRNAs that could be used as biomarkers of early prognosis (survival and progression), easily measured in blood samples from patients with colon cancer. But other molecules contained in exosomes could also be of interest.


Eligibility Criteria:
Inclusion Criteria:

* Person included in the AGARIC study
* Person who provided consent or non-opposition to inclusion in the study
* Available blood sample in the AGARIC biobank at the Biological Resource Centre (Dijon)

Exclusion Criteria:

NA
Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients

Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing total knee arthroplasty.

Participants undergoing total knee arthroplasty will be randomly assigned to treatment group or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000 (Monofer®) or normal saline will be intravenously administered depending on the group assigned. The dose of iron isomaltoside will be determined based on patient's body weight using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin, transferrin saturation, and phosphorus level will be checked at preoperative day, postoperative day 1, 7, and 30.

The primary outcome is the incidence of postoperative anemia at 30 days after surgery. Secondary outcomes included the incidence and amount of red blood cell transfusion during admission period, hospital length of stay, the incidence of surgical site infection, and quality of life during postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing total knee arthroplasty

Exclusion Criteria:

* bilateral total knee arthroplasty
* hematochromatosis or hemosiderosis
* hemolytic anemia
* history of drug allergy
* liver cirrhosis or hepatitis
* systematic lupus erythematosus
* rheumatic arthritis
* allergic disease
* history of transfusion within one month from surgery
* parturient
Testing Different Messaging Approaches to Increase Activation of a HealthyFood Benefit in Adults With Diabetes

The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy foods they purchase at selected grocers. And, while overall enrollment in the program is high, there is particular interest in increasing enrollment in the benefit amongst Vitality members with diabetes. One presumed barrier to enrollment in the benefit amongst members with diabetes is a misperception of the particular relevance of the benefit and healthier food choices for their personal health. Improved messaging regarding the HealthyFood benefit and its particular salience for individuals with diabetes may be an effective means of increasing activation of the benefit in this population. The proposed study will be a collaboration between Discovery Health/Vitality and researchers at the Perelman School of Medicine at the University of Pennsylvania. In the proposed RCT, Vitality members with diabetes will be randomised to different types of messages regarding the HealthyFood benefit. The investigators will then compare the effectiveness of these different messaging strategies at increasing activation of the HealthyFood benefit amongst Vitality members with diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Adults over age 18
2. Vitality health members who have not yet enrolled in the Vitality HealthyFood benefit
3. Diagnosis of type 2 diabetes (based on registration for chronic benefits for type 2 diabetes)
4. Have registered on to Discovery Health/Vitality website in the past (marker of Internet access and availability of email address)

Exclusion Criteria:

* Anyone who does not meet above criteria
Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?

Post-operative nausea and vomiting (PONV) is not only unpleasant for patients but also can delay hospital discharge and increase cost of stay. In some cases, when severe vomiting occurs, pain scores seem to be increased. The overall incidence of PONV is 30% and increases to 79% in patients at high risk for this post-operative outcome. The NUSS procedure is considered to be a procedure with a high risk for the outcome of nausea and vomiting.

The rationale is to do a prospective study in patients who have been diagnosed with Pectus Excavatum and who are undergoing a NUSS procedure (pectus excavatum correction) and to evaluate the effect of Acupressure on the post-operative outcome of PONV in these patients. Also, to determine whether there are any secondary outcomes related to pain scores and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* age 8-40 years old
* ASA 1-3
* males \& females

Exclusion Criteria:

* local infection of the site - P6
* acupuncture treatment within 8 weeks of the preoperative period
* coagulopathy is a contraindication for Acupuncture but not Acupressure
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness

In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)

  * Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
* Has less than 4 years elapse since the initial onset of active-phase of symptoms
* Has a body mass index (BMI) of \<30 kg/m\^2
* Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
* Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
* For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
* Suitable for outpatient treatment
* Additional criteria may apply

Exclusion Criteria:

* Poses a current suicide risk
* Has a history of poor or inadequate response to treatment with olanzapine
* Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has \> 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime
* Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) \>2 months prior to Visit 1
* Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine
* Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1
* Taking any weight loss agents or hypoglycemic agents
* Has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy
* Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks
* Has started a smoking cessation program within the past 6 months
* Has a history of diabetes
* Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
* Additional criteria may apply