cyrilzakka/clinical-trials huggingface dataset:
Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?

Sepsis is the most common cause of acute kidney injury (AKI) in critically ill patients and is associated with a high mortality rate. Currently there is no available specific treatment to prevent or treat AKI in this setting. Many experimental and clinical data suggest that Nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. The main objective of the study is to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. A 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "Nicotinamide" group.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
* Written informed consent

Exclusion Criteria:

* Presence of inclusion criteria for more than 24 hours
* Immediate indication to start renal replacement therapy at the time of randomization: Hyperkalemia≥ 6.5 mmol /l, metabolic acidosis with pH \<7.15 not controlled by medical treatment, diuretic resistant acute pulmonary edema or accumulation of a toxic requiring dialysis.
* Formal indication of Nicotinamide supplementation according to the attending physician (eg pellagra, undernutrition, severe alcoholism)
* Known severe chronic kidney disease (clearance \<30 ml /min) in the last 3 months preceding the setic shock or kidney transplant recipient.
* Moribund patient (estimated survival less than 24 hours)
* Patient who are not expected to survive to day 30 due to terminal-stage disease (terminal respiratory or heart failure, Child C cirrhosis, uncontrolled cancer)
* Resuscitated cardiac arrest
* Pregnant or lactating
* Legal tutorship and guardianship
* Lack of social security coverage.
Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema

The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).

This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 years or older
* Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation).
* Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study
* Patient diagnosed with type 1 or 2 diabetes mellitus
* Patient who has been given appropriate information about the study and who has given his/her written, informed consent

Exclusion Criteria:

* Patient with other retinal disease at the time of inclusion
* Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept
* Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor)
* Patient taking part in an interventional study
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.

Ticagrelor is a novel, direct-acting, reversibly binding P2Y12 receptor antagonist. When related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. Current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in CAD patients. However, increasing evidence showed ticagrelor increased the risk of bleeding. Recent studies showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. So the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in Chinese patients with stable CAD.

Eligibility Criteria:
Inclusion Criteria:•

* Aged ≥18 years
* Subjects had documented with stable CAD
* Women were required to be postmenopausal or surgically sterile
* Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization
* Patients were required to discontinue aspirin at least 14 days before randomization.

Exclusion Criteria:

* Acute coronary syndrome
* Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period
* Platelet count \<10×10\^4/μL
* Hstory of bleeding tendency
* Diagnosed as respiratory or circulatory instability
* Allergy to ticagrelor or clopidogrel
Wound Infiltration and Breast Cancer Surgery

Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection

This is a prospective, double-blind, randomized, single centre study Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection are included in the study. Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality are excluded.

Patients are allocated randomly into two groups on the morning of surgery, using random numbers and sealed envelopes. general anaesthesia using propofol and sufentanil for induction, and sevoflurane In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under general anesthesia with propofol, sufentanil, sevoflurane and nitrous oxide for maintenance. Twenty milliliters of the allocated solution are used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision. Postoperatively, 8 tablets of paracetamol 500 mg were let at patient' disposal every 24 hours for 3 days. If pain control is not adequate patients receive 5 mg of subcutaneous morphine as a rescue.

Pain intensity is measured on a visual analogue scale graded from 0 to 100. Measurements are performed at rest and on operated arm abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery. The value of maximum abduction angle is noted.

To evaluate quality of life patients are asked to score on a 4 points scale graded from 0 (the worst) to 3 (the best) the following items: sleep - fatigue - global activity - relationship with relatives - state of mood. A global score is attributed to each patient as the sum of categorical scores. Evaluation is performed at 24, 48 and 72 hour after the end of surgery.

Patients are evaluated at two month for residual pain at rest and on movement using a visual analogue scale and for quality of life as previously defined.

Eligibility Criteria:
Inclusion Criteria:

* Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection

Exclusion Criteria:

* Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality
Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty

Evaluation of a new technique of liver retraction for the exposure of the His angle in gastric bypass Roux-en-Y surgery.

Obesity is a chronic disease of clinical treatment initially, but with precise surgical indications regulated by national and international health organizations. Among the surgical techniques, the gastric bypass Roux-en-Y is considered the "gold standard" for its efficiency and low morbidity and mortality. In gastric laparoscopic surgery it is necessary to move the liver in order to ensure adequate working space and a good view. Conventional laparoscopic retractors surgery are generally coarse, require an additional incision for its installation, or handling by an assistant during surgery and involve risk of liver injury. The objective of this study was to evaluate the efficacy of a flexible liver retractor in the exposure of the His angle in Roux-en-Y gastric bypass for morbid obesity. This was a prospective, controlled, open and comparative study, with 100 patients randomly divided into two groups (conventional and flexible retractor), with medical indication for bariatric surgery. Data were recorded during surgery in both groups for comparison of the two hepatic retraction techniques.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 - 65 years, both genders, with indication of bariatric surgery according to IFSO criteria.
* Agreed to participate and signed informed consent form.

Exclusion Criteria:

* Patients who did not agree to participate and / or any other condition that the investigator judged relevant for not participating in the study were excluded.
A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers

The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers aged between 18 and 45 years old;
* Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28);
* The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;

Exclusion Criteria:

* The participant were deemed unsuitable for participating in the study by the investigator for any reason.
Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

The main objective of the present study will be to establish whether a slow (within 160 days) or a rapid (within 60 days) withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure free for at least 2 years. Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries and death.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of focal or generalized epilepsy (according to International League Against Epilepsy 1989 criteria)
* age at epilepsy onset of 16 years or older
* seizure freedom for at least 2 years
* treatment with one of the antiepilepsy drugs currently available for monotherapy in Italy: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid zonisamide)
* adherence to the protocol and visit schedules.

Exclusion Criteria:

* inability to understand the aims or modalities of the study;
* current pregnancy or plans to become pregnant during withdrawal period;
* history of seizure relapse after discontinuation of treatment;
* history of psychogenic non-epileptic seizures (PNES);
* history of status epilepticus
Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis

The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain in women with endometriosis or adenomyosis.

Chronic pelvic pain(CPP) is a common disease among women, and its prevalence ranges from 4 to 25 percent. There are various conditions associated with CPP, including gynecologic, urologic and gastointestinal problems. Endometriosis is the most common diagnosis made at the time of gynecological laparoscopy performed to evaluate CPP. Treatments of CPP with endometriosis include medical(analgesics, oral contraceptive pills, gonadotropin releasing hormone(GnRH) agonist, etc.), surgical and combined treatment. Progestins, danazol, estrogen-progestin pills, or GnRH agonists are commonly used as a concurrent treatment along with surgery. However, a systematic review on the comparison of postsurgical hormonal suppression to surgery alone concluded that, while postoperative medical therapy decreased recurrence rates, there was no significant benefit on the outcomes of pain and pregnancy rates. Therefore there is a need for postoperaive medical therapy for pain relief. In this study, the investigators propose a randomized, sham-controlled trial to investigate the efficacy of acupuncture as a pain control for the patients dignosed endometriosis during laparoscopic surgery due to CPP, and have been on 6 month-scheduled GnRH agonist treatment as a postoperative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed pathologically of Endometriosis or Adenomyosis among those who had undergone laparoscopic surgery due to pelvic pain
* Patients who have been on GnRH agonist treatment for 6 months after being diagnosed Endometriosis or Adenomyosis
* Patients who agreed a written consent by their own will
* Patients' compliance and geographical adjacency appropriate for proper follow up survey
* continuous pelvic pain over VAS 5 during past 1 week on screening visit(after 6 weeks of surgery) (0='no pain', '10=most severe')

Exclusion Criteria:

* Those who had taken hormones or drugs that can affect diagnosis of endometriosis or adenomyosis for past 1 year
* Patients found to have malignant tumor of uterus and adenexa, PID or pregnancy during surgery
* Allergies to metal or contraindications for acupuncture treatment (ex: coagulopathy, epilepsy)
* Unable to participate in clinical trial by doctor's judgment
* irritable bowel syndrome
Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

This study intends to adopt the method of multi-center prospective randomized controlled study. The aim of this study is to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening.


Eligibility Criteria:
Inclusion Criteria:

* 1)Pregnant women assessed as at high risk of preeclampsia 2) live pregnancy 3) gestational weeks \< 16 weeks 4) agree to randomized drug intervention studies 5) follow up regularly and obtain reliable pregnancy outcomes

Exclusion Criteria:

* 1)with severe fetal or chromosomal abnormalities 2) induced labor or spontaneous abortion due to social factors 3) absolute or relative contraindications to aspirin use (allergy to aspirin or other salicylate, or other ingredients of the drug;Acute gastrointestinal ulcer;Active bleeding;In patients with severe G6PD deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia.Aspirin asthma)
Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With Multiple Sclerosis.

patient with multiple sclerosis will undergo and completed comprehensive survey measuring body mass index and assessment of obesity ,health related quality of life,disability,relapsing and complete data on their dietary habits.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 40 years of age
* males or females
* all cases of diagnosed multiple sclerosis under treatment or not

Exclusion Criteria:

* disable cases
* long standing disease more than five years.
Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)

The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.


Eligibility Criteria:
Inclusion Criteria

* Provide written informed consent before initiation of any study related procedures.
* Be at least 18 years of age.
* Be scheduled for CABG, CABG and single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study.

Exclusion Criteria

* Confirmed pregnancy at time of randomization via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
* Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
* Intracranial neoplasm, arteriovenous malformation or aneurysm.
* Dependency on renal dialysis or creatinine clearance \<30 mL/min.
* Ongoing treatment with warfarin (or other oral anticoagulant) at the time of randomization.

Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is \< 1.3 times control in the absence of heparin therapy.

* Known allergy to Angiomax or hirudin-derived drugs, or known sensitivity to any component of the product.
* Patients receiving clopidogrel (Plavix®) within the previous 5 days of randomization
* Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if abciximab (ReoPro®) or 24 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®) of randomization.
* Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to randomization.
* Patients receiving LMWH or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
* Refusal to undergo blood transfusion should it become necessary.
* Any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
* Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
* Planned (\>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.
A Population-based Prospective Study of Metastatic Colorectal Cancer (CRC) Patients in Finland

* A population-based prospective study to evaluate clinical behaviour, resectability and survival in 1st line metastatic colorectal cancer (CRC) patients in Finland
* Primary objective: To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
* Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy and targeted drugs with overall response rates (ORR), failure free survival (FFS), progression free survival (PFS), and overall survival (OS); To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and tumour block biomarkers and DNA polymorphisms that may predict drug effects, resectability and clinical behaviour of the tumour


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease
2. Age \> 18
3. Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy)
4. Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee \[IEC\]) will be obtained prior to study
5. No informed consent will be obtained from patients participating in the data collection study obtaining data from hospital charts. No blood sampling, nor contacting of patients will be performed.
Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis

To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis
Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH)

The purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across MUSC. The researchers in these labs will collect tissue, blood and saliva samples before surgery and during surgery to see if there are any changes in the samples. They will compare the changes in the samples to the clinical outcomes. Patients will also be given surveys to evaluate patient preferences, anxiety/distress, symptom severity, support by HPV status.

The primary objective of this exploratory, proof of concept study is to facilitate translational science spanning clinicians and basic scientists to obtain tissue samples, PDX models, and clinical data in order to successfully analyze tissue linked to clinical outcomes in head and neck cancer, resulting in the methodological and statistical framework for a larger scale clinical trial in the future. While the incidence of HNSCC has been steadily decreasing over the last thirty years, the incidence and prevalence of oropharyngeal cancer squamous cell carcinoma (OPSCC) and young patients with oral tongue cancer has increased in the face of an overall decline in smoking prevalence. Over the past few years, evidence has emerged that oropharyngeal cancer is rising in incidence so rapidly that it has been described as an "epidemic" and that it has or soon will surpass cervical cancer in both incidence and mortality. In fact, over 30,000 patients will be diagnosed with oropharyngeal cancer in the US per year, making it the most rapidly rising head and neck cancer in incidence. Despite this unique etiopathogenesis, treatment and toxicities related to treatment have not changed. This collaboration and interdisciplinary study will be the first of its kind to address these important issues of cancer site, HPV status, tobacco history, gender, age, and race using both patient tissue and PDX models to identify novel and unique biomarkers. Also, innate to this project is the link between five separate laboratories each conducting unique biomarker analysis.

Eligibility Criteria:
Inclusion criteria:

1. Age \> 18 years
2. Ability to sign informed consent
3. Newly diagnosed or recurrent oral cavity squamous cell carcinoma of the tongue (stage I-IVa) or oropharyngeal squamous cell carcinoma confirmed by pathology report. Patients with Unknown primary of the neck that is HPV+ are eligible.
4. Planning to undergo surgery as a part of definitive treatment

Exclusion criteria:

1. Squamous cell carcinoma metastasis to node(s) of neck with unknown primary tumor site that is HPV negative.
2. Already received some treatment, such as chemotherapy, radiation, or surgery for his/her disease at another institution when presenting to MUSC. An exception is neoadjuvant PD-1 blockade.
3. History of radiation therapy, for any indication, to the head and neck region