cyrilzakka/clinical-trials huggingface dataset:
Application of Polygenic Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer

This study dynamically monitored the prognosis of stage I-IV colorectal cancer patients who could receive radical surgical resection by detecting the levels of polygene methylation in plasma samples from patients with colorectal cancer. In patients with colorectal cancer feasible radical surgery, plasma ctDNA methylation detection was performed before and after surgical treatment and during regular follow-up to explore the predictive effect of plasma ctDNA methylation status at different time points on postoperative recurrence. To explore whether postoperative dynamic monitoring of plasma ctDNA methylation can be used for adjuvant chemotherapy efficacy evaluation and whether it can indicate tumor recurrence and metastasis earlier than imaging examination.

1. Patients initially diagnosed with primary colorectal cancer were enrolled for screening, and plasma samples 1-2 days before radical bowel resection were collected for polygene methylation detection.
2. The postoperative follow-up was 2 years, and the reexamination included CT/MRI imaging assessment, blood CEA, and dynamic monitoring of plasma ctDNA methylation level. Blood samples were collected for 9 times.
3. Results analysis: To explore the application value of ctDNA methylation-MRD detection in the prediction of postoperative tumor recurrence risk after radical resection of colorectal cancer; The correlation between preoperative ctDNA methylation level and prognosis of early colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type);
2. Patients diagnosed as stage I-III and feasible for radical bowel surgery;
3. Patients diagnosed by stage IV (only colorectal cancer patients with liver metastasis at the time of diagnosis) and feasible radical bowel resection or complete resection of liver metastasis;
4. No gender limitation, age ≥18;
5. ECOG score ≤1;
6. Life expectancy ≥5 years;
7. Those who fully understand the study and voluntarily sign the informed consent.

Exclusion Criteria:

1. Blood transfusion was performed during surgery or 2 weeks before surgery;
2. complicated with primary malignant tumors of other organs;
3. With colonic obstruction, intestinal perforation and other symptoms requiring emergency treatment;
4. Colorectal cancer was diagnosed with extrahepatic metastasis;
5. Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection;
6. Radical bowel resection was performed after endoscopic surgery;
7. Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer;
8. serious mental illness or drug abuse;
9. patients with serious heart, lung and vascular diseases who cannot tolerate surgery;
10. pregnant or lactating women;
11. Participate in other interventional clinical investigators within 3 months
12. Poor compliance, unable to complete the study according to the judgment of the researcher.
Routine or On-demand Fentanyl in Colonoscopy

Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely administered in most countries. In Norway, however, routine sedation is rare, and medication is normally given on demand, that is, if necessary during the procedure. The investigators want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of action, is better given before the procedure than during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Referred for out-patient colonoscopy

Exclusion Criteria:

* ASA-score 3 or higher
* Same day upper endoscopy
* Pregnancy
* Pacemaker
* Patient require medication before colonoscopy
* Previous resection of colon or rectum
* Significant psychiatric morbidity
* Oxygen saturation \< 95% without supplementary oxygen
* Contra indications to fentanyl
* Inability to sign inform consent
* Inability to understand information about the trial
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

The purpose of this study is to assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).


Eligibility Criteria:
Inclusion Criteria:

* Subject weighs \>=40 kg
* Subject has completed at least one dose step in SP1006, a previous study of rotigotine in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria
* Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study drug
* Subject is expected to benefit from participation, in the opinion of the investigator

Exclusion Criteria:

* Subject is experiencing an ongoing serious Adverse Event (SAE) that is assessed to be related to rotigotine by the investigator or Sponsor
* Subject has active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at the final evaluation visit of the previous rotigotine study (ie, Visit 10 of SP1006)
Macitentan to Prevent PRVO

About half of patients who suffer of a pulmonary embolism (blood clots in the lungs), do not clear completely the clots overtime, increasing the risk of having a new blood clot in the lungs and elevated blood pressure in the pulmonary artery; therefore, developing fatigue, shortness of breath, and heart failure.

The objective of this clinical trial is to compare 3 months of daily Macitentan (a medicine to increase the diameter of the pulmonary artery) in addition to blood thinners vs. blood thinners alone in patients with acute blood clots in the pulmonary artery:

Question 1: Whether the use of Macitentan in addition to blood thinners enhances the process of cleaning the blood clot in the pulmonary artery compared to blood thinners alone.

Question 2: Whether the use of Macitentan in addition to blood thinners is associated to improve the fatigue and shortness of breath in patients after a pulmonary embolism compared to blood thinners alone.

Participants will be asked to take a capsule for 3 months in addition to blood thinners. The capsule could contain either Macitentan (medicine) or a placebo (not medicine). In 3 months, participants will have a new image of the pulmonary artery to document the cleaning of the clots. Also, blood and urine samples will be collected, as well as a questionnaire will be filled out. In 6 months, patients will have repeated images of the heart as well as repeated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old.
* Acute high-risk or intermediate-risk PE diagnosed by CTPA within 28 days prior to enrollment

Exclusion Criteria:

* Contraindication for anticoagulation
* Allergy or contraindications to Macitentan or any other endothelin receptor antagonist.
* Surgical interventions to treat PE including catheter-directed thrombolysis, catheter-based thrombectomy, or surgical pulmonary embolectomy.
* Known inherited or acquired hypercoagulable states
* History of pulmonary embolism prior to index PE
* History of pulmonary hypertension including Group 1 (Primary pulmonary hypertension), Group 2 (secondary to left heart disease), Group 3 (secondary to lung disease), Group 4 (Chronic thromboembolic pulmonary hypertension)
* Severe chronic obstructive pulmonary disease
* Severe uncontrolled asthma
* Pregnancy or fertility treatment
* Breastfeeding
* Life expectancy is less than 6 months
* History of radiation therapy to the chest
* Current or previous use within 90 days of an endothelin-receptor antagonist, prostacyclin analogue, phosphodiesterase type 5 inhibitor, or nitric oxide donor.
* Severe allergic reaction to iodine contrast
* Subjects receiving CYP3A4 and CYP2C9 inhibitors or inducers such as rifampin, ritonavir, fluconazole, amiodarone
* Not able to read or understand the English language
Scalp Acupuncture for Dyskinesia After Ischemic Stroke

Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture.

A randomized, controlled, parallel, clinical trial. 116 ischemic stroke patients will be collected with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 15° and an insertion depth of 25-35 mm in the motor areas of the scalp. Twisting speed will be 200 times per minute. Acupuncture will be performed six times per day in 1-minute bouts, with a 4-minute rest following each bout. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline.

The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine.

Eligibility Criteria:
Inclusion Criteria:

* Meet to criteria for diagnosis and efficacy evaluation of stroke, formulated by The State Administration of Traditional Chinese Medicine Encephalopathy Emergency Cooperative Group in 1996 (trial implementation)

  * Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China in 2014 (Neurology Branch of Chinese Medical Association and Cerebrovascular Disease Association of Neurology Branch of Chinese Medical Association, 2015)
  * Ischemic stroke diagnosed by CT or magnetic resonance imaging (MRI), with the presence of stable vital signs and awareness
  * An age of 40-70 years Onset within 1-6 months
  * Motor dysfunction in the extremities
  * A Mini-Mental State Examination (Pangman et al., 2000) score \> 24 points

Exclusion Criteria:

* Consciousness disorder or severe cognitive impairment

  * Severe Parkinson's disease, heart disease, cancer, epilepsy, or chronic alcoholism
  * Hepatic or renal impairment
  * Hemorrhagic tendency
  * Sensitivity to acupuncture
  * Congenital disability
  * Pregnancy
  * Currently participating in other clinical trials
Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
* Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
* Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
* Body mass index (BMI) below or equal to 40 kg/m\^2

Exclusion Criteria:

* Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
* Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
* Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
* Life-threatening disease (e.g. cancer)
A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease

This study is evaluating the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild to moderate Alzheimer's disease.

This is a randomized, double-blind, dose-comparison concurrent control study to assess the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered by intravenous (IV) infusion to subjects with mild to moderate Alzheimer's disease.

Subjects will be randomized 1:1 to a low dose or a high dose of active treatment in a double-blind manner. All subjects will receive one infusion per day at the randomized dose for 5 consecutive days during Week 1 and, again, during Week 13 (for a total of 10 doses per subject). All IV infusions will take place at an inpatient research unit while the follow-up visits after each treatment period will be on an outpatient basis. Subjects will participate for a total of 6 months in this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
* MMSE Score 12-24 inclusive
* Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4
* Provided a signed and dated informed consent form (either the subject and/or subject's legal representative as well as the trial partner)

Exclusion Criteria:

* Evidence of clinically relevant neurological disorder(s) other than probable AD
* History of blood coagulation disorders or hypercoagulability; any concurrent use of an anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
* Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine, Axona, vitamin E supplementation or selegiline within 3 months prior to screening.
* Heart disease (or history thereof), as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure (New York Association Class II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood
* Prior hypersensitivity reaction to any human blood product or intravenous infusion; any known clinically significant drug allergy.
* Treatment with any human blood product, including transfusions and intravenous immunoglobulin, during the 6 months prior to screening.
* History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke, anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.
* Hemoglobin \<10 g/dL in women; and \<11 g/dL in men.
Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension

In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be studied.


Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of entry criteria for the preceding yearly study
* Male or female patients aged between 20 and 85 years
* Known history of mild to moderate essential hypertension requiring drug treatment, WHO grade I to II
* Controlled blood pressure (RR diastolic ≤ 90 mm Hg or 91 - 95 mm Hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day
* Final visit of the previous yearly study (Visit 4) completed as scheduled
* Informed consent to participate in the follow-up study

Exclusion Criteria:

* Violation of entry/exclusion criteria on enrolment in the preceding yearly study
* Occurrence of the following exclusion criteria in the intervening period:

  * Pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception
  * Secondary form of hypertension
  * Consumptive illness
  * Clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (NYHA Class III or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia
  * Myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study
  * Hypersensitivity to dihydropyridines
  * Concomitant long-term treatment (\> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants
  * Suspected alcohol, narcotic or drug abuse
CDI-988 Safety Study in Healthy Participants

The goal of this clinical trial is to learn about the safety and pharmacokinetics (PK, the amount of drug in the blood) of a new drug called CDI-988 in healthy volunteers.

The main questions it aims to answer are:

* Are there any side effects of the drug?
* What is the amount of drug that reaches the bloodstream? Participants will be assigned by chance to take either CDI-988 or placebo by mouth and have physical exams, electrocardiograms (ECGs), vital signs, and blood tests to look for any side effects.

CDI-988 is a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) 3-chymotrypsin-like (3CL) protease inhibitor for oral administration. This study is being conducted in 2 parts to examine the safety, tolerability, and PK of CDI-988 in healthy participants. Part 1 will entail escalating single doses in sequential cohorts and Part 2 will enroll escalating multiple-dose cohorts. Participants will be monitored for adverse events, vital signs, laboratory values, and electrocardiograms (ECGs).

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating females
* Body weight of at least 45 kg.
* Body mass index ≥18.0 and ≤32.0 kg/m2
* Good state of mental and physical health
* Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test

Exclusion Criteria:

* Received an investigational drug within 30 days
* Received a coronavirus disease 2019 (COVID-19) vaccine within 7 days
* Drug or alcohol abuse in the past 12 months
* Clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test results
* Clinically significant abnormal ECG or vital signs
Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery

Opioids are prescribed for moderate to severe pain disorders; however, there are contraindications and side effects that are common to all opioids. The investigators hypothesize using regional anesthetic during sinus surgery will reduce surgical pain, therefore decreasing the need for post-operative opioid medication. The primary of objective is to determine if a long-acting local regional anesthetic applied during a surgery will reduce post-operative oral opioid usage.

Opioid analgesics are prescribed for moderate to severe acute pain; however, there are contraindications, cautions, and side effects that are common with all opioids. Dependence and tolerance are also likely with regular opioid use, resulting in the current nationwide opioid epidemic. In Alabama alone, there were 343 opioid-related overdose deaths in 2016, 124 of which were related to prescription opioids. Alabama providers have the highest prescribing rate in the country, nearly twice the national rate, per the NIH/NIDA website. In 2015, the Centers for Disease Control (CDC) released prescribing guidelines relating to chronic pain, and in 2018 Alabama's Blue Cross/Blue Shield insurance group limited the supply of opioids allowed to their members to 7 days.

There is currently no clinical guideline for prescribing post operative opioid medications for functional endoscopic sinus surgery (FESS). A 2018 survey documenting prescribing patterns by 168 members of the American Rhinologic Society found that most physicians who participated prescribed, on average, 27 opioid pain pills for patients after surgery. Prior studies have been performed to help decrease the pain patient's feel after sinus surgery. Haytoglu in 2016 revealed that adding non-absorbable sinus packs loaded with local anesthetics such as bupivacaine achieved less pain values and improved patient satisfaction scores.

Given this current data the investigators believe injecting patients with a long acting analgesic during the procedure will help reduce post-operative pain. If the investigators can decrease the amount of pain patients have in the post-operative period, they can theoretically decrease the number of opioid pain pills prescribed. The investigators plan to also track the number of opioid pills consumed by patients in the post-operative period to obtain a somewhat uniform prescribing pattern within surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to sign informed consent form
* Able to comply with all study procedures and availability for the duration of the study
* Able to speak English
* Diagnosis of chronic rhinosinusitis
* Scheduled to receive functional endoscopic sinus surgery (FESS) at UAB

Exclusion Criteria:

* Current use of opioid medication
* Known allergic reactions to components of the study intervention
* History of IV drug use or abuse
* History of opioid abuse
* History of chronic pain disorder
* Treatment with another investigational drug or other intervention within 30 days