cyrilzakka/clinical-trials huggingface dataset:
SmartRisk Stroke Prediction by MRI of Carotid Disease

Atherosclerotic plaque at the carotid artery bifurcation is a major source of stroke. The purpose of this investigation is to determine the ability of the SmartRisk software module to predict stroke or stroke-related events due to carotid plaque within a high-risk population. The SmartRisk software module operates on magnetic resonance images (MRI) of the carotid artery wall.

Carotid artery disease (atherosclerosis) is a major cause of stroke that can be treated with carotid endarterectomy surgery (CEA) or stenting. Subjects with moderate, asymptomatic stenosis (50-79% narrowing) typically do not undergo intervention because the procedural risks outweigh the benefits. However, some of these individuals will have vulnerable plaque that places them at high risk of stroke, but current diagnostic techniques for vulnerable plaque are lacking. Recently, VPDiagnostics developed a new module - SmartRisk - that stratifies risk of stroke for stenotic (50-79% blockage) atherosclerotic plaque. The SmartRisk module uses MRI data to compute a risk assessment from a specific atherosclerotic plaque. A continuous risk value is generated and patients with risk values above a prespecified threshold are at elevated risk for cerebrovascular events arising from carotid artery disease. The purpose of this trial is to determine whether the SmartRisk module is effective at stratifying risk of a carotid-related cerebrovascular event in subjects with asymptomatic 50-79% carotid stenosis.

Eligibility Criteria:
Inclusion Criteria:

* 50-79% stenosis of the carotid artery
* age 18 or older
* no ischemic neurovascular symptoms within preceding 6 months

Exclusion Criteria:

* contraindication to MRI (e.g. weight \> 130 kg, pregnancy)
* prior or planned carotid endarterectomy or stenting
* history of atrial fibrillation
* prior neck irradiation
Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids

Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before.

The investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic grade I - III hemorrhoidal disease

Exclusion Criteria:

* Chronic liver disease
* Use of class 3 antiarrythmics
* Coagulopathy
* Grade IV hemorrhoidal disease
* Inflammatory bowel disease
* Pregnancy
A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy confirmed advanced/metastatic solid tumors of the following types: invasive ductal or lobular breast carcinoma (all histological and intrinsic subtypes), non-small cell lung cancer (NSCLC, all subtypes), gastrointestinal squamous cell or adenocarcinomas (including pancreatic cancer), bladder cancer, renal cell carcinoma, melanoma, and soft tissue sarcoma (all subtypes), who require and are being planned for palliative radiation therapy to at least one site of RECIST-measurable extracranial metastastic disease. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines.
* Patients with at least one additional site of RECIST-measurable extracranial metastasis measuring at least 4 cm in one axis and suitable for elective palliative radiation therapy. Patients should be asymptomatic or minimally symptomatic (e.g controlled by oral pain medications) and not in urgent need for palliation to this site of elective experimental treatment.
* Age ≥ 18 years
* ECOG Performance Status of 0 or 1.

Exclusion Criteria:

* Patients who are pregnant or breastfeeding
* Prior radiation therapy to the candidate metastatic sites under consideration for treatment ("re-irradiation" is disallowed).
* Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
* Patients with a "currently active" metastatic second malignancy.
* Patients on oral or parental corticosteroids. Physiological doses of steroids are permitted (eg for patients with adrenal insufficiency). If patients are on supraphysiological doses of steroids, these must be discontinued and held during the period of the study.
* Concomitant anti-neoplastic treatment is not allowed during the days of radiation treatment delivery and should be completed or held for 3 days prior to commencement of protocol treatment and for 3 days following completion of radiotherapy, or with resolution of associated acute toxicities.
* Unwilling or unable to participate in all required study evaluations and procedures.
* Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Structuring of Diabetes Care in Primary Health Care

The aim of this study is to evaluate the effectiveness of reorganization in Primary Health Care teams and individualized glycemic targets for type 2 diabetes.

The prevalence of diabetes is increasing in parallel with the obesity epidemic. Diabetes is, therefore, a costly disease for individuals and healthcare system, generating expenses in its management and its complications. Also, it has significant social cost related to reduction of productivity. This study will evaluate the effectiveness of a multimodal intervention for Primary Health Care (PHC) teams to increase the nurse clinical role and implement individualized glycemic targets and care plan for type 2 diabetes through a pragmatic cluster-randomized clinical trial, with 1:1 allocation of health units in Porto Alegre, Brazil. Two study arms will be evaluated: 1) intervention group: will receive a set of proposed actions (redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of care recommendations); 2) control group: usual follow-up in PHC.

Eligibility Criteria:
Health care unit:

Inclusion criteria

* Health unit has registered at least 50 users diagnosed with type 2 diabetes

Exclusion criteria:

* Health units that do not have a doctor and a nurse available on the same shift or do not have at least one doctor and a nurse willing to participate in the study.

Individuals:

Inclusion criteria

* Individuals with type 2 diabetes for at least one year
* In person diabetes consultation in the last six months

Exclusion criteria:

* Expected survival \< one year
Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.

To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes.

The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response.

Eligibility Criteria:
Inclusion Criteria:

Eligibility criteria were:

1. Not indicated for resection,
2. Liver function of Child-Pugh class A or B,
3. 3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter,
4. No portal vein involvement or extrahepatic metastasis,
5. Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct,
6. Platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and
7. No previous HCC treatment.

Exclusion Criteria:

Exclusion criteria were:

1. Encephalopathy,
2. Refractory ascites,
3. Active gastrointestinal bleeding,
4. Renal failure.
A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)

To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering

A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.

Eligibility Criteria:
1. Signed written informed consent before any study procedure is performed.
2. Male or female, 18 years ≤ age ≤ 75 years.
3. BMI ≤ 40kg/m2.
4. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout.
5. History of ≥2 gout flare within 12 months prior to screening.
6. Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening
Study on the Fetal Safety of New Coronavirus Vaccination for Couples During the Peri-pregnancy Period

All the pregnant women and newborns of both or one of the couples who gave birth in Ditan hospital were collected as the observation group, and the pregnant women and newborns of both husband and wife who gave birth in our hospital without new crown vaccine during pregnancy were collected as the control group. The incidence of adverse events during pregnancy of the two groups and the incidence of intrauterine development and congenital malformations of the two groups were observed to observe the physical and intellectual development of children in the two groups at the age of 1 year, and to explore the safety of perinatal neocrown vaccination.

This study is a prospective observational cohort study. All the pregnant women and newborns of both or one of the couples who gave birth in Ditan hospital were collected as the observation group, and the pregnant women and newborns of both husband and wife who gave birth in our hospital without new crown vaccine during pregnancy were collected as the control group. The incidence of adverse events during pregnancy of the two groups and the incidence of intrauterine development and congenital malformations of the two groups were observed to observe the physical and intellectual development of children in the two groups at the age of 1 year, and to explore the safety of perinatal neocrown vaccination.

Eligibility Criteria:
Inclusion Criteria:

* The pregnant women and newborns who were injected with the new crown vaccine during the perinatal period of both husband and wife or one of them were the observation group, and the pregnant women and newborns who were not vaccinated with the new crown vaccine during the perinatal period of both husband and wife were the control group. They were fully informed of the risk, voluntarily joined the study and signed the informed consent.

Exclusion Criteria:

* Both husband and wife or family have previously delivered congenital abnormal fetus;
* Neither husband nor wife was willing to participate in this study.
A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]

The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 40 years old at the time of signing the informed consent.
* Participants with Lp(a) ≥175 nmol/L at screening, measured at the central laboratory
* Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to screening and randomization and expected to remain on a stable regimen through the end of the Treatment and Assessment Period:

  * lipid-lowering drugs
  * testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
  * Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.

Male and/or Female

* Males who agree to use highly effective/effective methods of contraception may participate in this trial.
* Women not of childbearing potential (WNOCBP) may participate in this trial.

Exclusion Criteria:

* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
* Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:

  * major surgery
  * coronary, carotid, or peripheral arterial revascularization
  * stroke or transient ischemic attack
  * myocardial infarction or unstable angina
  * acute limb ischemia
* Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes.
* Have uncontrolled hypertension
Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture

Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.


Eligibility Criteria:
Inclusion Criteria:

Patients admitted to Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study.

Exclusion Criteria:

Exclusion criteria include

* age under 18
* allergy to TA
* known current or history of venous thromboembolism (VTE)
* history of known coagulopathy or bleeding disorder
* current subarachnoid hemorrhage
* previous history of seizures
* current use of estrogen/progesterone therapy
* renal failure defined as creatinine clearance less than 30 ml/min4
* multiple fractures
* pregnant or breastfeeding women
* planned nonoperative management of the fracture
Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. It is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. We conducted this study to see the analgesic effect of TAP block after caesarean section.

The study is being conducted, at Combined Military Hospital Sargodha, Pakistan, to compare the analgesic efficacy of TAP block in providing post-caesarean analgesia with the control group, in terms of mean postoperative use of opioids after caesarean delivery. Sixty patients have been randomly selected using non-probability, consecutive sampling, and applying inclusion and exclusion criteria. The study design is a randomized controlled trial with thirty patients in each group undergoing elective caesareans. All patients will be given spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section. Patients in Group A will receive bilateral TAP block with 20ml of 0.25% bupivacaine while 20 ml of saline will be injected in patients of Group B on both sides of midline after caesarean section, in addition to intravenous ketorolac 8hrly. The intensity of pain, total opioid consumption, presence of vomiting, and sedation will be noted until 24 hours after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective Caesarean section
* ASA 1-3
* 20yrs to 45yrs

Exclusion Criteria:

* Emergency Surgery
* known allergy to local anaesthetic
* severe pre-eclampsia
* placenta accreta
* ASA 4
* Coagulopathy
* Hemodynamically unstable
"The Evaluation of Stimulant Withdrawal"

The purpose of this research study is to determine whether Carvedilol, an FDA approved beta blocker, when administered for an 8-week period to veterans currently undergoing treatment for methamphetamine dependence (1) improves their ability to stay in treatment longer, (2)eases the aversive symptoms that accompany stimulant withdrawal, and (3) increases the time they remain abstinent from methamphetamine.


Eligibility Criteria:
Inclusion Criteria:

* Must have entered treatment into the outpatient Clinical Addiction Rehabilitation Section (CARS) through the US Portland Veterans Affairs Medical Center
* Must meet the clinical definition for methamphetamine dependence
* Self-reported methamphetamine use within 10 days of entering the study
* Must be able to understand and sign the consent form

Exclusion Criteria:

* Dependent on any other drug except nicotine, caffeine, marijuana and alcohol
* Pregnant or nursing mothers
* Psychosis
* Dementia
* Any serious medical condition that could be aggravated by the study protocol (Allergic reaction, Hypotension, Asthma, Bronchospastic conditions, Angina, Bronchitis, Emphysema, Bradycardia, Heart or blood vessel disease, Diabetes mellitus, Low blood sugar, Kidney disease, Liver disease or Overactive thyroid)
* History of withdrawal seizures or delirium tremors
* Use of MAO inhibitors within the last two weeks
* Considerable hepatocellular injury, including cirrhosis of the liver or liver function test levels higher than 2 times normal
Far Infrared Irradiation for Managing, Control and Treatment of Huntington's Disease (HD)

Huntington's disease (HD) is a fatal disease with profound neurological and behavioral features. HD is typically characterized by uncontrollable movements and psychological disturbances.

This study will investigate the use of far infrared radiation for control, management and treatment of HD.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have HD.

Eligibility Criteria:
Inclusion Criteria:

* People with HD

Exclusion Criteria:

* None
Absolute Bioavailability Study With Bexagliflozin

The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.


Eligibility Criteria:
Inclusion Criteria:

* body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
* no nicotine and tobacco consumption in the past 3 months
* willing and able to be confined to the clinical research facility as required by the protocol

Exclusion Criteria:

* clinically significant history of allergy to drugs or latex
* history of alcohol or drug dependence in the past 12 months.
* donation of a significant amount of blood in the past 2 months
* willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic
* exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation

The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.

This study was a first-in-human, open-label, non-controlled single ascending dose study of KTP-001 in male and female subjects between the ages of 30 and 70 years with a single herniated lumbar disc. After obtaining informed consent, subjects were evaluated during a screening period of no more than 3 weeks (21 days). This study was conducted in 10 centers in the US.

Subjects that met all screening requirements and inclusion criteria and none of the exclusion criteria were enrolled into the study. Overall, 24 subjects were enrolled and treated: 6 subjects in each cohort. Cohort 1 received a 5 μg/disc dose of KTP-001 by intradiscal injection. Following administration of study drug, subjects were confined to the study center for 24 hours to collect data for safety and efficacy measures and collect blood samples for safety, PK evaluation, exploratory PD and anti-KTP-001 antibody and then returned for further assessments at various intervals from weeks 1 through to month 24.

After all subjects in Cohort 1 had received study drug, safety measures were evaluated by a Data and Safety Monitoring Board (DSMB) to determine whether to escalate KTP-001 administration to the next dose level. If appropriate, Cohort 2 subjects received 15 μg/disc of KTP-001, Cohort 3 subjects received 50 μg/disc of KTP-001, and Cohort 4 subjects received 150 μg/disc of KTP-001 by intradiscal injection. All safety, PK, and exploratory efficacy assessments were performed for the subjects in the subsequent cohorts as were performed for Cohort 1.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had a single contained or noncontained (extruded) lumbar disc herniation (L3-L4, L4-L5 or L5-S1) diagnosed by clinical symptoms and/or physical findings and confirmed by MRI.
* Subject has leg pain with a documented positive straight leg raise (SLR) test or femoral stretch test (FST).
* Subject has experiences herniated disc symptoms for at least 6 weeks prior to the study without relief with pain medications and other therapies.
* Subject has a BMI of 18 to 35 kg/m2

Exclusion Criteria:

* Subject has a sequestered lumbar disc herniation or intrathecal herniation confirmed by MRI
* Subject has two or more symptomatic lumbar disc herniations
* Previous intradiscal therapeutic intervention or has had any lumbar surgery
* Presence of lumbar spine disease and/or deformity other than a lumbar disc herniation
* Active smoker or is unable to abstain from tobacco use for 2 weeks prior to study injection
* Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease