cyrilzakka/clinical-trials huggingface dataset:
A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.

Ankylosing spondylitis, radiographically negative axial spondyloarthritis, psoriatic arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, non-ocular Behcet's disease, and enthesitis-related arthritis are common diseases in rheumatology. Traditional anti-rheumatic drugs are less effective and have greater side effects than biological agents. At present, there has been no large-scale registration study on rheumatic autoimmune diseases such as spondyloarthritis in China. However, data such as patient characteristics, medication patterns, and patient outcome reports of different rheumatology diseases can often serve as a reference for rheumatology clinicians to reasonably select treatment methods for different patients. Therefore, a large-scale registration study is needed to fill the gap in multi-disease registration studies in rheumatology departments in China.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with rheumatic autoimmune diseases such as ankylosing spondylitis/radiologically negative axial spondyloarthritis/psoriatic arthritis/polymyalgia rheumatica/Takayasu arteritis/giant cell arteritis/ non-ocular Behcet's disease/ enthesitis-related arthritis;
2. Currently receiving or planning to receive fulvezinib treatment;
3. Can follow up according to the doctor's advice;
4. Able to understand and sign the informed consent form, understand the purpose of this study, and voluntarily participate in this study.

Exclusion Criteria:

1.Investigator believes will prevent the subject from following and completing the study protocol
A Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential Hypertension

A multicenter, randomized, double-blind, parallel, phase 2 study to explore the dose of HCP1803 in patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions

   * mean sitSBP \<180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
   * 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg at Visit 2

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1.
3. Secondary hypertensive patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with other reason
Flupenthixol Treatment in Schizophrenic Cocaine Abusers - 1

The purpose of this study is to evaluate the safety and efficacy of flupenthixol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.


Eligibility Criteria:
Please contact site for information.
Lidocaine Infusions for Rib Fractures

Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. In addition, they will receive other pain medications, such as acetaminophen, gabapentin, and opioid pain medications. Our primary outcome is a decrease in their opioid medication requirements.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 or older with 2+ rib fractures or \> 65 with 2+ rib fractures Enrollment within 16 hours of admission Inability to receive epidural placement or other catheter-based regional anesthesia (coagulopathy, anticoagulation, bacteremia or infection over epidural site, patient refusal, vertebral fracture, spinal cord injury, inability to cooperate with procedure, BMI \> 40) Isolated rib fracture (no other major injury or anticipation for invasive procedure)

Exclusion Criteria:

Inability to participate in traditional pain measures Severe alcohol withdrawal Chronic pain requiring opiates prior to admission GCS \< 13 or inability to report pain Medical instability Positive pressure ventilation, either via non-invasive mask or endotracheal tube Hemodynamic instability or shock Flail chest with clinical evidence of paradoxical rib motion Contraindication to lidocaine History of or current bradycardia (HR \< 50) or heart block (Mobitz II or 3rd degree) New onset or uncontrolled seizures Allergy to amide-type local anesthetic

Enrollment in other study that may affect the results of this study
Exceptional Responders With Solid Tumor Cancer to Chemotherapy

This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.

This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of solid tumor carcinoma.
* Patient is treatment-naïve or currently receiving chemotherapy.
* ECOG performance status (any).

Exclusion Criteria:

* HIV positive on antiretroviral therapy
* Pregnant or lactating
* Prior organ allograft
* Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults

MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial. The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ASCVD).

For the MITIGATE study, eligible members receiving care within Kaiser Permanente Northern California (KPNC) will be identified and screened electronically in a 1:10 intervention to control allocation (i.e., IPE vs. usual care) stratified by age and pre-existing respiratory status. Patients randomly assigned and enrolled into the intervention arm will be asked to take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion. Patients assigned to the control arm (i.e., usual care) will be passively followed only electronically via the electronic health record (EHR).

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent (for the intervention arm only)
* No prior history of confirmed COVID-19 (i.e., based on a positive FDA-approved assay for SARS-CoV-2 and no documented FDA-approved serological test results for antibodies to SARS-CoV-2 found in health system databases)
* Established ASCVD (i.e., defined as prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, ischemic stroke, and/or peripheral artery disease)
* At least 12 months of continuous health plan membership and prescription drug benefit prior to enrollment
* A registered e-mail address with the health care delivery system in order to facilitate obtaining electronic consent for study participation

Exclusion Criteria:

* Receipt of IPE on or within 12 months before the day of enrollment
* Known hypersensitivity to IPE, fish, and/or shellfish
* Documented use of any omega-3 fatty acid medications or dietary supplements containing omega-3 fatty acids in the EHR
* Women who are pregnant or planning to become pregnant
* Hospitalization for myocardial infarction and/or elective percutaneous coronary intervention within the past 1 month
* Currently receiving triple anti-thrombotic therapy
* Stage D heart failure
* Severe liver disease
* End-stage renal disease requiring chronic dialysis or estimated glomerular filtration rate \<15 mL/min/1.73 m2
* Metastatic cancer and/or receiving active systemic chemotherapy
* Institutionalized and/or receiving palliative care
Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

The purpose of this study is to compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect.

Patients with recent-onset CRVO (lasting for less than 1 month)are randomly assigned to one of 3 groups: hemodilution using erythrocytapheresis alone, 3 monthly injection of ranibizumab alone, or both.

Patients are followed monthly during the 6-month study.

Eligibility Criteria:
Inclusion Criteria:

* CRVO confirmed by fluorescein angiography
* duration from onset of 1 month or less
* visual acuity of 20/32 or less

Exclusion Criteria:

* neovascular complication
* extensive retinal ischemia requiring prompt panretinal photocoagulation
* hematocrit level lower than 38%
* previous laser or surgery in the study eye, etc
Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma

The purpose of this study is to determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility Criteria:
Inclusion criteria:

* Must have diagnosis of relapsed or refractory multiple.
* bone marrow function \[ANC (absolute neutrophil count) greater than 1000/mm3\]; platelet count greater than or equal to 75,000/mm3.
* renal function (calculated creatinine clearance \>50 mL.min, albumin less than or equal to 500 mg).

Exclusion criteria:

* Failed more than 3 prior lines of therapy including stem cell transplant.
* Females who are pregnant or nursing.
* Unstable blood pressure.
* Significant heart conditions or history of thrombosis.
* Any unstable, pre-existing major medical condition or history of other cancers.
* Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
Non-Invasive Model for Fibrosis Regression in HBV Patients

A total of 1000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are retrospectively enrolled. All the patients received NAs treatment. Blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers were collected. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death were collected. Fibrosis regression prediction model based on dynamic changes in liver stiffness will be developed based on the retrospective cohort. An independent cohort of CHB patients with liver biopsy performed at least 1 year after antiviral therapy will be retrospectively enrolled for model validation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with liver biopsy performed at least 1 year after antiviral therapy;
* Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment.

Exclusion Criteria:

* Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy;
* Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases;
* Patients with malignant lesion on liver image;
* Patients with other uncured malignant tumors;
* Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases;
* Pregnant or lactating women;
* Patients with any other reasons not suitable for the study.
Effect of High Monounsaturated Fat Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes

The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.

The incidence of type 2 diabetes has increased steadily over the last three decades. Although medical nutrition therapy is an integral component of diabetes management, nutrition recommendations for diabetes have often been based on clinical experience and expert consensus, rather than on carefully controlled clinical trials. The expert consensus on medical nutrition therapy is that carbohydrate and monounsaturated fat together should provide approximately 60-70% of total energy intake. This recommendation accommodates parties on both sides of a debate over what constitutes the optimal macronutrient composition of a diet for type 2 diabetic patients. On one side are proponents of high carbohydrate, low fat diets who contend that this regimen promotes the lowering of total- and LDL-cholesterol and is less calorically dense than diets containing a higher percentage of fat. On the other side are advocates of high monounsaturated fat, Mediterranean-type diets who cite data from short-term studies indicating that this approach decreases postprandial levels of plasma glucose, insulin, and triglycerides, and increases HDL-cholesterol more than isocaloric high carbohydrate diets. However, there is concern about the potential for high fat diets to increase energy intake and weight gain among free-living subjects. To make definitive, scientifically-based diet recommendations, it is essential that controlled long-term trials be conducted to demonstrate the health effects of specific percentages of monounsaturated fats and carbohydrates in the diets of persons with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 27-40 kg/m2
* 30-75 years of age
* Stable body weight for the preceding 6 months
* Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
* HbA1c of 6.5 to 9.0
* Treatment by diet or oral agents only

Exclusion Criteria:

* Pregnancy or lactation
* Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
* Untreated thyroid disease or hypertension
* Hypertriglyceridemia with levels of TG \> 500 mg/dl
* Use of insulin
* Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
* Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).
A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)

An Open-Label, multicenter study in male pediatric patients with cerebral x-linked adrenoleukodystrophy (cald) to assess the effects of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)


Eligibility Criteria:
Inclusion Criteria:

* Males aged ≥2 and ≤12 years with a diagnosis of X-linked ALD
* White matter involvement as determined by cerebral MRI lesions without Gd enhancement at baseline (Population 1), or with Gd enhancement at baseline (Population 2).
* Major Functional Disabilities (MFD) score of 0.
* Baseline Loes score \>0 and ≤10
* Gadolinium Intensity Score \>2

Exclusion Criteria:

* Previous HSCT
* Too far progressed inflammatory brain lesions
Glycaemic and Insulinaemic Responses After Consumption of FOS.

The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 25.0 kg/m² (included)
* Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit
* Be used to have breakfast
* Non-smoker for at least 3 months
* For the female participant: not being pregnant or breastfeeding and using efficient birth control
* Signed the consent form
* Able to follow the instructions of the study
* Health insured
* Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).

Exclusion Criteria:

* Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not)
* Fasting blood cholesterol over 6.35 mmol/L
* Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma)
* Fasting blood insulin under 20 mU/L
* Fasting HbA1c under 7%
* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not
* History of dietary allergies or coeliac disease
* History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease
* Somatic or psychiatric disorders
* Renal insufficiency (kidney failure)
* SGOT or ALAT over 52.5 U/L
* Smoker
* Consuming more than 3 alcoholic beverage a day
* Weight varied 3 kg the last 3 months
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

This trial is conducted in Europe, North America and the United States of America.

The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Male or female equal to or above 18 years of age
* HbA1c (glycosylated haemoglobin) 7.0 - 10.0% \[53 mmol/mol - 86 mmol/mol\] (both inclusive), confirmed by the central laboratory
* Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
* Body Mass Index (BMI) below or equal to 40 kg/m\^2

Exclusion Criteria:

* Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
* Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
* Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
* Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
* Screening calcitonin above or equal to 50 ng/L
* Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* History of pancreatitis (acute or chronic)
Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus

The purpose of this study is to determine effectiveness of parents' manipulation in newborn with talipes calcaneovalgus over observation group.

Talipes calcaneovalgus is one of the common foot deformity in newborn. Most of patients can be cure without specific treatment. Manipulation was easy method that parents can preform by their own and may be beneficial in speeding resolution of deformity.

Eligibility Criteria:
Inclusion Criteria:

* all newborn with talipes calcaneovalgus

Exclusion Criteria:

* patient associated with congenital musculoskeletal anomaly
* patient with other serious medical condition