cyrilzakka/clinical-trials huggingface dataset:
Study of Aldafermin (NGM282) in Participants With Impaired Renal Function

This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Renal Function.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate:

  1. Mild renal impairment: eGFR 60-89 mL/min/1.73m²
  2. Moderate renal impairment: eGFR 30-59 mL/min/1.73m²
  3. Severe renal impairment: eGFR \< 30 mL/min/1.73m²
* Healthy control subjects with normal renal function will be matched (age ± 10 years; sex, race, BMI ± 15%) to their respective subject in the impaired renal function groups and have eGFR ≥90 mL/min/1.73m . Healthy control subjects should have no systemic chronic disease.
* Males and Females age 18-75
* Body mass index (BMI) 25-40 kg/m²

Exclusion Criteria:

* Renal allograft recipients
* History of renal cell carcinoma or any history of metastatic disease involving the kidney
* End Stage Renal disease, requiring or not requiring dialysis
* Subject requiring or anticipated requirement of dialysis within 3 months of study entry
* Diagnosis of acute kidney injury/acute renal failure, or hospitalization for kidney related issue within 3 months of Screening
* Any renal disease or related condition actively being treated other than chronic kidney disease
* Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact renal function within 2 weeks of Screening
* History of treatment for a chronic condition with a medication that is known to have nephrotoxic potential, and after treatment, renal function/status has not been fully evaluated
* Uncontrolled hypertension
* Uncontrolled diabetes
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)

The main objective of this study is to document that the thrombectomy catheter (Rev-01) is effective and safe when used for revascularization in subjects with acute ischemic stroke within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom treatment with IV t-PA has been ineffective.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject presenting with clinical signs and symptoms consistent with a diagnosis of acute ischemic stroke
* Onset of symptom is within 8 hours prior to treatment with Rev-01
* Treatment with IV t-PA is ineligible or ineffective
* Occluded (presenting TICI score of 0 or 1) M1 or M2 of MCA, basilar or vertebral artery, or intracranial segment of ICA, confirmed by angiography that it is accessible to the Rev-01
* NIHSS score is 8-30
* Prior to new focal disabling neurologic deficit, mRS score was 0-2
* Age from 20 y.o. to 85 y.o.
* Written informed consent to participate by subject or legal representative

Key Exclusion Criteria:

* Subject presenting; ICA dissection, Angiitis, Arterial tortuosity that would prevent the device from reaching the target vessel, Arterial stenosis \> 50% that would prevent the device from reaching the target vessel, Evidence of acute intracranial hemorrhage, Evidence of mass effect or intracranial tumor, Evidence of extended early ischemic changes
* Subject with more than two major artery occluded
* Known sensitivity or ineligible to radiographic agent, or metallic allergy
* Administration of dabigatran or heparin within 48 hours preceding the onset of stroke and have an elevated APTT or PTT above twice of the normal range for the laboratory at presentation
* Known bleeding diathesis of current use of oral anticoagulants (e.g., warfarin sodium) with International Normalized Ration (INR) \> 3
* Platelet count \< 30,000/mm3
* Glucose \< 50 mg/dL
* Severe sustained hypertension (SBP \> 185mmHG or DBP \> 110mmHG) refractory to pharmacological management
* Life expectancy of less than 90 days
* Pregnancy or females who are lactating
* Current participation in an investigational drug or device study
* Otherwise determined by investigator to be medically unsuitable for participation
Evaluation of Different Etiologies of Obscure Ascites

Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is most commonly observed in patients with cirrhosis and resulting portal hypertension (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a malignancy


Eligibility Criteria:
Inclusion Criteria:

* Patients with ascites
* serum ascites albumin gradient \>1.1.

Exclusion Criteria:

* ascitic fluid serum ascites albumin gradient \<1.1.
* Haemorrgaic ascites;
* chylous ascites
A Single-Use Duodenoscope in a Real-World Setting

This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.

This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. Subject is indicated and scheduled for an elective, non-emergent ERCP.
3. Subject is willing and able to give informed consent and HIPAA authorization.

Exclusion Criteria:

1. Subject has altered pancreaticobiliary anatomy including:

   1. Billroth II
   2. Roux-en-Y gastric bypass
   3. Loop gastric bypass
   4. Post-Whipple
   5. Roux-en-Y hepaticojejunostomy
2. Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
3. Subject has any of the following severe co-morbid conditions

   1. Morbid obesity (BMI ≥ 40)
   2. Unstable cardiopulmonary conditions
   3. Severe and uncorrectable coagulopathy
   4. Severe and uncorrectable thrombocytopenia
4. Subject has clinically significant esophageal, pyloric or duodenal strictures.
5. Subject has been previously been treated under this investigational plan.
6. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
7. Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
8. Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.
Sporadic Inclusion Body Myositis Natural History Study

This is a prospective natural history study on patients with clinically defined sIBM. Participants will be assessed every 6 months over two years (five visits total). We will include 150 participants, enrolled across 13 sites, with sporadic IBM, diagnosed according to established criteria.

This is a prospective natural history study on patients with clinically defined sIBM. Participants will be assessed every 6 months over two years (five visits total). We will include 150 participants with sporadic IBM, diagnosed according to established criteria. Participants will require an routine serum sample via blood draw to evaluate for NT5c1A antibody status. This testing will be performed at Washington University School of Medicine in the Neuromuscular Laboratory. Investigators will be blinded to antibody status. A subset of participants (40) will undergo a muscle biopsy at the Baseline visit.

Aim 1. To determine for the first time whether NT5c1A antibodies mediate disease progression over a two-year interval in patients with sIBM.

We will perform a prospective, non-interventional, observational study on patients with sIBM with follow up and evaluations every 6 months over a two-year time frame. Primary analyses are: 1) the rates of disease progression and severity as measured by rates of decline in IBM Functional Rating Scale (IBMFRS) score and Timed Get Up and Go (TUG); 2) the presence or absence of serum antibodies to NT5c1A; and 3) the presence and frequency of variant T-cells in the serum and skeletal muscle.

Aim 2. To perform a detailed morphological, histochemical and immunohistochemical analysis of fresh muscle biopsy specimens obtained from a subset of patients with sIBM.

Aim 3. To characterize the distribution of "immunosenescent" lymphocytes in circulating blood from patients with sIBM.

Aim 4. To quantify the decline in the respiratory function of sIBM patients.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 40 years and older
2. Fulfills ENMC 2011 criteria of clinically definite or probable sporadic Inclusion body myositis (sIBM)
3. Disease onset is within the past 10 years of the time of Baseline visit
4. Able to participate and comply with study related procedures
5. Able to provide written consent

Exclusion Criteria:

1. Current or very recent use (within last 6 months of the Baseline visit) of immunomodulation or immunosuppression therapy.
2. Current or very recent use (within last 90 days of the Baseline visit) of an investigational medication or therapy.
3. Co-existing significant medical or surgical conditions that, in the opinion of the investigator, will influence study participation or alter natural history.
Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.


Eligibility Criteria:
Inclusion Criteria:

* Children of 6 to \<60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
* In good health as determined by: medical history, physical examination, clinical judgment of the investigator.
* Able to comply with all study procedure

Exclusion Criteria:

* Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease;
* History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
* Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease;
* Bleeding diathesis;
* Surgery planned during the study period;
* Receipt of another investigational agent within 90 days
* Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
* Ever received two doses of an influenza vaccine before the study
* Receipt of an influenza vaccine within 6 months prior to Visit 1;
* Experienced a temperature 38.0°C within 3 days prior to Visit 1
the Association Between Thyroid Hormones and Metabolic Components in Patients With Obesity

This study collected clinical data of obese patients with euthyroid function, including age, gender, height, weight, BMI, waist circumference, blood pressure, fasting blood sugar, blood sugar 2 hours after sugar load, fasting plasma high-density lipoprotein cholesterol, fasting three acyl glycerin, free iodine thyroid hormone (FT3) and free thyroid hormones (FT4), thyroid stimulating hormone (TSH), follow-up information and etc. Via analyzing the data, the investigators want to investigate the association between thyroid hormones (THs) and metabolic components in obese patients with euthyroid function and to present the cutoff values of THs in order to provide new information for the risk stratification of metabolic syndrome in obese patients with euthyroid function.


Eligibility Criteria:
Inclusion Criteria:

* 1) age ranged from 18-65 years old, 2) BMI over 27.9kg/m2,3)TSH，FT4, and FT3 within the range of 0.38-4.34mIU/L, 10.5-24.4mIU/L, and 2.8-6.3mIU/L, respectively.

Exclusion Criteria:

* secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) severe heart, liver and kidney dysfunction
Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR+, HER- Breast Cancer Patients

The goal of the experiment is surgical de-escalation. Patients with newly diagnosed cT1-3, cN1, cM0 and HR+, HER2- breast cancer and low clinical risk usually first receive breast cancer surgery, after which chemotherapy can be added based on the final anatomopathological results or additional Gene Expression Profiling (GEP) testing.

Chemotherapy helps reduce the cancer recurrence or metastasis risk. Adjuvant chemotherapy (AC) can be given for large tumours, aggressive tumours with high grade tumour cells, or if axillary lymph node invasion is discovered during surgery. If the investigators were able to identify patients requiring chemotherapy prior to surgery, they could treat them with Neo-Adjuvant Chemotherapy (NAC) instead. By using MammaPrint® GEP, the investigators would be able to stratify patients into either a low- or high-risk category. Since the high-risk group is known to benefit from chemotherapy to improve overall survival, they would be treated with NAC, which could also potentially lead to surgical de-escalation. Breast conserving procedures, such as a lumpectomy instead of a mastectomy, could allow more aesthetically pleasing results and increase patient quality of life. Using NAC for patients with axillary lymph node invasion could lead to nodal complete pathological response (cN1 -\> ypN0), allowing patients that are willing to enter the TADANAC trial a lymph node sparing procedure instead of a full axillary lymph node dissection.


Eligibility Criteria:
Inclusion Criteria:

* Tumour characteristics: HR+, HER-
* Histopathological tumour characteristics: cT1-3, cN1, cM0, all histological types included
* Age: 18-85 years

Exclusion Criteria:

* Tumour characteristics: cT4, cN2-3, cM1
* Age: \<18 or \>85 years old
* Received chemotherapy in the last 5 years
* Pregnancy
Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of COPD.

Exclusion criteria:

* Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
* Other inclusion and exclusion criteria will be evaluated at the first study visit.
Blood Pressure Monitoring in Hypertensive Populations: Device Testing, Feasibility, Acceptability

The goal of this study is to test a novel cuffless blood pressure (BP) monitoring device (BIO-Z) within adults with hypertension (high blood pressure) for clinical use.

The main questions it aims to answer are:

* To validate a novel cuffless blood pressure (BP) monitoring device (BIO-Z) within adults with hypertension (high blood pressure)
* To assess BP monitoring accuracy, against reference BP measurements captured by a Finapres Nova® continuous BP monitoring device in correspondence with blood pressure monitoring devices standards.

Researchers will test the device against the Finapres Nova® blood pressure monitoring device.

The purpose of this study is to evaluate a novel cuffless blood pressure monitoring device for clinical use. This device is a cuffless blood pressure watch worn on the wrist called BIO-Z. The device will be tested against the Finapres Nova® which is FDA-approved to capture continuous BP measurements. The participant will only need wear a wristband, potentially eliminating the need to perform cuff-based readings. During the 2-hour visit, research coordinators will conduct exercises to change BP and compare the values gathered by the BIO-Z watch with the Finapres Nova® device and a standard blood pressure cuff. The investigators will also test whether the Bio-Z can capture blood pressures that are in the low and high range, and whether motion affects the quality of measurement. The ultimate goal is to develop a device that passively collects blood pressure continuously, which is more convenient than a standard blood pressure cuff. 15 Participants will have the option to complete study procedures twice more, spaced one week apart, for a total of three weeks of participation.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive volunteers who have a history of hypertension or a BP \>140/90 mmHg on two consecutive ambulatory visits within the last year.
* Able to read, understand, and provide written informed consent in English
* Willing and able to participate in the study procedures as described in the consent form
* Able to communicate effectively with and follow instructions from the study staff

Exclusion Criteria:

* Persons with pacemakers and/or a non-sinus rhythm (A-fib)
* Persons who are taking 4 or more anti-hypertensive medications
* Persons on dialysis
* Persons who are unstable
* Persons with tremors
* Persons with known peripheral artery disease
* Persons with more than 10 mmHg differential blood pressure between right and left arm
* Persons taking medications that might affect the hypothalamic-pituitary-adrenal axis
* The investigators will exclude persons who are known to be pregnant after 20 weeks because of physiological changes in BP after 20 weeks of pregnancy; and will refer to Electronic Health Record data to determine pregnancy status at the time of screening. The investigators will not exclude participants of childbearing age or who become pregnant during the study since there are no risk of the devices to a pregnant person.
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension

This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination.

This is a phase IV, open-label, prospective, long-term cohort, observational study to identify the predictive model of cardiocerebrovascular risk factors in elderly patients with more than three antihypertensive agents in patients with essential hypertension in Korea.

Eligibility Criteria:
Inclusion Criteria:

1. A patient over 65-year-old with essential hypertension
2. A patient with essential hypertension who require treatment with 3 or more antihypertensive medication, as determined by investigator's decision
3. A patient with no MACCE within 6 months prior to the enrollment
4. A patient who voluntarily signed the informed consent form

Exclusion Criteria:

1. A patient who participates in clinical trial
2. A patient who are contraindicated for the Truset tablet according to the label.
3. A patient who is unable to complete the study judged by the investigator.
Ex Vivo Study of the Heracure Device for Intra-uterine Morcellation After Vaginal or Laparoscopic Hysterectomy

Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.

The purpose of this clinical investigation is to evaluate the safety and efficacy of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing hysterectomy due to benign gynecologic disease

Exclusion Criteria:

* Subject is not suspected of malignancy
Deutsches Device Qualitätsregister

It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.

The possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. Every German Center, implanting ICDs or CRT-devices, is encouraged to contribute to this register; data are collected by use of an electronical CRF.

Eligibility Criteria:
Inclusion Criteria:

* The Device register will include all consecutive patients with an intended implantation of an ICD / CRT.

Exclusion Criteria:

* Missing signed informed consent
Surgical Decision Making Among People With Inflammatory Bowel Disease

This is a study for people with inflammatory bowel disease ("IBD"--that is, ulcerative colitis, Crohn's colitis, or indeterminate colitis). We are studying how people with IBD decide to have surgery when a doctor has told them they should think about having their colon (large bowel) removed. This surgery is called a "colectomy." Patients will be asked to fill out a questionnaire that takes about 60 to 90 minutes to complete. Questions ask about patients' background (age, etc.) and their IBD. They also ask about patients' decision to have surgery or not to have surgery. For instance, what kinds of things did they think about? Some questions ask about other people who affected the choice and how patients felt about the help they got from others. People who wish to join the study will receive payment to thank them for their time.

* Patients must be at least 18 years old
* Patients must speak English
* Patients must have been told by their doctor to think about having surgery to take out their colon to (a) lower their risk for cancer or (b) because they have pre-cancer (called "dysplasia")
* Patients do not need to have had the surgery--they may have already had the surgery, they may not have had it yet, or they may have decided they do not want to have it


Eligibility Criteria:
Inclusion Criteria:

1. Have been told by a doctor that they have ulcerative colitis, Crohn's disease, or indeterminate colitis.
2. Be at least 18 years old
3. Speak English
4. Have been told by a doctor to think about having surgery to take out their colon ("colectomy") within the last 3 years