cyrilzakka/clinical-trials huggingface dataset:
China National Study of Adrenal Venous Sampling

This multicenter study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of adrenal venous sampling (AVS) via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be aslo analyzed in this study.

Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. This multicenter registry study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of AVS via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be also analyzed in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 65 with no limits in sex;
2. Patients with confirmed primary aldosteronism;
3. Patients or their legal representatives sign written informed consent approved by the ethics committee；

Exclusion Criteria:

1. Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
2. An estimated glomerular filtration rate \<45 ml/min/1.73 m2, or serum creatinine \>176 μmol/L；
3. Patients who refuse adrenalectomy;
4. Suspected of having an adrenocortical carcinoma;
5. Allergy to contrast agent;
6. Pregnant, nursing, or planning to become pregnant
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).


Eligibility Criteria:
Inclusion Criteria:

Part A - Healthy Volunteers:

* Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
* Additional inclusion criteria apply

Part B - Psoriasis Subjects:

* Male or female of non-reproductive potential subjects with PsO between 18 to 55 years-of-age
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of moderate to severe plaque PsO
* Diagnosis of plaque PsO for at least 6 months
* Moderate to severe plaque PsO defined by:
* A minimum PASI score of ≥ 10
* Psoriasis involving ≥ 10% of the Body Surface Area (BSA)
* Additional inclusion criteria apply

Exclusion Criteria:

Parts A - Healthy Volunteers:

* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* Recent or on-going infection(s)
* Underlying condition(s) that predisposes the subject to infections
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
* Additional exclusion criteria apply

Part B - Psoriasis Subjects:

* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* Recent or on-going infection(s)
* Underlying condition(s) that predisposes the subject to infections
* Guttate, pustular, or other non-plaque forms of PsO
* Evidence of skin conditions other than PsO (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
* Additional exclusion criteria apply
Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)

Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics. Consequently, some people with severe infection retain antibiotics for too long (risking adverse effects), whilst others excrete antibiotics too quickly (risking under-treatment).

Mathematical models can help researchers understand drug handling variability (known as pharmacokinetics) between people. These models require very accurate information about drug administration and drug blood concentration timings. Researchers usually rely on someone recording these timings, but recording errors can make models inaccurate.

We would like to understand if using data from routinely used electronic drug infusion devices (recording the exact time of administration) can improve the accuracy of pharmacokinetic models. We intend to investigate this with an antibiotic (vancomycin) that clinicians already routinely monitor blood concentrations for. Adults and children treated at St George's Hospital intensive care units will be invited to participate in the study which will last for 28-days within a 14-month period. Participants will donate a small amount of extra blood and provide researchers access to their clinical data. Blood will be taken at special times during vancomycin treatment from lines placed as part of standard treatment, minimising any pain or distress. There will be no other changes to patient's treatment.

In the future, data from this study might help change the way we dose antibiotics. The National Institute for Health and Care Research and Pharmacy Research UK are supporting the study with funding.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to either adult or paediatric intensive care unit (ICU) and receiving intravenous vancomycin (continuous or intermittent infusion only), to prevent or treat a clinical infection
* Informed consent form signed by participant/parent/legal guardian/legal representative (as determined by age group/capacity, consent may be retrospective) or signed informed personal/nominated consultee declaration
* Age from 1-day since birth

Exclusion Criteria:

* Previous enrolment into this study
* Treating clinician feels participant unlikely to survive beyond 48-hours from enrolment or treatment has been withdrawn for reasons of palliation
* Absence of in-dwelling vascular access from which samples may be drawn or removal of in-dwelling access prior to retrieval of a 3rd blood sample (for assay of vancomycin concentration)
* Non-continuous renal replacement (i.e. intermittent haemodialysis/ peritoneal dialysis)
* Hypersensitivity or allergies to vancomycin, its excipients, or the infusion fluid
* Treatment outside an ICU area

In paediatrics:

* Required blood sampling exceeds 3% of total blood volume in a four-week period or 1% at any single time (European Medicines Agency, 2009)
* Where there is disagreement between child consent/assent and parental/ legal guardian consent/assent
Nutritional Support in Femur Fracture Rehabilitation

This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. Femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Eligibility Criteria:
Inclusion Criteria:

* age 60 years or older
* admission for physical rehabilitation after surgery for femur fracture
* informed consent

Exclusion Criteria:

* Any malignant disease during the last five years
* Known kidney failure (previous glomerular filtration rate \<30 ml/min);
* Known liver failure (Child B or C)
* Psychiatric disease
* Severe cognitive impairment (Mini Mental State Examination \<18)
* Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
* Indications related to the study product:

  1. More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
  2. More than 500 mg of daily calcium intake from medical sources.
  3. Adherence to a high-energy or high-protein diet (up to three months before starting the study)
  4. Hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance)
* Indication to or ongoing artificial nutrition support
* Inclusion in other nutrition intervention trials
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Refusal
Naltrexone Treatment of Alcohol Dependence

The long-range goal of this ongoing research program is to find more effective treatments for alcohol dependence by combining medication with the appropriate psychosocial support. This proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in three types of treatment settings; (2) to assess the effects of psychosocial support on medication compliance and treatment retention; and (3) to investigate the individual characteristics that may predict who is likely to benefit from additional psychosocial support versus simple medication management.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for current diagnosis of alcohol dependence.
* Subjects used more than 15 standard alcohol drinks (average)/week with at least 1 day of 5 or more drinks in the past 30 days.
* Successful completion of medical detoxification.
* Lives within a commutable distance to the Treatment Research Center and agrees to follow-up visits.
* Understands and signs the informed consent.

Exclusion Criteria:

* Current diagnosis of any substance dependence other than alcohol, nicotine, or marijuana.
* Evidence of opiate use in the past 30 days.
* Current treatment with psychotropic medications, including disulfiram (Antabuse) (excluding short-term use of benzodiazepines for detoxification).
* History of unstable or serious medical illness, including need for opioid analgesics.
* Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, and current severe psychiatric symptoms.
* Use of an investigation medication in the past 30 days.
* Female subjects who are pregnant, nursing, or not using reliable method of contraception.
A Computer-Based System for Symptom Reporting in Patients With Cancer Undergoing Treatment

This pilot trial studies the usability and usefulness of a computer-based system for reporting symptoms in patients with cancer undergoing treatment. Cancer patients undergoing cancer treatment are not always comfortable contacting the doctor when experiencing symptoms. A computer based platform, where patients can input symptoms, may seem less intrusive than a phone call and may improve patient access to care.

PRIMARY OBJECTIVES:

I. To assess the usability and usefulness of a computer-based system for cancer patient symptom reporting.

SECONDARY OBJECTIVES:

I. To collect preliminary effectiveness data: quality of life outcomes with the Function Assessment of Cancer Therapy - General (FACT-G) and self-efficacy as measured by Chronic Disease Self-Efficacy Scale, Revised (CDSES-R).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive usual care for 3 weeks, then use a computer-based symptom reporting system for 3 weeks. Caregivers may assist patients in the use of the computer based symptoms reporting system.

ARM II: Participants use a computer-based symptom reporting system for 3 weeks, then receive usual care for 3 weeks. Caregivers may assist patients in the use of the computer based symptoms reporting system.

After completing study intervention, participants are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT: Active outpatient cancer treatment (chemotherapy, immunotherapy, radiation, and hormonal therapy)
* PATIENT: No clinical evidence of cognitive or psychological impairment.
* PATIENT: Home internet access on computer or phone.
* CAREGIVER: Selected family member or close friend of the cancer patient matching the patient inclusion criteria outlined above.

Exclusion Criteria:

* Inability to provide informed consent.
Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function

This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45.

The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be randomized at the beginning of the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the first period, and will receive the other medication the second six-weeks of the study. At the very beginning of the study and at the end of each six-week treatment period, subjects will come to the hospital various tests including non-invasive blood vessel imaging tests, blood draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment periods, there will be a four-week medication-free washout period.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy female postmenopausal volunteers, as defined by absence of menses for at least 12 months and follicle stimulating hormone (FSH) 30 IU/L;
2. Age 45 to 75 years;
3. Systolic blood pressure \<140 and \>90 mmHg and diastolic blood pressure \<90 and \>60 mmHg at the screening visit;
4. No personal history of diabetes;
5. Body mass index \< 30 kg/m2;
6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram).

Exclusion Criteria:

1. Current smoking, defined as smoking within the 12 months before the screening visit;
2. Alcohol intake \>1 beverage per night or history of alcohol abuse;
3. Current or past recreational drug use;
4. Personal history of hypertension, cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), hyperlipidemia, diabetes (defined as a fasting glucose ≥126 mg/dL), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression, or illness requiring overnight hospitalization in the past 6 months;
5. Risk factors for arterial or venous thromboembolism;
6. Personal history of breast cancer or any other type of cancer;
7. Personal history of endometrial hyperplasia, endometrial cancer, or unexplained vaginal bleeding;
8. History of cervical cancer or abnormal pap smear
9. Prescription or herbal medication use, excluding thyroid hormone supplementation;
10. Ischemic changes on resting electrocardiogram;
11. Serum creatinine ≥ 1.3 mg/dL.
12. Serum potassium level \> 5.0 mmol/L;
13. Known hypersensitivity to any of the study drugs;
14. Other active medical problems detected by examination or laboratory testing, except for treated hypothyroidism.
15. Pregnancy
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension

The purpose of the study is to evaluate the long-term safety, efficacy, and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension.

This study consists of an open label treatment period of 52 weeks followed by a 2-week safety follow-up period. Eligible subjects for MLS-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (ICF), to transition to this open label extension (OLE) study at either the end-of-study (EoS) visit or the end-of-treatment (EoT) visit as required in the parent study protocol.

A Randomized Treatment Withdrawal (RTW) substudy will be performed in a subset of subjects meeting eligibility criteria.

Subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they may remain on study until marketing authorization or early termination of the trial by the sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent signed by the participant, obtained before any study-related assessment is performed
2. At least 18 years of age at the time of signing the informed consent form (ICF)
3. Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol
4. Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug
5. Willing and able to comply with the study instructions and attend all scheduled study visits

   \[Randomized treatment withdrawal substudy only\]
6. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant, or are breast-feeding
2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
3. In the opinion of the Investigator, any condition that will preclude participation in the study

   \[Randomized treatment withdrawal substudy only\]
4. Non-compliance with study medication(s) (defined as taking \<75% or \>125% of the study drug provided) during the first 12 weeks of MLS-101-901
Web-app Based Lifestyle Physical Activity Promotion Program (WPAPP) for Middle Aged Latinas

The purpose of the proposed project is to conduct a pilot randomized controlled trial (RCT) of the Web-App based Lifestyle Physical Activity Promotion Program (WPAPP) for middle-aged Latinas. The WPAPP is a web application (app) to promote lifestyle physical activity that was developed and tested with Korean American middle aged women. It shows promise for effectiveness with Latinas. The specific aims are:

1. To test the feasibility and satisfaction of the WPAPP modified for Latinas.
2. To examine preliminary effectiveness of the WPAPP-Latina on increasing physical activity and decreasing depressive symptoms.


Eligibility Criteria:
Inclusion Criteria: women aged 40-60 who self-identify as Latina or Hispanic women, are able to read and write in English or Spanish, live in the United States, and can use the app and complete online data collection using a smart phone, tablet, or computer.

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Exclusion Criteria: pregnancy within 3 months of starting the study, having or being of high risk for cardiovascular or musculoskeletal illnesses or injuries

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Autologous BMMNCs Combined With Educational Intervention for ASD

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear cell infusion combined with educational intervention for children with autism spectrum disorder (ASD). Inclusion criteria: Male/Female patients diagnosed with Autism disorder based on DSM-V scale, the patient is between 3 to 7 years old, a patient has a medium level to server level of autism (CARS score\>=30 to \<50), VARS-2 \>=50, patient's parent or caregiver must have the educational level of high school or above, patient's family has given consent to participate in the study. Exclusion criteria for treatment group: patient above seven years of age and smaller than 3-year old, autistic patients having epilepsy, hydrocephalus with ventricular drain, allergy to anesthetic agents, severe health conditions such as cancer, failure of heart, lung, liver, or kidney, active infections, children with birth defects of the spine.

A total of 54 patients with autism spectrum disorder (aged 3-7) will be recruited and divided into two groups: the control group (only intervention education) (n = 27) and the treatment group (bone marrow mononuclear cell transplantation combined intervention education (n =27). The bone marrow mononuclear cell will be applied to 27 patients in the treatment group infuse via the intrathecal administration. The primary outcome is measured by the number of AEs/SAEs during BMMNCs infusion. The secondary outcome was measured by clinical examinations performed at baseline and then at 02, 06, and 12 months after the first infusion. Multiple tools were used to diagnose and determine the severity of ASD, including DSM-5, CARS, the Vineland Adaptive Behavior Scales Second Edition (VABS-II), and the Clinical Global Impression (CGI). DSM-5, which was published in May 2013, provides new diagnostic criteria for ASD

Eligibility Criteria:
Inclusion Criteria:

* Patient is between 3 to 7 years old
* Male/Female patient diagnosed with Autism disorder according to the diagnostic criteria for Autism Spectrum Disorder in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Patient has a medium level to the most severe level of autism (CARS score \>=34 to 50)
* Patient's parent or caregiver must have an educational level of high school or above
* Patient's family has given consent to participate in the study

Exclusion Criteria:

* Patient is above seven years of age
* Autistic patient having epilepsy
* Patient with coagulation disorders
* Hydrocephalus with ventricular drain
* Allergy to anesthetic agents
* Sever health conditions such as cancer, failure of heart, lung, liver, or kidney
* Active infections