cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)

The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, 50 years of age or older at the time of informed consent
* Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
* BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye

Exclusion Criteria:

* Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
* Previous or concurrent macular laser treatment (study eye)
* Cataract or refractive surgery within 3 months prior to baseline (study eye)
Effectivity and Safety Study of Trans-artificial-urethral Resection of Female Urethral Caruncle

To explore the minimally invasive and exhaustive treatment of female urethral canruncle by using trans-artificial-urethral resection of the canruncle. The investigators plant to recruit patients using this surgical method and study the effectivity of this method.


Eligibility Criteria:
Inclusion Criteria:

- patient with urethral caruncle

Exclusion Criteria:

- recurrence urethral caruncle
Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients

The aim of the study is to investigate the optimized treatment strategy of hypertension, so as to make more patients to reach the blood pressure goals and to reduce cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in the study if they are essential hypertension, 50-79 years of age with at least one cardiovascular risk factor and sign the informed consent forms. This project is a multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE) trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between 4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or standard management regimen; Patients will also randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where the patients in.

This study is aimed to observe the main outcome (stroke, myocardial infarction and death from cardiovascular disease) differences between different groups.

Eligibility Criteria:
Inclusion Criteria:

* essential hypertension
* 50-79 years old
* with at least one of the cardiovascular risk factor
* sign consent forms

Exclusion Criteria:

* secondary hypertension
* attack of cerebrovascular events or myocardial infarction within recent 3 months
* coexistence of severe cardiomyopathy, rheumatic or congenital heart diseases
* unstable angina
* severe hepatopathy or nephropathy (ALT elevation \> 2 fold or serum creatinine \> 2.5mg/dl)
* malignant tumor
* gout
* women taking contraceptives or with pregnancy
* allergic history to the research drugs
* validated contradiction to the research drugs
* participating in other clinical trials
* unable for long-term follow-up or poor compliance
* unsuitable for clinical trial at the discretion of doctors in charge
Tranexamic Acid in Surgery of Advanced Ovarian Cancer

The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery.
* Understand and speak Swedish
* Accept participation in the study after written and verbal information and sign informed consent.

Exclusion Criteria:

* Allergy to tranexamic acid
* Having had tranexamic acid within the recent 30 days
* Previous or present episode of thromboembolic events .
* Previous or present treatment within the recent 3 months with anticoagulant.
* Previous or present known coagulopathy
* Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin.
* Significant renal failure with serum-creatinine \> 250 µmol/l.
* Severe psychiatric dysfunction or mentally substantially disabled.
Tele-BA for Home-Delivered Meals Clients

The purpose of this study to evaluate aging-service integrated, video-conference-based approaches to improve homebound seniors' social engagement and activities.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Clients of the Meals on Weals program
* ≥60 years old
* Score between 6-9 on the Hughes three-item version of the UCLA Loneliness Scale

Exclusion Criteria:

* Dementia, as indicated by a score \> 3 on the Six Item Screen
* Clinically significant depression, as indicated by a score ≥15 on the Patient Health Questionnaire (PHQ-9)
* Active suicide risk, as indicated by a positive response on any item of the Columbia Suicide Severity Rating Scale (C-SSRS)
* Uncorrectable hearing or vision impairment
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* IgA nephropathy confirmed by renal biopsy
* Hypertension (\<= 125/75 mmHg)

Exclusion Criteria:

* Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks
* Severe hypertension (\<= 180/110 mmHg) or secondary hypertension
* Patients with history of allergy or adverse effect for aliskiren
* Renal dysfunction (estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2)
* Pregnancy
* Patient treated with cyclosporine
* Hyperkalemia (serum potassium \>= 5.6 mmol/L)
* Autoimmune disease including systemic lupus erythematosus
* Patients inadequate for the study
To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms

The purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms.


Eligibility Criteria:
Inclusion Criteria:

* female outpatient greater than or equal to 65 years of age
* have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months
* have at least 7 incontinence episodes per week. For patients with MUI, at least 50% of the IEF must be due to stress.
* is ambulatory and able to use a toilet independently and without difficulty

Exclusion Criteria:

* at Visit 1 have a positive urine culture or a history of four or more urinary tract infections (UTIs) in the preceding year
* have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry
* began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study.
* have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or Parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract.
* intake of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomisation or at any time during the study
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes

The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.

FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).

Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.

Eligibility Criteria:
Inclusion Criteria:

PERSONS WITH DIABETES

* Ages 18-24
* Have a diagnosis of T1D and has been taking insulin for at least one year
* Comfortable sending and receiving texts
* Can speak, read, and write in English
* Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
* Using a continuous glucose monitor (CGM)

SUPPORT PERSONS

* Age 18 or older
* Can speak, read, and write in English or Spanish
* Comfortable sending and receiving texts

Exclusion Criteria:

PERSONS WITH DIABETES

* Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
* Plans to live outside the country during the study period

SUPPORT PERSONS

* Shares a phone with the person with diabetes
* Plans to live outside of the country during the study period
Telerehabilitation for Patients Diagnosed With Coronavirus

In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country. It did not take long for this epidemic to spread to the world. After that, World Health Organization declared this epidemic disease as a pandemic. As of now, the number of coronavirus deaths increased to 108,281 worldwide. Total number of cases approached 1,800,000 according to the latest information. While the number of healed patients was highest in China, 77,525 people with COVID-19 recovered.

COVID-19 is a highly contagious respiratory infectious disease that can cause respiratory, physical and psychological dysfunction in patients. Respiratory rehabilitation reduces the patient's symptoms of dyspnea, relieves anxiety and depression, reduces the patient's need to apply to the hospital, increases functional capacity and improves the patient's quality of life. Respiratory rehabilitation, according to the feedback from China, is very important for patients in the clinical treatment and recovery process after treatment. Rehabilitation of people with mild disease after discharge is mainly based on improving physical fitness and psychological adaptation. It is also aimed to gradually restore the individual's ability to the activity before the disease and return to the community as soon as possible. Individuals with COVID-19 who have respiratory and / or limb dysfunction and chronic disease after discharge should receive respiratory rehabilitation therapy. According to the current findings of the patients discharged from severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS) and the clinical experience of patients with Acute Respiratory Distress Syndrome (ARDS) patients who recovered after discharge, COVID-19 patients may have physical fitness, dyspnea after activity, and muscle atrophy. (Including respiratory muscles and trunk muscles) It is recommended to use respiratory videos and booklets as the main method for respiratory rehabilitation in isolated patients at home. Telerehabilitation method is also a different recommendation option for rehabilitation.

The purpose of this study is to investigate the effects of exercises performed by telerehabilitation in patients diagnosed with COVID-19 followed at home. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with COVID-19,
* Having been diagnosed in the last 1 week,
* Being between the ages of 18-70,
* Patients who continue to be followed at home

Exclusion Criteria:

* Hospitalization patients
* Having a serious cognitive impairment
* Having serious hearing and vision problems
Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions.

* This study is designed to determine the safety and feasibility of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG), determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities, and determine if intravenous ICG improves surgical resection.
* At the time of surgery, the indocyanine dye will be injected intravenously. The investigators will use a dose of 0.5 mg/kg administered prior to VATS.
* The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lesions most likely to contain tumor cells.The surgeon will also look at lymph nodes to see if metastatic disease can be found in this location using this technique. The lymph nodes are processed to look for metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with intra-thoracic lesions that require resection for therapeutic or diagnostic purposes as recommended by their thoracic surgeon.
* 18 years of age or older
* Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

Exclusion Criteria:

* Subjects who do not wish to have subsequent surgical resection
* A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient
* Pre-operative spirometry that suggests the patient is at high risk or cannot undergo resection of the primary tumor.
* Iodide or seafood allergy
Long-term Follow-up of Subjects with Sickle Cell Disease Treated with Ex Vivo Gene Therapy

This is a multi-center, long-term safety and efficacy follow-up study for subjects with sickle cell disease who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After completing the parent clinical study (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in the study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent for this study by subject, or as applicable, subject's parent(s)/legal guardian(s)
* Treated with drug product for therapy of sickle cell disease in a bluebird bio-sponsored clinical study

Exclusion Criteria:

* There are no exclusion criteria for this study
Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.

The treatment of parapneumonic infections (infection in the pleural space) at the Denver Health Medical Center is not standardized, and timing for advanced interventions such as fibrinolytic therapy or surgical decortication remain unclear. The definitive treatment strategy in these patients may be sub-optimal, and lead to prolonged hospitalization and morbidity. This is concerning as the mortality rate of community acquired pneumonia triples in the presence of a parapneumonic process (5-15%) and can reach over 25% if it becomes bilateral(1). Prompt recognition of pleural space infections is essential for reducing morbidity and mortality. This is attributable to the progression of the disease from a simple fluid collection amenable to pleural space drainage, to necrotizing empyema requiring thoracotomy decortication and open drainage. The keys to management of parapneumonic effusions are early diagnosis, appropriate therapeutic intervention, and recognition of failure of conservative management. The investigators propose that a standardized pathway for identifying and treating parapneumonic effusions will be an important quality improvement. A key gap in the literature remains if patients with parapneumonic infections that cannot be drained with a chest tube should undergo a trial in intrapleural fibrinolytic therapy, or if they should go directly to video assisted thoracic surgery (VATS) for decortication of all infectious material.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary service
* Pleural fluid pH \<7.3
* SICU placed chest tube
* Subsequent transfer to SICU

Exclusion Criteria:

* Existing malignancy
* Malignant cells from initial pleural fluid sample
* End stage liver disease (Child's B or greater)
* Coagulopathy
* Unable to tolerate surgical procedure
* Frank purulent drainage (needs OR regardless)
* Recent surgery of abdomen or thorax precluding the use of tPA
* Baseline neurologic impairment requiring a proxy for consent
Urolithin A Supplementation in Middle-aged Adults With Obesity

The goal of this clinical trial is to learn about the effect of urolithin A, a dietary supplement, on blood flow in middle-aged adults with obesity. The main question it aims to answer is:

- Does urolithin A supplementation improve blood flow in large and small blood vessels in middle-aged adults with obesity?

Participants will be asked to:

* Take the dietary supplement daily for 4 weeks
* Attend two study visits to have their blood vessels checked, answer questionnaires, and give a sample of blood

Researchers will compare people who took the dietary supplement with others who took a placebo to see if the blood flow in the blood vessels improved.

This study aims to measure the effect of urolithin A supplementation on endothelial function, cerebral blood flow regulation, and serum biomarkers of NO bioavailability and mitochondrial function in middle-aged adults with obesity. Briefly, 54 adults aged 40-64 years of age with a body mass index equal to or greater than 30 kg/m2 will be recruited to participate in a double-blind placebo-controlled parallel study for 4 weeks. Participants will be randomly assigned to intervention or control group. Those in the intervention group will consume 1,000 mg of urolithin A daily in the form of softgel capsules, whereas those in the control group will consume a placebo. Data collection will occur at baseline (day 0) and endpoint (day 28). The investigators will compare outcomes between control and intervention group. Researchers expect that urolithin A supplementation in middle-aged adults with obesity improves endothelial function and cerebral blood flow regulation, and that this improvement is accompanied by changes in biomarkers of NO bioavailability and mitochondrial function.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40-64 years old, inclusive
* Obesity \[BMI ≥30 kg/m2\]
* Ability to read, write, and speak English
* Competence to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women, or women who intend to become pregnant within the study period
* History of uncontrolled hypertension
* History of uncontrolled type 1 or type 2 diabetes mellitus
* Significant cardiac disease or chest pain in the last 6 months
* History of untreated depression or anxiety
* History of cognitive impairment
* History of uncontrolled significant GI disease (e.g., IBS, Crohn's disease)
* Allergy or intolerance to one or more of the intervention components
* Undergoing treatment for active cancer
* History of neurodegenerative disorders (e.g., multiple sclerosis)
* Presence of any condition affecting swallowing ability
* Any other medical condition that the investigators deem would adversely affect the participant's safety or ability to complete the study