cyrilzakka/clinical-trials huggingface dataset:
Long-Term Follow-up Safety of Clonidine Micropellets

Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.


Eligibility Criteria:
Inclusion Criteria:

* Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.

Exclusion Criteria:

* Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures.
* Subjects who were unblinded to their treatment in STX-015-18-01 study.
Getting Under the Skin of the Menopausal Hot Flush

The aim of this research is to 1) test how the skin blood vessels and sweat glands function in women who experience hot flushes by using skin microdialysis to deliver small amounts of substances to the skin that cause increased skin blood flow and sweating, and 2) examine the structure of the skin blood vessels and sweat glands in the skin of women who experience hot flushes by taking a very small skin biopsy. Any changes in the function or structure of the skin blood vessels or sweat glands in women with hot flushes would increase our understanding of what causes hot flushes and help to design effective treatments.

In a cross-sectional design, participants will attend the laboratory on two separate occasions. At visit 1, anthropometric measurements will be recorded and a venous blood sample will be collected to determine hormone status (e.g. oestradiol level) and pro-inflammatory markers (e.g. IL-8, Prostaglandin 2E). Participants will then undergo assessment of post-ganglionic skin blood vessel and sweat gland responsiveness (transdermal/cutaneous microdialysis). At visit 2 (\~7 days later), participants will undergo a skin punch biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>45 years for the postmenopausal cohort and aged 18-30 years for the premenopausal cohort
* Female
* Amenorrhoeic for \>6 months (postmenopausal criteria)
* \>4 hot flushes per day (symptomatic postmenopausal criteria)
* Eumenorrhoeic with regular menstrual cycles (premenopausal criteria)
* Healthy
* Non-smoker
* BMI 18-30 kg/m2
* No history of cardiovascular or respiratory disease
* No history of metabolic disease e.g. type II diabetes
* Drink \<14 units of alcohol per week
* Not taking any medication or treatments to alleviate hot flushes

Exclusion Criteria:

* Aged \< 18 years or 31-44 years
* Male
* Smokers
* Medical history of cardiovascular/respiratory disease
* Medical history of metabolic disease e.g. type II diabetes
* Drink \>15 units of alcohol per week
* On medication or treatments to alleviate hot flushes or have taken such medication/treatment within the previous 6 months
* BMI of \<18 or \>30 kg/m2
* Vaccination (\<1 week) due to induced systemic inflammatory reaction
* Local forearm infection
* Allergy to local anaesthetic/Marcain/amide-group anaesthetics
* Pregnant
Survey on the Pharmacy Follow-up of Alli Purchasers

To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing to lose weight.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have been recognized as being eligible for treatment, who have agreed to pharmacy follow up, and have given their informed consent to take part in the survey.
Emergency Department Home Blood Pressure Monitoring and BpTRU Study

The purpose of this study is to evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.

Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring \& evaluate reliability of ED measured elevated blood pressure compared to the BpTRU

Eligibility Criteria:
Inclusion Criteria:

* One elevated blood pressure greater than 120 systolic and/or 80 diastolic
* BpTRU device blood pressure greater than 120 systolic and/or 80 diastolic while in ED

Exclusion Criteria:

* Prior history of hypertension
* Currently on antihypertensives or receiving prescription on discharge
* Pregnancy
* History of atrial fibrillation
* Dialysis patient
* Nursing home or rehabilitation center resident
* Admitted
* Moving out of the area in next 30 days
* Substance abuse
* Prisoner
* Presenting for psychiatric complaint requiring constant observation
* Inability to give informed consent (intoxicated, altered, non-English speaking)
* Presenting with symptoms of hypertensive emergency
* Inability to demonstrate adequate use of the home blood pressure device in the ED
* Arm circumference less than 9 inches or greater than 17 inches
Remodulin® to Oral Treprostinil Transition

This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets).

This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.


Eligibility Criteria:
Inclusion Criteria:

* Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis of PAH
* Have stable disease as confirmed by recent right heart catheterization and a Baseline 6MWD of at least 250 meters
* Have been receiving Remodulin for at least 90 days and at a stable dose for at least 30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75 ng/kg/min, inclusive
* Must be also receiving an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable dose for at least 30 days prior to Baseline

Exclusion Criteria:

* WHO functional class III and IV subjects will be excluded
A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women

The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

1. Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
2. Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
3. Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
4. Have a normal mammogram at the time of study screening.

Exclusion Criteria:

1. A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
2. A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
3. Unexplained vaginal bleeding within the 3 months prior to study entry.
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality. Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function. The aim of present study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

Design: A prospective, randomised, placebo controlled study. 2 year treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Males and females above 18 years of age
* Patients having been treated with chronic hemodialysis for at least 6 months
* Patients with documented cardiovascular disease, at least one of the following

  1. Angina pectoris
  2. Previous Acute myocardial infarction
  3. Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
  4. Previous Transitory Cerebral Ischemia
  5. Previous Apoplexia Cerebri
  6. Symptoms of peripheral vascular disease
* Written informed consent

Exclusion Criteria:

* Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
* Patients undergoing peritoneal dialysis
* Any condition associated with a risk of poor compliance, as judged by investigator
* Pregnant or breastfeeding
* Participation in other clinical studies involving treatment with drugs.
Short-term Outcomes of SILS+1 Versus CLS for Distal Gastric Cancer

To evaluate the short-term outcomes of single-incision plus one-port laparoscopic surgery (SILS + 1) versus conventional laparoscopic surgery(CLS) for distal gastric cancer whose clinical stage was cT1-3N0-2M0

The gastric cancer patients with cT1-3N0-2M0 were randomized at a 1:1 ratio to the CLS group or the SILS+1group, then it will evaluate the short-term outcomes between two groups.

Eligibility Criteria:
Inclusion Criteria:

* pathological diagnosis of gastric cancer
* clinically diagnosed cT1b-3N0-2M0 lesions according to the 8th Edition of the American Joint Committee on Cancer(AJCC) Cancer Staging Manual(measured using abdominal CT)
* tumor size ≤ 5cm
* planned to conduct subtotal gastrectomy

Exclusion Criteria:

* preoperative radiotherapy and chemotherapy
* tumor perforation
* severe mental disease
Study to Evaluate the QT / QTc Interval Prolongation Potential of Vericiguat

The primary objective of this study was to investigate whether there is a clinically meaningful effect on QTc change from baseline relative to placebo after administration of 10 mg at steady state in patients with stable CAD (coronary artery disease).


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable CAD (coronary artery disease) defined by:

  * clinically stable for at least 3 months
  * coronary artery stenosis in any of the 3 main coronary vessels
  * or history of myocardial infarction
* Sinus rhythm at screening
* Interpretable echocardiographic images
* Age: 30 to 80 years
* Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg/m²

Exclusion Criteria:

* Ejection fraction (EF) below 30% at screening
* Progressive angina with symptoms of worsening of angina within the \<3 month
* History of recent myocardial infarction or unstable Angina
* Documented current relevant coronary stenosis ≥90% in any of the main 3 coronary vessels without bypass graft
* Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months or patients with stroke at more than 3 months
* Insulin dependent diabetes mellitus
* Clinically significant and persisting cardiac ischemia
* Atrial fibrillation, pacemaker, defibrillator, second and third degree atrial-ventricular (AV) block
* Known clinically relevant ventricular arrhythmias
* Clinically relevant heart failure with reduced left ventricular ejection fraction
* Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis; any other moderate or severe valvular failures
* Valve replacement
* Hypertrophic obstructive cardiomyopathy (HOCM)
* Previous or imminent cardiac transplantation
* Known long QT syndrome or prolongation of the QT interval with ongoing proarrhythmic conditions
* Co-medication with drugs known to have QT prolonging effect
* Intolerance of fluoroquinolones, including moxifloxacin
* History of serious adverse effects e.g. tendinitis and tendon rupture, arthralgia and effects on the peripheral and central nervous system while taking fluoroquinolones including moxifloxacin
* History of tendon diseases or tendon injury caused by quinolones
* Treatment with fluoroquinolones, including moxifloxacin during the last 2 weeks
* Treatment with organic nitrates during the last 3 months
* Treatment with riociguat during the last 3 months
* Treatment with phosphodiesterase (PDE)-5 inhibitors during the last 14 days
* Systolic blood pressure below 110 or above 160 mmHg at screening visit
* Diastolic blood pressure below 50 or above 100 mmHg at screening visit
* Heart rate below 50 or above 100 beats/min (taken from ECG measurement) at first screening visit
* Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m\*2
Forehead Lift Fixation

To compare periosteum versus bone fixation in forehead lift.

Forehead lift method of fixation is variable and lots of different methods have been described with different rates of success.

The comparison of to different techniques in a RCT has not been reported before.

The objective is to compare periosteum versus bone fixation in forehead lift, in a randomized, blinded, controlled, split-face trial.

Eligibility Criteria:
Inclusion Criteria:

* Eye brow malposition
* Forehead wrinkles

Exclusion Criteria:

* Previous surgery
* Forehead trauma or scar
Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology

The goal of the study is to develop a novel approach to obtain real time optical biopsy of urinary tract pathology (e.g., bladder tumors) during urinary tract endoscopy using a novel fibered confocal microscope.


Eligibility Criteria:
Inclusion Criteria:Research subjects with suspected urinary tract pathology (e.g., bladder tumors) who are scheduled to undergo cystoscopy with possible excisional biopsy (e.g. transurethral resection of bladder tumor) in the operating room.\&#xA; Exclusion Criteria:History of hypersensitivity to fluorescein; active urinary tract infection; pregnant; currently breast feeding;
Integrative Analysis of CRC Liver Metastasis

The investigators will perform integrative analysis of CRC liver metastasis

The investigators will analyzed proteomes of paired normal colorectal tissues and colorectal cancer (CRC) with or without liver metastasis, sequenced transcriptomes, performed whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal colorectal tissue, primary colorectal carcinoma, and its synchronous matched liver metastasis, as well as analyzed genomics of CRC characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 75 years with histologically proven CRC
* No severe major organ dysfunction
* WHO performance status of 0 or 1
* No prior cancer chemotherapy

Exclusion Criteria:

* Age ≥ 76
* Severe major organ dysfunction
* World Health Organization (WHO) performance status of \>1
* Prior cancer chemotherapy
Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection

This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female between the ages of 18-65
* Willing and able to provide informed consent
* Willing to follow protocol-specified contraception requirement

Key Exclusion Criteria:

* Have extensive fibrosis or cirrhosis of the liver
* Have or had liver cancer (hepatocellular carcinoma)
* Family history or personal history/current thyroid disease on or off replacement therapy
* Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
* Females who are breastfeeding, pregnant or who wish to become pregnant during the study
* Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Phase I Multiple-Ascending Dose (Japan)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days


Eligibility Criteria:
Inclusion Criteria:

* Japanese male and female subjects
* Ages 20 to 70 years old
* Established diagnosis of T2DM
* BMI \< 32 kg/m2
* Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
* HbA1C 6.0 - 10.0%

Exclusion Criteria:

* Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
* History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
* History of incontinence or bladder dysfunction including nocturia
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment.

Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.

The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load.

In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV). Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP, NFV, or RTV.

Prior to randomization to a NFV- or RTV-containing regimen, patients are stratified by HIV RNA (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.

Eligibility Criteria:
Inclusion Criteria

Your child may be eligible for this study if he or she:

* Is HIV-positive.
* Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18).
* Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy.
* Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy.
* Is able to receive at least one of the following: RTV, NVP, or NFV.

Exclusion Criteria

Your child will not be eligible for this study if he or she:

* Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry.
* Has a history of pancreatitis or peripheral neuropathy.
* Has cancer requiring chemotherapy.
* Is allergic to the study medications.
* Is taking certain medications.
* Is pregnant.
FaceBase Biorepository

The purpose of this study is to find out if there are any genetic differences between people with and without disorders of the head, face, and eye. We will create a biorepository of samples from people with and without these types of birth defects. A biorepository is a collection or "bank" of human tissue materials (such as blood or saliva) for research purposes. These samples will then be available to investigators studying these disorders.

Samples from the FaceBase Biorepository and data collected from these samples will be available to investigators who are studying birth defects of the head, face, and eye. Data and samples will be deidentified prior to use by other investigators. Researchers will be allowed to use samples and medical information only after approval by the FaceBase Biorepository Data Access Committee. Once the FaceBase Biorepository Data Access Committee has established that the proposed use of the samples and clinical data meet the criteria for sound, ethical research, then the investigator will be granted permission to use a small portion of the sample and have access to clinical data stored in the computer database. Investigators who are not part of the FaceBase Biorepository Research Team will not know participant's names or other personally identifiable information.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Individual with a craniofacial anomaly or family member of an individual with a craniofacial anomaly

Exclusion Criteria:

* Non-English speaking
* Prisoners
* Minors in foster care or wards of the court
Digital Health Literacy on COVID-19 for All: Co-creation and Evaluation of Interventions for Ethnic Minorities and Chinese People With Chronic Illnesses in Hong Kong

During the pandemic, people are anxious for information, and electronic platform serves the purpose of having first-hand health information and spreading it to massive population within a short time. However, the source and credibility of the influx of online information are hard to be verified. Digital health literacy (DHL) is the capacity to access, understand, evaluate, and apply health information from electronic sources, which is an important attribute that everyone should possess. Recent studies from our group in Hong Kong have shown that, during the COVID-19 pandemic, DHL is an issue facing people of all ages, especially ethnic minorities (EMs), people with chronic illnesses (PWCI), and professional and lay caregivers (CGs). Considering that, the present research project aims to co-create DHL interventions with these three groups of people to meet their specific needs in DHL, in addition, to assess the efficacy of the DHL interventions on eHealth literacy, vaccine literacy, and actions taken for COVID-19 prevention. The present research is a 4-year project, involving three phases. Phase 1 involves focus group interviews and cognitive interviews with the three groups of people for developing interventions and evaluating the proposed interventions. Phase 2 involves individual interviews with the three groups of people for testing the feasibility and acceptability of the interventions. Phase 3 involves a 6-month longitudinal quantitative research, testing for the efficacy of the interventions in three dimensions: literacy, attitude, and behavior. Participants from the three groups will be invited to join virtual or face-to-face training, watch short videos on social media, participate in virtual bi-weekly group discussion, and fill in questionnaires for five times during the course of the study. This co-creation of new knowledge by stakeholders and researchers is expected to increase the uptake of the research outcomes and adoption of the DHL interventions.


Eligibility Criteria:
Inclusion Criteria:

* ethnic minorities (EMs), people with chronic illnesses (PWCI), and caregivers (CGs)
* able to use a computer, smartphone, or laptop to access the Internet at home

Exclusion Criteria:

* diagnosis of an acute psychotic disease or life-limiting condition; having a visual, auditory, or fine motor disorder.