cyrilzakka/clinical-trials huggingface dataset:
Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients

This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.

This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.The hypertensive patients with chest pain for suspicious coronary heart disease were seriesly enrolled. All the patients underwent coronary angiography or coronary CT angiography to exclude the diagnosis of obstructive coronary artery disease . Coronary flow reserve (CFR) is an integrated measure of flow through both the large epicardial arteries and the coronary microcirculation. In the absence of obstructive stenosis of the epicardial arteries, CFR is an indicator of coronary microcirculatory function，which can be assayed by Transthoracic Doppler echocardiography. The symptoms of anxiety were measured with Self-rating Anxiety Scale (SAS) . According to the SAS score,the patients were divided into anxiety group and non-anxiety group.We assessed the association of anxiety with coronary microcirculatory function.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clear diagnosis of hypertension (≥1 year, drug control within 140/90mmHg); (2) Significant coronary artery stenosis was excluded by imaging within 1 year (≤50%); (3) Age between 18 and 80.

Exclusion Criteria:

1. CHD, heart valve disease, congenital heart disease, cardiomyopathy and pericardial disease; (2) Left ventricular ejection fraction (LVEF) \<50%; (3) Increased markers of myocardial injury; (4) Diabetes mellitus, connective tissue disease, chronic obstructive pulmonary disease and malignant tumor; 5) Severe hepatic and renal impairment (Cr ≥120 umol/L, ALT ≥120 umol/L); 6) Pregnant women.
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach but has been also identified in a variety of other organs. Alike, a wide range of central and peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study are:

A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30, 35-45, 60-70 years).

B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with major depression (age range: 20-65 years).


Eligibility Criteria:
Inclusion Criteria:

* Healthy females and males
* Male and female patients with major depression

Exclusion Criteria:

* Life time or family history of psychiatric or neurological disorders
* Sleep disturbances
* Shift work
* Any current disease
* Any medication
* Long distance flight within 3 months prior to study entry
* Smoking
* Any medication during the week prior to study entry
* Any current disease other than major depression
Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.


Eligibility Criteria:
Inclusion Criteria:

* Female diagnosed with stress urinary incontinence

Exclusion Criteria:

* Currently taking a monoamine oxidase inhibitor
Diaphragm Training Ultrasound

Common neurological indications of intubation and initiation of mechanical ventilation (MV) include ischemic and hemorrhagic stroke, neurotrauma, and intracranial hemorrhage. Mechanical ventilation is frequently applied to protect the airway from the risk of aspiration and to prevent both hypoxemia and hypercapnia, which are two major systemic factors of secondary brain insult.

Mechanical ventilation after endotracheal intubation predisposes these patients to an increased incidence of pulmonary complications such as ventilator-associated pneumonia (VAP), increased risk of deep vein thrombosis, bedsores, increased hospital stay, and poor clinical outcome.

The weaning process from MV involves the reduction of ventilator parameters and Extubation. Daily, careful evaluation of clinical and neurological conditions and completion of spontaneous breathing trial (SBT) should be considered in order to recognize and facilitate the process of withdrawal of the MV.

The diaphragm which is the principal respiratory muscle provides nearly 75% of the resting pulmonary ventilation. However, In ICU patients, the diaphragm is vulnerable to damage from hypotension, hypoxia, and sepsis. Diaphragmatic dysfunction and atrophy is the main precipitating factor for difficult and successful weaning.


Eligibility Criteria:
Inclusion Criteria:

* patients attached to mechanical ventilation will be included in the study after the informed consent of the legal guardian.

Exclusion Criteria:

* Patients with severe acute lung injury, morbid obesity, chest wall deformity, direct diaphragmatic injury, cervical spine and patients who require neuromuscular infusion will be excluded from the study.
ADHOC Mindfulness-Based Research

The AMBR Study (ADHOC Mindfulness-Based Research Study) is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV over the age of 50. It is a substudy of the ADHOC study (ClinicalTrials.gov identifier NCT04311554).

The AMBR Study is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV who are over the age of 50 and enrolled in ADHOC (ClinicalTrials.gov identifier NCT04311554). The intervention consists of 14 mindfulness audio lessons, each approximately 20-minutes long. The mindfulness lessons are designed to develop three core skills: concentration (the ability to maintain focus on present-moment experiences), clarity (the ability to pinpoint exactly what you are experiencing in each moment), and equanimity (openness to experience).

Eligibility Criteria:
Inclusion Criteria:

* ADHOC participant with a score of 4 or higher on the 3-item Loneliness Questionnaire from their ADHOC profile
* Clinical diagnosis of HIV
* Able to read and write in English
* Able and willing to provide online informed consent and complete study activities online
* Access to a smartphone or computer

Exclusion Criteria:

- Acute medical problem(s) requiring immediate inpatient treatment
Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters

The purpose of this observational study is to survey the safety and effectiveness of the product under the real condition of usual practice in Taiwanese hypertensive patients. During the 8-week observation, the safety profiles and the clinical evaluation in between doses through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will be concluded.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria:

1. Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic blood pressure (BP) \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg).
2. Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

Exclusion Criteria:

1. Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
2. Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
3. Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
UNTIRE: Cancer-related Fatigue With Digital Treatment

This research is being done to find out if using a smartphone app as digital treatment to reduce Cancer Related Fatigue is feasible and easy to use.

This research study is evaluating a smartphone application named the "Untire" app. The Untire app was designed as a digital treatment plan for people experiencing Cancer Related Fatigue (CRF).

This is a single arm, pilot study evaluating the feasibility, acceptability, and effectiveness of a self-managed digital therapeutic application, the Untire App, for the treatment of cancer-related fatigue in the Colorectal (CRC) cancer patient community.

The Untire app was developed by Psychology Oncologists and combines proven treatments for Cancer Related Fatigue like cognitive behavioral therapy, mindfulness exercises, physical activities, education, and positive tips. The Untire app helps a patient recognize and learn about daily behaviors, fatigue levels, and energy levels. The Untire app has been tested on all different cancer types globally and has been proven to decrease fatigue and improve overall quality of life but this is the first-time investigators are examining the strengths and weaknesses of using the Untire app as a digital treatment plan for Cancer Related Fatigue.

The research study procedures include screening for eligibility and study interventions including smartphone app use and evaluations with questionnaires and follow up visits.

Participants will be in this research study for up to 12 months.

It is expected that about 60 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years of age
* Owns a smart phone or Ipad
* Diagnosis of Metastatic Colorectal Cancer, adenocarcinoma
* Actively undergoing treatment for Metastatic disease
* Speak and read English at a 6th grade level or higher
* A score of 1 or greater on the PRO CTACE DFCI fatigue (questions 53a or 53b)

Exclusion Criteria:

* Patients in Surveillance
* Patients receiving end of life care
* Patients taking dexamethasone other than for the control of nausea
* Patients taking methylphenidate (Ritalin) for the treatment of CRF
Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as second-line treatment in patients with AGC.

For patients with advanced gastric cancer, combination chemotherapy has been shown to improve the quality of life and overall survival (OS) compared with best supportive care alone. Docetaxel is an active agent for treating patients with gastric cancer. S-1, an oral 5-FU prodrug, is active against AGC as a single agent or in combination with cisplatin in phase III trials. Therefore, a single-arm phase II study was conducted to investigate the efficacy and safety of biweekly docetaxel and S-1 (DS) combination therapy as second-line treatment in patients with previously treated advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years old;
2. Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
3. The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease.
4. Relapse within 6 months after adjuvant chemotherapy;
5. ECOG (Eastern Cooperative Oncology Group)performance status 0-2;
6. At least 1 measurable lesion should be present（RECIST1.1）
7. Available Organ function: Neutrophils\>2g/L, Hemoglobin\>9g/L, Blood platelet \>100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)\<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)\<1.0 ULN; Cr \<1.0ULN
8. Signed informed consent.
9. Life expectancy ≥3 months;

Exclusion Criteria:

1. Previous treatment with taxanes (not including intraperitoneal use of taxanes);
2. Known history of hypersensitivity to study drugs;
3. Active CNS metastases not controllable with radiotherapy or corticosteroids;
4. Pregnant or breast feeding women;
5. Severe co-morbid illness and/or active infections;
6. Active and uncontrollable bleeding from gastrointestinal tract
7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol;
8. Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
9. Known HIV infecton.
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy

The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.

This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.

Patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female at least 18 years of age
* For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient is scheduled to have a bunionectomy
* Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery

Exclusion Criteria:

* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen
* Patient is hypersensitive to any of the medications to be used in the study
* Patient has taken another investigational drug within 30 days prior to Screening
Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit

This is a single-center study retrospectively evaluating a local clinical routine to administer norepinephrine in midline catheters, with regard to complications and patient outcomes

Se attached study protocol

Eligibility Criteria:
Inclusion Criteria:

* Administration of norepinephrine in a midline catheter in an intermediary care unit
* In Skåne university hospital
* From 2019 to 2023-03-31

Exclusion Criteria:

* Patients who have actively disabled review of their electronic medical record
Topical Endoxifen in Women

Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the Karma Cohort
* Attending the national mammography screening program, i.e., aged 40-74 and have performed a screening mammogram maximum 3 months prior to study inclusion
* Mammographic density \~4.5 % density (volumetric) measured by Volpara, at the screening mammogram performed in connection to baseline (maximum 3 months prior to inclusion). The threshold value of 4.5% corresponds to the clinical Bl-RADS score A
* Postmenopausal, defined as no period of menstruation during last 12 months independent of any hormonal treatment
* Informed consent must be signed before any study specific assessments are performed

Exclusion Criteria:

* Any previous or current diagnosis of breast cancer (including carcinoma in situ).
* Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix.
* A history of major surgery of the breast, e.g., reduction or enlargement, which might affect density measurements.
* Mammographic Bl-RADS malignancy code 3, or above, at baseline mammography, or at mammography during time of treatment. Recall for additional examinations due to technical problems with the mammogram is accepted.
* Currently using estrogen and progesterone based hormone replacement therapy (oral or patches). Local estrogen treatment is accepted (ex. Vagifem).
* Non-medical approved drugs against hot-flashes including phytoestrogen.
Effectiveness of Photodynamic Therapy in the Disinfection of Root Canals in Patients With Apical Lesion

The object of the present study is to compare the effectiveness of conventional endodontic treatment with that of endodontic treatment combined with Photodynamic Therapy (PDT) in patients with apical lesion. Clinical and radiographic examination of the patients will be used to evaluate the presence of apical lesion, size of the lesion, and PAI index. Microbiological examination (evaluation of UFC/ml) will be carried out to assess the disinfection of the root canals. The success rate of the treatment will also be assessed. Endodontic treatment will be carried out in accordance with habitual standards and practices. PDT will be applied with diode laser (660 nm, 100 mW) and methylene blue will be used as photosensitizer (PS). Patients of the Endodontics Service of Universidad San Sebastián (Santiago campus) will be recruited for the study.

The object of the present study is to compare the effectiveness of conventional endodontic treatment with that of endodontic treatment combined with PDT in patients with apical lesion. A randomized, clinical, superiority trial will be carried out, controlled, blinded and masked, with 3 parallel arms.

The patient sample will be randomized in 3 treatment groups: the first is the placebo group which will receive conventional endodontic treatment (ET) and a simulated treatment with the equipment in which no radiation will be emitted; the second group will receive conventional ET associated with PDT with diode laser at 660 nm, fluence 10 s/canal; and the third group will receive conventional ET associated with PDAT with laser at 660 nm, 20 s/canal. The photosensitizer used in the PDT will be methylene blue.

Clinical and radiographic examination of all the patients will be used to obtain baseline values (T0) and values 6 months post-treatment (T1). The presence and size of apical lesion will be assessed at T0 and T1, the percentage reduction of the lesion will be calculated and the PAI index will be used as a scoring system to assess the lesion. The success rate will be assessed for each group 6 months after completion of the treatment. Disinfection of the root canals will be assessed by analysis of colony formation (ufc/ml); biological samples will be taken with paper cones inserted into the root canals to the apical region at two moments: Baseline (before treatment, T0); after instrumentation with PDT (experimental groups) and without PDT (placebo group). Adverse events will be analysed; a serious adverse event for this study is any unfavourable odontological event that the investigators believe to bear a causal relation with the experimental intervention.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for this study must comply with the following for randomization:

1. Adult patients of either sex
2. No general biological risk
3. At least 1 molar with pulp necrosis and apical lesion

Exclusion Criteria:

1. Pregnancy
2. Patients requiring complex dental rehabilitation due to major coronal destruction
3. Individuals with cognitive disability making conventional treatment impossible
Default Options in Advance Directives

In a multicenter, randomized clinical trial of default options in advance directives among patients with incurable diseases, we will determine whether this simple and readily scalable intervention can improve patients quality of life and reduce resource utilization without reducing the number of days that patients are alive and living outside of an acute-care hospital.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Fluent in English
* Has seen current physician at least once prior to current visit
* Resident of Pennsylvania or New Jersey
* One or more of the following diagnoses:
* Amyotrophic lateral sclerosis
* Stage IIIB or IV non-small cell lung cancer, pancreatic cancer, or cholangiocarcinoma
* Stage IV breast, colon, esophageal, gastric, pancreatic, prostate, uterine, cervical, ovarian, or urothelial cancer; paraganglioma, or pheochromocytoma
* Stage C or D hepatocellular carcinoma
* Stage IV renal cell carcinoma
* Stage IV or V chronic kidney disease
* Mesothelioma or any malignancy metastatic to the pleura
* Other incurable interstitial lung diseases with at least severe restriction on most recent pulmonary function tests or eligible for long-term oxygen therapy
* Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry or eligible for long-term oxygen therapy
* Congestive heart failure with NYHA Class IV status or Class III plus 1 heart failure related hospitalization in the past 12 months or ACC stage D or C classification with 1 heart failure related hospitalization in the past 12 months

Exclusion Criteria:

* Currently listed for or being considered for solid organ transplant
* Patients with a previously signed advance directive or living will.
The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)

Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and c-LMA in infants.


Eligibility Criteria:
Inclusion Criteria:

* infants (0-1 year of age)
* who scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

* patients with an abnormal airway
* with reactive airway disease
* with gastroesophageal reflux disease
* with chronic respiratory disease
* has a history of an upper respiratory tract infection in the preceding 6-week period