cyrilzakka/clinical-trials huggingface dataset:
Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

Background: venous thromboembolism (VTE) is a common complication in critically ill patients, admitted to the Intensive Care Units (ICUs). At the present time, there is no validated score to estimate risks and benefits of antithrombotic pharmacological prophylaxis in this subset of patients.

Aim of the study: investigating potential harms and benefits of a protocol for systematic screening of DVT in critically ill patients, admitted to an ICU.

Expected relevance: systematic screening for deep vein thrombosis (DVT) through ultrasound (US) lower limb veins examination could help defining the indication to antithrombotic pharmacological treatment, but no protocol of systematic screening has been validated so far. Furthermore, the screening could be associated with over-diagnosis and consequent over-treatment, as well as increased management burden for the caregivers and higher healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Admission to the ICU

Exclusion Criteria:

* duration of stay in ICU \<5 days
* SARS-CoV-2 infection
* established DVT or pulmonary embolism at admission
* established coagulation disorder
* presence of inferior vena cava filter at the admission
* admission/discharge to the ICU of another hospital
Noise Reduction Preferences in Teenagers and Pre-teens

Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.

The purpose of this study is to evaluate the preferences for hearing aid noise reduction settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing aid Bluetooth streaming programs for this population. Subjective preferences will be obtained by having the participants listen to a noisy scene with different levels of noise reduction, to which they are blinded, and rate their preference. Blinded objective speech performance testing will be completed by a) finding the signal-to-noise ratio at which participant can correctly repeat back 50% of the target words, and b) measuring the percent of words correctly repeated during a noisy listening task. These tasks will be done using different levels of noise reduction. Subjective preferences for accessing Bluetooth streaming will also be obtained by asking participants which method they prefer (phone, hearing aid, or touch control).

.

Eligibility Criteria:
Inclusion Criteria:

* mild, moderate, or moderate-severe bilateral sensorineural hearing loss
* native English speakers with ability to communicate verbally
* able to read and follow directions
* access to smartphone and willing to download a hearing aid app
* experienced hearing aid user (6+ months)

Exclusion Criteria:

* unable to follow verbal directions
* unable to communicate verbally
* unable to wear study devices for required home trials
* active middle ear infection
* unable to attend lab visits required for study
Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

The purpose of this study is to determine whether Cyclosporin A (CsA) - an immunosuppressant drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of unexplained recurrent miscarriages, as compared with that treated with Dydrogesterone-an active comparator. The hypothesis is based on the evidence found in vitro and in vivo experiments that CsA can induce maternal-fetal tolerance so that it may reduce the risk of miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Both the woman and her husband agree to participate and sign the informed consent form.
* Have a history of two or more unexplained recurrent miscarriages.
* Spontaneous conception.
* Gestational age less than 5 weeks.
* Have a normal menstrual cycle (\>=23 and \<=35 days) and biphasic pattern of basal body temperature before pregnancy.
* No significant chromosomal aberrations in the couple.
* Semen quality tests show not apparent abnormalities in husband

Exclusion Criteria:

* Age below 18 or above 41 years at conception.
* Present pregnancy is a result of donor insemination or egg donation.
* Significant uterine anomalies detected by ultrasonography, hysterosalpingography, or hysteroscopy.
* Contraindications of CsA (e.g. severe infectious diseases, tumor or immunodeficiency) or Dydrogesterone.
* Smoking more than 20 daily.
Diabetes Prevention and Control in the Workplace: A Pilot Study

This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.


Eligibility Criteria:
Inclusion Criteria:

* Adult employees of Onondaga County

Exclusion Criteria:

* Not an employee of Onondaga County
* Less than age 18
PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial

PROTECT-SYNC study is a multicenter, randomized, controlled trial. A total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period. The purpose of this study to compare the clinical outcomes of Left Bundle Branch Area Pacing (LBBAP) compared to Right Ventricular Pacing (RVP) in bradyarrhythmia patients who require high burden of ventricular pacing (\>40%).

PROTECT-SYNC study is a multicenter, randomized, controlled trial that is designed to assess whether LBBAP may reduce the risk of composite primary endpoint including all cause mortalty, HF hospitalization and/or urgent HF related visit, occurrence of pacing induced CMP, and CRT-upgrade event, compared to RVP in patients who require substantial (\>40%) ventricular pacing. Patients who require pacemaker and substantial (\>40%) ventricular pacing will be randomized to LBBAP or RVP group, and a total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. At least 19 years old and willing and capable to give informed consent
2. Patients who is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

3 Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (\>40%) is anticipated

Exclusion criteria:

1. Incapacitated or unable to read or write
2. Patient who is an indication of ICD or CRT
3. History of prosthetic valve surgery on tricuspid valve
4. Prior myocardial infarction including ventricular septum
5. Life expectancy \< 12 months due to any condition
6. Unavailable for at least 24 months of follow-up visits
7. Pregnant or breastfeeding at the time of signing consent
8. Prior Heart transplant surgery
9. Persistent Left Superior Vena Cava (PLSVC)
Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care

There is recent evidence that early palliative care administered to patients helps for their quality of life (QoL). It is however not part of the standard multidisciplinary treatment.

This study intents to evaluate the effect of early palliative care in patients with advanced Non-Small Cell Lung Cancer (NSCLC) compared to the standard of care.

The multidisciplinary approach of palliative care for symptom management has an impact on the quality of life (QoL) of patients and their families. The World Health Organization (WHO) and the American Society of Clinical Oncology (ASCO) recommend incorporating early palliative care, simultaneously with cancer treatment. Unfortunately, this recommendation has not been followed in many cancer centers and late referrals to hospice are still frequent.

Patients with lung cancer have more symptoms than patients with other cancer. The impact on QoL and symptom management has acquired a great relevance. However, few studies demonstrating the benefit of early incorporation of palliative care in the management of patients with advanced lung cancer have been shown.

Palliative care is defined as the care given to patients with progressive active and advanced disease, and its main purpose is the relief and prevention of suffering and improving QoL.

In Mexico, the law defines palliative care as comprehensive care for those illnesses not responsive to curative treatment and include, but are not limited, to pain and other symptoms associated with the disease and psychological care, social and spiritual, of the patients and their families.

Psychological aspects The psychological manifestations in patients with lung cancer are determined by several factors. Depression and anxiety are the most common psychological reactions. It has been identified that 25% of cancer patients suffer from major depression at some point during the course of the disease and has been associated with decreased survival and QoL. Patients with anxiety disorders become more attached to medical treatment but seek alternative treatments more often. The main objective of psychological interventions is reducing maladaptive emotional reactions. In advanced stages, caregivers also confront stress and depression that could lead to health problems.

Nutritional aspects Malnutrition is reported in 60 to 79% in patients with lung cancer and is the largest contribution to morbidity and mortality. Cachexia is responsible directly or indirectly to death in one third of patients. The objectives of nutritional support are: improving tolerance to specific cancer treatment, decreasing the incidence of complications and, improving the QoL. Thus, it is necessary to conduct an early diagnosis of nutritional status in order to design nutritional intervention and improve their sense of comfort and QoL.

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage IV
* ECOG 0-2
* Patients treated virgin
* Receive platinum-based chemotherapy

Exclusion Criteria:

* Suicide Risk
* Delirium
* Cognitive impairment
Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients

AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO. As of July 2024, 37 patients have been treated through this FDA-EAP including patients diagnosed with relapsed or recurring glioblastoma, inoperable/chemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell Non-Hodgkin's Lymphoma and metastatic pancreatic cancer. Drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Identification of Breath Biomarkers in Head and Neck Squamous Cell Carcinoma

In this study the Investigators aim to determine specific volatile compounds present in breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before and after tumour resection or before and after chemotherapy +/- radiotherapy using gas chromotography-mass spectrometry. The Investigators hypothesize that study participants with a tumour will display a distinct set of volatile organic compounds than can serve as potential cancer biomarkers.

Head and neck cancer diagnosis is devastating as it frequently disrupts one's ability to communicate, swallow and breathe. Each year, physicians diagnose approximately 650,000 cases of head and neck cancer worldwide. Many people with head and neck cancer have their cancer detected late, and this can result in a poor clinical outcome. One strategy to improve the clinical outcomes for people with a head and neck cancer is to develop a non-invasive screening assay using breath biomarkers. Such a diagnostic tool will identify at-risk individuals early, and potentially offer improved and cost-effective treatment.

The idea of using human breath samples to detect cancer began with the observation that dogs can be trained to "sniff out" certain types of cancers from urine and blood. Since then the presence of various volatile organic compounds from many types of cancers, including: lung, skin, breast, prostate, and bladder have been characterized. These studies are ongoing, but promise to revolutionize the way physicians screen cancer in the future.

In this pilot study, the Investigators aim to determine specific volatile organic compounds present in breath samples of patients with oral cavity or oropharyngeal cancer before and after tumor resection, or before and after definitive chemotherapy/radiotherapy. As head and neck cancer can result in significant functional deficit, early detection is the key to improving clinical outcome. Much anecdotal evidence exists for the presence of distinct odor emissions from the tumor bed of head and neck cancer patients. Therefore, the identification of specific volatile organic compound to head and neck cancer will undoubtedly lead to a novel, cost-effective screening strategy for early detection of head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years
* Clinical diagnosis of oral cavity or oropharyngeal squamous cell carcinoma

Exclusion Criteria:

* Evidence of metastatic disease
* Previous treatment of this cancer with surgery, chemotherapy or radiotherapy
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo

The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.

Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat, moisture, maceration, friction, or lack of air circulation. It is typically chronic with insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo frequently worsened or colonized by infection, which most commonly is candidal but also may be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis, has been used by physicians for the treatment of intertrigo; however, there is a paucity of data in the literature regarding the use of Vusion ointment in this indication.

This study is the first to formally investigate the efficacy and safety of Vusion ointment for the treatment of intertrigo.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of intertrigo

Exclusion Criteria:

* Pregnancy
* Use of systemic or topical antifungal or corticosteroid treatment in the previous 14 days or during the 3-month treatment period
* allergy of sensitivity to Vusion
* undergoing warfarin anticoagulation
* alcohol or drug abuse
* Investigator determines they cannot particpate
* history of non-compliance or poor cooperation
* participation in an investigaitonal drug study within 30 days of Baseline Visit
Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.

This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.

This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or secondary infertility undergoing endometrial preparation for an embryo transfer using standard doses of oral or transdermal estrogens.
* Age between 18 and 50 years.
* Normal uterine cavity verified by imaging techniques.
* Serum progesterone documented on the day of embryo transfer.

Exclusion Criteria:

* Patients with a history of endometritis.
* Patients diagnosed with Asherman's syndrome.
* Patients with a different supplementation regimen or doses than those of the study groups.
ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION)

The ELECtrode configuraTION CRT Study (ELECTION)

Cardiac resynchronization therapy (CRT) is an accepted treatment for selected heart failure patients. This therapy is delivered using a device (pacemaker (PM) +/- defibrillator (ICD) ) and leads placed in the right atrium (RA), right ventricle (RV) and left ventricle (LV). Rates of LV lead implantation failure and post operative lead related have decreased dramatically over the years, however, the incidence of lead dislodgement and phrenic nerve stimulation is still high. This study is a prospective evaluation of the benefits of having various pace/sense electrode configurations available in a CRT system.

Eligibility Criteria:
Inclusion Criteria:

* Patients selected for a Guidant system, symptomatic heart failure, LV dysfunction, QRS width \> 120 ms, \> or = 18 yrs, able to understand the procedure, available for follow-up.

Exclusion Criteria:

* \< 18 years, life expectancy \< 6 months, expectation of heart transplantation during the study period, patients who have or are likely to receive a mechanical tricuspid valve, documented aortic stenosis, hypertrophic obstructive cardiomyopathy, inability or refusal to complete the follow-up at an approved centre, enrollment in another cardiovascular clinical investigation unless approved by the Manager of Clinical Studies, Guidant Canada, inability or refusal to sign consent.
Clinical and Paraclinical Characteristics of Severe Bronchiolitis in Children From 2 Months to 12 Months at the Children's Hospital 1 in Ho Chi Minh City - Vietnam

Goal: The aim of this study is to determine the epidemiological, clinical, paraclinical characteristics and treatment of severe bronchiolitis at the Children Hospital N01 in 2001-2002.

Materials and method: in this cross-sectional study, specimens of 51 patients with severe bronchiolitis at the Children Hospital N01 from March, 1 st 2001 to February, 28th 2002 are described and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* children younger from 2-12 months present fever (usually ≤38.3ºC \[101ºF\]) ,cough, and respiratory distress (eg, increased respiratory rate, retractions, wheezing, crackles)
* preceded by a one- to three-day history of upper respiratory tract symptoms (eg, nasal congestion and/or discharge) \]
* Respiratory distress.

Exclusion Criteria:

* refusal to give informed consent
* mucus sample Barlett \<=0
The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients

We assessed serum CGRP concentrations before and after treatment in two hundred episodic migraine patients according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years. We divided them into two groups first one received Ibuprofen 200-400 mg as a treatment for acute migraine attacks and lacosamide 50 mg Bid for 3 months, and the other group received only Ibuprofen 200-400 mg as a treatment for acute migraine attacks.

Two hundred episodic migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years with migraines. We divided them into two groups first one received Ibuprofen 200-400 mg as a treatment for acute migraine attacks and lacosamide 50 mg Bid for 3 months, and the other group received only Ibuprofen 200-400 mg as a treatment for acute migraine attacks. Our selected patients were naive and didn't receive any other prophylactic therapy for migraine.

for each patient, the investigators did

1. detailed history taking with stress on Age, sex, and criteria and type of migraine
2. general examination
3. full neurological examination: Full neurological examination
4. Laboratory investigations include: Serum creatinine, Liver functions test to exclude any metabolic disorder.
5. Approximately 5 ml of venous blood was drawn from all participants and centrifuged at 1000×g for 10 min. Serums were separated from the blood sample and stored at - 20 ℃. The serum calcitonin gene-related peptide (CGRP) concentrations will be measured by adapting the enzyme-linked immunosorbent assay (ELISA) kit following manufacturer protocols.
6. Serum level CGRP before starting treatment and after three months of treatment
7. MRI T1, T2, and flair to exclude any secondary cause of headache.

Eligibility Criteria:
Inclusion Criteria:

* Naive migraine patients according to the International Classification of Headache Disorders 3rd edition aged 10-55 years,

Exclusion Criteria:

* Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
* patients with major systemic diseases such as malignancy, collagen diseases, liver diseases, and renal diseases.
* patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or HbA1C more than 6.5.
* patients with valvular and ischemic heart diseases,
* patients who received prophylactic treatment for migraine,
* patients with any contraindications to lacosamide.