cyrilzakka/clinical-trials huggingface dataset:
The COVID-RASi Trial (COVID-19)

The COVID-RASi study is an international randomized clinical trial that will evaluate the potential benefit of angiotensin modulators on clinical outcomes, in COVID-19 patients. The purpose of this study is to determine if renin-angiotensin system inhibitors (RASi), with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), has a beneficial effect in patients with COVID-19 infections, by reducing ICU admission, ventilator requirement or death. We would also like to determine if there are differences between ACEi and ARB therapeutic treatments. With the increasing potential of long COVID symptoms, at the 1 year follow up, a primary endpoint will be the quality of life of study participants, as assessed by ongoing symptoms and/or the standardized questionnaires.

The goal is to determine if RASi with ACEi or ARB, has a beneficial effect in patients with COVID-19 infections, by reducing hospitalizations, ICU admission, ventilator requirement or death.

This is a multi-centre study, conducted in major centres treating COVID-19 patients in-hospital and in various outpatient settings.

Patients admitted to hospital or outpatients that test positive for COVID-19 and meet the inclusion/exclusion criteria will be eligible to participate in this study. All study participants will not be on RASi (ACEi/ARB) treatment at the time of consent. Participants will be randomized to initiation of ACEi vs ARB treatment vs no RASi treatment as part of care for COVID-19 in a 1:1:1 ratio.

The patient will be followed by their physician according to usual clinical care. Sites will complete research-related follow-ups at 24 hours, 7 and 28 days to asssess patient's clinical status, side effects and the achievement of clinical endpoints by telephone interviews. Phone call follow ups will also be conducted at 6 months and 12 months after enrollment in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with COVID-19 diagnosis with laboratory confirmation within the last 30 days AND
* Age 40 years old or greater if outpatient OR age 18 years old or greater if inpatient (admitted to the hospital) at time of recruitment

Exclusion Criteria:

* Contraindication to ARB or ACEi, including severe aortic stenosis and angioedema
* Patients who are currently on active treatment with ARB/ACEi
* Known bilateral renal artery stenosis
* Systolic BP ≤90 mmHg
* eGFR\<30 ml/min, if not receiving dialysis treatment
* K\>5.5 mmol/L on screening laboratory testing
* Recent history of dizziness, vertigo, related to hypotension or orthostatic hypotension, that can lead to contraindication to ACEI/ARBs
* Acute respiratory distress syndrome requiring invasive ventilation
Pre-Clinical Models in Gynecological Tumors A Tissue Repository

The purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. This material will be used in studies to better understand the molecular biology of endometrial cancer.

BACKGROUND AND RATIONALE

This protocol will create a central repository for banking tumor and other tissues as well as serum from patients with uterine corpus tumors. In addition, this protocol will also serve as a central repository for serum and tissue to healthy post-menopausal and peri-menopausal controls.

There will be an "internal" bank. The internal bank will have samples available to UNM investigators.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing hysterectomy, or who have endometrial cancer, and are under routine surveillance.
* Patients may have received prior hormonal, cytotoxic chemotherapy, irradiation or surgical therapy.
* Healthy post-menopausal and peri-menopausal women.
* A consent form must be signed by the patient prior to study entry.

Exclusion Criteria:

Study Patients:

* Patients who do not have primary uterine corpus tumors.
* Patients with less than one gram of tumor tissue available to procurement.

Controls:

* Patients unwilling to have their medical records reviewed for height, weight, and general medical history (see attached data sheets).
Shoulder Passive Range of Motion and Positioning Exercise on Hemiplegic Stroke Patients

Several factors associated with the hemiplegic shoulder pain after stroke includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. In this study, the investigators aim to usie high frequency ultrasound to evaluate the relationship between stroke patients with poor shoulder motor function and shoulder tendon injury. Also, assumed that performing passive range of motion and positioning training might prevent tendon injury of shoulder and hemiplegic shoulder pain in either acute or chronic stage of stroke.

Hemiplegic shoulder pain is a common complication. Several factors associated with the hemiplegic shoulder pain includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. Flaccidity has a positive association with soft tissue injury or tendon injury of the shoulder.

In the preliminary study, base on the sonography results, it is found that the possibility of getting tendon injury or inflammation on the affected shoulder joint is higher in the group of patients who were with worse motor functions during the rehabilitation in hospital.

In this study, one hundred acute stroke patients with hemipelgia will be enrolled. And those participants would be separated into 2 groups: control group (Brunnstrom stage IV-VI) and experimental group (Brunnstrom stage I-III). Clinical characteristics and physical findings will be recorded on the admission date. During the process, the investigators will use high frequency (5-12 MHz) musculoskeletal ultrasound to evaluate those tendons around bilateral shoulder joints on the admission date and at 2 weeks later. In the first year after stroke, half patients in those 2 groups will perform positioning training and passive range of motion for affected shoulder either during hospitalization or after being discharged. Then, the investigators will execute physical examination and use high frequency ultrasound to evaluate those tendons around bilateral shoulder joints of the participants twice after 6 months and 12 months. Then, the investigators will discuss the incidences of shoulder tendon injury after receiving rehabilitation program according to ultra-sonographic findings.

Eligibility Criteria:
Inclusion Criteria:

* stroke with hemiplegia
* age between 18-80

Exclusion Criteria:

* recurrent stoke patient
* previous history of shoulder pain, any injuries and operation in shoulder joint, frozen shoulder, tendinitis in shoulder joint,
* any other systemic neuromuscular disease
* cognition or language impairment leading to communication difficulty
Five Factor Model Treatment for Borderline Personality Disorder

The primary purpose of this study is to explore acceptability, feasibility, and preliminary efficacy of a novel cognitive-behavioral treatment for borderline personality disorder (BPD). Extant treatments for this condition are intensive, long-term (usually at least one year), and have, understandably, focused on targeting the life-threatening and therapy-interrupting behaviors that often characterize this disorder. BPD, however, is a heterogeneous disorder with diagnostic criteria that can be combined to create over 300 unique symptom presentations (Ellis, Abrams, \& Abrams, 2008); to date, no treatments have been explicitly designed with lower risk presentations of BPD in mind. This is unfortunate, as there is evidence to suggest that the majority of individuals with BPD do not demonstrate the recurrent life-threatening behaviors that warrant intensive, long-term care (Trull, Useda, Conforti, \& Doan, 1997; Zimmerman \& Coryell, 1989). Additionally, various studies have shown that the difficulties experienced by individuals with BPD can be understood as manifestations of maladaptive variants of personality traits (e.g., Mullins-Sweatt et al., 2012). Specifically, individuals with BPD demonstrate high levels of neuroticism, and low levels of agreeableness (antagonism) and conscientiousness (disinhibition); these traits may not be universally present across all individuals with BPD, perhaps underscoring the heterogeneity in presentations of this condition.


Eligibility Criteria:
Inclusion Criteria:

-diagnosis of borderline personality disorder (BPD)

Exclusion Criteria:

* diagnosed psychological conditions that would be better addressed by alternative treatments
* previously received more than 5 sessions of cognitive behavioral therapy in the past 5 years
* concurrent psychotherapy
* medication instability
Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound microbubble contrast material, and to see if results from ultrasound contrast studies can predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass will be examined to see if:

1. benign kidney masses can be distinguished from kidney cancers and
2. if slow growing, lower risk cancers have different blood flow compared to clear cell cancer which is the most common type of kidney cancer.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient who is planned or scheduled for surgical excision or biopsy of a solid or complex cystic renal mass would be eligible for the study
* Histology of the renal mass must be unknown at the time of enrollment
* Patients who have renal masses that are evident on conventional US imaging
* Patients will have a correlative abdominal CT and/or MRI

Exclusion Criteria:

* Patients with any history of cardiac shunts.
* Patients with history of pulmonary hypertension or unstable cardiopulmonary conditions, including patients on mechanical ventilation.
* Patients without peripheral IV access
* Pregnant patients and children
* Patients with any known contrast allergies, allergy to perflutren, or any components of Definity or microbubble contrast
* Patients who have renal masses that are not evident on conventional US imaging
Study of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma

anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM


Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ;
2. N2-3 disease (UICC/AJCC 8th) with necrosis or/and ECM;
3. with sufficient organ and bone marrow function;
4. ECOG (Eastern US Cooperative Oncology Group) score \< 3
5. with good compliance and cooperation to treatment and follow-up
6. agree to use effective methods of contraception during the study period and within 180 days of the last study administration.

Exclusion Criteria:

1. patients with other malignant tumors diagnosed within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\]
2. patients with bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers or fracture;
3. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C.
4. Active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin \>38.5℃ 1 weeks ago (except for tumor related fever determined by researchers).
5. Abnormal coagulation (INR \> 1.5 or APTT \> 1.5 × ULN), bleeding tendency or undergoing thrombolysis or anticoagulation. Long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy is required.
6. serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study
7. Allergy to the drugs in the study
Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size

The main objective of this study is to assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days) for patients with early stage lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AJCC sixth edition Stage Ib or II non-small-cell lung cancer with cytology or biopsy proven disease and a minimum tumor size of 3.5 cm are eligible.
* To be considered node negative for N2 disease, patients will have mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on FDG PET in those areas.
* All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to co-morbid conditions.
* The CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion is determined to be in a location where RFA is technically achievable based on the proximity of adjacent organs and structures.
* Age ≥ 18 years old
* Performance Status 0-2 (ECOG)

Exclusion Criteria:

* History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA of \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
* Previous chest radiation to the region of interest.
* Pregnant or lactating women.
* A clinical diagnosis of bronchoalveolar carcinoma (BAC) will be made for patients in whom tissue diagnosis is by cytology alone with adenocarcinoma shown and the following radiographic criteria are met.
Text Messaging to Reduce High-risk Alcohol Use Among Older Adults

High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment.


Eligibility Criteria:
Inclusion Criteria:

* consumption of \> 10 standard drinks á 12 gram ethanol per week (i.e., high-risk alcohol use defined by the Danish Health Authority) in the past four weeks
* desire to reduce drinking
* age 55 to 80 years
* mobile phone ownership and willingness to receive and respond to text messages
* fluency in Danish.

Exclusion Criteria:

* drinking more than 53 standard drinks per week in the last four weeks
* past 12 month alcohol withdrawal symptoms or lifetime history of serious withdrawal symptoms (e.g., seizures)
* score above 12 on the Short alcohol withdrawal scale; SAWS
* possible drug dependence (i.e., use of illegal drugs or psychotropic medication taken without prescription more than once a month)
* indication of serious psychiatric illness (lifetime diagnosis of psychosis or bipolar disorder, inpatient treatment or medication for these, recent suicidality)
* current alcohol/drug abuse treatment or a desire to start alcohol/drug abuse treatment during the study
* medical condition that requires abstinence from alcohol
* wish to achieve abstinence (applied to secure a focus on reduction)
* lack of understanding of study protocol or reading difficulty as evidenced by a score of less than 7 out of 10 on the consent form quiz.
Arterial Remodeling in Smokers

Cigarette smoking is the most important modifiable cardiovascular risk factor leading to endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the study was to investigate the effect of smoking on vascular response to transradial coronary angiography (TCA).


Eligibility Criteria:
Inclusion Criteria:

* all subjects underwent a TCA

Exclusion Criteria:

* acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) CRP \> 1 mg/dl malignant disease
Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

In line with the ever-growing aging of Western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. The alteration of vascular function (at the cerebral and systemic level) with aging is an important feature in the clinical picture including a decrease in physical and cognitive capacities. Although physical activity is recognized as an essential means of combating the effects of aging, optimizing its effects by defining the most effective strategies of practice remains a key objective. Offering alternative interventions to exercise training is also necessary for people who are unwilling or unable to engage in a physical activity program. In this context, hypoxic conditioning, alone or in conjunction with rehabilitative exercise training, is a new therapeutic modality with strong preclinical validity, in particular from a cardiovascular standpoint, and used in other pathologies to improve cardiovascular function and exercise performance and quality of life. Our aim is, therefore, to investigate the effect of hypoxic conditioning (alone or in conjunction with exercise training) on cerebrovascular health in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* 60 to 80 years of age;
* Being physically inactive (less than 150 min/week of moderate to intense physical activity);
* No chronic cardiovascular, respiratory, metabolic or neuromuscular disease counterindicating an exercise training or hypoxic conditioning program;
* Health coverage;
* Being able to provide written fully informed consent.

Exclusion Criteria:

* Body-mass index \>30 kg/m2;
* Smoking (\> cigarettes/day);
* Alcohol use (\> 10g/day);
* Mental disorder or history of mental disorder;
* Beta-blockade treatment;
* Inability or refusal to provide informed consent;
* No health coverage
* People exceeding the annual ceiling of allowances received as a result of their participation in other clinical trials;
* People deprived of freedom by judicial or administrative decision;
* People subject to legal protection, who cannot be included in clinical trials.
Acute Effects of Inhaled Treprostinil in Fontan Patients

In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable Fontan patients. Investigators will also assess the effects of resting and acute rises in exercise induced systemic venous pressure on liver stiffness and will also assess whether treprostinil will attenuate the acute stiffness increase that investigators expect to see. This will be a prospective, randomized, double-blinded placebo controlled, crossover trial. Following recruitment and informed consent, each participant will undergo three study visits, including baseline testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 years and older
2. Single ventricle patients status post Fontan procedure

Exclusion Criteria:

1. Clinically unstable: these are patients who are experiencing new cardiovascular symptoms such as worsening shortness of breath, new onset arrhythmia, uncontrolled heart failure, or evidence of clinically significant cirrhosis or renal failure.
2. Evidence of Fontan pathway or intra cardiac obstruction as identified on prior clinically indicated imaging studies (echocardiography and MRI);
3. Evidence of left or right systemic ventricular systolic dysfunction with an Ejection fraction of \<40% on either echocardiogram or MRI from previously documented clinical data;
4. Presence of uncontrolled arrhythmias;
5. Unable to perform exercise testing for any reason or if deemed by the PI or designee that exercise testing would not be in the best interest of the participant
6. Currently pregnant and/or breastfeeding
7. Patient unable to provide informed consent
8. BMI \> 30 mg/m2
Quantitative Dynamic Contrast Enhanced Breast MRI

The purpose of this study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular MRI. DCE MRI uses a new way of collecting and analyzing the images or pictures which provides doctors extra information not available with standard imaging methods. This includes information about the blood vessels of different breast diseases. Pictures produced this way look just like the regular MRI pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination ordered by your physician to evaluate your breast lesion, thus increasing the exam time (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used in your treatment and will not affect the type of care you receive for your breast lesions.

Our aim is to perform dynamic contrast enhanced (DCE) MRI on 150 patients during their routine breast MRI examination at MSKCC. This will add extra 10 min scanning time to the routine examination. High resolution (submillimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the DCE MRI data. These results will be correlated with pathology to determine new pharmacokinetic threshold so that the negative predictive value for benign lesions is close to 100%. The improvement in diagnostic specificity may help to reduce unnecessary biopsies in the future.

Eligibility Criteria:
Inclusion Criteria:

· scheduled for breast MRI interventional procedure for a known breast lesion.

Exclusion Criteria:

* patients who would be normally excluded from undergoing an MRI examination patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* patients who are unable to cooperate for an MRI, and/or have known reaction to gadolinium contrast agent.