cyrilzakka/clinical-trials huggingface dataset:
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs

Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives

Early postoperative mobilization is essential for rapid functional recovery after surgery and it is considered a cornerstone in the so-called fast track multimodal perioperative approach, which includes early ambulation, oral nutrition, multimodal opioid-sparing analgesia and optimized fluid therapy. This strategy has improved patient outcome after surgery and reduced hospital length of stay. Immobilization after surgery is associated with increased risk of complications including venous thromboembolism (deep venous thrombosis, pulmonary embolism), muscle wasting, pneumonia and atelectasis, thereby impending convalescence.

However, early postoperative mobilization can be delayed due to failed orthostatic cardiovascular regulation, resulting in postoperative orthostatic hypotension (OH), defined as a decrease in systolic blood pressure \> 20 mmHg or diastolic blood pressure \> 10 mmHg or postoperative orthostatic intolerance (OI), characterized by dizziness, nausea, vomiting, visual disturbances or syncope.

Previous studies investigating the incidence and pathophysiology of postoperative OI and OH included mixed patient populations. Hitherto no studies have been performed looking into the incidence and pathophysiologic hemodynamics of postoperative OI and OH specifically in patients receiving angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), antihypertensive agents with potential effects on cardiovascular compensatory functions.

The current study aims therefore to estimate the incidence and gain knowledge on pathophysiological hemodynamics of postoperative OI and OH in patients receiving ACEIs and ARBs.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary unilateral total hip arthroplasty (THA) in spinal anaesthesia in standardized fast-track setting
* Habitual use of angiontensin-Converting Enzyme Inhibitors (ACEIs) and/or angiotensin 2 receptor blockers (ARBs) on any indication
* Patients \> 18
* Patients that understand and speak Danish
* Patients that have provided written informed consent

Exclusion Criteria:

* Alcohol abuse
* Any type of substance abuse
* Chronic pain treated by habitual use of opioids
* Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs
* History of cerebral apoplexy or transitory cerebral ischemia
* History of previous orthostatic intolerance or hypotension
* History of diabetes mellitus
* History of following diseases of the autonomic nervous system: Parkinson disease, multiple sclerosis, multiple system atrophy, autonomic neuropathies
* Cognitive dysfunction
* Dementia
* American Society of Anesthesiologists (ASA) \> 3
PEEK Versus Metallic Attachment-retained Obturators

Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases.

Eighteen participants were randomly divided into three parallel groups (n=6). Participants of PEEK group received attachment-retained obturators with milled PEEK framework, metal group received an attachment-retained obturator with metallic framework and conventional group received conventional clasp-retained obturators with metallic framework (Control group). Evaluation included radiographic evaluation and patients' satisfaction where two scales were followed in this study, including "The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one way ANOVA test.

Eligibility Criteria:
Inclusion Criteria:

* patient underwent surgical removal of half of maxilla
* participants with a sufficient number of natural teeth(class I and \\or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,

Exclusion Criteria:

* participants are exposed to radiotherapy or chemotherapy during last year.
* participant with congenital defect
Stem Cell Therapy in Mental Retardation

The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed cases of mental retardation
* age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia
Definitive Therapy for Oligometastatic Solid Malignancies

Patients with metastatic cancer are usually treated with systemic therapy (treating the entire body) with the assumption that any localized treatment of clinically apparent metastases would not impact survival. In the setting of increasingly effective systemic therapy and limited metastatic disease, aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival.

Up to recently it has been assumed that in the setting of metastatic solid tumors, locoregional control of clinically apparent metastases does not substantially impact survival due to undetectable micrometastic (clinically not visualized) disease that ultimately lead to treatment failure/progression. However, as more advanced systemic therapy continue to improve control of micrometastatic disease, failures at the original sites of disease remain common. Furthermore, some studies have shown locoregional treatment of limited clinical metastases to actually improve survival. Therefore, the investigators hypothesize that aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival or alter the course of the disease in some patients with limited metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* 4 or less distinct sites of active disease. Locoregional disease counts as one site
* All sites of disease can safely be encompassed by radiation fields to doses ≥ 45 Gy (biologic equivalent dose) and/or removed completely with surgery and/or completely ablated with other appropriate site-specific techniques.
* sufficient blood cell counts and adequate liver function

Exclusion Criteria:

* Hematologic malignancies
* Distinct sites of disease \> 4
* Karnofsky Performance Status \< 70
* Unexplained weight loss \> 10 %
* HIV, chronic viral hepatitis, or any chronically active infection
* Life expectancy \< 6 months for any reason
Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first CELSENTRI® Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered CELSENTRI® Tablets.
Impact of Embryo Cryopreservation on Birth Weight

Birth weight (BW) is higher after frozen embryo transfer (FET) than after fresh embryo replacement. No study has compared the BW of siblings conceived using the same oocyte/embryo cohort. The aim of this study was to determine whether the freezing-thawing procedure is involved in such difference.


Eligibility Criteria:
Inclusion Criteria:

* sibling pairs where fresh embryo replacement resulting in a singleton live birth was followed by transfer of one or two frozen embryos from the same cohort that resulted in a singleton live birth, between May 2007 and June 2015.

Exclusion Criteria:

* Twin pregnancies and stillbirths were excluded. If the BW of at least one sibling was unknown, the pair was not included in the study.
Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.

OBJECTIVES:

* Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.
* Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients.
* Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).

OUTLINE: This is a multicenter study.

Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast.

Patients are followed at 12-18 and 24-30 months.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast

  * Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
* Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
* Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
* Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
* No remote history of breast cancer
* No new breast symptoms within the past 60 days for which further evaluation is recommended
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 18 and over

Sex

* Female

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Cardiovascular

* No pacemaker
* No magnetic aneurysm clips

Other

* Not pregnant
* No implanted magnetic device
* No severe claustrophobia
* No other contraindications to MRI
* No psychiatric, psychological, or other condition that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* At least 6 months since prior anticancer chemotherapy

Endocrine therapy

* No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)

Radiotherapy

* Not specified

Surgery

* Not specified
Effect of an Exercise Program of the Scapular Muscle Stabilizers in Amateur Kayakers Shoulder Pain

The purpose of this study is to determine whether a specific strengthening program for the stabilizing scapular muscle can reduce shoulder pain of amateur kayaker.


Eligibility Criteria:
Inclusion Criteria:

* There Have Been practicing kayaking over 3 years.
* There Have Been shoulder pain during sports at least 1 month of evolution

Exclusion Criteria:

* Shoulder pain was caused by a traumatic injury.
* To be in medical, pharmacological or shoulder physiotherapy treatment during the study.
* To have been surgically intervened in the shoulder
Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients

An optimal nutritional status is essential for healthy ageing. Telemonitoring might contribute to maintaining or improving nutritional status in elderly people.The objectives of this pilot study are to test the feasibility, acceptability and implementation fidelity of telemonitoring of nutritional parameters in community-dwelling older adults; to test the study procedures for effect evaluation; and to determine the likelihood of achieving desired impact on the primary and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

Having a care referral for at least one of the following types of care:

* Domestic care
* Personal care
* Nursing care
* Individual or group support

Exclusion Criteria:

* Severe cognitive impairment (Mini Mental State Examination (MMSE) \< 20)
* Receiving terminal care
* Expected length of receiving home care \< three months
* Not having a television at home
* Clients with a visual impairment (not able to watch the television screen)
* Clients with a physical impairment in such a way, that they are not able to use the telemonitoring system
* Clients with nursing home care
Biodex Balance System in Patients With Parkinson's Disease

Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises

This study was planned based on the hypothesis that exercises based on visual feedback applied to patients through games will increase patient compliance and improve balance better than conventional exercise.Previous studies have shown that the Biodex balance device has positive contributions to balance in neurological and orthopedic rehabilitation applications.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's diagnosis and Hoehn Yahr stage I-III
* Not changing medical treatment in the last three months
* Mini mental test score is over twenty-four

Exclusion Criteria:

* Vestibular hypofunction
* Neurological disease other than Parkinson's disease (multiple sclerosis, stroke, myopathy)
* History of lower extremity surgery (such as arthroplasty, anterior cruciate ligament repair)
* Upper limb amputation in the participant
* Impairment in cognitive functions
* History of psychotic illness
* Presence of stage 4 gonarthrosis history of malignancy
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.

A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.

Eligibility Criteria:
INCLUSION CRITERIA

1. Age \>18 years
2. Patients providing written informed consent
3. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication

EXCLUSION CRITERIA

1. Known CAD (myocardial infarction, PCI, CABG)
2. ACC/AHA Class I or III indication for ICA
3. Non-cardiac illness with life expectancy \<2 years
4. Inability to provide written informed consent
5. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
6. Pregnant women
7. Allergy to iodinated contrast agent
8. Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate \<30 ml/min
9. Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
10. Heart rate ≥100 beats per minute

12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index \>35
Effect of Tumescent Lidocaine on Platelet Function

The purpose of this study is to evaluate the effect of lidocaine, delivered into subcutaneous tissue for tumescent local anesthesia, on platelet activation following the tumescent liposuction.

The current research study is intended to examine this hypothesis by determining if tumescent lidocaine increases the results of a test which measures the volume of bleeding which occurs when a tiny standardized incision is made on the forearm. This test is the BA test. The investigators will do BA tests before and after infiltration of lidocaine in the form of tumescent local anesthesia for liposuction and then compare the differences of these BA test results.

The purpose of the present research project is to study how platelet function after surgical trauma (liposuction) is affected by tumescent lidocaine. The investigators hypothesize that lidocaine, delivered in the form of tumescent local anesthesia, inhibits surgical trauma-induced platelet activation as measured by the in-vivo Klein Bleeding Area test (www.onlinePFT).

The Klein Bleeding Area (BA) test is an extension of the classic Ivy Bleeding Time (BT) test. The BT test, an in-vivo test for an abnormal bleeding tendency, involves making a small standardized cut in the skin and measuring the duration of bleeding. The BA test has significantly more sensitivity and specificity than the BT Test.

This research project is a dosage-response clinical trial in which the predictor variable is the milligram per kilogram (mg/kg) dosage of tumescent lidocaine and the response variable is the Bleeding Area (BA). A result indicating that tumescent lidocaine does indeed impair post-operative platelet function would justify a subsequent randomized clinical trial of tumescent lidocaine for preventing post-operative thromboembolism.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have requested tumescent liposuction
* Healthy adults
* ASA Class I, II, or III

Exclusion Criteria:

* Known allergy to lidocaine
* younger than 18 years
* Positive serology for Hepatitis C, HIV
* Chronic fatigue Syndrome
* known bleeding disorder
* significant psychiatric problems
* History of seizures
* Clinically significant cardiac arrhythmia
* Conditions predisposing to surgical site infections
* Active bacterial infection
* taking drugs know to affect hemostasis
LDCT in COVID-19 Pneumonia: a Prospective Moscow Study

Hypothesis: low-dose chest computed tomography, has the same accuracy for the diagnosis of pneumonia compared to the routine protocol. In total, 230 patients are planned to be enrolled in the study.

Each patient will have 2 studies (routine chest CT and low-dose chest CT) sequentially during one visit to the computed tomography room.

As of 30 April 2020, there were over 3 million confirmed cases worldwide, of which over 200,000 were fatal. In Russia at the time of writing, 106 thousand cases of COVID-19 were registered in 78 regions, with 11619 recovered and 1073 dead. Initial prospective analysis of clinical data from 41 patients in Wuhan, with laboratory confirmation of the 2019-nCoV-2 virus, showed that 2019-nCoV-2 caused severe illness, clinically similar to SARS, which sometimes led to the need for hospitalization in the intensive care unit (13 out of 41 \[32 %\]) and death (6 out of 41 \[15%\]). All patients with pneumonia in this study had changes in the chest CT scan: preliminary reports indicated that all patients had bilateral lung infiltration.

Given the current prevalence of the disease and the nonspecific symptoms, we expect a significant increase in chest CT scans shortly. A low-dose chest CT scan can be performed with an effective dose of no more than 3.5 mSv, which is much lower than the dose received with a standard protocol - 8-10 mSv.

The investigators hypothesize that a patient with suspected pneumonia can have a low-dose chest CT scan instead of a standard CT while maintaining the accuracy of the method in the diagnosis of inflammatory pulmonary tissue infiltration. The advantage of participating in the study for the patient is the possibility of obtaining an image without motion artifacts that may be associated with coughing, possibly affecting the patient's management tactics.

The study is intended to provide answers to the following questions:

The primary point of the study is to evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia. The expected correlation percentage is 90%.

The secondary point of study No. 1 is the threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan. Expected threshold - 10 mm.

The secondary point of study No.2 is the number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan. Expected number - more than two zones.

In the future, it is planned to use the obtained anonymized data to enter the international registers of images of pneumonia caused by COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* A referral from the attending physician for a chest CT scan
* Suspected pneumonia
* Signed informed consent
* Over 18 years old
* Both male and female

Exclusion Criteria:

* Pregnant or nursing women
* Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)
* Patients after surgical intervention at the level of the chest organs
* Cancer patients