cyrilzakka/clinical-trials huggingface dataset:
Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband

In this study, the investigators will compare the accuracy of the Biostrap wristband, a wearable device with a clinical-grade Photoplethysmography (PPG) sensor, to measure ejection fraction and cardiac output in patients undergoing a cardiac ultrasound and pulmonary arterial catheterization, respectively.

This in an introductory clinical study with both cardiac patients undergoing elective cardiac ultrasound and cardiac ICU patients with pulmonary arterial catheters featuring Biostrap wristband. This is a single site, non-blinded, non-randomized study. The wristband is a wearable device that contains a clinical-grade Photoplethysmography (PPG) sensor which will measure parameters quasi-continuously and non-invasively. The device, Biostrap wristband, will measure cardiac ejection fraction (EF) and cardiac output (CO). We will enroll a total of 100 patients: 2 groups of 50. 50 patients undergoing an elective cardiac ultrasound as part of their routine medical care will wear the device for 1-2 hours as an outpatient depending on the duration of the test. 50 hospitalized patients with a scheduled or completed pulmonary arterial catheter inserted as part of their standard medical care will wear the device for 7 days.

The investigators will perform a retrospective analysis comparing the accuracy of EF and CO measured by the device in comparison to those from a 'reference device', which is the cardiac ultrasound for ejection fraction and the pulmonary arterial catheter for cardiac output values. Cardiac Ultrasound and pulmonary arterial catheters are standard of care procedures.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age.
2. Subjects who are undergoing elective cardiac ultrasound as an outpatient for group 1 or are scheduled for/completed a pilmonary arterial catheterization for group 2.
3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Subject is unable or unwilling to wear the wristband for the required duration.
Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome

1. Clinical Objective : To improve the growth of these children
2. Genetic objective : A study of the genetics of the syndrome


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with Noonan's syndrome with a height \< -2 SD and no progressive cardiopathy

Exclusion Criteria:

* Age \< 3 years
* Height ≥ -2 SD

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment

ATTR amyloidosis is a serious condition with significant morbidity and mortality. In Germany, there are numerous unreported cases of untreated patients, and diagnosing and initiating treatment often requires multiple specialized tests. To address this, a study is being conducted to determine if virtual reality (VR)-based patient education can improve diagnosis rates, treatment initiation, and medication adherence compared to standard education methods.

Tafamidis is effective in reducing mortality and hospitalization in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), and adherence to the drug is generally high. However, the main challenge lies in timely diagnosis and initiation of therapy. Virtual reality (VR) offers an immersive educational tool that surpasses conventional methods like brochures and videos, with patients preferring VR glasses. By preparing patients through VR, they can engage in informed conversations with physicians, understand the diagnostic process better, and be motivated to initiate therapy promptly. VR empowers patients and saves valuable time for physicians, and it has been well-received even among older cardiovascular patients

Eligibility Criteria:
Inclusion Criteria:

* patients who present themselves for assessment of an unclear septal thickening with suspicion of cardiac amyloidosis.

Exclusion Criteria:

1. \< 18 years
2. Active Medication with tafamidis
3. Cardiovascular Disease
4. highly impaired vision or hearing
5. advanced dementia syndrome
6. epilepsy
7. insufficient language skills
Observational to Investigate the Efficacy of CRESTOR 5mg in Reaching LDL-C Target Goals in Patients Who Are at High Risk for a Cardiovascular Event

Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C target goals in both statin naïve and statin treated primary and secondary prevention patients at high risk for a cardiovascular event.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a high risk of a cardiovascular event as defined by the European guidelines.
* The patient is statin-naive (i.e. has not used a statin \> 2 months), or is currently treated with atorvastatin, pravastatin or simvastatin.
* An LDL-C level is known for the statin-naive patient or for the statin used during visit 1.
* It has been decided to start the patient on CRESTOR 5 mg.
* The patient is prepared to give permission to the coded data being made available to AstraZeneca

Exclusion Criteria:

* The patient is known to have complaints of myalgia, myopathy or liver function impairment (including elevated levels of serum transaminases) where there is a causal relationship with the statin treatment.
* Contraindications for treatment with CRESTOR (see 1 B1 text).
* Patients with a family history of dyslipidemias, for instance familiar (combined) hypercholesterolemia
Predictors of Outcome in Patients With Pleural Infection at Sohag University Hospital

pleural infection remains a common medical problem with significant mortality and morbidity despite a better undrstanding of the aetiology , pathophysiology and recent advances in management approaches .

the cornerstones of the managment op pleural infection include early identification of cases and accurate diagnosis . suitable antibiotic therapy , nutrition managment , efficient drainage of infected collection via chest tube with or without adjunctive therapies including intrapleural agents and ultimately surgical managment .


Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 years old with pleural infection

Exclusion Criteria:

* hemothorax
* chest trauma within 3 month
* underwent thoracic surgery within 60 days
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device

The aim of the current study was to investigate the effect of a chitosan brush on the treatment of residual pockets in patients already treated for periodontal disease. Thirty-six patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative therapy and exhibited at least two residual periodontal pockets ≥ 5mm that bled on probing, were randomly assigned to two groups. In the test group debridement of residual pockets was performed with ultrasonic scaler and the chitosan brush, whereas in the control group only ultrasonic scalers were used.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 or over
* Subjects diagnosed with chronic periodontitis, Stage III or IV, and had received full mouth scaling and root planning at least three months prior to baseline examination
* Subjects with at least two residual periodontal pockets of at least 5mm depth that bled on probing
* Full mouth plaques scores ≤20%

Exclusion Criteria:

* Subjects that had received antibiotic therapy 6 months prior to initial examination
* Subjects with compromised systemic conditions
* Patients undergoing chemotherapy or radiotherapy
* Pregnant or lactating women
Scapular Mobilization on Inspiratory Capacity of Post-CABG Patients

To determine the effects of scapular mobilization on pulmonary functions of post-CABG patients.


Eligibility Criteria:
Inclusion Criteria:

* CAD patients undergone CABG surgery (Post-Op. Day#. 01).
* Both genders (male and female).
* Aged between 40 to 70 years .
* Patient having oxygen saturation (SPO2) of more than or equal to 90% with 25% of fraction of inspired oxygen (FiO2) - (possibly nasal cannula inserted).

Exclusion Criteria:

* Patients with low glasgow coma scale (GCS) score (less than 15).
* Patients having inspiratory capacity of 3500ml and above.
* Patients on ventilator.
Improve MRI Diagnosis

The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.

"The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.

The decision criterion for considering a new sequence as superior to the standard sequence will be based on two measures:

1. The proportion of patients for whom the new sequence was preferred, which must be greater than or equal to 75%;
2. Inter-observer agreement (Cohen's Kappa coefficient), which must be greater than or equal to 0.8; When these two criteria are met, the new sequence will be considered superior to the standard sequence"

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient who signed a consent to participate in the study
* Affiliated patient or beneficiary of a social security scheme
* Patient having an MRI scheduled as part of their care pathway
* Absence of prohibition of participation in another research

Exclusion Criteria:

* Patients under guardianship or curators
* Pregnant or breastfeeding patients
* Patients responding to a contraindication to performing an MRI
* Patient under state medical aid (AME)
* Adult patients protected by law
Intrapleural Minocycline After Aspiration of Spontaneous Pneumothorax

The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.

Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration. The primary goal is to test if intrapleural minocycline can reduce the rate of recurrence. The secondary goals are to evaluate the safety profile, short-term results, and long-term effects of minocycline pleurodesis after simple aspiration. The sites of study include National Taiwan University Hospital and Far Eastern Memorial Hospital. A total of 300 patients (150 patients in each arm) will be included for this study.


Eligibility Criteria:
Inclusion Criteria:

1. 15-50years old
2. primary pneumothorax first attack
3. viceral pleura to chest wall more then 2 cm on CXR

Exclusion Criteria:

1. the lungs unable to expad fully after aspiration
2. continuous leakage of air through chest tubes
3. status complicated with hemothorax
4. status post previous chest surgery or pleurodesis
5. patient unwilling to accept the trial
Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

This study addresses the question if patients with fractures of the humeral shaft and primary radial nerve palsy gain nerve recovery.

Additionally the influence of injury mechanism, fracture type, and treatment modality on nerve recovery should be evaluated.

Adult fractures of the humeral shaft account for approximately 3% of all fractures; most can be treated nonoperatively. Due to the anatomy of the radial nerve and the entrapment between fragments in spiral fractures of the humerus, these injuries are associated with primary radial nerve palsy in up to 18%.

Therefore, the purpose of this study was to assess the influence of injury mechanism, fracture type, and type of surgical treatment on time to onset of nerve recovery and time to full nerve recovery in patients with humeral shaft fractures and concomitant primary radial nerve palsy.

A retrospective analysis of prospectively collected data for all patients treated with humeral shaft fracture and primary radial nerve palsy at an academic Level-I trauma center was performed. Between 1994 and 2013 a total of 615 patients with traumatic humeral shaft fractures were treated at the department. The dataset was examined for completeness and accuracy. Patients with an incomplete dataset, those with a pathologic or periprosthetic fracture, patients with non-surgical treatment, or who were younger than 18 years of age were excluded from this series. According to these criteria, a total of 50 patients with a humeral shaft fracture and primary radial nerve underwent surgical treatment

Eligibility Criteria:
Inclusion Criteria:

* patients treated with humeral shaft fracture and primary radial nerve palsy between 1994 and 2013 at the Department of Trauma Surgery, Medical University of Vienna
* surgical treatment
* complete data sets
* minimum 18 years of age

Exclusion Criteria:

* Patients with an incomplete dataset
* those with a pathologic or periprosthetic fracture
* patients with non-surgical treatment
* or who were younger than 18 years of age
Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer
* Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
* Recent completion of first hormone treatment \[intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue\]
* Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

Exclusion Criteria:

* Bone or soft tissue metastases
* Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack
The Effect of Progressive Relaxation and Breathing Exercise on Sleep Quality and Exercise Self-Efficacy in Patients With COPD

Aim: This study was conducted to determine the effect of progressive muscle relaxation and breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive pulmonary patients.

Methods: This study was conducted as a randomized controlled experimental study. The study was conducted with 64 chronic obstructive pulmonary patients, where 36 of them were in the intervention group and 34 in the control group. Data of the study were collected using the descriptive information form, the Pittsburgh Sleep Quality Index, and the Exercise Self-Regulatory Efficacy Scale (Ex-SRES) for patients with COPD.

Results: When the total scores pertaining to the sleep quality index and exercise self-efficacy of the individuals in the intervention and control groups were compared, it was found that there were statistically significant differences in the intervention group compared to the control group (p \< 0.05).

Keywords: Exercise Self-Regulatory Efficacy, sleep quality in patients with COPD, PGE along with breathing exercises, pulmonary rehabilitation


Eligibility Criteria:
Inclusion Criteria:

* were to be 18 years of age or older
* not using sleeping pills
* verbally stating that they have moderate and severe sleep disorders.

Exclusion Criteria:

* having any lung disease other than COPD
* having cardiological problems (heart failure, uncontrollable hypertension, history of angina and myocardial infarction, heart valve problems), psychotic disorder,
* inability to communicate verbally and having hearing problems.
Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer

To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC


Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer
* Received only one prior treatment (not including radiation)
* Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines
* Life expectancy of ≥ 4 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal and hepatic function
* Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN Exclusion Criteria:
* Brain metastases requiring treatment
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
* Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
* Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EGFr tyrosine kinase inhibitors
* Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
* Prior therapy with sirolimus, sirolimus analogs
* Immunosuppressive agents within 28 days before enrollment
Trial of Fresh Start Weight Loss Intervention in WIC Participants

The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.

The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.

Eligibility Criteria:
Inclusion Criteria:

* 6 months or less postpartum
* Speaks English
* BMI 25 or greater
* Client of WIC program, Worcester MA

Exclusion Criteria:

* Not able to give informed consent
Sex Differences in the Vascular Effects of E-cigarette Use

The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored.

In this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a dime-sized area of the skin in otherwise healthy young (18-24yrs) chronic e-cigarette users. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, we also draw blood from the subjects to measure circulating factors that may contribute to cardiovascular health and examine markers of inflammatory activation. We will also collect urine from female participants to measure estradiol.


Eligibility Criteria:
Inclusion Criteria:

* 18-24 years old
* one of the following:

  1. have no history of e-cigarette use
  2. be a current e-cigarette user who has been using e-cigarettes for 6 months or longer

Exclusion Criteria:

* history of cardiovascular, metabolic, and/or skin diseases
* body mass index \>30 kg/m2
* blood pressure ≥140 systolic and/or ≥ 90 diastolic
* current or history of tobacco cigarette use
* current antihypertensive or cholesterol-lowering medication
* current use of cannabis, marijuana, and/or other illegal substances
* current use of stimulant drugs
* currently pregnant or breastfeeding
* allergy to materials used during the experiment (e.g. latex),
* known allergy to study drugs
* healthy control subjects will also be excluded if they have ever used e-cigarettes in the past