cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction

The primary objective of this post-market study is to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction using validated questionaires.

Eligibility Criteria:
Inclusion Criteria:

Eligible subject will meet all the following:

* 1. Age 18 or older 2. Willing and able to provide informed consent 3. Willing and able to comply with the study protocol 4. Seeking treatment for nasal obstruction 5. NOSE score of ≥ 60 at Baseline 6. Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):

  * Use of external nasal dilator strips (e.g., Breathe Right Strips)
  * Q-Tip test (manual intranasal lateralization)
  * Use of nasal stents
  * Cottle Maneuver (manual lateral retraction of the cheek)

Exclusion Criteria:

Eligible subjects will NOT meet any of the following:

1. Prior surgical treatment of the nasal valve
2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months
3. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
4. Known or suspected to be pregnant or is lactating.
5. Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.
6. Current participation in any study or participation in any study less than 6 weeks before study date 1.

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Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding

This study was to investigate the diagnostic value of ultrasonography and blood flow measurements in uterine arteries and spiral arteries by transvaginal color Doppler ultrasonography in the detection of the endometrial pathology in women with postmenopausal bleeding.

This prospective Cross-sectional Observational study will be conducted at the Department of Obstetrics and Gynecology, Banha University, Egypt during the period starting from January 2014. The study protocol will be approved by the Local Ethics Committee and written informed consent will be obtained from each patient before the study commenced.

Seventy patients with postmenopausal bleeding will be included in the study after verbal consent. They will be recruited from patients attending gynecologic clinic in Banha University hospital.

All patients will be subjected to the following:

For all included women the following will be done:

1. Full history taking.
2. Complete general, abdominal, and local examination.
3. Ultrasonographic assessment of the uterus

All data were performed for all patients in the lithotomy position after they had emptied their bladder using a 7.5 megahertz transducer by a single operator.

1. Using colour Doppler in the 2D mode, flow velocity waveforms were obtained from the ascending main branch of the uterine artery on the right and left side of the cervix in a longitudinal plane before they entered the uterus.
2. The gate of the Doppler was positioned when the vessel with good colour signals was identified on the screen. Pulsatility index of the uterine arteries were calculated electronically when similar consecutive waveforms of good quality were obtained and the averaged uterine PI.

   Pulsatility index (PI):

   This index, also known as the mean pulsatility index, to distinguish it from the peak to peak pulsatility index, is expressed by: PI= (S-D) / Mean Where S is the peak systolic velocity, D is the end diastolic velocity and velocity is the time averaged maximum velocity over the cardiac cycle (1).
3. Blood flow velocity waveforms were evaluated in the spiral arteries at the sub endometrial region that is within 1 mm of the originally defined myometrial-endometrial contour (2).

Histopathological diagnosis of endometrium obtained by biopsy is the gold standard for diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Endometrial thickness ≥ 5 mm measured by two-dimensional transvaginal ultrasound.
2. Pap smear is negative for malignancy.

Exclusion Criteria:

1. Postmenopausal woman on hormon replacement therapy.
2. Trans-vaginal examination not possible (Vaginal stenosis or patient refusing trans-vaginal ultrasound).
3. Adnexal pathology.
4. General causes of bleeding e.g: Hemophilia , anticoagulation therapy
A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

MEN16132 is a non-peptide bradykinin B2-receptor antagonist showing analgesic and anti-inflammatory activity in nonclinical osteoarthritis models. This study is being conducted as a dose finding study to determine the safety and efficacy of MEN16132, given as three doses/four treatment regimens in comparison to placebo, as well the time to onset and duration of effect.

Eligibility Criteria:
Main Inclusion Criteria:

* Male or female patients ≥40 years old.
* Symptomatic primary knee osteoarthritis (ACR criteria) since ≥6 months prior to screening, Kellgren Lawrence Grade 2 or 3, and representing an indication for intra-articular drug injection.
* \>50 mm VAS pain score assigned to the index knee at WOMAC VA 3.1-A1 (pain while walking on a flat surface).
* \>125 mm VAS pain score assigned to the index knee at WOMAC VA 3.1 A subscore (total pain).
* Pain in the index knee on at least 50% of the days in the month preceding the screening.

Main Exclusion Criteria:

* Patients with Kellgren \& Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
* Knee condition representing an indication for surgery
* Patients with Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
* Patients with isolated patella-femoral syndrome or chondromalacia.
* Patients with OA predominant in the lateral compartment or any significant valgus deformity.
* Patients with any other disease or condition interfering with the free use and evaluation of the index knee for the 3 month duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis).
* Major injury or surgery to the index knee within the previous 12 months prior to screening.
* Severe hip osteoarthritis ipsilateral to index knee.
* Any pain \>30 mm VAS that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
* Any pharmacological or non-pharmacological treatment started or changed during 4 weeks prior to randomisation or likely to be changed during the duration of the study
* Use of systemic or topical corticosteroids \>10 mg prednisolone equivalent per day during 30 days prior to randomisation.
* Use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics) during 1 or 2 weeks prior to randomisation.
* Any intra-articular or local periarticular punction, injection or surgery to the index knee during the 6 months prior to screening.
Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer Patients

The aim of our study was to compare the daily living activities with a performance-based protocol in lung cancer patients and healthy controls.

Lung cancer is the abnormal proliferation of cells in the lung tissue and a mass in the lung. The primary symptoms of this health problem include cough, dyspnea, chest pain, hemoptysis and sputum. In addition to these symptoms, muscle strength, respiratory function and effort level are decreased.

Inadequate daily living activities in cancer patients are expressed.But studies evaluating the activities of daily living in patients with lung cancer are inadequate and patients are evaluated only using scales. For the measurement of functional status in daily living activities, these scales provide important information about the detection of symptoms and the progression of the disease. However, it is very difficult to determine the limitation of perceived difficulty in daily living activities with these scales. In addition, since these scales are a method of measurement, the objectivity is open to discussion. It is thought that a performance-based protocol will facilitate the detection of limitations and provide more objective findings. We think that the Londrina protocol fully reflects the activities of daily living and thus will give us an objective measurement.

This study will show us the problem and its cause in daily life activities in patients with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* To have a diagnosis of lung cancer
* Complete chemotherapy
* Complete radiotherapy
* Coopere,
* Accepts participation in the study will be included in the study

Exclusion Criteria:

* Neurological, cognitive or orthopedic diseases that affect the measurements
* Acute infection
* Individuals with other chronic diseases that may affect their walking will not be included in the study
Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.

The purpose of this study is to determine if any specific patient characteristics lead to improved outcome of IBS treatment, when conventional treatment as well as Cognitive Behavioral Therapy is used in combination.

Although research has demonstrated the efficacy of various psychological and pharmacological treatments for irritable bowel syndrome (IBS)1, health professionals have limited information about how to determine which specific treatment regimens lead to optimal outcomes for specific IBS populations 2,3. A prevalent syndrome, with high healthcare costs, IBS is a debilitating chronic functional bowel disorder with increasingly interconnected psychosocial and gastrointestinal afflictions4. In general, IBS sufferers have not been found to respond consistently to a single medication or class of medications5. In the wake of the failures of medical therapies, many psychological interventions, adjunct to standard IBS treatments, have been examined1,6 such as Blanchard and Scharff's 2002 review of 12 random controlled trials that found strong evidence for the utility of hypnotherapy, cognitive behavioral therapy (CBT), and brief psychodynamic psychotherapy in helping to alleviate IBS symptoms7. Similarly, in a more recent study involving a meta-analysis of seventeen studies, with randomized trials comparing classes of psychological interventions, found that these psychological treatments also play a role in improving quality of life of IBS suffers1. Among these psychological interventions, cognitive behavioral therapy (CBT), a prescriptive therapy that specifically targets faulty thinking patterns, has been found to be quite effective in many empirical investigations. Recent evaluations of CBT interventions have found the therapy to have a direct effect on global improvements of IBS symptoms and quality of life8. Despite its demonstrated effectiveness, however, CBT does not work for all patients3,6,8. The successes of medical therapy alone compared to a treatment regimen combining psychological and pharmaceutical interventions have been greeted with mixed results- leading to the unnecessary waste of health resources in the course of treatment3,6. To decrease medical costs, as well to foster optimal treatment for IBS patients, there is a need for a better method of identifying which patients will most benefit from specific treatment options s (i.e. conventional medical treatment versus standard treatment and CBT)2,3.

Eligibility Criteria:
Inclusion Criteria:

* All newly diagnosed IBS patients using Rome III criteria above the age of 18.

Exclusion Criteria:

* Patients with non-functional GI disorders, severe psychiatric disorders, including psychotic disorders, actively suicidal or alcoholism/other drug dependencies.
* Pregnant women and minors(under age 18) will also be excluded.
* Prisoners will also be excluded.
Lymphocytic Subsets and Cytokine Production With H. Pylori Infection

The aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing immune mechanisms responsible for the chronicity of the disease and its associated lesions.

Helicobacter pylori, a Gram-negative spiral bacterium, has been first isolated from a patient with chronic active gastritis since 1982. Recent studies strongly suggest that chronic infection with H. pylori is tightly associated with chronic gastritis, peptic ulcer, and gastric carcinoma. However, only a minority of infected people develop signs and symptoms of gastric pathology. Thus, both host and microbial factors may lead to different outcomes of infection. In spite of high prevalence in general population and increasing clinical attention has been paid on this infection, the knowledge of pathogenic mechanism of H. pylori infection is still limited and little is known about the role of host immune response in the pathogenesis of disease.The aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing immune mechanisms responsible for the chronicity of the disease and its associated lesions.

Eligibility Criteria:
Inclusion Criteria:

* H. pylori infection

Exclusion Criteria:

* none
Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children

Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic malnutrition caused by chronic diseases.

We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.

Malnutrition prevalence upon admission to paediatric hospitals remains considerably high, ranging from 7.3 to 17.9% in the developed world with higher prevalence rates in infants and toddlers and particularly high rates for specific medical conditions. Several studies have reported deterioration of nutritional status during hospitalization. Screening children for malnutrition risk is recommended by a number of international organizations such as the American Society for Parenteral and Enteral Nutrition (ASPEN), the European Society for Parenteral and Enteral Nutrition (ESPEN) and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).

Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) was chosen for this study because it is highly applicable, frequently used by nurses and has shown high reproducibility, as well as concurrent and predictive validity. The tool was developed by McCarthy et al11 in England. It collects the following information to assess nutritional risk for a patient: discrepancy between the weight and height percentile weight for the age expected nutritional risk caused by clinical diagnosis, recent changes in the appetite. The assessment results are used to define if there is a need for a referral to a full nutritional assessment.

We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in Pediatrics among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized during the study,
* patients hospitalized for more than 24 hours. The children will be enrolled from 3 internal medicine and surgical departments, children's parents will give their consent and will be able to understand and sign the consent forms

Exclusion Criteria:

* children \< 1 year of age,
* children \> 17 years of age,
* children hospitalized for less than 24 hours,
* children in the intensive care unit or following hospitalization in the intensive care unit.

Statistical analysis for STAMP validation will be performed using Kappa (K) test. Chi square test will be used in order to calculate the effect of STAMP use
Serious Game for Parkinson's Disease Patients

In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Gait and balance disorders
* Chronic bilateral deep brain stimulation of the subthalamic nucleus (\> 1 year).

Exclusion Criteria:

* Dementia
* Ongoing severe medical condition that prevented assessments
Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)

This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.


Eligibility Criteria:
Inclusion Criteria:

* less than or equal to 7 kg
* order for nasal continuous positive pressure

Exclusion Criteria:

* patients greater than 7kg
* patients that do not have informed consent
ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill Patients

Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in critically ill patients.

Comparison of different marker for length of stay in the ICU in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ICU

Exclusion Criteria:

* Not able to understand German
Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

The study gives an overview of surgically treated rotator cuff injury patients in Tartu University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair.

First stage of the study describes the study population, etiology of the injury (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are in line with the preoperative imaging studies or not.

Second stage of the study focuses on atraumatic tendon tears assessing structural integrity of the tendons 5 years after repair using ultrasound imaging. The main question is - does the findings correlate with clinical outcomes and patient satisfaction.

Participants of the second phase of the study will be asked for an appointment to have their shoulders examined with ultrasonography and clinical outcomes are measured using the American Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and The Constant-Murley score (CMS).

High numbers of re-tear after rotator cuff surgery have been shown, though not always influencing patient satisfaction. If there is an atraumatic tendon tear, the risk of having a contralateral rotator cuff tendon tear is high.

The aim is to study surgically treated rotator cuff injury patients 5 years after repair to evaluate tendon integrity on ultrasonography and answer the question do the findings correlate with functionality and patient satisfaction. It has been shown that people over the age of 66 who have been diagnosed with rotator cuff tendon tear, have up to 50 % chance of having a rotator cuff tendon tear in contralateral shoulder (Yamaguchi, et al. 2006). Therefore the study will evaluate the function and the integrity of the rotator cuff in both shoulders.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent rotator cuff repair by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.
* Subject gives an informed consent and is willing to come for one outpatient visit.

Exclusion Criteria:

* Patients who underwent rotator cuff repair for traumatic tears are excluded from clinical assessment (stage II).
* Patients who underwent revision surgery are excluded from clinical assessment (stage II).
Evaluating Serum Sex Steroid Hormones

The purpose of this study is to evaluate the reproducibility of measurements of sex hormone levels in serum samples. Researchers will collect blood from 60 healthy adults, including 20 men, 20 premenopausal women, and 20 postmenopausal women. Blood samples will be collected after study participants have fasted overnight.

This evaluation of the reproducibility of serum sex steroid measurements has two components. The first is the evaluation of reproducibility of laboratory measurements of steroid sex hormones in men. This is an ancillary study to serve as a quality control (QC) measure for the ongoing DCEG Prostate Tissue Study (ORSH#: OH99-C-N025; principal investigator: Dr. Ann Hsing) so that high-quality assays can be chosen to quantify steroids in tissue. Pending satisfactory performance in serum, we will then evaluate the reproducibility of tissue hormone measurements by Gas Chromatography-Mass Spectrometry (GC-MS) or by Liquid Chromatography - Mass Spectrometry-(GC-MS) or by Liquid Chromatography- Mass Spectrometry- Mass Spectrometry (LC-MS-MS) before incorporating them into the Prostate Tissue Study. The second component of this study involves evaluation of the reproducibility of sex steroid hormone measurements in pre- and postmenopausal women. This component, although not part of the Prostate Tissue Study, is included in this summary because the laboratory, assay methods, and blood collection procedures used in the female component are identical to those in the male component and these two components will run in parallel.

The present study will evaluate the reproducibility of serum sex steroid assays using two different assay methods in different laboratories. Specifically, the study will investigate assay reproducibility at Dr. Fernand Labrie's laboratory using GC-MS and LC-MSMS and at Dr. Frank Stanczyk's laboratory using radioimmunoassay (RIA). We propose to collect overnight fasting blood from 60 healthy subjects (20 men aged 50-65, 20 premonopausal women, and 20 postmenopausal women). Once collected, the blood will be separated and aliquotted into multiple vials. Serum from each subject will be sent to Dr. Labrie, who will perform CG-MS or LC-MSMS assays, and to Dr. Stanczyk, who will perform RIA, at four different time intervals. Subject recruitment and blood collection will be performed by Westat. BBI Biotech will ship and store the specimens after they have been collected.

Eligibility Criteria:
* INCLUSION CRITERIA:

We plan to recruit healthy men aged 50-65 from Westat employees and family and friends of Westat employees.

One month later we will recruit 20 pre menopausal women (aged 20-40) and 20 post menopausal women (aged 55-75).