cyrilzakka/clinical-trials huggingface dataset:
The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA

The term "Overlap Syndrome" (OS) is used to describe the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: 1) participation in life situations; 2) physical activity; and 3) cardiovascular health. The investigators long-term goal is to develop an exercise strategy tailored to Veterans with OS which will reduce the risk of functional decline through increased PA.

The term "Overlap Syndrome" (OS) is used to describe the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single patient. Veterans with OS who also have excessive daytime sleepiness (EDS-OS) are at highest risk for functional decline yet have the greatest barriers to exercise training. Thus, there is a critical need to identify novel exercise strategies that meet the individual needs and capacities of Veterans with EDS-OS. The investigators propose to test moderate intensity interval training (MIIT), a novel exercise intervention whose translation into durable lifestyle change may be facilitated by the feasibility of short bouts of increased PA. The investigators proposal addresses key knowledge gaps in rehabilitation research by investigating the clinical phenotype of EDS-OS to determine the association with functional outcomes and response to a novel exercise intervention with the goal to reduce functional decline.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD and OSA, i.e., Overlap Syndrome Diagnosis of Overlap Syndrome (both COPD and OSA), confirmed in CPRS from spirometry or pulmonary function test of FEV1/FVC \<70 for COPD and a polysomnogram or home-based study for OSA.
* Montreal Cognitive Assessment (MoCA) \>20

Exclusion Criteria:

* CAD, as defined by anyone of the following: history of CABG, prior positive stress test for ischemia, infarction or angina or medical problem
* Orthopedic problems as defined by joint pain limiting ambulation
* Fall risk, defined as more than 2 falls in the prior month
* Hospitalization in prior month
* Daytime home oxygen 6. Participation in structured exercise, defined by the Physical Activity Scale for the Elderly (PASE) as more than 1 hour of activity spent in moderate activity and any strenuous activity performed over prior 7 days.
Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This continuation of the study will analyze 30 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend.


Eligibility Criteria:
Inclusion Criteria:

* At least three (3) months post-operative with no other surgical procedures conducted within the past six months

  * Between 30-80 years of age
  * Body weight of less than 280 lbs
  * Must be between 160cm (5'3) and 193cm (6'4) tall
  * Body Mass Index (BMI) \>18.5 and \<35
  * Judged clinically successful with a Knee Society score (KSS) of greater than 80
  * Have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain
  * Must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (DKB), all without assistance
  * Will have a DePuy Attune PS TKA

Exclusion Criteria:

* Pregnant or potentially pregnant females will be excluded from the study.
The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique

To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy technique.


Eligibility Criteria:
Inclusion Criteria:

* Megaureter.
* Ligated Ureter during surgery.

Exclusion Criteria:

* Neurogenic bladder
* Surgical wound infection
Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
* Blood pressure greater than or equal to 130/85 mmHg AND
* hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
* abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
* triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
* fasting blood glucose greater than or equal to 110mg/dL

Exclusion Criteria:

* Insulin depended diabetes or type-1 diabetes
* Severe or resistant hypertension
* Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
* Any acute or chronic inflammatory disease
* Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start
* Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception);
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)
Jejunoileal vs Gastric GIST in the Era of Imatinib.

Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.

Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.


Eligibility Criteria:
Inclusion Criteria:

* Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.

Exclusion Criteria:

-
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

This is a phase II, randomized, controlled, multi-center study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age
* Able and willing to provide informed consent
* Able and willing to comply with protocol visits and procedures
* Target ulcer duration of ≥4 weeks

Exclusion Criteria:

* Ulcer of a non-diabetic pathophysiology
* Known or suspected allergies to any of the components of MEBO
* Malignancy on target ulcer foot
* Non-compliance in the screening or run-in period
Effects of Selective Dorsal Rhizotomy on Non-ambulant Children With Bilateral Spastic Cerebral Palsy

Children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments.

increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions.

selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. Therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy

Eligibility Criteria:
Inclusion Criteria:

* CP, spastic diplegia
* 4-7 years of age
* On Level IV-V on Gross Motor Function Classification System
* At least six months after the last Botulinum toxin A injection in the lower extremities
* Average intelligent quotient according to medical records for active participation
* Partial trunk control (sitting with support).

Exclusion Criteria:

* Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
* Ankle clonus
* Exaggerated deep tendon reflex in the legs
* Babinski sign;
* Moderate to severe signs of dystonia, athetosis or ataxia.
The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions

This study evaluates the effect of breast reconstruction surgery on respiratory functions. 45 patients elected for unilateral or bilateral breast reconstruction surgery will go through respiratory function examinations a month prior to the surgery, one month after surgery and three months after surgery.

Breast reconstruction surgery using tissue expander and implant technique is the most common breast reconstruction surgery. During this procedure, the surgeon will insert a silicone expander under the Pectoralis Major muscle. In order to fully cover the expander, the surgeon will detach the Serratus Anterior \[SA\] muscle from its natural attachments in the rib cage and will attach the free edges to the lateral edge of the Pectoralis Major muscle. After the wound is healed, a gradual inflation of the expander with a physiological fluid will be done by injecting the fluid into a subcutaneous filling port connected to the expander by silicone tubing. When the tissues around the expander will reach the required size, the tissue expander can be replaced by a permanent silicone implant.

The SA attachments are to the superior angle, medial border and inferior angle of the scapula and to the first to eighth ribs. Its main functions are stabilization and protraction of the scapula and turning the glenoid cavity superiorly in abduction of arms. In addition, the SA is an accessory respiratory muscle: when the scapula is stabilized, its contraction will lift the rib cage in order to help breathing. The importance of the SA in breathing has been examined since the late 19th century and until this day it is not fully agreed upon. Most studies agree that the SA major role in breathing is in deep breaths and is that the muscle is most effective for this purpose when arms are lifted.

Since breast reconstruction procedure includes detachment of the SA from the rib cage and there by canceling its respiratory function, an examination of the respiratory functions before and after the procedure is in order to determine whether or not the overall respiratory functions had been effected.

45 patients elected for unilateral or bilateral breast reconstruction surgery will go through respiratory function examinations a month prior to the surgery, one month after surgery and three months after surgery. The examinations will include the following tests: Spirometry: FVC, FEV1, MVV. Lung capacities: FRC, RV, TLC. Breathing muscle strength: MIP, MEP.

Eligibility Criteria:
Inclusion Criteria:

* all subjects were elected for a unilateral or bilateral breast reconstruction using tissue expander by the Oncoplastic Committee of the plastic surgery unit in Carmel Medical Center.
* all subjects agrees to enroll in research

Exclusion Criteria:

* subject is in a mental or physical condition that does not allow her to go through respiratory function tests.
* subject was found with a respiratory disfunction or disease in the first respiratory function tests.
Collection of Human Biological Samples for the Development and Validation of New Methods of Diagnosis and for the Realization of Expertises Diagnostics in the Field of Infectious Diseases and Tropical

Direct constitution of collections from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality controlled.

Direct constitution of collection from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality controlled.

This collection will allow, as a priority, a development stage, ie the establishment of the proof of concept of new diagnostic methods in the field of infectious and tropical diseases.

There will be 2 cohorts (= arms) for this study: the main cohort of healthy volunteers and the N cohort, which will consist of patients with neuro-meningeal disease of infectious appearance and followed in specialized consultation.

Eligibility Criteria:
Inclusion Criteria:

* major subject
* affiliated or benefiting from social security
* having signed the information and consent form
* negative HIV and HCV serology and negative HBV or vaccine serology (or old healed infection profile)
* for cohort N: neuromeningeal infection during dianostic exploration

Exclusion Criteria:

* Volunteers with a severe or chronic pathology significantly disturbing one or more bio-clinical parameters and / or requiring the regular intake of certain drugs (anti-inflammatories or corticosteroids for example).
* Woman whose pregnancy is known during the visit.
* Acute infection within 15 days or taking antiviral, antibiotic, antifungal or antiparasitic drugs in the last 15 days.
* Subject participating in a biomedical research or in a period of exclusion of a biomedical research.
* When monitoring O +, AB +, A + and B + blood group whose erythrocyte base is kept for CEPIA research, in case of antimalarial (travel), a minimum of 5 half-lives after the last dose of antimalaria.
The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis

The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with theophylline plus low-dose formoterol-budesonide in subjects with bronchiectasis.

Non-cystic fibrosis bronchiectasis is an orphan disease caused by the pathogenic vicious circle including infection, inflammation and airway repair. Today's principle of treatment is to break the cycle of inflammation and infection. Nowadays, most clinical trials are anti-infective treatment by antibiotics trying to break this cycle by reducing the bacterial load, which may cause bacterial resistance. There were still some anti-inflammation trials by using inhaled corticosteroids(ICS). Tsang and Martínez-García showed that inhaled corticosteroids reduced IL-1,IL-8 levels and sputum inflammation cells, and improved sputum volume as well as quality of life, though the corticosteroid must be high dose or medium dose combined with long-acting ß2 adrenergic agonists. As described in asthma and chronic obstructive pulmonary disease(COPD), theophylline can improve the activity of histone deacetylase (HDAC) and then enhanced the anti-inflammatory effect of steroids. We hypothesis that theophylline may have the same effect in subjects with bronchiectasis. Theophylline plus inhaled low-dose formoterol-budesonide may improve quality of life and reduce airway inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-70 years old with non-cystic fibrosis(CF) bronchiectasis, free from acute exacerbations for at least 3 months.Stable phase of the disease.

Exclusion Criteria:

* Patients with a cigarette smoking history of more than 10 packs-year. Patients with COPD. Patients with traction bronchiectasis due to advanced fibrosis. Patients with known intolerance for theophylline. Patients with asthma. Patients with other disease disturbing outcomes of the trials. Patients without consent.
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study

Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.

Category C2 Medicine product without CE label.

Objective(s):

Phase 0: Imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. Phase 1: Determination of accurate radiation dose in vivo; dose exposure should remain within the range specified in the investigational brochure. Evaluation of cohort size for phase 2. Phase 2: Assessment of the diagnostic performance of phase contrast mammography compared to conventional digital mammography.

Ouctomes: Sensitivity and specificity of phase contrast mammography compared to conventional digital mammography.

Measurements and procedures:

Phase 0: Phase contrast mammography of the mastectomy, tumorectomy or breast biopsy samples is performed after breast surgery in addition to the standard clinical procedures Phase 1: Phase contrast mammography is performed before the operation in case of known breast carcinoma in addition to the standard clinical procedures Phase 2: Phase contrast mammography is performed directly in the clinical routine. The result is compared with the result of the conventional digital mammography and the ultrasound examination.

Number of Participants with Rationale:

Phase 0: expected to be 30 Phase 1: expected to be 20 Phase 2: expected to be 300 (correct number will be defined according to Phase 1)

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria -Phase 0:

  * \>18 years
  * Mastectomy, tumorectomy or biopsy planned
  * Informed consent of the patient

Inclusion criteria -Phase 1:

* \>18 years
* BI-RADS 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy);
* Scheduled for mastectomy or breast conserving surgery with radiotherapy.
* Informed consent of the patient

Inclusion criteria - Phase 2:

* \>40 years
* undergoing mammography for screening or diagnostic purpose.
* Informed consent of the patient

Exclusion Criteria:

* Exclusion criteria for all three Phases:

  * Breast implants. The women will be asked, if they have a breast-implant.
  * Inability to understand the study procedure due to cognitive or linguistic deficits.

Exclusion criteria for patients, participating in Phase 1 and Phase 2:

* Pregnancy
* Breast-feeding.
* Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months
Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC

Lung cancer is one of the most common malignant tumors worldwide and the mortality ranks first in the world. In recent years, with the development of targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, the inoperable advanced tumor remains the main reason for the poor prognosis of lung cancer. Thus, we aim to carry out this single-arm, prospective study to evaluate the safety and feasibility of surgery after conversion therapy for locally advanced and advanced non-small cell lung cancer.

Previous studies have shown that selective surgery after conversion therapy is feasible and safe in locally advanced or stage IV patients, and indicates potential benefits for these patients. However, surgery after conversion therapy is difficult and has high risk of postoperative complications which requires strict operation indications and patient screening. At present, there are only relevant retrospective studies and no prospective evidence. Therefore, our team plans to carry out this single-arm prospective clinical trial to evaluate the safety and feasibility of surgery in patients with locally advanced and advanced non-small cell lung cancer after conversion therapy, so as to lay the foundation for further research and clinical application.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent;
* More than 18 years old with no limit of sex;
* Pathologically confirmed stage T4N0-3 or T1-3N2-3 NSCLC with residual tumor after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) evaluated operable for radical resection; pathologically confirmed stage IVA NSCLC evaluated operable after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.);
* ASA score: I-III;
* Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria:

* Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation;
* Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
* Unable to receive radical resection;
* Need of palliative or emergency operation due to lung abscess or hemoptysis;
* Having received neoadjuvant chemoradiotherapy.