cyrilzakka/clinical-trials huggingface dataset:
Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT

Stereotactic body radiotherapy (SBRT) has emerged as one of the leading curative method for early stage non-small cell lung cancer (NSCLC). However, assessing the status of the disease during post-SBRT follow up presents a challenge. Currently, chest Computed Tomography (CT) is the main technique to detect whether cancer has come back, but this method has demonstrated poor accuracy and reliability in determining if the observed post-operative lung changes are benign or malignant.

Positron-emission tomography (PET) is an imaging technique that uses special radioactive tracers to cell growth. The use of PET scans with a tracer that target the pathways of DNA synthesis may be more accurate than CT for detecting if the cancer has come or not.

The purpose of this study is to see if a PET radiotracer called 18F-FLT (3'-deoxy-3'-fluorothymidine) can identify cancer recurrences accurately compared to regular CT scans.

Stereotactic body radiotherapy (SBRT) has demonstrated an impressive 3-year control rate of higher than 90% for early stage NSCLC, leading to increased use of this technique as a curative method for lung cancer treatment. With growing clinical experience with this technique, post-SBRT follow up has received more attention. Follow up after SBRT is done primarily by thorax CT, which is affected by radiation-induced radiographic lung changes that can resemble or obscure local recurrence.

FLT (3'-deoxy-3'-fluorothymidine) is a thymidine analogue which is non-toxic in tracer doses, and can be labeled with 18F. FLT-PET is a type of imaging (similar concept to the widely used 18-FDG PET-CT) that is based on integration of thymidine into DNA for assessment of proliferation. Conceptually, increased DNA synthesis is correlated to tumor aggressiveness and response to therapy, more so than glucose utilization - as in FDG-PET could be.

The purpose of this study is therefore to see what added information the use of FTL-PET can provide in distinguishing between changes in the lung that occur as a result of treatment that are not cancerous and those that are due to recurrence or progressive disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Must have been treated at or plan to be treated at Princess Margaret Cancer Centre with SBRT for an early-stage NSCLC (T1N0M0; T2N0M0; or T3N0M0 chest wall primary tumours only) and are either:

   1. Prior to treatment with lung SBRT (for Cohort 1)
   2. Have radiographic findings on that are felt to be related to fibrosis at any time point following lung SBRT
   3. Have radiographic findings on CT that are suspicious for recurrence at any time point following lung SBRT
3. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

1. Previous systemic therapy
2. Previous thoracic radiotherapy(excluding the index lung SBRT treatment)
3. Active malignancy other than lung cancer
4. Unable to remain supine for more than 30 minutes
5. If taking the drug Antabuse
6. Pregnancy
Kefir and Metabolic Syndrome

Metabolic syndrome is a cluster of metabolic disorders which increases the risk for diabetes and cardiovascular disease. In recent years, research has shown that probiotics may have positive effects on metabolic syndrome components. Although several health-promoting effects of kefir, have been suggested, there is limited evidence for its potential effect on metabolic syndrome. Therefore, it is necessary to clarify the effects of kefir on metabolic disorders including obesity, dyslipidemia, diabetes, and hypertension. To address the research gap, this study aimed to investigate the effects of daily kefir consumption on metabolic syndrome components, inflammatory response and gut microbiota composition in adults with MetS. The study was planned as a randomized, controlled, parallel design and completed with a total of 62 individuals who were diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria. Participants were randomized into two groups and received daily 180 ml of kefir (n=31) or milk (as control) (n=31) for 12 weeks. Participants were assessed at baseline, week 4, week 8, and week 12 and at all controls dietary records, anthropometric measurements, and blood samples were collected. At baseline and 12th-week fecal samples were also collected in order to analyze gut microbiota composition.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old subjects
* Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria.

Exclusion Criteria:

* Existence of lactose intolerance
* Existence of type 1 diabetes
* Existence of abnormal thyroid hormone levels
* Existence of chronic gastrointestinal system disease
* Existence of cancer
* Existence of severe liver disease
* Existence of kidney insufficiency
* Existence of immunodeficiency
* Taking medication to regulate blood glucose (except metformin) or lipid levels
* Taking antibiotics prior to one month of the study
* Consuming regular probiotic food or supplement
* Taking supplement which may affect the metabolic outcomes such as prebiotic or omega-3
* Dieting for weight loss or for another disease
* Being pregnant and breastfeeding.
Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)

This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed breast cancer
* presence of distant metastasis
* radiation therapy using IMRT, SBRT, or proton therapy is done or planned
* Able and willing to comply with the study protocol

Exclusion Criteria:

* unable to adhere to the study protocol
Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease

Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD), affecting the decline of pulmonary function, quality of life and increasing morbidity. The use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated.

The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which reflect local or systemic inflammation and oxidative stress. The relationship between the presence of some of these compounds and the exacerbation of COPD has never been studied.

The aim of this study is to identify a cluster of VOC in COPD patients during an acute exacerbation of the disease, compared to a stable condition (3 months after discharge). Investigators also will seek for a relationship between VOC and the etiology of exacerbation (bacterial, viral, inflammatory).


Eligibility Criteria:
Inclusion Criteria of COPD group:

* COPD stages 2 and 3 of GOLD score (30 ≤ forced expiratory volume at one second (FEV1) \< 80% of predicted value),
* exacerbation confirmed clinically (increased dyspnea, cough or expectorations \> 48 hours)

Inclusion Criteria of non COPD group:

* No smoker (\<100 cigarettes/year)

Exclusion Criteria of COPD group:

* Diagnosis of COPD not confirmed.
* Instable clinical status with respiratory failure and indication of mechanical ventilation.
* Bronchodilator treatment changed
* Antibiotic treatment started in the 10 last days before admission

Exclusion Criteria of non COPD group:

* Chronic inflammatory disease
* Any respiratory disease
* Oral corticosteroid treatment during the last month
Efficacy of LAMA Added to ICS in Treatment of Asthma

The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess its safety.


Eligibility Criteria:
Inclusion Criteria:

* History of asthma ≥ 5 years and diagnosed before 40 years old
* Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5
* Pre-bronchodilator FEV1 ≥40% and \<90% of their predicted normal value
* Positive reversibility test

Exclusion Criteria:

* Pregnant or lactating women
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Patients treated for asthma exacerbation in the 4 weeks prior to study entry
* Patients who are in therapy for gastroesophageal reflux disease
* Patients who have a clinically significant cardiovascular condition
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

The purpose of this study is to evaluate the effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.

Effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis. A prospective randomized controlled trial is being conducted in Carmel Medical Center, Haifa, Israel. Patients are being randomized into one of two arms. One arm receives sinus irrigation with saline in conjunction with IV antibiotics, the control arm receives the same regimen of IV antibiotics without the sinus irrigation. Quality of life, CT scans and nasal endoscopy parameters are collected before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (over 3 months) maxillary and ethmoidal rhinosinusitis (verified by a CT scan)
* Over 18 years of age
* Signed informed consent
* Not participating in another clinical study

Exclusion criteria:

* A previous sinonasal surgery or craniofacial trauma
* Isolated frontal or sphenoidal sinusitis
* Immunosuppressed (diabetes, cancer, etc.)
* Craniofacial deformity
* Allergic fungal sinusitis
* Nasal polyposis
* Rhinosinusitis of dental origin
* Bleeding tendency (e.g., chronic coumadin treatment)
* Patients participating in other clinical study
* Patients with penicillin allergy
* Patients with Augmentin resistant bacteria in cultures
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

The overall aim of the study is to determine the efficacy of oral ifetroban, a novel antagonist of T prostanoid (TP) receptors, as a treatment for patients with aspirin-exacerbated respiratory disease (AERD).

The protocol involves a 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban in patients with AERD. At the end of the 4-week treatment phase (ifetroban or placebo) each subject will undergo a graded oral aspirin desensitization procedure in order to initiate high-dose aspirin therapy, which is standard-of-care at our institution and is the only available therapy known to modify the course of AERD.

Eligibility Criteria:
Inclusion Criteria:

1. History of AERD, defined as meeting the diagnostic triad with:

   * History of physician-diagnosed asthma and
   * History of physician-diagnosed nasal polyposis and
   * History of pathognomonic reactions aspirin or other nonselective cyclooxygenase (COX) inhibitors.
2. Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 6 months)
3. Age between 18 and 70 years
4. No current smoking (not more than one instance of smoking in the last 3 months)
5. Non-pregnant

Exclusion Criteria:

1. Hypersensitivity to montelukast
2. Current use of zileuton
3. History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
4. Current use of any NSAIDs aside from the aspirin provided during the study
5. Current use of beta blockers
6. Use of any biologics within the last 4 months prior to initiating the study
Emotional and Cardiac Impact of Postpartum Haemorrhage

To assess the impact and to identify the main risk factors for psychological and cardiac morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum hemorrhage

The HELP- MOM study is an observational study that seeks to identify the major determinants of morbidity induced by postpartum hemorrhage (PPH) in the short and medium term. Even if PPH remains the leading cause of death in the world and in France , its main impact in so-called developed countries is not so much maternal mortality ( which is very small ) but induced morbidity.Data from the literature suggest that in a number of cases, PPH is associated with cardiac abnormalities. The nature of the abnormalities, their potential impact on the functioning of the cardiovascular system of women and their evolution over time (possibility of persistent sequelae) are not known. Similarly, it is known that the postpartum period of normal pregnancy followed by a normal delivery is at risk of psychological disorders in the mother. The PPH is a very serious situation where sometimes the vital prognosis of the mother was committed. Again, determining the exact nature and consequences of psychological harm secondary PPH are not known. Finally, fertility and the risk of recurrence after an episode PPH are also poorly understood. Outside hysterectomy hemostasis which permanently affects the fertility of the patient, the severity and type of management of PPH most likely affect fertility. Only a long-term monitoring could help address this issue. Thus, HELP MOM - study aims to address these issues. To do this, HELP MOM, was divided into two sub- studies : 1) HELP-MOM 1 "multidisciplinaire" which corresponds to the cohort of patients in whom psychological state will be studied in the immediate waning PPH then during a 6 months through appropriate questionnaires , 2 ) HELP-MOM 2 "cardio" that corresponds to the cohort of patients who experienced a cardiac abnormality in the initial management and will therefore be included in a cardiac monitoring.

Eligibility Criteria:
Inclusion Criteria:

HELPMOM1 :

* Patients with postpartum hemorrhage and receiving sulprostone
* Patient affiliated with social security

HELPMOM2 :

* Enrolled HELMOM1
* Presence of one or more items from the following list at the moment of PPH:

  * elevated troponin ("classical" or ultra) exceeds 5 times the normal value (about\> 0.20 g / ml depending on the laboratory) and / or
  * electrocardiographic abnormalities (ST-segment abnormalities and / or T wave abnormalities searched in all 12 leads) and / or
  * rate of BNP (Brain Natriuretic Peptide) greater than 100 pg / m

Exclusion Criteria:

HELPMOM1:

* Age \< 18 years
* Hemorrhage caused by a miscarriage, a clandestine abortion, fetal death in utero or medical or voluntary termination of pregnancy.

HELPMOM2:

- Patient with pace maker
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors

The objective of the present study is to implement and evaluate the effect of a counseling program to promote healthy eating and practice of physical activity in the nutritional status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.

Endometrial cancer (EC) is the fifth most commonly diagnosed malignant neoplasm among women worldwide. The incidence of EC is higher in high-income countries, but it has been increasing in low- and middle-income countries.

The main risk factors for EC include the presence of comorbidities, such as diabetes mellitus and hypertension, as well as conditions associated with prolonged exposure to estrogens. Obesity is recognized as a major risk factor for many cancers, including EC. Multiple mechanisms related to obesity are probably involved in the carcinogenesis of EC. Among obese women in the postmenopausal period, there is an increase of bioavailable circulating estrogens. These estrogens come from the aromatization of androgens in adipose tissue and from increased circulating estrogens secondary to the reduced synthesis of sex hormone binding globulin (SHBG) in the liver. Insulin resistance, hyperinsulinemia, increased secretion of adipocytokines and pro-inflammatory cytokines may also play a role in the carcinogenesis of EC.

Although the incidence of EC is remarkable, insufficient data has addressed the impact of obesity on EC outcomes. Since about 70% of women diagnosed with endometriod EC are obese, the consequences of obesity-related diseases should be taken into account in order to implement strategies to improve survival outcomes among these women.

Sedentary lifestyle and physical inactivity also seem to be relevant, and have been identified as predictors of poor prognosis in patients with different types of cancer. However, the role of lifestyle (including eating and social habits and physical activity) on endometrial cancer prognosis has not been assessed prospectively yet. Studies assessing nutritional status and lifestyle before and after EC diagnosis may elucidate whether and when these factors influence clinical outcomes, including long-term survival.

Eligibility Criteria:
Inclusion Criteria:

* endometrial cancer patients undergoing surgical treatment

Exclusion Criteria:

* previous oncologic treatment
* cancer stage IV according to the International Federation of Gynecology and Obstetrics (FIGO)
* patients who report physical activity over 150 minutes/week of moderate or vigorous intensity
* individuals with decompensated diabetes mellitus or hypertension
* patients who have a contraindication to physical activity.
Oklahoma Native American Women's Osteoporosis Screening Study

Native American women may be considered high risk for osteoporosis due to lifestyle factors and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate their rate of bone loss; 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2 follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA and logistical regression.

Osteoporosis, characterized by decreased bone density and deterioration in bone microarchitecture, is estimated to afflict 1 out of 2 women over the age of 50 years. These estimates are based primarily on Caucasian populations with limited information in Native Americans. Native American women may be considered high risk for osteoporosis due to lifestyle factors in conjunction with the incidence of diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers, aged 50+ years, who are eligible for health care through Indian Health Services; 2) to evaluate their rate of bone loss, 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Native American women aged, 50+ years, who are eligible for services through Indian Health Services in the Oklahoma City (OKC) Area will be recruited. Participants will undergo a baseline osteoporosis risk assessment, i.e. medical history, dual-energy x-ray absorptiometry (DXA) scans, dietary and physical activity assessment, and optional blood draw, and then encouraged to return to their primary care physician for counsel and/or treatment. Serum markers of bone metabolism, endocrine parameters (e.g. vitamin D metabolites) and inflammatory molecules will be assessed for participants that consent to the blood draw. All participants will receive educational information related to osteoporosis risk and prevention, and follow-up visits scheduled at the end of Year 1 and Year 2. Data will be analyzed using repeated measures ANOVA and logistical regression with the α set at 0.05 for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Native American women who are eligible fore services at Indian Health Clinics in OKC
* 50 years of age or older

Exclusion Criteria:

* Women who weigh more than 300 lbs or who are pregnant or cognitively impaired
RetroBRACE - Clinical and Functional Outcomes 2 Years After Primary ACL Repair (Internal Bracing)

The purpose of this study is to quantify 2-year postoperative clinical and functional outcomes including side-to-side differences in gait function, balance, proprioception and muscle strength in patients treated by ACL repair with Internal Brace Ligament Augmentation.

Rupture of the anterior cruciate ligament (ACL) is one of the most common injuries. In recent years, arthroscopic techniques have rapidly evolved with advanced tools such as suture anchors, resolvable pins and internal bracing techniques. One of the very latest developments in internal bracing and repair for proximal ACL ruptures is the InternalBraceTM (Arthrex Inc., Naples, Florida, USA). The purpose of this study is to quantify 2-year postoperative clinical and functional outcomes including side-to-side differences in gait function, balance, proprioception and muscle strength in patients treated by ACL repair with Internal Brace Ligament Augmentation.

Eligibility Criteria:
Inclusion Criteria:

* 2 years since ACL repair and Internal Brace Ligament Augmentation

Exclusion Criteria:

* Revision surgery within 2 years after primary repair (ACL, Total or Partial Knee Arthroplasty, Joint Infection, Fracture around knee level)
* BMI \> 35 kg/m2
* Previous injury and surgical procedures of the contralateral knee
* Neuromuscular disorders affecting lower limb movement
* Additional pathologies that influence the mobility of the knee joints
* Inability to provide informed consent
New Stent Retriever, VERSI System for AIS

To confirm efficacy and safety of VERSI system for acute ischemic stroke

Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure

Eligibility Criteria:
Inclusion Criteria:

* onset to treat within 8 hours
* NIHSS 8 or more
* ASPECTS 5 or more
* Target vessel is ICA, MCA, VA, BA, PCA
* non-eligible or failed IV rt-PA

Exclusion Criteria:

* known hemorrhagic tendency
* arterial dissection, vasculitis
* allergy for contrast media
* other inappropriate condition
Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

This study will compare the safety and efficacy of \[S,S\]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
2. Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
3. Score of 4 or higher on the Clinician Global Impression - Severity scale

Exclusion Criteria:

1. Significant comorbid psychiatric diagnoses
2. Significant risk of suicidal or violent behavior