cyrilzakka/clinical-trials huggingface dataset:
Optoacoustic Images Versus Imagio® Ultrasound

The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.

This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study (NCT01943916) or the Reader-01 Feasibility Study (NCT03708393) are not eligible to participate as readers in this Pivotal Study.

Imagio® \[Ultrasound (IUS) + Optoacoustic (OA)\] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.

Eligibility Criteria:
Inclusion Criteria:

* One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)
* Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol
* Patient age, indication for study entry and available medical history
* Evaluable mammograms and OA and IUS video loops and stills for each mass

Exclusion Criteria:

* Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers
* Reader-02 Proficiency Test and training cases
Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

Awareness about the disease in Russia is extremely low both among doctors and especially among patients. To date there are no data on the prevalence of the disease in Russia. This is the first study to show patient profile, main trigger factors and concomitant diseases among patients with Irritable Bowel Syndrome (IBS) in Russia. Also treatment characteristics for these patients in Russia will be measured. This study fills a lack of scientific data about prevalence of IBS and additional information.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-50 y.o
* Patients suffering from Irritable bowel syndrome (abdominal pain and changes in bowel habit) as defined by Rome IV criteria and the absence of any relevant structural disease
* Patient's written authorization to provide data for the program
* Patients who are able to input him/herself data into patients' part of Electronic Data Capture (EDC)

Exclusion Criteria:

Presence of alarm features:

* positive family history of colorectal cancer, inflammatory bowel disease, celiac disease
* rectal bleeding in the absence of documented bleeding hemorrhoids or anal fissures
* unintentional weight loss
* severe anemia (according to local laboratory reference values)
* Fever (\> 37,5 degree Celsius)
* Night symptoms appearance

Other:

* Significant and progressive change in: enlargement of the liver, spleen, lymph nodes; ascites; palpable mass in the abdomen / pelvic
* Pregnancy or lactation or the inability to use adequate contraception during the study;
* Other conditions that made the patients participation impossible (by investigator judgment)
* Previous enrollment in any other clinical study during the course of this study, including participation in a study within 30 days prior to informed consent.
* Prescribed by Health Care Professional(s) (HCP) and being currently treated or having been treated with spasmolytics within the 3 months prior to entering the study.
Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort

National guidelines about post-operative fasting after general anesthesia are missing.

Current clinical practices are highly variable and no study has ever evaluated on a large scale the real risk of an early drinks recovery in postoperative period.

The aim of this study is to state the impact of early drinks recovery after general anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled surgery
* General anaesthesia with laryngeal mask or endotracheal intubation.
* Length of surgery \< 4 hours

Exclusion Criteria:

* Emergency surgery
* Intra-cranial, cervical or Ear, Nose and Throat surgery
* Guts surgery with guts anastomosis.
* Glottic topical anesthesia
* Patient with nasogastric tube
* Aspiration during surgery or during PACU stay
Multidomain Interventions for Elderly Individuals in Residential Structures

The "Multidomain Interventions to improve the COgnitive and fUNctional well-being of elderly individuals in residential sTructures" (I-COUNT) study aims to test the feasibility and the effectiveness of a multidisciplinary intervention among elderly individuals living in long term care facilities (LTCFs). The intervention will include selected physical and cognitive training activities administered and monitored by new technologies, a dietary intervention including also functional foods, and the administration of vaccines according to the National plan. The multidomain intervention will last 6 months and will be compared with the standard care adopted in the same LTCFs.

I-COUNT is a randomized controlled trial that will be conducted among residents in two residential facilities in Italy. Sixty participants will be enrolled in each residential facility (30 control group, 30 intervention group).

During the first phase of the study, eligible residents of the participating LTCFs will be enrolled according to the following inclusion and exclusion criteria. Baseline evaluations will be based on a geriatric multidimensional assessment including body composition assessment, physical performance assessment, Mediterranean diet adherence assessment, psychological and neuropsychological evaluations. Blood, plasma, stool and urine samples will also be collected.

In phase two, which will last 6 months, participants in the intervention group will undergo the planned interventions, while controls will be asked to continue with their usual activities. The physical activity will consist of three 40-minutes sessions per week, with personalized exercises prescribed by a physiotherapist and performed in small groups, under supervision. The cognitive training will be based on the computer program Remote stimulation for Cognitive Decline (RECODE), developed by the Department of General Psychology, University of the Padua, with two sessions per week. The intervention group will also receive functional foods (sourdough bread enriched with a vegetable matrix rich in polyphenols (olive leaves) and vegetables enriched with probiotics (artichokes)).

In phase 3, participants will be reassessed at 3 months (gut microbiota only), and 6 and 9 months after the start of the intervention (selected biomarkers, nutritional and anthropometric status, psychological health, physical performance tests, cognitive function, acceptability of the technological monitoring and interventions).

Eligibility Criteria:
Inclusion Criteria:

* age ≥70 years;
* resident in the identified LTCFs for at least 6 months;
* able to communicate and collaborate with the research team;
* Mini-Mental State Examination-MMSE ≥18.

Exclusion Criteria:

* estimated length of stay in the LTCFs\<6 months;
* estimated life expectancy \<6 months;
* previous gastrectomy or colectomy;
* presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG);
* presence of dysphagia;
* inability to undergo psychometric tests for any reason;
* history of psychiatric illness according to clinical anamnesis;
* inability to walk.
FDG PET/CT and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma

FDG-PET/CT is an established modality in various stages of management of lymphoma but definitive information regarding the diagnosis, prognostication, and further management is provided by histopathological examination. Combining the two modalities may provide an incremental benefit by identifying better sites for targetting biopsy and for better verification of sites and causes of FDG uptake seen during PET/CT.

Written informed consent was obtained from all the participants for PET/CT-guided biopsy. The procedure details, related risks, and benefits were explained to all the participants. A multidisciplinary team including hemato-oncologists, nuclear medicine physicians, and pathologists were involved in the project. A hemato-oncologist decided the biopsy indication after discussing it with the nuclear medicine physician. FDG avid lesions in a clinically suspected case of lymphoma or a suspicious, residual FDG avid lesion detected at the time of follow-up PET/CT imaging in a patient with a prior diagnosis of lymphoma were sampled. The per and post-procedural complications and management were maintained in the institutional PET data registry and the final histopathological diagnosis obtained was also collected.

Eligibility Criteria:
Inclusion Criteria:

* FDG avid lesion in a clinically suspected case of lymphoma.
* Suspicious, residual FDG avid lesion detected at the time of follow-up PET/CT imaging in a patient with a prior diagnosis of lymphoma either at the end-of-treatment or during surveillance.

Exclusion Criteria:

* Deranged coagulation profile.
* Inaccessibility of the lesion for a percutaneous biopsy.
* Resolution of the lesion at the time of biopsy planning.
* Participant is not willing for the procedure.
* Pregnant females and participants less than 18 years of age.
Carotid Plaque Length to Predict Cardiovascular Events

This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 3000 patients for suspected CAD who referred to coronary angiography from January 2017 through December 2018.

Patients with coronary artery disease who were confirmed by coronary angiography were eligible for the study. Carotid ultrasonography was performed before coronary angiography, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients≥18 years old, those who underwent carotid ultrasonography and first coronary angiography simultaneously.

Exclusion Criteria:

* Patients with known coronary artery disease, previous coronary or carotid revascularization, missing carotid ultrasound or coronary angiography results.
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe rheumatoid arthritis who completed the WA19926 core study. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
* No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
* Receiving treatment on an outpatient basis
* Females of childbearing potential must agree to use at least one adequate method of contraception, including a method with a failure rate of \<1% per year, during the treatment period

Exclusion Criteria:

* Pregnant or lactating women
* Patients who have prematurely withdrawn from the WA19926 core study for any reason
* Treatment with an investigational agent or cell-depleting therapies since the last administration of study drug in the WA19926 core study
* Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study
* Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
* Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
* Inadequate liver, hematologic or renal function
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Known active or history of recurrent infections
* Evidence of active malignant disease, malignancies within the previous 10 years (except for basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
* Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
A New Protocol for the Management of Dental Erosion in Rugby Players

The aim of the present study is to provide a new domiciliary oral care treatment for enamel remineralization in rugby players patients using mouthguards. Patients selected for the study will be randomly divided and allocated in two groups according to the treatment:

* Group 1: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day
* Group 2: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Patients will be given instructions for the cleaning of their mouthguards. The periodontal evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).

The aim of the present study is to provide a new domiciliary oral care treatment for enamel remineralization in rugby players patients using mouthguards and to prevent further worsening of dental erosion. Patients selected for the study will sign the informed consent and will be randomly divided and allocated into two groups:

* Group 1: SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice a day
* Group 2: SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

Patients will be given instructions for the cleaning of their mouthguards. The periodontal evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate to the study
* Rugby players

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients suffering from neurological disorders
* Patients suffering from psychological disorders
* Pregnant or breastfeeding women
Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients

Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed.

Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients The aim of this study is to assess the feasibility and safety of "one shot" extrcorporeal CO2 removal device, in reducing the PaCO2 level

Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed.

Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients Recently extracorporeal CO2 removal have been shown to avoid the need of endotracheal intubation in COPD patients with an episode of Acute Hypercapnic Respiratory Failure In this pilot physiological study we want to assess the safety and efficacy of this technique in reducing the PaCO2 level in those COPD patients with chronic hypercapnic respiratory failure non responding to chronic NIV.

Eligibility Criteria:
Inclusion Criteria:

* COPD ( FEV1/CVF \<0.70 post bronchodilation)
* stable PaCO2 \>55 mmHg non respondent to long-term NIV (at least one week). This means a decrease in PaCO2 during spontaneous breathing, at least 4 hrs after the termination of NIV, of\< 6%
* pH \> 7.35
* clinical stability

Exclusion Criteria:

* Mean Arterial Pressure \< 60 mmHg
* contra-indication to heparin
* Body Mass Index (BMI) \> 30 kg/m2;
* presence of sleep apnea or overall syndrome
Iressa 2nd Line Phase III Study in Japan

In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
* You have been treated with chemotherapy including platinums for NSCLC.

Exclusion Criteria:

* You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
* You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
* You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
Atrial Fibrillation Recurrence After Cryoballoon Ablation

The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our current method of ICE-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation
* At least 18 years old
* Able to read and understand informed consent

Exclusion Criteria:

* Unable to give informed consent
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery

The goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results. We hope that such a questionnaire will improve the understanding of breast surgery results and patient care.


Eligibility Criteria:
Inclusion Criteria:

* All stages (1-4)
* Age \> or = to 18 to 85 years.
* Postoperative Group: Male and Female patients who have undergone mastectomy, breast reconstruction, reduction, augmentation, bariatric or body contouring surgery between 1 month to 8 years ago

Or

* Preoperative Group: Male and Female patients who are scheduled to undergo mastectomy, breast reconstruction, reduction, or augmentation or body contouring surgery

Exclusion Criteria:

* Inability to speak or understand English
* Active psychiatric illness, cognitive or sensory impairment
* Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions
TKA Melatonin and Sleep Quality

This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.

This study will compare postoperative sleep quality in two groups of patients undergoing primary total knee arthroplasty (TKA):

* Group 1 will take one melatonin (5 mg) tablet nightly, \~30 minutes before bedtime during the 6 week postoperative period
* Group 2 will take one placebo (5 mg Vitamin C) tablet nightly, \~30 minutes before bedtime during the 6 week postoperative period

The primary outcome will be sleep quality at 6 weeks. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The survey will be administered preoperatively, 6-weeks, 90-days and 1 year postoperatively. Preoperative surveys will be completed in-person, on-site by study participants. All postoperative surveys will be distributed via email.

Secondary outcomes include:

* (KOOS Jr, LEAS, VR-12, VAS) administered preoperatively, at 6-weeks, 90-days and 1-year post-operatively.
* Total opioids prescribed in first 3 months postoperative will be collected using iStop
* Frequency of CMS defined surgicalcomplications in the first 90-days after primary TKA.
* Adverse events of Melatonin during the first 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks)
* Study medication compliance at 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks)

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary, unilateral TKA
* Primary diagnosis of osteoarthritis (OA)
* Aged 18+
* Subject is opioid naive (has not taken opioids during the 6 months prior to surgery)
* Subject is not currently taking sleep medication
* English speaking
* Has working email (for survey purposes)

Exclusion Criteria:

* Patients with diagnosis other than OA including: Inflammatory arthritis; Post-traumatic OA; Chronic pain; Insomnia\*; Depression\*; Anxiety\*; Any active sleep disorder
* Planned contralateral knee or subsequent total joint arthroplasty within 90 days
* Any planned surgery within 90 days
* Patient taking medication for depression or insomnia or anxiety during the 6 months prior to surgery
* Patients with renal or hepatic disorders as these can affect melatonin metabolism

  * Insomnia, anxiety, and depression will be defined as use of controlled medication for that disorder which will be identified in istop or HSS record of the patient filled in the 6 months prior to surgery