cyrilzakka/clinical-trials huggingface dataset:
Safety and Feasibility of the Tandem Snare Device

The device is intended to endoscopically transect polyps in the gastrointestinal tract (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis. The Tandem Snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. This is a feasibility study aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.

The colonoscopy procedure is considered the "gold standard" for detecting, diagnosing and treating abnormalities in the colon. Detection and removal of colon polyps is the most significant benefit colonoscopy provides toward the reduction of colorectal cancer mortality and morbidity. The Tandem Snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. The technology may eliminate the repeated bites with the intervention tool or the need to use additional intervention tools such as the net. It may improve visual perception for resecting the polyp without losing it while removing from the colon. Consequently it may increase the potential for complete polypectomy and reduce intervention time and repetitions, polyp lost, risks and cost. This is a feasibility study aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Adults \> 18 Years
2. Subjects have been scheduled for colonoscopy
3. Subject has signed the informed consent

Exclusion Criteria:

1. Suspected or known active Inflammatory Bowel Disease (IBD)
2. Coagulopathy or thrombocytopenia.
3. Taking dual anti platelet therapy or anti coagulants.
4. Bowel preparation is deemed poor by colonoscopist.
5. Subjects with known or detected (during colonoscopy) moderate/severe diverticular disease.
6. History of familial polyposis (FAP).
7. History of prior surgery to colon and/or rectum.
8. ASA ≥ IV.
9. Pregnancy (as stated by patient).
10. Subjects with altered mental status/inability to provide informed consent.
11. Patients who have participated in another interventional clinical study in the last month.
12. Subject under a condition which in the investigators opinion may put the subject at significant risk, confound study results, or interfere significantly.
Perioperative Sleep Quality and Postoperative Pain Outcomes

This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.


Eligibility Criteria:
Inclusion Criteria:

* able to read, understand, and speak English
* are undergoing ACL repair or reconstruction
* have availability of a mobile device/computer to receive text messages

Exclusion Criteria:

* \< 10 or \> 18 years of age
* have a history of sleep-disordered breathing including sleep apnea
* have a history of chronic pain or current opioid use
* have a history of developmental delay that would preclude study participation
Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy

Allergen immunotherapy (AIT) is used for the control of allergic diseases that are not completely responsive to avoidance strategies and/or pharmacotherapy. It is also considered the main treatment with the potential to modify allergic disease evolution. It's efficacy and safety in allergic rhinitis and asthma is supported by large systematic reviews and is recommended as a cornerstone treatment option in allergic disease. Molecular based allergy diagnosis has greatly evolved and the knowledge of molecular allergen sensitization pattern has been used to better define the allergen extract composition of AIT. However, uncertainty remains if this strategy is related to an increase of efficacy. Regulation of allergen extracts for allergen immunotherapy are currently underway in Europe, but there is still lack of standardization of relevant allergens and important differences are seen between allergenic contents.

Therefore, we aim to evaluate, in a real-life setting, the impact of using molecular-based diagnosis versus standard diagnostic tools in the efficacy of aeroallergen immunotherapy, using a pragmatic randomized controlled trial design and also to address the impact of the discrepancy between individual aeroallergen sensitization profiles and the major allergen molecular content of aeroallergen immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with medical indication for aeroallergen immunotherapy(AIT) for allergic rhinoconjunctivitis or asthma, accordingly to the AIT guidelines;
* Over 5 years of age;
* Evidence of IgE-sensitization (positive skin prick tests and / or serum specific-IgE)
* Patients have indication to AIT to house dust mites and/or grass pollen, association with other allergens is not an exclusion criteria

Exclusion Criteria:

* Previously performed allergen immunotherapy
* Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy
Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

The purpose of this study is to investigate feasibility aspects of an intervention targeting problems in managing daily tasks due to mild-to-moderate poststroke cognitive impairments. We will specifically address uncertainties related to intervention content and delivery, and trial design and conduct.


Eligibility Criteria:
PATIENTS:

Inclusion criteria:

* first-ever symptomatic stroke,
* age ≥ 18 years,
* residence in Frederiksberg Municipality, Denmark,
* independent in pre-stroke everyday life (≤ 2 points on the modified Rankin Scale, mRS),
* experiencing problems in performing ADLs due to cognitive impairment; these problems are expected to still be present at hospital discharge,
* medical condition allows commencement of rehabilitation focused on ADL and cognition
* fully aware or mild-to-moderate unawareness of deficits (≤ 2 points on the Bisiach Anosognosia Scale, BAS),
* a global cognitive function corresponding to ≥ 17 points on the Montreal Cognitive Assessment, MoCA,
* ≤ 10 points on the depression subscale of the Hospital Anxiety and Depression Scale, HADS,
* able to provide informed consent, as evaluated by the recruiting healthcare professional(s),
* logistically possible to perform baseline assessments and create an individualised intervention plan during hospital stay
* provides informed consent

Exclusion criteria:

* psychiatric conditions causing difficulties or preventing participation, as evaluated by the recruiting health care professional(s)
* communication problems causing difficulties or preventing participation, as evaluated by the recruiting healthcare professional(s)

CAREGIVERS:

Inclusion criteria:

* appointed as close carer (by a patient who consented to participate),
* age ≥18y,
* provides informed consent.

Exclusion criteria:

-communication problems or other issues causing difficulties in participation as evaluated by the recruiting healthcare professional(s).

Patients without a close carer will not be excluded.

CLINICAL STAFF:

Inclusion criteria:

* appointed as local project managers, or OTs or NPs who conduct assessments or deliver the intervention in the participating centres,
* provides informed consent.

Exclusion criteria:

- unable to to follow a preliminary English version of the intervention manual.
Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings

The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 2-12 years old,
* Presenting with complaint of sore throat
* Parental consent given and child assent if 5 years or older

Exclusion Criteria:

* The parent/guardian reported oral antibiotic use in the past 3 days or injectable penicillin in past 28 days prior to screening
* Had a history of rheumatic fever or rheumatic heart disease
* Required hospitalization for any reason at the time of enrollment
* Had previously been enrolled in the study
MarginProbe® System U.S. Post-Approval Study

The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin\* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery.

\*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be randomized to either standard of care with additional inspection ('SOC + Additional inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm).

The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It will be used by the surgeon during lumpectomy procedures only in patients randomized to the "Device+SOC" arm.

Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.

Eligibility Criteria:
Inclusion Criteria:

* Women histologically diagnosed with carcinoma of the breast
* Women with non-palpable malignant lesions, requiring image guided localization.
* Undergoing lumpectomy (partial mastectomy) procedure
* Age 18 years or more
* Signed ICF

Exclusion Criteria:

* Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast)
* Bilateral disease (diagnosed cancer in both breasts)
* Neo-adjuvant systemic therapy
* Previous radiation in the operated breast
* Prior surgery in the same site in the breast
* Woman histologically diagnosed by an open biopsy procedure
* Implants in the operated breast
* Pregnancy
* Lactation
* Participating in any other investigational study for either drug or device which could influence collection of valid data under this study
* Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)
Evaluation of a Touchless Vein Scanner for Venepuncture and Cannulation in Pediatric Patients

Evaluation of the AccuVein ® AV 300 vein scanner in clinical routine in a pediatric operation room setting for a 4 weeks period. Assessment of usability, anonymous clinical register of every venepuncture(age, gender, size, weight, punction site, number of attempts, time until successful cannulation, local anaesthesia, general anaesthesia, pain scales: faces pain scale und BPS/BPOS).

For application of drugs and liquids a peripheral venous access is necessary in anaesthesiological procedures.The peripheral venepuncture is a painful procedure and induces a higher level of perioperative stress in children.

The punction of peripheral veins in children can be made difficult by the often distinctive amount of subcutaneous fat or other medical conditions.

The AccuVein ® AV300 vein scanner is a contactless, laser-driven device made for facilitate the search for peripheral veins up to a depth of 7mm. This could lead to a minimization of time until successful puncture and smaller number of failures.

Eligibility Criteria:
Inclusion Criteria:

* age from 0 to 17 years
* perioperative indication for peripheral venous access
* regular work time of the operation room from 7 am to 4 pm

Exclusion Criteria:

* age more than 17 years
* no indication for or already established venous access
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) of 18.0 - 40.0 kg/m\^2
* Meets criteria for the diagnosis of schizophrenia
* Resides in a stable living situation when not hospitalized
* Is willing and able to provide government-issued identification
* Additional criteria may apply

Exclusion Criteria:

* Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
* Subject initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
* Subject poses a current suicide risk
* Subject has a history of treatment resistance
* Subject has a history of poor or inadequate response to treatment with olanzapine
* Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
* Subject has a diagnosis of moderate or severe alcohol or drug use disorder
* Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
* Additional criteria may apply
Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).

For enrollment information see the Central Contact information below


Eligibility Criteria:
Inclusion Criteria:

* Part A: Relapsed or refractory leukemia for which no standard therapies are anticipated to result in a durable remission
* Part B: AML who have had no more than two prior relapses or failed to achieve remission after at least one induction treatment.
* Patients with prior allogeneic transplants who remain clinically stable for ≥2 weeks or more off immunosuppressive therapy

Exclusion Criteria:

* Promyelocytic acute myelogenous leukemia
* Prior allogeneic transplant requiring immunosuppressive therapy or treating physician does not consider patient to be a candidate for allogeneic transplantation.
* Liver injury
"Lived Experience, Representations and Psychic Processes in Patients Awaiting Kidney Transplantation"

The kidney transplant remains the privileged treatment of the terminal renal insufficiency. This care is complex for the patient both on a medical surgical plan and by the psychic reorganizations. Among the temporary contraindications of transplantation, us retrouvonsdes psychological reasons. The research work consists in highlighting the psychic mechanisms of the subjects awaiting kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* stade 4 or 5 renal insufficiency
* Registered on waiting list for a first kidney transplant

Exclusion Criteria:

* in ward
* Unsigned consent
* Already transplanted
Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days

The purpose of this study is to understand the mechanisms for oscillations of dietary fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over interval of 3 to 4 days.

You will be expected to keep diet records for 17 consecutive days. You will start with a fasting screening visit (only water allowed). A physical exam and Medical history it taken at screening visit. Your body composition will be gathered by CT and Dexa Scan. Blood and urine will be collected for a chemical profile and other determinations. Questionnaires will be administered along with an accelerometer to be worn for the remainder of the study. The final day you will return the dietary records, accelerometer, and a few procedures will be performed as weight.

Eligibility Criteria:
Inclusion Criteria:

* You are a dietitian or a senior level or graduate level dietetics student
* You are between the ages of 21-55 years inclusive and a nonsmoker
* you are not a restrictive diet or strenuous exercise regimen
* You typically eat several meals per day

Exclusion Criteria:

* You have an eating disorder or history
* You abuse alcohol or other substances, and consume no more than 3 alcoholic drinks per day
* You have no current regular use of some over-the-counter medication or prescription medication, excluding headache medicines, blood pressure medications, etc.
* You have gained/lost more than 10 pounds of body weight in the last year
* You have recently had or anticipating significant life changes during the course of your participation in the study.
* You have an eating disorder or history
* You have a major psychiatric illness or history
* You have no serious current clinical disease or surgical condition that may interfere with the study.
Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen.

Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients.

This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of ovarian cancer
* Disease recurrence between 6 and 12 months after a first-line platinum based therapy
* Indication for chemotherapy, but no more than 2 previous lines of previous therapy
* Life expectancy of more than 3 months

Exclusion Criteria:

* Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix)
* ECOG Performance Status at least 3
* Previous treatment with stealth liposomal doxorubicin
* Residual peripheral neuropathy Grade 3 or higher
* Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
* Neutrophils \< 2000 x mm3, platelets \< 100000 x mm3
* Inadequate renal function (creatinine no greater than 1.25 x normal values) or liver function (ALT or AST no greater than 1.25 x normal values)
* Present or suspected hemorrhagic syndromes
* Inability to comply with protocol and follow-up
* Inability to access study site for clinical visits
* Refusal of informed consent
The Application of Lung Ultrasound Combine With Diaphragm Ultrasound During Thoracic Surgery

Perioperative lung-protective strategies had been advocated in one-lung ventilation but normal respiratory functions were yet impacted during videoassisted thoracoscopic(VATS) surgery. The primary aim of this study was to investigate respiratory complications after OLVby using bedside lung ultrasonography combine with diaphragmatic ultrasonography.

Perioperative lung-protective strategies had been advocated in One-lung Ventilation(OLV) of videoassisted thoracoscopic(VATS) surgery but normal respiratory functions were yet impacted during general anesthesia, mechanical ventilation, loss of respiratory muscle tone and intrathoracic surgery. Lung ultrasonography has been confirmed to be a available tool for rapid confirming atelectasis, pleural effusion , pneumonia and pneumothorax. Diaphragmatic excursion were well correlated with vital capacity by lung function testing and diaphragmatic ultrasound imaging was demonstrated accurately to identify atrophy and impaired contractility or motion of the diaphragm.The primary aim of this present study was to investigate respiratory complications after OLV in the postoperative period by using bedside lung ultrasonography.The secondary aim was to evaluate the variation of lung ventilation during thoracoscopic surgery through lung ultrasonography combine with diaphragm ultrasound and assess the accuracy of ultrasound to confirm proper endobronchial intubation.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective thoracoscopic surgery of OLV, over 18 years of age

Exclusion Criteria:

* noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, a history of respiratory infection, a history of chronic obstructive pulmonary disease(COPD), a history of Chronic Heart Disease(CHD), received brachial plexus nerve block or general anesthesia within 2 weeks before surgery , received former thoracic procedures (e.g.,thoracotomy, thoracoscopy or thoracic drain)
Nutrient Supplementation Influences Mitochondria Adaptation

Twenty-four well trained runners (VO2max 60.73.7 ml O2 Kg-1 min1) completed a six week block randomized controlled intervention period. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO2max, training and performance status. The PRO- CHO group ingested a protein beverage (0.3g kg-1) before and protein-carbohydrate beverage (0.3g protein kg-1 and 0.1g carbohydrate kg-1) after each exercise session. The CHO group ingested energy matched carbohydrate. Post-absorptive muscle biopsies were obtained pre and post intervention for analysis HAD, CS and PGC-1. Subjects completed two physical tests 6 km performance test (pre, week 1 and week 6) and aVo2max test (pre and post intervention).


Eligibility Criteria:
Inclusion Criteria:

1. maximal oxygen uptake (VO2max) of \>50ml O2 kg-1 min-1 for women and \>55ml O2 kg-1 min-1 for men,
2. running at least 3 times a week and
3. running being the primarily training form

Exclusion Criteria:

1. use of medicine
2. diagnosed metabolic diseases
3. injuries which hindered running and body mass index (BMI) \< 25 kg m-2
Odiparcil QT Definitive Study

This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.


Eligibility Criteria:
Inclusion:

* Healthy volunteers

Exclusion:

* Cardiac abnormalities
* Hepatic or renal insufficiency
* Anti-coagulant medications
* Bleeding history