cyrilzakka/clinical-trials huggingface dataset:
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy

The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. pathological diagnosis of invasive breast cancer
2. breast surgery within the past 2-8 weeks
3. adult female
4. must be able to use mobile phones
5. speak and write Chinese fluently to sign the informed consent

Exclusion Criteria:

1. severe comorbidity that interferes with outcome evaluation
2. insufficient Chinese language skills
3. inability to use mobile phones
4. cognitive disability to give informed consent
Acarbose, Postprandial Hypotension and Type 2 Diabetes

Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied.

The study hypothesis is that administration of Acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with Type 2 diabetes.

Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying.

This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo. Order of treatment assignment will be done in randomized fashion. A total of approximately 200 cc of blood will be drawn during each meal test.


Eligibility Criteria:
Inclusion Criteria:

* age 65 year and older
* Type 2 diabetes

Exclusion Criteria:

* less than 65 years of age
Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation

The purpose of this study is to compare non-operative treatment versus operative treatment in patients who suffer a complete, acute acromioclavicular (AC) joint dislocation. This study will show if one method is superior to the other and will also show advantages and disadvantages associated with each treatment method.

All patients presenting to the hospital with a Type III, IV or V acute acromioclavicular (AC) joint dislocation and meeting the eligibility criteria will be approached and asked to enter this prospective, randomized clinical trial. After obtaining consent, the subject will be managed in accordance with one of the two randomized treatment strategies. The first treatment strategy will involve conservative (nonoperative) management of the AC joint dislocation. The second treatment strategy will involve operative fixation (i.e. ORIF) of the dislocation with a hook plate and screws.

The subjects in both treatment groups will receive post-operative care according to the same standards and protocol. The surgeon and research staff will be responsible for study follow-up (clinical and radiological assessment) of the patient on admission (baseline), on discharge from the hospital and at post-operative intervals of six weeks, three months, six months, one year and two years. Primary and secondary outcomes will be monitored at these post-operative intervals.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 16 to 65 years of age
* Grade III (3), IV (4) or V (5) dislocation of the acromioclavicular (AC) joint (evidenced by no contact between the distal clavicle and the acromion as seen in standardized radiographs)
* Closed injury
* AC joint dislocations within 28 days post injury
* Provision of informed consent

Exclusion Criteria:

* Grade I(1), II (2), or VI (6) subluxation/dislocation of the AC joint
* Open AC joint separation
* Scapulothoracic dissociation
* Presence of vascular injury
* Dislocations over 28 days post-injury
* Limited life expectancy due to significant medical co-morbidity
* Medical contraindication to surgery (including pregnancy)
* Inability to comply with rehabilitation or form completion
* Inability to provide informed consent
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, patients not mentally competent to give consent, etc.)
Efficacy of Different Toothbrushes and Hygiene Regimen

To evaluate: 1) Evaluate the efficacy of a regimen commercially available versus brush alone on established plaque and gingivitis on adolescents. The Group 1 will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash, and the other Group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste; 2) The level of halitosis. Two calibrated and blinded examiners (Cohen Kappa 85%) will evaluate the gingival condition using the visible plaque indices, a simplified oral hygiene index - IHOS and gingival bleeding index, with the aid of a WHO probe. For the evaluation of halitosis levels, all individuals will respond to a questionnaire regarding personal data, general and oral health, which includes hygiene habits and received previous guidelines for the procedures to be performed in the second moment. At the next consultation, subjects will be assessed clinically for halitosis using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan), in addition to the evaluation of the tongue flap index (ISL), pH and salivary flow. The evaluations will be in the following periods: baseline, 1, 3 and 6 months of brushing. Data will be submitted to descriptive statistical analysis to demonstrate the distributions frequency of biofilm indices and gingival bleeding. The differences in the criteria evaluated will be submitted to Fisher's exact test (α = 0.05) and their performance at different times will be evaluated by the Mann-Whitney test (α = 0.05).


Eligibility Criteria:
Inclusion Criteria:

* Good general health;
* Age 12 to 17;
* Absence of motor, comprehension and cognitive difficulties that impede adequate oral hygiene.

Exclusion Criteria:

* Active dental caries with cavity exposing dentin (visible cavity) on teeth for which the simplified oral hygiene index will be used. If these teeth are not present, adjacent teeth may be considered;
* Teeth with formation defects and dental crowding;
* Periodontal disease (tooth mobility \> 2 mm, pocket \> 5 mm, gingivitis);
* Parafunctional habits (bruxism, nail biting), active clamps for removable partial dentures, use of orthodontic appliance;
* Volunteer or legal guardian who does not agree with the terms of the study or has difficulty appearing for the follow up appointments;
* Pregnant volunteers;
* Use of medications that alter gingival health, such as antibiotics, in the previous three months;
* Use of mouthwash or toothpaste containing products for the control of biofilm;
* Smokers;
* Systemic disease (diabetes).
Functional Proteomics of Alveolar Macrophages

The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).

Our research goal is to identify new targets and strategies to help care for patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic airway inflammatory disorder characterized by a progressive loss of pulmonary function. Mononuclear phagocytes are known to be critically involved in both repair/remodeling and destructive events in COPD. Although smoking is the chief environmental risk factor for COPD, the molecular details responsible for the genesis and progression of smoking-mediated COPD require further investigation. In searching for new knowledge and research strategies for this challenging topic, we have made substantial progress in mononuclear phagocyte proteomics and laid the groundwork for this translational research of COPD.

Eligibility Criteria:
Inclusion Criteria:

* COPD, smoker
* COPD, non smoker

Exclusion Criteria:

* none
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions

This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
3. Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter;
4. Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up.

Exclusion Criteria:

1. Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
3. Patients with in-stent occlusion;
4. Patients with unprotected left main coronary artery disease;
5. Women who are pregnant or lactating;
6. Patients who are participating in clinical trials of other drugs or medical devices;
7. Patients with contraindications to the investigational device;
8. Other patients considered by the investigators to be unsuitable for this trial.
A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting

This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery.

Patients undergoing coronary artery surgery routinely receive aspirin therapy, as a standard treatment for preserving bypass graft patency. Although the dual antiplatelet therapy post CABG has not been recommended by guideline, present studies indicated the patients could benefit from the dual anti-platelet therapy. Using clopidogrel+aspirin could significantly reduce the early saphenous vein graft occlusion. . Many surgeons empirically prescribe dual anti-platelet therapy in spite of the indeterminacy of the clinical effects. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD.

Eligibility Criteria:
Inclusion Criteria:

* Female and/or male and ≥ 18 and \<80 years of age
* Isolated CABG for the first time
* either on- or off- pump

Exclusion Criteria:

* Combined valvular surgery.
* A second surgery.
* Emergency surgery (a selective operation which change to emergency surgery in some special medical condition).
* Serum creatinine\>130μmol/L.
* Oral clopidogrel therapy stops less than 5 days before the surgery.
* Oral anti-coagulation therapy (warfarin) that cannot be withheld.
* History of gastrointestinal or vaginal bleeding, Active pathological bleeding (e.g. active gastroduodenal ulcer or cerebral haemorrhage), history of postoperative gastrointestinal bleeding.
* Uric acid nephropathy, history of postoperative gastrointestinal bleeding.
* History of cerebral haemorrhage.
* Any other condition that may influence platelet count and function.
* Postoperative chest drainage \> 200 ml/hr for two hours and more, re-operation for bleeding with persistent cardiac tamponade.
* Treated with IABP or ECMO after operation.
* Any other condition that may put the patient at risk (e.g., recurrent ventricular arrhythmias, peri-operative myocardial infarction, cancer).
* Contraindication to aspirin, clopidogrel and ticagrelor or other reason that study drug should not be administered (e.g., hypersensitivity, moderate or severe liver disease).
* Previous enrollment in other investigational drug or device study within 30 days.

Being or planning to pregnant.
Evaluation of Right Ventricular Systolic Function by TAPSE Parameter From Subcostal View

The purpose of this study is to validate a new echocardiographic parameter evaluating right ventricular function.

The key conventional echocardiographic parameter evaluating right ventricular systolic function is the tricuspid annular plane systolic excursion (TAPSE). It is measured in apical four chamber view by conventional M-mode imaging. Other echocardiographic parameters of right ventricular systolic function (Fractional Area Change; Tricuspid Lateral Annular Systolic Velocity; Right Ventricular Index of Myocardial Performance) are evaluated in apical four chamber view as well. However, this view might not be clearly visible in the clinical setting of critical illness and subcostal view is often preferred for its higher quality. Unfortunately, conventional M-mode can not be used for measurement in this view but anatomical M-mode imaging can. Therefore, the investigators decided to evaluate whether TAPSE measured in subcostal view by anatomical M-mode (sTAPSE) correlates with conventional TAPSE and whether reliably reflects systolic right ventricular function.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination

Exclusion Criteria:

* Age \<18 years
* Insufficient imaging quality of transthoracic echocardiography
* Refusal of echocardiographic examination by patient
Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation

The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.

Whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. This procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area.

CT scan of temporal bone is part of systematic preoperative assessment. Technological advances in radiology during the last decades now provide inframillimetric resolution. Thus, otologic surgeons wish they could anticipate round window exposure from these CT scan. This could decrease the procedure duration, complication occurrence, or improve surgical strategy.

Several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone CT scan. However, these diagnostic tests performances have not been assessed for most of them, or compared between them.

Eligibility Criteria:
inclusion criteria :

* patients undergoing cochlear implantation in Reims universitary hospital during the inclusion period
* patients who agree to participate in the study
* patients who had preoperative temporal bone CT scan

exclusion criteria : patients who have :

* temporal bone malformation on temporal bone CT scan or MRI
* chronic otitis media (except simple middle ear effusion)
* middle ear surgery antecedent
* cochlear implant in the context of a reimplantation
Neural Mobilization in Cervico-Brachial Neuralgia

This study aimed to compare the effectiveness of neural mobilization (NM) combined with conventional rehabilitation versus conventional rehabilitation alone in patients with chronic common cervico-brachial neuralgia (CBN), focusing on pain, cervical range of motion (ROM), functional disability, and psychological state.

A randomized controlled trial was conducted including patients with chronic CBN. They were randomized into two groups: control group received standard rehabilitation, while NM Group received the same treatment with additional NM techniques. Evaluations were conducted pre- and post-treatment, assessing pain, cervical ROM, functional disability and psychological state via the Beck Depression Inventory.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* with chronic common CBN

Exclusion Criteria:

* secondary CBN
* prior cervical surgery
* cervical trauma
* recent central or peripheral neurological conditions
* unstable cauda equina lesions,
* untreated tumors or infections.
Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies tissue samples from patients with non-small cell lung cancer.

OBJECTIVES:

* To identify and characterize single nucleotide variations (SNVs) in non-small cell lung cancer (NSCLC) specimens.
* To identify and characterize structural variations in the genomes of NSCLC specimens.
* To identify and characterize other genomic alterations including, but not limited to, expression profiling and methylation.

OUTLINE: DNA and RNA extracted from archived specimens are analyzed for single nucleotide variations, structural variations in the genomes, and other genomic alterations including, but not limited to, gene expression profiling and methylation. Clinical data related to disease, treatment, and recurrence from each patient sample is also collected.

Eligibility Criteria:
* Patient must have been registered to CALGB 140202.
* Tumor histology should be either primary adenocarcinoma or squamous cell carcinoma of the lung.
* Patients are eligible for this study if their samples from CALGB 140202 are available.
* All living patients must sign the CALGB 151107 consent form to be eligible for this trial.
Effect of Dietary Habits on Metabolic Health

The goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.

More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. This research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. This research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and T2D.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 37.9 kgm-2
* Adults with regular sleep-wake timing
* Non-smokers
* Completion of medical and psychological screening tests
* Able to spend 14 consecutive days in the sleep laboratory

Exclusion Criteria:

* BMI \< 25 or \> 37.9 kgm-2
* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Donating blood within past 8 weeks
* Worked night or rotating shift work within past 3 years
* Hearing impairment
* Drug or alcohol dependency
Phase 1 Study of OSI-930 in Cancer Patients

Open label, phase 1, dose escalation

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose on both once daily (QD) and twice daily (BID) schedules.

Patients may continue to receive OSI-930 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Eligibility Criteria:
Inclusion Criteria:

Histologically or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists.

Age \>/= 18 years, ECOG PS 0-2, life expectancy \>/= 12 weeks Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed. Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration.

Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months).

Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects. A minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive.

ANC \>/= 1.5 x 10\^9/L, PLT \>/= 100 x 10\^9/L; bilirubin \</= 1.5 x upper limit of normal (ULN), AST and ALT \</= 2.5 x ULN; creatinine \</= 1.5 ULN Accessible for repeat dosing and follow-up. Patients must practice effective contraceptive measures throughout the study. Provide written informed consent.

Exclusion Criteria:

Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days.

History of allergic reaction attributed to a similar compound as study drug. Significant cardiac disease unless well controlled, poorly controlled hypertension.

Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation.

History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate.

Concurrent anticancer therapy. Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose. Pregnant or breast-feeding females.