cyrilzakka/clinical-trials huggingface dataset:
Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride

Comparative study on the efficacy of two mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride in the reduction of plaque score in individuals with spontaneous gengivitis


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Smoking
* Drugs prior month
* Dental hygiene \<6 months
* Pregnancy
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.

Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GAD (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
* Subjects must have a HAM-A total score \>/= 20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of \>/= 9 and a Raskin Depression Scale score \</= 7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
* Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder; Obsessive compulsive disorder; Panic disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder.
* Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic disorder; Delirium, dementia, amnestic and other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders.
* Antisocial or borderline personality disorder.
* Serious suicidal risk per the clinical investigator's judgment.
Specifying Interventions From the Sickle Cell Disease Implementation Consortium (SCDIC)

The goal of this study is to specify the interventions, implementation strategies and control conditions from the Sickle Cell Disease Implementation Consortium (SCDIC) using a mixed-methods approach to study site materials and conduct semi-structured qualitative interviews with site representatives (N=3 per site). We focused on the Emergency Department Working Group from the SCDIC working groups.

The long-term goal of this line of research is to identify the most effective components of SCD interventions while also identifying effective implementation strategies informed by a systematic and rigorous work done by the members of the SCDIC consortium to improve the quality of life of people with SCD, a life-threatening hematological disorder. This study aims to collect detailed information about the planned interventions, the implementation strategies and the control conditions from each site.

Eligibility Criteria:
Inclusion Criteria:

* three representatives of each of the SDIC sites: the Principal Investigator, and two people nominated by the PI.

Exclusion Criteria:

* none
To Perform a Post-market Study of the Performance of the Idylla ThyroidPrint Assay Using Clinical Samples in Predicting the Nature of Indeterminate Thyroid Nodules (ITNs) Across Multiple Centers.

To perform a post-market study of the performance of the Idylla™ ThyroidPrint® Assay using clinical samples in predicting the nature of indeterminate thyroid nodules (ITNs) across multiple centers.

This is a multicenter, non-interventional (observational), prospective, post-market study, matching the Idylla™ ThyroidPrint® RUO Assay result to the gold standard of surgical pathology.

The study population is defined as cases where the thyroid nodule has been reported as indeterminate.

Primary endpoints are the calculation of the sensitivity, specificity, and the negative and positive predictive values of the Idylla™ ThyroidPrint® RUO Assay for indeterminate thyroid nodules.

Secondary endpoint: to assess the failure rate of Idylla™ ThyroidPrint® RUO Assay, including errors and invalids; describe the nature of false negative and false positive cases.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid nodule ≥1.0 cm
* With indeterminate cytology
* Surgery due to be performed

Exclusion Criteria:

* Specimens which fail to meet the inclusion criteria.
* FNA fixed in formalin or transferred in alcohol-based collection buffers which is not according to the protocol instructions.
* RNA extracts.
* Patients with ultrasound evidence of malignant cervical adenopathy
Endometriosis Patients Undergoing Quinagolide Treatment

Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies, diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic lesions.


Eligibility Criteria:
Inclusion Criteria:

* Hyperprolactinemia
* Unexplained infertility
* Endometriosis
CLIF Correction VS. Conventional Correction Strategy for ASD

The present study intends to: 1）establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel surgical technique of CLIF correction for ASD compared with the conventional correction strategy; 2）analyze the postoperative clinical and imaging results, and to explore the related complications and preventive measures; 3） establish 2-year follow-up to further quantify the clinical and radiographical outcomes of CLIF correction.

Adult spinal deformity (ASD) is the most common spinal deformity in the elder, which often causes the low back pain and/or physical deformity. Severe cases need surgical treatment. Because the conventional posterior approach had the disadvantages of big trauma and slow recovery, and the elder were always complicated with complicated medical diseases, the perioperative risk was high. At present, the novel surgical technique of CLIF correction was a popular way for ASD treatment. Preliminary results showed that it had less trauma, shorter operation time, faster recovery, fewer complications and remarkable clinical and adiographical outcomes. Therefore, the present study intends to: 1) establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel CLIF correction for ASD treatment compared with the conventional correction strategy; 2) establish 2-year follow-up to further quantify the clinical and radiographical outcomes, and to explore the related complications and preventive measures;. Therefore, the present project aims to explore the best surgical plan for treating ASD by studying the safety and effectiveness of the novel CLIF correction, and provide new surgical strategies for minimally invasive and Individualized treatment for ASD.

Eligibility Criteria:
Inclusion Criteria:

* adult spinal deformtiy;
* 40yrs≤age≤80yrs;
* Lenke-Silva classification II-V grade;
* ineffective with conservative treatment;

Exclusion Criteria:

* severe osteoprosis with T value \<-2.5;
* with preliminary spinal surgery;
* ASA score≥III grade;
* more than II degree spondylisthesis;
* with mental disease;
Investigation of the Gut Microbiota in Acute Myeloid Leukemia Receiving Two Different Induction Therapies

In this observational single-center cohort study, metagenomic Next-Generation Sequencing (mNGS) will be used to investigate the features and changes of gut microbiota in acute myeloid leukemia (AML) patients during the treatment of two different induction therapy regimens \[standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy\].

Infections remain one of the major complications during induction therapy of acute myelocytic leukemia (AML). Previous studies have shown that the variation of gut microbiota was an effective predictor for infection development of AML during induction therapy. A growing number of patients with AML received bcl-2 inhibitor-based targeted induction therapy. The investigators assume that there are different effects of bcl-2 inhibitor-based induction therapy on gut microbiota compared with standard intensive chemotherapy (7+3 regimen). Metagenomic Next-Generation Sequencing (mNGS) will be used to perform the investigation of gut microbiota in AML receiving two different induction therapies. And the relationships of gut microbiota with infection complication will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 65\> =Age (years) \>= 18;
2. Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1,2;
4. Patients will receive standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy;
5. Patients have not received prior therapy for AML (except hydroxycarbamide);
6. Liver function: Total bilirubin lower than 3 upper limit of normal (ULN); Aspartate aminotransferase (AST) lower than 3 ULN; Alanine aminotransferase (ALT) lower than 3 ULN (except extramedullary infiltration of leukemia);
7. Renal function with creatinine clearance rate (Ccr) higher than 30 ml/min;
8. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Acute promyeloid leukemia;
2. AML with central nervous system (CNS) infiltration;
3. Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance) or gastrointestinal surgery;
4. HIV infection, Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment;
5. Severe and active infection that is difficult to control and cannot tolerate induction therapy;
6. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen;
7. Antibiotic exposure within 30 days before enrollment (carbapenems and/or tigecycline were not included, penicillin, cephalosporins and quinolones could be included)
8. Patients reject to participate in the study;
9. Patients with severe heart failure (grade 3-4) or patients deemed unsuitable for enrolment by the investigator.
Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.

A single-center, prospective, single-blind randomized study to evaluate the efficacy of colchicine versus placebo in patients with documented FAI ≥ -70.1 HU of the proximal segment of the right coronary artery and/ou left anterior descending coronary artery and non-calcified or mixed plaques on coronary angiography performed electively after 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes over 18 years of age;
* Patients undergoing coronary CT angiography from May/2021
* CT angiography showing non-calcified or mixed coronary plaques and high FAI value (\> -70.1 HU) in the proximal segment of the right and/or anterior descending coronary artery with
* Willing and able (in the opinion of the investigators) to fulfill all study requirements

Exclusion Criteria:

* Past history of acute myocardial infarction
* History of percutaneous or surgical myocardial revascularization
* History of previous cardiac surgery or congenital heart disease
* Current use of colchicine
* Autoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapy
* Active neoplasm with indication of surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasm and who underwent curative surgery without need for treatment in the last 12 months will be allowed)
* Inflammatory bowel disease or chronic diarrhea
* Clinically significant non-transient hematologic abnormalities
* Renal dysfunction (GFR \< 30 mL/min/1.73 m² and/or serum creatinine \> 2.5 mg/dL or \< 220 µmol/l)
* Severe liver disease (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \> 3x ULN in the last 6 months)
* Drug addiction or alcoholism
* History of clinically significant sensitivity to colchicine
* Inability to sign the informed consent form
* Participation in another study
Ovarian Cancer Patient-Centered Decision Aid

The objective of this study is to develop and test a new decision aid -named Patient Centered Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on their own preferences and personal clinical characteristics, described in terms that are meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient- and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized controlled trial (RCT).

The investigators hypothesize that PCOA will be significantly better than usual care, resulting in patients reporting more satisfaction with their treatment decision, less decision regret, better quality of life, and more satisfaction with their care compared with similar patients not having access to PCOA. If these hypotheses are substantiated, patients and providers will have an improved model for communication and decision making, leading to better patient outcomes.

Ovarian cancer is typically diagnosed at an advanced stage and carries the highest fatality-to-case ratio of all gynecologic malignancies diagnosed in the United States. Arguably the most effective treatment regimen to date is provided through intraperitoneal (IP) chemotherapy delivery, together with intravenous (IV) chemotherapy, which in the most recent phase III randomized trial conferred the longest median survival (65.6 months) ever reported in advanced ovarian cancer, compared to 49.7 months in the IV-only treatment arm. However, during active treatment, patients randomized to the IP therapy group reported significantly worse quality of life (QOL), and more treatment-related toxicities. In short, women are less likely to die if they receive an IP component to their chemotherapy, a finding that was underscored by an NCI Clinical Alert. However, there may be greater toxicity with IP treatment. The tradeoff between short-term reduced QOL and longer survival is difficult for patients to understand and then incorporate meaningfully into their decision-making process. In fact, for reasons that are not entirely clear, many patients are not offered IP therapy. Patient-centered care requires that they be given the opportunity to participate in treatment decision-making.

Eligibility Criteria:
Inclusion Criteria:

* RCT participants will include stage III optimally debulked advanced ovarian cancer patients from urban and rural regions of the country, who will be randomized to either our patient-centered decision-aid or the usual care control arm

Exclusion Criteria:

* By the nature of the neoplasm under study, gender specific (ovarian cancer), only female patients will be included
* Patient enrollment will include women from all English speaking ethnic groups

  -\> the age of 21
* All minority ovarian cancer survivors will be eligible
* Women under age 21 will not be included in this study because it is not common to be diagnosed with advanced epithelial ovarian cancer in females under age 21
Distal Clavicle Resection With Rotator Cuff Repair

The purpose of this study is to determine whether distal clavicle resection is effective treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear.

Today, acromioclavicular joint syndrome is itself rarely a cause for hospital visit, and the need for its treatment is even rarer. In comparison, patients who suffer rotator cuff tear accompanied by shoulder impingement syndrome often complain of acromioclavicular joint pain. However, often patients who complain of severe pain have no positive findings on X-ray or MRI, or any sign of impingement. On the other hand, there are patients with positive findings on X-ray or MRI who have only little pain. Even a patient who in the out-patient-department complained of acromioclavicular joint pain on pressure may feel pain on pressure in the physical exam performed for rotator cuff tear surgery. The opposite is very frequent as well, so it is often different depending on the time and the performer. In the literature, there are some authors who maintain that a distal clavicular resection must be done when surgery is used to treat the impingement syndrome, while on the other hand, there are those who endorse only complaining (an operation to trim the distal clavicle and the protruding part of adjust the plane acromion in order to level their plane), and also those who propose an all or none approach to either perform a distal clavicular resection or not at all. Thus, there are varying opinions depending on the authors; moreover, these are all observational studies, and none report on the rotator cuff tear injury. The authors of this study hypothesize and will prove that since the osteoarthritic change and pain of the acromioclavicular joint is secondary to impingement syndrome, distal clavicular resection on rotator cuff repair surgery will have no long term effect.

Eligibility Criteria:
Inclusion Criteria:

* rotator-cuff tear requiring repair
* acromioclavicular joint tenderness more than moderate(Pain Visual Analogue Scale 4-7)
* acromioclavicular arthritis(Petersson Grade II-III)

Exclusion Criteria:

* Arthritic changes of glenohumeral joint
* Combined infection
* Mini-open, open procedures
* Complete subscapularis tear
* Incomplete repair
* Neurologic abnormality including axillary nerve
* Adhesive capsulitis
* Prior surgery, trauma, or infection on shoulder girdle
* SLAP lesion or biceps tendon lesion without rotator-cuff tear or impingement syndrome
Quality of Life in Younger Leukemia and Lymphoma Survivors

RATIONALE: Collecting information about the effect of hematologic cancer and its treatment on quality of life may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma survivors.

OBJECTIVES:

* To collect preliminary data to determine the extent to which there is impairment in quality of life of young adult survivors of hematologic malignancies.
* To identify the most common areas of concern in these survivors.
* To explore patterns of quality-of-life impairment associated with age, gender, and type of treatment (transplant vs non-transplant) in these survivors.

OUTLINE: Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Survivors of leukemia (i.e., acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or chronic lymphocytic leukemia) or lymphoma (i.e., non-Hodgkin lymphoma or Hodgkin lymphoma) who have received any cytotoxic or radiation therapy
* Received treatment for leukemia or lymphoma 1-10 years ago

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
* Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
* Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening

Exclusion Criteria:

* Total Fasting Triglyceride ≥ 400 mg/dL
* Renal Dysfunction or nephrotic syndrome or history of nephritis
* Significant cardiovascular disease or cardiovascular event within the past 3 months
A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment

Observational, prospective and multicenter study in approximately 25 sites nationwide. The investigators participating in this study will be rheumatologists specializing in this pathology.

The study will include patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.

Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study, which will not occur earlier than 6 months (± 4 weeks after treatment start). Therefore, the choice of the therapeutic strategy will be made independently by the physician.

Before entering the study, all patients shall sign an informed consent to participate in the study, including permission to retrieve data from their medical records and to complete questionnaires regarding their quality of life.

To avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all consecutive patients who attend to a routine follow-up visit and have been prescribed apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the study. All consecutive patients who can be contacted 6 months (+/- 4 weeks) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection


Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 18 years.
* Patients diagnosed with psoriatic arthritis according to the CASPAR criteria\*.
* Patients who, following the routine clinical practice, initiated treatment with apremilast 6 months (±4 weeks) before their inclusion in the study.
* Patients naive to biologic treatments.

Exclusion Criteria:

* Patients who reject to sign the informed consent.
* Patients enrolled in a clinical trial within the 4 weeks preceding the baseline visit or for the duration of apremilast treatment.