cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis

The aim of this trial was to establish the clinical efficacy of Listerine and chlorhexidine (CHX) when used as a cooling agent with ultrasonic instrumentation, on periodontal parameters and halitosis.

Ninety patients with periodontal disease participated for the study. Individuals were randomly selected to a control and test groups. At baseline, all subjects completed a questionnaire and carried out an examination. Standard periodontal outcome variables were assessed. For both groups, the plaque index (PI), gingival index (GI), pocket depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL) scores were enrolled at baseline and after 30 days. Volatile sulphur compound (VSC) levels were evaluated by a Halimeter (Interscan Corp., Chatsworth, CA, USA) at baseline (T0), immediately after treatment (T1), and at 7 (T2), 14 (T3) and 30 days (T4).


Eligibility Criteria:
Inclusion Criteria:

* In the present trial, who had periodontitis from patients undergoing periodontal treatment at the Department of Periodontology of our institution

Exclusion Criteria:

* Individuals who presented any systemic disorders which cause halitosis (diabetes mellitus, nephropathy, liver disease, gastrointestinal diseases, respiratory problems), pregnancy or lactation, individuals who had taken antibiotics over the last 6 months or permanently used any drugs, individuals who had any form of periodontal treatment within 6 months prior to the study.
Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring

An imaging method has been developed that uses near infrared light as an adjunct to ultrasound for better diagnosis and for monitoring tumor response. This study will use a new, non-invasive way to evaluate breast lumps using a low power light source \& ultrasound to see if breast lumps are benign or cancerous. This study will also evaluate if this new technique might be useful in assessing response to chemotherapy.

The investigators propose to validate the utility of the investigators novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. The investigators unique hybrid technique is implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the inverse optical tomography reconstruction. As a result, the optical tomography assisted with US has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. Initial results with a group of 200 biopsied patients have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response.

Objective of this study is to validate the investigators initial results that NIR light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years and older who have breast lumps or abnormalities (actual or suspected) are eligible for the study.
* Women and members of all races and ethnic groups are eligible for this study.
* Diagnostic Group: These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities.
* Neoadjuvant Chemotherapy Group: These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy. These patients may be identified from the diagnostic group or after initial diagnosis. Patients will only be enrolled to one of the two groups.
* Process Validation Group: This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy. Data from the NIR/US scan will be used to validate instrument measurements.

Exclusion Criteria:

* All Subjects who fail to meet the inclusion criteria are ineligible for the study.
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy

The purpose of this study is to investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility.

Forty individuals seeking treatment for an alcohol or cocaine use disorder at the Substance Abuse Treatment Unit (SATU) will be randomized to receive cognitive remediation therapy with or without additional compensation based on performance. Participants will use the computerized cognitive remediation program (PSSCogRehab 2012) three times per week for four weeks. The primary outcome measure will be an improved performance on the computerized tasks, with secondary outcomes of changes in cognitive functioning (e.g., attention, concentration, memory) as measured by neuropsychological tests between baseline and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years old
* Primary Alcohol and/or Cocaine Abuse/Dependence Diagnosis
* Abstinence from all drugs/alcohol for 30 days
* Mild cognitive impairment
* Sufficiently stable and plan to commit to 4 weeks of outpatient treatment
* Fluent in English and 6th grade reading ability

Exclusion Criteria:

* Severe cognitive impairment indicative of dementia
* Untreated bipolar or psychotic disorder
* Have current legal case pending such that incarceration during 4-week study is likely
The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE

The aim of the project is to assess the correlation between the results of high-resolution oesophageal manometry and specific biomarkers of inflammation (eotaxin 3, major basic protein, IL-5, IL-13, TGF-beta1) with symptoms of dysphagia, endoscopic and histological features and the assessment of quality of life in patients with eosinophilic esophagitis.

Research hypothesis: The results of high resolution esophageal manometry (HRM) and specific inflammatory biomarkers correlate with symptoms of dysphagia, endoscopic and histological features, and assessment of quality of life in patients with eosinophilic oesophagitis. HRM, along with the determination of specific inflammatory biomarkers present in the peripheral blood, may serve as a less invasive method of assessing the effectiveness of the treatment of eosinophilic oesophagitis in relation to the currently used endoscopic examinations.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age,
* patients referred for endoscopic diagnostics due to dysphagia.

Exclusion Criteria:

* already diagnosed chronic diseases with possible eosinophilic infiltration of the gastrointestinal tract (eosinophilic esophagitis, eosinophilic gastroenteritis, Crohn's disease, celiac disease),
* rheumatological, dermatological and genetic disorders with possible peripheral eosinophilia,
* dysphagia caused by a diagnosed neoplastic infiltration of the esophagus.
Fibrinogen Concentrate (Human) - Efficacy and Safety Study

This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).

It is estimated that 150-300 patients in the U.S. suffer from afibrinogenemia. Substitution with cryoprecipitate or alternative treatments have limited safety and efficacy.

The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma) in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used as a historical control.


Eligibility Criteria:
Inclusion Criteria:

* Documented congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia), expected to require treatment for bleeding
* Presenting with an episode of acute bleeding (either spontaneous or after trauma) not requiring surgery
* Provide informed consent

Exclusion Criteria:

* Life expectancy \< 6 months
* Bleeding disorder other than congenital fibrinogen deficiency, but including dysfibrinogenemia
* Treatment with any investigational medicinal product (IMP) in the 30 days prior to enrollment
* Treatment with any fibrinogen concentrate or other fibrinogen containing blood product in the 2 weeks prior to enrollment
* Treatment with any coagulation active drug (i.e., non-steroidal-antirheumatics, warfarin, cumarin derivates, platelet aggregation inhibitors) in 1 week prior to enrollment or as a planned or expected medication during the time period from Day 1 until 24 hours after the last FCH infusion
* Presence or history of hypersensitivity to FCH
* Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment
* Presence or history of arterial thrombosis within 1 year prior to enrollment
* Presence or history of hypersensitivity to human plasma proteins
* Presence or history of esophageal varicose bleeding
* End stage liver disease (i.e., Child Pugh score B or C)
* Planned or expected surgery (i.e., for bleedings from aneurysm or splenic rupture)
* Pregnancy, or an intention to become pregnant during the study
* Currently breast-feeding, or with the intention of breast-feeding during the study
* Human immunodeficiency virus (HIV) positive
* Polytrauma, present or within 6 months prior to enrollment
* Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery (IVR), if available (\< 0.5 (mg/dL)/(mg/kg))
* Previous inclusion and treatment in the prospective part of the study
* Participation in any clinical study in the 30 days prior to enrollment
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer

This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.

The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven carcinoma of the pancreas that is locally advanced
* ECOG performance status 0- 2
* Adequate labs
* No prior abdominal radiation therapy
* No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years
* All disease must be encompassed within a radiotherapy portal
* Not pregnant or nursing

Exclusion Criteria:

* Patient has metastatic disease on radiological staging
* systemic therapy.
* Patient has known active infection with HIV, hepatitis C or hepatitis B
* Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
* Patient is deemed to be have obvious resectable disease at presentation
* Received any investigational agent within a month prior to enrollment.
* Neuroendocrine tumors of the pancreas
Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).

This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.


Eligibility Criteria:
Inclusion Criteria:

Be 18 years of age or older at the time of enrollment.

Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.

Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.

Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.

Be willing and capable of giving informed consent.

Be willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

Subject is pregnant or nursing.

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.

Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.

Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).

Have prior experience with SCS.

Be concomitantly participating in another clinical study.
Flat Dose Vs. Weight-based IP Chemotherapy for CRS/HIPEC

Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected peritoneal surfaces, has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited. Additionally, hyperthermia is known to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth of peritoneal penetration.

This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity, compared with the HIPEC flat dosing approach in patients undergoing CRS/HIPEC.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis
* ECOG performance status \< 3
* Candidate for grossly complete cytoreductive surgery
* Life expectancy greater than 3 months
* Adequate organ and marrow function
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Any extra-abdominal metastases
* Untreated lung metastases
* Liver metastases not amenable to resection or ablation
* Known brain metastases
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Presence of residual significant adverse events attributed to prior cancer treatment
* Currently receiving any other investigational therapeutic agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.
* Pregnant or breast-feeding women
* Uncontrolled ongoing illness
Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. The investigators intend to objectively test memory and examine MRI images of the brain of patients with CF.

Patients with CF have several potential risk factors which may predispose them to memory problems. Because the CF population has historically only been young, this is not something that has been focused on. No research has currently identified whether patients with CF have a much earlier risk of developing cognitive impairment or how CF impacts on the brain.

There has not previously been work in this area of CF and the investigators are in a unique position with the Cardiff University Brain Research Imaging Centre (CUBRIC) and its expertise to be able to perform Magnetic Resonance Imagining (MRI) scans and neurocognitive testing on patients with CF for the first time.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged greater or equal to 30 years

  * A diagnosis of CF
  * Primary school education or above
  * Able to provide informed consent

Exclusion Criteria:

* Contraindications to MRI as found on the CUBRIC screening form (including presence of indwelling metal devices/clips)

  * Existing neurological disease affecting cognition (including stroke and traumatic brain injury)
  * Existing diagnosis of dementia documented in medical notes
  * Vascular complications of diabetes
  * Requiring supplemental oxygen -long term or overnight
  * Hepatic failure
  * Overt psychiatric disorders
  * Past or present alcohol or recreational drug misuse
  * Pregnancy
  * Current infection Smoker
Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer

The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)

The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901) using 16α-18F-Fluoro-17β-estradiol (FES) positron emission tomography (PET) imaging

Eligibility Criteria:
Key Inclusion Criteria:

1. Patients with histologically-proven, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, inoperative, and/or mBC
2. Tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (SERM, SERD, or aromatase inhibitor) in the metastatic setting
3. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1 or clinically evaluable disease
4. Greater than or equal to 18 years of age
5. Patients must be post-menopausal
6. Life expectancy \>3 months

Key Exclusion Criteria:

1. Greater than 3 lines of endocrine therapy for metastatic disease.
2. Prior anti-cancer treatment or investigational drug therapy within the following windows:

   1. Tamoxifen or fulvestrant therapy \< 42 days before 1st 18FES-PET scan
   2. Any other anti-cancer endocrine therapy \< 14 days before 1st dose of study drug
   3. Any chemotherapy \< 28 days before 1st dose of study drug
   4. Any investigational drug therapy \< 28 days or 3 half-lives (whichever is longer) prior to the 1st dose of study drug 2. Patients with untreated or symptomatic central nervous system (brain) metastases 3. Patients with known endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding, or cysts
Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting

The purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic and asymptomatic patients with finding of significant carotid stenosis

Exclusion Criteria:

* patients with acute injuries to the baseline MRI of the brain,
* patients with active bleeding,
* contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 to ≤ 80 years of age
* Diagnosis of heterozygous familial hypercholesterolemia
* On a stable dose of an approved statin and lipid regulating medication
* Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* LDL or plasma apheresis
* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes, poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/= 18 years of age
* moderate to severe active rheumatoid arthritis of \>/=6 months duration
* inadequate clinical response to current non-biologic DMARDs
* current DMARDs must be at stable dose for 8 weeks prior to study entry
* oral corticosteroids (\</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for \>/=4 weeks prior to screening

Exclusion Criteria:

* rheumatic autoimmune disease other than RA
* history of or current inflammatory joint disease other than RA
* previous treatment with any biologic DMARD
* functional class IV as defined by the ACR classification
* intra-articular or parenteral corticosteroids within 6 weeks prior to screening
Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

Erectile dysfunction (ED) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor treatment?


Eligibility Criteria:
Inclusion Criteria:

* Records of men aged \>18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008
* no prior PDE5 inhibitor prescription before the index prescription
* continuous enrolment with medical history for ≥60 months prior to the index prescription date

Exclusion Criteria:

* Records of female subjects and any male subjects not meeting the inclusion criteria will be excluded
* A subject can only be selected once independent of the assignment to the target or the control populations.