cyrilzakka/clinical-trials huggingface dataset:
Comparing Buccal Infiltration and Inferior Alveolar Nerve Block for Extraction of Mandibular Teeth

This study compares the effectiveness of two techniques of local anesthesia in the extraction of mandibular teeth. One group received inferior alveolar nerve block and the other group received buccal infiltration of 4% Articaine

Inferior alveolar nerve block is the commonly used local anesthetic injection technique for extraction of mandibular teeth. Buccal infiltration technique alone is considered to be ineffective in treating mandibular teeth due to the thickness of buccal cortical plate. However, buccal infiltration, if provided with an agent with higher penetration capability, may be used instead of Inferior alveolar nerve block. Articaine, due to its thiophene ring, has higher liposolubility and bony diffusion than any other agent.

This study compares the effectiveness of inferior alveolar nerve block and buccal infiltration using 4% Articaine in the extraction of mandibular teeth

Eligibility Criteria:
Inclusion Criteria:

* Mandibular teeth
* grossly decayed teeth
* root stumps
* therapeutic extractions
* American society of anesthesiologist classification I \& II patients

Exclusion Criteria:

* patients allergic to local anesthesia
* infected teeth
* grade 2 and grade 3 mobile teeth
* patients already taking medications which influences the anaesthetic assessment
Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine

This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.


Eligibility Criteria:
Inclusion Criteria:

Patients must give written informed consent and have a diagnosis of hypertension:

Untreated patients must have an msSBP ≥ 150 mmHg and \< 180 mmHg at both Visit 1 and Visit 101. Pre-treated patients must have an msSBP ≥ 145 mmHg and \< 180 mmHg after wash out at Visit 101. All patients must have an office msSBP ≥ 145 mmHg and \< 180 mmHg at the completion of the 4-week run-in epoch (at the randomization visit (Visit 201).

Patients must successfully complete ABPM and pass technical requirements at Visit 201.

Exclusion Criteria:

Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg).

History of angioedema, drug-related or otherwise. History or evidence of a secondary form of hypertension. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.

History of myocardial infarction, coronary bypass surgery or PCI during the 12 months prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply
FlexToBa for People With Multiple Sclerosis

The purpose of this study is to test the effectiveness of a DVD-delivered, home-based six-month physical activity intervention for people with Multiple Sclerosis.

Persons with MS are less likely to be active than their healthy counterparts, a statistic that is compounded by the symptom manifestations of MS. However, there is increasing evidence to support the importance of physical activity in MS. Unfortunately, structured, safe, and efficacious physical activity programs that are often conducted in medical or university settings are often not accessible to many older adults with or without MS. We propose to conduct a randomized controlled pilot trial testing the efficacy of a DVD-delivered physical activity intervention which targets factors that have the potential to reduce disability in older adults with MS. This DVD-based intervention has been previously approved by the IRB at the University of Illinois for a similar study with low-active, community-dwelling older adults (IRB Protocol Number: 09765). This novel intervention provides systematic, programmatic activities with alternative versions of each exercise that allow individuals of all capabilities to complete the program successfully. It focuses on improving flexibility, strength, and balance and has been demonstrated to be feasible, well-accepted, and efficacious in a large sample of older adults without MS. Importantly, intervention resulted in clinically significant improvements in the Short Physical Performance Battery, reliable determinant of disability, institutionalization, morbidity, and mortality. If such an intervention was equally successful in older persons with MS, this could have considerable public health impact.

Eligibility Criteria:
Inclusion Criteria:

* being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months;
* aged 50 years and older;
* fluent in English;
* relapse-free in the last 30 days;
* ambulatory with minimal assistance(i.e., walk independently or with a single-point assistive walking device such as a cane);
* the provision of medical clearance for participation in a physical activity program by participants' physicians, along with a physician-confirmed diagnosis of MS (communication with physicians will be facilitated by research staff).

Exclusion Criteria:

* self-reported physical activity on a regular basis within the last six months (2 times or more per week);
* younger than 50 years of age;
* relapse in the last 30 days;
* no regular access to a television;
* no physician-confirmed diagnosis of multiple sclerosis;
* unable to successfully score above 21 (out of 39)on the Telephone Interview of Cognitive Status questionnaire (TICS-M).
Impact of a Training in Therapeutic Education on the Relation Between Care Givers and Their Patients

This study aims to describe the impact of a training in therapeutic education on the relation between a caregiver and his/her patients.

Subjects are recruited among health professionals attending a training in therapeutic education. Then they are asked to identify up to 5 of their patients to be contacted by the researcher for an interview.

Individual semi-structured interviews are conducted with 20 duo "caregivers / patients" before the training, 1 month and 6 months after the training.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate to 3 interviews

Exclusion Criteria:

* Not fluent French speaker
* Patient under guardianship
Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status

This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection. The objectives are to determine the incidence of fracture among persons with and without HIV infection, compare risk factors for fracture among persons with and without HIV infection, and to examine the associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture among persons with HIV infection.

This study uses data from the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database. The study has two analytic components. The first is a retrospective cohort study comparing subjects without HIV infection to subjects with HIV infection for the incidence of and risk for fracture, including the use of anyARV drugs in persons with HIV infection. The second is a nested case-control study limited to persons with HIV infectiion within the cohort. Cases are those with incident fractures occurring after the diagnosis of HIV infection, and controls those without a fracture. Cases and controls will be compared for risk factors for incident fracture including ARV drug exposure. The drug exposures will include individual nucleoside reverse transcriptase inhibitors (NRTIs) (as permitted by sample size) and the other ARV drug classes.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria was continuous enrollment for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database during the interval between January 1, 1997 and March 31, 2008, age 18 years of age and older, and continuous eligibility for pharmacy benefits during IHCIS enrollment.

Exclusion Criteria:

* Exclusion criteria were membership in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database without a valid gender or age record, less than 12 months continuous enrolment, and member residence in the 'national' census region. This latter grouping represented members who were either not living in the continental US or were masked for confidentiality reasons based on IHCIS archiving of data per the Health Insurance Portability and Accountability Act.
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

This is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease (CKD).

Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week
* Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period
* Adequate iron substitution

Exclusion Criteria:

* Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy
* History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies
* Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection
* Hepatitis C infection on an active treatment
* Symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III and IV)
* Unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization
* Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization
* History of malignancy of any organ system
* Systemic lupus erythematous
* Immunocompromized patients

Other In-/Exclusion criteria may apply
A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide

The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* signature of informed consent
* Age \>= 18
* histologically or cytologically confirmed small cell lung cancer (SCLC)
* extensive stage SCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
* brain metastases that are asymptomatic and do not require steroid control
* females of child bearing potential must use two forms of birth control

Exclusion Criteria:

* pregnant or lactating females
* prior use of cytotoxic chemotherapy
* surgery within 14 days of study
* radiation within 14 days of study
* prior therapy with CC-4047 (pomalidomide), lenalidomide or thalidomide
* concurrent use or anticipated use of anti-cancer agents
* absolute neutrophil count (ANC) \< 1500/mm\^3
* platelets \< 100 x 10\^3/µL
* serum creatinine \>2.5 mg/dL
* serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \> 3.0 x upper limit of normal (ULN)
* serum total bilirubin \> 1.8 mg/dL
* uncontrolled hypercalcemia
* creatinine clearance \<50 mL/min
* uncontrolled hypertension
* neuropathy \>= grade 2
* body mass index (BMI) \>= 40
* any other active invasive malignancy requiring treatment
* known chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
* inability or unwillingness to comply with birth control requirements
Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter :

Inclusion Criteria:

* Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2

Exclusion Criteria:

* Other cytostatic treatment, other malignity, severe comorbidity
oxLDL in Diabetes Mellitus Patients and Disease Periodontal

Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.

Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters. 44 patients will be divided into 2 groups: Diabetic Patients with Chronic Periodontitis (DM2DP) and Diabetic Patients without Chronic Periodontitis (DM2). The DM2DP group will receive periodontal debridement and DM2 group will be treated with supragingival scaling. Both groups receive board control every 3 months. At baseline, 3 and 6 months after treatment, will be held making the clinical periodontal parameters (plaque index, gingival index, probing depth, gingival recession relative clinical attachment level and Periodontal Inflamed Surface Area (PISA) index) and blood collection for assessment serum inflammatory markers (oxLDL, LDL, HDL, total cholesterol, triglyceride, Interleukin (IL) IL-6, IL-8, IL-10, Tumor Necrosis Factor (TNF-α) and CRP). Biochemical analyzes will be carried out by Z-scan technique. The data obtained before and after periodontal therapy will be analyzed using the Shapiro-Wilk test.

Eligibility Criteria:
Inclusion Criteria:

* individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%;
* be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm;
* present at least 20 teeth;
* agree to participate in the study and sign the informed consent form

Exclusion Criteria:

* patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin;
* have undergone periodontal treatment in the last 12 months;
* have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months;
* make use of medications that can alter the marking and concentration of oxLDL, for example, statins;
* have changed the medication for glycemic control in the last 3 months;
* present dental elements with pulpal or periapical inflammation.
STAIR for Trauma and Emotion Dysregulation

This study will examine the impact of Skills Training in Affective and Interpersonal Regulation (STAIR) group, using self-report measures, on Posttraumatic Stress Disorder (PTSD), emotional dysregulation, borderline personality disorder symptoms, global psychopathology, and access to quality mental health care. Aims include assessing the feasibility of STAIR, reducing patients' trauma and emotion dysregulation symptoms, examining whether STAIR may be used as an alternative to DBT for patients on the DBT, and improving patient satisfaction and clinic efficiency


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older.
* Have a DSM-5 diagnosis and/or symptoms for which DBT is an indicated treatment
* Meet DSM-5 criteria for a diagnosis of posttraumatic stress disorder (PTSD)
* Meet criteria at a subclinical level for BPD (a minimum of three symptoms)
* Must be able to make group commitments for attendance, safety, and sobriety during group

Exclusion Criteria:

* If currently receiving individual therapy that follows the DBT protocol or is an evidence-based trauma-focused therapy
* If the STAIR therapy group is determined to be clinically contraindicated
Sensitivity of Frequent SARS-CoV-2 (COVID-19) Rapid Antigen Testing Regimen

This study aims to assess how an at-home COVID-19 frequent testing regimen using the CoV-SCAN test kit and a paired phone application to help interpret the test result compares to once-a-week or three-times-a-week polymerase chain reaction (PCR) (molecular) testing to identify a SARS-CoV-2 infection.

Employees and cast members at Media and Entertainment Company and its affiliates will be recruited to test whether frequent use of CoV-SCAN will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing.

Antigen tests are simple to perform, have a rapid turn-around time of 15-30 minutes, and a lower cost than molecular tests. Because antigen tests do not incorporate an amplification step, they are intrinsically less sensitive than PCR molecular tests. Nevertheless, several investigators have examined the feasibility of screening populations of individuals in a low SARS-CoV-2 infection prevalence situation, such as the workplace or schools, with rapid antigen tests in place of the molecular tests. Using viral kinetics, knowledge of what level of viral load is required for transmission of culture-competent virus, test sensitivity and modeling, they have come to the conclusion that more frequent testing with a test with lower sensitivity that has a quick turn-around time is better than a test with high sensitivity with a longer turn-around time. Therefore, the goal of this study is to test the hypothesis that frequent testing with a relatively sensitive lateral flow antigen test performed at home using self-collected anterior nasal swabs will be superior to once a week or less PCR testing and non-inferior to three times a week PCR testing in an employment screening setting with a relatively low incidence of new SARS-CoV-2 infections. This study aims to assess how an at-home COVID-19 frequent testing regimen using a Rapid Antigen Screening Test (RAST) and a phone application to help interpret the test result compares to once-a-week or three-times-a-week PCR (molecular) testing to identify a SARS-CoV-2 infection. We expect to recruit up to 4,400 employees and cast members of Media and Entertainment Company and its affiliates to test whether frequent use of the RAST will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing. Recruitment and the study will continue until at least 31 or at most 148 true positive SARS-CoV-2 molecular results are reached.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older;
* Have a smartphone;
* Understand and read English;
* Will be on one production location for at least three weeks following enrollment to the study;
* Will be willing to be contacted by the Study Coordinator after leaving one production location to facilitate continued access to weekly molecular testing;

Exclusion Criteria:

* Have received any dose of COVID-19 vaccination;
* Have been diagnosed with COVID-19 infection.
Chronic Pain Risk Associated With Menstrual Period Pain

The purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives (OC) can be used to reverse this chronic pain risk.

Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected to reduce COS and decrease the risk of developing CPP.

Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of reproductive-age women. One out of every five of those women in turn will develop chronic pelvic pain (CPP), yet women without dysmenorrhea rarely report CPP. CPP disorders such as irritable bowel syndrome (IBS) and painful bladder syndrome (PBS) can cause severe, unrelenting pain due to a lack of effective treatments.

This study consists of 2 aims.

Aim #1: To determine if dysmenorrhea with concomitant bladder pain sensitivity exhibits neurophysiological features consistent with established CPP. Women with chronic pain or dysmenorrhea without COS will be used as controls. Quantitative sensory testing (QST) and a noninvasive bladder pain test that investigators validated previously be used to determine whether impairments in descending inhibition and pelvic sensitivity are responsible for vulnerability to COS in women with dysmenorrhea. EEG will be recorded to look for differences in brain activity in response to sensory stimulation between participants cohorts.

Aim #2: To differentiate the individual contributions of circulating sex hormones and repeated sensitizing events (painful menses) on descending and peripheral mechanisms of bladder pain. The same QST/bladder pain measures studied in Aim #1 will be retested within the dysmenorrhea+COS group following a one-year randomized trial of cyclical OCs vs. continuous OCs vs. no treatment. An observational arm of PBS participants will receive continuous OCs and serve as controls.

Eligibility Criteria:
Inclusion Criteria:

All

* Reproductive age women (18-45)

For dysmenorrhea and D+COS group only:

* Participants must have had regular (22-45 day) menstrual cycles over at least a two month period preceding testing

Exclusion Criteria:

All

* presence of active pelvic or abdominal malignancies (primary or metastatic)
* active genitourinary infection in the last four weeks
* unable to read or comprehend the informed consent in English
* unwilling to undergo pelvic examination/testing
* presence of hypertension or risk for developing hypertension, and

For dysmenorrhea and D+COS group only:

* absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) unwilling to take either cyclic or combined OCs
* unwilling to withdraw from OCs for two months prior to the sensory testing study visit.