cyrilzakka/clinical-trials huggingface dataset:
Sarcopenia in Older Patient With Prostate Cancer, Prevalence and Incidence After Androgen Deprivation Therapy

Prostate cancer is the most common cancer among men 50 years and older and mainly affets patients 75 years old.

Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after surgery. Current therapies induce inhibition of sexual hormones as androgens among which testosterone. These therapies present side effects which have to be acknowledeged during the elaboration therapeutic startegies in older patients: hypogonadism induced by androgen deprivation therapy (ADT) causes loss of bone mineral density, diminution of lean body mass and increase of fat body mass.

Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. In addition to aging, many factors may contribute to sarcopenia as cancer and/or ADT. This cohort study aims to evaluate risk factors associated to sarcopenia prevalence and the relationship between ADT and sarcopenia incidence, in patients 70 years or older with localized or locally advanced prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 years and older
* Proven localized or locally advanced prostate cancer
* Treated by radiotherapy associated to ADT
* CGA needed (screened by G8 Score ≤14)

Exclusion Criteria:

* Protected pateint under guardiaship
* Metastatic prostate cancer
* Patient refusal
* Patient cripled with severe dementia
Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial

compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.

patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years.

Eligibility Criteria:
Inclusion Criteria:

* presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6)
* vital teeth
* no sensitivity to teeth percussion
* no spontaneous pain
* no radiolucency in the periapical or furcation area of teeth
* complete and normal occlusion
* good oral hygiene

Exclusion Criteria:

* poor oral hygiene
* severe or chronic periodontal problems
* periapical lesions
* heavy bruxism
* non-vital teeth
* visibly cracked teeth
* spontaneous dental pain
* sensitivity to teeth percussion
Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer

This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent, triple-negative breast cancer who either have not received treatment (first-line) or have progressed after one conventional cytotoxic chemotherapy regimen (second-line).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast
* Confirmed availability of tumor tissue

Exclusion Criteria:

* Prior therapy with two or more regimens for metastatic breast cancer
* Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1
* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1
* Prior therapy with a taxane for metastatic breast cancer
* Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor (VEGF) pathway-targeted therapy following diagnosis of breast cancer
* Prior therapy with hormones and/or trastuzumab
* Inadequate hematology, renal, or hepatic organ function

Bevacizumab Exclusion Criteria:

* Uncontrolled hypertension (systolic pressure greater than \[\>\] 150 millimeters of mercury \[mmHg\] and/or diastolic pressure \> 100 mmHg), with or without anti-hypertensive medication
* Evidence of bleeding diathesis or coagulopathy
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer

The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven Adenocarcinoma of the Prostate
* Clinical stage T1c, T2a or T2b
* PSA less than 20 ng/ml
* Gleason Score 6 or 7

Exclusion Criteria:

* Age less than 18 years
* Clinical stage T2c, T3 ou T4
* Clinical Stage N1
* Clinical Stage M1
* Prostate Specific Antigen (PSA) more than 20 ng/ml
* Gleason score 8 or higher
* IPSS score 19 or higher with alpha-blockers
* Past radiation therapy to the pelvis
* History of Collagen Vascular Disease
* History of Inflammatory Bowel Disease
* Bilateral Hip Prosthesis
Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM

B-ME is a research intervention study designed to address the needs of African American men who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is to decrease HIV risk behaviors among African American MSM using an intervention developed by and for African American MSM.

The hypothesis guiding this study is: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group.

The Specific Aims of this study are 1) to further explicate and develop the intervention, 2) to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of research on HIV prevention/risk reduction practices for African American men who have sex with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving B-ME intervention to receiving basic men's health and wellness messaging (standard of care), hypothesizing: hypothesizing: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group. The study will utilize a pre-test/post-test design with participants randomized to intervention and comparison groups; have a strategy to retain at least 80% of participants through study completion; collect data at baseline, at 3 months post-intervention, and at 6 months post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex events; (2) number of unprotected sex events with persons of unknown HIV status; (3) frequency of HIV testing, and (4) increased communication between partners about sex and strategies for reducing the risk of HIV infection.

Eligibility Criteria:
Inclusion Criteria:

* a) Be 18 to 55 years old b) Self identify as African American (Black national) c) Self identify as a male (because this is a study of an intervention to impact change among Black MSM, only self identified males will be included, therefore no females or transgendered identified persons will be included).

  d) Report being sexually active in the past 30 days (ie., one or more instances of vaginal or anal sex with a male or female) e) Report at least one instance of unprotected anal or oral sex with a male identified partner in the past year f) Have not previously participated in the CTCA intervention. g) Have not received an evidence-based HIV prevention intervention in the past 180 days

Exclusion Criteria:

* Men are ineligible to participate in the trial if they:

  1. Identify as a transgender woman; OR
  2. Plan to move before the end of the study; OR
  3. Have participated in any HIV or substance use prevention studies in the last 180 days.
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A (FVIII:C \<= 1%)
* Male subjects between 12 and 65 years of age
* Body weight 25 kg to 110 kg
* Previously treated with FVIII concentrate for at least 150 EDs

Exclusion Criteria:

* Other coagulation disorder than hemophilia A
* Present or past FVIII inhibitor activity
Personalised Health Recommendations to the General Population Through an Integrated AI Guided

This clinical study aims to be used to implement and validate the AIDA tool in two phases:

* Phase 1: Risk stratification and personalised recommendations \& Model development
* Phase 2: Mechanistic Model (Bioresource) development \& testing

The AIDA objective (project) is to develop and validate a multidisciplinary AI-powered assistant that helps clinicians diagnose precancerous inflammation, suggests personalised therapeutic strategies for medical treatment and follow-up, and makes personalised recommendations for monitoring patient health status, thus contributing to gastric cancer prevention. This prospective clinical study aims to implement and validate such tool.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care
* Availability of a signed informed consent form to participate in the study

Exclusion Criteria:

* Patients to whom an endoscopy is performed for the follow-up of another illness such as oesophageal varices and/or for therapy such as endoscopic dilation, feeding tube placement or endoscopic resection
* Subjects with a clinical diagnosis of gastric diseases other than GIM or GC
* Patients who have received antimicrobials during the four weeks prior to the endoscopy
* Patients who have received proton pump inhibitors and/or bismuth-based treatments at least two weeks prior to the endoscopy
* Subjects for whom clinical data are not available: H. pylori status, eradication treatment, sex, age, tobacco smoking, and first-degree family history of gastric cancer
* Subjects who lack the mental capacity to understand the nature and requirements of the study and who lack the ability to give informed consent
Study of Stomatognathic System of the Obese Subjects

The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects.

The aim of this study was to identify differences in the stomatognathic system between obese and normal weight subjects. The habitual chewing of a French bread and deglutition of solids and liquid was evaluated five times in obese subjects and controls. The tonus of the lips, tongue, cheeks, masseter and temporal muscles were evaluated by clinical observation and palpation and defined as either normal or reduced. Twenty obese patients (body mass index (BMI) \> 30kg/m2) and twenty volunteers of normal weight (BMI 18.5-24.9 Kg/m2) were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults male and female
* healthy dentate
* body mass index (BMI) higher than 30 Kg/m2 for the obesity group and (BMI) lower than 25/m2 for the normal weight group.

Exclusion Criteria:

* face deformity
* alterations in morphology of lips and tongue
* without teeth or with lack of one tooth (excluding third molars)
* Malocclusion Angle's Class II and III
* pain during chewing
* pathology of the temporomandibular joint
* neurological pathology
Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing

Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy plays an indispensable role in the course of breast cancer treatment, and the radiation dermatitis is the major side effect affected quality of life. Radiation dermatitis can be divided into acute and chronic. Severe acute radiation dermatitis affects the quality of life of patients during the course of treatment, and may cause treatment interruption and affect the efficacy. Chronic radiation dermatitis may cause irreversible skin problems, and lead to so-called "radiation-irritated skin" (radiation-irritated skin) seriously affects the quality of life of breast cancer patients after treatment.

This study will enroll 30 breast cancer patients who received whole breast radiation therapy after breast conserving surgery. Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up" effect.

Subjects will need to come back to clinics for assessment weekly during radiotherapy, 2 weeks after radiotherapy, and 6 weeks after radiotherapy. The evaluation includes physical examinations, questionnaire surveys, skin observation and measurements, and photographs. The total study time is at least 3 months. The target area of radiation-irritated skin condition will be observed and graded according to CTCAE rate. The skin physiological parameters will be detected by MoistureMeter SC, Vapometer, SkinColorCatch and HX-YL001 infrared thermometer.

Statistical analysis of skin physiological parameters is used to evaluate the efficacy of FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be males or non-pregnant females at least 20 years of age.
* Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
* Patients were scheduled to receive five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy or hypofraction irradiation fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy.
* Participant must give informed consent.

Exclusion Criteria:

* Bilateral breast cancer
* Previous radiotherapy to the chest
* Chemotherapy concurrent with radiation treatment
* Prior breast reconstructions, implants, and/or expanders
* Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
* Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE)
* Participation in any clinical trial in the prior 30 days from baseline.
* Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy

The aim of this study is to evaluate the effect of smoking cessation on inflammatory markers following non-surgical treatment of periodontal disease. This is to assess the period of smoking abstinence needed before any periodontal surgery in order to reverse the negative effects of the reported increased levels of inflammatory markers (IL-1β and PGE2 in this study) associated with smoking on the healing and the periodontium.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced chronic periodontitis upon clinical examination with clinical attachment loss (CAL) more than 5 mm.
* Patients willing to quit smoking to be included in two groups, while patients unwilling to quit smoking to be included in the third group, and the non-smokers as the fourth group.

Exclusion Criteria:

* Any systemic illness known to affect the outcome.
* Systemic antimicrobial or anti-inflammatory drug therapy within the last 3 months prior to the study.
* Patients unable to perform routine oral hygiene procedures.
* Patients using other forms of tobacco.
Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings

A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care.

Participants are prospctively recruited and enrolled to participate in the study. The Capillary (fingerstick) whole blood, and venous whole blood samples (in serum separating tube (SST) and Ethylenediaminetetraacetic acid (EDTA) tube) are collected by a healthcare professional. Serum and plasma samples will be extracted through laboratory processing of the collected serum separating tube and Ethylenediaminetetraacetic acid VWB, respectively. The collected samples of capillary will be tested on iStatis HBsAg Test. The collected Ethylenediaminetetraacetic acid and serum separating tube VWB will be shipped to the central laboratory to appropriately process and extract serum and plasma samples. Ethylenediaminetetraacetic acid VWB, plasma and serum will be tested on iStatis HBsAg Test in the laboratory. An aliquot of the obtained plasma sample will be further tested for reference and confirmatory testing.

The results from iStatis HBsAg Test results will not be used for participant management decisions.

Eligibility Criteria:
Inclusion Criteria:

* Participants/subjects (males, females, and pregnant women) getting tested for Hepatitis B virus for one or more of the following reasons:

  * at risk for Hepatitis B virus
  * having signs and symptoms indicative for Hepatitis B virus
  * Routine testing Unknown or other reasons will be captured
* Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.

Exclusion Criteria:

* Participant younger than 18 years old
* Participants unable to provide written informed consent
Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation

A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation


Eligibility Criteria:
Inclusion Criteria:

* women between age of 18 to 50, diagnosed with AVM
* hemodynamically stable at clinical presentation

Exclusion Criteria:

* unstable patients
* contraindication to treatment
* US examination not in the US department
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data

Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the United States. Therapy for IBS is generally unsatisfactory, and takes an additive approach whereby medications are prescribed according to each type of symptom the patient experiences. Accumulating evidence indicates that persons with IBS have a heightened perception of stress, and chronic stress has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health and decreased stress perception. The clinical literature suggests that mindfulness-based interventions may lead to improvement in many disorders including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose of this study is to collect survey pilot data to determine whether an 8-week program of mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care, and we seek approval only to collect survey data before and after the MBSR course. This study will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical trial of MBSR.

Aim 1: Apply measures of IBS symptom severity, depression and quality of life before and after the MBSR course, to assess whether there is evidence of benefit, and allow calculation of standardized effect sizes. Aim 2: Apply a validated measure of mindfulness before and after treatment. Aim 3: Explore the relationship between IBS symptoms, mindfulness score, and frequency of mindfulness practice.

Eligibility Criteria:
Inclusion Criteria:

* All patient who enroll in a MBSR course

Exclusion Criteria:

* Psychosis, borderline personality, active substance abuse
Plethysmographic Waveform for Monitoring the Quality of Cardiopulmonary Resuscitation

Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early identification ROSC is very important. Now there is no an easy, non-invasive and real-time method to monitor the quality of CPR. In this study the investigators hypothesis the pulse oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR to the physicians.


Eligibility Criteria:
Inclusion Criteria:

* cardiopulmonary arrest, without do-not-resuscitation(DNR) patients
* After cardiac arrest, there is no more than 10 minutes until basic life support.
* must be carried out advanced life support (tracheal intubation and end-tidal carbon dioxide monitoring)
* comply with ethical requirements and signed informed consent

Exclusion Criteria:

* DNR patients
* rib fractures
* hemorrhagic shock caused cardiac arrest
* severe anemia, hemoglobin less than 7g/dl
* tension pneumothorax without closed drainage
* pulmonary embolism or pericardial tamponade caused cardiac arrest
* onychomycosis
* people who paint fingernails
* clearly influential peripheral oximetry underlying diseases (such as Raynaud's phenomenon, vasculitis)
* The study physicians believe there is any case is not suitable for inclusion.