cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)

This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe \[EZ\] 10 mg/Atorvastatin \[Atora\] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with hypercholesterolemia. The primary hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Japanese outpatient with hypercholesterolemia.
* Females must be non-reproductive potential or agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
* Agree to maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Exclusion Criteria:

* Uncontrolled hypertension
* Type 1 or uncontrolled type 2 diabetes mellitus (treated or untreated)
* History of coronary artery disease (CAD) Homozygous familial hypercholesterolemia or has undergone LDL apheresis
* Had a gastrointestinal tract bypass, or other significant intestinal malabsorption
* History of cancer within the past 5 years except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer
* Human immunodeficiency virus (HIV) positive
* History of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy
* Consumes more than 25 g of alcohol per day
* Consumes more than 1L of grapefruit juice per day
* Currently following an excessive weight reduction diet
* Engaging in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study
* Hypersensitivity or intolerance to ezetimibe or atorvastatin
* History of myopathy or rhabdomyolysis with ezetimibe or any statin
* Pregnant or lactating
* Taking any other investigational drugs and/or has taken any investigational drugs within 30 days
Patient Engagement in Perioperative Pain Management Project

Previously, the study team evaluated the implementation and effectiveness of the Johns Hopkins Perioperative Pain Program (PPP), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. Based on the findings of that project, the study team developed an educational intervention intended to improve patient engagement in perioperative pain management. In this project, the study team will formally implement a randomized controlled trial to evaluate the effectiveness of the intervention developed.


Eligibility Criteria:
Inclusion Criteria:

* All patients in Johns Hopkins Personalized Pain Program Clinic

Exclusion Criteria:

* Active suicidal ideation at study entry
* Primary psychotic disorder
* Non-English speaker
Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis

The study will examine whether the provision of psychosocial support services for cancer patients in acute care can be optimized by the use of a structured combination of screening procedures with physician interviews and structured patient pathways.

There is strong evidence that a third of all cancer patients in acute care are suffering from mental health conditions and that a third expresses the need for professional psycho-oncological support.

However, physicians and nurses do not always identify these patients in need for support. Screening questionnaires are significantly better to identify distressed patients however the use of screenings alone does not necessarily improve the patients' emotional well-being.

Purpose of this study is to evaluate a psychosocial stepped care model which aims to decrease the patients' distress.


Eligibility Criteria:
Inclusion Criteria:

* patients in acute care for cancer
* written informed consent
* 18 years and older
* ability to complete questionnaires

Exclusion Criteria:

- insufficient command of German
Analysis of Molecular Markers of Drug Resistance in Tumor Biopsies From Previously Untreated Aggressive Non-Hodgkin's Lymphoma

Although the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets \[including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D(1), cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers\], involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.

Although the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets using immunohistochemistry and cDNA microarray expression profiling (including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D1, cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers), involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.

Eligibility Criteria:
Prior enrollment on the clinical trial of ProMACE-CytaBOM versus ProMACE-MOPP (81-C-0166) or Short Course ProMACE-CytaBOM (87-C-0180) for the treatment of previously untreated aggressive lymphomas.

Informed consent for participation in the above clinical trials.

Adequate biopsy material from initial biopsy and/or biopsies at relapse of disease.
Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.

The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.

Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.

Eligibility Criteria:
Inclusion Criteria:

* Medically confirmed diagnosis of persistent asthma
* Able to demonstrate reversibility of at least 12% with albuterol inhalation
* Use of short-acting b-2 agonists for rescue \>= 5 times within 2 weeks prior
* Able to produce an FEV1 between 45 and 85% of predicted
* Willing to perform study procedures for about 14 weeks.

Exclusion Criteria:

* Use of inhaled corticosteroids within 4 weeks
* Use of oral/parenteral corticosteroids within 8 weeks
* Use of long-acting beta-2 agonists or montelukast within 2 weeks
* History of life-threatening asthma attack within 3 months
* Female of child bearing potential.
Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording

The researchers are trying to determine whether the Alivecor device can simulate other electrocardiogram (ECG) leads to record electrical activity.


Eligibility Criteria:
Inclusion Criteria:

* Individuals greater than 18 years old getting an ECG

Exclusion Criteria:

* Patients unwilling or unable to provide informed consent
In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy

The investigators hypothesize that optimize our risk prediction for pelvic floor disorders after childbirth by taking into account intrinsic women's pelvic floor characteristics and their changes during pregnancy. Shear Wave Elastography (SWE) is a new technology that allowed an in vivo assessment of elastic properties of tissues. The main endpoint of this study is to describe biomechanical changes that occurs into women's pelvic floor during pregnancy using SWE technology.

An ancillary study will investigate the reproducibility of the assessement of the viscoelastic properties of the levator ani muscle, the biceps brachii muscle and the gastrocnemius medialis muscle using shear wave elastography in a nulliparous non-pregnant women cohort

Each woman included in the princeps study undergo 3 visits during pregnancy (14-18 weeks, 24-28 weeks and 34-38 weeks).

Each visit contain a clinical pelvic floor assessment (POP-Q), an ultrasound pelvic floor assessment, an ultrasound pelvic floor muscles (levator ani and external anal sphincter) viscoelastic properties assessment using shear wave elastography and an ultrasound peripheral muscles (biceps brachii and gastrocnemius medialis) using shear wave elastography.

The main objective is to describe changes in viscoelastic properties of pelvic floor muscles during pregnancy. Secondary objectives are to compare muscular behavior of pelvic floor muscles and peripheral muscles during pregnancy.

Data about the delivery are also collected in order to analyse preliminary data about the hypothetic association between viscoelastic properties of women's pelvic floor and both mode of delivery and perineal trauma at childbirth.

An ancillary study involve non-pregnant nulliparous women in oder the investigate the reproducibility of shear wave elastography assessment of the levator ani muscle. Secondary objective is to investigate this reproducibility for biceps brachii and gastrocnemius medialis muscles.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous pregnant women
* Age \>18 years
* Normal pregnancy
* BMI \< 35 Kg.m-2
* Without previous pelvic floor disorders
* Without muscular diseases, psychiatric diseases

Exclusion Criteria:

* Parous women
* Previous pelvic floor disorders
* BMI \> 35 Kg.m-2
* Age \< 18 years
* Psychiatric diseases, muscular diseases
* Pathological pregnancy

For the ancillary study about the reproducibility on non-pregnant women

Inclusion Criteria:

* Non pregnant women
* Age \>18 years
* BMI \< 35 Kg.m-2
* Without previous pelvic floor disorders
* Without muscular diseases, psychiatric diseases

Exclusion Criteria:

* Parous women
* Previous pelvic floor disorders
* BMI \> 35 Kg.m-2
* Age \< 18 years
* Psychiatric diseases, muscular diseases
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer with accompanying pathology report;
* Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
* Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
* Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;
* Estimated life expectancy of at least 3 months

Exclusion Criteria:

* Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
* Pregnant or lactating;
* Known or suspected brain metastasis or leptomeningeal disease;
* History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;
* For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.
ICBT for Children With FAPDs - the Child's Pain Regulation

Functional abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. FAPDs are often sustained into adulthood and a large Swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. Internet-cognitive behavioral therapy (Internet-CBT) can improve FAPD symptoms, but a significant number of children does not respond to the treatment.

We will here determine the pain regulation in children with FAPDs, compared with healthy controls, and assess:

What aspects of the child's pain regulation is related to improvement for children with FAPDs engaging in Internet-CBT?

Does some aspects of the child's pain regulation change during treatment?


Eligibility Criteria:
Inclusion Criteria:

Children 8-17 years with FAPDs: Have been offered treatment at BUP Internetbehandling for FAPDs.

Children 8-17 years without FAPDs: Not affected by recurrent (every week) or persistant pain during the last year.

Exclusion Criteria:

Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)
Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh

The proposed study will compare the benefits, harms, and comparative effectiveness of intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations and clinical circumstances. A subset of the data will be analyzed to compare the benefits, harms, and comparative effectiveness of the laparoscopic and open approaches to adhesiolysis. A comprehensive array of health-related risk factors and patient-centered outcomes will be assessed in the investigators diverse patient population for proper multivariate data analysis.

Specific Aim I: To evaluate and compare the adhesion characteristics of intraperitoneal barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.

Specific Aim II: To evaluate and compare the adhesion-related complications and adhesiolysis-related complications of intraperitoneal barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.

Specific Aim III: To determine the comparative effectiveness of intraperitoneal barrier-coated versus non-barrier-coated ventral hernia repair mesh in reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations and clinical circumstances.

Specific Aim IV: To evaluate and compare the adhesiolysis-related complications of the laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair.

Specific Aim V: To determine the comparative effectiveness of the laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 18 years of age
* prior ventral hernia repair with intraperitoneal placement of mesh (open or laparoscopic approach; absorbable barrier-coated mesh, permanent barrier-coated composite mesh, permanent barrier-coated noncomposite mesh, non-barrier-coated polypropylene mesh, or biologic mesh)
* subsequent abdominal procedure requiring exposure of entire surface area of intraperitoneal mesh

Exclusion Criteria:

* less than 18 years of age
* inability to verify intraperitoneal mesh type or location
* active abdominal wound infection or open abdominal wound
Study on the Influence of Climatic and Environmental Factors on Respiratory Diseases in Sanya, Hainan Province, China.

To investigate the Influence of Climatic and Environmental Factors on Respiratory or Allergic Diseases in Sanya.

The study is an observational research, which will recruit the community migratory old people and children at school using cluster sampling in Sanya by Sanya Maternal and Child Health Care Hospital (Sanya Women and Children's Hospital). Sanya Central Hospital(Hainan Third People's Hospital) and People's Hospital of Sanya will assist to diagnose old people disease. The data of climate and environment will be obtained from Sanya Meteorological Administration and Sanya Municipal Ecology and Environment Bureau.

1. The primary purpose is to investigate the influence of the unique tropical climate and environmental factors on the migratory old people with diseases such as asthma, allergic rhinitis, COPD or atopic dermatitis in Sanya from northern China, and to provide scientific evidence for publicity of the tourism and the health care industry.
2. The secondary purpose is to investigate prevalence and risk factors of asthma, allergic rhinitis and atopic dermatitis among children in Sanya, which will provide a base for prevention and control strategies.
3. The third purpose is to retrospectively analyze the influence of climate and environmental factors in Sanya on children with asthma, allergic rhinitis and atopic dermatitis in the past decade, and a comparative analysis of the incidence on children in Sanya and Shanghai.

Eligibility Criteria:
Inclusion Criteria:

* 50-80 years-old migratory people with asthma, allergic rhinitis, COPD or atopic dermatitis from northern China;
* 3-12 years-old children in Sanya;
* Agree to participate this study.

Exclusion Criteria:

* Disagree to participate this study;
* Having other respiratory diseases which can influence airflow, such as lung cancer, tuberculosis, pneumonia, bronchiectasis, etc;
* Inability to understand the study procedures or inability/reluctance to answer questionnaire judged by the investigator.
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)

This study is a prospective, phase 2 extension study of participants previously enrolled in NTMT-01 and NTMT-02. This study is designed to evaluate long term safety and efficacy of the NT-501 implant in participants previously enrolled in the NTMT-01 and NTMT-02 protocols.


Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in the NTMT-01 or NTMT-02 protocol and received the NT-501 implant and/or underwent a Sham procedure
* Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents, and provide written informed consent.

Exclusion Criteria:

* There are no Exclusion Criteria
Cellular and Molecular Inflammatory Mechanisms Leading to Bone Resorption in Peri-implantitis Vs Periodontitis

Recent data found that peri-implantitis may differ from periodontitis at the histological level in terms of extent and composition of the cellular components. From human biopsies, it has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger proportion of granulocytes and macrophages in peri-implantitis lesions compared to periodontitis lesions. Following experimental peri-implantitis, it has been observed a continuing bone loss around dental implants after ligature removal; whereas, such a progression was not observed around teeth after cessation of the experimental periodontitis. The factors influencing the recruitment and the activation of osteoclasts in both diseases have not been compared yet.

Hypothesis : The more rapid and more severe alveolar bone destruction occurring in peri-implantitis compared to periodontitis is due at least in part to differences in the inflammatory process in these diseases.

Aim: to study the cytokine profile produced by gingival explants from periodontitis or peri-implantitis sites and to test the consequences on alteration of bone remodelling activity using in vitro approach.

Materials and methods The investigators will establish a collection of human gingival samples from patients undergoing surgical treatment of periodontitis or peri-implantitis. The investigators will test pro-inflammatory cytokines and chemokines release and consequences on osteoclast differentiation and activity.


Eligibility Criteria:
Inclusion Criteria:

* Beneficiary by national health insurance
* Age: over 18 year-old
* Non smoking
* Good health

  ---For the periimplantitis group:
* patients formerly treated with a non surgical procedure without antibiotics with at least one functional dental implant with at least on pocket deeper than 5 mm with bleeding on probing and radiographical alveolar bone loss.

  ---For the periodontitis group:
* patients formerly treated with a non surgical procedure without antibiotics for a generalized severe chronic periodontitis (in accord to Armitage 2009) and needing a resective surgical procedure (periodontal pockets deeper than 5 mm with bleeding on probing)

  ---For the healthy group:
* patients with good health without periodontal or peri implant disease needing gingivectomy (crown lengthening, esthetic surgery)

Exclusion Criteria:

* Smokers
* Patients treated with antibiotics or NSAID during the last 3 months
* Patients suffering from a chronic infectious, inflammatory or auto-immune disease (non equilibrated diabetes mellitus, rheumatoid arthritis, spondylarthrosis, Gougerot-Sjögren, Crohn, Behcet, Horton, obesity, chronic end renal disease, cardiopathies....)
* Pregnant women
* For the healthy group : bleeding on probing on the site.