cyrilzakka/clinical-trials huggingface dataset:
Empower Breastfeeding Education Program

This study results of integrated breastfeeding education program (IBEP) will guide in designing a theory-based breastfeeding educational module on promotion of optimal breastfeeding practice in new mother and her partner. The current novel education curriculum incorporated breastfeeding simulation, mindfulness training, and professional support will provide important information in supporting use of IBEP in enhancing participants self-efficacy. This study will show on how simulation teaching and mindfulness training can be utilized in the field of perinatal teaching to achieve better health outcomes.

To achieve optimal breastfeeding practice, the development of an integrated breastfeeding education program (IBEP) which incorporates simulation education, mindfulness training, professional support targeting the self-efficacy of participants is of vital importance. A randomized controlled trial of an integrated breastfeeding education program focusing on participants will be designed with two study objectives: 1) to evaluate the effects of IBEP on the primary outcome measures of breastfeeding practice as following: a) early initiation of breastfeeding, b) exclusive breastfeeding rate, c) predominate breastfeeding rate; 2) to examine the effects of IBEP on the secondary outcome measures, psychosocial correlates of exclusive breastfeeding including a) breastfeeding self-efficacy, b)anxiety, c) depression, d) mindful awareness e) infant feeding attitude. These objectives will be examined among participants in six time periods: a) during pregnancy 24 to 32 weeks education program b) 34 to 40 weeks of pregnancy (after class or third trimester), c)1 week, d) 4weeks, d) 3 months, e) 6 months postpartum, while the indicators of breastfeeding practice will be examined at the four periods following delivery.

It is hypothesized that 1) the intervention will result in a better effect on all primary outcome measures, as compared to those in the control group. Specifically, participants in IBEP group will show 10 % or greater difference in exclusive breastfeeding rates at six months than participants in the control group, 2) participants in the IBEP group will demonstrate larger effects on breastfeeding self-efficacy and mindfulness, and lower anxiety and depression than those in the control group.

Eligibility Criteria:
Inclusion Criteria:

Aged 20 years and above. During the first or second trimester of pregnancy. Willing to breastfeed after delivery Singleton pregnancy. Participants are able to attend the breastfeeding class.

Exclusion Criteria:

Chronic medical conditions. Abnormal fetal screening. Preterm delivery before 37 weeks gestational weeks.
Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer

The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.

There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old, male or female
* Gastric cancer with measurable lesions, and the diameter is at least 1 cm
* Karnofsky score: at least 70
* Estimated survival: at least 6 months
* No prior target therapy or radiotherapy
* No severe hypertension, cardiac disease, or diabetes mellitus
* Normal blood routine and chemical tests
* Signed consent

Exclusion Criteria:

* Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
* Extensive distant metastases
* Pregnancy or in lactation
* Allergic to 5-Fluorouracil
Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology

Scurvy is an almost forgotten carential pathology, caused by a deep vitamin C (or ascorbic acid) deficiency, a priori exceptional in industrialized countries. According to the French National Authority for Health standards, hypovitaminosis C is defined as a plasma vitamin C level of less than 23 μmol/L. This deficiency would affect 5 to 10% of the general population in industrialized countries and from 17% (clinical scurvy) to 47% (biological hypovitaminosis C) of vulnerable populations (malnutrition, hospitalized patients...). Vitamin C is essential for collagen synthesis. It plays a cofactor role in the synthesis of catecholamines precursors and takes action in synthesis of certain amino acids.

In rheumatology, pain is a recurring reason for consultation. In a context of treated chronic inflammatory rheumatism (RIC), while most of patients seem in remission or in reduced activity of their disease, all real-life studies show that 30 to 40% of them complain of residual pain, 70% of chronic fatigue and 20-25% of symptoms similar to secondary fibromyalgia. Currently, authors suggest the interest of vitamin C analgesic properties, especially in musculoskeletal pain, due to the role of ascorbic acid in neurotransmitters. Vitamin C would act as a cofactor for a family of biosynthetic and regulatory metalloenzymes. Thus, the authors suggest the potential of vitamin C in an analgesic mechanism involving the biosynthesis of opioid peptides.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years-old,
* followed for chronic inflammatory rheumatism (RIC): spondylo-arthritis (including spondylitis and psoriatic rheumatism) and lupus,
* with RIC in remission or low activity definec according to the following criteria: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) criteria and Bath Ankylosing Spondylitis Fonctional Index (BASFI) questionnaire for spondylitis and psoriatic rheumatism, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score for lupus,
* having given written consent after written and oral information,
* member of the social security system,
* basic treatment for the disease not modified for at least 6 months, without modification at baseline
* persistence of painful complaints not objectively explained by his RIC.

Exclusion Criteria:

* pregnant or nursing patient,
* patient protected by law or under guardianship or curatorship, or not able to participate in a clinical trial under L.1121-16 article of French Public Health Regulations,
* patient participating in or having participated in another drug clinical trial in the month prior to inclusion.
Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be administered either alone or in combination with high or low dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be administered either alone or in combination with high or low dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

Eligibility Criteria:
Any patient age greater than or equal to 18 with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months will be considered.

Serum creatinine of 2.0 mg/dl or less.

Bilirubin 1.6 mg/dl or less.

WBC 3000/mm(3) or greater.

Platelet count 90,000 mm(3) or greater.

Serum AST/ALT less then two times normal.

ECOG performance status of 0 or 1 or 2.

Patients of both genders must be willing to practice effective birth control during this trial.

No patients who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer.

No patients who have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. Patients with cardiovascular disease will be eligible to receive peptide in IFA alone.

No patients who require steroid therapy.

No patients who are pregnant (because of possible side effects on the fetus).

No patients who are known to be positive for hepatitis BsAG or HIV antibody (because of possible immune effects of these conditions).

No patients who have any form of primary or secondary immunodeficiency. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
Computer-delivered Psychosocial Intervention for Adolescent Substance Use Disorders

The purpose of this study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders.

Substance use among youth remains a major public health problem. About half of all 12th graders have tried an illicit drug and over 72% of this same age group have used alcohol. Rates of abuse of prescription opioids among youth are estimated to have increased about 542% in the past decade. Although effective substance abuse treatment programs for youth exist, they are currently of limited reach. Only 1 in 10 adolescents who need substance abuse treatment receive any care. An interactive, computer-delivered psychosocial (skills-training) intervention has the potential to address these challenges, as it allows for complex interventions to be delivered at a low cost, without increasing demands on staff time or training needs. It may also be highly acceptable to youth and enable widespread dissemination of science-based treatment in a manner that ensures fidelity.

In this project, we plan to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders. The content of this program will be based in a model of psychosocial substance abuse treatment for youth that has been shown to be effective in prior scientific research. It will be provided via an interactive, delivery system that employs informational technologies that are effective in promoting relevant knowledge and skills. Adolescents in substance abuse treatment will help shape the development of this program. To our knowledge, the planned program will be the first interactive program to provide comprehensive, psychosocial substance abuse treatment to adolescents via computer-based technology.

This research will contribute new information relevant to increasing the delivery of science-based psychosocial treatment to adolescents with substance use disorders in a manner that is cost-effective and which may promote the adoption of effective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-nicotine alcohol or drug use disorder
* English speaking
* Parental consent to participate for adolescents under the age of 18.

Exclusion Criteria:

* Clinical diagnosis of psychiatric disorders that require intensive level of services, such as active psychosis, active mania or active suicidality
* Plan to move out of the area within the next 3 months
* Insufficient ability to understand and provide informed consent/assent to participate
* Lack sufficient ability to use English to participate in the consent/assent process, the interventions or assessments
Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation

Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Up until today, very little is known about the metabolic alterations in the retina of glaucoma patients, since only techniques for surrogate measurements of metabolism (like blood flow velocities and vessel diameter) were available. Oximetry has provided us with an important tool to study metabolism in glaucoma, and to correlate these findings with the available blood flow evaluation techniques. Preliminary results by the group of Prof Stefánsson (2011) with the dual wavelength oximeter pointed out that deeper glaucomatous visual field defects are associated with decreased arteriovenous differences in retinal oxygen saturation. These data suggest that a change in oxygen metabolism occurs in glaucomatous retina. This reduced oxygen metabolism may be related to tissue atrophy. However, this explanation is still hypothetical, since the relation between these oximetry results and structural changes in the optic nerve have not been studied yet.

1. What are the oximetry values in a normal population of within the same age group as the glaucoma population? To answer this question, a normative database of the investigators retinal oximetry device needs to be constructed for healthy controls.
2. Do glaucoma patients have different retinal oximetry values than these normal patients? Are there any differences in retinal oxygenation between these glaucoma groups? To answer these questions, oximetry measurements will be performed in patients with normal tension glaucoma (NTG) and primary open angle glaucoma (POAG).
3. Is there an association between structural optic disc and retinal nerve fibre layer changes, using Heidelberg Retinal Tomography (HRT), with alterations in retinal vascular oxygen saturation in NTG and POAG patients?
4. Are blood flow measurements, using colour Doppler imaging (CDI), correlated with alteration in retinal vascular oxygen in NTG and POAG patients?

1. Oximetry pictures will be taken and analysed.
2. CDI exam will be performed.
3. Visual field examen will be performed.
4. HRT will be performed.

Eligibility Criteria:
Inclusion Criteria:

* individuals over 18 years old
* willing to sign an informed consent and able to comply with the requirements of the study
* having no other ocular diseases besides glaucoma

Exclusion Criteria:

* history of ocular trauma
* intraocular surgery (except for cataract surgery)
* eye disease (except glaucoma)
* systemic diseases with ocular involvement like diabetes
Gene Expression Profiles in Chronic Periodontitis

Current concepts of the causes of periodontitis implicate a bacterial infection as the primary cause of the disease. Several bacterial species residing in a biofilm on tooth surfaces are closely associated with periodontitis. Chronic periodontitis (CP) is initiated and sustained by bacterial plaque, but host defense mechanisms play an integral role in its pathogenesis.

Gene expression profiling is a powerful means of generating comprehensive genome-level data sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides significant insight information for these diseases. Gene expression profiling may provide an evidence for involving genes in the pathogenesis of CP and generate further information other than clinical signs and symptoms of CP.

The aim of this study was to identify gene-expression patterns of patients with chronic periodontitis by whole-transcriptome gene-expression analyses.


Eligibility Criteria:
Inclusion Criteria:

1. CP patients had at least 20 teeth exhibiting \>30% of measured sites with \>5mm clinical attachment loss.
2. Had bleeding on probing (BOP) at \>50% of the proximal sites.

Exclusion Criteria:

1. Had any known systemic diseases that can influence the periodontal status, oral diseases other than chronic periodontitis and ongoing orthodontic therapy.
2. History of hepatitis, HIV infection, or diabetes; requirement for antibiotic prophylaxis, pregnancy or lactation; and long-term use of anti-inflammatory drugs.
3. Should be free of systemic diseases
4. Individuals had to be older than 18 years of age.
Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery

Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined general-spinal anesthesia for cardiac surgery for 12 years. We hypothesized that compared to general anesthesia, the combined techniques would provide comparable intraoperative hemodynamics and improved postoperative analgesia. This study subjected these techniques to a double-blind randomized trial.

Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined general-spinal anesthesia for cardiac surgery for 12 years. We performed a trial in order to determine if our clinical impressions of the techniques would be confirmed. We hypothesized that compared to general anesthesia, the combined techniques would provide comparable intraoperative hemodynamics and improved postoperative analgesia. This study subjected these techniques to a double-blind randomized trial.

METHODS

After IRB approval, 63 consenting patients undergoing non-emergent coronary artery bypass grafting (CABG) entered a randomized, double-blind trial. Patients received lorazepam 0.03 mg/kg preoperatively, and midazolam 0.03 mg/kg during line insertion and induction. Spinal procedures, performed by an unblinded study anesthesiologist, preceded general anesthesia, which was induced with propofol and rocuronium, and maintained with isoflurane through CPB, and propofol thereafter. All caregivers were blinded to group assignment. Opioid and spinal management defined 3 groups:

GA: Sufentanil IV: 3 μg/kg induction, 1 μg/kg x 2 prn; mock spinal SO: Sufentanil IV: 0.2 μg/kg induction, 0.1 μg/kg x 2 prn; Spinal: sufentanil 50 μg, morphine 0.5 mg, hyperbaric SL: Sufentanil IV: 0.2 μg/kg induction, 0.1 μg/kg x 2 prn; Spinal: sufentanil 25 μg, morphine 0.5 mg, bupivacaine 9.75 mg, hyperbaric

When patients were stable in ICU, propofol was stopped and an extubation protocol begun. Patients received scheduled NSAID and prn opioid, IV or PO. The chi-square test and ANOVA using the Scheffe method for multiple comparisons were applied appropriately.

The primary end points of the study were analgesic requirements, visual analogue pain scores, and duration of endotracheal intubation in the intensive care unit. Secondary endpoints were intraoperative hemodynamic variables, blood catecholamine and lactate levels, anesthetic supplementation, and vasoactive drug support.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing non-emergent primary coronary artery bypass grafting using cardiopulmonary bypass

Exclusion Criteria:

* \< 25 or \> 80 years of age
* left ventricular ejection fraction \< 35%
* receiving inotropic or intraaortic balloon therapy at time of surgery
* receiving intravenous heparin therapy at time of surgery
* pre-existing back problems in the lumbar area
* clinical or laboratory evidence of coagulopathy
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.


Eligibility Criteria:
Main Inclusion Criteria:

* Systemic Sclerosis (SSc), diffuse or limited.
* SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.

Main Exclusion Criteria:

* Digital ulcers due to conditions other than SSc.
* Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
* Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life-threatening condition.
* Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
* Treatment with inhaled or oral prostanoids one month prior to randomization.
* Previous treatment with bosentan.
Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions.

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions. As tumor samples can be difficult to collect, we hope to be able to collect similar genetic information from blood or urine samples that we find in tumor tissue. Ultimately, we hope to identify genes important to cancer cells that could potentially identify standard-of-care or research-based recommendations for therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 18 years of age or older
* Metastatic breast cancer and treatment with prior chemotherapy
* Any clinical phenotype (Triple negative, Hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-positive)
* Patient must have received a metastatic tumor biopsy within 3 years prior to the date of the first planned blood sample for the study and have tissue available from this biopsy
* Able to voluntarily provide informed consent

Exclusion Criteria:

* Women who are pregnant or nursing