cyrilzakka/clinical-trials huggingface dataset:
Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy

This study will evaluate the ability of the vaccine to produce antibodies against herpes zoster virus (shingles) and safety of vaccination with Varicella Zoster Vaccine in patients with moderate to severe psoriasis who will initiate biologic therapy 4 to 6 weeks after vaccination.

Varicella Zoster Vaccine will be administered 4 to 6 weeks prior to receipt of biological therapy and will be compared against placebo.

This double-blind study will enroll approximately 50 adult patients with moderate-to-severe plaque psoriasis in approximately 3 centers in Canada. Study products will be assigned randomly at a 4:1 ratio.

For each patient who is included, the study may last up to 22 weeks, including the screening and the follow-up period. During the study, subjects will come to the dermatology clinic up to 4 occasions: for a screening visit, Baseline visit, Day 42 as well as 84 days after they started taking the biological treatment for a last visit. If patients develop a varicella-like or shingles-like rash at any time after they received the vaccine, they will be requested to come back to the clinic within 72 hours of rash onset (preferably within 24 hours) for examination. Subjects will be asked to provide a lesion swab/vesicular fluid in this case.


Eligibility Criteria:
Main Inclusion Criteria:

1. Outpatient men or women aged 50 years or older
2. Must have moderate-to-severe plaque psoriasis for at least 6 months, and for whom a decision to use biologic therapy has been made, with biologic therapy planned to be initiated within the next 4-6 weeks.
3. History of varicella, or having resided in Canada for at least 30 years.

Main Exclusion Criteria:

1. Have received Varicella Zoster Vaccine vaccine or known allergies to the Varicella Zoster Vaccine vaccine or its excipients including neomycin and gelatin
2. Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukemias, lymphoma, other conditions affecting the bone marrow or lymphatic system, immunosuppression due to HIV/AIDS, cellular immune deficiencies.
3. Current use of non-topical antiviral therapy with known activity against varicella-zoster virus.
4. Exposure to varicella or zoster within 28 days prior to vaccination.
5. Patients who are diagnosed with herpes zoster at the time of the vaccination.
6. Active untreated tuberculosis.
Understanding Barriers to Initiation and Adherence to Endocrine Therapy in Young Breast Cancer Survivors of Diverse Backgrounds

The overall goal of this study is to qualitatively explore how behavioral, cultural, psychosocial, and economic barriers and facilitators affect the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer

A qualitative study that will use interviews to gain an in depth understanding of factors affecting the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer

Eligibility Criteria:
Inclusion Criteria:

* Are Hispanic, Latina, Black, or identify as socio-economically disadvantaged (any racial/ethnic background) as measured by an item of financial distress answering that they are "having difficulty paying the bills no matter what they do" to a question about their current household financial situation.18, 19
* report a history of Stage 1-3 breast cancer
* reports HR+ breast cancer and confirm that they have had a discussion with their doctor about adjuvant ET; OR indicate that they are taking ET, even if they do not know their HR status, answer they are HR-, or do not recall having a discussion about ET)
* not in active treatment (e.g., chemotherapy, radiation), with the exception of Herceptin
* at least 3 months, but no more than 3 years out of completion of active treatment
* no evidence of recurrent/metastatic disease
* at least 18, but\< 45 years of age at diagnosis of first invasive breast cancer
* English or Spanish speaking
* are willing to consent to the interview

Exclusion Criteria:

* HR- breast cancer and indicate they are not taking ET
* HR+ breast cancer but do not confirm discussion of ET or indicate they are taking ET
* Stage 0 (DCIS) breast cancer
* Recurrent or metastatic disease
* Less than 3 months or more than 3 years post-active treatment
* Less than 18 years old or ≥45 years old at diagnosis
Quality of Life With Bone Conduction Hearing Device

The aim of this study is to compare the audiological and quality of life performance patients have with an ADHEAR (adhesive bone conduction device) compared to no hearing device.

Patients will be recruited at the outpatient's department of the Medical University of Vienna - Otorhinolaryngology department. Patient will be asked to participate in the study when inclusion and exclusion criteria are met. Mostly patients scheduled for a surgery improving conductive hearing loss or scheduled for implantation of an implantable bone conduction hearing aid will be included in the study.

Patients who do not use a hearing aid and who are not planning on using a hearing aid meeting the inclusion and exclusion criteria will also be asked to participate in the study. After inclusion in the study patients will be asked to fill out two questionnaires (quality of life and hearing specific questionnaire). They will then be fitted with an ADHEAR device and undergo unaided and aided soundfield audiometry. Randomization will be carried out (Randomization ratio 1.4:1) and patients in the intervention group will keep the device for the following 4 months with one visit after the first probation time of one month. At the one month mark patients in the control group will be asked to fill out the two questionnaires. Patients in the control group will be asked to return to the department and fill out the three questionnaires (SSQ-12 (Speech Spatial and Hearing Questionnaire), AQoL(Assessment of Quality of Life) and In-house questionnaire). Further audiologic assessment will be carried out. At this appointment patients will be able to talk about their experiences in the probation period und easily terminate the study in case of insufficient improvement, pain, skin irritations or other issues. At the four month mark patients in both groups will be asked to return for audiologic assessment and for filling out the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral and/or bilateral conductive hearing loss (CHL)
* Conductive hearing loss \>10 decibel on average
* Subjective benefit from the device
* Subjects aged 13 years or older
* Capable of the German language
* Willingness and ability to perform all tests required for the study
* Signed, and dated informed consent before the start of any study specific procedure

Exclusion Criteria:

* Pregnancy or breastfeeding
* Patient uses a hearing aid or plans to acquire a hearing aid
* Patient is intolerant of the materials as described by Manufacturer
* Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
* Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
* Patient presents with retrocochlear, or central auditory disorder.
* any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis

Single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from CARTOFINDER.

A total number of 30 patients will undergo catheter Ablation for persistent AF. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. CARTOFINDER-guided mapping will be performed during the ablation procedure followed by AF ablation. The individual relationship between atrial fibrosis and potential ablation targets will be accessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing their 1st AF ablation procedure for persistent atrial fibrillation (AF) as per recent Heart Rhythm Society (HRS) consensus document
2. Able to understand and willing to sign the Informed Consent Form.
3. Age ≥18 years.

Exclusion Criteria:

1. Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent.
2. Previous left atrial ablation or surgical procedure
3. Renal failure with CrCl \<60 ml/min
4. Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
5. Mental or physical inability to take part in the study
6. Uncontrolled hypertension
7. Morbid obesity (BMI \> 35), or inability to be placed in MRI due to body mass.
POLARSTEM Retrospective Multicenter Study

The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.

The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance

This is a multicenter retrospective longterm clinical outcome study conducted in up to 6 hospitals in France. 502 subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years. Subjects who have not reached the 10-year post surgery timepoint will be invited to a 10-year post-operative follow-up visit to obtain the clinical and radiographic outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Subject required and received primary total hip arthroplasty between 2002 and 2005.
2. Subject received the POLARSTEM™ Ti/HA unilateral or bilateral, due to severe hip joint damage resulting from arthrosis, degenerative disease, traumatic events, inflammatory or rheumatoid processes.
3. Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™).
4. Subject was aged between 18 and 75 at time of surgery.
5. Signed Informed Consent (ICF).

Exclusion Criteria:

1. Subject received the cemented POLARSTEM™.
2. Previously failed endoprosthesis and/or THR components in relevant hip.
3. Medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.
Effect of Laser Acupuncture on Postnatal Pelvic Girdle Pain

this study was done to evaluate the effect of laser acupuncture on pelvic girdle pain postnatal females' patients.

Postnatal pelvic girdle pain might be addressed as a gynecologic challenge in the 21 century in women of all ages and it frequently occur simultaneously. Various forms of postnatal pelvic girdle pain were aggravated by moderate daily activities. Laser acupuncture is a therapeutic modality focuses on selected acupoints in a safe maneuver

Eligibility Criteria:
Inclusion Criteria:

* Fifty-four women suffering from postnatal pelvic girdle pain, clinically diagnosed by a gynecologist.
* Their ages were ranged from 20-45 years old.
* Their body mass index (BMI) was ranged from 25-29.9 kg/m2.
* They shouldn't have any musculoskeletal or neurological disorders.

Exclusion Criteria:

* Current pregnancy.
* Malignant condition
* History of acute infection
* Neurological problem
* Mental problem to prevent evaluation and cooperation.
* Having uncontrolled metabolic diseases like diabetes and thyroid disease.
* Athletic females.
Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis

Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There are treatments available to help manage these symptoms like weight loss, and analgesics. Surgery is the appropriate treatment in patients who have failed these conservative treatments. The aim of this clinical study is to assess safety of autologous cultured chondrocyte intra-articular injection and obtain its clinical results in patients with severe hip osteoarthritis.

In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited. All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post injection for 6 months at time intervals. Parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. These effects are measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis diagnosed by MRI

Exclusion Criteria:

* Pregnancy or lactating
* Positive tests for HIV, HCV, HBV
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder.
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation

This single center phase 2 clinical trial, is designed for confirming the efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with previous kidney transplantation.

The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus have been recognized.

The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.

The study primary efficacy endpoint is graft survival defined as insulin independence and HbA1c \< 8% at 1 year post first transplant. Secondary outcomes are graft function and metabolic control

The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide and diagnosis of diabetes for at least 5 years.
* Recipient of renal transplant with good function (creatinine clearance \>/=60 ml/min)
* Stable immunosuppression consisting of any combination of sirolimus, tacrolimus for at least 6 months, without major complications
* Ability to give informed consent.
* Age greater than or equal to 18 years or less than or equal to 65 years
* No evidence of liver disease (liver enzymes \< twice the upper limit of normal)

Exclusion Criteria:

* Age below 18 years and above 65 years
* Significant cardiovascular disease, including non-correctable coronary artery disease and/or recent myocardial infarction(within last 12 months); extensive peripheral vascular disease not correctable by surgery, unstable angina
* Untreated proliferative retinopathy.
* Recent Cerebrovascular accident (within last 12 months)
* Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB
* Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix.
* History of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy.
* Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment.
* Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy
* Fasting C-peptide \> 0.2 ng/ml
* Creatinine \> 25mg/l
* Alkaline phosphatase, total bilirubin, Alanine Aminotransferase (ALT)or Aspartate Aminotransferase (AST) \> twice the upper limit of normal
* Significant liver disease (elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).
Diabetes and Psychological Profile

This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* patients who have been given information about the research
* patients with National Health Insurance
* diabetic patients (type 1 or 2)
* patients \> 18 ans

Exclusion Criteria:

* Adult patients under guardianship or intellectually dependent
* patients without National Health Insurance
Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer

This research study will test whether using wearable fitness trackers with a social incentive, delivered through a game-based mobile health intervention, increases physical activity and quality of life in ovarian cancer survivors.

Nearly 50% of ovarian cancer survivors experience poor quality of life, fatigue, and anxiety after completing surgery and chemotherapy to treat their disease. Moreover, many ovarian cancer survivors become deconditioned during treatment; 40% report significant drops in activity during the year after diagnosis, and only 20% meet the recommended guidelines for physical activity.

Interventional exercise studies are urgently needed to determine whether increasing physical activity improves outcomes in ovarian cancer survivors. In other cancers, physical activity improves quality of life and mental health, while reducing the risk of cancer recurrence and death. To date, however, most studies have focused on patients with curable breast and prostate cancers. The effects of physical activity on understudied populations, including ovarian cancer survivors, are unknown. Furthermore, although ovarian cancer survivors report an interest in participating in home-based walking programs, few formal programs exist.

Stepping into Survivorship is a single-arm study designed to test the effectiveness of a wearable fitness tracker with a game-based mobile health intervention that leverages social support to increase physical activity in ovarian cancer survivors. At the start of the study all participants will track their daily step counts using a wearable fitness tracker (e.g. Fitbit) to determine how many steps they walk in an average day. Next, they will set an increased step-goal and receive daily, individualized feedback based upon their performance.

Participants will also choose a team partner (i.e. family or friend) to receive a wearable fitness tracker and together they will track their steps, earning non-financial micro-incentives (e.g. points, levels, badges) when they achieve their collaborative goals. This game-based mobile health intervention is designed to enhance collaboration, accountability, peer support, and ultimately physical activity among ovarian cancer survivors and their friends/family members.

This research is being done to improve participants' quality of life. The investigators hope that the use of wearable fitness trackers with a game-based mobile health intervention will help participants increase their physical activity and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible if they have newly diagnosed ovarian cancer
* Are ≤6 months of completing chemotherapy
* Read English
* Do not have cognitive, visual, or orthopedic impairments that would preclude participation
* Plan to continue treatment at Dana-Farber Cancer Institute

Exclusion Criteria:

* Participants will be excluded if they are already participating in an mHealth intervention
* Are unable to ambulate
* Do not have a smartphone to transmit data from the wearable tracker
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.


Eligibility Criteria:
Exclusion Criteria

Concurrent Medication:

Excluded:

* Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 \[CYP3A4\] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events \[i.e., cardiac arrhythmia, prolonged sedation\]).
* Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
* Ketoconazole, itraconazole, and clarithromycin.
* Concomitant systemic therapy for acute opportunistic infection or malignancy.

Excluded:

Life expectancy less than 12 months.

Prior Medication:

Excluded:

* Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
* Prior antiretroviral agent within 14 days of initiating study treatment.
* Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.

Patients must:

* Have a diagnosis of HIV infection.
* Have CD4 counts greater than or equal to 50 cell/mm3.
* Have a life expectancy greater than or equal to 12 months.
* Be post-pubescent.
Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area

Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. In these persons, frequent bacterial infections ("acute attacks") of the legs adversely affect physical health, economic well-being, and quality of life. Prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being.

Methods. To determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute attacks monitored monthly for 12 months. Both groups received specific instructions on washing and skin care.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for participation include those who are currently enrolled in the lymphedema treatment program in Leogane who 1) have been trained in the techniques of self-care, 2) who live in a 10-km radius of the hospital, and 3) for whom we have adequate data on incidence of acute bacterial infections, risk factors for infection, and ability to comply with the treatment protocol (particularly hygiene).

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Exclusion Criteria: Don't meet inclusion criteria.

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