cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season

A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adults aged \>60 years on the day of enrollment
* Written informed consent
* Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine for season 2011/2012
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/day prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (including leukemia, HIV seropositivity) or cancer
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Participation in another clinical trial
* Employee at the investigational site or relative of the investigator
* Anticipated non-compliance with study procedures
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* A positive HIV antibody test (ELISA confirmed by Western blot).
* Chronic renal failure managed by a stable hemodialysis regimen.
* Acceptable hepatic function defined by specified lab values.
* Life expectancy \> 6 months.
* Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Active, serious opportunistic infections at the time of study entry.
* Fever \> 100 degrees F at study entry.
* Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).

Patients with the following are excluded:

* Active, serious opportunistic infections at the time of study entry.
* Fever \> 100 degrees F at study entry.
* Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).

Prior Medication:

Excluded within 2 weeks of study entry:

- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity.

Excluded within 4 weeks of study entry:

- Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2.

Excluded within 8 weeks of study entry:

- Other antiretroviral agents (e.g., zidovudine \[AZT\], suramin, ribavirin, HPA-23, foscarnet, dextran sulfate, disulfiram, ddA/ddC, or dideoxycytidine).

Active drug or alcohol abuse.
Effect of Education on the Responses to Meal Ingestion

The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low temperature and 25 g bread) will be studied in a parallel design. The effects of education will be tested in two different groups in random order: real versus sham education. In each group the responses to a probe meal will be tested on 2 different days before and after the intervention. Participants will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the probe meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility Criteria:
Inclusion Criteria:

- non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
High-Dose Imatinib for Relapsed/Refractory c-Kit Positive Acute Myelogenous Leukemia (AML)

This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Response is assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.

Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Novartis provided supplies of imatinib for all patients included in the study.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years,
* AML in first or second relapse,
* refractory AML
* performance status of 0-2 on the Eastern Cooperative Oncology Group scale,
* adequate hepatic and renal functions (AST or ALT \<= 5 times the upper limit of normal
* creatinine \< 2 times the upper limit of normal)

  * 20% blasts in bone marrow,
  * 70% of bone marrow blast population c-kit positive as assessed by immunophenotyping
* Bcr-Abl negative chromosomal analysis (assessed by fluorescence in situ hybridization; FISH), and no chromosome 5-12 translocation

Exclusion Criteria:

* Previous treatment by Imatinib
* Secondary AML
Mommy-Baby Treatment for Perinatal Depression

Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* 18 years and older
* between 12 and 30 weeks gestation
* Score greater than or equal to 13 on Edinburgh Depression Scale
* Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified
* English Speaking

Exclusion Criteria:

* Substance abuse or dependence in past 3 months
* Active suicidal or homicidal ideation
* Bipolar disorder, psychotic disorder
* unstable medical condition or other medical/obstetrical complication
* Evidence of severe intimate partner violence
* Ongoing psychosocial or pharmacotherapy for depression
The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period

Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum).


Eligibility Criteria:
Inclusion Criteria:

* Being a woman between 18-35 years old
* Between the 6th and 8th weeks postpartum
* Native Turkish
* Having the appropriate technological infrastructure to participate in an exercise session via the Internet (for the TR-PFMT group)

Exclusion Criteria:

* Number of births \>2
* The week of pregnancy \<32
* Having a history of 3rd and 4th-degree perineal tears
* Cesarean birth
* Inability to contract the pelvic floor muscle (pelvic floor muscle strength ≤2 according to the Modified Oxford Scale)
* The electromyography values of the abdominal muscles or hip adductors during contraction of the pelvic floor muscles are more than 10 microvolts
* The presence of neurological, orthopedic, psychiatric, hematological or cardiovascular disease that would prevent PFMT as questioned by the gynecologist
* Body mass index ≥ 25 kg/m²
* The presence of active urinary tract or vaginal infection in the last week
Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy

This is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in Institute of Bio-Stem Cell Rehabilitation UAB - sponsored clinical studies. After completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. No investigation drug product will be administered in the study


Eligibility Criteria:
Inclusion Criteria:

Provision of written informed consent for this study by subjects or as applicable parent legal guardian. Treated with drug product for therapy of premature ovarian insufficiency in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.

Diagnosed of premature ovarian insufficiency ESHRE:

* Women age of 18 to 40 years
* Have experienced 4 months of oligo/amenorrhea
* Two serum follicle-stimulating hormone (FSH was \>40 mIU/ml levels in the menopausal range, obtained at least a month apart
* lower FSH levels ( 25 mIU/ml)
* anti-Müllerian hormone (AMH) serum levels ( 3.0 ng/ml)

Exclusion Criteria:

There are no exclusion criteria for this study
Real Life Experience of the Use of Isomers as ALENCAL (Levamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients

This is a Phase 4, observational, open study in patients whom their doctor for clinical practice prescribes levamlodipine. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8, or clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose primary physician based on their clinical condition and locally approved use will be eligible to participate in this study, and have been prescribe with Levamlodipine.
Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients

Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.


Eligibility Criteria:
Inclusion Criteria:

1. Laboring patients between the ages of 18 and 45 with a BMI of less than 45

Exclusion Criteria:
Clinical Case Series Evaluating Skin Wellness System

The purpose of this evaluation is to observe the performance of two (2) different skin care treatment protocols on the skin:

#1 Kendall™ Body Wash \& Shampoo in combination with the Moisture Barrier Cream; or #2 Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.

The scientific evidence supports using these types of skin care products to keep the skin healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are preferred over soap and water and can be applied on all areas of the skin. The Moisture Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch, and ring worm to relieve itching, soreness, and irritation.

The Kendall™ Body Wash \& Shampoo is a no-rinse cleanser that gently removed dirt, urine, and stool while maintaining the natural pH of the skin (although it contains a shampoo component); it can be applied on all areas of the skin. Kendall™ Moisture Barrier Cream performs as a barrier to moisture and irritants when the natural barrier ability of the skin has been compromised.

Kendall™ 2-in-1 Cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool and protects the skin from damage. Kendall™ Antifungal Cream is used on fungal infections to relieve itching and discomfort.

Eligibility Criteria:
Inclusion Criteria:

Adult subjects with any of the following indications:

* Erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal incontinence
* Irritated, unbroken skin (perineal area)
* Fungal infection present in the perineal area

Exclusion Criteria:

* An existing pressure ulcer of any stage where the product will be applied
* Subjects not expected to survive the two week trial
* Subjects under age 18
* Subjects unable to provide informed consent (or whose designated power of attorney is unable to provide)
* Subjects with known sensitivity to any product preservative or other ingredient.
Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.

The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old who has provided his/her written informed consent
* Patient who can be monitored by the same investigation team throughout the duration of the study
* Patient who agrees to wear effective venous compression every day, associated with the trial dressing
* Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3
* Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2
* Ulcer duration between 3 and 36 months
* Ulcer where the surface area is 70% or more covered by fibrinous tissue
* Ulcer at least 3 cm away from any other lesion
* Ulcer moderately or strongly exudative justifying the use of an absorbent dressing

Exclusion Criteria:

* Female patient of child-bearing potential who has no effective means of contraception
* Patient who is pregnant or breastfeeding
* Patient taking part in another therapeutic trial
* Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid)
* Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment
* Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy
* Patient with a systemic infection not controlled by suitable antibiotic treatment
* Patient who, during the 3 months before inclusion, presented a deep vein thrombosis
* Ulcer where its surface is totally or partially covered by black necrotic plaque
* Ulcer which is clinically infected
* Ulcer requiring surgical treatment or for which surgery is programmed during the six weeks following inclusion
* Malignant ulcer
Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy

Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. These changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. These symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause (GSM). General or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. Non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned.

The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM. This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. This simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. It restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with GSM who can benefit of this therapy.


Eligibility Criteria:
Inclusion Criteria:

* Women over 40 years of age
* Patients with natural menopause or menopause secondary to cancer treatment (breast, pelvis or other)
* Patients with vaginal and/or urinary, non-vulvar GSM
* Patients for whom CO2 laser therapy is proposed

Exclusion Criteria:

* Vulvovaginal infections (vaginosis)
* Uninvestigated vaginal hemorrhage
* Herpes
* Pregnancy or breastfeeding
* Cervico-vaginal pathology (cervical and/or vaginal dysplasia)
* Suspected or diagnosed HPV
* Significant vaginal prolapse
* Patients on hormone replacement therapy
Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

The effect of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) has been based on systemic outcome measures, however, little is known about the effectiveness of this intervention on patients' lung function. The forced expiratory volume in one second (FEV1), despite of being the gold standard for assessing lung function in COPD, is poorly responsive to pulmonary rehabilitation. Thus, an objective and responsive outcome measure to assess the effect of pulmonary rehabilitation on lung function is needed.

Computerized respiratory sounds have been found to be a more sensitive indicator, detecting and characterizing the severity of respiratory diseases before any other measure, however its potential to detect changes after pulmonary rehabilitation has never been explored. Therefore, this study aims to assess the effects of pulmonary rehabilitation on the characteristics of computerized respiratory sounds in patients with COPD.

A randomized controlled study with one group undergoing pulmonary rehabilitation (n=25) and other group receiving standard care (n=25) will be conducted. The pulmonary rehabilitation program will included exercise training (3\*week) and psychoeducation (1\*week).

Computerized respiratory sounds, lung function, exercise capacity, quadriceps muscle strength, health-related quality of life and health services use will be assessed in both groups, at baseline, immediately post-intervention and at follow-ups (3 and 6 months after PR).

Descriptive and inferential statistics will be used.

It is expected that significant changes occur on the characteristics of computerized respiratory sounds in patients enrolled in the pulmonary rehabilitation group, in comparison with patients receiving standard care. Thus, computerized respiratory sounds could provide a simple, objective and non-invasive measure to assess lung function changes after pulmonary rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria;
* ≥ 18 years old;
* clinical stability for 1 month prior to the study (no hospital admissions, exacerbations or changes in medication);
* able to provide their own informed consent.

Exclusion Criteria:

* presence of concomitant respiratory diseases;
* presence of severe psychiatric conditions;
* presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease.