cyrilzakka/clinical-trials huggingface dataset:
Cut Off for the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients

CMV disease is a challenge to the success of renal transplantation. Recently, the investigators analyzed data from 792 renal transplant recipients performed at our hospital between 1999 and 2005. After the usual exclusions, 663 patients were analyzed. This population showed that the incidence of CMV disease is stable and occurs in approximately 20-22% of all patients and invasive disease in approximately 5% every year. In seronegative patients and those receiving anti-lymphocyte (AL), CMV prophylaxis, done with ganciclovir for 90 days is our routine and in the majority of transplant centers. In seropositive patients without associated risk factors (such as the use of AL) universal prophylaxis is not done. Rather, in this group, early diagnosis, by detection of antigenemia or viremia by quantitative PCR, is performed in patients who show symptoms compatible with CMV disease. In the investigators analysis the incidence of CMV disease in seropositive patients is around 16%. These patients are usually hospitalized and treated with GCV IV for 14-21 days. This leads to an additional costs of admissions, biopsies for the diagnosis of disease invasion, etc. Besides these costs, the survival of the grafts in the long run is lower in patients with CMV disease than in those without CMV, particularly when associated with acute rejection. In recent years, monitoring of viremia (PCR / antigenemia) and preemptive treatment when it reaches substantial values, have increasingly been suggested. Patients in whom the detection of viremia in progressive values is detected would be treated as outpatients before the disease develops. To turn this hypothesis into reality, there is an urgent need to define cutoff values for CMV-PCR in the detection of developing CMV disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 14 years and younger than 75 years
* Seropositive for CMV (IgG)
* Kidney transplant recipients

Exclusion Criteria:

* Patients who received anti-lymphocyte induction
* Patients with organ transplants double
Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
* Her-2negative breast cancer or unknown Her-2 status.
* at least 1 measurable lesion as defined by RECIST.
* ECOG status 0-1
* adequate bone marrow, hepatic and renal function.
* left ventricular ejection fraction of greater than or equal to 50%.
* willingness to discontinue hormonal therapy.

Exclusion Criteria:

* any previous chemotherapy for advanced disease.
* prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
* symptomatic brain metastases.
* prior anti-IGF-1R based investigational therapy.
* peripheral neuropathy greater than grade 2.
Hepato-pancreato-biliary Abnormalities in Fibrous Dysplasia of Bone/McCune Albright Syndrome

Fibrous dysplasia of bone /McCune Albright syndrome (FD/MAS) is a rare bone disease caused by somatic mutations in GNAS gene. This GNAS mutation predisposes to cancers, including breast cancer, thyroid cancer, chondrosarcoma and osteosarcoma, as well as biliary tract anomalies, liver-tumors or pancreatic tumors - IPMNs. Intraductal papillary and mucinous neoplasms of the pancreas (IPMN) are cystic intraepithelial ductal lesions developed at the expense of pancreatic ducts. They are pre-cancerous lesions, requiring monitoring and, in case of progression or malignant degeneration, surgical resection. Pancreatic MRI screening of patients with polyostotic FD and MAS is recommended.

The aim of this study is to investigate the epidemiology and characteristics of these hepato-pancreato-biliary abnormalities (prevalence, age of onset, degeneration), based on magnetic resonance imaging (MRI) realized during the follow-up of patients with FD/MAS treated in a French FD expert center.

A better understanding of these IPMNs and other digestive abnormalities will enable clinicians to improve the management and monitoring in this high-risk population.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years with polyostotic FD/MAS
* Followed up in the national FD reference center (Lyon) or in a FD French expert center: Angers, Bordeaux, Brest, Caen, Clermont-Ferrand, Lille, Marseille, Montpellier, Nice, Paris, Poitiers, Rennes, Saint-Etienne, Strasbourg.
* who had an hepato-bilio-pancreatic MRI during their follow-up, since January 2002
* No objection to data collection

Exclusion Criteria:

-Opposition to data collection
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes

The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female subjects 18 years of age and older, with no past or present history of any significant internal disease
* Subjects who:

  * show a high degree of fluorescence of the facial skin under a Wood's lamp, indicating the presence of P acnes
  * have Baseline P acnes count of \> 10,000 per cm2 CFU of the facial skin (forehead)
  * have high level resistance to erythromycin, variable resistance to clindamycin, resistance to tetracycline and variable resistance to doxycycline and minocycline

Exclusion Criteria:

* Subjects who exhibit any skin disorders of an acute or chronic nature (e.g., psoriasis, eczema, etc)
* Subjects who have taken topical or systemic antibiotics within 4 weeks prior to baseline assessments
* Subjects who have used other medications which may influence skin surface P acnes levels
* Subjects who are unwilling to refrain from using toners, astringents or other drying agents on the face during the study
Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy

The study proposes to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.

This study proposes to: (1) to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic (body structure and body function) changes not observed with normal saline injections, in children with spastic diplegic CP who walk with a flexed-knee gait pattern; (2) to assess whether physiologic changes translate into functional (activity and participation) improvements; (3) to evaluate family's perception of change in function, activity, participation, and quality of life.

This study will demonstrate if BTX-A injected into overactive hamstring muscles of children with spastic cerebral palsy (CP) and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the International Classification of Functioning, Disability, and Health (ICF). It is a multi-center, prospective, randomized, double-blind trial comparing results of injection of BTX- A and placebo saline in controls, into overactive hamstring muscles, using multiple outcomes measures. Temporal-spatial gait parameters, instrumented 3DGA kinematics, passive ROM, spasticity measurement with both Ashworth and Tardieu scales, muscle strength/control, Gross Motor Function Measurement (GMFM), Pediatric Outcomes Data Collection Instrument (PODCI), Gillette Functional Assessment Questionnaire (FAQ), 6-Minute Walk Test, and Goal Attainment Scale (GAS), assessing all ICF domains, will be collected at baseline and at 1 month, 3 months, and 6 months post-injection. Power analysis demonstrates the need to randomize 250 children (125 with BTX-A, 125 with saline), allowing for attrition. Nine participating hospitals will contribute patients.

Eligibility Criteria:
Inclusion Criteria:

1. Spastic cerebral palsy;
2. Bilateral lower extremity involvement;
3. Spasticity present in the hamstrings;
4. Flexed knee gait \>15 degrees by observation (OGS);
5. Age between 3 and 18 years old; (
6. GMFCS Level I to Level IV; (
7. Able to walk a minimum of 4 complete steps without resting with and without braces/shoes a minimum of 3 times;
8. Able to follow simple commands;
9. Cooperative with physicians and therapist;
10. Able to tolerate application of equipment to the skin.

Exclusion Criteria:

1. Rhizotomy surgery within the last 1 year;
2. Lower extremity surgical procedures (soft tissue or bony) within the past 1 year;
3. Currently implanted and operating Intrathecal Baclofen Pump (oral baclofen OK);
4. Lower extremity BTX-A injections within the past 6 months;
5. Multilevel BTX-A injections;
6. Gait trainer reliance;
7. Serial casting 3 months prior to or during study protocol.
AIDS Wasting in Women: Anabolic Effects of Testosterone

The study is a 6 month, placebo-controlled study of transdermal testosterone for women with HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone levels. This study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open label transdermal testosterone for an additional 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera
* Documented HIV infection
* Free testosterone level 3.0 pg/mL
* Weight \< 90% or weight loss \> 10% of pre-illness weight

Exclusion Criteria:

* Pregnant or actively seeking pregnancy
* Breast feeding
* New opportunistic infection diagnosed within 4 weeks of the study
* Requiring parenteral nutrition or pharmacologic glucocorticoid therapy
* Intractable diarrhea (6 stools/day)
* Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace
* New retroviral therapy within 6 weeks of study
* SGOT \> 5 X normal and/or clinically significant liver disease
* Creatinine \> 2.0 mg/dL and/or clinically significant renal disease
* Hgb \< 8.0 g/dL
* Active substance abuse or alcoholism
Do Change in Life Style Improve Work Ability?

The main aim of this Cohort trial is to get more information about how life style changes affect work participation for people with BMI above 30. The information can contribute to improving the quality of occupational rehabilitation programs in the specialized health care services and for others who work with weight loss programs and work related rehabilitation programs.

The goal of rehabilitation, in general, is to help people to reach and maintain their optimal function and copying capabilities and to promote independence and participation in society. For occupational rehabilitation is the goal also to increase function and work ability to prevent the individuals permanent to fall out of working life. People with high BMI needs beside work rehabilitation also focus on life style changes to reduce consequences of obesity. The Central Norway Regional Health Authority (HMN RHF) has initiated action to reduce work absence and consequence of obesity by introducing a work related rehabilitation program for people with BMI above 30. This program combines work participation and life style changes and exists only in two institutions in Norway. The goal of the program is to increase function and work ability and weight loss. The program is new, and few documents exist on the effect and the correlation between life style changes and work ability. There is also need to question whether obesity is the reason for work absence or is there other factors that affect work ability. This trial wants to follow-up a group of people who have been participating occupational rehabilitation at Muritunet.

Eligibility Criteria:
Inclusion Criteria:

1. People who are on sick leave or stands in danger of being sick because of problems related to obesity.
2. The participants must have a realistic opportunity to return to work.
3. Body mass index above 30
4. Age 18-67 years.

Exclusion criteria;

1. People with a severe eating disorder.
2. People without a capacity to consent.
3. People with severe alcohol and/or drug abuse.
4. People with a major mental illness.
5. Being pregnant.
6. People with a health condition that contraindicates physical activity.
7. People who receive work assessment allowance.
8. People with or plan to apply for disability benefits.
9. People with permanently adapted work.
Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography

The purpose of the study is to evaluate if metformin is taken up into the failing myocardium. Recent experimental and epidemiological studies have shown beneficial effects of metformin on heart failure. It is unknown whether this effect is direct or indirect.

The aim of the study is to investigate if metformin is taken up in heart failure using a novel 11C-metformin tracer and positron emission tomography (PET).


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic heart failure, Left Ventricular Ejection Fraction \<45%
* New York Heart Association (NYHA) class I, II, III
* Relatively preserved renal function (eGFR \> 30 ml/min)
* Ability to understand the written patient information and to give informed consent
* Negative p-HCG for women of childbearing potential

Exclusion Criteria:

* Known allergy to metformin
* Age \< 18 years
* Current abuse of alcohol or drugs
Validation of Capillary Serum Sodium Levels

Prospective interventional study to determine sodium levels in capillary blood via finger prick. The goal is to determine if this technique is suitable and equal to a standard venous blood collection for the analysis of blood sodium levels.The purpose is to compare both sodium levels to determine if they are equal so the technique can be used in a clinical setting for people who need regular blood collections for the determination of sodium, for example after the start of desmopressin use.

Currently, serum sodium levels are determined by standard venous blood sampling. This method is invasive, painful and a relatively large amount of blood is drawn (5ml). Repeated blood draws are necessary in certain patient groups. If sodium values can be determined on a capillary blood sample instead of a classic venous blood sample, the total blood volume will be smaller. In addition, in the future, the aim is to perform capillary blood sampling at home and to send the sample by courier, thus saving the patient a trip to the doctor's office or a nurse at home.

The aim of this prospective interventional study is to validate the sodium values on a capillary blood sample obtained via fingerstick (250µL). To demonstrate that the obtained values are reliable and clinically useful they will be compared one-on-one with the sodium values determined on a standard venous blood sample. Since it is important to validate a broad range of sodium values, a heterogeneous study population is chosen to obtain sufficient variation.

Patients admitted to the Urology department at UZ Gent will be informed verbally and in writing about the content and purpose of the study. If they are interested in participating, they will be asked to sign the consent form. At the moment the already planned venous blood collection, a capillary blood sample will be taken as well via a finger prick. A number of blood drops (250 µL) are collected in a standard Lithium-Heparin tube and will be collected by lab Maenhout for further analysis. The venous blood sample, which is taken as part of the therapy/diagnosis (independent of the study, standard of care) during admission, is analyzed by the clinical lab of UZ Gent.

The sodium values from the capillary blood draw will be compared with the values from the venous blood draw, with each patient acting as their own control. There is no need to have the venous blood samples analyzed by Labo Maenhout, as the clinical lab of UZ Gent uses the same technique for sodium determination (indirect determination) as Labo Maenhout.

The sodium values obtained through capillary and venous blood sampling will be statistically analyzed using a Passing-Bablok regression model.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years or older
* admitted to the urology ward

Exclusion Criteria:

* none
S90652 in Paediatric Hypertension

The aim of the study is to assess the acceptability, safety and pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril given in hypertensive children


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive children

Exclusion Criteria:

* Renal failure
* Unstable renal function
* Hyperkaliemia
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk

Heavy bleeding after childbirth, known as a postpartum haemorrhage (PPH), causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The I'M WOMAN trial is a research study to see whether giving TXA just before childbirth will stop women developing PPH. The trial will assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid on PPH, side effects and other important maternal health outcomes.

Postpartum haemorrhage (PPH) causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The WOMAN trial recruited over 20,000 women with PPH and found that intravenous (IV) TXA given soon after PPH onset, reduces bleeding deaths by about a third. Early TXA also reduces blood loss in surgery and death due to bleeding after traumatic injury. The World Health Organization recommends that all women with PPH should receive TXA as a first line treatment.

TXA is more effective when given soon after the bleeding starts. Every fifteen minute delay reduces the survival benefit by about 10%. This suggests that giving TXA around the time of childbirth might prevent PPH. Although several clinical trials have examined the effectiveness of TXA for the prevention of PPH, the results are inconclusive. Trials of tranexamic acid for PPH prevention give the trial treatment after cord clamping, which may be too late to prevent bad bleeding in some women, as bleeding tends to happen soon after childbirth. Because PPH only affects a small proportion of births, the healthcare community need good evidence on the balance of benefits and harms in this population before using TXA to prevent PPH.

The I'M WOMAN trial will evaluate the effects of TXA for PPH prevention in women with one or more risk factors for PPH having a vaginal or caesarean birth. The trial will also evaluate the effect of the route of TXA administration. TXA is usually given by slow IV injection. However, recent research shows that TXA is well tolerated and rapidly absorbed after IM injection, achieving therapeutic blood levels within minutes of injection. There may be fewer side effects with IM TXA because peak blood concentrations are lower than with the IV route, as well as practical advantages.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older who are admitted to hospital to give birth vaginally or by caesarean section, who have one or more known risk factors for PPH

Exclusion Criteria:

* Women who have a clear indication or contraindication for TXA
Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development

The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.


Eligibility Criteria:
Inclusion Criteria:

* This is Phase II trial-subjects have already completed Phase I.
* Traumatic brain injury (TBI).
* Results of the blood work from Phase I shows that your growth hormone levels are low.

Exclusion Criteria:

* Have not completed Phase I of the study.
Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial

Chronic obstructive pulmonary disease (COPD) is a lung condition affecting 1 in 6 Canadians and does not have a cure. Flare-ups of COPD are the most common reason someone goes to hospital in Canada. This is made worse because within 30-days of having a flare-up, 1 in 5 patients will come back to hospital for the same problem.

Flare-ups of COPD often have many causes and these are different person to person. Sometimes it is related to behaviours such as smoking or not using medicines properly. Other times, it is from lung inflammation. Education programs that help people learn about their disease and maintain healthy behaviours, and using phlegm to decide on which medicines will be useful, have been studied separately and appear to work, but many people still have flare-ups. To help fix this problem, we need to look carefully at each patient, to make sure they are on the right medicine but also have the right behaviours and support to benefit from medical care.

The goal of this project is to see if patients who are taught the right behaviours and have their lung inflammation controlled with the right medicines will have fewer COPD flare-ups than those who get normal care.

STRIVE is a randomized-controlled trial comparing a two-pronged intervention, including sputum-biomarker-directed treatment of airway inflammation, and comprehensive care management, to usual care, for COPD patients with frequent exacerbation from two sites.

The intervention consists of 6-months of comprehensive care management (CCM) and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits will occur at 2, 6 and 16 weeks after hospital discharge. For the intervention group, the key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Spontaneous sputum biomarkers will be used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* \>=2 exacerbations of COPD in the last 12-months, FEV1/FVC\<0.7 or radiologic emphysema, with a \>-10 pack-year smoking history

Exclusion Criteria:

* severe mental illness not controlled by medication or life-expectancy less than 6-months