cyrilzakka/clinical-trials huggingface dataset:
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff

In this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for CDAD. We expect to enroll approximately 40 patients over a period of two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who are unresponsive to standard antimicrobial therapy for CDAD.

During the course of this study we expect that IVIG group compared with placebo group will have fewer number of stools per day (\< 3 per day). Secondary endpoints will include normal WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and decrease in length of hospital stay.

Subjects will sign a written informed consent prior to any study procedures. Patients will be monitored closely during the infusion of the study medication and will continue to be monitored on a daily basis up to the time of discharge. Data collection will include vital signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.

See "Brief Summary" for details

Eligibility Criteria:
Inclusion Criteria:

1. Males and female greater than 18 years of age
2. Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness
3. Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD
4. A score of 6 or 7 on the C.Diff Severity and Prognosis Score (CDSPS) scale27,28,29,30 OR failure to respond (as identified by a score of 4 or more on the CDSPS scale below) to any of the following: a 4-day or more course of oral or IV metronidazole 500 mg po TID or QID; or to a 4-day course of oral vancomycin 125-500 mg po Q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po Q6 hours and IV metronidazole 500mg IV Q8 or Q6 hours and/or vancomycin enemas.

CDSPS SCALE (each item is scored as one point for a 7 point maximum total)

1. underlying immunosuppression/chronic medical condition
2. altered or depressed mental status as defined by medical chart documentation
3. abdominal pain and/or distention
4. WBC \> 20,000 or \< 1,500 and/or bandemia \> 10%
5. hypoalbuminemia (\<3 mg/dL)
6. ascites (clinically or per CT scan findings per medical chart)
7. abnormal CT scan findings per medical chart -

Exclusion Criteria:

1. Pregnant or lactating women
2. Selective IgA deficiency
3. Hypersensitivity to immune globulin, human albumin, or thimerosal -
Echinacea Safety Study

Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during October and November 2009 and will be treated with either Echinacea or placebo over a period of 4 months.

Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at least a possible causal relation to the treatment) will be recorded.

Common cold related symptoms will be recorded in a daily diary.


Eligibility Criteria:
Inclusion Criteria:

* On average more than 2 cold episodes per year
* Age above 18 years
* Good physical condition
* Signed informed consent

Exclusion Criteria:

* Women without appropriate and effective contraception
* Participation in a clinical trial 30 days prior to this trial
* Pregnant or breast feeding women
* Subjects with pre-existing cold symptoms for more than 24h at inclusion
* Concurrent participation in another clinical trial
* Intake of antimicrobial and/or antiviral medications at inclusion
* Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 gr and / or 10 cigarettes per day)
* Psychiatric disorders which may influence the results of the trial,
* epilepsy, suicide attempts
* Planned surgical intervention during the trial.
* Serious chronic diseases which influence the absorption, metabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukaemia,
* collagen disorders and multiple sclerosis
* Known AIDS, HIV-infections and autoimmune diseases
* Known diabetes mellitus (type 1)
* Corticosteroid-treated asthma
* Atopic and allergic subjects (under medicinal treatment)
* Known allergy to plants of the composite family (Asteraceae)
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars

While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our assessing the effects of fractional vascular lasers on burn scars. It has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft).

Objective:

To determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.


Eligibility Criteria:
Inclusion Criteria:

* living in Winnipeg
* burn scar 6-12 months old
* Fitzpatrick skin type I-III
* thermal burn scar on trunk or extremities

Exclusion Criteria:

* open wound
The Naples Pediatric Food Allergy (NAPFA) Score

Food Allergy (FA) is one of the most expensive allergic disorders in the pediatric age, and affecting up to 10% of children worldwide, it is recognized as a global health problem. The Oral Food Challenge (OFC) is the gold standard for FA diagnosis, but it is time-consuming, expensive, and potentially dangerous, as it can determine severe anaphylaxis. In addition, causing long-lasting impact on patient anxiety and mental health due to the physical duress and health risks involved with its application, OFC strategy is little applied in clinical practice with consequent diagnostic errors and delays. The goal of the Naples Pediatric Food Allergy (NAPFA) score is to develop a new clinical score including the main anamnestic, and clinical features for the easy identification of pediatric FA in primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* subjects aged between 0-14 years with suggestive history of food allergy

Exclusion Criteria:

* Exclusion criteria: age \>14 years
* chronic systemic diseases,
* malignancy,
* immunodeficiency,
* infectious diseases,
* autoimmune diseases,
* inflammatory bowel diseases,
* celiac disease,
* metabolic and genetic diseases,
* cystic fibrosis,
* chronic pulmonary diseases,
* gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,
* neurologic and/or neuropsychiatric disorders,
* gastrointestinal tract eosinophilic disorders,
* use of immunomodulating drugs in the previous 4 months
* use of steroids and antihistamines in the previous 2 weeks
Readmission in the Case of Patients With Heart Failure

Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.

Investigators goals are to make an inventory of PRADO-IC project in terms of its effectiveness on readmission of patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* Patient readmitted for heart failure

Exclusion Criteria:

* Population whose age is less than 18 years
Exercise for Breast Cancer Patients (EXCAP)

The purpose of this study is to examine if exercise helps improve cancer-related fatigue.

Hypothesis: A structured home-based walking and progressive resistance exercise program will be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine profiles in breast cancer survivors as well as those receiving radiation treatment.

Fatigue is a frequently reported side effect of cancer treatment. Fatigue related to cancer and its treatment is different from fatigue occurring in other situations and its specific causes have not been identified. Exercise may or may not improve this type of fatigue. The purpose of this study is to examine how cancer treatments impact normal lifestyle physical activity patterns and participation in physical activity, as well as the ability of a walking and progressive resistance exercise program to reduce cancer-related fatigue in breast cancer patients. This study also examines if the walking and progressive resistance exercise program improves other factors such as quality of life, depression, anxiety, ability to sleep, self esteem, cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and immune function (as measured by inflammatory cytokines).

Eligibility Criteria:
Inclusion Criteria:

* Have a primary diagnosis of breast cancer,
* Have a functional capacity rating of 60 or greater on the Karnofsky Performance Scale, when assessed by the oncologist (or physician's designee)
* Be breast cancer survivor(e.g., surgery, radiation therapy, chemotherapy, hormone therapy). Have a life expectancy of \>1 year as determined by the patient's oncologist.
* Have the approval of their treating physician, study physician(or physician's designee) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program.
* Be able to read English.
* Be 21 years of age or older.
* Give informed consent.

Exclusion Criteria:

* Have bone metastases that preclude participation in an exercise program either due to symptoms such as pain or location of bone metastasis.
* Have physical limitations (i.e. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in sub-maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the PAR-Q and radiation oncologist (or physician's designee)
* Be identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form.
Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography

The purpose of this research study is to collect data/measurements that are routinely collected in standard of care cerebral angiogram

Research for this study is to determine how the injection of contrast material influences vessel measurements, as these measurements guide device selection when interventions are warranted.

The data will be used to determine if there is a significant change in vessel diameter with intra-arterial injection of contrast material in cerebral angiography, how changes in force of contrast injection augments the significance of the changes in vessel geometry, and the extent of propagation downstream from the catheter tip that such changes in vessel diameter are detected and found to be significant, as these changes could potentially lead to less optimal device selection by providing an overestimation of true vessel diameter.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving care at WFBMC that will be undergoing a standard of care cerebral angiogram who are anticipated to have a minimum of 2 images for an individual view required for the necessary data collection

Exclusion Criteria:

* Patients who are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.
Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index

The purpose of this study is to determine the effect of inhaled anesthetic drugs upon diastolic heart function (heart suction and filling performance) in patients who are undergoing coronary bypass surgery.

Diastolic heart dysfunction is a significant cause of cardiovascular morbidity and is the cause of symptomatic heart failure in approximately one half of patients who are admitted to hospitals with heart failure symptoms. However, diastolic heart function remains difficult to measure objectively without cardiac catheterization. Diastolic heart dysfunction is also common among patients undergoing coronary bypass grafting (CABG) surgery. Despite the ubiquitous use of inhaled volatile drugs to maintain anesthesia in these patients, their effects upon diastolic heart function remain unclear.

Eligibility Criteria:
Inclusion Criteria:

* Non-emergent coronary bypass grafting surgery
* Left ventricular ejection fraction of 40% or greater

Exclusion Criteria:

* Myocardial infarction within 4 weeks
* Greater than mild cardiac valvular pathology
* Body mass index greater than 35
* Cardiac dysrhythmias or pacemaker therapy
* Left bundle branch block
* Uncontrolled gastroesophageal reflux disease
Realization of Sequencing of All Known Human Genes in Case of Detection of Cerebral, Renal or Ophthalmological Fetal Malformations During Pregnancy in Order to Make an Etiological Diagnosis and to Precise the Fetal Prognosis

Congenital malformations concern 3% of pregnancies; most of them can be seen during pregnancy. For some malformations, an invasive sample (trophoblast biopsy or amniocentesis) is proposed to search a chromosomal abnormality by the technique of DNA chip. However, some strongly suggestive signs of a genetic (and not chromosomal) pathology have a very low diagnostic rate with this technique. In the absence of an etiological diagnosis, the prognosis for the unborn child is very difficult to assess, as we can't know if the fetal malformation is really isolated or associted to other unseen features as part of a syndromic condition.

For some malformations strongly suggestive of a genetic condition, we propose to realize an exome (i.e. all coding parts of the genome) sequencing of the trio (child and the 2 parents) with a delivery time compatible with the emergency situation of a pregnancy (6 weeks maximum). We will apply bioinformatics filters to analyse only genes known to be involved in the malformation present in the unborn child and thus avoid the identification of variants in unrelated genes. These lists of genes have been previously validated by the Rare Disease Health Sectors and the affiliated diagnostic laboratories. The selected malformations are: 1) anomalies of the central nervous system (microcephaly (\<- 2DS) with anomalies of gyration, anomalies of the posterior fossa, anomalies of the midline except agenesis of the corpus callosum), 2) ophthalmological anomalies (microphthalmia, hyperplasia vitreous) and 3) renal abnormalities (large hyperechoic kidneys).


Eligibility Criteria:
Inclusion Criteria:

* Father and mother of an unborn child past the age of majority
* Consent dated and signed by the mother and by the father
* Father and mother able to understand the objectives and risks of the study
* For the mother, pregnancy in progress (between 12 and 34 weeks)
* For the mother, pregnancy with the presence of a malformation on ultrasound, confirmed by a doctor from the multidisciplinary diagnostic prenatal center, entering into the indications retained for this study
* Clinical validation of the couple's eligibility by an expert for some of selected indications
* Father and mother affiliated to a social protection health

Exclusion Criteria:

* Identified genetic or chromosomal abnormality explaining the observed malformation
* Inability to give informations to the father and / or mother (father or mother in emergency or life-threatening situation)
* Father and / or mother under the protection of justice
* Father and / or mother under guardianship or curatorship
* Nursing woman
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients

The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy (ERT).

This study is being conducted to satisfy post-marketing commitments to monitor anti-idursulfase antibody development in Hunter syndrome patients after long-term idursulfase enzyme replacement therapy. The study will be conducted as a sub-study within the Hunter Outcome Survey (HOS). Hunter syndrome patients in the HOS who have previously received idursulfase as well as treatment-naive patients who will begin idursulfase treatment within 30 days of study enrollment will be included.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following criteria to be considered eligible for enrollment:

* The patient is male and enrolled in the HOS (i.e., meets the entry criteria of a documented diagnosis of Hunter syndrome)
* The patient is ≥ 5 years-old
* The patient is on idursulfase treatment or scheduled to begin idursulfase treatment within 30 days of study enrollment
* The patient, patient's parent(s), or patient's legally authorized guardian must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient, patient's parent(s), or patient's legally authorized guardian.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for this study:

* The patient has received biologic/ERT products other than idursulfase, or other investigational product(s) for any reason within 30 days prior to study entry.
* The patient has a life expectancy of \< 2 years
* The patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making implementation of the protocol difficult; has an uncooperative attitude; is unable to return for safety evaluations; or is otherwise unlikely to complete the study, as determined by the Investigator.
Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders

The purpose of this study is to determine whether Integrated Treatment is effective in the treatment of anxiety and/or depression with co-occurring substance use disorders.

Patients with mental disorders and co-occuring substance use disorders are characterized by high suicide rates, high treatment drop-out rates and long-lasting interpersonal, work, school, health and legal problems. Because mental disorders and substance use disorders co-exist and interact, it may be important to provide a treatment that addresses the substance misuse and mental health problems in an integrated and comprehensive way. Additionally, the health services for patients with mental health and substance use disorders are usually provided by different services and health professionals that rarely cooperate or have qualifications on both kinds of disorders. This also calls for an integration of the services on an organizational level. This approach of integrating services and treatment approaches for both diseases in a comprehensive way is called Integrated Treatment. Several studies have shown that Integrated Treatment is effective in treating the comorbidity of severe mental illness and substance use disorders. The over-all aim of this study is to evaluate the effects of evidence-based Integrated Treatment in anxiety and/or depression with co-occurring substance use disorders. The effects of the treatment will be assesses on changes in substance use and psychopathology.

Comparison: patients receiving treatment-as-usual or non-manualized treatment at general mental health outpatients clinics.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of substance use disorder
* clinical diagnosis of anxiety disorders
* clinical diagnosis of nonpsychotic mood disorders
* written consent
* planning to live in the catchment area during the treatment

Exclusion Criteria:

* schizophrenia spectrum disorders
* other psychotic disorders
* mental retardation
* nicotine abuse/dependency only
* prescription drug abuse/dependency only
* planning to move out of the catchment area during the study
* not able to read or write Norwegian
A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies

Regorafenib is an anti-cancer drug that blocks several proteins which are involved in the growth of cancer. It has been approved for different types of cancers of the digestive system and is being tested for use in some other solid tumors. Cancers that start in an organ, a muscle, or a bone form a solid tumor.

This study is for participants with solid tumors who have been taking regorafenib in other Bayer studies. They can continue taking regorafenib if it is working when treatment with regorafenib in their previous study ends.

The main purpose of this study is to find:

* How safe is the continued treatment with regorafenib in participants with solid tumors?
* How well is the continued treatment with regorafenib tolerated by participants with solid tumors?

Participants will continue with the same dose of regorafenib that they were taking in their previous study as long as the treatment works for them/they want to continue the treatment/other medical conditions do not prevent them from participating in the study. For participants that are under 18 years of age, regorafenib tablets will be taken by mouth once daily for 2 weeks and repeat again after a 1-week gap. For participants that are over 18 years of age, regorafenib tablets will be taken by mouth once daily for 3 weeks and repeat again after a 1-week gap.

At the start of the study, researchers will review participants' records from the previous study. During the study, researchers will use blood samples and X-rays taken from participants under the age of 18 years to check how safe regorafenib is for children. They will also monitor any medical problems that participants may have during the study. After the last dose, follow-up will be done either within 14 days when participants visit their study doctor or within 30-35 days by phone call.

Both the researchers and the participants will know the dose of regorafenib the participants receive during the study.


Eligibility Criteria:
Inclusion Criteria:

* Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment.
* Participant is currently benefiting from treatment with regorafenib monotherapy. All participants must meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
* Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

Exclusion Criteria:

* Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study.
* Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy.
* Participants are using one or more of the prohibited medications listed in the respective feeder study protocol.
* Participant has been previously permanently discontinued from regorafenib treatment.