cyrilzakka/clinical-trials huggingface dataset:
Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine

The purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.

This was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. The primary outcome was quality of life, assessed by the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and after 10 days of treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific IgE measured by Radioallergosorbent Test (RAST) or skin tests
* patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities)

Exclusion Criteria:

* pregnancy or breast-feeding;
* non-allergic rhinitis (vasomotor, infectious or drug-induced);
* known hypersensitivity to antihistamines;
* clinical disorders that might affect the assessment;
* nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation;
* therapy with immunotherapy;
* use of antihistamines or disodium cromoglycate within the past four weeks;
* use of topical or systemic corticosteroids, immunosuppressants or any investigational drug within the last two weeks;
* use of topical antihistamines or nasal decongestants within the last 48 hours;
* use of deposit steroid within the last month.
Antioxidant Supplements in the Reversal of Schistosomal Peri-portal Fibrosis

Liver fibrosis is the most serious complication of schistosomiasis mansoni. However only limited proportion of subjects with infection develop this pathology and there is limited knowledge on risk factors for the differential morbidity patterns observed in endemic communities. Our preliminary cross-sectional study indicated that serum levels of antioxidants may be related with the development of fibrosis. The present project is a randomised double blinded placebo controlled prospective study investigating the role of food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards to the extent of fibrosis reversal.

Schistosomiasis is the second leading parasitic disease worldwide, after malaria. Liver fibrosis is the most serious complication of schistosomiasis mansoni which can lead to reduced work capacity and early death in endemic countries. There is, however, limited knowledge on the development of liver fibrosis and the differential patterns morbidity observed in endemic communities. Our preliminary cross-sectional study in Ethiopia seems to indicate that serum levels of antioxidants may influence the development of fibrosis. The present project is a translational study combining basic antioxidant laboratory work with is a randomised double blinded placebo controlled prospective study in endemic areas in Ethiopia, investigating the role of food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards to the extent of fibrosis reversal. In addition, analysis of dietary intakes of antioxidants among communities with comparable levels of S. mansoni infection but with differing levels of schistosomal periportal fibrosis will be undertaken to compare serum levels of antioxidants and prevalence of liver fibrosis. Furthermore we plan to assess development of schistosomal peri-portal fibrosis in a cohort of students established 9 years back who had comparable levels of community prevalence of schistosomiasis but with differing access to fruits and vegetables. Research on this topic has a high priority globally which is in line with the millennium development goals. Knowledge in this field will also add to our understanding of fibrosis development in general and to the efficacy of clinical treatment of schistosomiasis in particular.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with schistosomal periportal fibrosis will be eligible for the study

Exclusion Criteria:

* Subjects with acute malaria, tuberculosis or other chronic diseases such as diabetes mellitus, cardiovascular disease or cancer will be excluded from the study.
A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease

Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.

This will be a multi-center, randomized, double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in 30 untreated patients with Gaucher disease. Patients will receive IV infusion of prGCD every two weeks at the selected medical center. The duration of the study will be nine months. At the end of the 9-month treatment period (20 visits, 38 weeks) eligible patients will be offered enrollment in an open-label extension study.

There will be two treatment groups, 15 patients in each treatment group.

Treatment Group I: 30 units/kg every 2 weeks. Treatment Group II: 60 units/kg every 2 weeks.

All patients will have pharmacokinetic data collected over approximately 3 hours with frequent blood samples following the first and final doses of prGCD.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years or older
* Confirmed enzymatic diagnosis of Gaucher disease
* Splenomegaly defined as greater than eight times the expected volume (measured volume divided by estimated volume (0.2% of body weight)\] as determined by MRI volumetric analysis
* Female patients of child-bearing potential who agree to use a medically acceptable method of contraception
* Thrombocytopenia (defined as platelet counts below the lower limit of normal) and/or anemia (defined by hemoglobin level at least 1 g/dL below normal range according to sex and age).
* Patients who have not received ERT in the past or patients whoc have not received ERT in the past 12 months and have a negative anti-glucocerebrosidase antibody test.
* Patients who have not received substrate reduction therapy (SRT) in the past 12 months.
* Ability to provide a written informed consent.

Exclusion Criteria:

* Currently taking another experimental drug for any condition
* Pregnant or nursing
* Presence of HIV and/or, HBsAg and/or hepatitis C infections
* Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease.
* Previous anaphylactoid reaction to Cerezyme® or Ceredase®.
* History of allergy to carrots.
Prevention of Adolescent Major Depression

The main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other selected mental health parameters are investigated.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate level depressive symptoms (RBDI self-report scale)
* adequate knowledge of the Finnish language
* informed consent from the adolescent (all) and his/her parent (under 15 years)
* healthy controls comprise subjects with no depressive symptoms

Exclusion Criteria:

* ongoing major depression, dysthymia or bipolar disorder
* ongoing other severe psychiatric illness precluding group participation
* mental retardation
BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal

This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization.

Hospitalizations can be difficult for patients with cancer, especially when they are transitioning home. Patients and caregivers are often expected to perform complex medical and nursing tasks with little or no preparation. Patients and caregivers report high levels of unmet needs for information about how best to manage symptoms and new medical procedures (such as managing new tubes, lines or drains).

The study team has developed a research project which aims to address these needs. If a patient agrees to participate in the study, she will take part in a program called BOLSTER (Building Out Lifelines for Safety, Trust, Empowerment and Renewal). BOLSTER will provide patients and caregivers with education and skills training, symptom management, and support across care settings.

Eligibility Criteria:
Patient inclusion criteria

* Adults (≥18 years old);
* GYN or GI cancers receiving anti-neoplastic therapy;
* Hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. PleurX catheter);
* Plan to receive ongoing care at DFCI;
* Willingness to be audio taped for the study (for monitoring of study fidelity).
* Have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a PleurX catheter, or need for total parenteral nutrition)

Patient exclusion criteria

* Unable to read and respond to questions in English;
* Cognitive impairment;
* Unable to complete the baseline interview;
* Plan for immediate hospice referral

Caregiver inclusion criteria

* Adults (≥18 years old);
* Family member or friend of an eligible patient;
* Willingness to be audio taped for the study (for monitoring of study fidelity);
* Willingness to participate in study visits

Caregiver exclusion criteria:

* Unable to read and respond to questions in English,
* Cognitive impairment
* Unable to complete the baseline interview
The Efficacy of Computerized Cognitive Training in Adults With ADHD: Change in ADHD Symptoms, Executive Functions and Quality of Life Following Three Months of Training.

The study group of Adults with ADHD who will receive cognitive (executive attention) computerized training will show significant improvement in ADHD symptomatology,neuropsychological measures,daily functioning and quality of life.

A significant difference will be found between the study group and the control group (adults with ADHD that will receive a simplified cognitive training program that does not challenge their executive functions)on the above measures.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18-60);
* 9 years education;
* Diagnosis of ADHD;
* Executive function deficit in daily life;
* Signed informed consent.

Exclusion Criteria:

* Change in pharmacological treatment and/or received new treatment for ADHD in the last three months;
* Other current serious neurological disorder (e.g. epilepsy, brain injury, neurodegenerative disease), other major current and sever psychiatric disorder (axisI);
* Color blindness.
Venous Thrombectomy/Thrombolysis Outcome Registry

Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines .


Eligibility Criteria:
Inclusion Criteria:

•Data obtained in line with good clinical practice, applicable laws and regulation

Exclusion Criteria:

-
Physiology and Residual Ischemia After Percutaneous Coronary Intervention

Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).

Despite successful PCI and complete revascularization, about 25% of patients will present with angina and/or positive exercise testing during follow-up. With recurring or persistent symptoms, a number of those patients will be referred for control angiography. This might create a significant burden for health systems as well as putting patients to undergo further interventions without clear demonstration of ischemia.

Assessing physiology and fractional flow reserve in particular after PCI could represent a further step to determine whether stent implantation and stenosis removal will be effective to relieve subjective and objective signs of ischemia.

Hypothesis:

Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below ischemic threshold) in \> 20% of cases despite optimal stent implantation and angiographic result.

The use of physiology assessment in previously intervened vessels in patients referred for persisting or recurring angina might help operators to decide upon further intervention.

Eligibility Criteria:
Inclusion Criteria:

* Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation.

Exclusion Criteria:

* Unable to understand study design or objectives of study.
* Unable to sign informed consent.
* Evidence of in-stent restenosis or significant untreated coronary lesions (initial incomplete revascularization)
* Inability to comply with the study follow-up
The Effects of Leucine on Body Weight

Protein-rich diets appear to show some benefits in promoting weight loss. It is thought that increased intake of leucine may account for some of this effect. This study is designed to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply to humans.

Specifically, our team would like to determine whether oral leucine supplementation in overweight/obese humans increases metabolic rate, reduces body weight, improves glucose utilization and/or, reduces circulating fat levels in the blood. We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This study will should provide data that can be used to design more definitive trials with regard to dietary leucine supplementation.

Hypothesis

This pilot study is designed to accomplish the following two goals:

1. to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply in humans. Specifically, we want to determine whether oral leucine supplementation in overweight/obese individuals' increases basal metabolic rate, reduces body weight, improves glucose tolerance and/or insulin sensitivity, and/or reduces circulating Low-density Lipoprotein (LDL)-cholesterol levels.
2. To provide data that can be used to design more definitive trials with regard to dietary leucine supplementation.

We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This would in turn lead to more rigorous clinical trials involving larger sample sizes, and with diverse populations of different gender, age, and ethnic groups. Future trials may also be directed to determine minimal doses and durations of leucine supplementation that are capable of achieving clinically significant improvement in the cardio-metabolic risk profile in people.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 year old overweight/obese
* healthy men and women
* Body Mass Index (BMI) of 28-35

Exclusion Criteria:

* unusual or extreme dietary or exercise habits
* daily leucine supplement use
* inability to follow instructions to drink liquid meals
* type 1 diabetes or type 2 diabetes on drug treatment(diet controlled diabetics will be enrolled after consulting with their treating physicians)
* hypothyroidism or hyperthyroidism
* chronic wasting diseases (Acquired Immune Deficiency Syndrome (AIDS), cancers, cirrhosis, renal failure, Chronic Obstructive Pulmonary Disease (COPD), heart failure)
* drug or alcohol abuse
* tobacco smoker within the past 6 months
* pregnancy or lactating
* use of medications known to affect carbohydrate or lipid metabolism, satiety, or hunger
* anemia
* abnormal liver function tests (LFTs)
* women who are of child bearing age without adequate birth control modality
A Study of LY3090106 in Japanese and Caucasian Healthy Participants

The main purpose of this study is to evaluate the safety of a study drug known as LY3090106 in healthy Caucasian and Japanese participants. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug. The study will last about 12 weeks, not including screening or additional follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy Japanese or Caucasian
* Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have participated, within the last 30 days, in a clinical study involving an investigational product (IP). If the previous IP has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
* Have had symptomatic herpes zoster within 3 months of screening
* Show evidence of active or latent tuberculosis (TB)
* Have known hypogammaglobulinemia or a screening serum immunoglobulin (Ig) G \<565 milligrams per deciliter (mg/dL)
* Have received live or attenuated vaccine(s) within 1 month of screening, or intend to during the study
* Are immunocompromised
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. Participants with any prior exposure to ixekizumab, tabalumab or other biologic agents directly targeting Interleukin 17 (IL-17) and/or B cells (e.g., rituximab, belimumab, etc.) are excluded
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered Subcutaneously to Healthy Volunteers

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS TMPRSS6-Lrx Administered Subcutaneously for up to 44 Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-65 inclusive at the time of Informed Consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI \< 32 kg/m2

Exclusion Criteria:

* Clinically significant abnormalities in medical history or physical examination
* Clinically significant lab abnormalities that would render a subject unsuitable for inclusion
* Known history or positive test for HIV, HCV, or HBV
* Treatment with another Study Drug, biological agent, or device within one-month of Screening or 5 half-lives of investigational agent, whichever is longer
* Smoking \> 10 cigarettes per day
* Regular excessive use of alcohol within 6 months of screening
* Current use of concomitant medications other than occasional acetaminophen (paracetamol) or ibuprofen unless approved by Sponsor Medical Monitor
* Considered unsuitable for inclusion by the Investigator or Sponsor
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery

The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis. Patients referred for surgical aorticvalve replacement will be offered to participarte in the study.

The main questions the study aims to answer are:

1. Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase, Angiotensin-II, ACE, ACE2 and Angiotensin receptor 1 and 2.
2. Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system.
3. Gender differences in LV remodelling associates with different levels of sexual hormones.

Patients participating in the study will be asked to undergo:

* Cardiac ultrasound, MR- and CT-scan prior to surgery
* Blooddraw prior to surgery.
* Heartmuscle biopsy during surgery
* Cardiac MR-scan 1 year after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Severe AS (estimated by the local heart team, aortic valve area\<1cm2) referred for AVR at the cardiology department at Odense University Hospital
2. Age \> 18 years
3. Signed informed consent

Exclusion Criteria:

1. Bicuspid aortic valve.
2. LV systolic dysfunction (LVEF\<50%).
3. Patients with concomitant moderate-severe aortic valve regurgitation.
4. Concomitant moderate-severe mitral valve regurgitation.
5. Moderate to severe nephropathy (s-creatinine \>200 mmol/l)
6. Unwilling to participate in the study.
7. Claustrophobia.
8. Permanent cardiac devices (pacemaker and ICD)