cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).

This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an Extension phase which consisted of a dose-blinded period and an open-label period.

In the Core phase, patients were randomized to receive a fixed dose of fingolimod (0.5 mg/day), fingolimod (1.25 mg/day) or placebo for up to 24 months.

For the Extension phase, patients who were treated with fingolimod during the Core phase continued treatment at the assigned dose level, while those previously treated with placebo during the Core phase were re-randomized in a 1:1 ratio to receive one of the two doses of fingolimod (1.25 mg or 0.5 mg). All patients in the extension received blinded investigational drug: fingolimod 1.25 mg and 0.5 mg in capsules for oral administration once daily until the decision to discontinue the fingolimod 1.25 mg dose became effective and subsequently all patients were switched to open-label fingolimod 0.5 mg.

With the implementation of Amendment 11, the 1.25 mg dose was discontinued and all patients were switched to fingolimod 0.5 mg dose. With the implementation of Amendment 12, all patients treated with Placebo in the fingolimod Core phase were switched to treatment with 0.5 mg fingolimod per day. The Extension phase continued until all patients either discontinued or transferred to Study CFTY720D2399 (NCT01201356; initiated in September 2010).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
* Patients with a relapsing-remitting disease course
* Patients with expanded disability status scale (EDSS) score of 0-5.5

Exclusion Criteria:

* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
* Pregnant or nursing women

For inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of a School-based Influenza Vaccination Program

The purpose of this study is to determine whether inactivated influenza vaccines are effective to protect school children and their households from getting influenza infection and further prevent student's absenteeism.

School children were found to be the possible spreaders of the influenza. The successful prevention measure on school children was crucial for controlling the epidemic. In Taiwan, the national influenza immunization program on the grade 1-2 students started in winter, 2007. In this intervention study, the two study townships with 27 schools were included as our study population. The three time questionnaires were issued for collecting the health status of the children during the influenza season. The information on the vaccines' safety was also collected after the vaccination. The community collaborative clinics were responsible for taking the specimens.

Eligibility Criteria:
Inclusion Criteria:

* All elementary and junior high school students living in Shinwu and Guanyin townships were eligible to be enrolled into this study
* Agreed inform consent to participate in this study
* Complete three times questionaire follow-up

Exclusion Criteria:

* One junior high school in Shinwu township because it had both high school and junior high school
Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers

The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male adult between 18 and 55 years of age
2. Healthy according to medical history and medical examinations at screening
3. Signed informed consent
4. Prepared to grant authorized persons access to medical records
5. Likely to comply with instructions

Exclusion Criteria:

1. History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial
2. Positive Tuberculin Skin Test (TST) result at screening
3. Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening
4. BCG vaccination any time before entering the trial
5. History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction
6. Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
7. ANA-Titer, HBV, HCV, HIV sero-positive at screening
8. C-reactive protein level \> 50 mg/L at screening
9. Clinically significant abnormal laboratory test results at screening as assessed by the investigator
10. Severe ongoing viral or bacterial infection that might affect the cell mediated immune response
11. A condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access
12. Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination
13. Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination
14. Known hypersensitivity to any of the vaccine components of the investigational vaccines
15. Intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the Ag85B-ESAT-6 antigen
16. Pregnant according to a urine pregnancy test at inclusion
17. Females not willing to use contraceptives or breast feeding
18. Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial
Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function

The purpose of this study is to evaluate safety and effectiveness of normal parathyroid tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of parathyroid gland during thyroid surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by benign thyroid disease undergoing thyroidectomy
Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)

In summary, there are currently many therapeutic tools for achieving some degree of control or even cessation of tobacco addictive use. No single therapy seems to have proven itself sufficiently effective to be the preferred treatment axis in the management of this addiction. We can also point out that so far the main treatments aimed at reducing or controlling the craving phenomenon are of a pharmacological nature, thus exposing the participants to the side effects inherent to this type of treatment. In this perspective, the establishment of non invasive brain stimulation (TdCS), acting in a targeted manner on craving and whose effects would be mild and transient, appears quite justified, especially in addition to psychotherapy. In the context of the management of addictive pathologies, the choice of smoking dependence seems relevant to us insofar as this addiction represents a major public health problem.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 18
* Nicotine dependent subjects according to the Fagerström test (score ≥5)
* Subjects consuming daily tobacco.
* Subjects understanding and reading French and able to express themselves in this language.
* Signed informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and agrees to participate in the study and to comply with the requirements and limitations of this study
* Affiliation to the French social security scheme or beneficiary of such a scheme.
* No other method to decrease or stop smoking at the same time as the study.

Exclusion Criteria:

* Guardianship
* Pregnant or lactating woman
* Patient under AME
* Subject being in the exclusion period of another study or provided for by the "National Volunteer File".
* Subjects with intracranial hypertension
* Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator.
* Treatment with buproprion or varenicline in progress
* Episode or family history of epilepsy, convulsion.
* Disease causing damage to the brain (aneurysm, tumor, ...).
* Cochlear or ocular implant.
* Stimulator or cardiac defibrillator.
* Presence of metal in the skull (clip on aneurysm, prosthesis, ...).
* Eczema on the scalp.
The Effect of Intravenous (IV) Patient Controlled Analgesic (PCA) With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy

The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients scheduled for elective ureteroneocystostomy were enrolled.

Exclusion Criteria:

* History of allergy to aspirin or NSAIDs
* Peptic ulcer disease, and renal function impairment.
* And local infection foci on back, spinal anomalies
* Infectious diseases
* Neurologic disorders
* Seizures and coagulopathies were excluded for sacral epidural block.
Regional Anesthesia Practice in Greece

The purpose of this structured questionnaire is to provide useful insight on the practice of regional anesthesia in Greece and depict the result of educational efforts taking place in the country to expand the knowledge and practice of regional anesthesia in the country


Eligibility Criteria:
Inclusion Criteria:

* greek anesthesia practitioners

Exclusion Criteria:

* nurses
* operating department assistants
* surgeons
IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(\<=30%) when compared to a control group of patients undergoing best medical care.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women of any ethnic origin 18 ≤ aged≤ 65 years
2. EF≤40 (by Echocardiography) and regional wall motion abnormality
3. Not responding to standard therapies
4. the New York Heart Association (NYHA) class ≥ III
5. Myocardial infarction due to coronary artery atherosclerotic disease
6. An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
7. Normal liver and renal function
8. No or controlled diabetes
9. Able to give voluntary written consent and understand the study information provided to him

Exclusion Criteria:

1. Participation in another clinical trial within 30 days prior randomisation
2. Previously received stem/progenitor cell therapy
3. Pregnant women
4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
5. Cardiogenic shock requiring mechanical support
6. Congenital / valvular heart disease
7. Implantable cardioverter defibrillator (ICD) transplant
8. Platelet count \<100.000/µl, or hemoglobin \<8.5 g/dl
9. Impaired renal function, i.e. creatinine \>2.5 mg/dl
10. Fever or diarrhea within 4 weeks prior screening
11. History of bleeding disorder within 3 months prior screening
12. Uncontrolled hypertension (systolic \>180 mmHg and diastolic \>120 mmHg) or Sustained ventricular arrhythmia
13. Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)

This study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels.

The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment.

Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home)
2. Are diagnosed with moderate or complex structural congenital heart disease
3. Live within 120 miles of Nationwide Children's Hospital

Exclusion Criteria:

1. Do no speak or write proficiently in English
2. Have cognitive impairments that would interfere with the completion of study procedures
3. Are diagnosed with a genetic syndrome (e.g., Downs, Marfans)
4. Have been engaged in a formal exercise program within the past 6 months
5. Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months
6. Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity
7. Are unable to complete a treadmill-based exercise stress test
8. Are currently pregnant
9. Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)
10. \>150 min/weekday of moderate-to-vigorous physical activity per the accelerometer
11. Do not have access or a device for videoconferencing with the coach
Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification

The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis.

Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.

Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.

Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women
* 60-80 years
* osteopenia

Exclusion Criteria:

* Calcium metabolic, thyroid, liver or kidney disease
* Diabetes
* Obesity
* Myocardial infarction or other arteriosclerotic events
* Angina pectoris
* Vitamin D \< 50 nmol/L
* Treatment with vitamin K antagonists
* Use of vitamin K supplements in the last month or for more than 3 months at any time
* Treatment with drugs with known effects on bone metabolism or glucose metabolism.
* Smoking in the last 12 months
* Drug or alcohol abuse
* Allergy to calcium, vitamin D or vitamin K.
Open Dialogue About Complementary Alternative Medicine

The purpose of this phase III parallel-group randomized controlled trial is to assess the efficacy of open dialogue about complementary alternative medicine integrated in conventional oncology care (ODC-COC). The investigators hypothesize that patients in the intervention group participating in an ODC-COC with a nurse specialist report better quality of life compared to patients in the control group receiving standard care alone.

Patients randomized to the intervention group will participate in a scheduled ODC-COC with a specialist nurse, who has completed the Fellowship in Integrative Medicine at the University of Arizona. This is a training program for health professionals in empowering individuals and communities to optimize health and well-being through evidence-based, sustainable and integrative approaches. The ODC-COC will be based on the fundamentals of person-centered care according to this program and include patient preferences and wishes, reliable information and counselling and advice about the potential risks and benefits of using complementary alternative medicine as an adjunct to conventional oncology care.

The dialogue lasts approximately 60 minutes and will take place as soon as possible and no later than two weeks after enrolment. The same nurse will conduct all dialogues. According to patient needs and wishes there may be a follow-up dialogue over the telephone or in the Oncology Outpatient Clinic. The potential second dialogue is estimated to last approximately 30 minutes.

Participants in the control group will receive standard information including reference to www.KABcancer.dk, which is a website presenting research on CAM, including information about its potential effects and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Speaks and reads Danish
* Diagnosed with a new primary cancer or a relapse of cancer within the last 3 months
* Planned or initiated medical oncology treatment at the Department of Oncology, Vejle Hospital
* At least two months of oncology treatment is realistic based on clinical assessment
* Life expectancy of at least six months
* Informed consent

Exclusion Criteria:

-Participation in other trials
Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention

The asthma clinical practice guidelines categorize with the highest evidence level the effectiveness of educational programs. However, health care professionals not regularly applied it. This may contribute to inadequate control of the disease. Consequently, their designs and implementation strategies should be reviewed.

Hypothesis. An asthma educational program based on a limited intervention, managed by professionals with minimal training in education, could provide a significant decrease in the morbidity of the disease.

Objective. Determine the effectiveness, in terms of prevention of exacerbations (future risk) and improved asthma control (current control) of an educational program based on a reduced or minimal intervention.

Method. A prospective, multicentre, centre randomized ("clusters analysis"), controlled, designed to evaluate the efficacy (reduction of exacerbations) and control degree control (increased ACT score) of an asthma educational program based on a limited intervention in patients with mild to moderate persistent asthma with an ACT \<20. The cases included will be distributed into three arms: the intervention group, who will take the limited educational asthma program; clinical practice group, who will not receive any specific education; and education "gold standard" group, which will receive a formal program of structured and individualized education. 250 cases will be including from 25 Spanish centres (pulmonary and primary care): 10 allocated to the intervention group, 10 clinical practice group, and 5 of the gold standard group. Each centre will enrol 10 patients and will be followed for a year in four programmed visits. At baseline and at follow-up visits, will be collected in each patient: ACT score, the number of emergency room visits, unscheduled visits, hospital admissions, cycles of oral prednisone (\> 15 days), compliance level, spirometric values and daily dose of inhaled corticosteroid (microg. or equivalent per day). Patients in the intervention group will receive the limited educational asthma program, which have three parts: basic information, establishment and revision of a small Action Plan (MiniPlan) and training and review of the inhalation skill of the prescribed device. Educators involved will attend a short workshop (6 h), where they will be trained in the program.

Eligibility Criteria:
Inclusion Criteria:

* Male and female asthma patients with mild or moderate persistent asthma after treatment according to criteria of the GINA2009.
* Aged 18 and under 70 years.
* With ACT (Asthma Control Test) \<20 treated at the outpatient clinics of the participating centers.

Exclusion Criteria:

* Severe exacerbation of asthma (which required emergency room visit and/or hospitalization) within 30 days prior to visit 1.
* Severe disabling comorbidity.
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease.

This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial

Exclusion Criteria:

* Subjects who had an ongoing serious adverse event from the SP650 double-blind trial that was assessed as related to study medication