cyrilzakka/clinical-trials huggingface dataset:
A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)

This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core study on SC or IV TCZ and, based on the Investigator's judgment, may continue to benefit from TCZ treatment in this study investigating the SC formulation
* Receiving treatment on an outpatient basis
* Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol

Exclusion Criteria:

* Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) core studies for any reason
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Evidence of serious uncontrolled concomitant disease or disorder
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
* Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
* History of or currently active primary or secondary immunodeficiency
* Oral corticosteroids at greater than (\>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose
* Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline
* Treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and enrollment in the long-term extension study
* Pregnant or breastfeeding women
* History of alcohol, drug, or chemical abuse within 1 year prior to Screening
Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography

RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Having an 2D-STE interchangeable parameter would allow accurate measurement of RV systolic function before, during and after cardiac surgery. However, to date, there are no data on the interchangeability of RV-LSF measurements performed in TTE and TEE.

The aim of the study is to evaluate the interchangeability of TTE and TEE measurements of RV-LSF during cardiopulmonary bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\>18 years)
* Patient hospitalized at the Amiens University Hospital for scheduled cardiac surgery under cardiopulmonary bypass.
* Information of the patient and collection of his non-opposition

Exclusion Criteria:

* Patient with a contraindication to the realization of TEE (gastric or mediastinal pathology)
* Patient with poor echogenicity on TEE not allowing evaluation of 2D-STE parameters of the right ventricle
* Patient with a rapid supraventricular rhythm disorder (HR \> 100) at the time of TTE and/or TEE.
Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia

The main goal of this study is to get to know if applying both, pain neuroscience education (PNE) plus strength training (ST) will reduce the pain of fibromyalgia (FM). Both therapies have shown evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their efficacy in combination.

At present, the increase in knowledge about the neuroscience of pain has led to the integration of psychological factors, such as cognitions and beliefs about pain, fear-avoidance behaviors or catastrophism within the integrative perception of the concept . This has led to the development of therapeutic strategies aimed at the reconceptualization of pain through a treatment method called Pain Neuroscience Education (PNE), having shown evidence in the treatment of pain, disability, catastrophism and physical performance.

But despite current advances in pain neuroscience, there are still pain syndromes, such as fibromyalgia, that are the subject of debate and controversy. Fibromyalgia is a syndrome that causes generalized musculoskeletal pain, fatigue, sleep disorders, and physical disability. It is the main cause of chronic generalized musculoskeletal pain, with a prevalence of 1-5% of the world population. Scientific research has provided new insight for the diagnosis of fibromyalgia patients, who are characterized by a central sensitization process.

Objectives:

To assess the effectiveness of Pain Neuroscience Education and Strength Training to decrease pain and disability; and increasing quality of life and functionality in patients with Fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with fibromyalgia.
* Duration of pain greater than one year.
* Generalized or present pain in more than two body regions.
* Not having participated in pain neuroscience education program.
* Not having participated in physical exercise programs in the last three months.

Exclusion Criteria:

* Presence of other diseases not related to the musculoskeletal system.
* Being under medical treatment not related to pain.
* being under physiotherapeutic treatment related to pain.
* Unavailability to carry out a physical exercise program.
* Pregnant or puerperium women.
* Inability to perform or complete the necessary tests to measure the study variables.
Effects of Slow Breathing on Blood Pressure and Autonomic Function

Hypertension is a chronic disease that affects about 23% of the brazilian population. The treatment of hypertension by pharmacological intervention is efficacious, but has side effects and significant costs. Techniques that reduce the respiratory rate are shown as a effective non-pharmacological treatment in controlling blood pressure. Evidence has shown that a slow and deep breathing rate, around 10 breaths per minute or less, significantly reduces blood pressure. However, the physiological mechanisms involved in blood pressure decrease due to decreased respiratory rate are not yet known. Therefore the goals of this study will evaluate the chronic effect of breathing exercise guided on office and 24 hours blood pressure and analyse the chronic effect of breathing exercise guided over the autonomic function in hypertensive patients in stages 1 and 2.


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients with or without use of antihypertensive drug therapy with office systolic blood pressure between 140 and 179 mmHg and / or office diastolic between 90 and 109mmHg).
* Adults over 18 years.
* Both genders.

Exclusion Criteria:

* Use of medications that alter sympathetic nerve activity (beta blockers and / or sympatholytics).
* Use of three or more classes of antihypertensive drugs
* Secondary Hypertension
* Chronic Respiratory Disease
* Diabetes Mellitus.
* Chronic Kidney Disease with Clearance Creatinine \<60 ml/min
* Congestive heart failure
* Coronary disease
* Pregnant
* BMI \> 30 kg/m2
Chemotherapy-Related Toxicities In Ovarian Cancer Patients

Primary Objectives:

1. To assess the preferences of women with ovarian cancer, their clinical caregivers, familial caregivers, and a control group for toxicities associated with chemotherapy.

   * To compare preferences of women with ovarian cancer to preferences of their clinical caregivers.
   * To compare preferences of women with ovarian cancer to preferences of their familial caregivers.
   * To compare preferences of women with ovarian cancer to preferences of a women in the control group.
2. To prospectively collect quality of life data from women with ovarian cancer.
3. To prospectively collect symptom assessment data from women with ovarian cancer.

Patients in this study will be recruited from the Gynecologic Oncology Clinic waiting area. All participants (patients, family and clinical caregivers, control group women with no cancer) in this study will take part in an interview to see how they feel about the different side-effects of chemotherapy. The interview will involve reading short descriptions of the side-effects and then answering some questions that ask for an opinion. The actual interview will take about 30-45 minutes to complete. The interviews will either take place in private conference rooms in the clinic or in private rooms at the Ambulatory Treatment Center (ATC).

Patients will also be given quality of life and symptom assessment questionnaires. The questionnaires are simple to read and quick to answer. The questionnaire takes about 15 minutes to complete.

The participant's involvement in this study is limited to the questionnaire/interview. Once that is done, the participant is finished with the study.

This is an investigational study. A total of 288 people will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Women with epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are currently undergoing chemotherapy
2. Women with a history of epithelial ovarian cancer presenting to the UTMDACC Gynecologic Oncology Clinic who are seen in follow-up
3. Women who are at least 18 years of age
4. Women who speak English
5. Clinical caregivers of patients with ovarian cancer (UTMDACC gynecologic oncologists, UTMDACC gynecologic medical oncologists, UTMDACC registered nurses and licensed vocational nurses in the UTMDACC Gynecology Clinic, and UTMDACC gynecologic oncology fellows and residents)
6. Familial caregivers of patients with ovarian cancer (primary caregiver)

Exclusion Criteria:

1. Participants who are non-English speakers
2. Participants who are less than 18 years of age
Reduction of Environmental Tobacco Smoke (ETS) Exposure at Home: the BIBE Study

Main objective: to determine the effectiveness of a brief opportunist educational performance directed to the parents who smoke -- inside the context of programmed visits of paediatrics in primary care -- to reduce the exposure of the babies to secondhand smoke (SHS)

Secondary objectives:

1. Smoking reduction / quitting of the mother and/or the father
2. To determine the relationship between the level exposure to SHS and main related variables


Eligibility Criteria:
Inclusion Criteria:

* Smoking parents with babies minor 1 year-old

Exclusion Criteria:

* Parents reporting diagnosis of major psychiatric illnesses
* Parents reporting active addictive substances consumption
* Parents in active smoking cessation treatment
Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance

Phase IV, multi-center, non-treatment, observational, registry study to determine long term effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.

The primary objective of this study is to determine the impact of long term AVONEX® treatment on physical status, measured by expanded disability scale score (EDSS), of patients with Multiple Sclerosis (MS) after their first clinical event (clinically isolated syndrome) and Magnetic Resonance Imaging (MRI) consistent with MS.

Secondary objectives are to determine the impact of long term therapy with AVONEX® on the following:

a) MRI parameters- new or enlarging T2 lesions, T2 lesion volume, T1 lesion volume, brain parenchymal fraction (BPF) b) Quality of Life (QoL): Heath Status Questionnaire (SF-36) c) Symbol Digit Modality Test (SDMT)

2. To determine the long term impact of therapy on the following in patients treated at the onset of clinically isolated event (CIS)

1. EDSS
2. MRI parameters
3. SF-36
4. SDMT

   3. To determine early clinical and MRI predictors of disease progression.

   Approximately 383 patients participated in CHAMPS, the original AVONEX® placebo trial, will be approached for study participation. The patient population will be divided into two cohorts.

   Cohort 1: Patients that participated in CHAMPS and CHAMPIONS 10 will be approached for study participation at approximately twenty-four CHAMPIONS Continuation investigative sites.

   Cohort 2: Patients that participated in CHAMPS will be located and approached for study participation. Patient that participated in CHAMPIONS 10 will not be excluded from Cohort 2. Efforts will be made to potentially locate patients through either the original CHAMPS investigative sites, through the Biogen Idec patient services database, and/or a third party (i.e., patient location service vendor) or some combination of the three. .

   For both cohorts, public databases may be utilized for patient reported death.

Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible to be screened for this study if all of the following criteria are met:

  1. All patients must have been originally enrolled in CHAMPS, regardless of randomization arm. Only Cohort 1 patients must have been enrolled in CHAMPIONS 10.
  2. Willing and able to provide informed consent (Cohort 1), waiver of informed consent (Cohort 2), or reported patient death through public database search.
  3. Ability to read and write English (patient reported assessment tools are in English only).

Exclusion Criteria:

* Candidates will be excluded from study screening if any of the following exclusion criteria exist:

  1. Patients not participating in the original CHAMPS study.
  2. Alternative diagnosis to MS discovered.
  3. Patient unwilling or unable to provide informed consent (Cohort 1) or waiver of informed consent (Cohort 2), as applicable.
  4. Any other reasons that, in the opinion of the Investigator (Cohort 1) or Patient Coordination Center (Cohort 2), the patient is determined to be unsuitable for enrollment into this study.
Comparison of Papillary Balloon Dilatation Vs.Sphincterotomy for Lithotripsy in Difficult Sphincterotomy or Distal CBD Tapering

Compare endoscopic papillary balloon dilatation vs. endoscopic sphincterotomy for bile duct stones in:

* when sphincterotomy is difficult (periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis)
* when there is distal CBD tapering.

Endoscopic papillary balloon dilatation is an alternative to endoscopic sphincterotomy for treating bile duct stones:

* easier and as effective. But...
* a higher risk of pancreatitis.

Conditions including periampullary diverticulum, prior EST, Billroth-II anastomosis, or distal CBD tapering pose difficulty in EST and lithotripsy with increased risk of complications.

Whether EPBD or EST is superior in efficacy or safety under such circumstances is not clear.

Eligibility Criteria:
Inclusion Criteria:

* Choledocholithiasis with
* Difficult sphincterotomy:periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis
* or distal CBD tapering.

Exclusion Criteria:

* Patients in whom no endoscopic papillary balloon dilatation or endoscopic sphincterotomy was performed for lithotripsy
Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure

The purpose of this study was to measure potential mood, cognition and blood pressure effects of theobromine and caffeine in healthy women

Background Previous research has shown that naturally occurring chocolate ingredients theobromine and caffeine have positive effects on mood.

Objectives: To assess mood and cognition in adult subjects after the consumption of capsules filled with 1. placebo, 2. theobromine alone, 3. caffeine alone or, 4. theobromine and caffeine combined together.

Study design: Double-blind, placebo-controlled, randomized, cross-over design, with a 1 week washout period in between.

During the 4 weeks intervention period, once a week one of the 4 types of test products were consumed with 250ml of water in a randomized order;

1. placebo capsules
2. theobromine capsules (700 mg),
3. caffeine capsules (120 mg),
4. mix of theobromine (700 mg) and caffeine (120 mg). Twenty-four healthy female subjects (and 4 reserve subjects) were recruited for a four week intervention period in total with every week a 4 hrs measurement day and one of the interventions.

Primary parameters: mood (via a Bond-Lader/ caffeine visual analogue questionnaire), cognition (Digit Symbol substitution) Secondary parameters: blood pressure

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age at start of study 18 till 70 years
* Body Mass Index (BMI) between 20 and 30 kg/m2 inclusive
* Reported alcohol consumption for females \< 21
* Willing to refrain from caffeine and theobromine for 24 hours
* Apparently healthy: no reported current or previous metabolic diseases, chronic gastrointestinal disorders, cardiovascular or psychiatric disease which might effect study measurements assessed by Research physician
* willing to consume animal foods products (gelatine).
* Consumes caffeine (7 cups of either tea, cola or coffee per week minimum)
* Having a general practitioner (GP)

Exclusion Criteria:

* Being an Unilever employee
* Blood pressure above 160/90 mmHg at screening and irregular heart rate
* Using or planning to use any medically prescribed diet or weight-loss diet
* Reported intense sporting activities \> 10 h/w
* Subjects who undergoing medical treatment that may interfere with the study outcome.
* Reported weight change ± 10% during a period of 6 months prior to the study
* Reported intolerance or allergy for one of test products or standardized meal
* The habit of smoking during the past half year, drug use during the past half year or using nicotine containing medicines during the past month
* Reported lactating (or lactating \< 6 weeks ago), pregnant (or pregnant \< 3 months ago) or wish to become pregnant during the study
* Not able to perform the computer tasks assessed during screening
* Reported participation in night shift work during the study period
Influence of Spinal Manipulative Therapy Upon Stroop Task Performance

The purpose of this study is to determine if spinal manipulative therapy can affect cognitive processing as determined by performance on a Stroop task. It is specifically hypothesized that number of errors and response times will decrease as a result of spinal manipulative therapy.


Eligibility Criteria:
Inclusion Criteria:

Normal healthy

Exclusion Criteria:

No spinal manipulation one week proceeding trial No stimulants or depressants
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy

To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of epilepsy on up to three concomitant anti-epileptic drugs
* Subjects on levetiracetam immediate release (IR) can be enrolled if on a stable dose for 7 days

Exclusion Criteria:

* Subjects with a history of status epilepticus within 3 months of Visit 1
* Subject has difficult venous accessibility
Measuring the Quantities of Food Consumed by Patients Hospitalised in a Geriatric Centre

The objective of the study is to measure the quantities of food consumed at each meal by a representative part of the population of patients hospitalised in each department of the Champmaillot Geriatric Centre.

To do so, the quantity eaten will be quantified by weighing the amounts served and subtracting the weight of the left-overs. These measurements will allow us to provide more appropriate meals in the second step.


Eligibility Criteria:
Inclusion Criteria:

* Persons aged ≥ 65 years
* Persons hospitalised in the Champmaillot Geriatric Centre

Exclusion Criteria:

* Persons at the end of life
Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients

The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV, in clinical practice, it was expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive patients. However, those targets can't be get in most patients by 48 weeks of interferon treatment, and some patients need extended treatment to enhance the rate of HBeAg seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of interferon in HBeAg positive chronic hepatitis B patients will be evaluated.

In this cohort study, the HBeAg positive chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The rates of HBeAg seroconversion, HBsAg loss, and sustained viral response will be evaluated after treatment and follow up.

Eligibility Criteria:
Inclusion Criteria:

* HBeAg positive chronic hepatitis B patients

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study

For more than seven years an osteopath has been working in the palliative care unit (PCU) and in both palliative care mobile team (PCMT) as a member of the multidisciplinary team. The patients referred to the osteopath by the palliative care physicians present pains related to cancer, but also to the treatment, in particular to surgery or radiotherapy. The osteopath can help with other symptoms such as constipation or dyspnoea. As this approach is provided in complement of the medicinal approach, it is not considered as an alternative medicine but as a complementary medicine associated to a conventional care. It seemed relevant to the investigators to ask the cancer patients undergoing osteopathic sessions for pain how they saw this complementary therapy.


Eligibility Criteria:
Inclusion Criteria:

* Advanced illness patients with cancer pain, PS 0 to 2, willing to take part in the study and having signed the informed consent form

Exclusion Criteria:

* Non-communicating patients and patients whose cancer has been cured.
* Patients with fractural risk.