cyrilzakka/clinical-trials huggingface dataset:
RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will test the safety and efficacy of rituximab in the treatment of patients with anti-MAG polyneuropathy.

Acting of a polyneuropathy for which there is not any treatment of reference today (see supra), a test of double-knowledge versus placebo is justified. Acting of a chronic polyneuropathy, the clinical evaluation must be led over one one year period. Acting of a sensitive polyneuropathy and the awaited benefit being the IMPROVEMENT OF the CLINICAL SIGNS, the principal criterion is a sensitive score in addition validated in chronic sensitive polyneuropathies immunodeficiency syndrome.

The patients answering the criteria of inclusion and none inclusion (see V-2) will be randomized in 2 groups: the first group will receive a perfusion IV of rituximab to the amount of 375 mg/m2 of body surface, once per week, during 4 weeks (see VII-3); the second group will receive 4 perfusions IV of placebo according to same methods'. The evaluation (see VI-1) will be carried out at the time of the randomization, then repeated in 3 months, 6 months, 9 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* IgM monoclonal gammopathy
* Anti-MAG antibody titers \> 1.1000 BTU (ELISA)
* Worsening polyneuropathy with INCAT score \> 4
* Informed consent

Exclusion Criteria:

* Severe comorbidity
* Other concurrent causes of polyneuropathy
* Concurrent immunosuppressive therapies (wash-out \> 3 months)
* Previous treatment with rituximab
* Lymphoproliferative disease indicating other immunosuppressive treatment
* Unability to follow-up
* Previous documented side-effects with components involved in the tested drug
* White cell count \< 1500/mm3 or platelet count \< 75.000/mm3
* Patient under law
Cash Payment and Counseling During Pregnancy

Smoking during pregnancy has harmful effects on both mother and unborn child. Studies have shown that small rewards can help smokers to quit. In our current study, we ask how such rewards are most effective in supporting smoking cessation in pregnancy.

We would like to include up to 15 pregnant women. Inclusion criteria are: (i) current pregnancy, between pregnancy week 15 and 23 and, (ii) current smoking of at least one cigarette per day. After an initial survey, the participating women are scheduled twice a week for counseling and evaluation of their smoking status.They will receive cash payment of 25 Euro if her carbon monoxide reading does not exceed the value "3", on two consecutive dates per week. A second survey will be conduced in pregnancy week 36 and a third survey, eight weeks postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Current smoking, at least one cigarette per day
* Pregnancy, between pregnancy week 15 and 23

Exclusion Criteria:

* Inadequate language skills
* Cognitive impairment
A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants

The purpose of this study is to characterize the immune response in vivo using approved vaccines and antigen challenges, as well as a skin wounding challenge to stimulate the immune system.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilogram (kg)
* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (for Cohort 3) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* All women must have a negative highly sensitive serum (Beta-human chorionic gonadotropin \[Beta-hCG\]) pregnancy test at screening and a negative urine pregnancy test predose on Day 1

Exclusion Criteria:

* History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
* History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, bleeding disorders, rheumatologic, psychiatric, or metabolic disturbances, and atopic dermatitis
* Known allergies, hypersensitivity, or intolerance to any of the interventions in this study or their excipients
* History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
* Contraindications to the use of any of the study interventions per prescribing information
A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)

A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.


Eligibility Criteria:
Inclusion Criteria:

* Patient is HIV positive
* Patient agrees to use (or have their partner use) birth control as defined by the study doctor

Exclusion Criteria:

* If female, pregnant or breastfeeding
* Patient has used an investigational agent in the last 30 days
* Patient has acute hepatitis
* Patient has received MK0518 (raltegravir) before
* Patient has used another experimental HIV-integrase inhibitor
Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder

This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability, and pharmacokinetics of HT-2157 in healthy normal volunteers

Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in patients with major depressive disorder

This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability, and pharmacokinetics of HT-2157 administered for 7-days in healthy normal volunteers

Part 2 is a randomized, double-blind, placebo-controlled, multiple ascending-dose evaluation of the safety, tolerability, pharmacokinetics of HT-2157 administered for 21-days in patients with major depressive disorder. The primary objective of Part 2 is to assess the CNS penetration of HT-2157 in cerebrospinal fluid. In addition, the potential activity of HT-2157 in this patient population may be assessed using exploratory biologic and pharmacodynamic markers of potential efficacy

Eligibility Criteria:
Main Inclusion Criteria (Part 1)

* No clinically relevant abnormalities
* Age 18 to 55 years, inclusive
* Body Mass Index (BMI) of 18.5 to 32 kg/m2

Main Inclusion Criteria (Part 2)

* No clinically relevant abnormalities
* Age 18 to 55 years, inclusive
* Body Mass Index (BMI) of 18.5 to 32 kg/m2
* Mild-to-Moderate major depressive disorder

Main Exclusion Criteria (Part 1)

- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs

Main Exclusion Criteria (Part 2)

* Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
* Current and primary Axis I disorder other than MDD
uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. The objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional PET/CT and the quantitative kinetic parameters including glucose metabolic rate (Ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). All the neck lymph nodes suspected for metastatic in PET/CT were biopsied under the guidance of ultrasound for a pathological diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be informed of the investigational nature of this study and given written informed consent.
* Aged between 18-65, male/female.
* Histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III)..
* Fertile women should practice contraception during the study period.
* HGB ≥90g/L ,WBC ≥4\*109/L , PLT ≥100\*109/L,
* With normal liver function test (ALT and AST ≤2.5\*ULN, TBil ≤2.0\*ULN)
* With normal renal function test (serum creatinine ≤1.5\*ULN)

Exclusion Criteria:

* Women in pregnancy or lactation
* Patients with diabetes
* Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
* Already involved in other clinical trial.
* Mental disorder, civil disability, limited capacity for civil conduct.
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects

The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in constipated adolescent subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at between 12-17 years of age
* Weight more than 40 kg (88 lbs.).
* Constipated, defined by the following criteria

  1. Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:

     1. Straining during \> 25% of defecations
     2. Lumpy or hard stools in \> 25% of defecations
     3. Sensation of incomplete evacuation for \> 25% of defecations
  2. Loose stools are rarely present without the use of laxatives
  3. There are insufficient criteria for irritable bowel syndrome - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements

Criteria A, B and C must be fulfilled for the last 12 weeks with symptom onset at least 6 months prior to diagnosis.

* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, intrauterine device, double-barrier method, depot contraceptive, sterilized, or abstinence)
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
* Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
* Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
* Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 3
* Subjects who are pregnant or lactating, or intend to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to the study medication
* Subjects taking narcotic analgesics or other medications known to cause constipation
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
* Subjects with an active history of drug or alcohol abuse
* Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
* Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
Healthy Together Program Evaluation (Phase 3)

Healthy Together is a program that promotes the achievement and maintenance of healthy weights in children and their families.

The purpose of the Phase 3 scale up project is to expand the reach and impact of Healthy Together (HT), by supporting the integration of the HT program into core services of organizations serving children (up to 18 years) and families, particularly those from under-served populations across diverse communities and settings in Canada. The HT program offers a flexible, effective, integrated approach, relevant to multiple contexts, creating potential to become a sustainable approach to promoting healthier weights in Canadian children. The objectives of the evaluation for Phase 3 are to:

1. Describe the effectiveness of the HT program in relation to knowledge, attitude and behavior change at the individual, family, and community level.
2. Monitor quality and sustainability of HT, when offered as part of core service by organizations to meet diverse community needs and cultural contexts.
3. Create an effective knowledge mobilization framework to increase practice and policy influence of HT, in collaboration with regional, provincial and national networks.

Eligibility Criteria:
Community partner organizations with capacity and infrastructure to implement the HT program are eligible to be implementation sites. Priority is given to community organizations serving Indigenous, immigrants/refugees, low income/low literacy groups, and families residing in rural communities. All sites will be required to integrate HT into their existing services.

Inclusion criteria for each participant group are as follows:

Families: HT is designed for children (up to 18 years of age) and families. Children and families participating in programs offered by the partner organizations are eligible to attend HT. All interested families will be able to access the program regardless of their previous knowledge or skill level. Participants do not have to be overweight/obese to participate in sessions.

HT Facilitators: Staff members who are identified by the partner organizations, trained to implement the HT program and directly involved in HT program delivery will be eligible to participate in the evaluation.

Directors of Partner Organizations: Partner organizations will be asked to identify a director (supervisor) that has administrative responsibility for overseeing the delivery of services for children/families that includes the HT program.

National Advisory Committee (NAC): Members of the National Advisory Committee established by The Bridge Youth and Family Service Society for Phase 3 of this project.

Exclusion Criteria:

Family members who have not participated in any of the HT sessions offered as part of on-going services provided by the partner organization.
Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients

This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a biopsy proven head and neck cancer, early or advanced stage, primary or recurrent tumor,
* Planning to receive daily fractionated radiotherapy for over 4 weeks' duration
* Karnofsky Performance Score (KPS) of at least 70
* Able to describe pain
* Able to swallow food and water
* Able to sign consent

Exclusion Criteria:

-
Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

This work aims at comparing the analgesic effect of Thoracic Epidural Magnesium sulfate versus Fentanyl when added as adjuvants to Bupivacaine in patients with multiple traumatic fracture ribs.

Rib fractures are a common condition following trauma with a reported incidence of up to 10% in trauma in general, and up to 39% in blunt chest trauma. Traumatic rib fractures are associated with significant morbidity and mortality, and mortality rates reaching 10-16% has been reported. An estimated one third of patients with traumatic rib fractures develop secondary pulmonary complications with an associated mortality rate as high as 65% . Pain is recognized as a contributing factor to adverse outcome in traumatic rib fractures due to pain-induced inadequate respiratory efforts leading to atelectasis, difficulties in clearing secretions and an increased risk of developing pneumonia. Consequently, adequate analgesia is considered a core intervention in the management of patients with traumatic rib fractures.

There are a variety of ways to manage a patient's pain. Oral analgesic drugs and regional modes are more likely to be used .

Regional analgesia is often supplemented with a small dose of either NSAIDs or opioids and pain reduction is typically strong and immediate. There is little sedation, so evaluation of head and abdominal injuries is easier. A major disadvantage is the technical complexity of the procedures, leading to occasional errors in the administering of the treatments. They can also be painful while the needle is entering (or catheter is being installed), toxicity is a possibility, and the patients require more intensive monitoring and care by the physicians and nurses. There are a variety of modes; the four most common are TEA, thoracic paravertebral block, intercostal block, and intrapleural block. This study focuses on thoracic epidural analgesia.

Narcotic infusions and continuous local anesthetic can be delivered through thoracic or lumbar epidural catheters. Opioid receptors exist in the spinal cord that can alter the perception of pain without needing stimulation of receptors in the brain. After inserting the catheter into this area, local anesthetics and narcotics are administered, blocking the anterior and posterior nerve roots crossing this space. The anesthetic/analgesic agents diffuse across the dura and begin to block sensory nerves. Motor nerves are affected to a lesser degree. It takes a large dose to achieve the desired effect.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 16 years of age and greater
2. Non-intubated at the time of block placement
3. Traumatic Rib Fractures two or greater
4. Block must be done within 12-24 hours of presentation to the emergency room
5. ASA physical status: I-II

Exclusion Criteria:

1. Patient refusal
2. BMI more than 30 kg/m2
3. Need for mechanical ventilation on admission
4. Hemodynamic instability
5. Haemothorax or Pneumothorax
6. Contraindications of performing blocks as coagulopathy, vertebral column deformities, local infection
7. Traumatic head injury
8. Allergy to local anesthetic agents
Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU

Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.

We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 yrs
* expected length of stay in the ICU higher than 72 hours
* motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview

Exclusion Criteria:

* Opposition expressed by the patient, his/her legal representative or a member of his/her family
* Pregnant woman
* Resuscitated cardiac arrest before inclusion
* Patient carrying a pacemaker or an implantable defibrillator
* Patient under extracorporeal membrane oxygenation
* Severe acute cerebral disease requiring deep sedation
* Brain death
* Guillain-Barré syndrome
* Myasthenia gravis
* Known Dementia than can affect the main endpoint assessment
* Deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or floating clot in femoral, iliac of inferior vena cava veins
* Unstable traumatic injuries of the spine
* Severe skin disease or surgical reasons that either prevent performing electrostimulation or bicycling in the next 2 days, or prevent patient's verticalization or transfer to chair in the next 5 days
* Amputation of a lower limb at the trans-metatarsal level or higher
* Inclusion in another interventional study with muscle strength assessment as the primary endpoint
* Moribund patient