cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Complications of Ibrutinib Therapy

Ibrutinib, the first BTK inhibitor (BTKI) to be approved, improves progression-free survival (PFS) and overall survival (OS) over alternative therapies in relapsed/refractory and treatment-naive chronic lymphocytic leukemia (CLL). Ibrutinib has also been found to be effective in mantle cell lymphoma, Waldenström's macroglobulinemia and marginal zone lymphoma. However, ibrutinib treatment is associated with an increased risk of atrial fibrillation (AF), with an estimated 2-year AF rate of 16% in patients treated with ibrutinib during a median follow-up of 28 months. In most studies, AF was identified by reports as a treatment-related adverse event, and systematic screening for AF was not performed. As AF is often paroxysmal, the more intensive the screening, the higher the incidence. In a prospective cohort study of 53 patients treated with ibrutinib for CLL, patients were monitored by pulse palpation and ECG every 3 months. The cumulative incidence rate of ibrutinib-associated AF was 23% at 12 months and 38% at 2 years. The management of ibrutinib-associated AF is challenging due to difficulties in balancing the benefits of anticoagulation to mitigate the risk of stroke and the bleeding risk associated with ibrutinib. AF is a frequent reason for discontinuation of ibrutinib therapy, and can result in significant morbidity.

In addition to this arrhythmogenic effect, ibrutinib is also significantly associated with the onset or worsening of arterial hypertension. Finally, an increased risk of serious ventricular rhythm disorders has also been suggested by pharmacovigilance databases, but not yet confirmed by prospective clinical studies.

The study proposes a comprehensive cardiovascular approach, at baseline and during follow-up of patients on Ibrutinib, using innovative markers to anticipate patients most at risk of developing these cardiovascular effects, but also to detect them as early as possible in order to avoid the complications they may generate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for ibrutinib treatment for hematologic reasons
* Patients aged 18 and over
* Patients who have given their free, written and informed consent to this study after being informed (or by the patient's representative if the patient is unable to express his or her consent).

Exclusion Criteria:

* Person not affiliated to national health insurance
* Patient under legal protection (curatorship, guardianship)
* Patient subject to a safeguard of justice measure
* Pregnant, parturient or breast-feeding women
* Previous treatment with ibrutinib
* Follow-up planned in another center
* History of atrial fibrillation
CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris

A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

1. Must provide Informed consent.
2. Male or female aged 16 to 44 inclusive.
3. Moderate to severe facial acne vulgaris as defined in the protocol.

Exclusion Criteria:

1. Positive testing for HIV, HBsAg, or hepatitis C virus (HCV).
2. Females who are pregnant, lactating, or planning to become pregnant during the study.
3. Any systemic medical condition which, in the opinion of the investigator, would put the participant at risk by participation in the study.
4. Any systemic or dermatologic disorder that, in the opinion of the investigator will interfere with the assessment of the study endpoints (e.g. psoriasis).
5. Concurrent or previous use of an investigational drug or device within 30 days prior to screening.
6. The presence of acne conglobata, acne fulminans, secondary acne, or nodulocystic acne.
7. The presence of known or suspicious unresolved dermatological cancerous or pre-cancerous lesions.
8. Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430 or any of its components.
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
* Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
* Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be provided as per documented regulations 15 unstained slides (10 minimum) will be acceptable
* At least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow function, renal and liver functions

Exclusion Criteria:

* Prior systemic therapy directed at advanced or metastatic RCC
* Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
* Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
* Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
* Newly diagnosed or active brain metastasis
* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
* Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
* Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
* Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)
Effects of a Nutritional Supplementation on the Functional Status of Frail Elders With Low Socioeconomic Status (SES)

The purpose of this study is to determine whether protein-energy nutritional supplementation improves geriatric function in community-dwelling frail older adults of low socioeconomic status.

Chronic undernutrition is a common condition in older people, and is clearly an important component of frailty. However, the effect of protein-energy nutritional supplementation on the functional status of frail older people is controversial. Some investigators suggested that, if nutritional or functional status has deteriorated too far, it could be very difficult for single nutritional supplementation to reverse malnutrition progression or functional decline.

The investigators believe one of the reasons for these ineffective results, especially for the community-dwelling frail elderly, may be due to a lack of regard to the socioeconomic status of the study population. For this reason, the investigators recruited a study sample with low socioeconomic status and evaluated the effect of protein-energy nutritional supplementation on their disability scores and physical performance.

Eligibility Criteria:
Inclusion Criteria:

* Older adults over 65 years of age, registered in the National Home Healthcare Service database
* Require more than 5 seconds to perform 3m walking test (Usual Gait Speed \<0.6 m/sec)
* Get less than 24 points on Mini Nutritional Assessment (Mini Nutritional Assessment \<24)

Exclusion Criteria:

* Unable to walk or are too functionally deteriorated to receive home health care services
* Who were participating in any kind of exercise program or clinical nutrition program
* who were restricted to a high-protein diet by an internist (i.e., for liver failure or severe renal failure)
Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.

The objective of this study is to assess the efficacy and tolerance of a single cycle of rituximab in control of bullous pemphigoid.

the main objects are :

1. to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
2. to avoid the use of corticosteroid in long time,
3. to evaluate duration of control disease and side effect with a single cycle of rituximab.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 and \< 80
* karnofsky \>= 50%
* bullous pemphigoid clinical indication
* cortico-dependent bullous pemphigoid in relapse for the second time
* contraception used in female patient
* consent obtained from patient

Exclusion Criteria:

* localized bullous pemphigoid in relapse (\<400cm2)
* pemphigoid of pregnancy
* dermatosis with IgA
* pemphigoid with mucous damage
* pregnant woman or nursing mother
* woman able to have a baby and without contraception during the clinical trial period
* age \< 18 or \> 80
* karnovsky \< 50%
* significant disease or uncontrolled disease
* serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
* patient with depletion lymphocytic treatment or with initial rituximab treatment
* unstable angina or ischemic heart disease
* cardiac insufficiency
* cardiac rhythm trouble uncontrolled
* evolutive infection
* immunodepression
* neutrophil polynuclear in blood \< 1.5 G/l and /or platelet blood concentration \< 75G/l
* positive HIV serology
* positive hepatitis B and / or C serology
* concomitant immunodepressor treatment able to induce depletion lymphocytic treatment
* no consentment
* antecedent of serious chronic or recurrent infection or other underlying pathology able to induce serious infection
* antecedent of deep tissue infection occurred the previous year of inclusion
Perioperative Analgesic Modalities for Breast Cancer Surgeries

The incidence of breast cancer is among women world wide, detection increased with introduction of mammography as a screening tool. surgical resection of breast cancer contributes to the generation of acute and chronic post mastectomy pain. This study aims at comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding pain control and possible side effects

One of the most common types of cancer affecting women is breast cancer. Surgical resection is one of the main approaches applied for solid tumors. surgical approach for breast cancer involve the breast region. Various analgesic modalities are used for proper perioperative pain control. Morphine has always been considered as the gold standard analgesic, however opioids have multiple side effects. Several loco-regional techniques have been introduced for breast surgery pain management including serratus plane block (SPB) and erector spinae plane (ESP) block. In this study the investigators are comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding intraoperative and postoperative analgesia, time to first analgesic, any possible side effects

Eligibility Criteria:
Inclusion Criteria:

* female 18-65 years old patients undergoing modified radical mastectomy

Exclusion Criteria:

* patient refusal, local infection at site of block coagulation defect abnormal kidney or liver functions
The Effect of Patellar Taping and Isometric Strength Training on Quadriceps Strength with Patellofemoral Pain Syndrome.

Patellofemoral pain syndrome is one of the most common young adult female complaints, caused by changes in the patellofemoral joint's physical and biomechanical properties. This study compared the Short-term effects of patellar taping combined with isometric contraction of quadriceps muscle strengthening at 900 or 600 knee angles on quadriceps strength and functional performance in a female patient with patello-femoral pain syndrome (PFPS)

Quadriceps muscle strength Pain intensity Knee function

Eligibility Criteria:
Inclusion Criteria:

* knee pain for at least eight weeks that was aggravated by activities such as descending and ascending stairs, squatting, and running.
* knee pain with a positive J sign (lateral tilt of patella)
* more symptomatic and mal align knee included in case of bilateral involvement and a sign of patellar malalignment on the radiograph.

Exclusion Criteria:

* History of knee fracture
* Patella dislocation
* knee deformity (e.g., genu varum)
* Knee Flexion contracture
* Ligament/meniscal injuries,
* NSAID or intra-articular injection, or knee Osteo arthritis.
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women

Excessive body weight and obesity have reached epidemic proportions over the last few decades, which may cause many chronic diseases. Maintaining a healthy life style could decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body composition and the mechanism of obese women. The pilot study will recruit twenty healthy subjects, and served test food to determine low GI food. In the experiment period, twenty women age from 20-50 years will be recruited. To be included in the study, subjects should have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline \> 80 cm). Before dietary intervention, participants will receive food choice table and dietary questionnaires to record their dietary intake.

The study will be a randomized, crossover, controlled clinical trails. The experiment period have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6 week, subjects will measurement their body composition (body weight, body mass, waist and hip circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical analysis will be performed by paired t-test. The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women.


Eligibility Criteria:
Inclusion Criteria:

* BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline \> 80 cm )

Exclusion Criteria:

* Cardiovascular disease
* type 2 diabetes mellitus or impaired glucose tolerance
* serious liver or renal disease, gastro-intestinal disease
* proceed serious diet control for formerly three months
* take any supplemental food products or medications known to influence lipid or carbohydrate metabolism
Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding

This study will investigate the potential impact of arts-informed, technology-based patient education material, and specifically, the role of multimedia imagery on patient comprehension, perceived satisfaction, anxiety levels, and informed decision-making.

Based on an inter-professional approach to support a new role in patient care, this research addresses both literacy and health literacy issues within the context of current challenges to healthcare delivery and associated fragmentation in continuity of care. Patient education is a key component in the delivery of comprehensive care and it is the potential for on-line patient education that provides the basis for research.

Eligibility Criteria:
Inclusion Criteria:

The following inclusion criteria will be used: Participants must be:

1. Newly diagnosed breast cancer patients
2. A minimum age of 18 years or older
3. Able to read and write in English and/or French
4. Have a confirmed diagnosis of any of the following:

   1. Infiltrating ductal carcinoma
   2. Ductal carcinoma in situ (Grade III)
   3. Lobular carcinoma in situ (Grade III)
   4. Infiltrating lobular carcinoma
5. Have access to, and the ability to use, a computer

Exclusion Criteria:

* The following criteria will be reasons for exclusion from the study:

  1. The participant has a serious psychiatric or cognitive impairment that would prevent the patient from completing the study requirements.
  2. The participant has a previous history of breast cancer
Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer

The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy

The study will recruit patients with newly diagnosed colorectal cancer and that has not yet undergone any chemotherapy treatment. Individuals that meet the inclusion criteria are randomized by means of a computer program on two study groups: 1) supplemented Experimental: receive 2g/day supplementation encapsulated fish oil for 9 weeks. 2) No intervention - control: not receive supplementation of fish oil or placebo. Will be assessed the effects of supplementation on the standard profile of cytokine production, nutritional status, and proportion of incorporation of these fatty acids in blood cells (mononuclear and red blood cells).

Blood samples are collected before the start of first chemotherapy and nine weeks later. Supplementation in the experimental group also will start on the first day of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years
* Histopathological diagnosis of colorectal cancer
* Beginning of chemotherapy in the target institution
* Agree to participate in the study \[signature of IC\]

Exclusion Criteria:

* Age \<19 years
* Being in palliative care
* Inability to oral intake
* Allergic to the fish and fish products
* Owning with hyperlipidemia requiring drug treatment
* Consumption prior to the study of fish oil or supplements containing omega-3 PUFA
* Being in medical treatment with some nonsteroidal anti-inflammatory
* Have some kind of infection
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a body mass index (BMI) of 18.0-30.0 kg/m\^2, inclusive, at Visit 1 and Visit 2
* Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
* Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
* Subject has maintained a stable body weight (change \</= 5%) for at least 3 months prior to Visit 1 based on self-report
* Additional criteria may apply

Exclusion Criteria:

* Subject has any of the following psychiatric conditions per DSM-5 criteria:
* Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
* Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
* Drug-induced or toxic psychosis
* Any other psychiatric condition that could interfere with participation in the study
* Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
* Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
* Additional criteria may apply
Improving Diabetes Care Via Telephone Assessment and Patient Education

The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management (ATDM) system that administers patient assessments and targeted self-care education between clinic visits.

Background:

The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management (ATDM) system that administers patient assessments and targeted self-care education between clinic visits.

Objectives:

In this ongoing study, we are determining: 1) the reliability and validity of Automated Telephone Disease Management (ATDM) assessments of patients' glycemic control, health-related quality of life (HRQL), self-care, and satisfaction with care; 2) the extent to which these assessments identify patients at risk for poor outcomes; and 3) the cost-effectiveness of an intervention in which ATDM assessment reports are provided regularly to patients' primary care providers.

Methods:

We are refining and expanding previously-developed ATDM assessment instruments by incorporating measures of patient-centered outcomes. We are enrolling 450 patients from VISN 12 and VISN 21. Patients receive weekly ATDM assessments for six months. Other data on their health status and service use are being collected from medical records, laboratory tests, telephone surveys, and Austin Automation Center files. After determining the concurrent reliability, validity, and prognostic significance of the ATDM assessments, we will examine variation in ATDM-reported outcomes across Networks, facilities, and patient groups. In the second phase of the study, we will conduct an effectiveness trial with a one year follow up period. We will use the findings from our process evaluation to modify the ATDM assessments and design provider feedback reports. We will enroll 240 patients from the two Networks (i.e., 480 patients overall). Patients will be assigned to experimental or usual care control groups using a combination of randomization and cutoff-based assignment. We will measure the intervention's impact on patients' glycemic control, symptoms, self-care, and patient-centered outcomes. We will use VA costing database and Medicare claims files to evaluate cost-effectiveness.

Status:

Analyses of ATDM assessment data suggest that this method is feasible with VA diabetes patients and provides comparable data regarding patients' satisfaction with care and functioning to telephone surveys. Other analysis suggest that VA interpersonal processes of care and rates of cost-related medication adherence problems are as good or better than that experienced by patients with comparable characteristics treated in other systems of care.

Eligibility Criteria:
Inclusion Criteria:

Patients enrolled in VISN 12 and VISN 21

Exclusion Criteria: