cyrilzakka/clinical-trials huggingface dataset:
Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.

In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care.

Currently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.

The BREFORM project proposes to train health professionals in an early psychoeducation program, the BREF program, in order to implement it in their structure, and to evaluate its impact on the burden of caregivers of users living with a first psychotic episode or a schizophrenic disorder.

Regarding caregivers' outcomes:

outcome measures will be assessed at baseline (visit 1, V1), 6 weeks (Visit 2, V2), 6 months (Visit 3, V3), 12 months (Visit 4, V4) after baseline in the active group and in the treatment as usual group

Regarding patients' outcomes:

outcome measures will be assessed at baseline and 12 months after baseline in the active group and in the treatment as usual group

Regarding mental health professionals' outcomes:

outcome measures will be assessed before, after and 16 months after the training course

Regarding the psychiatric departments' outcomes:

outcome measures will be assessed at baseline and 36 months after baseline

Eligibility Criteria:
Inclusion Criteria:

* people over 18yo
* first-degree relatives (parents, siblings, children) or spouse of the patient
* primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM5)
* consenting to participate to the study

Exclusion Criteria:

* mental disorder on Axis I
* having already benefited from a family intervention such as psychoeducation
* caring for several people with severe psychiatric disorders
* receiving income for the caring activities
* being legally responsible of the patient
* having difficulty understanding fluent French
* illiterate
Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings

The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria
* Patients with RA with a moderate disease activity (SDAI: \> 11 and 26)
* Biologic-naive patients with treatment history csDMARDs
* Patients who meet the following criteria by hematological examination:

  * Peripheral white blood cell count: 4,000/mm3
  * Peripheral lymphocyte count: 1,000/mm3
  * Blood β-D-glucan negative
* Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
* Patients initiated with abatacept at per their physician's therapeutic decision

Exclusion Criteria:

* Past history of hypersensitivity to the components of the abatacept preparation
* Disease complications from a comorbidity
* Active infectious disease
* Been judged by the investigator or the co-investigator as being inappropriate

Other protocol defined inclusion/exclusion criteria could apply
Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis

The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution.

This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.


Eligibility Criteria:
Inclusion Criteria:

* First onset of an optic neuritis lasting for less than 1 month
* With a brain MRI that does not meet the MS criteria

Exclusion Criteria:

* Contra-indication to MRI
* Pregnant or lactating woman
* History of known ipsilateral optic neuritis
* Ophthalmologic comorbidity in the ipsilateral eye that may interfere with the interpretation of the examinations
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.


Eligibility Criteria:
Inclusion Criteria:

* Patients who satisfy both of the following diagnostic criteria:

  1. Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.
  2. Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.
* Hospitalized patients or care facility patients or care at home patients
* Patients with an MMSE score of 1 to 22
* Patients who have the agitation defined according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

Exclusion Criteria:

* Patients who have dementia other than dementia of the Alzheimer's type
* Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5.
* Patients diagnosed with any of the following disorders according to DSM-5:

  * Schizophrenia spectrum and other psychotic disorders
  * Bipolar and related disorders
  * Major depressive disorder
Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients

The efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent the most challenging group for the identification of anatomical landmarks. With the use of ultrasound, we can visualize the images of the anatomical structures in the back. Some anesthesiologists believe ultrasound can help in the placement of an epidural, and routinely use it to assist in determining needle entry point in your back as well as estimating the depth at which the epidural space will be found. Our hypothesis is that the use of lumbar spine ultrasound imaging will accurately determine the epidural space depth and the epidural insertion point in obese patients.

Recent technical advances, especially the evolution of ultrasound technology, have helped to some extent in circumventing some of the limitations of epidural anesthesia. The efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent are the most challenging group for the identification of anatomical landmarks, it is important to determine if ultrasound imaging is a useful technique in this population.

All the patients will undergo ultrasound imaging of the lumbar spine just before epidural insertion. Ultrasound imaging will be performed by one of the investigators. A different anesthesiologist will perform the epidural procedure based on the US information provided by the investigator. The investigator will provide information to the epidural performer on the insertion point, the angle of needle insertion and safe approximate distance before reaching the epidural space to facilitate the epidural performance. To maintain blinding and to prevent performer bias, the exact depth of the epidural space from skin, as seen on the ultrasound will not be disclosed. The investigator, with the aid of an in-built caliper, will measure this distance at a later time before saving the image.

The results of this study are expected to determine the clinical reliability of ultrasound imaging in visualizing the anatomical structures relevant to the technical performance of epidural analgesia in the obese population. Since technical difficulty in performing epidurals is more commonly encountered in obese patients, ultrasound visualization would improve the overall success of the technique by predicting the depth of the epidural needle to be inserted. In turn, the complication rate would be minimized.

Eligibility Criteria:
Inclusion Criteria:

* Full term pregnant patients requesting labor epidurals
* Pre-pregnancy BMI greater than 30

Exclusion Criteria:

* Known spinal deformities
* Previous back instrumentation
* Pre-pregnancy BMI less than 30
DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer

Preclinical studies provide strong support for the concept that fasting evokes resistance to multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance. Accordingly, the currently available preclinical evidence suggests that short-term fasting protects normal cells against the perils of chemotherapy. In contrast, cancer cells are not protected, as a result of their self-sufficiency in growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR reduces the severity of toxic side-effects of chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to chemotherapeutics. Importantly, extensive preclinical evidence and preliminary clinical data indicate that a specifically designed very low calorie, low amino acid substitution diet ("Fasting Mimicking Diet, FMD") has effects on cancer therapy that are very similar to those of fasting. This study aims to evaluate the impact of the FMD on tolerance to and efficacy of neoadjuvant chemotherapy in women with stage II or III breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer receiving neoadjuvant AC-T
* Measurable disease (breast and/or lymph nodes)
* HER2 negative core biopsy Age ≥18 years
* WHO performance status 0-2
* Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements
* Willing to fill in quality of life questionnaires
* Able to read and write in Dutch

Exclusion Criteria:

* History of breast cancer (invasive or non-invasive)
* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
* Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Diabetes Mellitus
* Body mass index (BMI) \< 19 kg/m2
* Pregnancy or lactating
* Significant food allergies which would make the subject unable to consume the food provided (ex: nuts or soy)
* Any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods.
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy

Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy.

Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 30 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.

Eligibility Criteria:
Inclusion Criteria:

* Adults male and female age of or above 18 years
* Symptomatic chronic calculous cholecystitis
* Ultrasound confirmed Gall bladder stones

Exclusion Criteria:

* Complicated chronic calculous cholecystitis
* Malignant Gall bladder
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a cancer diagnosis
* Be 18 years of age or older
* Patients who rate depression or anxiety \> 5 based on a 10 point scale
* Patients expected to live greater than 6 months
* Serum bilirubin and creatinine \< 1.5x upper limit of normal
* AST and ALT \< 3 times upper limit of normal
* Willing and able to provide written informed consent
* Able to complete self-assessment questionnaires

Exclusion Criteria:

* Patients not diagnosed with cancer
* Antidepressant prescribing performed by a non-Moffitt psychiatrist after enrollment onto the clinical trial
* Known Pregnancy
* History of liver or allogenic stem cell transplant
* Patients with a known cognitive impairment (e.g., delirium, dementia, etc.) or psychological impairment (e.g., schizophrenia, bipolar disease, etc.) other than depressive and anxiety symptoms.
Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)

Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

Since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects against COVID-19 in vitro. The investigators aim to study the security and efficacy of this drug in trough a double blinded randomized clinical trial. Recruited patients with severe respiratory disease from COVID-19 will be randomized to an intervention group (400mg per day dose of hydroxychloroquine) and placebo. The investigators' main outcome will be all cause hospital mortality. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease. Results will be compared in an intention to treat analysis. All clinical, analysis and data team members will be blinded to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. negative pregnancy test in women
3. COVID-19 confirmed by rtPCR in any respiratory sample.
4. Severe COVID-19 disease defined as any from the following:

   1. Pulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia
   2. Need for mechanical ventilation (invasive or non invasive )
   3. Sepsis/septic shock.

Exclusion Criteria:

1. history of anaphylactic shock to hydroxychloroquine.
2. History of previous administration of chloroquine or hydroxychloroquine (within 1 month)
3. decision of attending physician by any reason.
4. History of chronic hepatic disease (Child-Pugh B or C)
5. History of Chronic renal disease (GFR less than 30)
A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.


Eligibility Criteria:
Inclusion Criteria:

* （Saftey Lead-in + phase 3）Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious
* （Saftey Lead-in + phase 3）human epidermal growth factor receptor type 2 (HER2)-negative metastatic breast cancer
* （Saftey Lead-in + phase 3）had received ≤2 lines of chemotherapy for mBC
* （Saftey Lead-in + phase 3）Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
* ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
* ECOG performance status 0-1.
* Adequate bone marrow, kidney and liver function.

Exclusion Criteria:

* Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
* Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed
* Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
* Known to be human immunodeficiency virus positive
* Known active hepatitis C virus, or known active hepatitis B virus
* Untreated and/or uncontrolled brain metastases
* Pregnant or breast-feeding women
Early Identification and Action in CKD

Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is screened and treated according to recommended guidelines. Using a cluster-randomized, controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize 6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a pharmacist-directed "CKD Action Plan" (group 2). Determining the impact of the CKD Action Plan on screening and treatment guideline adherence is the primary goal of this pilot study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* eGFRCR value between 45-59 ml/min/1.73m2 in the prior 12 months
* scheduled laboratory appointment for serum creatinine testing within the next 30 days
* average systolic or diastolic blood pressure reading of at least 150 or 85 mm Hg, respectively, during the prior 12 months.

Exclusion Criteria:

* fewer than 2 blood pressure readings in the prior 12 months,
* pregnancy
* current hospitalization
* life expectancy less than 6 months as determined by the study investigators
The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)

The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). The patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.

Study Objective

The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds, specifically addressing:

1. baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial.
2. randomization compliance rate.
3. ease of protocol implementation in the out-of-hospital setting.
4. adverse rate of Hypertonic Saline Dextran (HSD) infusion.

The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16
* Initial assessment of Glasgow Coma Score (GCS) 8 or less
* Blunt traumatic mechanism of injury

Exclusion Criteria:

* Known pregnancy
* Penetrating primary injury
* VSA prior to randomization; previous intravenous therapy ≥ 50 ml
* Time interval between arrival at scene and intravenous access exceeds four hours
* Amputation of above wrist or ankle
* Any burn (thermal, chemical, electrical, radiation)
* Suspected hypothermia
* Asphyxia (strangulation, hanging, choking, suffocation, drowning) and fall from height ≤ 1m or ≤ 5 stairs.
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
* Brain metastases for which surgical resection is not a treatment option
* Patients must have failed at least one previous treatment for brain metastases
* Requiring corticosteroids for symptom control
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* Increasing corticosteroid dose during the 7 days prior to study entry
* Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
* Concurrent administration of any anticancer therapies other than those administered in the study
* Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug