cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder

INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings. The use of repetitive transcranial magnetic stimulation (rTMS) has been presented as an effective, safe and well-tolerated alternative to the treatment of uni- and bipolar depressive episodes. Recently, a new rTMS protocol was introduced, theta-burst stimulation (TBS), whose studies have shown similar efficacy with a shorter time interval than conventional rTMS. Most clinical trials performed to date evaluate the use of TBS in patients with unipolar depression or mixed samples of uni and bipolar patients. The effectiveness of TBS exclusively in BD has not been properly studied. METHODS: We will perform a 6-week, double-blind, randomized, parallel-group, sham-controlled clinical trial of active or sham TBS. We will recruit 60 patients aged between 18 and 65 years with a diagnosis of BD type I in a current moderate or severe major depressive episode resistant to at least two first- or second-line pharmacological treatments, according to CANMAT guidelines. The primary outcome measure will be the assessment of TBS efficacy through difference in scores on 17-item Hamilton Depression Scale (HAM-D) from baseline until the end of week 6 of intervention between active and sham groups. KEYWORDS: randomized clinical trial; transcranial magnetic stimulation; bipolar affective disorder; major depression.


Eligibility Criteria:
Inclusion Criteria:

* Current moderate or severe major depressive episode in bipolar I disorder assessed with Hamilton Depression Rating Scale (HAM-D) score ≥ 17 points.
* Any appropriate first or second line pharmacological regimen in accordance with Canmat guidelines to treat a major depressive episode in bipolar I disorder:

Quetiapine 300 - 600 mg/dia; Lithium serum levels 0,6 - 1,2 meq/L; Lamotrigine 100 - 200 mg/dia; Lurasidone 20 - 120 mg/dia; Divalproex; Lithium/Divalproex + Lurasidone; Lithium/Divalproex + Lamotrigine; Olanzapine 5 - 20 mg/day + Fluoxetine 20 - 60 mg/day; Lithium/Divalproex + SSRI/Bupropion.

Exclusion Criteria:

* Concomitant diagnosis of other neuropsychiatric disorders such as: schizophrenia, dementias, mental retardation, organic mental disorder, or epilepsy;
* Acute suicide ideation (assessed by interview and clinical evaluation);
* Acute psychotic depression (assessed by interview and clinical evaluation);
* Suspected or confirmed pregnancy;
* Women in breastfeeding;
* Severe or unstable clinical disease;
* Previous rTMS treatment;
* Specific contraindications to TBS: previous epileptic seizures; change in electroencephalogram at some point in life; previous stroke; previous severe traumatic brain injury (with neurosurgery); metallic object on head (except mouth) as projectile piece, surgical clip, welding fragments; any implanted device (cardiac pacemaker, intravenous catheter).
Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi)

Systemic Lupus Erythematosus (SLE) is chronic and systemic autoimmune disease that mainly affecting women and leading to organ damages especially skin, joints, kidneys, central nervous system and heart. In SLE, immune system dysfunction leads to autoantibodies, autoreactive T cells and pro-inflammatory cytokines production. These elements will initiate and maintain organ damages. Patients with SLE have disease flares followed by period of remission. Flares can occur because of stress, infections, surgery, pregnancy or ultraviolet exposition. Furthermore the chronic nature of SLE is an important factor of depression in these patients.

Qi Gong is an ancient Chinese practice based on relaxation movements, posture and breathing in order to harmonize the body and mind. This practice improves the general state by reducing fatigue and improving sleep. The beneficial effect of Qi Gong in medicine has been studied in several diseases including cancer, diabetes, arterial hypertension and fibromyalgia. Qi Gong seems interesting in depressed patients but also to reduce stress in healthy subjects.

The aim of this study is to evaluate the effects of Qi Gong on quality if life in patients with SLE. Patients will have two lessons of 60 minutes per week for three months and a collective lesson of 90 minutes per week for three months. The teacher of Qi-Gong will evaluate adherence to the practice of Qi Gong every week. Clinical and biological data will be collected at baseline and at 2th, 4th, 6th, 9th and 12th month. Different evaluation scores and neurotrophin levels will be collected at baseline and at 6th month.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Lupus Erythematosus (SLE) according the American Rheumatology Association (ARA) and/or Systemic Lupus International Collaborating Clinics (SLICC) Criteria
* Free and Clarified Consent Term signature.

Exclusion Criteria:

* Patients who have other rheumatologic diseases (rheumatoid arthritis, sjogren syndrome, fibromyalgia, ankylosis spondylitis);
* Systemic Lupus Erythematosus Disease Assessment Index (SLEDAI) \> 5;
* Patients with malignancy;
* Patients who do not accept the study rules as time and/or follow-up exercise program time proposed;
* Suspected or pregnancy confirmation;
* Patients with Inability or unwillingness to understand and/or sign informed consent
Dairy Based Probiotic Intervention and Cognitive, Emotional, and Inflammatory Outcomes

The purpose of this study was to determine the effect of dairy-based probiotics on cognitive function, emotional wellbeing, and inflammation. Subjects were assigned to either consume 6 oz of yogurt/day or abstain from consuming yogurt and other probiotic-containing foods for 12 weeks. Subjects completed baseline testing and 12-week follow-up testing consisting of a laboratory blood draw to assess inflammatory biomarkers, and a computerized assessment to evaluate cognitive and emotional wellbeing measures.


Eligibility Criteria:
Inclusion Criteria:

* ability to participate in a 12-week study
* at least 50 years of age
* not currently taking a probiotic dietary supplement
* willing to refrain from consuming probiotic dietary supplements or fermented foods for 12-weeks
* willing to have blood drawn twice
* willing to consume yogurt daily for 12 weeks

Exclusion Criteria:

-
Quality of Life in Chinese Working and School Age Population With MDD

Major depressive disorder (MDD) is a common mental illness with high prevalence and global burden. Previous studies revealed that over 70% patients in remission still had decreased quality of life, severe function impairment, low positive mental health score and poor coping ability. However, few studies focus on working and school age patients with MDD. A GBD survey showed that over 40% MDD patients are 15-50 years old. Therefore, we initiate the present multi-center cross-sectional survey to investigate the associations between clinical symptoms, cognitive function, occupational/study ability, and quality of life in Chinese working and school age population with MDD who are in remission.

This is a multi-center cross-sectional study. Patients with MDD who received medication treatment and achieved remission for at least 8 weeks will be enrolled. For all the participants, demographic information will be collected; clinical symptoms, cognitive function, occupational/study ability, and quality of life will be evaluated by using 17-items HAMD, PHQ-9, HAMA, PSQI, SHAPS, HCL-32, SDS, LEAPS, QOL-6, PFQ and THINC-it toolkit.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients;
* Men or women aged between 16 and 50, with junior high school education or above;
* According to medical history, patients should be diagnosed with major depressive episode by two or above psychiatric doctors based on ICD-10 criteria;
* According to assessment, patients should meet the DSM-5 criteria for MDD when in past episodes;
* Patients received stable ant-depression medication treatment for at least 8 weeks before enrolment;
* 17-item HAMD total score ≤ 7;
* Willing to participate in this study, and sign an informed consent.

Exclusion Criteria:

* HCL-32 total score \< 12;
* Diagnosed with bipolar disorder;
* Suffering from some serious physical diseases (e.g. moderate or severe brain injury, central nervous system diseases, or other unstable physical condition affecting the whole body) adversely affects the performance on neuropsychological test or rating scales;
* Received ECT in the past 6 months.
Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial

Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.

The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk \[HBR\] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows:

* If the patients are at HBR (HBR is defined according to ARC-HBR criteria: meeting at least 1 major or 2 minor criteria), 1-month DAPT will be given regardless of clinical presentation or lesion complexity.
* In the patients are at non-HBR, 3-month DAPT will be given in those treated for unstable angina and/or complex lesions (complex lesion is defined as meeting at least one of the following: number of stents implanted ≥3, number of lesions treated ≥3, 3-vessel treated, bifurcation PCI with 2 stents, total stent length ≥60mm, or chronic total occlusion).

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥19 years
2. Patients who received new generation zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease
3. Provision of informed consent

Exclusion Criteria:

1. Age ≥ 85 years
2. Acute myocardial infarction

2. Left main bifurcation requiring 2-stent technique 3. Pregnant women or women with potential childbearing 4. Life expectancy \< 1 year 5. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 6. Inability to understand or read the informed consent
Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.

Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. In recent years we have used the bipolar energy for resection of polyps by hysteroscopy, becoming a routine clinical practice and universally accepted.

Resection of endometrial polyps laser energy has recently begun to be used with satisfactory results, so studies are needed to analyze these results and compare it with the usual techniques .

This time in advance of medicine, it is appropriate to introduce minimally invasive procedures , allowing resection of endometrial polyps on an outpatient basis without anesthesia and acceptable to most patients.

These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .

Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients

Main objective: To assess the tolerability of diode laser in the treatment of endometrial polyps using a visual analogue pain scale.

Secondary objectives:

* Determine if complete resection of polyps is achieved with both methods.
* Compare the time spent on the removal of the polyp in each of the hysteroscopic methods.
* To evaluate the safety of the laser diode with respect to the bipolar electrode (vagal syndrome, uterine perforation, infection, bleeding).
* Assess the recurrence of polyps after 3 months of resection (via hysteroscopy).
* Compare the degree of patient satisfaction with the different methods.

Design: randomized single blind clinical trial corresponds to an experimental analytical study. The patients randomly into 2 groups will include: Group A bipolar electrode treatment Versapoint and Group B diode laser treatment. Randomization was performed using a random table with 2 groups, generated in Microsoft Office Excel. The sample size needed to detect a difference in visual analog pain scale of a point with respect to the laser diode bipolar electrode is calculated; assuming a standard deviation of 1.75, a sample size of 49 patients in each group (98 would be needed in total), to a level of significance of 5% (0.05 α) with a power of 0.80 (beta 0.20). Assuming a loss of individuals from 5 to 10%

Eligibility Criteria:
Inclusion Criteria:

* patients previously diagnosed of endometrial polyps that can be resected. The diagnosis will be made hysteroscopically. The patient must be informed about the study, and sign the informed consent.

Exclusion Criteria:

* the usual exclusion criteria for surgical techniques, pregnant patients, patiens under 18 patients who did not sign the informed consent
RH Genotype Matched RBC Transfusions

To determine the feasibility and efficacy of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.

This is a Phase 1/2 trial in patients with Sickle Cell Disease requiring chronic red cell transfusions. RH genotyped donor units will be obtained from the New York Blood Center. Patients will be matched with donor units whose RH genotypes predict no foreign Rh protein exposure to the patient. This will provide red cell matching at a level above the current standard of care (serologic C, E, and K matching). Patients will receive RH matched red cells for the duration of their chronic transfusion therapy or up to three years, whichever is shorter. In the pilot phase, we have determined it is feasible to identify RH matched donor units for the patient's RH genotype for every scheduled transfusion. We will now continue to show feasibility as well as determine efficacy by monitoring Rh alloantibody formation.

For subjects with a history of stroke/recurrent transient ischemic attack or other indication who require tight control of Hb S, and RH genotyped blood is not available, standard of care serologic matched blood would be administered rather than delaying transfusion and risking higher Hb S level.

For all subjects, standard of care serologic matched blood would be administered rather than delaying transfusion beyond 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age \>6 months
* Diagnosis of SCD, all genotypes
* Require a period of chronic red cell transfusion therapy
* Subject/parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

* Rare RH genotype that would preclude identification of sufficient RBC units
* Antigen negative requirements due to alloimmunization that would preclude identification of sufficient RBC units
* Alloimmunized to D antigen
* Rh alloimmunized patients for whom providing RH genotype matched blood would expose the patient to an antigen that would not be consistent with standard of care and blood bank protocols
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Tocopherol is a Novel Treatment for Cancer Related Mucositis

The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant and non-lactating females, 18 years of age or older at the time of screening, who are to receive myeloablative agonists with or without total body irradiation (TBI) in preparation for either allogeneic or autologous HSCT. Patients who are to be hospitalized and are expected to remain hospitalized until marrow recovery.
* Karnofsky performance status of 60 or greater or ECOG performance status of 2 or less.
* Normal dental examination as assessed by the investigator.

Exclusion Criteria:

* Clinically significant acute and active oral cavity infection.
* Patients taking any investigational or other non-approved oral therapy for oral mucositis.
* Known hypersensitivity to Vitamin E.
Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine

This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.

One of today's main challenges in stroke medicine is to further decrease event-to-treatment-time. On-site, pre-hospital, clinical assessment of patients with suspected acute stroke can optimize further diagnostic and treatment pathways after patient arrival at the dedicated stroke center. A telemedical approach (interactive video and audio streaming) allows time efficient pre-hospital triage, via patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire. This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.

Eligibility Criteria:
Inclusion Criteria:

* suspected acute stroke as per the first judgement of the paramedics on-site

Exclusion Criteria:

* Patients with a known history of epilepsia or non-epileptic seizures
* Patients after/while displaying an epileptic seizure
* Recent head trauma
* Patient with a reduced Glasgow Coma Scale or other condition not allowing Rapid Arterial oCclusion Evaluation (RACE) examination
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 to ≤ 75 years of age
* On a statin or a low dose statin with stable dose for at least 4 weeks
* Lipid lowering therapy has been stable prior to enrollment
* Fasting triglycerides must be \< 400 mg/dL.
* Subject not at LDL-C goal

Exclusion Criteria:

* New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction \< 30%
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
* Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c \> 8.5%)
* Uncontrolled hypertension
Early Identification and Effective Management of Pediatric Sepsis

In patients diagnosed as sepsis on PICU admission, early and accurate identification of patients who will develop organ dysfunction (severe sepsis) is critical for effective management and positive outcome. A multiple marker approach would improve clinical utility compared with use of a single marker. The primary goal of this part of study is to define a combination of multiple markers, derived from novel biomarkers (nCD-64, IL-27, sTREM, HLA-DR, IL-10), metabolomics and routine clinical parameters, which could predict severe sepsis and determine the severity of disease.

We intend to enroll pediatric sepsis patients at four PICUs and divide them into two groups based on clinical outcomes: severe sepsis group (patients who progress into severe sepsis), sepsis group (patients who do not progress in to severe sepsis). We intend to perform predictive modeling using multivariable analyses of the novel biomarkers and derive a biomarker panel and algorithm for early diagnosis of severe sepsis. The predictive value of the biomarker panel for early identification of severe sepsis will be compared with established indices, such as PRISM III and pSOFA score.

Eligibility Criteria:
Inclusion Criteria:

* The presence of at least two of the following four criteria, one of which must be abnormal temperature or leukocyte count:

  * Coreb temperature of \>38.5°C or \<36°C.
  * Tachycardia, defined as a mean heart rate \>2 SD above normal for age in the absence of external stimulus, chronic drugs, or painful stimuli; or otherwise unexplained persistent elevation over a 0.5- to 4-hr time period OR for children \<1 yr old: bradycardia, defined as a mean heart rate \<10th percentile for age in the absence of external vagal stimulus, β-blocker drugs, or congenital heart disease; or otherwise unexplained persistent depression over a 0.5-hr time period.
  * Mean respiratory rate \>2 SD above normal for age or mechanical ventilation for an acute process not related to underlying neuromuscular disease or the receipt of general anesthesia.
  * Leukocyte count elevated or depressed for age (not secondary to chemotherapy-induced leukopenia) or \>10% immature neutrophils
* A suspected or proven (by positive culture, tissue stain, or polymerase chain reaction test) infection caused by any pathogen OR a clinical syndrome associated with a high probability of infection. Evidence of infection includes positive findings on clinical exam, imaging, or laboratory tests

Exclusion Criteria:

* patients without informed consent
* discharge within 48 hours