cyrilzakka/clinical-trials huggingface dataset:
RELAXED: Recurrent Embolism Lessened by Rivaroxaban for Acute Ischemic Stroke

Early recurrence of cardioembolic stroke in patients with atrial fibrillation is common, reaching approximately 6% within 30 days after initial stroke. Therefore, it is preferable to provide early anticoagulation for cardioembolic stroke. However, early anticoagulation may increase the risk of hemorrhagic transformation of cerebral infarcts. It is difficult to decide the timing of initiation for anticoagulant therapy in stroke patients with non-valvular atrial fibrillation (NVAF). In 2013 the European Heart Rhythm Association presented the practical guides for oral anticoagulants in NVAF patients, which recommend that the optimal time to start anticoagulant therapy should be determined according to the stroke severity. However, this recommendation is principally an experts' opinion and is not suitable in the clinical practice in Japan.

RELAXED, a multicenter observational study is planned to evaluate the efficacy and safety of an oral direct activated coagulation factor Xa inhibitor, rivaroxaban, for acute ischemic stroke patients with NVAF in consideration of the infarct size, timing of initiation for rivaroxaban medication, and other patient characteristics, and thereby to determine the optimal timing of the initiation during acute ischemic stroke. The consecutive acute ischemic stroke / transient ischemic attack (TIA) patients with NVAF who are treated with rivaroxaban will be enrolled. The infarction size at 0-48 hours after stroke onset will be measured by the diffusion weighted image (DWI) MRI. The primary efficacy endpoint is recurrent ischemic stroke within 3 months. The primary safety endpoint is major bleedings within 3 months. The optimal timing to initiate rivaroxaban during acute ischemic stroke is determined by analysis of co-relation between primary endpoints and the infarct size / time to initiate rivaroxaban.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA)
* Having non-valvular atrial fibrillation
* Visiting the clinic/hospital within 48 hours of the onset of acute ischemic stroke or TIA
* Identification of an infarct in the middle cerebral artery (MCA) territory (symptoms ascribable to ischemia in the MCA territory in TIA patients)
* Initiation of treatment with rivaroxaban within 30 days of the onset of acute ischemic stroke or TIA
* Written informed consent by patients

Exclusion Criteria:

* hypersensitivity to rivaroxaban 2) Active bleeding (clinically significant hemorrhage) including gastrointestinal hemorrhage
* liver disease complicated with coagulation disorder
* liver disorder corresponding to Child-Pugh Class B or C
* renal failure (creatinine clearance: \<15 mL/minute)
* poorly controlled hypertension (higher than 180/100)
* Woman who are or are likely to be pregnant
* Ongoing treatment with HIV protease inhibitors including ritonavir, atazanavir and indinavir
* Ongoing treatment with itraconazole, voriconazole and ketoconazole
* Active bacterial endocarditis
* Patients considered by the investigator to be unsuitable for participating in this study
Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.

This study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lymphohistiocytosis.


Eligibility Criteria:
Inclusion Criteria:

* 1.Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
* 2.Patients were older than 2 years of age.
* 3.Estimated survival time ≥ 1 week.
* 4.Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index \>250.
* 5.sign informed consent.

Exclusion Criteria:

* 1.Heart function above grade II (NYHA).
* 2.Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
* 3.Pregnancy or lactating Women.
* 4.Allergic to pegylated liposomal doxorubicin or etoposide.
* 5.Active bleeding of the internal organs.
* 6.HIV antibody positivity.
* 7.Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable).
* 8.Participate in other clinical research at the same time.
* 9.The researchers considered that patients are not suitable for the study.
Dermal Substitute and Topical Negative Pressure in Burns

The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months.

Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.

The standard therapy for full thickness wounds is transplantation with a split thickness skin graft. However, scars usually develop as a result of this therapy. Previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. One of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. Since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. It now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing.

Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>=18 yrs with acute burns/trauma wounds that require skin grafting
* Minimal study wound surface 10 cm2
* Maximal study wound surface 300 cm2
* Maximal TBSA 15% full thickness wounds
* Informed consent

Exclusion Criteria:

* Patients with wounds without adequate possibility to apply VAC
* Immunocompromised patients
* Infected wounds
* Pregnant patients
* Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).
CoSeal for Hemostasis of Aortic Anastamoses

Surgery on the aorta can be associated with significant blood loss. Most commonly this is due to bleeding at the site of aortic anastomosis. Surgical bleeding is associated with significant morbidity.

One way to prevent bleeding is to use a special glue (sealant) after performing large connections on the aorta. The goal of this study is to compare the different methods surgeons use to stop/prevent bleeding.

The study team will collect medical information about patients before, during, and after surgery on their aortas, including the methods used to prevent bleeding. This information may help doctors improve the way that they care for these patients.

Bleeding is a major complication of cardiac surgery, and a significant cause of morbidity and mortality \[1-4\]. Hemostasis can be challenging during complex cardiac surgery, particularly due to friability of the tissue, coagulopathy, poor visualization of the surgical field, and limited accessibility to bleeding sites \[5\]. Failure to achieve and maintain hemostasis and reinforce fragile tissue may result in additional bleeding, which can further reduce visualization, increase operative blood loss, lengthen surgery, increase the use of blood products, and contribute to postoperative complications and reoperation \[1-4\].

Postoperative bleeding is a significant concern in cardio-thoracic surgery. Bleeding, either intraoperative or postoperative, has been associated with extended in-hospital length of stay, reoperations, severe morbidity and death \[12\]. In addition to surgical technique, a variety of therapeutic agents are available to assist in hemostasis. Surgical sealants are used to prevent suture line bleeding when ligation or conventional methods are ineffective or impractical \[13\]. CoSeal® Surgical Sealant (CoSeal®, Baxter, Westlake Village, CA) is a synthetic polyethylene glycol (PEG) polymer \[11, 13\]. The polymers cross-link with proteins in the tissue and begin to gel in approximately 5 seconds and set within 60 seconds, forming a strong, flexible, clear, degradable hydrogel that adheres to both tissue and synthetic graft surfaces \[11, 13-14\]. A secure seal is maintained through covalent tissue bonds even under high pressures in vessels, such as the aorta \[15\]. The gel is completely resorbed within 30 days \[14\].

Eligibility Criteria:
Inclusion Criteria:

* The study will include all patients undergoing cardio-thoracic surgery requiring a large aortic anastomosis.

Exclusion Criteria:

* Patients with severe preoperative coagulopathy, connective tissue disorders and disseminated intravascular coagulopathy (DIC) will be excluded.
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection

The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C virus (HCV) subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C virus infection including treatment naive subjects as well as subjects who are partial responders and relapsers to prior interferon therapy
* \>18 years of age
* Negative skin test for hypersensitivity to saccharomyces cerevisiae.

Exclusion Criteria:

* Non-responders to previous interferon treatments
* Cirrhosis
* HCV treatment within 3 months
* Hepatitis B infection
* HIV infection
Treatment of Bacterial Vaginosis

We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated for decreasing the prevalence of these complications. The etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Further, half of all women who meet the clinical diagnostic criteria for BV are asymptomatic and treatment of these women remains controversial. More detailed characterization of the origins, natural history and response to therapy would supply data to guide control efforts. We will approach these problems through a multifaceted interdisciplinary evaluation of women with and without BV.

The specific aims {and hypotheses} of this project are:

1. To conduct studies to determine optimal agents and duration of therapy for BV {Hypothesis: Longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of BV; response to therapy differs between women with asymptomatic BV and symptomatic BV}
2. To examine the role of condoms in the prevention of BV {Hypothesis: BV is a sexually transmitted infection, thus recurrence rates of BV will be lower among women with higher condom usage rates}
3. To further explore the role of Mobiluncus spp., organisms strongly associated with the syndrome, by utilizing specimens derived from the above studies.

{Hypothesis: Mobiluncus is involved in the pathogenesis of BV at least in a subset of women, and the persistence of this organism is associated with lack of cure and recurrence of BV}

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic bacterial vaginosis

Exclusion Criteria:

* Pregnancy
* Other genital infections
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)

Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (\<= 75 kg or \> 75 kg).


Eligibility Criteria:
Inclusion Criteria:

* Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD

Exclusion Criteria:

* Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
* Known non-responder to stimulant medication
* Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
* Conduct Disorder, hypertension, history of seizure
* Tic disorder or Tourette's disorder
A Social Media Intervention on Promoting Oral Heath Among Iranian Adolescents

Online social networking sites, such as Telegram, possess a number of useful features that could enhance oral health promotion interventions, including the ability of users to share personal information, which is aggregated and displayed to other users .This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving oral health in adolescents and their mothers. Participants will be allocated in three groups with a) an intervention group in which mothers and children receive the intervention and questionnaires via Telegram, b) only the children receive the intervention via Telegram and mothers and children receive the questionnaires, and c) mothers and children are in active control group and only receive the questionnaires. The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on Oral health behaviors. There will be 3 assessment points in time, baseline, 1 month and 6 months after the interventions.

The primary outcome of this study is to estimate the dyadic mechanisms between mothers and their children regarding improving oral health. Secondary outcome is to investigate whether oral health behavior did improve in the intervention groups in general and also to find the psychological mechanism behind the changes during the time of the study.


Eligibility Criteria:
Inclusion Criteria:

* aged 12 to 16
* possess a smartphone
* able or willing to give informed consent

Exclusion Criteria:

* They are not engaged in other oral-health education or research program.
* They have no physical and/or mental disabilities that will impede their ability to perform their own oral hygiene activities.
Medical Expulsive Therapy for Ureter Stone Using Naftopidil

This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

1. Enrollment

   1. patients with ureteral stones of sizes from 3 to 10 mm
   2. patients aged more than 18 years
2. Randomization

   1. naftopidil 75 mg qd for 14 days or placebo
   2. Standard treatment with pain-killers were also applied.(aceclofenac)
3. Follow-up for 28 days

   1. We confirm the stone free status by CT or X-ray films at 14th and 28th days.
   2. Rates of active treatment will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* \>= 20 years
* single 3 to 10 mm ureter stone (longest diameter)

Exclusion Criteria:

* Presence of multiple ureter stones
* Renal insufficiency (serum Cr \> 1.4 mg/dL)
* Febrile urinary tract infections(fever \> 38°C, evidence of urinary infection)
* pregnancy or breast feeding
* solitary kidney
* hypersensitivity to naftopidil
* current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)
* moderate or severe cardiovascular or cerebrovascular disease
* hepatic dysfunction (\>2 x normal upper limit)
* significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption
Education Impact on Rehabilitation of Hospitalized Patients With Pneumonia and COVID-19

The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to pneumonia with confirmed COVID-19.

The planned group size is 60 patients diagnosed with pneumonia and confirmed COVID-19. The given population was calculated based on the sampling calculator, considering the following parameters: fraction size, confidence level, and maximum error. Eligible patients will be randomly divided into two groups: a study group (30 patients) undergoing pulmonary rehabilitation supplemented with an education program, and a control group (30 patients) undergoing conventional pulmonary rehabilitation. Patients of both groups will be included in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of three hours daily. The program will be applied individually to each patient and include in-bed assisted exercises, airway clearance techniques, effective cough exercises, pursed-lips breathing, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises. Patients from the study group will additionally undergo daily education using an original brochure containing information about self management during the treatment process, the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise. The test will be performed two times: before the start of rehabilitation and after completing the rehabilitation program. The patients' condition and the rehabilitation effects will be assessed using the following measures:

* Vital capacity (Voldyne 5000)
* Oxygen saturation (pulse oximeter)
* Acid-base balance (gasometry)
* Fatigue (modified Borg scale)
* Physical performance (Sit-to-Stand Test)
* Dyspnea assessment (MRC dyspnea scale)
* Anxiety and depression (HADS scale)
* Activities of daily living (Barthel scale)

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization due to pneumonia due to COVID-19
* Positive SARS-COV-2 PCR test
* Independence in in-bed sitting position with lower extremities placed on the floor
* Age 40 y.o. to 70 y.o.
* No additional respiratory support (e.a. cardiopulmonary bypass machine, ventilator)
* Informed, voluntary consent to participate in research.

Exclusion Criteria:

* Hospitalization due to pneumonia with negative SARS-COV-2 PCR test
* Unstable medical condition hindering performing the examination
* Age under 40 y.o. and over 70 y.o.
* Cognitive deficits impairing the ability to understand and execute commands
* Concomitant oncological, neurological, orthopedic, and psychiatric diseases may affect the examined persons' circulatory and respiratory functions, functional efficiency, quality of life, and emotional state.
* Failure to complete a 14-day rehabilitation program
* Lack of informed, voluntary consent to participate in research
A Survey on Psychosomatic Health Status of Chinese Population

A Survey on Psychosomatic Health Status of Chinese Population

This is a nationwide cross-sectional study to investigate psychosomatic symptoms among genral population in China. This study will also focus on the relationship between psychosomatic symptoms and functions and wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old and above;
* Able to complete the scale independently;
* Subjects read informed consent through online questionnaires and agreed to cooperate with relevant assessments.

Exclusion Criteria:

* Individuals with severe physical disease;
* Individuals with cognitive impairment;
* Individuals who cannot finish the online survay independently.
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents

This study will evaluate whether a behavioral activities treatment program improves symptoms of depression in nursing home residents.

Depression is a common mental disorder that affects nearly half of all older people living in nursing homes. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affect people's sleep patterns, concentration, and energy levels. In addition, nursing homes are often understaffed and very busy, making it difficult for older people with depression to receive a proper diagnosis and adequate treatment. Recent studies have shown that an increase in pleasurable activities among residents in nursing homes can improve symptoms of depression. The purpose of this study is to determine whether symptoms of depression can be reduced by increasing opportunities for nursing home residents to engage in pleasant events and build better relationships with nursing home staff members.

Participating nursing homes will be randomly assigned to have their residents receive behavioral activity treatment (BE-ACTIV) or treatment as usual for 12 weeks. Potential participating nursing home residents will complete two brief tests regarding memory, attention, and symptoms of depression. An hour-long interview will then be conducted during which eligible participating residents will discuss their symptoms of depression, rate their health and level of functioning, and assess the quality of their relationship with a staff member. Residents receiving BE-ACTIV will meet with a therapist for weekly 30-minute sessions for 10 weeks. During these sessions, residents will discuss their activity participation and any pleasant events that they recently experienced. Therapists and nursing home activities staff will work together to incorporate more activities of interest into each resident's schedule. Residents of nursing homes assigned to receive treatment as usual will be asked to rate their mood once a week for 10 weeks. Researchers will observe each resident, regardless of treatment group, for 5-minute intervals at various times during the study to assess mood and activity levels. All participating residents will undergo a second interview after 10 weeks to discuss any changes or improvements in mood, symptoms of depression, activity level, or their relationship with staff members. All participating residents will be assessed after 3 months and again after 6 months post-treatment to determine whether the BE-ACTIV program was successful in improving symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* Nursing home residents in long-term care beds with an expected stay of 3 months or more
* Geriatric Depression Scale score of at least 11
* Meets DSM-IV criteria for major depressive disorder or research diagnostic criteria for minor depressive disorder

Exclusion Criteria:

* Mini Mental State Exam score below 14
* Referred to hospice care for a terminal condition
* Current unstable or terminal medical condition
* Suicidal
* Meets DSM-IV criteria for bipolar disorder