cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome

Corona virus disease 2019 (COVID-19) has been declared as a Pandemic by the World Health Organization (WHO). According to WHO report on March 31st 2020, globally COVID-19 have infected over 750,000 people and caused over 36,000 deaths with case fatality rate of 4.85%. In Indonesia, COVID-19 have infected 1,414 people and caused 122 deaths with case fatality rate of 8.63%. In severe cases, COVID-19 causes complications, such as acute respiratory distress syndrome (ARDS), sepsis, septic shock, and multi-organ dysfunction syndrome (MODS), where age and comorbid illnesses as a major factor to these complications. Up to this point there are several promising therapies for COVID-19 but is not yet recommended and in need of further research. The use of convalescent plasma has been approved by the US Food and Drug Administration (FDA) through the scheme of emergency investigational new drug (eIND). This method has been used as the treatment in several outbreak or plague cases over the years, such as the flu epidemic in 1918, polio, measles, mumps, SARS (severe acute respiratory syndrome), EVD (Ebola virus disease) and MERS (middle-eastern respiratory syndrome) and this treatment shows better outcome. Several case report on the use of convalescent plasma for COVID-19 patients with ARDS and mechanical ventilation has been reported and shows promising outcome. Nevertheless, larger and multicenter research need to be done to assess and evaluate the effectiveness and safety of convalescent plasma therapy on for COVID-19 patients with ARDS.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than equal to 18 years.
* COVID-19 confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR)
* Having severe pneumonia.
* PAO2 / FIO2 \<300.

Exclusion Criteria:

* Contraindication to blood transfusions (fluid overload, history of anaphylaxis of blood products)
* Multiple and severe organ failure, hemodynamically unstable
* Other uncontrolled infections
* Disseminated intravascular coagulation (DIC) which requires a replacement factor/FFP
* Hemodialysis patients or CRRT (continuous renal replacement therapy)
* Active intracranial bleeding
* Significant myocardial ischemia
* Receiving tocilizumab treatment
Harnessing Generativity Among Young Adult Cancer Survivors

Short, online interventions designed to enhance well-being may be particularly amenable for use with adolescent and young adult (AYA) cancer survivors (age 15-39 at diagnosis), an understudied group in the cancer community. The benefits of psychological well-being on both physical and mental health outcomes are well-known and, in recent years, researchers and policymakers have begun to view the period of adolescence and young adulthood as a window of opportunity to instantiate lasting habits and behaviors. Growing evidence suggests that prosocial behavior-a behavior that can be reliably manipulated through a short online intervention-may have beneficial effects on well-being and physical health. This has yet to be tested in AYA cancer survivors.

Drawing from the literature on positive psychology and prosocial interventions, the proposed study will test the feasibility and efficacy of an 8-week online peer helping intervention designed to increase well-being among AYA cancer survivors. AYA cancer survivors (n = 176) will be recruited and randomized to one of three conditions: a peer helping condition, a cancer-specific writing plus peer helping condition, or a cancer-specific writing condition (control condition). The second group was added in response to a previous study, which found that writing about one's experience prior to helping other survivors may be more beneficial. Participants will complete a weekly writing activity once per week for 4 weeks, with instructions administered via a weekly email. Participants will also complete online assessments before, during, and after the 4-week intervention period.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cancer (any type) between the ages of 15 and 39 years
* have completed primary treatment and are in remission (partial or complete)
* between the ages of 18 and 39 years
* fluent in English
* have access to the internet and email.

Exclusion Criteria:

-none
Investigating Patient Satisfaction With Oral Anti-Cancer Treatment

Prospective non-interventional non-controlled multicenter observational study to evaluate aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an oral anti-cancer drug.

The main objective of this study is to evaluate the patient perspective in the treatment of advanced renal cell carcinoma with an oral anti-cancer drug.

The following aspects will be investigated:

* Intrinsic desire for information about treatment.
* Patient satisfaction with treatment information.
* Patient satisfaction with treatment.
* Medication adherence.
* Health-related quality of life.
* The role of different health care professionals in the treatment of RCC with oral drugs

This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years or older, and who can be contacted by phone and/or e-mail are eligible for the study

Exclusion Criteria:

* Patients who are not able to understand Dutch or French will be excluded from the study
Characterization of Colorectal Neoplasia

This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 years or older undergoing screening colonoscopy for CRC
* Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation

Exclusion Criteria:

* subjects at high risk for colorectal cancer
* subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes
* patients with previous resection of the sigmoid rectum
* patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings
* patients who perform an emergency colonoscopy
It is a Prospective Study Aiming to Identify Incidence and Prevalence of Cardiovascular Diseases, Changes in Physical Activity, Dietary Habits and Anxiety Depression Levels Through a Period of Time in the Naval Personnel (PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases)

Prospective study. Starting from 2014 all newly appointed 1st year cadets in Naval Academies will be enrolled until the class of 2025.

Physical examination, food frequency questionnaire, physical activity questionnaire, anxiety/depression questionnaire, medical history will be filled out at first interview.

Specific blood tests will be performed. Every participant will be interviewed every three years and will complete the same questionnaires.

Follow up period is determined ten years after last class enrollment


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Non signed consent form
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder

The purpose of the research is to test the effectiveness of the social story intervention delivered using the iPAD application "Going to Imaging" on the anxiety, challenging child behaviors, child injuries and completion rates among children with ASD undergoing medical imaging procedures. A secondary purpose is to test the effect of this intervention on the anxiety levels of the parents of ASD children undergoing medical imaging procedures.

Hypotheses:

H1: Children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging compared with children with ASD exposed to treatment as usual (TAU) will have:

1. Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline compared to up to two hours later).
2. Exhibit fewer challenging behaviors as measured by a behavior observation scale (developed for the study (up to 2 hours after baseline)
3. Higher procedure completion rate.
4. Shorter time to complete a procedure.
5. Less child injuries.

   H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging will have:
6. Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).

Parent state anxiety is measured at baseline with the 20-item State anxiety measure from www.mindgarden.com. Child anxiety is measured at baseline with vital signs (heart rate, blood pressure, respiratory rate). Behaviors will be observed and recorded on the behavior observation tool up to 2 hours after the baseline measure (during the imaging).

Eligibility Criteria:
Inclusion Criteria:

* Children with autism spectrum disorder
* English speaking parent or guardian.

Exclusion Criteria:

* Non-english speaking parent or guardian
* Severe autism as defined by caregiver or health care provider.
Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of irinotecan in treating patients who have refractory metastatic breast cancer.

OBJECTIVES: I. Assess the antitumor activity and toxicity of two different schedules of irinotecan in the treatment of patients with refractory metastatic breast cancer who have received 1 or 2 previous chemotherapy regimens (up to one prior therapy for metastatic disease and one for adjuvant therapy). II. Compare the time to progression, survival, and quality of life of these patients on these 2 different schedules of irinotecan.

OUTLINE: This is a randomized study. Patients are stratified according to dominant disease (visceral vs nonvisceral), performance status (0-1 vs 2), and prior chemotherapy in metastatic setting (yes vs no). Patients assigned to arm I receive irinotecan intravenously over 90 minutes every week for 4 weeks followed by a 2 week rest period. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients assigned to arm II receive irinotecan intravenously over 90 minutes every 3 weeks for 6 weeks. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are followed every 3 months for 2 years, then annually for 1 year.

PROJECTED ACCRUAL: A total of 42-100 patients (21-50 patients per arm) will be accrued for this study within 3.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast with progressing locoregional or metastatic disease Measurable or evaluable indicator lesion No uncontrolled CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 0.3 mg/dL above upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 1.0 mg/dL above ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No uncontrolled infection No chronic debilitating disease Not pregnant or lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy No more than 2 prior chemotherapy regimens for metastatic disease No more than 1 prior chemotherapy regimen in the adjuvant setting At least 1 prior regimen containing taxane or doxorubicin for metastatic disease or in the adjuvant setting Endocrine therapy: Not specified Radiotherapy: No radiotherapy to greater than 25% of bone marrow No prior treatment with strontium 89 Surgery: At least 4 weeks since major surgery Other: No concurrent metoclopramide
Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests

This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).

Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.

The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Seeking care at the CASO MDM health care center
* Accept to be followed at Saint-Antoine Hospital in the event of a positive test.

Exclusion Criteria:

* Currently under physician's care for viral hepatitis (HBV/HCV-specific) or HIV
* Already has been tested (must give any of the following as evidence):

  * results from HBV and HCV and HIV tests dating at least 3 months back
  * results from HCV and HIV tests dating at least 3 months back and HBV serology indicating that the participant is immunized against HBV.
The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease

The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis \> 50% on angiography, or history of documented myocardial infarction)
* Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
* Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
* On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
* No tobacco use within 3 months of the study
* No laboratory evidence of renal, hepatic, or hematological abnormalities
* Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
* Elevated levels of urinary and plasma F2-isoprostanes
* Elevated plasma levels of hs-CRP
Virtual Reality for Patient Informed Consent in Neurosurgery

The goal of this randomized controlled trial is to evaluate benefits of VR (virtual reality)-based patient informed consent in neurosurgery regarding subjective patient comprehension, patient-doctor relationship and anxiety.

Additionally, the investigators aim to assess the cost-benefit radio as well as feasibility in a clinical routine setting. Considering the increasing patient participation in decision-making, VR could lead to better understanding of complex surgical procedures, improving the perioperative process for both, patient and surgeon, and reduce anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age of 18 and 75
* Surgical clipping for intracranial aneurysm, resection of vascular malformations
* Craniotomy and Resection of intracranial tumors that can be segmented for VR

Exclusion Criteria:

* Visual or auditory impairment with no sufficient aid
* Patient that had VR informed consent for surgery before
* Psychiatric illness, cognitive impairment
Comparison of Two Intermittent Urinary Catheters

This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.

1. is male and at least 18 years of age.
2. is self-catheterizing at least 3 times a day.
3. has been performing catheterizations for at least 2 months.
4. is wheelchair bound.
5. is able to use a size 12 or 14 French straight catheter.
6. is willing and able to follow the study protocol and Investigator's instructions.
7. is in the opinion of the Investigator, qualified to participate.

Eligibility Criteria:
Inclusion Criteria:

* is male and at least 18 years of age
* is self-catheterizing at least 3 times a day
* has been performing catheterizations for at least 2 months
* wheelchair bound
* is able to use a size 12 or 14 French straight catheter
* is willing and able to follow the study protocol and Investigator's instructions
* is, in the opinion of the Investigator, qualified to participate

Exclusion Criteria:

* has cognitive impairments that preclude completion of study protocol
* cannot communicate as determined by the Investigator
* has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
* has a symptomatic urinary tract infection determined by interview
* has a retracted penis
* has participated in a study during the previous 30 days involving catheterization
* has been diagnosed with an enlarged prostate
* has urethral strictures, false passages, or urethral obstruction
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on this and other reports in the literature, SCI-related neuropathic pain is hypothesized to occur largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. Furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level SCI neuropathic pain and increases parietal operculum (partsOP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). Circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. The study aims to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Injured for \&gt; 3 months
* Completed inpatient rehabilitation and living in the community
* Chronic sublesional neuropathic pain defined as persistent pain (VAS grade 3-10) for three months or more
* For people of child-bearing potential: currently practicing an effective form of two types of birth control (defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly).

Exclusion Criteria:

* Progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
* Active use of drugs known to interact with brivaracetam: rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin.
* Brain injury or cognitive impairment limiting the ability to follow directions or provide informed consent
* Pregnancy or lactation
* Epilepsy or active treatment for seizure disorder
* Past or current suicidality
* Active treatment for psychiatric disease
* Drug addiction
* Moderate or heavy alcohol intake (up to four alcoholic drinks for men and three for women in any single day, and a maximum of 14 drinks for men and 7 drinks for women per week)
* Hepatic cirrhosis, Child-Pugh grades A, B, and C
* Impaired renal function (GFR\&lt;60ml/minute)
* Contraindications to brivaracetam or pyrrolidine derivatives including allergy
* Active clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
* History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of brivaracetam
* Use of any investigational drug 30 days prior to enrollment in this study
* Enrollment in another clinical trial.
A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis

The purpose of this study is to try to understand how histopcytosis can cause symptoms or problems in the brain. The tests being done in the study will look at memory and thinking as well as brain function via MRI scan.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years.
* Fluency in English
* Diagnosis of a histiocytic disorder as determined, in the opinion of the study PI, by a corroborating constellation of histopathology, clinical, and/or radiologic findings.
* Will undergo Standard of Care MRI.

Exclusion Criteria:

* Known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma)
* Prior stroke or intracranial hemorrhage
* Other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the PI or Co-PI to confound neuroimaging studies (e.g., demyelinating disease)
* Existing diagnosis of a psychiatric disorder or untreated mood disturbance
* Existing diagnosis of a neurodegenerative disease, such as Alzheimer's disease
* Chronic or daily excessive alcohol consumption as determined by the PI.
* History of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past
* History of severe claustrophobia or other contraindications to patient SOC brain MRI
* Prior intravenous cytarabine or cladribine
* Other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the PI or Co-PI to confound imaging studies or cognitive performance