cyrilzakka/clinical-trials huggingface dataset:
Diagnosis and Physiopathology of Insulin Allergy

Insulin allergy (IA) is still observed even with recombinant human insulin and insulin analogs.

Obviously, the usual attitude facing an allergy, i. e. exclusion of the allergen, poses problems in face of IA because insulin is often vital for the patient. IA is thus a complex situation in which a rigorous diagnostic procedure to identify the exact allergen is necessary to propose a therapeutic answer; the purpose of the study is 1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA.

Phenotype of the patient Investigation of allergy per intradermal testing using a wide range of insulin preparations Determination of immunologic and immunogenetic profile particularly CD4 + T cells and mast cells

Eligibility Criteria:
Inclusion criteria :

* Patients aged 18 years old and more with a written informed consent
* Experimental group : type 1 or type 2 diabetic patients with insulin allergy based on clinical criteria
* Active Comparator group: type 1 or type 2 diabetic patients insulin treated without insulin allergy

Exclusion criteria :

* Not willing participate
* Pregnancy
* Age below 18 years
* Severe Renal failure
* Severe Anaphylactic shock only for the experimental group
* No social security overture
Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma

Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
2. Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
3. Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
4. Patients with lesions in the head, neck, chest, or extremities
5. Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration

Exclusion Criteria:

1. Patients with obvious disseminated lesions
2. Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
3. Patients with active lesions / active multiple cancers in addition to the target lesion
4. Patients with infections that require systemic treatment.
5. Patients with active implantable medical devices
6. Patients with a history of BNCT treatment
Patients Decision-making in Rotator Cuff Surgery

The objective of this study was to evaluate the effect on patient treatment decision-making if information was given based on the benefit or on the side effect in rotator cuff disorders.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with rotator cuff tears at their first clinical visit

Exclusion Criteria:

* patients with a previous shoulder surgery, patients with worker's compensation and patients who were unwilling to participate and thereby not sign informed consent
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer

To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects with previously untreated metastatic pancreatic cancer using standard response criteria

A Phase 2, multicenter, open-label, randomized clinical trial. The study was to evaluate the efficacy and safety of ACP-196 plus nab-paclitaxel/gemcitabine compared with nab-paclitaxel/gemcitabine in subjects who have previously untreated metastatic pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* ECOG performance status of 0 or 1.
* Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
* No previous radiotherapy, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.

Exclusion Criteria:

* Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with endobiliary stents may participate as long the enrollment criterion relating to serum bilirubin concentration is met.
* Breastfeeding or pregnant
Clinical Validation of PROPECG-TMT

This clinical validation evaluates the performances of physicians with and without learning with PROPECG-TMT assistance for screening coronary artery revascularization on TMT-ECG.

There are two endpoints used to evaluate performances: Accuracy (primary endpoints with pair specificity/sensitivity, and PPV/NPV), and time needed for screening (secondary endpoints with time measurements in all cases).


Eligibility Criteria:
Inclusion Criteria:

* TMT ECG exams adjudicated as equivocal cases

Exclusion Criteria:

* Exams not converting to median beat ECG
* Exams not containing interpretable exercise
Efficacy and Safety of Low-dose Rituximab in the Treatment of Refractory Myasthenia Gravis

This study is designed to evaluate the effectiveness and safety of low-dose rituximab in patients with refractory myasthenia gravis.

The traditional treatment of MG is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70% of treated patients show an incomplete response, including 10 - 30% who are unresponsive. Corticosteroids and other immunosuppressive therapies presented also many side effects. The investigators propose to evaluate in a pilot, open, prospective, single central study, the interest of rituximab (RTX) in the treatment of patients with refractory MG. Fifty patients with refractory MG will be included in the study and divided into two stages: 14 patients in the first stage were followed up after using RTX according to the study protocol. The study will move into the second stage on if the number of effective cases is greater than 3, otherwise, the study will be discontinued (based on Simon's Optimal Two-stage Design). The remaining 36 patients were enrolled in the second stage. In the first and second stages, the treatment plan and follow-up plan were consistent. The therapeutical schema is rituximab 100-200 mg/week for a total of 2-4 times, followed by adequate organ function, laboratory parameters and assessment of MG after each injection and end of follow up for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 80 and under;
2. Myasthenia gravis:

   1. Patients who are diagnosed as generalized or ocular myasthenia gravis
   2. Patients must have disease refractory to treatment: the condition did not improve (QMG score decreased by less than 3 points after treatment) or even deteriorated after treatment with sufficient prednisone or other immunosuppressive agents.
3. Patients sign informed consent forms

Exclusion Criteria:

1. Over the age of 80
2. Patients with serious complications such as infection
3. Patients with active TB (during the screening period, a chest X-ray or chest CT would be performed unless the patient can provide chest X-ray or chest CT reports in the last month); or patients with active HBV, HBV DNA\> 200
4. Patients suffering from cardiomyopathy, acute coronary events, or severe arrhythmia.
5. Patients who were allergic to rituximab
6. Pregnant or suckling period woman
7. Patients accompanied with mental disorders and have difficult to communication
8. Patients with a significant abnormality in white blood cells, hemoglobin, and platelet count.
A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants

Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing the informed consent form (ICF).
* Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a minimum weight of 50kg.

Exclusion Criteria:

* Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of the study.
* Laboratory parameters outside of the laboratory normal range.
* Positive test results for alcohol or drugs of abuse.
* Treatment with an investigational drug within 90 days preceding the first dose of trial medication.
* Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients.
* History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
* Current smokers and those who have smoked within the last 6 months.
Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries

This study had 2 parts: A controlled Core and an open-label Extension.

* Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group, multicenter study evaluated the efficacy, safety and tolerability and PK of ofatumumab in patients with RMS.
* Extension part: The Core part was followed by an Extension part in which all patients received open-label ofatumumab. In the Extension part, patients were treated for at least 24 weeks and no longer than 48 weeks.

Sixty-four patients were randomized in a 2:1 ratio to ofatumumab or placebo in the Core part; half of the study patients were from Japan and the other half from the other countries.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis (MS)
* Relapsing MS (RMS)
* At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization
* EDSS score of 0 to 5.5

Exclusion Criteria:

* Primary progressive MS or SPMS without disease activity
* Patients with an active chronic disease of the immune system other than MS
* Patients at risk of developing or having reactivation of hepatitis
* Patients with active systemic infections or with neurological findings consistent with PML
ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.

The rapid spread of the novel coronavirus SARS-CoV-2 has resulted in pandemic levels and a global challenge in diagnosing infection. Diagnosing infection, defining recovery and immunity has been challenging. Health care providers in particular are very interested in knowing their status as they are highly exposed, and if infectious, can potentially transmit infection nosocomially (in the healthcare workplace setting) and to their household. In addition to understanding their exposure risk, infectious period, and immunity status, health care workers are reporting high levels of psychosocial distress including anxiety and burnout. The investigators aim to assess the baseline and cumulative seroprevalence of SARS-CoV-2 among health care workers using both quantitative and qualitative serological assays; describe psychosocial well-being and coping strategies among health workers in their institutional settings and describe how knowledge of one's serostatus affect psychosocial well-being, and coping strategies. Findings from this study will inform; 1) use of serological assays and testing algorithms, and 2) approaches to manage psychosocial stress for healthcare workers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate
* Understands and reads English

Exclusion Criteria:

* Younger than 18 years of age
* Mentally and/or physically unable to complete study requirements
Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome

The main objective of the study is to assess the feasibility, safety, and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome.

HCR040 is an investigational medicinal product whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2.

The main purpose of this study is to evaluate the safety and tolerability of a single administration of HCR040 using: a) two sequential escalating doses administered 96 hours post-injury to participants with moderate to severe acute respiratory distress syndrome (ARDS); and b) the determined maximum tolerated dose administered 96 hours post-injury to participants with moderate to severe ARDS. The study also includes initial exploration of efficacy.

Treatment is administered by intravenous injection.

The study has been divided into two phases:

Phase 1 (open label): 6 participants with moderate to severe ARDS will be included in 2 sequential cohorts.

Phase 2 (randomized, controlled, double-blind): 20 participants with moderate to severe ARDS will be randomly divided into two groups (control and treated).

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years
* Patients with criteria of moderate to severe ARDS according to the Berlin Conference.
* Berlin criteria of moderate to severe ARDS given simultaneously during the 24 hours prior to entry into the study
* Patients with invasive mechanical ventilation in controlled mode (VC, PC or VCRP) adjusted to Vt≤8 mL/kg, Ppl \<30 cmH2O and minimum PEEP of 8 cmH2O

Exclusion Criteria:

* Participation in a previous clinical study within 28 days prior to the ARDS situation
* Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation
* Inability to obtain Informed Consent
* Hemodynamic instability that contraindicates the intravenous cellular administration, within the defined time frame for inclusion in the study
* Alveolar hemorrhage or hemoptysis
* LTSV situation (Limitation of life support treatments)
* Major trauma in the previous 5 days
* Neoplastic processes at any time
* EPOC or severe home asthma or any other type of chronic respiratory disease requiring respiratory oxygen
* Known Child-Pugh liver disease score \> B9
* Pregnant women or women of childbearing age who are not using an adequate method of contraception, or who, if they are using it, are not willing to continue using it for the duration of the trial. If the patient is menopausal or sterile, it must be documented in the medical record
* Women who are breastfeeding if unwillingly to stop at the time of recruitment
* Pulmonary transplant
* Known grade III or IV pulmonary hypertension
* States of hypercoagulability
* History of DVP or PE in the last 6 months
EEG Characteristics in ECT

The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.

This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.

Eligibility Criteria:
Inclusion Criteria:

* Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features
* The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;
* Hamilton Depression Rating Scale 24-item (HDRS-24) \> 21; and
* Age range between 18 and 65 years of age.

Exclusion Criteria:

* Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness \> 5 minutes, epilepsy, Alzheimer's disease);
* Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
* Current drug or alcohol use disorder, except for nicotine and marijuana
* Adults unable to consent, pregnant women, prisoner
* Non-English speakers
* Patients that cannot tolerate Methohexital and Ketamine.
Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants

The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality

In order to define the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine, a novel principle of malaria intervention, the following parameters are evaluated: i) the level of protection from malaria attacks and episodes of anemia during the treatment period, ii) the level of protection from severe malaria during the treatment period, iii) the effect on malaria morbidity after sustaining treatment, iv) the decrease of overall morbidity and mortality, including the number of hospital admissions and visits of hospital outpatient departments v) the influence of the intervention on the development of drug resistances, vi) the impact of the intervention on the development of immunity, vii) the possible influence of the intervention on sub-clinical organ dysfunction due to chronic Plasmodium falciparum infection. Parts of the study are performed in collaboration with the Laboratory of Research, Hospital Albert Schweitzer, Lambaréné, Gabon and the School of Medicine and Health Sciences, University of Development Studies, Tamale, Ghana

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by parent/guardian (written or oral)
* Permanent residentship in the study area
* Age of 3 months +/-4 weeks

Exclusion Criteria:

* Hypersensitivity to sulfonamides or pyrimethamine (skin rashes, evidence of hemolysis including dark urine and/or purpura, presumptive signs of bone marrow depression such as sore throat and/or mouth ulcers)
* Other severe adverse events related to pyrimethamine-sulfadoxine application
* Signs of severe hepatic or renal dysfunction not due to malaria
* Other reasons after decision of the study physician
The Dementia Symptom Management at Home Program

Persons with dementia and their caregivers are often cared for in the community through home healthcare (HHC). While these patients and their caregivers need significant help and often have difficulty maintaining their quality of life, home healthcare clinicians are often unprepared to care for this population. This study will therefore examine the ability of an integrated, multi-pronged evidence-based practice intervention for home healthcare registered nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of care and quality of life for persons with dementia and their family caregiver. The investigators will enroll persons with dementia and their family caregiver upon admission to the HHC agency and examine their quality of life over 60 days following admission, comparing those who receive the intervention to those who serve as controls.

The Dementia Symptom Management at Home (DSM-H) Program is an integrated bundled implementation science intervention to improve interprofessional care in home healthcare (HHC). It consists of training, assessment instruments, patient-caregiver centered care plans and workflow changes. The investigators will perform a cluster randomized controlled clinical trial at a single, urban, non-profit HHC agency, randomizing care teams to either be trained in performing the intervention or serve as controls. The aims of this program are to examine the efficacy of this program to:

Aim 1: Measure the effects of DSM-H on pain, neuropsychiatric symptoms, and caregiver rated QOL in the person with dementia receiving HHC.

Aim 2: Assess the effects of DSM-H on QOL, burden and depression for the informal caregiver of persons with dementia receiving HHC.

Aim 3: Assess the effects of DSM-H on the number of emergency room visits and hospital admissions.

Eligibility Criteria:
Inclusion Criteria:

* patient-caregiver dyad admitted to the HHC agency
* Patients must be 65 or older and speak English and/or Spanish.
* Patient must have an informal caregiver who is at least 18 years old and spends at least 8 hours per week with the patient.
* Patients must score greater than 4 on the cognitive subscale of the Healthy Aging Brain Care Monitor signifying at least mild impairment

Exclusion Criteria:

* Patients with concomitant axis I disorders other than dementia, depression, adjustment disorders, sleep disorders.
* Patients being seen only in the behavioral health unit without another skilled need.