cyrilzakka/clinical-trials huggingface dataset:
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.

Bipolar I disorder (BD-I) is a severe brain disorder. At present, the treatment of BD-I, especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.

The subjects are bipolar depression patients. They have been treated for bipolar depression for at least four weeks but remain depressive. Participating in this study, they will continue the original treatment, and will be randomized, double-blindly to receive the NMDAE or placebo for 8 weeks. We will measure 6 cognitive domains (including 9 cognitive tests) and quality of life at weeks 0 and 8; and assess the Perceived Stress Scale, Global Assessment of Function (GAF), various scales for clinical symptoms, and side effects at weeks 0, 2, 4, 6, and 8.

The efficacies of NMDAE and placebo will be compared. Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 to 65 years of age;
* Satisfy a DSM-5-TR (American Psychiatric Association) diagnosis of BD-I, current episode depressed, after treatment of stable (i.e., at least 4 weeks) and adequate treatment of antipsychotic (quetiapine or lurasidone) and/or mood stabilizer;
* Have a 17-item Hamilton Depression Rating Scale (HAMD) score ≥18 and a Young Mania Rating Scale (YMRS) score ≤7 at baseline;
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Current substance abuse or history of substance dependence in the past 6 months
* History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
* Schizophrenia or other psychotic disorder
* Moderate-severe suicidal risks
* Severe cognitive impairment
* Clinically significant laboratory screening tests (including blood routine, biochemical tests)
* Pregnancy or lactation;
* Inability to follow protocol
Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy

The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).

The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).

The aim is to prove and evaluate the prophylasis effect of ketotifin from cardiotoxicity induced by anthracyclines therapy without decreasing the anti-tumor action of anthracycline.

Because coronaviruses theoretically induce iron overload so, ketotifen has a potential beneficial effect in the management of COVID-19 as well.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
* aged 30-60, and
* female subjects were included as they were female breast cancer patients, and,
* patients who had an adequate baseline echocardiography.

Exclusion Criteria:

* who had a history of heart failure,
* arrhythmia,
* cardiac catheterizations,
* angina,
* uncontrolled hypertension, and
* uncontrolled diabetes,
* patients with impaired liver function tests,
* patients who previously received anthracycline-containing regimens, and
* any cardiotoxic chemotherapy regimens, previous history of chest wall irradiation.
* Brian metastasis.
Hippocampal Stimulation in Chronic Low Back Pain

In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 months of back pain on a daily basis;
* male or female with no racial or ethnic restrictions;
* 18 to 75 years old;
* average back pain intensity \> 4/10 at study entry;
* must be able to read, understand, and sign consent form;
* generally healthy.

Exclusion Criteria:

* back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
* history of tumor in the back;
* back surgery within the past 6 months;
* Chronic neurologic conditions, e.g., Parkinson's
* involvement in litigation regarding back pain;
* other severe medical diseases;
* pregnancy;
* positive urinary screen for any recreational drugs,
* opioids use;
* use of anticoagulants (low dose ASA allowed);
* history of gastric ulcer; renal insufficiency or congestive heart failure,
* contraindication to MRI,
* contraindication to TMS; including history of seizure/epilepsy\*
* Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
* In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
* Diagnosis of major depression;
* Intra-axial implants (e.g. spinal cord stimulators or pumps)
A Study Evaluating ABT-199 in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1
* Diagnosis of multiple myeloma previously treated with at least 1 prior line of therapy (dose escalation only) or (safety expansion only) received treatment with a proteasome inhibitor or an IMiD(r) or immunomodulatory agent (e.g., thalidomide, lenalidomide). Induction therapy and following stem cell transplant are considered a single line of therapy.
* Measurable disease at Screening: Serum monoclonal protein greater than or equal to 1 g/dL by protein electrophoresis, or greater than or equal to 200 mg monoclonal protein in the urine on 24-hr electrophoresis, or serum immunoglobulin free light chain greater than or equal to 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio.
* Subjects with a history of autologous or allogenic stem cell transplant must have adequate bone marrow independent of any growth factor support, and have recovered from any transplant related toxicity(s); and either greater than 100 days post-autologous transplant (prior to first dose of study drug) or greater than or equal to 6 months post-allogenic transplant (prior to first dose of study drug) and not have active graft-versus-host disease (i.e., requiring treatment).
* Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening.

Exclusion Criteria:

* Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal), diagnosis of fever and neutropenia within 1 week prior to first dose of study drug
* Cardiovascular disability status of New York Heart Association Class greater than or equal to 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.
* Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease, that in the opinion of the investigator, would adversely affect his/her participation in the study.
* History of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions: adequately treated in situ carcinoma of the cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
* Tested positive for HIV or hepatitis.
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform

The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers

The RaniPill device is capsule-like ingestible device, which injects a microneedle containing a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human) open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®) will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg of octreotide. The bioavailability of octreotide will be determined by serial blood sampling in Groups A and B. Performance of the RaniPill will be evaluated in all groups.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Willing to comply with all study procedures and available for the entire duration of the study
* Age between 18 and 55 years
* BMI 17 - 32 kg/m2
* In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per investigator's judgment;
* Women of reproductive potential must use, between study day and the final study visit, a highly effective contraceptive, as defined in the Informed Consent Document, and have a negative urine pregnancy test at the time of screening, as well as on the day of study.

Exclusion Criteria:

* Unable to swallow an intact 000 capsule with water
* History of gastrointestinal surgery or illness, including diarrhea, constipation or other manifestations suggestive of abnormal digestion
* Use of an antacid, proton pump inhibitor or histamine H2 receptor antagonist within 5 days of study day
* Barium ingestion within 30 days of study day
* Allergy or sensitivity to contrast media, iodine, barium sulfate, or latex
* History chronic disease other than mild to moderate systemic hypertension
* Menstruation on day of dosing
* Pregnancy or lactating state
* Participation in an investigational or marketed drug trial within 30 days of the screening visit
* Low likelihood, in the investigator's judgment, to complete the study as required per study plan;
* Any other history which, in the investigator's judgment, makes the subject ineligible or exposes the subject to a risk;
* History of allergic reactions to a component of the RaniPill device or any allergic history other than common food (i.e. shellfish) or insect (i.e. bees) allergies;
* Febrile illness within 5 days;
* History of drug or alcohol abuse or any other factor that, in the investigator's opinion, may interfere with the subject's ability to cooperate and comply with the study procedures.
Study of the Increase in ICU Beds Capacity During COVID-19 Pandemic in France

For preventing the overwhelming of ICU beds capacity during COVID-19 pandemic in France, national and regional Health-Care institutions decided to optimize the Intensive Care Unit beds availability by opening new ICU beds in institutions with and without prior ICU. The Present study was design to retrospectively describe the origin of the ICU beds and human resources created during the COVID-19 outbreak in France.

Since December 2019, the SARS-CoV-2 coronavirus disease has caused a worldwide outbreak of respiratory illness that rapidly invaded leading the world (WHO). Its most severe form is dominated by an acute respiratory distress syndrome (ARDS) with other organ failures requiring mechanical ventilation and admission in Intensive Care Unit (ICU). With a wide pandemic effect and a long length of mechanical ventilation, the intensive care units were quickly full.

For preventing the overwhelming of ICU beds capacity, national and regional Health-Care institutions (then French Health minister, every Regional Health) decided to optimize the Intensive Care Unit beds availability by opening new ICU beds in institutions with and without prior ICU.

Daily ICU beds availability was assessed in each institution, and at the regional level to organize potential patient transfers across regional and national hospital. Moreover, an extraordinary mobilization and joint efforts of medical, paramedical and administrative staff allowed getting the caregivers for managing the most severe patients in each ICU. All physicians who could manage ICU patients were involved in this crisis. In this context, anesthesiologists (who have gotten an ICU education during their studies) were involved, as the surgical activity has been reduced to the vital procedures. This overall organization permitted the admission of more patients than the initial maximum national capacity of ICU beds.

Eligibility Criteria:
Inclusion Criteria:

* Hospital having ICU during COVID-19 outbreak in France

Exclusion Criteria:

* Hospital refuse to participate
Study of VX-985 in Subjects With Chronic Hepatitis C

The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of VX-985.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are male or females of non-childbearing potential aged 18 to 64 years(inclusive) with a body mass index (BMI) between 18 and 32 (kg/m2)
* Certain subjects must agree to use acceptable contraceptive methods as specified in protocol
* Subjects who are treatment naïve and are infected with genotype 1 chronic hepatitis C
* Subjects must be in good health and have normal laboratory values as judged by investigator
* Subjects must not have clinically significant abnormal results for physical examination

Exclusion Criteria:

* Subjects must not have received approved or experimental HCV therapy
* Subjects must not have evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
* Subjects must not have any known history of other cause of significant liver disease including hepatitis B, drug or alcohol-related cirrhosis, etc
* Subjects must not be diagnosed with or have suspected hepatocellular carcinoma
* Subjects must not have histologic evidence of hepatic cirrhosis on any liver biopsy or test capable of detecting cirrhosis within the past 2 years
* Subjects with a known history or other evidence of severe retinopathy or clinically significant ophthalmological disorder
* Subjects must not have a history of any illness that might confound the results of the study or pose an additional risk in administering study drug(s) to the subject e.g. history of cardiovascular or central nervous system disease, ongoing psychiatric disorder, poorly controlled diabetes, etc
* Subject must not have taken any of the prohibited medications within the specified time before study start or take certain medications (including herbal supplements) during the study
* Subjects must not have a history of drug or alcohol abuse or addiction within 6 months before the start of dosing, or test positive for alcohol or drugs of abuse
* Subjects must not have donated or had a significant loss of blood within 56 days of the start of dosing, or donated more than 1 unit of plasma within 7 days before the start of dosing
* Subjects must not consume excessive amounts of caffeine
* Subjects must not have participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months
* Subjects who are female and have a positive pregnancy test and/or who are considered to be of childbearing potential or are nursing.
* Subjects that have a female partner who is pregnant, nursing, or planning to become pregnant during the study or shortly after the study
Effects of Cognitive Intervention for Older Adults With Memory Decline: A Pilot Study

The purpose of this study is to evaluate the effects of training in memory skills vs. use of external memory aids on everyday memory functioning in older people with mild cognitive impairment.

Some older people experience memory loss that is worse than other people of their age, although they are not demented. This condition is known as mild cognitive impairment (MCI). Healthy older people can learn mnemonic strategies to improve their memory abilities. Can cognitive rehabilitation help people with MCI do better on mental tasks or maintain better functioning in everyday life? This study will evaluate the effects of two different rehabilitation programmes. Patients in the memory training group will learn mental strategies aimed at improving memory. Patients in the memory compensation group will learn to use external memory aids.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment

Exclusion Criteria:

* Unable to speak and understand English
* Unable to comply with treatment program due to significant comorbid illness; OR
* Anticipated inability to attend all study sessions
COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor

Collection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to hospital with biological samples positive for SARS-CoV-2
* Patients admitted to hospital with negative test but clinical and radiological characteristics highly suggestive of SARS-CoV-2 disease
* Patients discharged from emergency department with biological samples positive for SARS-CoV-2

Exclusion Criteria:

* None
Measuring Knowledge and Behavior After an Educational Program on Air Pollution as a Health Risk Reduction Strategy

Since air pollution contains harmful toxicants, it is important for potential exposure to indoor and outdoor air pollution to be considered as part of an overall health risk reduction strategy. This is a behavioral intervention to assess the effectiveness on an air quality education program in reducing exposure to air pollution and negative health effects. Trial participants will complete a pre-test and home air quality assessment tool. Then, they will participate in an educational module on air quality learn about suggestions to take to avoid exposure and complete a spot test. One month after the educational intervention, the participants will be contacted and asked qualitative questions to assess study effectiveness.

Potential exposure to indoor and outdoor air pollution must be considered as part of an overall health risk reduction strategy. Toxicants identified in outdoor air pollution, fine particulate matter (PM2.5), and photochemical ozone cause a systemic inflammatory response to the heart and lungs after exposure. Inside the home, health issues from exposure to carbon monoxide (CO), PM2.5, nitrogen dioxide (NO2) and volatile organic compounds (VOC) are intensified when the home is sealed with the windows and doors closed. This exploratory study seeks to promote health by teaching participants about strategies to reduce risks related to indoor and outdoor effects of air pollution.

Data collection will consist of an electronic demographic data collection form, home air quality assessment, pre-test and post-test around an educational program and follow-up interview one month after the educational program. Avoidance of air pollution as a health risk reduction method is identified in the literature, however, there is limited research addressing the influence of education on avoidance of environmental toxins as a health risk reduction strategy. Therefore this study will provide a foundation for developing broader educational and behavioral initiatives to improve health outcomes. Due to the COVID-19 pandemic, all aspects of this study will be completed either on-line via the Internet or by telephone.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18, speak and read English, have access to a computer or smart phone with Internet access.

Exclusion Criteria:

* Anyone not meeting Inclusion Criteria.