cyrilzakka/clinical-trials huggingface dataset:
Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease.

Coronaviruses (CoVs) are the largest group of viruses belonging to the Nidovirales order. They are enveloped, non-segmented positive-sense RNA viruses.

Coronavirus are believed to cause a significant proportion of all common colds in adults and children. The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The initial cases of 2019-nCoV occurred in Wuahn, China in December 2019.

A recent review evaluated the potential impact of 2019-nCoV in pregnancy. The authors reported published data on CoVs in pregnant women, including 2019-nCoV, severe acute respiratory syndrome (SARS-COV) and Middle East respiratory syndrome (MERS-COV). The review included 12 women with SARS-COV,4 11 women MERS-COV,5 and 9 women with 2019-n-CoV6 in pregnancy. No cases of vertical trasmission were reported, but the authors showed an high rate of preterm birth (45.8%), cesarean delivery (70.8%), maternal admission to intensive care unit (ICU) (63.3%), and maternal death (18.8%).

The aim of this study was to evaluate the pregnancy and perinatal outcomes of pregnant women with 2019-n-CoV.

This was a multicenter, retrospective, cohort study. Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV Data on recent exposure history, clinical symptoms or signs, laboratory findings, and maternal and perinatal outcomes were collected. All medical recors were sent to the coordinator center. Data were entered into a computerized database and cross-checked. If the core data were missing, requests for clarification were sent to the coordinators.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with laboratory-confirmed 2019-n-CoV
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

An open-label, randomized, crossover study to assess the pharmacodynamic effects of MAT-9001, an omega-3 free fatty acid compared to Vascepa (icosapent ethyl) on triglycerides and other lipoprotein lipids in men and women with elevated triglycerides.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥18 y of age
* Judged to be in generally good health
* Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening
* Body mass index of ≥20.0 kg/m2
* No clinically significant findings in a 12-lead ECG or physical examination
* Willing and able to undergo the scheduled study procedures
* Understands study procedures and signs forms documenting informed consent to participate in the study

Exclusion Criteria:

* Laboratory test result of clinical significance
* Uncontrolled hypertension
* Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder
* History of human immunodeficiency virus, hepatitis B or hepatitis C infection
* Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit
* Active systemic infection
* A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol
GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period \> 1 year ago or 6 months ago with FSH \>40) who have been diagnosed with breast cancer.

Postmenopausal breast cancer survivors who report at least one GSM sign or symptom will be offered participation in an observational, prospective open label trial. Study duration will be 6 months.

Evidence of GSM symptoms will be evaluated by a board certified gynecologist. Upon satisfying the prescreen requirements, the patient's information will be forwarded to the sub-investigator, who will confirm study eligibility and make the final determination verifying the diagnosis of GSM. Participants will be using commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity. Patients will record dosing on the Intake Diary. Outcome measures will include:

Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire will be administered at Baseline, at month 1, 3 and month 6. The FSFI (Female Sexual Function Index) questionnaire will also be used for sexually active patients at the same time points. This is an exploratory investigation. A planned paired T test will be applied to analyze the outcome and regroup after data has been collected on the first 14 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Postmenopausal women (defined as last menstrual period \> 1 year ago or 6 months ago with FSH \>40) who have been diagnosed with breast cancer including in situ carcinoma (DCIS, LCIS)
3. Have self-identified GSM signs and objective symptoms on baseline screening
4. Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.
5. Medical History review and Pelvic Exam by a board certified gynecologist for baseline assessment OR medical records review by a board certified gynecologist or delegated study staff to confirm diagnosis of GSM. If GSM is to be verified by medical record review, the sub-investigator will make the final determination of eligibility.

Exclusion Criteria:

1. Use of any estrogen containing product within 4 weeks prior to screening
2. Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy
3. Patients with non GSM related signs and symptoms as verified by a board certified gynecologist will be excluded.
4. Any concurrent illness or disorder that, per the opinion of the investigator, would preclude the patient from meeting the study requirements.
Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant

Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.

Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function.

Adult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.

Eligibility Criteria:
Inclusion Criteria:

* primary deceased renal transplant recipients
* adult (\>18 yo)

Exclusion Criteria:

* unable to drink N-acetylcysteine during the first 7 PO
* participation in other study
Feasibility Study of a Software Application for Patients Hospitalized After Suicidal Ideation or Suicide Attempts

The primary objective of this feasibility study is to assess the feasibility, and usability of a software application to deliver targeted interactive exercises to patients recently hospitalized for suicidal ideation or suicide attempts.


Eligibility Criteria:
Inclusion Criteria:

* English speaking male or female patients, 18-70 years
* Patients who have attempted suicide and voluntarily admitted themselves to an inpatient psychiatric unit or have clinically significant suicidal ideation and intent to harm themselves and are still on the inpatient psychiatric unit.
* Understand written and spoken English
* Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
* Willing and able to complete enrollment procedures
* Able to understand the nature of the study and provide written informed consent
* Able and willing to provide at least two verifiable contacts for emergency or tracking purposes.

Exclusion Criteria:

* Patients with active psychosis
* Patients who are acutely intoxicated at the time of enrollment
* Currently enrolled in other treatment studies for the symptoms and behaviors targeted
* Patients who are cognitively impaired
* Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit (e.g. critically ill patients) profile with respect to the software application that delivers interactive exercises.
AMP as a Better Delivery System of Adenosine

Adenosine and AMP are substances normally present in the body. Adenosine is also given for the treatment of some heart rhythm problems and may be used to reduce heart damage during heart attacks. The problem in using adenosine is that it is taken up by cells and, therefore, very little of the adenosine we give by vein or in the artery actually reaches the tissue. We propose to use AMP as a way to improve delivery of adenosine. AMP is inactive by itself, but is converted to adenosine in tissue. We hope that by giving AMP we will increase levels of adenosine in tissue. To see if this is true, we will give either adenosine or AMP into the forearm artery while we measure how much adenosine reaches the forearm tissue.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18-65
* Non smokers

Exclusion Criteria:

* Smokers
* Any chronic disease
Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA

Research participants diagnosed with knee osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. therapeutic exercises, 2. therapeutic exercises + chronic pain neuroscience education program. The primary outcome will be functional performance using a patient-reported measure, the Knee Injury and Osteoarthritis Outcome Score (KOOS).

The selected secondary outcomes will be pain intensity by the numerical pain scale (END), physical function reported by the patient by the patient-specific functional scale (EFEP), Pain self-efficacy questionnaire (PSEQ), functional mobility by the timed up and test (TUG), general effect perceived through the global perception scale (EPG), muscle strength through Maximum Voluntary Isometric Contraction (MVIC) and functionality and disability through the World Health Organization Disability Assessment Schedule (WHODAS).


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of knee osteoarthritis (knee pain for \> 3 months
* Morning stiffness \<30 minutes
* Crepitus
* Bone tenderness, and absence of palpable heat and/or diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on a scale 1 up to 4)

Exclusion Criteria:

* Hip OA
* severe osteoporosis
* Fibromyalgia
* Medical history of tumors or cancer
* Active inflammatory joint diseases (rheumatoid arthritis, gout)
* Undergoing any lower extremity joint replacement
* Neurological diseases (Parkinson's disease, stroke, Multiple Sclerosis, muscular dystrophy, motor neuron disease, Alzheimer's disease, cognitive and cardiopulmonary impairment that may prevent or limit the performance of exercises, use of a gait assistance device, history of recent knee trauma.
* Having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective in the last six months
Eccentric Cycling Exercise With Assistive Devices on Mitochondrial Metabolism in T Lymphocyte

Eccentric cycling exercise can be a promising modality fwith lower respiratory demands and higher power output. Assistive devices like neuromuscular electrical stimulation (NMES) and compressive garment (CG) accelerates muscle pumping and relieve the eccentric exercise-induced muscle soreness.

Phenotypes and mitochondrial metabolism are crucial to regulate acquired immnunity of T lymphocytes. The study aimed to investigate the effects of eccentric cycling exercise training combined with NMES and CG on mitochondrial phenotypes and bioenergetics in T lymphocytes in sedentary males. The hypothesis were an acute/intense exercise decreased the mitochondrial respiratory capacities of OXPHOS, ETS and bioenergetics, while eccentric cycling training could elevate the diminished mitochondrial functions.

Methods: Twelve sedentary healthy males were randomly assigned to either eccentric cycling with assistive devices (ECA, n=10) or eccentric cycling only (ECC, n=10). All participants performed ECA or ECC at an intensity of 60% to 120% maximal workload progressively on a costumed bicycle ergometer for 40 min/day, 5 days/week for 5 weeks. ECA performed NMES for 20min/session after cycling, while ECC was seated for resting 20 min. Systemic aerobic fitness, phenotypes of T lymphocytes, mitochondrial OXPHOS, ETS respiratory capacities, and bioenergetics in T lymphocytes were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle (exercise\<20min/session; \<1session/week for a year or longer).
* Nonsmokers, nonusers of medications/vitamins.
* No any cardiopulmonary, neuromuscular, and hematological risks.

Exclusion Criteria:

* Have regular exercise habits (i.e., exercise frequency once per week, duration \>20 min).
* Have retabolic or musculoskeletal disease.
Association of CD49d and CD44 in CLL Patients and Their Role in Prognosis

The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation

Chronic lymphocytic leukemia (CLL) is the most common type of chronic leukemia, accounting for approximately 40% of all leukemia's and mainly affecting older individuals. As it has a highly variable clinical course, identification of molecular and biological prognostic markers has provided new insights into the risk stratiﬁcation of patients with CLL .

The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation . CD49d (one of biomarkers) is one of independent prognostic risk parameter in CLL with important roles in shaping these interactions.

CD49d also is one of independent prognostic risk parameters in CLL that predict adverse outcome and linked to processes involved in interaction with the vascular endothelium and/or migration into the extravascular compartments .

The cell-surface glycoprotein CD44 is involved in cell motility, cellular trafficking, and stem cell differentiation . It contributes to the phenotypic hallmarks of many cancers, such as invasiveness, self-renewal, and sustained survival. CD44 transmits both growth and apoptotic signals, a functional duality that is also observed in hematologic malignancies.

CD44 expression in CLL is mediated by the tumor microenvironment. As a coreceptor, CD44 promotes leukemogenesis by regulating stimuli of MCL1 expression. Moreover, CD44 can be addressed therapeutically in CLL by specific antibodies.

Eligibility Criteria:
Inclusion Criteria:

* All patients are newly diagnosed as CLL

Exclusion Criteria:

* : patients with associated malignancies
Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

To study safety and feasibility of mild therapeutic hypothermia after decompressive hemicraniectomy compared with hemicraniectomy alone in patients with malignant cerebral infarction

The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, single arm, open-label, prospective design. The subject meeting inclusion/exclusion criteria will be assigned to treatment group.

The subjects of treatment group should be initiated hypothermia therapy as soon as possible after surgery (less than 6 hours). It can be duration at least 72 hours according to subject status. Also process of recovery temperature period will be allowed within 20-40 hours. After 6 month, 12 month of the onset of symptom, mRS score are measured. This is followed by closure of clinical trial.

Eligibility Criteria:
Inclusion Criteria:

A. Written informed consent obtained from the patient or his/her legally acceptable representative B. Acute ischemic stroke within middle cerebral artery or internal carotid artery occlusion

* Regardless of anterior cerebral artery (ACA) or posterior cerebral artery (PCA) involvement C. Patients of both sexes aged ≥ 19 years and ≤ 82 years D. NIHSS score ≥ 15 points, NIHSS loss of consciousness 1a score ≥ 1 point E. Patients with proximal cerebral arterial occlusion (such as middle cerebral or internal carotid artery) F. Unilateral ischemic lesion of at least 2/3 of the middle cerebral artery (MCA) territory involving basal ganglia confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
* Decided to perform decompressive hemicraniectomy within 48 hours after symptom onset - Onset time was defined as the time when patients were lastly seen normal

Exclusion Criteria:

A. Premorbid modified Rankin Scale (mRS) score ≥ 2 B. Presence of other type of brain lesions including traumatic brain injury, contralateral or infratentorial infarct.

C. Absence of bilateral pupillary reflex D. Known bleeding disorder or coagulopathy E. Sepsis F. End stage malignant disease G. Pregnancy or during breast feeding H. Life expectancy less than 3 year
Multisensory Augmentation for Post-stroke Standing Balance

Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.

The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.

Eligibility Criteria:
Inclusion Criteria:

* Experience of a stroke at least 6 months prior to participation
* Berg Balance Scale score less than 52
* Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole
* Provision of informed consent

Exclusion Criteria:

* Resting blood pressure higher than 220/110 mm Hg
* History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
* Pre-existing neurological disorders or dementia
* Severe visual impairment
* History of DVT or pulmonary embolism within 6 months
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
Transcranial Magnetic Stimulation for Treatment of Insomnia

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that has been approved as a treatment of depression in patients that have not responded to a trial of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and therefore is therapeutic. The investigators want to compare the change in insomnia scores between baseline and end of treatment in an open label trial with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).

Insomnia is a common clinical problem that affects about 25 million people in the US. Insomnia exacts health and economic consequences well beyond inadequate and non-restorative sleep. It increases healthcare costs, causes or adds to medical and psychiatric comorbidities, cognitive impairments, accidents, absenteeism and reduced quality of life. Treatment of insomnia is difficult and usually needs a multimodal approach incorporating various cognitive and behavioral approaches in addition to medication treatment. TMS and other neurophysiological studies have shown presence of a diffuse cortical hyper-arousal in patients with chronic insomnia. High frequency TMS (\>1 Hz) has been shown to be activating whereas low frequency TMS (\<1Hz) has been shown to be inhibitory in clinical and neurophysiological studies. TMS has been approved as a treatment of depression in patients who have not responded to a trial of at least one antidepressant medication. The goal of this study is to translate the knowledge learned from neurophysiological studies of insomnia to the clinical treatment of insomnia using TMS as the primary modality.

Aim: Compare the change in insomnia scores between baseline and end of treatment with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred for evaluation and management of insomnia to our sleep disorders clinic will be offered enrollment in this study
2. Patients must meet Diagnostic and Statistical Manual (DSM) IV criteria for Primary insomnia
3. Aged 21-65 years to target relatively healthy adults

Exclusion Criteria:

1. Patients with co-morbid depression
2. Substance abuse in last two weeks
3. No Psychotropic medication changes 2 weeks before start of TMS treatment and no changes during the 3 week treatment period
4. Patients with a major medical or psychiatric disorder that may be causing or contributing to insomnia: bipolar disorder, psychosis, anxiety disorders, dementia, seizure disorder and chronic pain
5. Patients with ferromagnetic material in their head or within 30 cm of the coil will be excluded