cyrilzakka/clinical-trials huggingface dataset:
Inhaled Ivermectin and COVID-19

Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Each country developed its own action plan depending on healthcare expertise and the available resources. There is no definitive therapy for Coronavirus disease-19 up till now. Many current and investigational drugs are used nowadays. Recent reports suggest a beneficial role of Ivermectin in the management of Coronavirus disease-19. A notice that necessitates further clinical studies.

The aim of this study is to assess the efficacy and safety of the usage of inhaled ivermectin in the management of Coronavirus disease-19.

Coronavirus disease-19 (COVID-19) is a pandemic disease which is caused by the SARS-CoV2 virus. It is one of the biggest single-stranded RNA viruses. SARS-CoV2 Viral polyproteins are responsible for viral replication and transcription while its protease enzymes are responsible for polypeptides cleaving and immune system blockage. They are considered to be an important therapeutic target.

Host immunological response against SARS-CoV2 could affect the disease outcome. Patients requiring ICU admission have higher levels of interleukins 6 - 10, tumor necrosis factor α (TNF-α), and fewer CD4+ and CD8+ T cells. The level of cytokines and lymphopenia is associated with pulmonary damage and respiratory distress.

Till now, there is no definitive therapy for COVID-19. Multiple current and investigational drugs are used such as Hydroxychloroquine, lopinavir/ritonavir, and Remdesivir.

Ivermectin: A potent anti-parasitic drug has shown to have an in-vitro antiviral activity against a broad range of viruses. It inhibits the interaction between the human immunodeficiency virus-1 (HIV-1) integrase protein (IN) and the importin (IMP) α/β1. But on the other hand, Ivermectin showed limited efficacy against DENV in phase III clinical trial that was done in Thailand in 2014-2017. Recent Studies proved the In-vitro effect and "subsequently" the possible therapeutic role of Ivermectin in the management of SARS-CoV2.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Age above 18
* Test positive for COVID-19 using Reverse transcription polymerase chain reaction (RT-PCR) prior to the start of study.
* Willing to participate in the study
* Mild to moderate severity index according to the WHO criteria

Exclusion Criteria:

* Hypersensitivity to the study drug.
* History of co-morbid conditions such as: uncontrolled hypertension and diabetes, retinal problems and chronic liver and renal disease.
* Women who are pregnant or breastfeeding.
Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma

This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

Eligibility Criteria:
Inclusion Criteria:

* 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.

Exclusion Criteria:

* patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.
Registry and Survey of Women With Pregnancy Related Cardiomyopathy

The goal of this study is to better characterize peripartum cardiomyoapthy or pregnancy-related cardiomyopathy by enrolling as many PPCM survivors as possible using both direct and web-based methods of recritment. Patients will anser a questionnaire regarding the onset, progression, treatment and follow-up of their diagnosis as well as the psychosocial aspects of PPCM.

The design of our study will utilize web-based recruitment methods with internet-based support groups for PPCM e.g. www.AMothersHeart.org (www.amothersheart.org/index.html). The directors of these websites will facilitate contact between our research staff and the several hundred members of these web sites.

An introductory letter will be posted on the website introducing the cardiovascular research team and describing the purpose, basic methods, and goals of our study. Website members who desire to participate can respond to a dedicated e-mail address we have set up and provide contact information so that we may get informed consent via telephone or mailed written consent. A telephone number will also be provided for participants so that they may call with questions regarding the study. Patients will then receive a questionnaire addressing our study goals. Questions will focus on obtaining family and social history, characterizing presenting symptoms, initial management, and clinical course following delivery of the fetus including extent of cardiovascular follow-up, date of echocardiograms performed, medications, and psychosocial support, if provided.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for inclusion if diagnosed with PPCM after January 1, 1994. Patients must be above the age of 18 years old with no prior cardiac history and no history of chronic drug or alcohol abuse. Diagnosis of PPCM must have been made prior after the 28th week of gestation and up to 6 months postpartum. Patients must have echocardiographic data confirming left ventricular systolic dysfunction by either depressed shortening fraction or depressed ejection fraction.

Exclusion Criteria:

Patients with an identifiable etiology for their heart failure will be excluded.
microRNA 155 Levels and Periodontal Microflora (Bacteria and Virus) in Preeclampsia.

Preeclamptic women with and without chronic periodontitis were recruited for the study. Subgingival plaque samples and placental tissue samples(postpartum) were obtained from the participants for the microbial analysis(bacteria, viruses) and MIR155 levels and comparison was done among groups. this study was designed in order to evaluate the role of periodontal microorganisms in preeclampsia and to find compare the MIR155 levels among participants, so as to check its importance as a biomarker for inflammatory disease like preeclampsia.

Four hundred forty five pregnant women, aged 18-35 yrs were selected and were divided into four groups. Controls- 145 systemically and periodontally healthy, Group A-100 Systemically healthy women with chronic periodontitis, Group B- 100 Preeclamptic women with chronic periodontitis, Group C-100 Preeclamptic women without chronic periodontitis. Age, BMI, Socioeconomic status and periodontal parameters such as plaque index(PI), bleeding on probing(BOP), probing pocket dept(PPD), clinical attachment level(CAL) were recorded. Subgingival plaque and placental tissues (postpartum) were collected and assessed for periodontal pathogens such as Tannerella forsythia(Tf), Treponema denticola(Td), Porphyromonas gingivalis(Pg), Prevotella intermedia(Pi), Fusobacterium nucleatum(Fn). Herpes Simplex Virus(HSV), Ebstein Barr Virus(EBV), Human Cytomegalovirus(HCMV). microRNA155 levels were also assessed and compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women within the age group of 18-35 years with single gestation, having ≥ 20 natural teeth, who did not receive periodontal treatment in last six months and willing to participate in the study were included for the investigation.

Exclusion Criteria:

* Pregnant women with current use of any form of tobacco, history of alcohol consumption and systemic medications were excluded from the study.
Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals

Passive accessory cervical mobilization is widely used as a clinical approach to the management of musculoskeletal pain of spinal origin. The purpose of the study is to determine if passive cervical mobilization can improve motor function in situations where motor performance is not impaired by the presence of pain.

Cervical mobilization has been shown to elicit effects on pain perception, autonomic function and motor function in subjects who experience musculoskeletal pain. The improvement in motor function may be a direct effect of the treatment or secondary to a hypoalgesic effect. This study aims to demonstrate whether it is possible to alter motor function following joint mobilization, in situations where motor performance is not impaired by pain.

Eligibility Criteria:
Inclusion Criteria:

* No history of neck or back pain over the last six months
* Without any previous experience with spinal manual therapy techniques

Exclusion Criteria:

* History of musculoskeletal or rheumatologic conditions
* Any kind of spinal surgery
* Dizziness
* Previous trauma to the cervical spine
* Neurological signs or symptoms
Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)

The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).

Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking. Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value. Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown. A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.

Eligibility Criteria:
Inclusion Criteria:

* Severe Traumatic Brain Injury (Glasgow Coma Scale \< 9)
* Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.
* Expected length of ICU stay \> 1 days

Exclusion Criteria:

* Patient's relatives refusal to patient's inclusion in the study
* Patients necessitating ongoing resuscitation
* End-stage in which death is imminent
* Deficient signal of rSO2 impeding its proper valuation
Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients

This study used polysomnographic technology and randomly selected 60 patients who met the diagnostic criteria for depression and non-organic insomnia as stipulated in DSM-5 into an intervention group (n=30) and a control group (n=30). The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone, while the control group was given citalopram hydrobromide combined with zolpidem. Both groups underwent PSG at baseline and 1 week after medication, and were assessed with the 17-item Hamilton Depression Rating Scale, Zung Self-Rating Depression Scale, Pittsburgh Sleep Quality Index, Arnsworth Insomnia Severity Scale, Antidepressant Side Effects Checklist, and the Drug Dependence Scale neuropsychological assessment at baseline, 1, 2, and 4 weeks after medication. The study aimed to explore the effects of single use of SMAs class antidepressants versus combination with other antidepressants on non-rapid eye movement sleep stage III in patients with depression and insomnia comorbidity, and to compare the effects of depression and insomnia in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient or inpatient patients;
* 18 years old ≤ 65 years old;
* Simultaneously meet the diagnostic criteria for depression and non organic insomnia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in the United States;
* 17 items of Hamilton Depression Rating Scale (HAMD-17) with a total score of ≥ 17 points;
* Pittsburgh Sleep Quality Index (PSQI) ≥ 16 points;
* Never used related antidepressants and sedative hypnotic drugs;
* Has a certain level of visual and auditory resolution, and no comprehension barriers;
* Capable of independently completing scale measurements;
* Education level above primary school;
* Obtain written informed consent from the patient, and obtain written informed consent from the legal guardian if the patient is incapacitated during the onset of the illness.

Exclusion Criteria:

* Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder, mental retardation, pervasive developmental disorder, delirium, dementia, cognitive impairment, alcohol dependence, etc
* Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, craniocerebral trauma, cerebral ischemia or hemorrhage;
* Patients with narrow angle glaucoma;
* History of epilepsy and febrile seizures;
* Individuals with a history of drug use;
* Positive for syphilis specific antibody and AIDS antibody;
* According to risk assessment, there are currently serious suicide attempts or individuals who are overly agitated Pregnant or lactating women, or those planning to conceive in the near future;
* Laboratory tests indicate the presence of liver and kidney function impairment in individuals;
* There are other individuals who meet the relevant contraindications for antidepressants.
A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
* Negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

* Skin disorder other than Atopic Dermatitis in the areas to be treated
* Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
* Clinically infected Atopic Dermatitis at baseline
* Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
* Known hypersensitivity to macrolides or any excipient of either study medication
* Chronic condition which is either not stable or not well controlled
* Pregnant or breast feeding an infant
Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women

The objective of our study is to evaluate the effect of CPAP on umbilical cord acid base status in morbidly obese women at the time of scheduled cesarean delivery. We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.

This is a randomized control trial comparing CPAP to routine airway management in morbidly obese patients undergoing scheduled cesarean delivery. Morbidly obese women meeting criteria for inclusion will be approached for participation. Women who are scheduled for cesarean delivery at Sentara Norfolk General Hospital will be approached at a prenatal appointment prior to scheduled date of delivery. If a woman agrees to participate in the study, she will be counseled and consented at that time.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18-45
* Body mass index of 40 kg/m2 or greater at the time patient is scheduled for cesarean delivery
* Singleton gestation
* Scheduled for primary or repeat cesarean delivery at Sentara Norfolk General Hospital
* Gestational age between 37+0 and 41+0 weeks at the time of delivery
* Non-stress test on admission with moderate variability, without repetitive late or variable decelerations
* Negative SARS-CoV-2 PCR test within 72 hours of procedure

Exclusion Criteria:

* Fetal growth restriction
* Active pulmonary diseases to include pneumonia, sarcoidosis, pulmonary hypertension, moderate or severe persistent asthma
* Suspected placenta accreta based on prenatal sonographic evaluation
* Active maternal infection to include pyelonephritis, appendicitis, upper respiratory tract infection, urinary tract infection or suspected intra-amniotic infection
* SARS-CoV-2 positive test within past 10 days or ongoing symptoms of SARS-CoV-2 to include cough, fever or shortness of breath with positive test greater than 10 days prior, or history of hospitalization for SARS-CoV-2 infection
* Fetus with aneuploidy or major anomaly
* Enrolled in another trial that may affect outcome
A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels

The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)


Eligibility Criteria:
Inclusion Criteria:

* BMI between 19-30

Exclusion Criteria:

* Significant result for C-SSRS at screening or baseline
* Single arm preference for IV procedures
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study

The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal
* Regular, consistent menstrual cycles
* Serum progesterone \> 6 ng/ml (19 nmol/L)
* 2 months history of PBLAC score of 150-500
* Maximum of 4 type I, type II, or intramural fibroids
* Patient is at low risk for cervical cancer
* Hemoglobin \> 6 g/dl
* Not at risk for pregnancy
* No desire for future fertility
* Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
* Willing to sign a consent form

Exclusion Criteria:

* Subserosal fibroids.
* Any fibroid that obstructs access to the endometrial cavity
* FSH \> 20 IU/L
* Pregnancy
* Evidence of disorders of hemostasis
* Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen
* SERMS/SPRMS within the last 6 months
* Current use of any IUD or use of Mirena IUS within the last 3 months
* Gynecological malignancy or hyperplasia
* Known/suspected abdominal/pelvic cancer
* Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease)
* Adenomyosis
* Previous surgical or ablative treatment for fibroids or menorrhagia
* Previous uterine artery embolization or occlusion
* Patient on anti-coagulation therapy
* Needing emergency surgery to treat fibroid symptoms
* Concomitant intrauterine polyps.
* Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data
* Contraindication to MRI
* Allergy to contrast media
* Mild renal insufficiency or worse
* Known renal disease
* Uncontrolled hypertension lasting 2 years or more
* Diabetes
* Uterine size \> 10 weeks or 10 cm from ectocervix to fundus.
Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension

The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
* Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to any of the formula compounds;
* Type 1 diabetes mellitus;
* Known or suspected secondary hypertension.
Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis

Spinal cord compression is commonly seen in patients with severe kyphosis. However, conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in microstructural integrity of the spinal cord around the apical vertebrae in these patients. The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).

Spinal cord compression is commonly seen in patients with severe kyphosis. However, conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in microstructural integrity of the spinal cord around the apical vertebrae in these patients. The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).

Twenty-four patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T MRI examination with DTI sequence were prospectively enrolled from July 2022 to January 2023. Patients were divided into three groups according to spinal cord/cerebrospinal fluid architecture (CSF) on sagittal-T2 MRI of the thoracic apex: Type A-circular cord with visible CSF, Type B-circular cord but no visible CSF at apical dorsal, and Type C-spinal cord deformed without intervening CSF. The Fractional Anisotropy (FA) values acquired from DTI were compared among different groups. Correlations between DTI parameters and global kyphosis (GK)/sagittal deformity angular ratio (SDAR) were evaluated using Pearson correlation coefficients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of hyperkyphosis;
* the apex located at the thoracal region (T1-T12);
* full DTI data;
* records of detailed and systematic neurological physical examination.

Exclusion Criteria:

* any case with active infection, tumor, or trauma;
* any cases of comorbidity of neurofibromatosis type I;
* any cases combined with spinal syringomyelia, split cord malformations or diastematomyelia, tethered cord syndrome;
* previous spinal surgery.