cyrilzakka/clinical-trials huggingface dataset:
Immunosupressive Treatment in COVID-19 Patients

SAM-COVID is a retrospective cohort study that aims to determine the impact of immunosuppressive drugs and immunoglubulins in the outcome of patients with COVID-19.

SAM-COVID is a retrospective cohort study of patients admitted to 66 Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presenting during admission with clinical and laboratory data suggestive of macrophage activation syndrome with the objective to investigate whether the use of immunosuppressive drugs (including high-dose steroids, tocilizumab, sarilumab, anakimra) or immunoglobulins in avoiding the need for invasive mechanical ventilation or in-hospital death.

The Ethics Committee for Research of Virgen Macarena and Virgen del Rocío University Hospitals approved the study and waived the need to obtain informed consent.

The data source was the electronic medical records. All data were entered directly by personnel at each institution using an online case report form (CRF), that satisfied local requirements of data confidentiality.

The variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results and at day 0, chest X-ray findings at baseline and during follow-up, medications with potential activity against COVID-19, supportive treatments including oxygen therapy, use of immunosuppressant medications or immunoglobulins, and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) admitted because of COVID-19 confirmed by PCR in nasopharyngeal swab or lower respiratory tract sample and presenting on a specific date (day 0) one clinical and one laboratory criteria of the following:

Clinical criteria:

* Temperature ≥38ºC.
* Worsening in oxygen requirements to achieve O2 saturation \>92%.

Laboratory criteria:

* Ferritin \>2000 ng/mL or increment in \>1000 ng/ML since admission.
* D-dimer \>1500 µg/mL (or duplicate in 24h)
* IL6 \>50 pg/mL.

Exclusion Criteria:

* Mechanical ventilation in day 0.
* Decision of provide only palliative care before day 0.
* Use of systemic steroids, tocilizumab, other immunosupressors, or immunoglobulins before day 0.
Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema

The unpredictable nature of the attacks is one of the essential characteristics of bradykinin angioedema. The two main difficulties for physicians managing a patient with bradykinin angioedema are to make the diagnosis and anticipate the severity.

Biomarkers can be used to diagnose, guide treatment, or predict the severity of a disease. However, the identification of biomarkers is currently difficult in bradykinin both for diagnosis and prognosis. While measurement of C4 and C1 inhibitor (quantitative and functional assays) allows the diagnosis of bradykinin angioedema due to C1 inhibitor deficiency, whether genetic or acquired, many patients with normal C1 inhibitor bradykinin angioedema, either hereditary or acquired, are still difficult to diagnose. For patients with hereditary angioedema with C1-inhibitor deficiency, there is no biomarker currently available to predict the severity. Any biomarker that could improve the diagnosis on the one hand, and improve the prediction of the frequency and severity of the response to treatment on the other hand, would obviously be extremely useful. The aim of our study is to assess the existence possible biomarkers for diagnosis and prognosis of bradykinin angioedema.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 : Patients with bradykinin angioedema
* Patient with biologically proven hereditary angioedema with C1 inhibitor deficiency,
* Or a patient with bradykinin angioedema related to a plasminogen or factor XII mutation,
* Or patients with bradykinin angioedema related to ACE inhibitors or ARB2,
* Or patient with acquired bradykinin angioedema due to C1 inhibitor deficiency,
* Age \> or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
* Having a blood collection scheduled as part of routine care
* Being insured by social security

Group 2 : Patients with histamine-mediated angioedema

* Patient with idiopathic histamine angioedema as determined by the referring physician
* Age \> or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
* Having a blood collection scheduled as part of routine care
* Being insured by social security

Exclusion Criteria:

* Minors or protected adults,
* Pregnant or breastfeeding woman,
* Person deprived of liberty,
* Person in an emergency situation,
* Person having refused or unable to give their non-opposition
Depakote-ER for Depressive and Bipolar Depression

Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.

Study is 6 weeks long, with 7 clinical visits.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS \< 12; MADRS \> 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics

Exclusion Criteria:

* Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality
The Stealth Pet Obedience Training Study

Americans love pets. Nearly 1 in 2 American households (44%) own at least one pet dog and more than 1 in 3 (35%) own a cat. The bond people form with their pets can be powerful and can provide many mental and physical health benefits. In the case of pet dogs, a strong dog-owner bond increases the odds of regular dog walking, which can help owners meet physical activity guidelines. When the bond is strong, owners feel a sense of responsibility to walk the dog, as well as motivation and social support to walk. Dog walking may be a particularly sustainable form of physical activity as dogs require regular exercise throughout their lives, across all seasons. Owners less bonded to their dogs are less likely to walk them regularly and 40% of owners report never walking their dog.

Obedience training may strengthen the dog-owner bond. Thus, the proposed study will test the hypotheses that obedience training can 1) strengthen the dog-owner bond, and 2) promote physical activity among owners. Forty dog owners who do not regularly walk their dog will be randomized to a 6-week obedience training course (n=20) or a control group that does not receive dog training (n=20). The investigators will assess the strength of the dog-owner bond (via questionnaires) and physical activity levels (via a wearable activity monitor) before training, immediately after completing training, and 6 weeks after completing training. The hypothesis is that the dog-owner bond will strengthen and physical activity levels will increase in the intervention group as compared to the control group. As over 50 million American households own a dog, support for this hypothesis would support further investigation of dog obedience training as a novel strategy for promoting public health.


Eligibility Criteria:
Inclusion Criteria:

* Age 21+ years
* Current dog owner
* Walk dog ≤3 for no more than 20 minutes
* Have not attended obedience training course
* English speaking

Exclusion Criteria:

* Have a dog with a history of aggressive behavior
* Have a dog overdue for rabies vaccination (self-reported)
* Self-report regular exercise over last 6 months
* Have any condition that limits walking ability
* Have uncontrolled hypertension or diabetes
A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19

This randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female, ≥18 years of age
* Be willing and able to give informed consent
* Screening/Randomization telemedicine visit within 2 days of testing positive test for COVID-19
* Having self-reported fever or cough for not more than 72 hours prior to COVID-19 testing
* Mild to moderate COVID-19
* Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Patients who are hospitalized for in-patient treatment or currently being evaluated for potential hospitalization at the time of informed consent for conditions other than COVID- 19
* History of chronic lung disease
* Ongoing requirement for oxygen therapy
* Shortness of breath in resting position
* Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) / Continuous Positive Airway Pressure (CPAP)
* Female patients who are pregnant, trying to become pregnant or lactating
* Is considered, in the opinion of the PI, to be unlikely for any reason to be able to comply with study procedures
A Predictive Model for Difficult Intubation

Failure in airway management is one of the most common anesthesia-related morbidity and mortality. Each individual airway assessment has limitation to predict difficult intubation.

Objective: To develop a scoring model from multiple airway assessment to predict difficult intubation.

Methods: This will be a retrospective analytic study. All airway assessment data from medical records of patients aged more than 18 years old underwent general anesthesia in Srinagarind hospital from January 2012 to December 2014 will be used to develop a new scoring prediction model.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing general anesthesia with endotracheal intubation

Exclusion Criteria:

* Incomplete airway assessment in medical record
Comparison Between the I-gel and Protector Supraglottic Airway Devices

This study aims to compare the learning curves of two different laryngeal mask airway devices, by evaluating their placement in adult patients performed by anesthesiology residents


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Patients older than 18 years
* Procedures in supine and lithotomy position

Exclusion Criteria:

* Tumors or anatomical anomalies of the upper airway
* Known history of difficult intubation
* Limited mouth opening less than 2cm
* Decreased compliance of the lungs or the thoracic cage
* Need of mechanical ventilation after the surgery
Impact of Serum Progesterone Levels on the Day of Β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.

Prospective cohort multicentric study including infertile patients undergoing a pregnancy test on βhCG day (around ET +11), after an ET in the context of an artificial cycle and receiving LPS with vaginal natural progesterone following the clinical practice in IVI RMA (Spain).

The investigation team have already demonstrated that serum progesterone levels measured on the ET day in artificial cycles are related to pregnancy outcome. In this line, this problem can be countteracted after supplementation with an additional source of external progesterone, achieving similar ongoing pregnancy and live birth rates in women with serum progesterone levels below and above the threshold point determined on the ET day.

Despite this, it has been observed apparent differences on the maintenance of pregnancy in patients with a positive pregnancy test according to their serum progesterone levels measured on day ET+11, which is the same day in which we perform the pregnancy test. These differences seem to be originated due to later higher clinical miscarriage rates in patients with lower serum progesterone levels on day ET+11, despite their positive pregnancy test.

This fact may be due to patientes low serum progesterone levels, insufficient to maintain an ongoing pregnancy. Taking this into account, this study aim to confirm that serum progesterone levels on βhCG day are indeed related to final pregnancy outcome and to evaluate if there is any cut-off point of serum progesterone levels, as we have previously found on the ET day.

Eligibility Criteria:
Inclusion Criteria:

* The subject must provide written informed consent prior to any study related procedures
* Women ≤50 years old
* BMI ≤ 35 kg/m2
* Adequate endometrial thickness (\>6.5mm) and pattern (Triple A structure) in the proliferative phase

Exclusion Criteria:

* Uterine Pathology, adnexal pathology
* Systemic diseases
The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

The objective of this study is to evaluate an educational program for Atrial Fibrillation patients under Warfarin treatment regarding to patients' knowledge of Warfarin, related life distresses and quality of life.

This is a parallel-group randomized controlled study. Four measurements were (a) knowledge of Warfarin; (b) life distresses caused by Warfarin treatment; and (c) quality of life as primary and secondary endpoint. All participants participated in a face-to-face interview during the pretest and at the 6-month follow-up in the outpatient department (OPD). Each subject in the experimental group was taught face-to-face individually according to investigator's brochure in the OPD by researchers trained in a standardized protocol. The control group received a brochure only.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Atrial Fibrillation by a physician and taking Warfarin as treatment
* 20 years old or older
* clear consciousness for communication
* willingness to participate in research

Exclusion Criteria:

* can not communicate clearly
* without willingness to participate in research
AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate when deciding the next step in management for a thyroid nodule. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer. This entry (Aim 1) has an associated study (Aim 2) registered under NCT04463719


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years old presenting for evaluation of a thyroid nodule

Exclusion Criteria:

* Patients with hyperthyroidism
* Patients with previous biopsy of the nodule of interest
* Pregnant patients
* Prisoners
Efficacy of ICU-VTE Scale in ICU Patients

Venous thromboembolism (VTE) is a common cause of morbidity and mortality among critically ill patients. No uniform standard model of VTE risk for critically ill patients was formatted by now. In 2020, Viarasilpa et al. developed the ICU⁃VTE rating table, mainly for ICU patients. However, it lacks validation. We examined and compared how well the ICU-VTE score predict and stratify VTE risk in comprehensive ICU patients.

Venous thromboembolism (VTE) is a group of thromboembolic diseases including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), which is a systemic disease caused by a combination of risk factors. The risk of venous thromboembolism can be greatly reduced by the preventive treatment of it in hospitalized patients according to their risk level. The common risk assessment tools for inpatient VTE include the Padua score for medical patients and the Caprini score for surgical patients, but there is no clinical basis for implementing risk assessment for critically ill patients. The question of how to perform VTE risk assessment in ICU patients to prevent and treat the occurrence of VTE is worth exploring.

This study was designed according to a prospective study method. Data and information were collected from the time the patients were admitted to the ICU to the time the patients were discharged from the ICU.There are three purposes for this study. First, to observe the predictive effect and evaluate the value of the ICU-VTE scoring scale in comprehensive ICU patients; Second, to compare the advantages and disadvantages of the ICU-VTE scoring tool with the Padua score (internal medicine) and Caprini score tool (surgery); To analyze the risk factors for VTE in comprehensive ICU patients and to optimize the VTE risk prediction model; Third, to look into the prevention and treatment of VTE in critically ill ICU patients.

Eligibility Criteria:
Inclusion Criteria:

* patients age greater than or equal to 18 years;
* Patients or their family members agreed to the study and signed informed consent.

Exclusion Criteria:

* Patients admitted to ICU with VTE diagnosis or diagnosed with VTE within 24 hours of admission to ICU;
* Use the therapeutic dose of anticoagulation before admission to ICU or within 24 hours in ICU;
* Expected ICU stay of less than 48 hours;
* Patients cannot obtain imaging data to confirm the presence of VTE during ICU admission
Probiotics in Respiratory Tract Infections in Children

The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children


Eligibility Criteria:
Inclusion Criteria:

* Age 3-12 yrs
* At least one episode of respiratory tract infection in the previous epidemiological season
* Direct telephone access available
* Informed consent signed

Exclusion Criteria:

* Vaccination against the influenza
* Chronic adeno-tonsillar pathology
* Recurrent otitis
* Sinusitis
* Respiratory allergy
* Acute or chronic intestinal disease with diarrhea and/or malabsorption syndrome
* Lactose intolerance
* Functional or organic constipation
* Down syndrome
* Congenital or acquired heart disease
* Cerebral palsy
* Any chronic hepatic, renal, metabolic, or immune system disease
Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's Disease

Parkinson's disease is one of the most prevalent motor disorders in the world . The disease is progressive and has no known treatment. In addition to a number of psychological and autonomic issues, the disease also cause movement abnormalities which are the most challenging problem because management is still limited by medication or traditional physiotherapy the most effective way to treat symptoms is through an interprofessional new modalities as sensory stimulation , this study will be the first of its type to measure the effect of sensory stimulation on static tremors. Also, this study is the first of its type to make a continues treatment protocol for patient with static tremors.

SO the purpose of these study will To investigate the effect of sensory electrical stimulation on resting tremors in Parkinson's patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 60
* Diagnosed with idiopathic Parkinson's disease with Magnetic resonance imaging of the brain
* All the patients will have mild to moderate symptoms based on (the Unified Parkinson's Disease Rating Scale UPDRS) ≥ 3
* Static tremors have been present at the hand and wrist
* Absence of other disorders that cause similar symptoms like dystonia

Exclusion Criteria:

* History of hand trauma causes stiffness
* Presence of other neurological problems interferes with diagnosis as hemiplegic stroke
* Secondary parkinsonism (drug-induced or vascular ) which has very low tremor magnitude which can not be detected The patient has a severe visual problem that does not allow following the instructions.
* The patient educational level does not allow for following the instructions.
Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

This is a clinical trial where 44 subjects dry eyes were instilled with Virgin Coconut Oil (VCO CL) using contact lenses as its vehicle. All subjects are healthy subjects with no other ocular diseases except for having some dry eye symptoms (included with McMonnies questionnaires). Parameters measured at baseline and after 15 minutes of insertion and were compared. The control eyes were inserted with contact lenses soaked in saline (CCL). The eye that wears the VCO CL or the CCL were chosen randomly by masked operator. At the end of this study, the parameters measured will indicate if the VCO CL was able to retain tears in the eye and remove the dry eyes symptoms.

A new study using contact lens pre-soaked in virgin coconut oil (VCO CL) was conducted to determine the safety of the agent on dry eye human. Efficacy of the VCO CL was assessed by measuring TBUT, anterior eye assessment, corneal staining, pH, and Schirmer value and the measurement of residual VCO volume in tears before instillation (0 minute) and at 15 minutes after insertion. Wilcoxon Signed Rank and Mann Whitney U Test were used to analyse any changes in all the measurable variables. The differences of the TBUT, corneal staining and residual VCO volume in tears value in both eyes were analyzed. These study data will suggest if the VCO CL is safe and effective and can be recommended to be used as an option for dry eyes in human

Eligibility Criteria:
Inclusion Criteria:

* Dry eye symptoms (according to McMonnies questionaires)
* Written consent

Exclusion Criteria:

* No ocular diseases
* No systemic diseases
* Not wearing contact lenses regularly for the past 6 months
Surfactant Nebulization for the Early Aeration of the Preterm Lung

Respiratory distress syndrome is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered via an endotracheal tube during mechanical ventilation. However, mechanical ventilation is considered an important risk factor for developing bronchopulmonary dysplasia.

Surfactant nebulisation during noninvasive ventilation may offer an alternative method for surfactant administration and has been shown to be promising in terms of physiological as well as clinical changes. In preterm infants with respiratory distress syndrome, the effect of intratracheally administered surfactant on lung function during invasive ventilation has been studied extensively. However, the effect of early postnatal surfactant nebulization remains unclear.

Therefore, the investigators plan to conduct a randomized controlled trial in order to investigate the effect of surfactant nebulization immediately after birth on early postnatal lung volume and short-term respiratory stability.


Eligibility Criteria:
Inclusion Criteria:

* inborn
* gestational age at birth from 26 0/7 to 31 6/7 weeks
* written informed consent

Exclusion Criteria:

* severe congenital malformation adversely affecting surfactant nebulisation or life expectancy
* a priori palliative care
* genetically defined syndrome