cyrilzakka/clinical-trials huggingface dataset:
IVC Variation After VT Challenge to Predict Fluid Responsiveness

The purpose of the study was to evaluate the efficacy of using the respiratory variation in inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge in mechanically ventilated patients after cardiac surgery.

The "tidal volume challenge" is a novel test to predict fluid responsiveness in patents in shock, ventilated using low tidal volume without spontaneous breathing activity. The test involves transiently increasing tidal volume from 8 ml/kg PBW to 12 ml/kg PBW for one minute and observing the change in PPV or SVV. The aim of this study was to evaluate whether the respiratory variation in inferior vena cava diameter after tidal volume challenge can predict fluid responsiveness in cardiac surgical patients with mechanical ventilation

Eligibility Criteria:
Inclusion Criteria:

* acute circulatory failure (low blood pressure or urine output, tachycardia, or mottling)
* clinical signs of organ hypoperfusion (renal dysfunction or hyperlactatemia)

Exclusion Criteria:

* a contraindication to elevation of tidal volume
* evidence of cardiac arrhythmia
* left ventricular ejection fraction less than 50%
* echocardiographic examination that showed the existence of severe tricuspid or mitral regurgitation or right heart dysfunction
* intracardiac shunt
* pulmonary hypertension
* severe chronic obstructive pulmonary disease
* a contraindication to the passive leg raising (PLR) test
* air leakage through chest drains
* abdominal compartment syndrome
* portal hypertension
* pregnancy
* inability to perform ultrasonography
Neonatal Sleep Intervention to Improve Postpartum Hypertension

The investigators are conducting a single center, randomized controlled trial testing the impact of a neonatal sleep intervention, the SNOO, on reducing maternal blood pressure (BP) in the postpartum period in women with hypertensive disorders of pregnancy. The SNOO is a responsive bassinet designed to automatically calm and consolidate infants by responding to their cries. Use of the SNOO has been demonstrated to improve infant sleep by 1-2 hours nightly, thus increasing maternal sleep time. The investigators plan for 110 women with pregnancies complicated by gestational hypertension or pre-eclampsia to be randomized 1:1 to either receive and use the SNOO responsive bassinet for their infants, or to receive the usual care of safe sleep education. Women will be followed longitudinally through 6 months postpartum with serial BPs, weights, mood assessments, and subjective and objective sleep assessments. The investigators hypothesize that for women with pregnancies complicated by gestational hypertension or preeclampsia, that poor maternal sleep quality contributes to increased BP in the postpartum period. The investigators further propose that compared to usual care (safe sleep education), an intervention targeted to improve neonatal sleep (the SNOO), and thus maternal sleep, will improve postpartum BP for these women.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Have a singleton, full-term (37 or greater weeks of gestation), live birth of a non-anomalous fetus
* Diagnosis of gestational hypertension or pre-eclampsia by American College of Obstetricians and Gynecologists criteria
* Enrolled in the institution's postpartum blood pressure remote monitoring program
* Willing to undergo randomization
* Willing to use the SNOO for their neonate in the postpartum period if randomized to that study arm

Exclusion Criteria:

* \<18 years old
* Non-English speaking
* Diagnosis of chronic hypertension
* Diagnosis of pre-gestational diabetes
* Diagnosis of cardiac disease
* Diagnosis of kidney disease
* Diagnosis of liver disease
* Infant admitted to the neonatal intensive care unit
* Intend to use the SNOO prior to study enrollment
* Not willing to be randomized
* Not willing to use the SNOO if randomized to that study arm
Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.

Owing to the virulent nature of early childhood caries (ECC) and its consequences if left untreated, immediate intervention is indicated to control the condition.

Barriers to intervention as young age, uncooperative patient behavior and lack of access to dental care are however, very common. The use of silver diamine fluoride as an anticaries agent is of growing popularity worldwide due to its promising results, safety of use, ease of application and relatively low cost. Further research is still required in order to provide evidence-based recommendations regarding the use of SDF in arresting early childhood caries. Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.

Eligibility Criteria:
Inclusion Criteria:

* For children:

  1. Healthy children.
  2. Age range 2-5 years.
  3. Informed consent (Appendix I)

For teeth:

* Teeth with active dentin lesions corresponding to ICDAS II score 5 and 6.
* Teeth having lesions that are considered active according to ICDAS II activity criteria for coronal primary caries.

Exclusion Criteria:

* For children:

  1. Children with systemic diseases.
  2. Children with reported allergy to silver or to any other component in the materials used.
  3. Children unable to return for recall visits.

For teeth:

* Clinical or radiographic signs of pulpal involvement.(pain, abscess, sinus, obvious discoloration, premature hypermobility, internal or external root resorption).
* Teeth with inactive lesions.
Observational Study in Japanese Type 2 Diabetes Patients

This study is designed to address the gap in the literature related to changing treatment regimen or formulation between different types of insulin, and how this change impacts quality of life, adherence, individual patient treatment satisfaction and glycemic control.

To measure changes in Health Related Quality of Life (as measured by the Insulin Therapy Related-Quality of Life: ITR-QOL) in insulin treated type 2 diabetes over a 12 weeks period following a significant change in insulin treatment regimen. Definition of significant change is a) increase or decrease the in number of injections per day, or/and b) change in formulation of insulin (human or analog insulin, basal or bolus, rapid or mix insulin), and/or c) change in administration method (syringe or pen, disposal or re-usable).

Eligibility Criteria:
Inclusion Criteria:

* Inpatients or outpatients with type 2 diabetes, aged 20 years or older, on insulin therapy who have planned to change insulin therapy during the registration period of the study
* Patients who have provided written informed consent to participation in the study after receiving explanations about the objective and other details of the study
* Patients who have received the same insulin therapy for 3 months or longer before informed consent. (i.e. receiving the same type of insulin preparation at the same dosing frequency regardless of insulin dose)

Exclusion Criteria:

* Patients who have planned to discontinue insulin therapy
* Patients incapable of completing the ITR-QOL, DTSQ and patient's questionnaire based on their self-ratings
* Patients with type 1 diabetes
* Patients who have used CSII or have planned to switch to CSII(continuous subcutaneous insulin infusion )
* Patients with poor treatment compliance as determined by their investigators based on the treatment history
Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation

Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels

HbA1C levels were evaluated in diabetic patients with COPD exacerbation on admission to the hospital and 3-months later. Demographic, clinical, laboratory variables and total steroid dose were documented. Age- and sex-matched group of diabetic patients with COPD who were admitted for other reasons, were asked to participate as a control group. Mann-Whitney and Chi square/Fischer's exact tests were used to compare between the parameters of the two groups. Wilcoxon signed rank test was used to compare between HbA1C levels at baseline and 3 months later. Multi-variate linear regression analysis was used to find predictors for increase in HbA1C levels in the patients' group.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with COPD exacerbation

Exclusion Criteria:

* Patients treated with steroids during the previous 3 months
Lactobacillus Reuteri Strains for Gingivitis Reduction

The aim of the present study was to investigate the potential beneficial effects in volunteer young adults of orally administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival inflammation. The null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration).

Aim. To investigate the potential beneficial effects in volunteer young adults of orally daily administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival inflammation. The null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration).

Methods. A randomized controlled parallel clinical trial was conducted in sixty young adults (18-35 yrs old) with chronic marginal gingivitis for one month. Initially, both study groups underwent conventional mechanical periodontal therapy/oral anti-plaque hygiene. However, the experimental group additionally received the administration of two daily tablets, containing both L. reuteri strains, for 30 days, while the control group did not. Different clinical outcome variables (plaque (PI) and gingival (GI) indices, bleeding on probing (BOP), and crevicular fluid volume (CFV)) were recorded and compared between the study groups, both at baseline and at the end of the interventions, 30 days later. Statistical descriptive and inferential tests were performed (data distribution normality, Student's t, and Wilcoxon-Mann-Whitney tests).

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers (at least for the last 6 months).
* Initial mean gingival index (GI) between 1.5 - 2.
* With a minimum of 20 teeth present in the oral cavity.

Exclusion Criteria:

* Periodontal pockets \> 4 mm.
* Recent intake of antibiotics or anti-inflammatory drugs and/or reception of dental prophylaxis.
* Daily consumption of analgesics, probiotics, or oral antimicrobial rinses/gels.
* Overweight (MCI \>25).
* Alcohol or recreative drug frequent consumers.
* Pregnancy or breast-feeding.
* Allergy or hypersensitivity to study products
* Fixed orthodontic appliances.
Self-regulation for Older Adults With Asthma Through Remote Education

This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for asthma.

The purpose of this study is to implement and evaluate an asthma self-management intervention through multiple locations in the United States that is tailored to the challenges older adults face and is based on an individual behavioral theory of change.

Eligible participants will be enrolled and participate for six weeks in the SOAR intervention.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of asthma
* Poorly controlled asthma, as evidenced by a score ≤ 19 on the Asthma Control Test
* Have a primary care provider willing to participate in the study by receiving email updates regarding the status of the participant

Exclusion Criteria:

* Physician diagnosis of any other significant cardiopulmonary disease (including chronic obstructive pulmonary disease)
* A greater than 20 pack-year smoking history
* Lack of telephone access
* Decreased cognitive capacity such that participation in the program would not be possible
Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)

BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous oxide has analgesic properties similar to those of opioids and is easy to administer. It has been shown in two small studies to be effective in treating migraine headaches.

RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment of acute migraine headaches in children and adolescents presenting to an Emergency Department?

DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be taken to examine change in pain scores before and after nitrous oxide treatment.

METHODS Each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment at multiple time-points.


Eligibility Criteria:
Inclusion Criteria:

* During the study enrollment period, eligible subjects will be English-speaking children and adolescents
* Between the ages of 8 - 18 years (inclusive)
* With history of migraine present for at least one year
* With previous migraine headaches conforming to ICHD-II diagnostic criteria
* Able to give assent according to institutional guidelines, and
* Have parental consent to participate.

Exclusion Criteria:

* Any patients will be excluded if he/she
* Has had any neurosurgical interventions
* Has underlying seizure disorders
* Presents with a headache of a different quality than their other migraines
* Has contraindications to nitrous oxide
* Unable to complete the pain assessment
* Does not have a dependable contact number for the follow-up call
Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery

The purpose of this study is to determine whether personalized titanium plates can achieve better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic surgery, and evaluate the feasibility of this technique in clinical application.

The repositioning of maxillary segment is essential for esthetic and functional outcomes in orthognathic surgery. With the giant leap in three-dimensional (3D) computer-aided surgical simulation (CASS) technology development, surgeons are now able to simulate various surgical plans in a computer to achieve the best possible outcome. In order to transfer the virtual surgical plan to the patient at the time of the surgery, surgical splints manufactured by computer-aided design and manufacturing (CAD/CAM) technique has been traditionally used to intraoperative reposition the maxilla. Nonetheless, the position of maxilla is still dependent to mandibular autorotation. The instability of the mandibular condyle-fossa relationship is a potential problem that may directly affect the placement of the maxillary segment at the desired position. Personalized titanium plates manufactured using titanium 3D printing technique have been used for maxilla repositioning and fixation to improve the operative accuracy in orthognathic surgery. Despite this, the evidence for advantage of this personalized titanium plates technique is not very strong and based on only a few studies.

The purpose of this study is to determine whether personalized titanium plates can achieve better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic surgery. The accuracy of using both methods for maxilla repositioning was quantitatively evaluated using linear and angular measurement. Secondary outcomes include operative time, amount of intraoperative blood loss, preoperative preparation time and treatment cost will also be measured to evaluate the feasibility of clinical application of personalized titanium plates technique in orthognathic surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who were diagnosed with skeletal dentofacial deformity and scheduled to undergo orthognathic surgery including maxillary surgery
* patients who were scheduled to undergo a computed tomography (CT) scan as a part of their diagnosis and treatment
* patients who agreed to participate in this study

Exclusion Criteria:

* Patients who had the previous orthognathic surgery
* Patients who had the previous maxillary or mandibular trauma
* Patients who had the maxillofacial tumor
* Patients who required the segmental maxillary surgery
* Oral soft tissues defect
* Within the infection period
* Craniofacial syndromes
* Bone metabolism disturbance
* Allergic to the titanium implant
* Unable to give informed consent
* Psychiatric disorders including dementia that may interfere with the study protocol
* Pregnancy
* Included in other studies
* Severe craniomandibular disorders
Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue) and neurological complications after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation high definition (HD-tDCS) have been proposed to minimize functional and structural impairments. Recently, I electroencephalogram (EEG) has been used as predictor of HD-tDCS effectiveness in diverse neurological populations. However, evidences about this tool utilization as efficacy predictor of tDCS in COVID-19 people rest inconclusive. Thereby, our objective is to evaluate HD-tDCS efficacy on fatigue, pain and functional capacity of patients with COVID-19 chronic.

We propose a sham-controlled randomized clinical trial with patients in COVID-19 chronic. They will be evaluated according to following eligibility criteria :

Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.

Patients will be allocated randomly to the experimental group or sham control. Sessions for experimental group consist of anodal HD-tDCS on Left diaphragmatic primary motor cortex associated to respiratory training (10 sessions, 3mA, 20 minutes/session). In the sham condition, the device provided a 30-second ramp-up period to the full 3 mA, followed immediately by a 30-second ramp down.

Patients will be assessed in three moments: pre-treatment, post-treatment and after 30 days treatment ending (follow-up).

Eligibility Criteria:
Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.
Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns

This study focuses on understanding the conditions that affect newborn health and survival from pregnancy to the first weeks of life at the Isidro Ayora Hospital. The investigators will review data from 2008 to 2022 to identify key factors that may contribute to complications, help improve medical care, and reduce risks for newborns. By doing so, we aim to provide better support to families, healthcare providers, and ensure safer births.

This research investigates the impact of various perinatal conditions-such as maternal health, prenatal complications, delivery methods, and neonatal management-on morbidity and mortality rates in newborns treated at the Isidro Ayora Obstetric-Gynecologic Hospital. Using a retrospective cohort design, the study analyzes data from 2008 to 2022 to identify patterns and correlations between perinatal factors and neonatal outcomes, aiming to inform evidence-based clinical practices and enhance neonatal care protocols.

Key aspects include evaluating the influence of gestational age, birth weight, maternal comorbidities (e.g., hypertension, diabetes), and obstetric complications on the health of neonates. Outcomes of interest include NICU admissions, length of hospital stay, and incidence of conditions such as respiratory distress syndrome, sepsis, and neonatal mortality. Findings will contribute to improving resource allocation, optimizing care strategies, and potentially guiding policy decisions to reduce adverse neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Neonates born at the Isidro Ayora Obstetric-Gynecologic Hospital between January 2008 and December 2022.
* Live-born neonates with complete medical records in the hospital's perinatal database.
* Neonates whose mothers received antenatal care and delivered at the hospital. Availability of maternal and neonatal data, including gestational age, birth weight, and outcome information.

Exclusion Criteria:

* Neonates with incomplete or missing medical records.
* Neonates born outside the hospital and referred postnatally.
* Stillbirths and pregnancies terminated due to maternal or fetal indications.
* Neonates discharged to other facilities immediately after birth without follow-up data in the hospital\&#39;s database.
Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia

* Brief Protocol: Treat the patients taking Taxotere+Epirubicin +Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE)treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
* Targeted patients: breast cancer
* Subjects were randomly divided into two groups. The test group received recombinant human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg treatment. Positive control group received recombinant human granulocyte colony stimuli Factor injection therapy
* Number of patients: 80

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65.
* Diagnosed breast cancer, suitable for TEC or TE .
* ECOG performance status 0 or 1.
* Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
* No obvious abnormal ecg examination.
* TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
* Cr, BUN≤2.5×ULN.
* Signed informed consent.

Exclusion Criteria:

* Chemotherapy within past 4 weeks.
* Uncontrolled inflammatory disease,axillary temperature≥38℃.
* Merging other malignant tumor.
* Pregnancy or nursing status.
* Participation in another clinical trial with and investigational product within 3 months prior to study entry.
* Severe diabetes mellitus, or poor blood sugar controller.
* Allergic disease or allergic constitution. History of protein allergy.
* History of drug addiction and alcoholism.
* Hematopoietic stem cell transplantation or organ transplantation.
* Antibiotics were treated within 72 hours before chemotherapy.
* Long-term use of hormones or immunosuppressive agents.
* Severe mental or neurological disease.
* Chronic disease of severe cardiac, kidney and liver.
* Other conditions that would be excluded from this study according to doctors'judgment.