cyrilzakka/clinical-trials huggingface dataset:
Effects of Contrast Media Temperature on Image Quality and Clinical Adverse Events in Coronary CTA

Extrinsic prewarming of iodinated CT contrast media (CM) to body temperature reduces viscosity and injection pressures. However, guideline recommendations on the necessity to prewarm iodinated CM are conflicting. And studies examining the effect of extrinsic warming CM for coronary CTA(CCTA) on clinical adverse events and image quality are lack.

Enrolled patients of chest pain or coronary artery disease screening were eligible for this a double-blinded, randomized noninferiority trial, and equally allocated into two group randomly: BBT-CM (basic body temperature) group received 37°C CM; RT-CM (room temperature) group received \~23°C CM. A state-of-the-art individualized CM (iopamidol at 370 mg I/mL) injection protocol was used, based on body weight.


Eligibility Criteria:
Inclusion Criteria:

* Coronary symptomatic patients (i.e., chest pain).
* Patients for Coronary artery disease screening

Exclusion Criteria:

* Hemodynamic instability
* Renal insufficiency (estimated glomerular filtration rate \<30 mL/min per 1.73 m2)
* Prior adverse reactions to iodinated CM
* Age younger than 18 years
* Inability to place an 18-gauge needle.
The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery Primiparous Mothers

Immediately after cesarean birth, many women suffer from breastfeeding problems due to pain, fatigue, activity intolerance, anesthesia, and delayed onset of lactation. Because of these avoidable problems, the baby cannot get enough breast milk, and mothers' postpartum comfort decreases.

This study aimed to investigate the effect of reflexology on lactation and postpartum comfort in primiparas giving births through cesarean section.

Methods: This randomized controlled trial was conducted with 100 women with first birth through cesarean section were investigated between May 2016 and May 2017. Expectant mothers were randomly included into an intervention and a control group. The intervention group consisted of mothers for whom reflexology was performed three times per day for 30 min every eight hours.

With face-to-face interviews, all participants were informed about the design, content and methods to be used in the study, and the sociodemographic data obtained self-reportingly from the primiparas were recorded. The data were collected between May 2016 and May 2017. In collecting the data related to primiparas and infants, a questionnaire structured by the researchers in light of literature was used, as well as The breastfeeding charting system (LATCH), The visual analogue scale (VAS) for signs of onset of lactation and The postpartum comfort questionnaire (PPCQ).

Eligibility Criteria:
Inclusion Criteria:

* primiparas delivering through CS,
* at the age of 18 and over,
* at ≤37 gestational weeks
* with one-fetus birth,
* with stable vital signs,
* those delivering under general anesthesia,
* except for CS and spinal/epidural anesthesia,
* with ability of communication in Turkish, and those accepting to participate into the study voluntarily.

Exclusion Criteria:

* primiparas with infectious diseases such as shingles, fungus, eczema, warts and callus in the intervention group,
* those with local infections like abscess,
* open lesion/wound, scar tissue, edema, hematoma, thrombophlebitis, deep vein thrombosis, coagulopathy, mass, varicosis, deformities on toes, recent fractures or dislocations, tearing of fascia and tendons,
* and with psychiatric disorders such as anxiety and depression, were excluded out of the study.
Being a Parent: Evaluation of a Parenting Intervention for Childhood Behavioral Problems

This randomized controlled trial aims to test the efficacy of an early parenting intervention for childhood behavior problems in the portuguese community. More specifically, this research intends to: 1) examine the effects of the parenting intervention in childhood behavior problems, positive parenting skills and parental concerns; 2) test participants' adherence, acceptability and dropout rates of the parenting intervention; and 3) qualitatively analyze the experience of parents' who received the intervention.

Researchers will compare an intervention group with a waitlist control group to see if there are any significant differences between these groups regarding childhood behavior problems and the aforementioned parenting dimensions.

Participants in both groups will be able to participate in the parenting intervention that has a duration of 9 weeks. Furthermore, they will be asked to fill in pre and post data.


Eligibility Criteria:
Inclusion Criteria:

* Primary caregivers who identify difficulties managing the behavior of a child between the ages of 2 and 11 years old.

Exclusion Criteria:

* Primary caregivers of children with serious neurodevelopmental or cognitive disorders diagnosed;
* Primary caregivers of children institucionalized;
* Primary caregivers who do not comprehend, read or write in portuguese;
* Primary caregivers inability to commit to weekly sessions.
Connect for Health Pediatric Weight Management Program

The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.


Eligibility Criteria:
Inclusion Criteria:

* All children receiving primary care at the participating health centers across the three health systems
Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa

The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults

Recombinant human deoxyribonuclease I (rhDNase, dornase alpha), administered by inhalation, is currently used as a mucolytic agent in the treatment of cystic fibrosis. This prospective, randomized, placebo-controlled, double-blind clinical study should carry out whether the therapeutic use of rhDNase can be extended to adults who are undergoing long term ventilation at the intensive care. It is hypothesized that mechanically ventilated patients show elevated concentrations of DNA in airway secretions, and that these pathological DNA levels are reduced by rhDNase. The primary clinical goal of the study is to establish wether ventilation times are shortend under inhalation of rhDNAse during the ventilation time. hDNase (verum) is compared with equal amounts of 0.9% saline solution (placebo).

Eligibility Criteria:
Inclusion Criteria:

* adult
* mechanical ventilation
* expected ventilation time 3 days or longer
* full therapy is possible
* expectet ventilation time not longer than 21 days

Exclusion Criteria:

* medicinal point of view: patient won´t survive the next 21 days
* concomitant pneumococcal disease (like tuberculosis, carcinoma)
* endotracheal bleeding
* pneumothorax with no relief (e.g. thoracic drainage)
* pregnancy
* breast feeding
* participation in another clinical trail
* mechanical ventilation since more than 48 hours
* mechanical ventilation on the basis of another reason than operation, trauma or pulmonary decompensation
Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention. A second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline. Although promising, the booster incorporated in the study needs further empirical refinement.

The current project seeks to build on past progress by further developing and refining the booster. In particular, the current project is an extension of previous work by expanding the investigation into complete social networks (students involved in Greek life). This booster contains feedback about alcohol use tailored to the recipient, and will be emailed 2, 6, 10, and 14 weeks after baseline (experimental condition), or not at all (control condition). This study will be conducted specifically with students who are members of fraternities or sororities at ODU (specifically, those in the organizations that agree to participate). This population engages in heavy alcohol use so is ideal for an alcohol intervention. Members of fraternities and sororities (i.e., "Greek life") engage in more frequent drinking, consume more when drinking, and have higher peak drinking occasions than students not involved in Greek life. We aim to administer the intervention and associated booster among complete networks of Greek organizations to examine how the intervention and booster and progress through social networks.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years old so that they can legally consent to participate.
* Participants must be an undergraduate student at the host institution and a member of a participating fraternitiy or sorority.

Exclusion Criteria:

* Under 18 years of age
* Not a member of a participating fraternity or sorority at the host institution.
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of Immunoglobulin A nephropathy
* estimated glomerular filtration rate \>60 mL/min/1.73 m2
* Proteinuria (first morning urinary protein:creatinine ratio \>1g/g creatinine)

Key Exclusion Criteria:

* Severe renal disease
* Pregnant or nursing
* Proteinuria \>8g/g creatinine or \>8g/day
* Systemic manifestations of Henoch-Schonlein purpura within 2 years prior
* Patients with Immunoglobulin A nephropathy deemed secondary to underlying disease
* Biopsy reported severe crescentic Immunoglobulin A nephropathy
* History of treatment with glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior
* History of clinically significant cardiac conditions
* History of cancer within 5 years prior
* Any infection requiring antibiotic treatment that has not cleared prior to study start
The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index

This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.

Intravenous volume replacement alter the dynamics of microcirculation. Perfusion index and pulse variability index are the recent parameters to evaluate the tissue microcirculatory condition. This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be taken to recovery room in the operating theatre and wait for 15 minutes to balance the skin temperature of the patients to the environment. Patients will be randomly divided into three groups using closed envelope technique as Group L (received 500 ml of Ringer's lactate), Group S (500 ml of saline) and Group H (received 500 ml of 6% hydroxyethylstarch). Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.

Eligibility Criteria:
Inclusion Criteria:

* having a fasting period of 8 hours
* quit smoking for 8 hours before the procedure

Exclusion Criteria:

* not to participate in the study
* presence of peripheral vascular disease
* a history of upper extremity surgery
* presence of any kind of psychiatric disease
The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis

The purpose of this study is to see how feasible is the use of compact EEG and paired audio technology to administer sleep interventions for inpatients with psychosis, to see if individuals that receive individualized technology-based sleep interventions experience improvements in sleep quality and to see if individuals that receive individualized technology-based sleep interventions experience improvements in symptomatology


Eligibility Criteria:
Inclusion Criteria:

* primary diagnoses of schizophrenia spectrum disorder or mood disorder with psychotic features, as determined by the treatment team or record review
* capacity to consent to the study as determined by licensed psychologists ( or the primary attending psychiatrist
* reported sleep dysfunction which will be determined by a subthreshold or more severe score ≥ 8 on the Insomnia Severity Index (ISI), and/or report experiencing nightmares at least once a week.

Exclusion Criteria:

* primary substance- or medical-induced psychosis
* intellectual and developmental disabilities
* neurodegenerative cognitive disorders
* implanted devices (e.g., Pacemakers)
* on one-to-one supervision or 15-minute safety checks for suicidality or aggression
* patients with roommates that are on 15-minute checks to minimize impact on study participants' awakenings
Pediatric Pain Assessment in the Emergency Department

To examine pediatric pain assessment in the Emergency Department

Phase 1 is a qualitative assessment of how pain is currently evaluated in the pediatric Emergency Department (ED). Initial triage encounters will be observed and audio recorded. In addition to determining how often the Wong Baker FACES Pain Rating Scale (WBF) is administered with the intended script, the investigators will determine if there are common variations from the recommended script. The investigators will also evaluate how often a caregiver's perception of the child's pain is considered when completing the WBF.

Phase 2 is a quantitative assessment to determine if neurocognitive development impacts the responsivity of the WBF and the Faces Pain Scale - Revised (FPS-R) as well as the cognitive age equivalent required to use these scales accurately. Patients presenting with acute pain will report their level of pain before and after analgesic intervention using both the WBF and the FPS-R. They will also subjectively report their change in pain following analgesic intervention. Once the patient's pain has improved, he/she will complete the BRIGANCE Early Childhood Screens III to determine his/her cognitive age equivalent. He/she will also complete a series of tasks aimed to assess ability to successfully use the WBF and FPS-R (matching, grouping, classification, and seriation skills). The results of the child's self-report of pain will also be compared to the caregiver's estimate of the child's pain.

Eligibility Criteria:
Inclusion Criteria:

* verbal patients
* pain score ≥ 6/10
* caregiver speaks English or Spanish

Exclusion Criteria:

* altered mental status
* history of traumatic brain injury (TBI)
* history of developmental delay
* history of Autism
* history of chronic pain, defined as persistent or recurrent pain in children with chronic health conditions
* non-verbal patients
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study

The purpose of this study is to determine whether Chinese medicinal herbs are effective and safe for treating novel influenza A (H1N1) infection.

The antiviral agent, oseltamivir, is recommended by the World Health Organization (WHO) to treat recent outbreak novel influenza A (H1N1) virus infection around world. But limited stock and resistant strain emergence raised increasing concerns. Chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. The investigators performed RCT to indicate that Chinese medicinal herbs was effective and safe for treating novel influenza A (H1N1) infection.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed novel influenza A(H1N1) case with laboratory evidence
* 70 years ≥ age ≥ 14years
* Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)

Exclusion Criteria:

* Age \< 14 years or \> 70 years
* Bronchitis, pneumonia, pleural fluid and interstitial infiltration showed by Chest radiology(x-ray or CT)
* Severe chronic underlying diseases: severe COPD(FEV1/EVC \<70% and FEV1 \<30% predicted or respiratory failure or congestive heart failure), severe hepatic disfunction（ALT or AST ≥3 times normal elevation), renal disfunction（Cr\>2mg/dL), chronic heart failure(NYHA Ⅲ-Ⅳ grade）
* Immunocompromised patients(cancer, organ transplant, AIDS and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months)
* Taken Chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks
* Inoculation influenza vaccination
* One of the following items appeared at the enrollment

  * respiratory failure：PaO2\<60mmHg and/or PCO2\>50mmHg or PaO2/FiO2≤300
  * circulation failure: despite adequate fluid resuscitation and cardiac output, systolic \<90mmHg or requirement inotropic support
  * renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, Cr or BUN≥1 time normal elevation
  * hepatic function failure: total bilirubin\>34μmol/L or ALT/AST ≥3 times normal - Other unappropriated enrollment situations considered by investigator
A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants

The purpose of this study is to assess the bioavailability of two different doses of venetoclax new high drug load formulation tablets relative to two tablets of the currently marketed venetoclax tablets under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal.
* A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Participant must be postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.

Exclusion Criteria:

- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
Choroidal Thickness in Glaucoma Patients and Healthy Controls

With the new software tool (EDI, enhanced depth imaging) of the Spectralis® spectral-domain optical coherence tomography (SD-OCT) it is possible to visualize and measure the choroidal thickness. In glaucoma a vascular component is known. Therefore a difference of choroidal thickness in glaucoma patients and healthy controls is proposed.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria: for both groups (glaucoma study group and control group):

men and women of at least 50 years of age

for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria: for both groups (glaucoma study group and control group):

* less then 50 years of age
* any pathology of the central retina
* any optic nerve disorder other then glaucoma
* retinal vascular disorder

for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma

for the control group: any diagnosis of glaucoma
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction

The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.

This study is designed as a randomized, double-blind, sham-controlled trial. Sixty healthy, able-bodied participants will be randomized 1:1:2:2 into one of four experimental groups:

Group 1: Active tAN for prophylactic treatment prior to acute stress exposure (N=10)

Group 2: Sham stimulation for prophylactic treatment prior to acute stress exposure (N=10)

Group 3: Active tAN for acute treatment during acute stress exposure (N=20)

Group 4: Sham stimulation for acute treatment during acute stress exposure (N=20)

Participants will complete a baseline performance of three tasks. tAN treatment will then be administered prior to or during an acute stress test. Participants will complete the same three tasks preformed at baseline. In addition to the tAN therapy earpiece, subjects will have biosensors attached to them to collect biomarker information.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 to 41 years old
2. Participant has the cognitive and physical abilities to carry out the study tasks
3. Proficient in the English language
4. Ability to understand the explanations and instructions given by the study personnel

Exclusion Criteria:

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
2. Participant has used any psychological stress-management intervention within the last 4 weeks
3. Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
4. Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
5. Participant is currently using anti-anxiety medications such as Xanax or beta blockers
6. Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
7. History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months
8. Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation
9. Participant has a history of epileptic seizures
10. Participant has a history of neurologic diseases or traumatic brain injury
11. Participant wears or utilized other devices that cannot be removed during the study (e.g., pacemakers, cochlear prostheses, neurostimulators)
12. Females who are pregnant or lactating
13. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial