cyrilzakka/clinical-trials huggingface dataset:
The Effect of Pseudoephedrine on Rhinitis and Sleep

The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue. We studied patients treated with placebo compared to FDA approved dose of pseudoephedrine and assessed sleep, QOL and daytime sleepiness.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65.
2. History of allergic rhinitis.
3. The ability to be placed on placebo without significant compromise in the quality of life.
4. General good health.
5. Ability to comply with the protocol and sign an informed consent.
6. Have daytime sleepiness by history.
7. Have poor sleep by history.
8. Have fatigue by history.
9. Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms.

Exclusion Criteria:

1. Age fewer than 18 or over 65 years.
2. A history of sleep apnea.
3. Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.
4. Non-allergic rhinitis.
5. Hypertension
6. Diabetes Mellitus
7. Inability to tolerate pseudoephedrine
8. Significant other diseases as determined by the investigator.
9. Use of a research medication within 30 days.
10. Use of a nasal steroid or topical antihistamine or decongestant within 30 days.
11. Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers.
12. Excessive use of alcohol or drug abuse.
13. Inability to stop medication use during run-in period.
14. Use of an oral antihistamine within 1 week of enrollment.
15. Failed to have benefit when pseudoephedrine was used for rhinitis or asthma in the past
Guangzhou Outdoor Activity Longitudinal Study

The purpose of this study is to assess whether outdoor activities are effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

1. To determine if increased engagement in outdoor activities reduces the development and progression of myopia in Chinese school children.
2. To identify the risk factors associated with the development and progression of juvenile-onset myopia.
3. To characterize the interaction between refractive error and education.

Eligibility Criteria:
Inclusion Criteria:

* All the students in Grade 1

Exclusion Criteria:

* No
Streptococcus Dentisani Colonization Capacity in a Split Mouth Model

Pilot study with healthy subjects to test the in vivo potential colonization ability of S. dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes. Saliva and plaque samples will be obtained at day 0, 14 and 28.

Phase I study, exploratory, prospective, mechanistic, to evaluate the capacity of

Streptococcus dentisani CECT 7746 of colonizing the tooth surface. The study will be carried out with 10 healthy subjects divided into two groups (n = 5 per group) that differ in the number of applications of probiotic:

Group A: participants who will receive a single application of the product during the initial visit Group B: participants who will receive 7 applications on consecutive days, with the first in the start visit. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes.The total dose received will be the same for both groups, and the total duration of the follow-up will be of 4 weeks from the first application also for both groups.

On day 0: Participants who meet the inclusion and exclusion criteria will be randomized in one of the two groups. Saliva and plaque samples will be obtained by the dentist, and all the participants will receive an professional teeth cleaning in one half of the mouth (quadrants 1-4). Afterwads, treatment will be applied by the dentist according to assigned group, and the randomized participants in the multiple-dose group will be explained how to perform the six successive applications at home every 24 hours.

On day 14: follow-up visit, saliva and plaque samples will be obtained from all participants. Patient assigned to the multi-dose group will return the used material On day 28th: final visit, saliva and plaque samples will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Absence of serious periodontal diseases (eg gingivitis, periodontitis)
* Ability to understand the requirements and implications of the study

Exclusion Criteria:

* Antibiotic consumption during the 30 days prior to the initiation of the study.
* Oral probiotics consumption during the 30 days before the start of the study
* Pregnant or lactating women
* Chronic diseases (eg, diabetes, kidney problems, cancer) or diseases that could affect salivary flow.
* Chronic treatment or medication that could reduce salivary flow, such as antidepressants or psychotropic drugs.
* Allergy to any of the product composition ingredients
Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less effective than RBC from adult donor for the treatment of anemia of prematurity in this group of patients.

Prematurity is an important maternal and child health problem due to its incidence and associated complications. Anaemia is a frequent problem in extremely preterm infants (EPI) whose treatment often requires red blood cell (RBC) transfusion. This product is currently obtained from adult blood (AB) donor. The incidence of some prematurity complications have been demonstrated to increase with AB-RBC tranfusions mainly because of the higher oxygen tissue release, such as retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and necrotizing enterocolitis (NEC). In addition, AB-RBC could contain small amounts of heavy metals that could be toxic for EPI.

RBC from umbilical cord blood (UCB-RBC) might be a better alternative as it does not change the hemoglobin profile and consequently might decrease the oxygen toxicity.

Several studies have evaluated the safety of UCB-RBC transfusions in preterm infants without finding a higher risk of complications compared with AB-RBC transfusions.

A pilot study has been designed to evaluate the safety of UCB-RBC for transfusion in EPI and to determine the feasibility and efficacy of UCB-RBC for transfusion in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from parents or legal guardians
* Preterm infants born earlier than 28 weeks of gestational age.
* Admission to the neonatal intensive care unit of the participating hospital (Hospital Clínic of Barcelona)

Exclusion Criteria:

* Previous transfusion
* Isoimmunization
* Hydrops fetalis
* Major congenital malformations
* Congenital infections
* Hemoglobinopathies
* Extreme urgency of blood availability (hypovolemic shock, disseminated intravascular coagulopathy...)
* Be part of another clinical trial that may interfere with the results
Mechanisms of Impaired Brain Blood Flow With Aging

Aging is the primary risk factor for Alzheimer's disease (AD), which is a rapidly growing public health concern. Understanding the mechanisms of normal brain aging may provide insight into the factors linking advancing age to increased risk for AD and thereby lead to new therapeutic targets for preventing or slowing AD progression. Cardiovascular changes, including impaired cerebrovascular function, occur with aging and may increase risk for AD; however, the mechanisms by which cerebrovascular function becomes impaired in older adults are incompletely understood. The overall goal of this project is to examine potential mechanisms of age-related declines in cerebrovascular function in humans. The investigators hypothesize that brain macro-vascular endothelial dysfunction, secondary to oxidative stress, plays an important role in mediating age-related changes in brain blood flow and cerebrovascular reactivity. The results of this pilot study have the potential to identify novel targets of cerebrovascular aging and will help guide the design of future clinical trials aimed at improving cerebral blood flow in older adults.


Eligibility Criteria:
Inclusion Criteria:

* 18-29 or 55-79 years old

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Blood chemistries indicative of abnormal renal, liver, thyroid and adrenal function (i.e., outside of normal reference range); estimated glomerular filtration rate using the MDRD prediction equation must be \>60 ml/min/1.73 m2;
* Abnormal blood chemistry that is clinically relevant or any blood chemistry marker that is +/-2.5x the upper or lower limit;
* Lack of a suitable temporal window for cerebrovascular assessments;
* Current smoking;
* Chronic clinical diseases (e.g., coronary artery, peripheral artery, or cerebrovascular diseases, diabetes, chronic kidney disease, COPD);
* Major psychiatric disorder (e.g. Alzheimer's disease or other form of dementia, schizophrenia, bipolar disorder, major depression within past two years);
* Neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct);
* Current medication use likely to affect CNS functions (e.g. long active benzodiazepines);
* Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders;
* Body mass index (BMI) \>40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes

Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI compared to contemporary cTnI assays.

The primary objective of the study is to determine the performance of a high sensitivity cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic accuracy of type 1 acute myocardial infarction (AMI).

The diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The sensitivity, specificity, positive predictive value and negative predictive value of the hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and potentially age derived 99th percentile upper reference limits (URL).

Investigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and percent changes over time) for their ability to contribute to the negative predictive value and hence potentially lead to an earlier rule out of AMI (improved specificity). Additionally, investigators will assess delta changes of the hs-cTnI assay for their potential contribution to the clinical differentiation of type 1 and type 2 (supply demand mismatch) MIs.

Lastly, investigators will compare the diagnosis of AMI based on the currently used contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the time to diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Two or more cTnI values ordered for any clinical indication with specimen available for hs cTnI assay
* 18 years of age or older
* EKG done on admission / presentation
* Agree to research disclosure

Exclusion Criteria:

* Admission through any venue other an emergency department
* Repeat admission for the same patient, only primary admission will be assessed
* Pregnancy
Objective Assessment of Behavioural Disorders in PD

The aim of this project is to measure behavioural disorders in Parkinson's disease (PD) patients in a more objective way, in order to facilitate the detection of those symptoms and improve the treatment of non-motor symptoms in Parkinson's disease.

Apathy and impulse control disorders (ICDs) are frequent non-motor symptoms of PD and negatively affect the quality of life of patients. Although healthcare professionals have begun to understand the extent of the problem faced by those suffering apathy or ICDs, accurate diagnosis is still difficult, as behavioural symptoms are often multidimensional, develop gradually over the course of months and clinical staff have to rely on the self-report of the patient or the report of a family member to assess them. To overcome this issue, the investigators aim to use information and communication technologies to measure apathy and hyperdopaminergic behaviours in PD patients with STN-DBS in an objective way, with the ultimate goal of improving the management of PD patients with STN-DBS.

To do so, the investigators will use three computer-based tasks that measure effort-based decision making and emotion processing in PD patients, and assess motor, cognitive and neuropsychiatric symptoms in parallel with scales and tests. In some select patients, motor symptoms and activity patterns will be monitored with an in-home sensor system before and after deep brain stimulation STN-DBS, and the above mentioned procedures will be repeated 4 months after STN-DBS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease.
* (Planned) STN-DBS.
* Able to understand instructions and provide informed consent.
* Native speaking or proficient French or German
* Montreal Cognitive Assessment (MoCA) with score ≥ 22
* Ability to manipulate handheld dynamometers

Exclusion Criteria:

* Disease affecting the brain other than Parkinson's disease
* Suffering from or diagnosed with ongoing psychiatric illnesses
* Severe somatic illnesses leading to reduced life expectancy
* Severe physical disability leading to impairment in basic functional activities
* Participation in a pharmacological study
* Inability to provide informed consent (legal guardianship)
An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters

To evaluate and compare the effects on safety measures and clinical chemistry after BLI800 in two groups of patients and one group of healthy controls. The patient groups will be those with mild or moderate hepatic impairment or moderate renal disease.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female adults who are:

  * With Child-Pugh Hepatic Dysfunction Stage A or B, or
  * With Moderate Renal Disease or
  * Healthy subjects matched to those who are enrolled in this study
* Subjects who are considered to have only clinically non-significant conditions, as judged by the Principal Investigator and based on physical examination, laboratory profiles, medical history and ECG.
* Female subjects who are not surgically sterile (i.e., having had a hysterectomy, bilateral oophorectomy or tubal ligation) or who are not at least 2 years naturally postmenopausal must agree to use an acceptable form of contraception.
* Provide voluntary consent in writing to participate in this study.

Exclusion Criteria:

* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects who, in the opinion of the Principal Investigator, have uncontrolled clinically significant pre-existing electrolyte disturbances, based on the Screening visit laboratory results.
* Subjects with present or prior NYHA Functional Classification grade III or IV congestive heart failure.
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
* Subjects with a history of allergic or adverse response to any BLI-800 component.
* Subjects who donated more than one pint of blood within 30 days prior to the study.
* Subjects who donated plasma within 7 days prior to the study.
* Subjects who had an abnormal diet or substantial changes in eating habits within 30 days prior to the start of the study.
* Subjects who have had a bowel cleansing procedure within the past month or who have taken a laxative within the 5 days (120 hours) prior to dosing or who require a laxative every day.
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST)

A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.

Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for \~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. This multi-center, prospective, registry study is designed to analyze the clinical characteristics and prognosis of different molecular subtypes of PTCL. The results can guide future precision therapy for PTCL.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2023 to December 2026 and detected by gene sequencing (NGS) with different molecular subtypes.
* Patients diagnosed with PTCL by histopathology from January 2023 to June 2023 and NGS detection can be performed if there is tumor tissue.
* Informed consented
* Age ≥ 18 years

Exclusion Criteria:

* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Not able to comply to the protocol for mental or other unknown reasons
* Patients with mentally disorders or other reasons unable to fully comply with the study protocol
* Pregnant or lactation
Control of Center of Mass to Predict Balance Ability and Fall Risks in Elderly

Falling among older adults is a major public health concern. In fact, falls are the leading cause of accidental death in older adults both in Taiwan and in the United States. In order to provide effective preventative strategies, the investigators must understand the mechanisms that cause older adults to fall. Thus, the investigators research aim for three objectives: (1) using biomechanical model to identify the deficits in neuromuscular control for older adults (2) to apply research findings to the development of new clinical methods for assessing and recovering balance control in older adults, and (3) to predict fall risks in 1-2 year for older adults from the research findings.


Eligibility Criteria:
Inclusion Criteria:

1. can stand for 5 minutes without support
2. with normal or corrected to normal vision
3. age between 20-35 years old for young adults group, and 65-80 years old for older adults group
4. had fall history in the past 3 years for the older adults group.

Exclusion Criteria:

1. pregnant women
2. with cancer diagnosis
3. with sensory-motor deficits
4. with osteoporosis for older adults group (T-score below -2.5)
Exercise Endurance Time on the 2nd Day at 2500 m High Altitude

The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension

Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Illness Management and Parental Adjustment to Cancer Treatment

The purpose of this study is to test the efficacy of a clinic-based intervention designed to reduce illness uncertainty for parents of children who have been recently diagnosed with cancer.

The proposed trial will test the efficacy of the parent-focused clinic-based Parent Uncertainty Management Intervention (PUMI) to improve the outcomes of children newly diagnosed with cancer and their parents. Participants will be randomly assigned to receive equivalent doses of either the PUMI or an Education/Support (ESO) group. Theoretically driven by Mishel's model of illness uncertainty, the PUMI will teach parents about uncertainty prevention and management through the use of medically-specific communication, information management, and problem-solving skills via in-clinic sessions and an online portal. Parents and children will complete measures online at baseline, 1-week, and 3-, 6-, and 12-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* The child has been diagnosed with leukemia or lymphoma, malignant solid tumor, or malignant brain tumor
* The child is being treated for cancer and returning to the medical center (CCHMC or OUHSC).
* The child is 18 years of age or younger
* Recruitment occurs within 2-12 weeks post diagnosis
* The parent is responsible for care and is willing to give consent and participate
* The child is willing to give assent or consent and participate (only for children 8 years old and older)
* The parent gives patient permission to participate.
* Parent is fluent in English

Exclusion Criteria:

* The child is experiencing an imminent medical crisis necessitating significant medical intervention
* The child with cancer is determined to be in the terminal phase of illness and/or is receiving end of life care
* The diagnosis is determined to be a relapse or a second malignancy
* The parent is currently being treated for a serious psychiatric disorder, or, evidences mental retardation
* The parent is younger than 18 years of age
* The parent is not English speaking
* The parent is unwilling to give written permission for child participation
* If the patient's treatment visit schedule is too infrequent to meet the study visit timeline requirements