cyrilzakka/clinical-trials huggingface dataset:
Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced.

Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit.
2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)

Exclusion Criteria:

1. Presence of central sleep apnea on polysomnography (central AHI ≥ 5)
2. Currently using and adherent to positive airway pressure therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report)
3. Monoamine oxidase inhibitor use
4. Urinary retention
5. Prematurity \< 32 weeks estimated gestational age
6. Seizure disorder
7. Untreated or inadequately treated hypothyroidism
8. Significant traumatic brain injury
9. Congenital heart disease and not cleared to participate by the patient's cardiologist
10. History of current, untreated depression
11. History of liver disease
12. 3+ or greater tonsillar hypertrophy
13. Positive urine pregnancy test
14. Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation \<90%)
15. Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5)

3. Absence of OSA defined as total AHI \<5 on baseline polysomnography
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors

The purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage II/III low- and medium-level rectal cancer with or without high-risk factors


Eligibility Criteria:
Inclusion Criteria:

1. The patient is between 18 and 80 years old;
2. Adenocarcinoma confirmed by pathology;
3. Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin is ≤10cm;
4. ECOG score ≤2

(4) Imaging diagnostic analysis was cT1-3NxM0; (for Phase II/III) (5) CT examination of the chest and abdomen and pelvis showed no evidence of metastasis (6) Patients undergoing chemoradiotherapy and surgery

Exclusion Criteria:

1. History of malignant tumors in the past;
2. Diagnosis of simultaneous multiple primary colorectal cancer or other cancers;
3. History of chemotherapy or radiotherapy prior to this trial
4. Those with contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency;
5. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;
6. Pregnant or lactating women;
7. Evidence of distant metastases prior to surgery
8. T4b tumors were found to invade the uterus, vagina, bladder, seminal vesicles, prostate, bone, and pelvic plexus
Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study

This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.

The clinical data of patients with unresectable solid tumors were collected retrospectively, who received two or more cycles of checkpoint inhibitor therapy. The progression-free survival (PFS), overall survival (OS) and related adverse reactions of the patients were followed up. To screen prognostic factors, develop predictive models and visualize them as nomograms.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old and gender is not limited.
* Patients with unresectable solid tumors confirmed by pathology or histology.
* Patients received checkpoint inhibitor therapy for 2 cycles or more.

Exclusion Criteria:

* Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
* Pre-existing thyroid dysfunction that cannot be maintained within the normal range even with medical treatment.
* Pregnant or breastfeeding women.
* Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
* The investigator judges that other conditions are not suitable for inclusion in the study.
Inhaled GM-CSF for Respiratory Virus-Associated Severe Pneumonia

This study will investigate the safety and efficacy of the administration of inhaled GM-CSF to patients with respiratory virus-associated pneumonia.


Eligibility Criteria:
Inclusion Criteria

Individuals must meet all of the following criteria to be eligible for inclusion in this study:

Male or female Age ≥ 18 years and ≤ 80 years Able to understand and willing to sign a written informed consent document, or if incapacitated, has a designated legal representative who is able to understand and willing to sign a written informed consent document Able and willing to adhere to study visit schedule and study procedures Currently either oro-tracheally or naso-tracheally intubated

Diagnosis of respiratory viral infection determined by:

Polymerase Chain Reaction (PCR)-based Respiratory Virus Panel (RVP) positive for at least one of the following:

Respiratory syncytial virus (RSV) Influenza A/B Parainfluenza 1/2/3 Human Metapneumovirus Adenovirus Rhinovirus

Exclusion criteria Individuals meeting any of the following criteria will be excluded from participating in this study.

Active tracheostomy History of either autoimmune PAP or primary genetic PAP diagnosis History of the presence of histopathologically- or radiographically-documented, clinically significant pulmonary fibrosis History of clinically significant cardiovascular disease including but not limited to Congestive heart failure associated with New York Heart Association (NYHA) Functional Classification of \>1 (i.e., with any degree of symptoms) History of typical or atypical angina within the past 6 months regardless of possible relief by nitrates History of clinically significant coagulopathy, bleeding diathesis, or other hematological disease History of severe allergic or anaphylactic reaction to sargramostim, other yeast-derived products, or any component of the study drug History of any other serious medical condition that, in the opinion of the Principal Investigator, would interfere with the ability of the patient to complete the study Concomitant current or recent prior use of specific medications including Lithium, either active or prior use within two weeks of screening and/or enrollment Active non-steroidal anti-inflammatory drug use, including but not limited to ibuprofen Women who are pregnant (i.e. have a positive serum pregnancy test), intending to become pregnant, breast feeding, or women of child-bearing potential who are unwilling to use contraception or maintain abstinence during the course of the study History of active tobacco/marijuana/e-cigarette use
Human Psychopharmacology of Salvinorin A

This study is characterizing the subject-rated and behavioral effects of salvinorin A in healthy volunteers. The investigators hypothesize the salvinorin A will have hallucinogen-like effects.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Have a high school level of education
* Have a self-reported interest in spirituality and altered states of consciousness
* Have used hallucinogens (e.g., LSD, psilocybin mushrooms, Salvia divinorum) including having used Salvia divinorum or salvinorin A by the inhalation route (i.e., volunteers without histories of Salvia divinorum or salvinorin A use by the inhalation route will be excluded)
* Be 21 to 65 years old
* Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session days.
* Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. As described elsewhere, exceptions include daily use of caffeine.
* Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocarroutine medical blood and urinalysis laboratory tests.

Exclusion Criteria:

General Medical Exclusion Criteria

* Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease
* Epilepsy with history of seizures
* Diabetes mellitus
* Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
* Currently taking psychoactive prescription medication on a regular basis
* More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table

Psychiatric Exclusion Criteria

* Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.
* Current severe Obsessive-Compulsive Disorder, Dysthymic Disorder, or Panic Disorder.
* Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression.
* Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.
* Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to salvinorin A.
Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants

The purpose of this study is to investigate the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs). The investigators also aim at identifying the underlying causes of these preventable ADRs. The endpoint measurements will be compared with a group of patients taking vitamin-K antagonists (VKAs). For this purpose, a protocol for a prospective observational study was developed. The study was approved by the Ethics Committee of the CHU UCL Namur (site Godinne) and the Cliniques Universitaires Saint-Luc. Patients admitted to the emergency department of these two teaching hospitals with a thrombotic or a bleeding event while under DOAC or VKA are included. After a comprehensive medication history, the appropriateness of prescribing is evaluated, using an adapted version of the Medication Appropriateness Index. Causality, severity and preventability of adverse events are assessed by two pharmacists and two hematologists using predefined scales. Second, for cases of serious and preventable ADRs, semi-structured interviews are performed with general practitioners to understand the underlying causes of medication errors. Based on the results, risk-minimization strategies that specifically target the problems encountered in clinical practice will be proposed.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the emergency department
* Presenting a thrombotic or a bleeding event
* Prescribed NOAC (rivaroxaban, dabigatran etexilate or apixaban) or VKA
Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery

This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.

PRIMARY OBJECTIVES:

I. To assess the ability of Cu-64-TP3805 to detect prostate cancer (PC) within the prostate gland, as compared with whole mount step-sectioned surgical pathology of the prostate after radical prostatectomy.

OUTLINE:

Patients receive copper Cu 64 TP3805 intravenously (IV) and undergo PET/computed tomography (CT) at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans.

After completion of study, patients are followed up at 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide signed informed consent and willingness to comply with protocol requirements
2. Biopsy confirmed presence of adenocarcinoma of the prostate gland
3. Have intermediate or high-risk PC as defined by \>= T2b disease, or Gleason score \>= 7 or prostate-specific antigen (PSA) \>= 10 ng/dL
4. Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic)
5. Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection

Exclusion Criteria:

1. Participating would significantly delay the scheduled standard of care therapy
2. Administered a radioisotope within 10 physical half-lives prior to study drug injection
3. Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells

patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion \&prednisolone \& LMWH

patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion begin in the cycle before embryo transfer \&prednisolone begin with the start of lipid emulsion \& LMWH begin with the day of ET

Eligibility Criteria:
Inclusion Criteria:

* patients with high peripheral NK cells \> 10% unexplained infertility cases cases with endometriosis

Exclusion Criteria:

* uterine factors poor responders\< 3 MII oocytes severe male factor \& Azospermia
Determination of Body Awareness and the Functional Movement in Patients With COPD

The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls.

It is aimed at investigating body awareness, and functional movement, and related factors in patients with COPD. The secondary purpose is to determine correlations between body awareness and functional movement, respiratory muscle strength and endurance, daily living activities, posture, and pain threshold in this study. The determination of correlations between functional movement, respiratory pattern, and functional exercise capacity is also purposed. In accordance with these purposes, at least 30 patients with COPD will be included and at least 30 healthy controls will be included. Tests and questionnaires will be used in order to determine the severity of disease. Lung function test and respiratory muscle strength and endurance test will be performed. Six Minute Walk Test will be performed for functional exercise capacity. To evaluate posture, the Corbin Postural Assessment Scale will be used. Pain and pain threshold will be assessed via Visual Analog Scale and an algometer, respectively. Body Awareness Rating Questionnaire will be used for evaluating body awareness. To evaluate daily living activities, Glittre Activities of Daily Living Test will be used. The Functional Movement Screen Test will be used for functional movement analysis. According to the results to be obtained, body awareness and functional movement will be determined in patients with COPD. It will guide professional working in this field.

Eligibility Criteria:
Inclusion Criteria for Chronic Obstructive Pulmonary Disease Group

* Being under 55 years old
* To be literate,
* Having volunteered to participate in the research,
* Stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system,
* Being clinically stable for the last 2 weeks.

Exclusion Criteria for Chronic Obstructive Pulmonary Disease Group

* Having history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery,
* Communication problems,
* Having a severe psychiatric disorder.

Inclusion Criteria for Healthy Control Group

* Not having any cardiopulmonary system disease or chronic systemic disease,
* To be literate,
* Being under 55 years old
* Be willing to participate in the study.
* Not having balance problems, musculoskeletal, neurological and psychiatric disorders that could prevent performing the test procedures.
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men

This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in younger endurance trained and sedentary men, and in older sedentary men.

Adrenocorticotropin (ACTH) secretion is normally exquisitely regulated through endogenous stimulation by corticotrophin-releasing hormone (CRH) and negative feedback inhibition by cortisol, resulting in a circadian rhythm of cortisol. Recent evidence suggests that older men, and younger men who are endurance-trained athletes, both have reduced sensitivity to negative feedback, and perhaps increased basal levels of cortisol and ACTH. To investigate these possibilities, we propose to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in younger endurance trained and sedentary men, and in older sedentary men.

Subjects will collect saliva during two evenings before additional testing, and will on the same evening collect urine for twelve hours, both for cortisol measurements. Blood samples will be collected to evaluate the response to dexamethasone. We also will assess ACTH and cortisol responses to medications that reduce negative inhibition of ACTH. This testing will occur in the evening and will include administration of the glucocorticoid antagonist mifepristone, the mineralocorticoid antagonist spironolactone, and/or a look-alike tablet, on four occasions.

Eligibility Criteria:
* INCLUSION CRITERIA:

Men aged 18 to 30 years of age are required for the young endurance trained and sedentary groups; men aged 65-80 years for the older study group, who will meet criteria for sedentary men below. Women and children are excluded to enhance homogeneity of responses and avoid the influence of menstrual cyclicity on the HPA axis.

Sedentary:

* Less than one hour physical activity per week for three years
* No change in exercise anticipated for 6 weeks

Trained:

* Greater than 45km (28 miles) running per week for at least 3 months
* No change in exercise anticipated for 6 weeks

For all participants:

* All races
* Sleep-wake cycle with sleeping at night, wakening between 5 and 8 AM
* BMI between 18 and 25 kg/M2
* Normal TSH and free T4

EXCLUSION CRITERIA:

For all participants:

* Sleep disorders as assessed by sleep apnea questionnaire
* Smoking
* No more than 2 servings of alcohol daily
* Medications known to affect the HPA axis or steroid metabolism, including narcotics, Glucocorticoids, megace or CYP3A4 modulators
* History of psychiatric or endocrine disorders
* Marijuana or other illicit drug use
* Recent appendicular or skeletal injury
* Uncontrolled hypertension
* Chronic pain requiring daily medication
* Current treatment with medications related to mineralocorticoid function such as potassium, ACE-inhibitors, ARBs, diuretics, spironolactone
* Frailty score of 4-7 on the Canadian Study of Health and Aging frailty scale (Rockman 2005)
* Overtraining syndrome will be an exclusion and will be assessed by questionnaire
* Abnormal creatinine level (greater than 1.2 mg/dl)
* Liver function tests greater than two fold normal
* Benzodiazepine use
Trial on the Effect of E-cigarette Advertising on Cigarette Perceptions in Adolescents

This research aims to investigate how exposure to advertising for Electronic Nicotine Delivery Systems (commonly called e-cigarettes) may lead to combustible smoking initiation in adolescents.

\[3/14/2020\]: Study recruitment temporarily halted due to the COVID-19 pandemic

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Exclusion criteria will include inadequate English proficiency, and diagnosis of a learning or vision disorder.
Nursing Practice Environment and Patient Safety in Primary Health Care

The goal of this study is to conduct an experimental, controlled, and randomized study, which will involve two data collection points - pre-intervention, post-intervention and a follow-up to asses the impact of the program. The study will be carried out with two groups - an intervention group and a control group, consisting of nurses interested in participating in the Positive Nursing Practice Environments Promotion Program (PAPEP), a multi-component intervention program aimed at promoting positive nursing practice environments. Participant allocation will be conducted randomly, using software to ensure stratified randomization of participants between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Nurses working in primary health care units

Exclusion Criteria:

* Nurses in primary health care who refuse to participate in the study