cyrilzakka/clinical-trials huggingface dataset:
Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure

Continuous positive airway pressure (CPAP) is the gold-standard treatment for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing in the overall population. CPAP has shown to be effective in reducing apnoea-hypopnoea index (AHI) as well as other OSA polysomnographic outcomes. However, the effectiveness of this device on OSA daily functioning and mood disturbances outcomes still remains unclear. The ADIPOSA study is aimed at determining the effects of three-month CPAP use on anxiety-depression symptoms in patients with OSA. Participants will be adults previously diagnosed with OSA who will be allocated to a CPAP-treatment group. Outcomes will be measured at baseline and intervention end-point (three months) including daytime sleepiness, daily functioning and mood (anxiety and depression symptoms), AHI, other neurophysical and cardiorespiratory polysomnographic outcomes, and body weight. ADIPOSA may serve to establish the effectiveness of CPAP on daytime functioning and mood disturbances commonly found on patients with OSA and, in turn, on other OSA outcomes related to anxiety-depression symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Previous clinical diagnosis of mild/moderate/severe OSA (AHI \> 5) by a healthcare professional
* Use of CPAP
* Motivation to participate in the study
* Willing to provide informed consent

Exclusion Criteria:

* Presence of any other primary sleep disorder
* Presence of any mental disorder (including depression, anxiety, and addiction to alcohol or other substances)
* Presence of any other severe organic disease, except for those comorbid to OSA
A Non-invasive Device to Remove Fluid From the Middle Ear

A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation.

The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum.
* In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).

Exclusion Criteria:

* First encounter: acute ear infection or Proper Otoscopy
* Second session: First review: Otoscopy / Timpneometry / Hearing test.
* Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

* Primary endpoint to assess progression-free survival
* Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
* Positive EGFR Mutation.
* No previous systemic anticancer therapy.
* Male and female patients aged over 70 years.
* Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
* Provision of written informed consent.

Exclusion Criteria:

* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented

A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Male and female subjects aged 18 years or older at Screening (18 subjects must be 65 years or older).
* Woman of childbearing potential (WoCBP) who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose. She must agree to use consistently and correctly (from Screening, during the entire study, and for at least 5-7 days after last study treatment administration) an acceptable method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated 1 month before first treatment administration.
* Woman of non-childbearing potential, i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone \[FSH\] test), with previous bilateral salpingectomy, bilateral-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.
* Body mass index (BMI) of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
* Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the study requirements.

Exclusion Criteria:

* Known hypersensitivity to daridorexant, or treatments of the same class, or any of its excipients.
* Any known factor or disease (e.g., unstable medical condition, significant medical disorder, or acute illness) that might interfere with subject's safety, study conduct, or interpretation of the results, such as

  * History of narcolepsy.
  * Shift work within 2 weeks prior to Screening, or planned shift work during the study.
  * Travel across 3 or more time zones within 1 week prior to Screening, or planned travel across 3 or more time zones during the study.
* Previous (i.e., within 2 weeks prior to first study treatment administration) and ongoing treatment with any prescribed central nervous system (CNS)-active medications, and/or diuretics that would affect nighttime rest, and/or moderate to strong cytochromes P450(CYP)3A4 inhibitors or inducers.
Noninvasive Intracranial Pressure and Hydrocephalus Patients

Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus are typically treated with a shunt in order to reduce ICP. At times the shunt can malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's shunt has malfunctioned.

A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art machine learning techniques can be leveraged to develop an algorithm that noninvasively estimates intracranial pressure. The resulting algorithm will accurately determine the presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 31 days - 35 years
2. Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency Department or on an inpatient service
3. Either hydrocephalus patients with a VP shunt in place (with or without suspicion of VP shunt malfunction), or patients with no known intracranial pathology.

Exclusion Criteria:

1. Pregnant patients
2. Incarcerated patients
3. Patients who object at any time to participating in the study.
Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer

The purpose of this trial is to determine whether the addition of systematic pelvic lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II endometrial cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven endometrioid or adenosquamous endometrial carcinoma.
* Patients having myometrial invasion
* Age =/\< 75 years
* Informed consent.

Exclusion Criteria:

* Serous papillary and clear cell tumors.
* Karnofsky index \< 80 or severe diseases contraindicating surgery
* Concomitant neoplasia (basalioma cutis excluded)
* Distant metastasis or abdominal metastasis detected intraoperatively.
* Absence of myometrial invasion at frozen section.
Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)

Patients who participated in the previous trial 28130, who were eligible, were entered into this trial. Patients who were randomized to placebo in the previous trial 28130 continued on placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose, were titrated to 900 mg Org 34517. Patients in this trial took their study medication for 2 weeks in order to study the safety and tolerability of Org 34517.


Eligibility Criteria:
Inclusion Criteria:

* have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of previous trial 28130;
* have a CGI of Severity score of 3 or greater at Day 43 of previous trial 28130 and at Day 1 of current trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted;
* be on a stable dose of 'usual treatment', which must consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes.

Exclusion Criteria:

* had experienced any of the following significant safety outcomes in previous trial 28130:

  * severe breakthrough bleeding;
  * diagnosis of prostatitis;
  * abnormal level of testosterone at Day 15 of previous trial 28130;
  * any adverse event deemed relevant for exclusion in trial 28133 by the investigator.
* had an abnormal PSA test at Day -7 of previous trial 28133
* were at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST at Day -7 or Day 1;
* were currently treated with carbamazepine or valproate, midazolam, or clozapine;
* had been treated with electroconvulsive therapy (ECT) in the current episode;
* were currently treated with more than one antidepressant, antipsychotic, or mood stabilizer;
* had 'usual treatment' started or discontinued in the 2 weeks before Day 1;
* had a 'usual treatment' dose change within one week prior to Day 1;
* had any clinically unstable or uncontrollable renal, hepatic, respiratory, hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy;
* had known hypersensitivity reactions to glucocorticoid antagonists;
* had any clinically significant abnormal laboratory data (e.g. aspartate amino transferase (ASAT) and/or alanine amino transferase (ALAT) values \> 2x normal range upper limit) or ECG results, or a clinically significant abnormal outcome at the physical examination at Day -7;
* had a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Day -7;
* had any untreated or uncompensated clinically significant endocrine disorder;
* were using hormone replacement therapy at Day -7;
* required concomitant treatment with corticosteroids (topical use was allowed);
* women of childbearing potential without adequate contraception
* women with a positive pregnancy test at Day -7 or 1, or are breast feeding mothers.
The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents

The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents


Eligibility Criteria:
Inclusion Criteria:

1. Age≤18 years old, gender no limited.
2. Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
3. Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
4. Previously not received radiotherapy.
5. Karnofsky Performance Scores ( KPS)≥60.
6. The expected survival time was \>3 months.
7. Neutropenia or agranulocytosis, no bleeding tendency.
8. No significant cardiac dysfunction or metabolic disease.
9. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \< 2.5×ULN（upper limit of normal）.
10. BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）\<1.5×ULN.
11. Written informed consent are acquired.

Exclusion Criteria:

1. With a history of systemic radiotherapy.
2. Infection difficult to control, the body temperature ≥ 38℃.
3. Other situation that investigators consider as contra-indication for this study.
NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 18 years of age or older on the date of informed consent.
* Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent.

Exclusion Criteria:

* Subjects who are unable to tolerate ophthalmic imaging.
* Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images.
* Subjects who cannot follow instructions to complete the required testing.
Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.


Eligibility Criteria:
Inclusion Criteria:

* The patient has read and agree to the consent
* Patient is 16 years or older (bones have finished growing)
* The injury happened in the last 14 days

Exclusion Criteria:

* The patient taking part in another study
* The patient has an infection at the operative site
* The patient has a health condition that affects bone healing or interferes with their ability to complete the study requirements (questionnaires, examinations), for example Paget's disease or osteomalacia
* The patient is taking medication that affects bone healing (such as systemic steroids)
* The patient has malignant (tumor) disease
* The patient is unable to attend follow-up clinic visits
Type 1 Diabetes Education and Support Study

Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

This research focuses on the unique needs of Black young adults aged 18-30 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population.

The specific aims for this study are to:

Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed \> 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team.

Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (\>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months post-baseline among participants randomized to T1DES compared to the diabetes education-only control condition.

The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.

Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente Georgia Member
* Aged 18 - 30 years
* Confirmed diagnosis of Type 1 diabetes
* Hemoglobin A1c \> 7.5 at time of enrollment
* a cell phone able to send/receive text messages
* Self-reported race of Black or African American
* Ability to read in English and provide informed consent

Exclusion Criteria:

* Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent
* Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
* Diabetes complications that would preclude participation in the study
Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder

The purpose of this study is to provide participants diagnosed with obsessive compulsive disorder (OCD) and completed one of the active study protocols at the Rodriguez Lab, with open/aftercare treatment.

After completing one of the active clinical studies participants have the option to enroll in this protocol that offers open treatment.

The goal is to compare two forms of current standard treatments, psychotherapy vs pharmacotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to speak and understand English
2. Capacity to consent (e.g. as determined by assessing the patient's understanding of the risks, benefits, and procedures of the study)
3. Completed an active study protocol at the Rodriguez Lab at Stanford University

Exclusion Criteria:

1. Children younger than 18
2. Active suicidality
Modafinil in Opioid Induced Sedation

* The primary objective of this study is to evaluate the efficacy of modafinil in the treatment of opioid induced sedation as measured by the Epworth Sleepiness Scale (ESS).
* The secondary objective is to estimate the frequency and severity of toxicity associated with Modafinil (400mg) in patients with opioid induced sedation.

Sedation is a common side effect of opioid analgesics. In patients where this remains a dose limiting toxicity, stimulants (caffeine, methylphenidate, ephedrine, amphetamine) have been the primary class of agents used to counteract sedation. Modafinil is a novel stimulant that is FDA approved for the treatment of narcolepsy and has a very different side effect profile than traditional stimulants. The potential role of this agent in the treatment of opioid induced sedation remains undefined. This study, which utilizes a prospective, randomized, blinded, cross-over design, will collect daily information on sedation (Epworth Sleepiness Scale), pain, opioid consumption, and adverse effects in 90 patients suffering from opioid induced sedation within the Johns Hopkins Medical Institutions.

Eligibility Criteria:
Inclusion Criteria:

* Epworth Sleepiness Scale \> 10
* Etiology of sleepiness is attributed only to opioids
* Patient must have been taking an opioid for more than 2 weeks or have been on a non-escalating dose of opioids for at least 1 week
* Patient must be able to give written informed consent
* Age \>18 years

Exclusion Criteria:

* Hypersensitivity to modafinil
* Mini-Mental Status Exam (MMSE) \< 25/30
* Renal impairment (calculated creatinine clearance \< 40)
* Hepatic dysfunction (total bilirubin \> 1.8, AST \> 75IU/l, ALT \> 100IU/l, prothrombin time \> 40%
* Known history of cardiovascular disease (i.e., left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, mitral valve prolapse, recent myocardial infarction, unstable angina, uncontrolled hypertension)
* Woman who are pregnant, breast-feeding or on hormonal contraception
* Patients taking tricyclic antidepressants, CNS stimulants, hormonal contraceptives or drugs that are inhibitors or inducers of CYP 3A4
Alveolar Cleft Reconstruction With Cortical-Shells

The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.

The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
2. good oral hygiene and general good health

Exclusion Criteria:

1. The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
2. Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
3. A history of previous failed alveolar cleft reconstruction.
Clinical and Instrumental Evaluation of Swallowing in Children With Cerebral Palsy

The purpose of this study is to correlate the alimentary consistencies and deglutition disorders in children with cerebral palsy.

Cross-sectional and quantitative study with sample consisted of 50 children with cerebral palsy. The data collection consisted in detection of the main dysphagic manifestations in different consistency of food and types of cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Children with Cerebral Palsy diagnoses were involved, independent from the pre, peri and postnatal factors and from the type of Cerebral Palsy

Exclusion Criteria:

* Children who presented oropharyngelarynx structural abnormality and/or impossibility to feed by oral way