cyrilzakka/clinical-trials huggingface dataset:
Spanish Registry of Patients with Sleep Apnea and Daytime Sleepiness

Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.

OSA patients will be evaluated at baseline, 6, 12, and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients who come to the sleep consultation for sleep study results for suspected OSA.
* Patients older than 18 years.
* Signature of the informed consent.

Exclusion Criteria:

* Psycho-physical inability to complete questionnaires.
* Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h/day), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome.
* Patients with \> 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp).
* A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions.
* Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g/day in men and more than 60 gr / day in women), absence of stable habitual residence, disorientation or non-compliance history).
* Any process, cardiovascular or not, that limits life expectancy to less than one year.
Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control

This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.

Orthokeratology (ortho-K) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. There is a need to identify the patients that could benefit most from this treatment. In order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. In addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of Orthokeratology among different individual patients in China.

Eligibility Criteria:
Inclusion Criteria:

* -6.0D≤SER≤-0.5D
* Astigmatism≤2.0D

Exclusion Criteria:

* Contraindications of wearing Ortho-K.
* Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
* Currently involved in other clinical studies.
Which is Better Between Single Chest Tube and Multiple Tubes Drainage in Primary Spontaneous Pneumothorax

There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis. After routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes

Primary spontaneous pneumothorax (PSP) occurs after the rupture of small bullae or a subpleural bleb in otherwise normal lungs. The indications for surgical treatment include persistent air leak after intercostal tube drainage, recurrent PSP, and contralateral PSP. The video-assisted thoracoscopic surgery (VATS) approach probably represents the treatment of choice for PSP.

The presence of a residual pleural space after surgery may be a factor associated with increased risk of recurrence. One possible hypothesis to explain the association between residual pleural space and recurrence of pneumothorax may be the failed pleurodesis due to lack of pleura-pleura apposition. Multiple chest tubes are effective in clinical practice, but there was no convinctive evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis. This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis.After routine procedure the participants will randomized to either placed multiple chest tubes or single chest tube.

The recurrence of the two group and other postoperative clinical parameters will be observed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax
* Underwent bullectomy and pleurodesis
* Postoperative indwelling chest tubes

Exclusion Criteria:

* Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax
* Previous surgery history
* People with severe comorbidities
Educational Intervention for Sleep Hygiene Nursing in Adolescents

There is an urgent need to influence the knowledge and beliefs associated with sleep (TV viewing, use of electronic devices, sedentary activity...) of school children through holistic interventions involving students, parents, teachers and other professionals in the education sector that can positively influence education. The project's main objective is to determine the acceptability and effectiveness of a school intervention consisting of counselling by family and community nurses. The methodological approach is Participatory Action Research (PAR), developed in three phases: exploratory, intervention, and evaluation. In the exploratory phase, which corresponds to a research study with a qualitative (focus groups and content analysis) and quantitative (questionnaires) approach, the study subjects will be students in the second year of secondary education in five schools in southern Spain (city and province), as well as parents and teachers. Sampling will be probabilistic. Following the action research cycle, the results of the exploration phase will be shared with all participants and will be considered for the intervention phase. This phase will aim to conceptualise/implement a sleep hygiene programme. It will take into account key aspects such as (i) health education, (ii) sleep hygiene, (iii) breathing control to facilitate sleep, (iv) sleep restriction, and (v) stimulus control. The programme will be implemented during 12 sessions of 30 minutes (intensive phase: 1 session/week for 3 weeks; maintenance phase: 1 session every 2 weeks) and will focus on cognitive-behavioural counselling. The intervention will be applied to the referred students from the participating schools. For this phase, the data analysis will be quantitative (pre-post intervention). The evaluation phase will occur 6 and 12 months after the intervention, with the same methodological approach as in the exploratory phase (quantitative and qualitative).


Eligibility Criteria:
Inclusion Criteria:

* All schoolchildren aged between 13-16 years who provide signed consent and participation by their parents/legal guardian.
* Schoolchildren taking medication that interferes with the sleep/wakefulness pattern or presenting pathologies that alter the sleep pattern (respiratory, digestive...) will also be considered.
* Family members of schoolchildren and teaching staff who agree to participate in the study will be included.

Exclusion Criteria:

* Failure to sign the informed consent and participation form
Incidence and Prognostic Value of Delirium in Patients With Acute Coronary Syndromes

The Purpose of this study is to evaluate the incidence of delirium in patients with acute coronary syndromes admitted to a Intensive Care Unit Patients.

The present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and prognostic significance of delirium in elderly patients with acute coronary syndromes

Eligibility Criteria:
Inclusion Criteria:

* Admission in Cardiac Intensive Care Unit
* Age ≥ 65 years

Exclusion Criteria:

* none
A Study to Validate Treadmill Parameters

The purpose of this study is to evaluate the accuracy with which a microprocessor-controlled treadmill delivers controlled postural disturbances.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with no medical conditions or previous injuries, trauma, or surgeries that reduce your balance, mobility or strength.
* Able to follow simple directions.
* Willingness to participate in the study.
* No restriction will be placed on gender, race, or ethnicity.

Exclusion Criteria:

* Current or chronic pain in your shoulders, elbows, hips, knees, ankles, feet, neck or back.
* Use of assistive device such as walker or cane.
Strength Training and Muscle Lipids

The purpose of this study is examine the effects of 8 weeks (3 days/week) of resistance exercise training in children 8 to 10 years of age on muscle strength and power, motor unit activation, and lipid profiles of the vastus lateralis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer males and females ages 8 - 10 years.

Exclusion Criteria:

* No history or ongoing neuromuscular diseases.
* No history or ongoing musculoskeletal injuries.
* No history or ongoing disease that effects metabolism.
Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients

The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis.

The Transanal Transection and Single-Stapled anastomosis (TTSS) technique has become a valid alternative to the standard double-stapled anastomosis approach in the surgical treatment of low rectal cancer. Recent evidence showed a significantly reduced number of anastomotic leaks in patients undergoing TTSS compared with patients receiving double-stapled anastomosis, suggesting that TTSS may be technically feasible and may provide a surgical advantage over the traditional double-stapled technique. However, these studies were severely limited by their single-center and retrospective nature. This study aims to confirm the retrospective findings by extending the data collection to additional countries and provide prospective data collection.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old) patients, men and women, diagnosed with rectal cancer scheduled for elective rectal resection with Total Mesorectal Excision (TME) with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS) approaches.
* Patients scheduled for open, laparoscopic, or robotic surgery.
* Patients preoperatively indicated for sphincter-saving procedures with or without protective-stoma.

Exclusion Criteria:

* Immediate or delayed hand-sewn coloanal anastomosis.
* Patients requiring abdominoperineal resection (APR). Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.
* Patients with concurrent or previous invasive pelvic malignant tumors. Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.
Investigations on Differences in Atorvastatin Metabolites Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

The primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse events, to elucidate whether differences in this ratio might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity.

The primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse events, to elucidate whether differences in this ratio might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. If this is shown, measurements of atorvastatin metabolites from patients experiencing muscle adverse events might be a valuable diagnostic tool to diagnose myopathy associated with statin treatment. The primary endpoint cut off level for present myotoxicity has been set to a ratio of p-hydroxyatorvastatin /atorvastatin of 0.15 from the previously performed pilot study (Unpublished data, Herman M et al). Values at or above this ratio will be considered as clinical significant indicia of statin related myopathy.

Secondary objectives include descriptively investigation of drug to metabolite cut off ratio for atorvastatin lactone/atorvastatin. Whether other cut off values, both for p-hydroxyatorvastatin as well as for atorvastatin lactone, give more precise identification of patients that are experiencing statin related myopathy compared to controls will also be investigated.

Explorative objectives of the study are to investigate possible in vitro phenotypic differences in isolated muscle cells from patients experiencing muscle toxicity compared to patients not experiencing muscle toxicity. If there are genetic differences between patients experiencing myotoxicity and those not, this difference is likely to show as phenotypic differences in in vitro studies of isolated muscle cells. If such phenotypic differences are present in vitro possible mechanistic causes will be further investigated.

Eligibility Criteria:
Inclusion Criteria:

* Suspected atorvastatin induced muscle adverse events.
* Signed informed consent.
* 18 years of age or older.
* Able to donate blood samples.
Efficacy and Safety of Trabecular Meshwork Microstent Drainage System ( MicroCOGO )

It is a prospective, multicenter, randomized, open label, parallel controlled, superiority clinical trial that evaluate efficacy and safety of Trabecular Meshwork Microstent Drainage System in Reducing Intraocular Pressure in Adult Patients With Mild to Moderate Open-angle Glaucoma Combined With Cataract.

The trial is a prospective, multicenter, randomized, open label, parallel controlled, superiority study. Eligible subjects will be randomly assigned to either test group or control group for treatment. The trial is divided into four research stages, with each subject expected to participate for maximum 14 months. The entire research phase includes:

Screening visit (V1, -60\~-1 day). Baseline visit (V2). Randomization and surgery (V3): The subjects will be randomly assigned in 2:1 ratio to either test group (phacoemulsification with implantation of IOL combined with implantation of trabecular meshwork microstent drainage system) or control group (phacoemulsification with implantation of IOL only).

Follow-up visits (V4 \~ V10): different time points after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male of female, age 18 years or older
* Mild to moderate open-angle glaucoma
* Cataract
* Average of IOP is less than or equal to 24mmHg with 1-3 drugs in the screening period
* All 3 diurnal IOPs after drug-eluting are greater than 21mmHg and less than or equal to 35mmHg, average of diurnal IOPs is at least 3.0mmHg higher than the pre drug-eluting IOP
* Cup to disc ratio (C/D) less than or equal to 0.8, or VFI greater than 75%
* Gonioscope shows that anterior chamber angle is open

Exclusion Criteria:

* Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders
* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma
Pain Evaluation and Treatment in the Emergency Department

All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. At the end of the triage process the triage nurse has to choose an emergency level and a main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain evaluation for 44 out of the SETS 98 presenting complaint.

The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria. The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.

All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. At the end of the triage process the triage nurse has to choose an emergency level and a main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain evaluation for 44 out of the SETS 98 presenting complaint.

After this evaluation, a protocol standardize administration of analgesia for patients presenting pain.

The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria for the 44 presenting complaints.

The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.

Eligibility Criteria:
Inclusion Criteria:

* adult (\>= 16y) patients admitted at GUH ED during one year
* presenting complaint requiring pain evaluation accordingly to the SETS criteria

Exclusion Criteria:

* \< 16 y
* presenting complaint that does not require a pain evaluation accordingly to the SETS criteria
Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.


Eligibility Criteria:
Inclusion Criteria:

Histologically proven adenocarcinoma of the prostate.

* Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
* Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
* Gleason score ≤ 7
* No evidence of distant metastasis
* Age 18+
* Informed consent signed in accordance with institutional protocol
* Pretreatment evaluations must be completed as specified in Section 7.0.
* ECOG performance status 0-1
* No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
* No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
* No previous or concurrent cytotoxic chemotherapy
* No radical surgery or cryosurgery for prostate cancer
* The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
* The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
* No current use of anticoagulation therapy, other than aspirin.
Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings

This study will assess the efficacy and mechanisms behind Energy Medicine in reducing chronic knee pain within an outpatient setting. This study will investigate a form of Energy Medicine (EM) performed by a natural solo practitioner, using a standard number of three sessions, which will compare to both positive and negative control groups. The positive control group will receive acupuncture and the negative control group will receive a sham intervention.


Eligibility Criteria:
Inclusion Criteria:

* Presence of knee pain lasting for at least six months
* No radiation of knee pain
* No acupuncture treatments in the previous six months
* Failure to respond completely to the medications given by their orthopedic or pain management specialist
* Knee pain on most days (4 out of 7 days of the week) with average self-reported severity of 4 or more out of 10 on a numeric rating scale (NRS)
* Complaints of morning stiffness lasting less than 30 minutes
* Not be in active physical therapy (PT) for the duration of the trial.
* Adult patients ≥18 years of age
* English speaking

Exclusion Criteria:

* Any concurrent diagnosis of systemic disease
* Other concurrent treatments such as massage, Acupcunture, PT or any kind of Energy Medicine
* Bleeding disorder
* Trypanophobia (fear of needles or injections).
* Have medical condition that causes difficulty in saliva production/collection (i.e.: Sjogren's Syndrome)
A Novel Multiplex ELISA Assay for Surveilling Patients with History of Bladder Cancer

Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.


Eligibility Criteria:
Inclusion Criteria

Participants must be:

* Age 18 years or older
* Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
* Participants may be treated with adjuvant intravesical therapy
* Willing and able to give written informed consent (see Appendix 1)
* Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

Exclusion Criteria:

Participants must not:

* Have had radical cystectomy
* History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years
* Have a known active urinary tract infection or urinary retention
* Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 60 days before consent, otherwise repeat.
* Have ureteral stents, nephrostomy tubes or bowel interposition
* Have recent genitourinary instrumentation (within 10 days prior to signing consent)
* Be unable or unwilling to complete the surveillance regimen