cyrilzakka/clinical-trials huggingface dataset:
An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators use the "tennis ball technique" where a tennis ball is fastened in the back of the night shirt in order to help patients compliance in avoiding the supine sleeping position. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to sleep two nights with the positioning measuring device, one night with a tennis ball in the back of the night shirt and one night without. Hereby the investigators search new knowledge concerning patients compliance and verification of the "tennis ball technique".


Eligibility Criteria:
Inclusion Criteria:

* Pars plana vitrectomy for macular hole, vitreomacular traction or epiretinal membrane where intra ocular gas tamponade is used.
* Informed consent

Exclusion Criteria:

* Age less than 18 years
Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients

Febrile neutropenia is a common complication in pediatric oncology patients. Standard of care requires admission of all patients for intravenous antibiotics until cultures are negative, patients are afebrile and there are signs of bone marrow recovery. This often results in prolonged hospital admissions with significant financial costs, decreased quality of life and potential secondary infections. More recent data suggests it may be possible to identify a "low risk" group that can be discharged prior to signs of bone marrow recovery. At this time, researchers have been unable to identify a model that is safe for early discharge across institutions.

1. Conduct a pilot study to determine the feasibility of using the Karius Assay to risk stratify pediatric oncology patients admitted with febrile neutropenia. This will provide preliminary data for a larger study which would randomize patients to early discharge vs. usual care.
2. Evaluate the Klaasen and SPOG clinical decision rules with and without the Karius Assay to predict patients at low risk for adverse infectious outcomes during admission. Adverse infectious outcome will be defined as: positive blood or urine culture, radiographic evidence of infection, admission to the intensive care unit or death.
3. Model potential cost savings of early discharge for patients deemed low risk for an adverse infectious outcome.

Eligibility Criteria:
Inclusion Criteria:

1) Pediatric oncology patients, aged 1-22, treated at Lucile Packard Children's Hospital (LPCH)

Exclusion Criteria:

1. Relapsed disease
2. Acute lymphoblastic leukemia during induction
3. Acute myeloid leukemia during any phase of treatment
4. Philadelphia-chromosome positive ALL
5. Down syndrome
6. Patients who have received an allogeneic stem cell transplant.
Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters

Literature regarding effects of goiter on the occurrence of obstructive sleep apnea (OSA) remains scarce. Reports have described cases of OSA in patients suffering from goiters, resolved after thyroidectomy.

It has been recently shown that goiters of a total volume exceeding 25 mL leads to \>30% tracheal compression.

The aims of the present study is to assess 1) the prevalence of OSA in patients suffering from goiters and planned for thyroidectomy 2) the role of thyroidectomy in OSA resolution in patients suffering from pre-operative OSA 3) the identification of predictors for persisting OSA.

Introduction

Literature regarding effects of goiter on the occurrence of obstructive sleep apnea (OSA) remains scarce. Reports have described cases of OSA in patients suffering from goiters, resolved after thyroidectomy.

It has been recently shown that goiters of a total volume exceeding 25 mL leads to \>30% tracheal compression.

The aims of the present study is to assess 1) the prevalence of OSA in patients suffering from goiters and planned for partial/total thyroidectomy 2) the role of thyroidectomy in OSA resolution in patients suffering from pre-operative OSA 3) the identification of predictors for persisting OSA.

Methods

Design Prospective study Settings Tertiary referral center, university hospital Patients Patients referred for partial/total thyroidectomy for goiter Baseline assessment All patients planned for thyroidectomy will be prospectively included. Exclusion criteria will be: previous cervical surgery/radiotherapy, language barrier, chest disease known to narrow upper airways.

Patient will be assessed by home Polysomnography(PSG), one night, Pulmonary function tests, including respiratory muscle strength, and comprehensive biological assessment of thyroid function.

Follow up Three months after thyroidectomy, the same assessment will be repeated.

Statistical analysis

Statistical analysis will be performed to determine the percentage of patients suffering from OSA before surgery (apnea-hypopnea index (AHI) \>5/hour of sleep on PSG). As the aim of the present study is to assess the role of thyroidectomy in OSA resolution, we will compare pre- and post-thyroidectomy PSG results in patients exhibiting AHI \>5/hour of sleep (chi square test). OSA resolution will be defined as decrease in AHI \> 50 % or reduction of AHI \<5hour of sleep. As one of the secondary aim is the identification of predictors for persisting OSA, multivariate analysis will be performed to assess factors of persisting OSA, among age, neck circumference, body mass index, sex, pre/post menopausal status and pulmonary function tests parameters.

Eligibility Criteria:
Inclusion Criteria:

°patients planned for thyroidectomy for goiter

Exclusion Criteria:

* previous cervical surgery/radiotherapy
* language barrier
* chest disease known to narrow upper airways
Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE)

The aim of this study of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT)


Eligibility Criteria:
Inclusion Criteria:

* Class3 Patients suffering maxillary collapse with a skeletal background
* Patients with retrognathic maxilla.
* Patients with anterior cross-bite or incisor end-to-end relationship
* Patients with unilateral or bilateral posterior crossbite.
* Patients with no periodontal disease.
* Patients with good oral hygiene and general health.
* No systemic diseases that may affect bone quality or interfere with orthodontic treatment.
* Patients with no previous orthodontic treatment.

Exclusion Criteria:

* previous orthodontic treatment.
* Craniofacial syndrome.
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients

Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 to ≤ 45 years of age upon entry into screening
* History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
* Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening

Exclusion Criteria:

* History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
* ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period
* Other headache disorders (except for episodic tension-type headache \<5 days/month)
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
* no previous systemic chemotherapy, radiation therapy or immunotherapy;
* Eastern Cooperative Oncology Group (ECOG) \>=2.

Exclusion Criteria:

* prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
* active, non-controlled systemic disease;
* any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).
Study Effect of Red Wine Consumption on Endothelial Progenitor Cells and Endothelial Function

Light-to-moderate alcohol consumption has been associated with a reduction of cardiovascular events, and red wine seems to offer more benefits than any other type of alcoholic beverages. However, the relationship between red wine consumption and endothelial progenitor cells (EPCs) remains unclear. The investigators examine whether intake of red wine could enhance the number or functional capacity of circulating EPCs by upregulation of nitric oxide (NO) bioavailability.

Moderate ethanol intake from any type of beverage has been shown to improve lipoprotein metabolism and lower cardiovascular mortality risk, but red wine, with its abundant antioxidant contents, seems to confer additional healthy benefits. Previous studies indicated that the beneficial effects of red wine are derived from increased endothelium-derived nitric oxide (NO), implying that enhanced NO bioavailability may mediate the cardiovascular protection provided by red wine.

Increasing evidence suggests that the injured endothelial monolayer is regenerated partly by circulating bone marrow derived-endothelial progenitor cells (EPCs), which accelerate reendothelialization and protect against the initiation and progression of atherosclerosis. Clinical studies demonstrated that the number of circulating EPCs predicts the occurrence of cardiovascular events and death from cardiovascular causes and may help to identify patients at increased cardiovascular risk. Although many epidemiologic studies have indicated that light-to-moderate consumption of red wine can reduce the incidence of CAD, the multifarious effects of red wine on circulating EPCs and endothelial function remain to be determined. Therefore, we design this study to test the hypothesis that intake of red wine can enhance the number and functional capacity of EPCs through increasing NO bioavailability.

Eligibility Criteria:
Inclusion Criteria:

* Forty young healthy subjects with no cardiovascular risk factors

Exclusion Criteria:

* History of hypertension
* Diabetes mellitus
* Symptoms of CAD
* Smoking
* Chronic renal insufficiency (serum creatinine \> 1.5 mg/dl)
* Inflammatory or liver diseases
* Regular alcohol consumption (drinking more than 20 g of ethanol per week)
Plant Stanol Esters and Influenza Vaccination

Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, recent studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI and age have previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming plant stanols prior to receiving the influenza vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 60 years or older (or 59, but turning 60 years during influenza season 2022/2023 (in line with RIVM guidelines))
* BMI between 20 and 35 kg/m2
* Currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to keep the intake of fish oil and vitamin supplements constant

Exclusion Criteria:

* Already received influenza vaccination in 2022
* Already had influenza in 2022
* Allergy to an ingredient of the chews
* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
* Excessive alcohol use (\>20 consumptions per week)
* Regular use of soft and/or hard drugs
Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

Clinical Study Objective:

To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency

Study Method:

Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. Adverse drug reaction will be confirmed during 24 weeks after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 19 or older
* Diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants
* No improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
* BCVA 20/40 or less at screening in the eye with the limbal stem cell deficiency
* Voluntarily agreed to participate in this study and signed a consent form

Exclusion Criteria:

* Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
* Difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
* Severe dry eye with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia \< 2 mm/5 min at screening)
* Acute ocular surface inflammation of both corneas at Visit 2
* Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
* Uncontrolled comorbidities such as moderate to severe infections and bleeding
* Positive for virus infection (HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, syphilis)
* Uncontrolled diabetes (HbA1c ≥9.0%)
* Uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg despite taking antihypertensives at screening)
* Uncontrolled glaucoma (IOP \> 21 mmHg despite taking glaucoma medication)
* Pregnant or lactating women
* Women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials
* Participation in another clinical study within 4 weeks
* Subjects judged by the investigator to be inappropriate to participate in the clinical study
Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

A randomized double blind control trial to investigate the safety and efficacy of subcutaneous ketamine for control of post operative pain in low resource settings.

A randomized double blind control trial. All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries at the Centre Hospitalier Universitaire de Kigali, Kigali, Rwanda will be invited to participate. Enrolled patients will receive subcutaneous ketamine (or placebo) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg. The primary outcome will be a reduction in mean Pain Scores using parametric statistical analysis to discriminate significance. Pain will be measured using an 11-point numerical rating scale. Secondary outcomes will be the presence of significant side effects. This trial is a partnership between the University of Saskatchewan and the National University of Rwanda with ethics approval from each institutions ethics board.

Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries during a one month period with expected post operative hospital admission

Exclusion Criteria:

* Allergy to Ketamine
* History of narcotic abuse or dependence
* Those patients for which decreased cognitive function is a barrier to accurate data collection
Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years

To highlight the incidence of adverse reactions of Qingkailing Injection.


Eligibility Criteria:
Inclusion Criteria:

* all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.
* in accordance with ethics requirements.

Exclusion Criteria:

* none.
Effects of Respiratory Physiotherapy in Critically Ill Patients Ventilated for More Than 48 Hours

This study aimed to determine the impact of providing chest physiotherapy on the duration of mechanical ventilation, intensive care length of stay, intensive care and hospital mortality in mechanically ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years, admitted to the ICU needing mechanical ventilation for longer than 48 hours

Exclusion Criteria:

* Patients with ventilatory failure due to neuromuscular dysfunction
Mitigating Post-Op RV Dysfunction After LVAD Implantation

This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.

The main purpose of this study is to learn more about protecting against RV dysfunction and RV failure (RVF) in patients receiving LVAD implantations.

This is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing LVAD implantation. Patients will receive their LVAD implantation as part of routine care. Patients will be randomized 1:1 to one of two arms, 1) standardized RV management arm, and 2) usual care RV management arm, which are both consistent with standard of care (SOC).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support

Exclusion Criteria:

* Patients with pre-operative right ventricular mechanical circulatory support or having high likelihood of requiring right ventricular mechanical circulatory support.
* Patients with RV implantable cardiac device (ICD)/pacemaker lead who are pacemaker-dependent
* Pregnant patients
Is There Effect of Adding Honey Intake to Free Walking in Metabolic Syndrome Children

Metabolic Syndrome is common in Children and complementary therapies are important in its treatment such exercise and functional food intake including honey.

Forty Children with metabolic syndrome will Assigned to group of free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking was supervised by authors via Videoconferencing Imo Program) and this group also will receive healthy dietary guidelines in addition to consuming natural honey for 12 weeks.. The other group that will contain 20 patients will take only free walking exercise and healthy diet guidelines for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 40 metabolic syndrome children

Exclusion Criteria:

* respiratory, cardiac , renal , liver problems
Study to Compare the Use of a Behavioral Health App Versus Care As Usual for 16-22 Year Olds with Depression

Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care.

The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions (Children's Hospital of Pittsburgh, Boston Children's Hospital, Rady Children's Hospital, San Diego).

After consent, participants will be further screened to determine eligibility. They will complete a brief Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) (SCID). If someone has been hospitalized in the past 3 months for dangerousness, or is diagnosed with severe current psychiatric disorders based on SCID V (Clinical Trials Version) for bipolar disorder, current substance misuse or dependence, or thought disorder they will not be eligible for this study and will be referred back to the clinician for further support.

PARTICIPANT PROCEDURES:

All participants who are eligible for this study, consent to participate, and are randomized to one of the two arms (dCBI+TAU or TAU) will be asked to complete self-report and blinded clinician administered measures on three occasions over 12 weeks (baseline, 6-, and 12-week time points). At enrollment and prior to randomization, each participant will be assigned a unique Study ID that will be used to code all data collected for research purposes.

Participants will be asked to complete self-report assessments via 1) self-administered completion of assessments through REDCap Cloud (i.e., online); 2) over the phone with a member of the Research Team who will enter the participant's responses into a secure web-based portal (REDCap Cloud).

Eligibility Criteria:
Inclusion Criteria:

* Age 16-22 inclusive recruited from outpatient pediatric clinic visit.
* Meeting positive screen criteria depression by PHQ-9 criteria (score greater than or equal to10).
* English-speaking (participant)
* Smart phone access

Exclusion Criteria:

* Extremely severe depression (PHQ-9 greater than 24; or active suicidal plan).
* Current dangerousness (based on Treatment for Adolescents for Depression Study (TADS) study criteria, 2004). Hospitalized for dangerousness within 3 months; Suicide attempt requiring medical attention within 3 months.
* Severe, current psychiatric disorders based on SCID V (Clinical Trials Version) for bipolar disorder, current substance misuse or dependence, thought disorder. Research coordinators who are trained to fidelity threshold will complete this measure with the patient.