cyrilzakka/clinical-trials huggingface dataset:
Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.

An observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. Subjects will be enrolled at Guangdong Provincial People's Hospital (GPPH) and three to five participating hospitals. All clinical interventions will follow the participating hospital's standard of care. Informed consent will be obtained from all study participants before study enrollment. After undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. All preoperative and postoperative medical records data will be submitted to a centralized database at GPPH through a secure online research platform.

Baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (BNP), echocardiography and electrocardiography. Besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.

Eligibility Criteria:
Inclusion Criteria:

1. Infants and neonates who are diagnosed with TAPVC
2. Infants and neonates who undergo initial surgical repair for TAPVC.

Exclusion Criteria:

1. Concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries.
2. Older than 1-year-old.
Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases

The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education.

Maternal morbidity is defined as ill-health in a woman during pregnancy, irrespective of pregnancy site or duration, which is caused or aggravated by the pregnancy or its management, but which is not caused by accident or incident. This concept ranges from mild to severe maternal morbidity (SMM). Maternal near-miss (MNM) and potentially life-threatening conditions (PLTCs) are included as SMM.(Mekonnen et al., 2021) . Maternal mortality is an indicator of many parameters of maternal health, such as women's status, access to care and quality of care in low resource settings.(Mohammed et al., 2020) Maternal near-miss precedes maternal mortality, and women are still alive indicating that the numbers of near-misses occur more often than maternal mortality.(Mekonnen et al., 2021) Maternal near miss case is defined as "a woman who nearly died but survived a complication that occurred during pregnancy, childbirth, or within 42 days of termination of pregnancy"(Ninama et al., 2022) High risk pregnancy is defined as one where pregnancy is complicated by factor or factors that adversely affects the outcome- maternal or perinatal or both. Women with high-risk pregnancies should receive care from a special team of health care providers to ensure the best possible outcomes. (Arjariya \& Tiwari, .2021) .High-risk pregnancy was classified based on the guidelines provided by Pradhan Mantri Surakshit Matritva Abhiyan (PMSMA) for identification of high-risk pregnancy by health-care workers. The parameters considered for diagnosis of high- risk pregnancy were also defined as per the guidelines provided by PMSMA. Antenatal women with the following conditions were categorized under high-risk pregnancy: a. Severe anemia with hemoglobin level 140/90 mmHg) b. Hypertensive disorder in pregnancy (blood pressure \>140/90 mmHg) c. Previous history of lower segment cesarean section d. Bad obstetric history (history of obstructed labor) e. Low-lying placenta or placenta previa. .(Arjariya \& Tiwari.,2021)

Eligibility Criteria:
Inclusion Criteria:

* all nurses staff

Exclusion Criteria:

* nurses who refuse participation
Study of Lamotrigine to Treat Ménière's Disease

This double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo or lamotrigine.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 18 years or older
* Diagnosed with unilateral definite Ménière's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT
* Active vertigo: at least two Ménière's vertigo attacks (defined as lasting 20 minutes or longer and associated with tinnitus, ear fullness, or low frequency hearing loss and nausea/vomiting) every four weeks during the eight-week qualification period and at least two more Ménière's vertigo attacks during the lead-in phase prior to randomization
* Documented unilateral lower frequency hearing loss defined as the four-tone average (arithmetic mean rounded to the nearest whole number) of the pure-tone thresholds at 0.25, 0.5, 1 and 2 kilohertz (kHz) more than or equal to 25 decibels (dB) of the worse audiogram during the six months before screening
* Have tried diuretics for at least one month and discontinued treatment due to continued vertigo attacks
* All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
* Willing to avoid pregnancy during the entirety of the study (abstinence or two forms of acceptable birth control, such as condoms and oral contraceptives)

Exclusion Criteria:

* Bilateral Ménière's disease
* Current or past history of migraine
* Any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of Ménière's symptoms
* Previous intolerance or sensitivity to lamotrigine
* On any prohibited medication within four weeks prior to the study
* History of tympanostomy tubes with evidence of perforation or lack of closure
* IT gentamicin injections or endolymphatic sac surgery within the last year
* History of or current immunodeficiency disease, nephrolithiasis, hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
* Family history of unexplained deafness
* Pregnant or breastfeeding
* Current diseases or conditions that may be associated with an altered perception of processing stimuli
* Current severe medical condition(s) that in the view of the investigator prohibits participation
* Previously used the investigational drug
* Current non-vertiginous dizziness (orthostatic or panic disorder) unless it could be clearly differentiated from Ménière's attacks by the participant
Impacts of Clinician-Mediated Report-Back

The study trains clinicians to return personal exposure results to study participants in pregnancy cohorts, and measures outcomes for environmental health literacy for both clinicians and study participants.

To design and implement clinic-based report-back for endocrine disrupting compounds and analyze the impacts of doing so, investigators train clinicians to report-back individual chemical results to study participants in two pregnancy cohorts and then evaluate outcomes for both clinicians and patients, including shifts in environmental health behaviors, using interviews and pre-and post-tests. All study participants will get a personal exposure report and 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive them in-clinic to measure additional benefits of clinical report-back for participant learning, exposure-related behaviors, and relationships to the study and clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Participants are of reproductive age

Exclusion Criteria:

* Under 18 years old or past reproductive age
Media Background and Test Performance

This study aims to test whether middle school students test performance is affected by background TV. Students will complete a high school entrance exam either with or without a TV on in the test room. Scores will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Grades 6-8

Exclusion Criteria:

* non english speaking
Ocular Safety and Usability Study for FYB201 PFS

The objective of the study is to assess the ocular safety of the FYB201 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.


Eligibility Criteria:
Inclusion Criteria:

1. Study eye deemed to be indicated for ranibizumab intravitreal injection therapy at the discretion of the Investigator.
2. Written and signed informed consent form (ICF) obtained before any study-related procedures are performed.
3. Have a confirmed diagnosis in one or both eyes of Neovascular (Wet) Age-Related Macular Degeneration (AMD) or Macular Edema Following Retinal Vein Occlusion (RVO).
4. Qualifies for treatment with ranibizumab-eqrn according to the USPI.
5. Aged ≥18 years at the time of signing ICF.
6. If a subject is already on a ranibizumab regimen, timing of study participation should correlate with the regimen.
7. Male study subject (if his female spouse/partner is of childbearing potential) must confirm that he is using two acceptable methods for contraception (one of which must be a barrier method) starting at signing ICF and throughout the clinical study period and for 3 months after study drug administration. Male study subject should agree to inform his partner of participation in the study and the need to avoid pregnancy. Surgically sterilized and non-sexually active male subjects do not require additional use of contraception.
8. Male study subject agrees not to donate sperm starting from screening and throughout the clinical study period and for 3 months after study drug administration.
9. Female study subject must be categorized by at least one of the following:

   * Not a Woman of Child-bearing Potential as described in Appendix 3 prior to signing ICF; or
   * Surgically sterile or having undergone a hysterectomy as categorized in Appendix 3 at least 1 month prior to signing ICF; or
   * Is using a highly effective contraception. All females of childbearing potential will be required to use highly effective contraception (as described in Appendix 3) starting at signing ICF and throughout the clinical study period and for 3 months after study drug administration.
10. Female study subject must not be lactating and must not be breastfeeding at screening until 3 months after study drug administration.
11. Female study subject must not donate ova starting at signing ICF and throughout the clinical study period and for 3 months after study drug administration.

Exclusion Criteria:

1. Have received IVT injection in the study eye within 3 months prior to Day 1 with any anti-VEGF therapy other than ranibizumab products (e.g. Lucentis®, Cimerli®, Byooviz®).
2. Intraocular corticosteroid administration in the study eye within 30 day prior to Day 1.
3. The study subject has/had fever or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to Day 1.
4. The study subjects with a history or evidence of SARS-CoV-2 infection in the last month prior to signing ICF or having been in confirmed contact with SARS-CoV-2 positive patients in the last 2 weeks before dosing.
Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension

The purpose of this study is to evaluate the efficacy of Remodulin in the treatment of adult patients with congenital heart disease and pulmonary hypertension. Baseline and post-treatment cardiopulmonary exercise tests will be performed.

A prospective, open-label, non-randomized multi-center study is proposed to assess the efficacy of Remodulin in adults with congenital heart disease and pulmonary hypertension. Subjects will be enrolled at UCLA and Ohio State University (PI: Curt Daniels, MD). The study will involve a six month trial of continuous subcutaneous Remodulin therapy, with assessments conducted prior to initiation of therapy and at 1 and 6 months following initiation of therapy. A separate initiation visit will be scheduled after the baseline visit in order to provide subjects with comprehensive training in the use and care of the Remodulin drug delivery system.

Baseline and post-treatment (6 month) assessments will include a history and physical examination, cardiopulmonary exercise test, six minute walking distance, serum brain natriuretic peptide (BNP), a Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) quality of life survey, and subjective assessment of functional capacity (New York Heart Association (NYHA) scale). The interim (1 month) follow-up visit will include a thorough review of adverse events associated with Remodulin therapy, functional class assessment, six minute walk distance, and serum BNP.

Remodulin will be initiated at 1.25 ng/kg/min and increased by 2-6 ng/kg/min weekly to a target dose of 40 ng/kg/min. If the initial infusion rate cannot be tolerated it will be reduced to 0.625 ng/kg/min. Changes in drug dose will be at the discretion of the investigators following review of interim events. If necessary, the dose may be decreased by 2 ng/kg/min every two days as tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Congenital heart disease with Pulmonary Arterial (PA) hypertension (repaired or unrepaired) defined as a mean resting directly measured Pulmonary Artery Pressure (PAP) of ≥35 mm Hg and/or doppler echo estimated PA systolic pressure ≥ 60 mm Hg.
* Patients already on phosphodiesterase type 5 inhibitor (PDE-5), Endothelin Receptor Antagonist (ERA), or inhaled prostacyclin are not excluded

Exclusion Criteria:

* Age \< 18 years
* Current intravenous or subcutaneous prostacyclin therapy
* Resting systemic hypotension (Systolic blood pressure \< 80 mm Hg)
* Women who are pregnant or may become pregnant (unwilling to utilize effective contraception), as well as nursing mothers
* Inability to ambulate
Compliance and Efficacy in the Use of PICOPREP®

The present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
* Patients who have been informed about the NIS and have given their written consent for participation

Exclusion Criteria:

* Patients in which prescription of PICOPREP® is contraindicated
Effects of Inspiratory Muscle Training on Dyspnea in Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP \> 60 cmH2O).

Dyspnea is the main complaint of patients with COPD. Dyspnea is explained largely by the distension, objectified by measuring inspiratory capacity (IC), which places the diaphragm at a disadvantage to be effective, which raises the sensation of dyspnea.

Currently, inspiratory muscles training is recommended by the French-language Society of Pneumology, in case of an objective reduction of the strength of these muscles (corresponding to maximum inspiratory pressure \<60 cm H20).

Eligibility Criteria:
Inclusion Criteria:

* Patient with COPD
* Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course

Exclusion Criteria:

* Pneumonectomy, Lobectomy less than 6 months
* Cardio-pulmonary anomaly
* Max inspiratory pressure \< 60 cm H2O
The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI

The purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not.

Ticagrelor is a new drug compared with clopidogrel. It has a stronger antiplatelet capacity. After PCI，whether using low molecular weight heparin can make patients better prognosis or not, What's more，full amount or half amount low molecular weight heparin?, also investigators want to explore that whether it may lead to more bleeding events.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old and ≤75 years ;
2. unstable angina, non-ST segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia;
3. voluntary participation in clinical trials, and informed consent;

Exclusion Criteria:

1. acute ST segment elevation myocardial infarction, stable angina pectoris;
2. aspirin allergy or resistance;
3. consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications;
4. patients have coagulopathy;
5. can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor;
6. can not complete revascularization;
7. NYHA ≥Ⅲ level or left ventricular ejection fraction \<40%;
8. severe liver and kidney dysfunction (ALT and AST were more than three times the upper limit of normal, creatinine clearance less than 30ml / min-1.1.72m-2);
The Galleri® Community Research Program

GRAIL, the company that developed the Galleri test and is sponsoring this study, would like to learn more from individuals who have received the Galleri multi-cancer early detection test.

The purpose of this study is to understand how health information can be accurately collected from the medical records of individuals who have received the Galleri test in a real world setting. The collected information may include relevant medical and cancer history, diagnostic test results, including the Galleri test result. This will help GRAIL build a future larger study for individuals who have taken the Galleri test. This future study is important for understanding patient journeys after a Galleri test (including any diagnostic testing done and any diagnoses made), for improving the Galleri test, and to contribute to other research on cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* Have received the Galleri test prescribed by a provider per clinical care
* Capable of giving signed and legally effective informed consent. Consent provided by a legally authorized representative is not permitted in this protocol.
* Have signed HIPAA authorization(s)\* form for their medical records to be released and used for this study.

Exclusion Criteria:

* Patients are excluded from the study if the patient is a GRAIL employee or contractor.
* Patients who have received the Galleri test in a GRAIL-sponsored research setting (i.e., clinical trial) are excluded.
Turkish Validation of the Geriatric Pain Measure - Short Form

This study aims to adapt, validate, and assess the reliability of the Geriatric Pain Measure - Short Form in Turkish. A total of 150 patients aged 65 years and older will complete the scale under the supervision of pain management and gerontology specialists. Reliability and validity will be evaluated using statistical analyses, including internal consistency, test-retest reliability, and correlation with validated pain and sleep scales. Ethical approval has been obtained, and all participants will provide informed consent.

For the Turkish adaptation, validation, and reliability study of the Geriatric Pain Measure - Short Form, permission was obtained from Dr. Eva Blozik, the original developer of the scale. The adaptation process will follow standard cross-cultural validation guidelines, including forward translation into Turkish by an expert group, back-translation into English by a separate expert group, and comparison of the back-translated version with the original English version for conceptual and linguistic accuracy. A multidisciplinary expert panel, including Turkish language specialists and pain management experts, will review the final Turkish version, making necessary cultural adaptations to ensure semantic equivalence. The study will involve 150 patients aged 65 years and older visiting the Pain Management Clinic, where they will complete the Turkish version of the scale under the supervision of pain management and gerontology specialists. Reliability will be assessed through internal consistency (Cronbach's alpha), test-retest reliability, and item-total correlations, while construct validity will be evaluated using factor analysis. Concurrent validity will be examined by correlating the Turkish version of the scale with other outcome measures. Ethical approval has been obtained from Başakşehir Çam and Sakura City Hospital Ethics Committee, and all participants will provide written informed consent before participation.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric patients with chronic pain
* Patients who agreed to participate in the study

Exclusion Criteria:

* Demantia
* Mental of physical disorders that effect patients answering the scales
* Diagnosis of malignancy
Serpin C and Soluble Fms-like Tyrosine Kinase-1 Levels in Normotensive Pregnant Women May Predict the Development of Preeclampsia

Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop PE during the course of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Normotensive pregnant women had singleton fetus presenting during the 1st trimester
* free of exclusion criteria

Exclusion Criteria:

* Age
* Sex
* Hypertension
Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults

The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes aged \>18 who participated in another study on TBE vaccination

Exclusion Criteria:

* Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.