cyrilzakka/clinical-trials huggingface dataset:
GERD in Children With Cystic Fibrosis

The purpose of this study is to use a survey to measure reflux symptoms in patients with Cystic Fibrosis who are on reflux treatment, and to monitor their symptoms after stopping the reflux treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children 6-17 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.
* GERD medications documented at visit 1
* Stable GERD medication dose for 3 months
* Pediatric GERD Symptom Assessment Score \<80
* Signed consent

Exclusion Criteria:

* Declining to participate in the study or sign consent
* Unwillingness to stop GERD therapy
* History of severe GERD per gastroenterology diagnosis and documentation
* GSAS score \>80
Dialyzing Wisely - Improving the Delivery of Acute Renal Replacement Therapy to Albertans

Implementation of an evidence-based and best practices acute RRT pathway aiming to decrease acute RRT program and healthcare systems costs while improving important patient-reported outcomes.

Providing acute dialysis to critically ill patients in ICU settings is resource and cost intensive. The daily costs of acute dialysis can range from $528/day for intermittent hemodialysis to $865/day for continuous renal replacement therapy. Providing acute dialysis in ICU settings requires a specialized team of nurses, educators, physicians and stakeholders to ensure its safe and effective prescription and delivery. Acute dialysis is typically delivered to some of the most acutely ill patients admitted to the ICU to support organ function and sustain life.

At present, there is not a standardized approach to the prescription and delivery of acute dialysis therapy in ICUs across Alberta. The DIALYZING WISELY program will implement a standardized approach to the delivery of best practices for acute dialysis therapy to all patients who receive treatment across ICUs in Alberta.

Eligibility Criteria:
Inclusion Criteria:

Patient in one of 15 adult and 3 pediatric intensive care units in Alberta Receive acute RRT as part of their usual clinical care during the intervention period

Exclusion Criteria:

* none
Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study

The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:

Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?

Participants will:

undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.

receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
* 2. Age range from 40 to 85 years old (including 40 and 85 years old);
* 3. BMI ≤ 35kg/m2;
* 4. 15% ≤ FEV1% pred ≤ 45%;
* 5. TLC\>100% pred, RV\>140% pred, and DLCO/red% ≥ 20%;
* 6. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
* 7. Quit smoking for more than 4 months;
* 8. The evaluation result of pulmonary bypass ventilation function is negative;
* 9. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.

Exclusion Criteria:

* 1. Being pregnant or breastfeeding;
* 2. PaCO2\>50mmHg and/or PaO2\<45mmHg;
* 3. Obvious bronchiectasis or other infectious lung diseases;
* 4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
* 5. Coagulation dysfunction, platelet count\<60e+09/L;
* 6. Myocardial infarction or congestive heart failure within the past 24 weeks;
* 7. Previous lobectomy, LVRS or lung transplantation;
* 8. Anticoagulant therapy that cannot be stopped before surgery;
* 9. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
* 10. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
* 11. Pulmonary nodules that require intervention;
* 12. Patients participating in other clinical trials;
* 13. Individuals with other contraindications to bronchial operations;
* 14. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.
Magnetic Resonance Imaging of Patients With Normal Tension Glaucoma

The purpose of this study is to study the occurrence rate of masses such as brain tumors in patients with newly diagnosed Normal Tension Glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Lack of understanding of the study
* Unable or unwilling to undergo MRI
Incremental Dialysis Decision Model Based on Expert-Guided Machine Learning

This observational prospective study combined clinical expert knowledge with machine learning to develop and validate a predictive model for incremental hemodialysis decision-making. The aim of the predictive model is to assist clinicians in developing individualized incremental dialysis treatment plans to optimize patient outcomes.

By collecting patients' clinical and biochemical parameters and combining them with experts' judgments of dialysis timing and frequency, the model can dynamically assess patients' risk of needing to increase the frequency of dialysis, thus assisting physicians in formulating individualized incremental dialysis regimens to optimize dialysis outcomes and improve patients' prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. New hemodialysis patients (Apr 2010-Jun 2024), started within 3 months, including transfers.
2. Age ≥18, stable hemodialysis \>6 months.

Exclusion Criteria:

1. Incomplete/unreliable data.
2. Twice-weekly palliative dialysis.
3. No baseline urine output or ≤200 mL/24h.
4. Liver disease, heart failure, or severe comorbidities.
Patellar Resurfacing in Total Knee Arthroplasty

Background:

The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required.

Purpose:

The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.

Exclusion Criteria:

* Patients who are not able to cooperate
* Serious deformity (not suitable for a standard CR prosthesis)
* Patellar thickness less than 18 mm
* Prior operation involving the extensor mechanism
* Rheumatoid arthritis
* Severe medical disability limiting the ability to walk
* Revision surgery
* Knees with predominantly patellofemoral arthrosis
Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea

The ophthalmic changes during long-lasting sleep apnea are lacking in description and assessment. The investigators intend to observe patients for a long time and observe if the changes in eye tissues are progressing over the years in easily recognizable patterns.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy,
* ongoing treatment of sleep apnea with positive airway pressure therapy,
* patients older than 18 years,
* signed inform consent

Exclusion Criteria:

* pregnant and breastfeeding persons
Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme

Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation.

During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a patient during cardiopulmonary resuscitation. This study intends to compare three commonly employed ventilation techniques. First, the traditionally bag-valve mask ventilation is commonly taught during CPR course, despite recent evidence suggesting low efficiency rates. Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high efficiency and safety in previous studies in the hand of experienced clinicians. Until now it is unclear if basically trained rescuers are better in ventilation with bag valve mask ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube. The purpose of this study is to compare in anesthetised patients airway management and ventilation with bag-valve mask, laryngeal mask and laryngeal tube.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II

  -\> 18 years old
* elective surgery in general anesthesia

Exclusion Criteria:

* Patient not sober
* BMI \> 35kg/m2
* Pathologies of cerebral spine or peripheral neurological deficit
* Hiatus hernia, history of gastric reflux
* Stomach or Esophagus -Operation in the medical history
* Acute respiratory infection or obstructive lung disease
* Non elective surgery
* facial deformity
Intrathecal Chloroprocaine for Lower Limb Arthroplasty

This study evaluates the perioperative course in adult patients undergoing total or partial knee arthroplasty, or total hip arthroplasty under chloroprocaine spinal anesthesia.

This study evaluates the failure rate of spinal anesthesia, the duration of surgical anesthesia, the needs for complementary intraoperative analgesia, the time for recovery, the incidence of urinary retention, postoperative nausea and vomiting, and length of stay in the recovery room in patients operated for knee or hip arthroplasty under spinal anesthesia with chloroprocaine 50 mg.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* with spinal anesthesia using 50 mg of chloroprocaine
* operated for total knee, unicompartment knee or anterior access hip arthroplasty
* in the period of years 2020 - 2021

Exclusion Criteria:

* expressed disagreement to to participate after receiving information notice
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Genotype 1 CHC
* treatment-naïve or relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia, or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab

Investigate the role of consolidative radiotherapy treatment at the thoraco-mediastinal level in the patient suffering from lung microcytoma - extensive disease and treated with chemo-immunotherapy with atezolizumab, in association with maintenance therapy with atezolizumab.

Prospective phase II study on patients affected by extensive-stage small cell lung cancer. The traditional treatment of lung microcytoma-extensive disease consists in platinum and etoposide-based chemotherapy. Radiotherapy of consolidation at the thoracic mediastinal level after chemotherapy may have an impact on survival and can be offered to patients in response to chemotherapy. Studies have recently shown that the addition of immunotherapy with atezolizumab to traditional chemotherapy improves survival compared to placebo. However, the use of consolidation radiotherapy was not permitted in the study thoracic level. Therefore the objective is to evaluate the efficacy and tolerance of the thoracic radiotherapy-immunotherapy association in the maintenance phase with atezolizumab of the treatment of lung microcytoma - extensive disease treated with chemo-immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of lung microcytoma;
* Age ≥18 years;
* Performance status according to ECOG 0-2;
* Extended disease at the time of first line oncological treatment;
* Initial staging and restaging after chemo-immunotherapy with CT, CT-PET FDG and brain MRI;
* In at least partial response (defined according to the Recist criteria \[18\]) after treatment chemoimmunotherapy according to the Impower 133 scheme;
* Haematological, respiratory toxicity ≤ G1, other toxicities ≤ G2 at the time of treatment radiotherapy;
* Pulmonary function tests at the time of radiotherapy treatment compatible with irradiation: FEV≥1.2 l or \>40%, DLCO≥50%;
* Written informed consent.

Exclusion Criteria:

* Previous radiotherapy treatment at the thoraco-mediastinal level;
* In disease progression after chemo-immunotherapy treatment.
Effect of Nitrate-rich Fruit and Vegetable Supplement on Blood Pressure

It is hypothesized that the daily supplementation of a nitrate-rich, two-ounce fruit and vegetable energy supplement (Isagenix International LLC) by healthy young adults with a would increase circulating nitrates and improve cardiovascular parameters compared to a nitrate-deficient placebo (prune juice).

Endothelial cells of the peripheral vasculature are key sources of vasoactive factors regulating healthy blood pressure. One of the primary vasodilatory factors released from these cells is nitric oxide (NO). Production of NO is stimulated both through enzymatic-dependent mechanisms via NO synthase, as well as from dietary intake of nitrate-containing foods or supplements that increase NO bioavailability. This study examined whether the daily consumption of a nitrate-rich, two-ounce fruit and vegetable energy supplement (Isagenix International LLC) would increase circulating nitrates and improve cardiovascular parameters compared to a nitrate-deficient placebo (prune juice). Healthy male adults aged 18-40y (n=45) were recruited to participate in this longitudinal double-blind, placebo-controlled, randomized clinical trial. Subjects maintained their typical diet and physical activity patterns during the study. Anthropometric and cardiovascular (blood pressure and flow-mediated dilation (FMD)) parameters, along with plasma nitrates and nitrites were measured at baseline and after one and two weeks of supplementation. Subjects also completed questionnaires on sleep quality and mood. It is hypothesized that the nitrate-rich FVS supplement will provide a good source of dietary nitrates and effectively reduced blood pressure in normotensive, healthy young males.

Eligibility Criteria:
Inclusion Criteria:

• healthy men aged 18-40y

Exclusion Criteria:

* hypo- or hypertension (blood pressure \< 100/65 or \>140/90
* cigarette use within past year
* food allergies
* specific medication use (nitroglycerin, beta-blockers, calcium channel blockers),
* unwillingness to drink juice concentrates and follow study restrictions.
Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients with Long COVID

The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme with monitoring via a mobile app produces medium-term improvements in self-management, fatigue and quality of life in patients affected by persistent COVID.

The main questions it aims to answer are:

* Will a multimodal program (exercise with education) improve the self-management ability of patients with post-exertional malaise?
* Does fatigue and quality of life will be improved in these patients?

Researchers will compare an experimental breath program to a control standard care group to see if multimodal program works to treat post-exertion malaise.

Participants will:

* Follow-up 12 weeks online sessions:

  1 weekly synchronous online session + 1 scheduled asynchronous session + educational resources
* Daily use of the app: daily log, education and questions


Eligibility Criteria:
Inclusion Criteria:

* Post COVID-19 condition: individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction
* Between 18 and 75 years of age
* Possibility of access and use of smartphone.
* Ability to attend the clinic in person for an initial session.

Exclusion Criteria:

* Patients with a history of respiratory or cardiovascular diseases prior to COVID-19, other acute or chronic diseases that may interfere with the study
* Pregnancy/breastfeeding
* Those with contraindications to respiratory muscle training.
The Sexual Health of Rectal Cancer Patients

We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn:

* How the treatment affects emotional and social well-being.
* How a new sexual health educational program affects you.

Cancer patients seek education for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to individuals who have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual health counseling program. It will teach participants skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of sexual health program with the standard care patients receive after treatment for rectal, colorectal or anal cancer.

This is a two year randomized clinical trial examining the feasibility, tolerability, acceptability (including adherence) and efficacy of an intervention designed to improve sexual functioning of survivors of rectal cancer.

We have completed enrollment of female patients and are currently collecting follow up data. Recruitment for male patients is ongoing. Male participants will now be randomized in a 3:1 ratio to either the intervention condition (n = 40) or the control condition (n = 40).

Eligibility Criteria:
Inclusion Criteria:

* At least six months post radiation and/or surgery for stage I-III rectal adenocarcinoma or rectosigmoid for cancer with an anastomosis at 15 cm or below and completed treatment
* At least six months post radiation and/or chemotherapy for anal cancer.
* Have no evidence of disease or recurrence
* For women indicate Indicate moderate satisfaction or below on their overall sexual life (a score of "4" or lower on the question "Over the past 4 weeks, how satisfied have you been with your overall sexual life?"
* For men indicate, and a score of "3" or lower on the question "How would you rate your confidence that you could get and keep an erection" for men) and a score of "2" or higher on the question "How much does this problem bother you?
* In the judgment of the consenting professional interventionists, able to communicate in English well enough to work with English speaking and complete the study assessments.
* Age 21 years or older.

Exclusion Criteria:

* Significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention.
* Are actively participating in protocol 06-151
* Participated in focus group or qualitative interview.
Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device

Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus

This is a prospective, non-randomized, multicenter follow-up study to collect long-term data on a cohort of patients who participated in the Aerin Medical TP668 study, "Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis". The study will be conducted in a maximum of 5 centers that participated and enrolled patients in the TP668 study.

Eligibility Criteria:
Inclusion Criteria:

* Received treatment for chronic rhinitis in Aerin Study TP668

Exclusion Criteria:

* Unwilling to participate in this long-term study
Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies

The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin


Eligibility Criteria:
Inclusion Criteria:

* Women with either ultrasound-documented dizygotic (DZ) twin pregnancy or those whose Panorama Test™ results suggest increased risk for vanishing twin

Exclusion Criteria:

* Monozygotic twin pregnancy
* Non twin pregnancy
* Maternal history of bone marrow or organ transplantation
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).


Eligibility Criteria:
Key Inclusion Criteria:

* Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
* Part B: Confirmed diagnosis of CSU for ≥6 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.

Key Exclusion Criteria:

* Part A: Any active urticaria that may interfere with study assessments.
* Part A: History of cold-induced anaphylaxis.
* Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria.
* Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions.
* Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results.
* Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.
* Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.