cyrilzakka/clinical-trials huggingface dataset:
Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery

Obesity is a non-communicable chronic disease of multifactorial, involving biological, historical, ecological, economic, social, cultural and political. Currently, bariatric surgery is considered an effective method of refractory obesity treatment, and only severe obesity effective treatment that leads to reduced long-term weight. It is well documented in the literature regarding the association of abdominal surgery and the incidence of respiratory complications and its main characteristics are: atelectasis, pneumonia, respiratory dysfunction and pleural effusion. All these respiratory complications can be minimized or avoided with the use of a respiratory therapy care protocol, since the pulmonary atelectasis is considered the main cause of complications. An arsenal of resources to physical therapy lung expansion, among these, the application of positive pressure through a valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive ventilation, and aims to prevent and / or improve the complications resulting from postoperative. The electrical impedance tomography (EIT) is an alternate to allow assessment of the respiratory system, without suffering the same interference conditions of patients, such as pain and bed rest. TIE consists of a method that measures passively regional lung ventilation. The aim of this study is to compare the effects of the application of EPAP and NIV on pulmonary ventilation we post bariatric surgery. This is a randomized controlled trial where patients will be divided into two groups: EPAP and NIV and assessed by spirometry, manometer and TIE. The techniques will be applied in the 1st and 2nd postoperative day where they will be evaluated before, during and after the application of the techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bariatric surgery, of both sexes and aged between 20 and 50 years.

Exclusion Criteria:

* severe lung disease;
* patients with congestive heart failure (NYHA Class III or IV);
* coronary artery disease;
* presented hemodynamic instability (MAP \<60 mmHg) or arrhythmias during the performance of techniques, plus any contraindications to perform the BS techniques, EPAP and NIV to consider: Trauma / facial injury that prevents the attachment of the mask, extreme anxiety, hypotension and lack of patient cooperation.
Qualitative Techniques to Define Meaningful Within-Patient Change in Symptoms of Advanced Cancer Patients

This study examines qualitative techniques in defining meaningful within patients changes in symptoms in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). This study may help researcher better understand how to interpret reports from patients about their cancer symptoms and treatment side effects.

PRIMARY OBJECTIVES:

I. To develop method to establish meaningful change in patient-reported outcomes (PROs).

II. To provide responder definitions in 2 ways:

IIa: Detectable change: within patient score change patients perceive but does not exceed a subjective threshold for a modification to patient care (for worsening) or conclusion of achieving therapeutic benefit (for improvement); IIb. Meaningful change: within patient score change that patients perceive and that does require modification in management (for worsening) or supports conclusion of therapeutic benefit (improvement).

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

PATIENTS: Patients take part in an interview on study.

PATIENT ADVOCATES: Patient advocate participants take part in an interview on study.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS

  * Patients with a diagnosis of cancer including solid tumor and hematologic malignancy at Mayo Clinic, Rochester
  * To ensure sampling patients likely to have experienced declines in fatigue, all patients will have had at least two in-person encounters for radiation or chemotherapy treatment within the 3 months prior to recruitment. The sampling methodology developed for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care survey will be modified and used to identify eligible patients from Mayo Clinic's electronic health record
  * As interviews will be conducted either in person or by video conference (Zoom, Teams, or similar), access to internet is required for those unable or unwilling to travel to the clinic for an in-person interview
  * Answered "Yes" to screening question: "In the past 3 months, have you experienced changes in your level of fatigue?" Yes/No
* PATIENT ADVOCATES:

  * Patient advocates recommended by the FDA to provide their input to help us in reaching a consensus in the way we define meaningful change (both improvement and decline) that came from patients in the first arm

Exclusion Criteria:

* PATIENTS

  * Unwilling to be audio recorded during the interviews
  * Answered "No" for the screening question
Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Total Knee Arthroplasty

The goal of this clinical trial is to find out the efficacy of diosmin and hesperidin on postoperative early rehabilitation after primary total knee arthroplasty. The main questions it aims to answer are:

Does diosmin and hesperidin combined drug decreases the lower extremity swelling, pain and increases the range of motion after primary total knee arthroplasty surgery compared to standard therapy group? Does diosmin and hesperidin combined drug decreases inflammation after total knee arthroplasty surgery.

Participants will take diosmin and hesperidin in addition to standard therapy for 14 days after total knee arthroplasty surgery. Lower extremity swelling, pain and range of motion of the patients will be recorded in every visit.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent unilateral primary total knee replacement surgery
* Patients who are functionally ASA 1, ASA 2 or ASA 3.

Exclusion Criteria:

* Patients \>80 years or \<18 years of age
* Patients with liver insufficiency
* Patients with allergy to diosmin or hesperidin
* Patients which are not capable to communicate
CHAMP: Study of NVK-002 in Children With Myopia

Stage 1: To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment period.

Stage 2: To observe safety and efficacy in subjects re-randomized to one (1) year of treatment with NVK-002 or Vehicle following 3 years of treatment in children with progressive myopia.

This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages.

Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications.

Stage 2 is a randomized follow-up phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to Vehicle only eligible for randomization to low or high-dose NVK-002.

Treatment arms are:

* NVK-002 low dose concentration
* NVK-002 high dose concentration
* Vehicle (placebo)

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 3 to ≤ 17.0 years.
2. Myopia SER of at least -0.50 D and no worse than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.

Exclusion Criteria:

1. If present, astigmatism more than -1.50 D in either eye.
2. Current or history of amblyopia or strabismus.
3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
5. Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.
6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.
Acceptability and Feasibility of a Stress Prevention Program Based on Meditation and Acceptance and Commitment Therapy for Staff at a Cancer Center

The MAEva program seems to meet the challenges of implementing meditation for cancer care workers. As part of our Quality of Life and Working Conditions initiative, the investigator decided to offer it to staff at our Cancer Center. The MAEva program is delivered in a closed format: participants commit to following, as far as possible, the three sessions of the program - one session per week for 3 weeks. During the sessions, it will be proposed to train meditative practices and three different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.

Before and after the program, participants will complete a quality of life evaluation, a perceived stress scale, and a questionnaire to assess psychological flexibility.

At the end of the program, each participant will be asked to complete a satisfaction questionnaire and a semi-directive interview, by videoconference, or by telephone in the event of digital impossibility with voice recording, to enable a qualitative analysis.


Eligibility Criteria:
Inclusion Criteria:

* Participant of legal age
* Willingness to participate in the program - voluntary registration
* Commitment to attend all 3 program sessions
* Schedule compatible with participation in the 3 program sessions
* Participant has understood, signed and dated the consent form
* Participant affiliated to the social security system

Exclusion Criteria:

* No desire to participate in the program - non-registration
* Previous participation in MAEva program
* No commitment to participate in the 3 program sessions
* Agenda incompatible with the 3 program sessions
Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma

The investigators do the clinical trial (patients with metastatic nasopharyngeal carcinoma treated with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib in patients with metastatic nasopharyngeal carcinoma, progressing after all approved standard therapies.

The study is an open-label, phase 1B study recruiting 18 patients. Patients were eligible to participate when they have histological or cytological documentation of the nasopharyngeal carcinoma. They must have received locally and currently approved standard therapies and to have disease progression after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects. The available standard therapies have to include one or more drugs of the following as were licensed: a fluoropyrimidine,taxane,DDP, gemcitabine.

Patients have to be aged 18 years or older and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; life expectancy of at least 3 months;and adequate bone-marrow, liver, and renal function at the start of the trial. Patients could not participate if they had previously received sorafenib or had uncontrolled medical disorders. All patients receive best supportive care, excluding other investigational antitumour agents or antineoplastic chemotherapy, hormonal therapy, or immunotherapy.Patients receive oral donafenib 200mg (CM4307) of each 4 week cycle until disease progression,death, unacceptable toxic effects, withdrawal of consent by the patient,or decision by the treating physician that discontinuation would be in the patient's best interest.The primary endpoint is safety.The second endpoint is progression-free survival.

Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological documentationof the nasopharyngeal carcinoma;
* Have received system standard therapies and to have disease progression(RECIST1.1) or to have stopped standard therapy because of unacceptable toxic effects.
* Standard therapies including as many of the following as were licensed: a fluoropyrimidine,taxol,DDP,or gemcitabine;
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Life expectancy of at least 3 months;
* Have adequate bone-marrow, liver, and renal function at the start of the trial. • Prothrombin time international normalized ratio≤2；or prothrombin time≤16 seconds;or activated partial thromboplastin time(APTT) ≤43 seconds;or TT≤21 seconds.

Exclusion Criteria:

* Patients have prior treatment with sorafenib;
* Patients have Central nervous system(CNS) involvement;
* patients have uncontrolled medical disorders.
Construction of a Recurrence Risk Prediction Model for Liver Resection Based on Drug Sensitivity of Patient-derived Hepatocellular Carcinoma Organoid

Liver cancer is the sixth most common malignant tumor worldwide and the third leading cause of cancer-related deaths. China is a high-risk area for liver cancer, accounting for approximately 55% of primary liver cancer worldwide. Liver cancer is highly malignant and easy to recur, which seriously endangers the life and health of our people. Hepatectomy is the preferred treatment for liver cancer, but the 5-year recurrence rate remains as high as 70%, severely limiting the effectiveness of the surgery. Therefore, exploring the risk factors and predictive methods for early tumor recurrence after liver resection in patients has high clinical value. Clinical practice has found that primary liver cancer patients can be treated with postoperative adjuvant transarterial chemoembolization (TACE) to prevent recurrence. However, the effectiveness of TACE varies among patients and may be related to tumor heterogeneity. However, many studies have reported that drug sensitivity testing based on patient derived organoids can indicate the clinical efficacy of drugs, but there is currently no relevant research indicating that organoids can reflect the therapeutic response of TACE. Therefore, the aim of this study is to explore the correlation between patient derived organoid drug sensitivity testing results and TACE treatment responsiveness and tumor recurrence, and further construct a column chart model to predict tumor recurrence after adjuvant TACE.


Eligibility Criteria:
The inclusion criteria were as follows: (1) age between 18 and 80 years; (2) postoperative pathological diagnosis of HCC; (3) adjuvant TACE performed 4-8 weeks after radical surgical resection; and (4) successful culture of PDTO, with sufficient quantity for drug testing.

The exclusion criteria were as follows: (1) patients with an American Society of Anesthesiologists (ASA) score greater than 3; (2) failure or contamination of PDTO culture; (3) failure to complete standardized adjuvant TACE treatment postoperatively; and (4) patients who received neoadjuvant or other adjuvant therapies, including radiotherapy and systemic treatments.
Comparison of Non-Invasive Blood Pressure Methods

The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.

The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.

This study will include up to 100 adults ≥ 18 years of age. The final subject database will contain no fewer than 85 subjects with a minimum of 255 paired observations. At least 90% of the subjects will contribute 3 paired observations, if necessary the balance of the data will be added from additional subjects.

An interim analysis will be conducted at the end of Part 1 data collection and will consist of simple statistics that will compare the test device tot he reference cuff non-invasive (auscultatory) reference sphygmomanometer.

Part 2 data collection will be conducted after Part 1 data collection interim report is reviewed and additional data collection is approved by the client. It will test an additional 55 subjects (plus extra subjects as replacements if necessary).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.
* Subject must be willing and able to comply with the study procedures.
* Subject must be ≥ 18
* Subject or legally authorized representative must be able to read or write in English.
* Subjects with a finger circumference \< 8.3 cm.in the range of 10-25 mm
* At least 30% of subjects shall be male and at least 30% of subjects shall be female

Exclusion Criteria:

* Lack of Informed consent.
* Subjects with deformities or abnormalities that may prevent proper application of the device under test.
* Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
* Subjects with known heart dysrhythmias
* Subjects with compromised circulation or peripheral vascular disease.
* Subjects with clotting disorders or taking prescribed blood thinners.
* Subjects that cannot tolerate sitting for up to 1 hour.
* Subject with a blood pressure demographic that has already been filled
Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)

The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.

Primary: Describe the efficacy of 0.25% and 0.5% topical timolol maleate Gel-forming solution (GFS) as assessed through Infantile Hemangioma (IH) changes in volume.

Secondary: Describe the safety of topical timolol maleate GFS for treatment of IH.

Eligibility Criteria:
Inclusion Criteria

1. Documented informed consent from legal guardian
2. 0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.
3. Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):

   1. Superficial lesion in the dermis
   2. Thin \<2 mm in thickness
   3. Small \>=5 cm at its longest dimension and \<=10cm2
   4. Involves skin or keratinized mucosa

Exclusion Criteria

1. History of previous treatment with any pharmacologic or laser therapy for IH
2. Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (TOF), hypertension, reactive airways disease)
3. IH that requires systemic therapy (defined by dynamic complication scale \>3)
4. IH of the non-keratinized mucosa
5. Infants with more than one hemangioma that requires therapy
6. Hemodynamically significant cardiovascular disease, as determined by the investigator
7. Known allergy to beta blockers or vehicle
8. Heart rate \<100 beats per minute at screening visit
9. Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block
10. History of Reactive Airways Disease (RAD)
11. Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.
ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events

Today 11 percent of China's population is over the age of 65, and according to United Nations, it will take China just 20 years for the proportion of the elderly population to double to 25%. As life expectancy has increased, application of Endoscopic Retrograde Cholangiopancreatography (ERCP) in super-aged (≥80 years of age) is no longer limited with increasing prevalence of choledocholithiasis, and malignancy in advancing age. This increasing may come with more difficulty in cannulation or more complications in senior patients. Regarding difficult cannulation, little is known about grading difficulty in the elderly and its relation with adverse events. Therefore, it is time to evaluate the risk factors of adverse events in super-aged patients with difficult bile duct cannulation.

AIM: To evaluate the incidence, causes, and management of difficult biliary cannulation during ERCP in elderly patients and its role as a risk factor for adverse events.

METHODS: A total of 614 patients, with a mean age of 65.3±16.7 years, underwent ERCP during the study period, were prospectively managed and divided into two groups based on their age. There were 146 patients aged 80 years or older in group A with the mean age of 84±3.4 years. The primary outcome measurements were the difficulty grade of papilla cannulation, clinical outcomes, and ERCP-related complications in the two groups. The adverse events were analyzed by logistic regression about patient age, co-morbidities, indications, and difficult cannulation grading.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent ERCP between July 2016 and January 2018.

Exclusion Criteria:

* We excluded the patients who underwent ERCP for the objectives of follow up, stent removing or taking a biopsy.
Reverse-Loop Upper Arm Arteriovenous Graft

Background: A conventional configured prosthetic arteriovenous graft (AVG) usually wastes most upper arm vessels that a reverse-loop design may conserve. This study examined the feasibility of the AVG construction and its outcome.

Methods: Retrospective review of clinical outcomes of reverse-loop upper arm AVG patients. Measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions


Eligibility Criteria:
Inclusion Criteria:

* compromized forearm and elbow options

Exclusion Criteria:

* unstable
Bosentan in Digital Ulcers

The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with SSc according to the classification criteria of the American College of Rheumatology
2. SSc patients with at least one DU at baseline qualifying as a CU (see definition section 3.2.2)
3. CU occurred \< 3 months and \> 1 week prior to randomization. The subset of patients with SSc felt to be at high risk for DUs will be identified in the screening period but will not be eligible for enrollment until a CU has developed
4. Male or female patients \>/= 18 years of age
5. Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination
6. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile
7. Signed informed consent.

Exclusion Criteria:

1. DUs due to condition other than SSc
2. Severe PAH (WHO class III and IV)
3. Systolic blood pressure \< 85 mmHg
4. Hemoglobin concentration \< 75% of the lower limit of the normal range
5. AST and/or ALT values greater than 3 times the upper limit of normal
6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
7. Severe malabsorption or any severe organ failure (e.g., lung, kidney) or any life-threatening condition
8. Pregnancy or breast-feeding
9. Previous treatment with bosentan
10. Treatment with any of the following: glibenclamide (glyburide), fluconazole, cyclosporine A, tacrolimus and any other calcineurin inhibitor 1 week prior to randomization
11. Local injection of botulinum toxin in an affected finger 1 month prior to randomization
12. Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, treprostinil sodium or other prostacyclin analogs) 3 months prior to randomization
13. Treatment with inhaled or oral prostanoids one month prior to randomization
14. Systemic antibiotics to treat infection of DUs 2 weeks prior to randomization
15. Treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction
16. Body weight \< 40 kg
17. Patient with conditions that prevent compliance with the protocol or adhering to therapy
18. Patient who received an investigational product within 1 month preceding screening
19. Known hypersensitivity to bosentan or any of the excipients.