cyrilzakka/clinical-trials huggingface dataset:
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Primary Objective:

To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Secondary Objective:

* To compare the overall survival in both treatment arms.
* To evaluate the objective response rate in both treatment arms.
* To evaluate the duration of response in both treatment arms.
* To evaluate the clinical benefit rate in both treatment arms.
* To evaluate progression-free survival on next line of therapy.
* To evaluate the pharmacokinetics of amcenestrant, and palbociclib.
* To evaluate health-related quality of life in both treatment arms.
* To evaluate the time to first chemotherapy in both treatment arms.
* To evaluate safety in both treatment arms.

Study duration per participant was approximately 59 months, which includes a 33- month treatment period.

Eligibility Criteria:
Inclusion criteria :

* Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment.
* Confirmed diagnosis of ER+/HER2- breast cancer.
* No prior systemic treatment for loco-regional recurrent or metastatic disease.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Participants should be willing to provide tumor tissue.
* Capable of giving informed consent.

Exclusion criteria:

* Known active brain metastases.
* Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD).
* Inadequate organ and marrow function.
* Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy.
* Pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods.
* Male participants who disagree to follow contraception.
* Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term.
* Participants with significant concomitant illness.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Pediatric Bronchoscopy and LUS

Rigid bronchoscopy is commonly used for diagnosing and treating lung and airway diseases, including foreign body removal. Patients often experience atelectasis post-procedure, which lung ultrasound (LUS) can effectively detect. LUS is a rapid, noninvasive imaging technique that provides real-time evaluation without the need for patient transportation. In this observational study, researchers will assess the incidence and severity of atelectasis in patients undergoing elective rigid bronchoscopy, comparing those who were intubated and awakened post-procedure with those who were not intubated. The study aims to determine whether intubation influences the development of atelectasis after bronchoscopy.

Rigid bronchoscopy has been used for many years in the diagnosis and treatment of various primary diseases of the lungs and airways, removal of tracheobronchial foreign bodies and therapeutic procedures for central airway pathologies. Most patients have atelectasis after the procedure. Lung ultrasound (LUS) has begun to take its place in clinical use as a new tool for the detection of both acute and chronical pathologies in the perioperative period and intensive care follow-up of patients. Its use is rapid, noninvasive, point-of-care, without radiation and no need patient transportation. The imaging pattern of atelectasis is similar to that of lung consolidation, and the B line image and loss of lung shear are considered typical findings. Atelectasis after a bronchoscopy procedure can be recognized with LUS. As standard procedure, after bronchoscopy, patients are given drugs (neostigmine or sugammadex) to reverse the effect of muscle relaxants and are allowed to wake up. During this time, patients are sometimes intubated until their respiratory function is fully restored and the patient wakes up. Which patient is intubated depends on factors such as the patient's comorbidities, lung capacity, the procedure performed and the clinician's preference. Intubation may reduce the development of atelectasis due to positive airway pressure. In this observational study, we aim to determine the frequency and degree of atelectasis in patients undergoing elective rigid bronchoscopy using lung ultrasound. Specifically, we will compare the frequency and degree of atelectasis in patients who were intubated and awakened after bronchoscopy and those who were awakened without intubation.

Eligibility Criteria:
Inclusion Criteria:

* Elective rigid bronchoscopy
* American Society of Anaesthesiologists (ASA) physical status I or II

Exclusion Criteria:

* Emergent rigid bronchoscopy
* ASA III or above
* Patients left intubated after the procedure
Correlation Between Serum Adiponectin And Resistin Levels And Degree of Hepatic Fibrosis in MASlD With type2 Diabetes Mellitus

Metabolic dysfunction asociated steatotic liver disease prevalence is 25%world wide diabetic patients have a risk for MASLD then have hepatic fibrosis so we study correlation Between Serum Adiponectin And Resistin Levels And Degree of Hepatic fibrosis In Metabolic dysfunction asociated steatotic liver disease in patients with type2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* patients of both sex who have type2 Diabetes Mellitus for less than five years

Exclusion Criteria:alcholics ,chronic liver disease elevated liver functions , sever infection

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A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.

Eligibility Criteria:
Eligibility Criteria:

To be eligible to participate in this trial, patients must meet all of the following criteria:

1. Completed one of the parent trials
2. Does not have a condition that would require withdrawal from one of the parent trials
3. Has no conditions requiring treatment with a prohibited concomitant medication
4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:

   At Baseline (Day 1)
   * CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
   * Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
6. Female patients of childbearing potential:

Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.

Acceptable methods of birth control in this study are the following:

* Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
* Placement of an intrauterine device (IUD)
* Placement of an intrauterine hormone-releasing system (IUS)
* Bilateral tubal occlusion
* Vasectomised partner
* Sexual abstinence.

Exclusion Criteria:
Pilot Study for the Evaluation of the More Stamina in Persons With Multiple Sclerosis

The overall study aims are to explore the feasibility, acceptability, and usability of More Stamina, a mobile app for fatigue self-management for persons with MS.

Multiple sclerosis (MS) is one of the world's most common neurologic disorders of the young adults leading to severe disability. Fatigue is one of most common symptoms that persons with MS experience, having significant impact on their quality of life and limiting their activity levels. Self-management strategies are used to support them in the care of their health. Mobile health (mHealth) solutions are a way to offer persons with chronic conditions tools to successfully manage their symptoms and problems. User-centered design (UCD) is a design philosophy that proposes placing end-users' needs and characteristics in the center of software design and development and involving users early in the different phases of the software life cycle. More Stamina is an mHealth solution created following UCD principles to help persons with MS manage their fatigue.

A mixed methods study was used to assess the feasibility, acceptability, and usability of More Stamina. The study took place between January and March of 2023 in Finland. A longitudinal cohort study took take place, along with think-aloud protocols, open-ended interviews and short answer questionnaires. The study enrolled 20 persons with MS that met the criteria who utilized the More Stamina solution for 60 days.

Eligibility Criteria:
Inclusion Criteria:

* be over 18 years old;
* have a confirmed MS diagnosis (including secondary, relapsing and progressive MS) for at least 1 year,
* have none to moderate physical disability (EDSS \< 6.5) at the time of recruiting;
* no major cognitive or haptile impairment influencing the ability to use the app;
* own a compatible smartphone device;

Exclusion Criteria:

* Refusal to participate or the informed consent process;
* Objective cognitive impairment that hinders the use of mobile applications;
* Physical or cognitive impossibility to use the visual interface of mobile applications;
* difficulties in access or availability for full attendance at the 3 encounters of the study.
A Study to Evaluate the Tolerability and Efficacy of Tamsulosin 0.4mg OCAS Formulation in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2mg Conventional Formulation

This is an open-label, single-arm, prospective interventional study to assess the tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

After obtaining informed consent, subjects who meet the inclusion criteria and not violating the exclusion criteria will be enrolled to receive Harnalidge® OCAS® 0.4 mg for treatment. The interventional period for the study is three months after the first date of enrollment or until the patients are discontinued the treatment of Harnalidge® OCAS®. All subjects will be instructed to contact the site if a patient's partner becomes pregnant during or within 90 days from the discontinuation of dosing, the investigator should report the information to the sponsor as if it is an SAE.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as LUTS associated with BPH
* Currently taking oral tamsulosin 0.2 mg for at least 4 weeks
* Unsatisfied with the treatment of tamsulosin 0.2 mg The definition of 'unsatisfaction' is based on patient's satisfaction. Investigator will ask patient one question "Are you satisfied with your current treatment?" prior to study enrollment
* IPSS-QOL score ≧3 points at baseline

Exclusion Criteria:

* Subjects who underwent prostatectomy during the period of one year prior to this study
* Subjects with neurogenic bladder dysfunction, bladder neck sclerosis, urethral stricture, prostatic cancer, cystolithiasis, severe vesical diverticulum, urinary tract infection
* Subjects with any other complication which may cause voiding dysfunction
* Subjects with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorders, orthostatic hypotension, or senile dementia
* Subjects clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
* Subjects who are currently participating in any other investigational drug study or who have participated in a study of an investigational drug within 3 months prior to this study
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty

The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Total Knee Arthroplasty in general anaesthesia
* ASA 1-3
* BMI 18-40
* Written informed consent

Exclusion Criteria:

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse
* Daily consumption of strong opioids
Creation of Home-based Asthma Real-World Measures With Mobile Health Study

Four novel biologic therapies (benralizumab, dupilumab, mepolizumab, reslizumab) have been recently approved for moderate-to-severe, eosinophilic or oral steroid-dependent asthma. The efficacy and safety of these therapies have been determined primarily by randomized clinical trials that compared annualized rates of significant asthma exacerbations (SAEs), lung function changes, and standardized symptom survey score changes in therapy-treated subjects in comparison to placebo matched controls. Yet, there is increasing interest to assess the efficacy, health benefits, and safety in medical therapies using real-world evidence (RWE). Further, home monitoring of asthma using mobile health (mHealth) technology may help scientists develop new and more sensitive indicators of asthma control that could improve clinical care. The hypothesis is that real world evidence, collected at home using several mobile health technologies, will help determine the efficacy, health benefits, and side effects of these therapies.

Objectives

1. Assess real-world evidence (RWE) indicators of worsening and improving asthma. Scientists will measure steps per day, duration and vigor of exercise per day, sleep quality, and the number of awakenings per night using Fitbit activity trackers. Scientists will measure symptoms using once-monthly custom survey delivered to participant smartphones via Twilio. Rescue medication use and adherence to maintenance medications may be measured using digital inhaler devices. Adherence to biologic use using HealthBeacon smart sharps containers may be measured. Measures collected will be correlated to patient-reported significant asthma exacerbations (SAEs), lung function (FEV1), and the asthma control test (ACT) collected in clinic every 3 months.
2. Use RWE to determine responses to biologic therapies. Scientists will combine at-home and clinic data to determine responses to biologics.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months
* OR -
* An asthma control test (ACT) score less than or equal to 19 despite regular use of inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the equivalent)
* Participants will need access to a smartphone (As of January 2018, \~ 80% of U.S. adults owned a smartphone (Mobile Fact Sheet, 2018))

Exclusion Criteria:

* Active smoking
* Any significant comorbid conditions that could inadvertently interfere with study results (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease)
* Conditions that require bursts of oral corticosteroids
* Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others) to be determined by the investigators.
Hypofractionated Radiotherapy Concomitantly With Weekly Boost for Breast Cancer Patients Treated With Conservative Breast Surgery

This is a retrospective study on evaluation of the efficacy and the safety of a hypofractionated radiotherapy course with weekly concomitant boost for breast cancer patients treated with conservative breast surgery .


Eligibility Criteria:
Inclusion Criteria:

1. women aged from 18 and up to 55 years old.
2. Histologically diagnosed with breast carcinoma (ductal and others )
3. All patients with conservative breast surgery.
4. Including all patients with in all stages except those stage IV.
5. All patients with clear free surgical margin.
6. patients received hypofractionated radiotherapy with weekly concomitant boost

Exclusion Criteria:

1. Evidence of distant metastatic deposites.
2. patients with mastectomy
3. patients with prior irradiation to thoracic region.
4. pregnancy or lactation.
Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Female aged 65 years or older
2. World Health Organization (WHO) performance status 0-2
3. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start
4. Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start
5. Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound
6. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound
7. Estrogen receptor status (ER) positive on biopsy
8. Her2 negative on biopsy
9. Grade 1 or 2 on biopsy
10. Planned surgery is a partial mastectomy with sentinel lymph node biopsy
11. Localisation markers placed before treatment

Exclusion Criteria:

1. Age less than 65 years
2. A known deleterious mutation in BRCA 1 and/or BRCA 2
3. Clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound
4. Tumor histology limited to lobular carcinoma only
5. Clinically positive axillary nodes (cN+)
6. Lymphovascular invasion on biopsy
7. Pure ductal or lobular carcinoma in situ on biopsy
8. Extensive intraductal component on biopsy
9. Neoadjuvant hormonal manipulation or chemotherapy
10. Prior history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial)
11. More than one primary tumor in different quadrants of the same breast
12. Diffuse microcalcifications on mammography
13. Paget's disease of the nipple
14. Previous irradiation to the ipsilateral breast
15. Presence of an ipsilateral breast implant or pacemaker
16. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment
17. Estrogen receptor status (ER) not known
18. Currently pregnant or lactating
19. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol
20. Geographic inaccessibility for follow-up
21. Lack of preoperative staging with breast and axillary ultrasound
22. Inability to adequately plan the patient for the experimental technique
The Effect Of A School-Based Physical Activity Educational Program

Regular physical activity of different intensity has many significant benefits for all ages, particularly adolescents. School-based educational programs about physical activity were found to increase the level of physical activity among adolescents positively. However, among adolescents in Jordan, few studies measured the impact of school-based educational programs on students' physical activity and knowledge levels. There is no single study that measured the students' physical activity self-efficacy. The study aimed to assess the effectiveness of a school-based physical activity program on adolescents' knowledge of the physical activity, physical performance, and physical self-efficacy. A Randomized Control trial (RCT) design was used among 210 8th grade school students (boys and girls) from four governmental schools in North of Jordan .

Background: Regular physical activity of different intensity has many significant benefits on the health of all ages, particularly adolescents. School-based educational programs about physical activity were found to increase the level of physical activity among adolescents positively. However, among adolescents in Jordan, few studies measured the impact of school-based educational programs on students' level of physical activity and knowledge, and there is no single study that measured the students' physical activity self-efficacy.

Aim: To assess the effectiveness of a school-based physical activity program on adolescents' knowledge of physical activity, physical performance, and physical self-efficacy.

Methods: A Randomized Control trial (RCT) design was used among 210 8th grade school students (boys and girls) from four governmental schools in North of Jordan during December and January. Physical Activity Questionnaire for older children (PAQ-C) scales, Physical self-efficacy scale, and Knowledge of Physical Activity scale were used to collect students' data. The duration of the educational program was four weeks, with a total of 7 hours. Ethical approval was approached from the Committee on Human Subjects Research at Jordan University of Science and Technology and the Ministry of Education before the data collection.

Eligibility Criteria:
Inclusion Criteria:

* all students boys and girls in 8th grade from selected schools affiliated with eight educational directorates of the Irbid governorate,
* who are ready to participate in the educational program and meet the inclusion criteria.

Exclusion Criteria:

* Students who have any medical problems (asthma, diabetes, cardiac problems) and physical disabilities were excluded.
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery

EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).

Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment

Eligibility Criteria:
Inclusion Criteria:

* Elective colo-rectal surgery with or without anastomosis and with or without stoma
* Patient age: 18-80

Exclusion Criteria:

* Pregnancy

  * Anesthesiology ASA score of 4 or above
  * fever or existing signs of infection at the time of surgery
  * Diabetes Mellitus type I or II with HbA1C level 12% or more
  * Persons with decubitus or diabetic ulcers
  * Subjects with peritoneal metastases
  * Patients with severe malnutrition as indicated by Prealbumin value of \<20
  * BMI ≥50