cyrilzakka/clinical-trials huggingface dataset:
Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care in Brazil.

To verify changes in physical activity levels, metabolic markers, and physical fitness as results of two physical activity interventions within the Brazilian public health system (primary health care).

The effects of two strategies - lifestyle counseling focused on physical activity, and supervised exercise - adapted to the Brazilian primary health care system and resources will be compared between them and with a control group. Subjects are healthy, physically inactive adults from a low socioeconomic area of Sao Paulo city. Evaluations will be done at the study baseline, 6 months, 12 months, and 18 months (6 months follow-up) after the beginning. The primary outcome is leisure-time physical activity.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more;
* To be registered in the Brazilian public health system.

Exclusion Criteria:

* Practice of leisure-time physical activity in the previous month;
* Practice of transport-related physical activity (walking or cycling) for at least 150 minutes in the previous week;
* Diagnostic of type II diabetes or severe arterial hypertension;
* Use of beta-blockers for treating hypertension or cardiovascular disease;
* Health problem or disease that would make the individual incapable of leaving home and making the journey to practice physical activity;
* Diseases such as cancer, cirrhosis, chronic kidney disease, chronic obstructive pulmonary disease osteoporosis and severe depression at advanced stages;
* Cognitive problem or disease that would not allow the individual from answering the questionnaire alone;
* Being morbidly obese, with a body mass index (BMI) ≥40 kg/m2;
* To have plans to move house over the two-year subsequent period;
* Being pregnant.
Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer

A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive and Her2 normal.

This is a single arm, non-randomized, open-label phase 2 study designed to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR-positive and Her2 normal. In this study 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be, in conjunction with Fulvestrant, PO daily.

Eligibility Criteria:
Inclusion Criteria:

1. ER+ Her2- breast cancer
2. Metastatic
3. Female, at least 18 years of age
4. Candidate for fulvestrant therapy - patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant
5. Measurable or evaluable by RECIST 1.1
6. ECOG PS 0-2
7. Able to swallow study drug and comply with study requirements
8. Tumor available for fresh biopsy (two biopsies - pretreatment as regards enzalutamide, and during treatment at 4 weeks). The patient will be also be asked if they would be willing to provide a third biopsy at time of progression.
9. If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression. Patients may have already gotten the loading dose of ovarian suppression. Pre- or peri- menopausal subjects must have a negative urine pregnancy test confirmed at screening.
10. ANC \>1000/uL and platelets \>75,000/uL at screening visit
11. Total bilirubin \< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)
12. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 times ULN or \< 5 times ULN if patient has documented liver metastases
13. Creatinine \< 1.5 times ULN
14. INR \< 1.5 times ULN, or if on warfarin, can safely transition off for biopsy
15. Willing to donate blood for research at 4 time points
16. Written informed consent obtained prior to biopsies and blood samples
17. Agreement to exercise appropriate use of contraception. Subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued.

Exclusion Criteria:

1. Current or previously treated brain or leptomeningeal metastases
2. History of seizures
3. Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464)
4. Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.
Spinal Mobilization With Arm Movement and Positional SNAGS in Cervical Radiculopathy Patients

Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session.

Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.

the objective of the study is To compare the effect of spinal mobilization with arm movement and positional SNAGs on pain and disability in cervical radiculopathy patients.

The study design will be Randomized ClinicalTrial The sampling Technique will be Consecutive sampling technique

Tool:

The Neck Disability Index (NDI): used for measuring functional improvement in the neck.

Numeric Pain Rating Scale (NPRS): used for measuring pain.

Inclinometer: used for measuring Range of motion of cervical region.

Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner criteria will be used to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session.

Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.

Eligibility Criteria:
INCLUSION CRITERIA

* Symptoms duration more than 6 months.
* Age 25 -60
* The patient has confirm the diagnosis of Radiculopathy of cervical origin,
* VAS more than 5
* A cluster of Wainner 3 positive out of 4 EXCLUSION CRITERIA
* Malignancy
* Infection (such as osteomyelitis or diskettes)
* Osteoporosis
* Inflammatory arthritis
* Fracture
* Pregnancy
* Uncontrolled hypertension or cardiovascular disease
* Carotid or vertebral artery disease.
* Trauma cases
Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma

Study of the activity of PD-1 inhibitors in metastatic uveal melanoma

The aim of the research is to study the activity of PD-1 inhibitors in patients with metastatic uveal melanoma and treated by Nivolumab and Pembrolizumab. These molecules have already received the authorities approvals. The data collected will be crucial for the understanding of the mechanism of PD-1 inhibitors and also for the futures studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic uveal melanoma
* Patients who received at least once injection of Nivolumab or Pembrolizumab in the case of the disease's treatment

Exclusion Criteria:

* Antecedent of another evolutionary tumor pathology
Environment Analysis Inside an Investigational Prescription Bottle

The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.

The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. The participant will be asked to keep the medication in the bottle and to remove each pill immediately before taking it.

The participant will not store medications in pill organizers, other pill bottles, pockets, purses, etc. The participant will keep a record of when the participant removes a pill from the bottle and takes it. Certain aspects of this study will be withheld from the participant to preserve the integrity of the study. This information will be revealed at the conclusion of the study.

Eligibility Criteria:
Inclusion Criteria:

* chronic pain \> 3 months duration
* major source of pain is due to low back pain diagnosis
* prescribed only one type of opioid: hydrocodone 10mg/325 mg acetaminophen
* Last urine drug study was done between 6-12 months ago
* will have a return to clinic visit in 3 months

Exclusion Criteria:

* concurrent use of other opioids
* use of intrathecal device
* use of spinal cord stimulator
* presence of pain due to cancer, chemotherapy, radiation treatment and/or cancer related surgery
* dementia
* illiteracy
Multi-Center Study Protocol: Impact of Sarcopenia in Early-Onset Colorectal Cancer.

Sarcopenia's role in early-onset colorectal cancer (EOCRC), a subtype increasingly diagnosed in individuals under 50 years, has not yet been investigated according to recent literature.

Understanding the prevalence and prognostic impact of sarcopenia in EOCRC could inform tailored therapeutic approaches and improve patient outcomes.

As reported by the GLOBOCAN study, EOCRC occurs in individuals younger than 50 years old. According to the GLOBOCAN estimates, there were 188,069 new cases of EOCRC, with an Age Standardized Incidence Rate (ASRs) of 2.9 per 100,000 person-years worldwide. Recent evidence suggested an increasing incidence rate for EOCRC in different populations, with greater changes in both developed and developing countries. Despite the declining trend in the incidence of CRC in the total population of the developed countries, the incidence rates for EOCRC were increasing both in the developed and developing world. Sarcopenia's role in early-onset colorectal cancer (EOCRC), a subtype increasingly diagnosed in individuals under 50 years, remains underexplored.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed EOCRC
* Emergency room access for suspected surgical pathology
* Age: 18-49 years at diagnosis.
* Available baseline CT or MRI scans for sarcopenia assessment

Exclusion Criteria:

* Presence of comorbidity conditions severely affecting muscle mass unrelated to cancer (e.g., neuromuscular disorders).
* Inadequate follow-up data or loss to follow-up
* No past oncological history
Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU

FILTRex is a single-centre, controlled, randomised, prospective, non-inferiority clinical trial to compare the efficiency and safety of prolonged (72-hours) versus standard (24-hours) duration of use for Heat and Moisture Exchange (HME) filters in adult mechanically ventilated critically ill patients

Rationale: Ventilator-associated pneumonia (VAP) is the most common hospital-acquired infection (HAI) in the intensive care unit (ICU), and its impact is very high in terms of morbidity, length of hospital stay and overall costs. Minimising manipulation and disconnection of the ventilator circuit by reducing the frequency of HME filter exchange may lower the risk of its secondary contamination, hence the incidence of VAP, while maintaining its efficacy in terms of sufficient humidification of the inhaled gas mixture and safety in terms of no or minimal change in resistance to airflow.

Aim: To test the effectiveness and safety of prolonged (72-hour exchange interval) use of a single HME.

Design: Prospective, single-centre, parallel-group randomised controlled trial. Subjects: ICU patients (general ICU)

Treatment in the intervention group: HME filter exchange every 72 hours

Control group: Standard-of-care: daily HME filter exchange

Primary outcome:

1. Presence of HME-associated adverse events (a composite endpoint of endotracheal tube occlusion or nosocomial tracheobronchitis or pneumonia).
2. The cumulative incidence of lower respiratory tract microbial colonisation analysed by the Kaplan-Maier method, censored in the case of ICU discharge or extubation \> 24h.

Secondary and exploratory outcomes: Differences in the relative risk of infection-related ventilator-associated complications, antibiotics (ATB) exposure analysis, length of ICU stay in days (time frame: three months), number of ventilator-free days (time frame: 28 days); differences in the incidence of endotracheal tube occlusion necessitating reintubation between individual groups, differences in airway resistance, humidity delivered to the patients and efficacy of HMEs between groups

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. In-patient in ICU and expected to stay \> 3 days
3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation ≥ 72h
4. Clinical Pulmonary Infection score (CPIS) less than six at the baseline 5 No history and symptoms of aspiration at the baseline

Exclusion Criteria:

1. Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation
2. Pregnancy
3. Acute respiratory distress syndrome
4. Body temperature \< 32°C
5. Airway bleeding or other contraindications for the use of HME
6. An early decision of treatment withdrawal
Angiotensin Converting Enzyme Inhibitors in Treatment of Covid 19

ACEIs as treatment for COVID19

ACEIs as suggested treatment for COVID19

Eligibility Criteria:
Inclusion Criteria:

* Patients infected with covid 19

Exclusion Criteria:

* allergy or contraindications to the drug
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain

The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.

164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.

Eligibility Criteria:
Inclusion Criteria:

* Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years.

Exclusion Criteria:

* Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period
Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases

N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and physical health by reducing membrane arachidonic acid (AA) and prostaglandin E2 (PGE2) synthesis, which might be linked to the somatic manifestations physical morbidity, such as Cardiovascular disease in depression. n-3 polyunsaturated fatty acids appears to be a promising treatment that is safe, beneficial to patients with Cardiovascular disease and depression. In this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in treating Cardiovascular disease patients with major depression after 12 weeks of intervention.

This is a 3-year study and a randomized, double-blind, and placebo controlled Clinical the study. investigators plan to enroll 60 subjects from cardiovascular department of China Medical University Hospital.Participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.The intervention period is 12 weeks. Evaluation of the depressive symptoms ( using Hamilton Depression Scale, HAM-D, and Beck Depression Inventory, BDI ) of the subjects who are enrolled into the study will take place at -1st, 0, 2nd, 4th, 8th, 12th week. The plasma level of n-3 polyunsaturated fatty acids, chemokines/cytokines, and Electrocardiogram will also be measured at the beginning and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Cardiovascular disease patients
2. The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.
3. Capacity and willingness to give written informed consent.

Exclusion Criteria:

1. cognitive impairment (Mini-mental state examination score \<24)
2. comorbid psychiatric disorders, psychosis, high risk of suicide, current substance use
3. an acute coronary syndrome within previous 2 months, left ventricular ejection fraction (LVEF)\<30%, advanced malignancy, or physical inability to participate
4. use of antidepressants, anticonvulsants, lithium, or n-3 polyunsaturated fatty acids supplements
5. coagulation disorders or sensitivity to n-3 polyunsaturated fatty acids
Multiparametric Magnetic Resonance Imaging (MRI) to Improve Bladder Cancer Staging and Treatment Decision-making

The therapeutic approach to bladder cancer is strongly dependent on tumor stage and grade. Patients with non-muscle-invasive tumors (NMIBC) are usually treated with surgical resection of the tumor alone, whereas patients with muscle-invasive tumors (MIBC) ideally undergo neoadjuvant chemotherapy (NCT) and subsequent cystectomy. Magnetic Resonance Imaging (MRI) is emerging as a new staging modality, given its non-invasiveness and excellent soft tissue contrast. However, more advanced multiparametric MRI techniques are yet to be comprehensively investigated in patients with bladder cancer. Recently, genetic characteristics of bladder tumors have been identified that show significant impact on response rates to neoadjuvant treatment. The combination of new multiparametric MRI (mpMRI) techniques and genetic analyses of the tumor might allow for a better assessment of the expected clinical course of the disease and support more personalized treatment approaches.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed or suspected primary bladder cancer and a circumscribed tumor/focal thickening of the bladder wall on initial imaging (ultrasound, CT) or cystoscopy with an approx. size of ≥ 1.5 cm/for which at least 2-3 TUR-B resection loops are necessary
* Informed consent as documented by signature (Informed Consent Form)

Exclusion Criteria:

* Prior TUR-B or other bladder treatment, prior treated bladder cancers, prior pelvic irradiation
* Women who are pregnant or breast-feeding. Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

The goal of this clinical trial is to evaluate the safety of the AQUABEAM Robotic System in treating patients with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Stage ≤ T2c
* PSA ≤ 20 ng/ml
* Prostate volume ≥ 30 ml
* Grade Group (GG) 1 or 2: If GG 1: ≥ 3 cores positive for cancer. Note, multiple positive from any MRI targeted lesion will be considered as a single positive core.

Exclusion Criteria:

* Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy.
* Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months.
* Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
* Evidence of bone metastasis.
* Evidence of extracapsular involvement.
* Evidence of seminal vesicle invasion on DRE or MRI read as "definite", "probable" or "consistent with"
* Any condition or history of illness or surgery that may pose an additional risk to men undergoing the Aquablation procedure.
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region.

Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.


Eligibility Criteria:
Eligible subjects shall meet all following criteria:

* Appropriately signed and dated informed consent.
* Age ≥18 years at time of consent.
* CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I).
* Sinus rhythm
* QRS duration ≥130 ms
* Left bundle branch block
* Left ventricular ejection fraction ≤35%
* Symptomatic heart failure NYHA class ≥ II
* Documented stable medical treatment for at least 6 months
* No cardiovascular intervention during the last 6 month

Exclusion Criteria are:

* History of persistent or permanent atrial fibrillation
* Previous pacemaker or ICD implantation
* Indication to pacing due to bradycardia
* Patients considered for His bundle pacing or cardiac conduction pacing
* Patients with unstable angina
* Subject experienced a recent myocardial infarction, within 40 days prior to enrollment
* Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
* Subject is implanted with a left ventricular assist device
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
* Subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period)
* Subject has congenital heart disease
* Subject has a mechanical right-sided heart valve
* Subject has a life expectancy of less than one year in the opinion of the investigator
* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
* Subject is enrolled in one or more concurrent studies that would confound the results of this study
* Patients who have contraindications to CT scanning.
* Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 \< 40 ml/min/1.73m2