cyrilzakka/clinical-trials huggingface dataset:
App for Adverse Events to Oral Chemotherapy - Pilot Study

In recent years, the treatment paradigm for hormone receptor positive, HER2-negative disease has shifted from "chemotherapy for visceral disease" and "hormone therapy for bone disease" to "chemotherapy only for visceral crises or endocrine resistance". In recent years, CDK4/6 inhibitors have been added to the therapeutic arsenal. A meta-analysis of clinical trials of first-line metastatic CDK4/6 inhibitors showed an improvement in progression-free survival but an increase in toxicities compared to endocrine therapy alone. Other commonly used oral therapies for breast cancer are mTOR inhibitors and capecitabine. Other oral molecules will be added to the therapeutic arsenal in the coming years (e.g. alpelisib and tucatinib), each with specific toxicities.

Newer targeted therapies given in combination with endocrine therapies for breast cancer (eg with palbociclib, everolimus, and capecitabine) pose a challenge to health care providers because they are oral drugs. For "traditional" intravenous chemotherapy, patients must go to the hospital regularly, which allows close care by a team of doctors, pharmacists and nurses dedicated to breast cancer. On the other hand, for oral agents, monitoring is less systematic. Monitoring and managing the toxicities of oral treatments becomes a challenge. Suboptimal management of side effects can compromise patients' adherence to their treatment, have a negative impact on their side effects and increase costs for the healthcare system. Systematic follow-up is therefore necessary.

In the information age, public access to the Internet is increasing and most households in the province of Quebec now have access to the Internet, either on a smart phone, tablet or computer. Recent studies have shown that having a system to "self-report" side effects could even improve the survival of cancer patients and reduce costs. Apps allow patients to take an active role in their healthcare.

With the availability of an increasing number of oral therapies, monitoring the toxicities experienced by these patients is becoming a challenge and oncology teams need tools to help them ensure patient safety. At the same time, patients clearly want more information. The potential benefits and ease of use of web interfaces and patient portals for the management of oral therapy toxicities are appealing, but there is a lack of studies on them.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age
* metastatic breast cancer
* receiving oral chemotherapy (palbociclib, everolimus, or capecitabine)
* possess an smartphone, a tablet, or a personal compiter

Exclusion Criteria:

* cognitive impairments
Healthy Moms Alcohol Intervention

The study proposes to test the efficacy of a primary care-based brief intervention with women who resumed heavy drinking during the post-partum period and who used alcohol during a previous pregnancy. The trial will also examine the effects of tobacco use, illicit drug use, depression and domestic violence on alcohol use.


Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing age (18-40) who drank alcohol during their previous pregnancy and who report drinking above recommended limits in the post partum period.

Exclusion Criteria:

* N/A
Ultrasound and Phonophoresis in Carpal Tunnel Syndrome

In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic carpal tunnel syndrome.

Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided three groups. The first group was ultrasound group, the second group was PH group and the third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1% dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm² ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston Symptom Severity Scale, Functional Capacity Scale, grip strength and electroneurophysiological evaluations were compared before the treatment, after the treatment and three months later.

Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)

Exclusion Criteria:

* The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic diseases, acute trauma, pregnancy etc.)
* cervical radiculopathy
* etiologic factors which predispose to or polyneuropathy
* reinnervation or fibrillation potentials in their abductor pollicis brevis muscles
* physical or medical therapy within 3 months for CTS and steroid injection applied
* experience CTS median nerve trauma and CTS surgery
* serious thenar atrophy and anesthesia
* contraindication in steroid treatment (steroid allergies, hypertension etc.)
* contraindication in ultrasonic therapy (bleeding disorders, acute inflammation of the joints, acute infections, cancer and precancerous lesions, arteriovenous circulatory disorders etc.)
Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction in Vietnamese HIV-Infected Patients

This study is to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.

An observational study to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients in the NHTD -ACC cohort who are under cART or will start cART and can provide written informed consents.

Exclusion Criteria:

* HIV-infected patients who drop out of treatment within 6 months from the entry.
Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring intubation in the ICU
* Predicted duration of mechanical ventilation \> or = 48h
* Age \> or = 18 years

Exclusion Criteria:

* Contraindication for semirecumbent position
* Contraindication for enteral nutrition
* Pregnancy
Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients

With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* Between 8 and 21 years of age, inclusive
* Newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy
* Life expectancy of at least one year
* Able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable

Exclusion Criteria:

* Presence of visual impairment to an extent that the patient is unable to complete the computer testing
* Contraindication to MRI scan (i.e. due to cardiac pacemaker)
* Presence of programmable shunt or dental braces
* Requires sedation for MRI scans
Contributions of Transesophageal Echocardiography in Liver Transplant Surgery

The goal of this study is to describe the safety and impact of transesophageal echocardiography in instability episodes during liver transplantation, especially during reperfusion stage.

After institutional review board approval, this study was performed in Vall d´Hebron University Hospital including patients undergoing liver transplantation Interventions: peroperative transesophageal echocardiography A transesophageal echocardiography scan was performed in case of hemodynamic instability episodes, and immediately after vascular unclamping.

The investigators registered percentatge of patients with diastolic/systolic dysfunction, hypovolemia, vasodilatation, embolism and percentatge of patients with postreperfusion syndrome

A TEE scan was performed in case of hemodynamic instability episodes defined by a decrease of 30% of the mean arterial pressure (MAP) during at least 1 min, and in all patients during immediate graft reperfusion phase and up 30 minutes.

The instability hemodynamic state was classified into four categories: diastolic failure, systolic failure, hypovolemia and vasodilatation.

The diastolic evaluation was performed at ME 4C view using pulsed doppler of the mitral and tricuspid valve at the level of the leaflet tips and tissue Doppler motion of the mitral and tricuspid annulus. The systolic evaluation was performed using tissue Doppler motion of the mitral and tricuspid annulus evaluating S´. Hypovolemia was registered such low filling pressures (mitral lateral E/e´\<10 m/s), cardiac index \< 2.5 l . min-1 . m-2 and close approximation of the papillary muscles in the TG Mid SAX view. Vasodilatation was registered such low filling pressures (mitral E/e´\< 10 m/s) and CI \>2.5 l. min-1 . m-2).

An assessment of cardiac filling volumes and contractility, were obtained at two levels: the mid-esophageal four-chamber view (ME 4C) to evaluate the interaction of left and right ventricles and detect possible venous air embolism; and in the trans-gastric mid short axis view (TG mid SAX), to evaluate left ventricular size for the diagnosis of hypovolemia secondary to hemorrhage or altered venous return due to surgical maneuvers on the liver, and segmental wall motion. If the TG mid SAX view was not possible due to the posterior retraction of the stomach during surgery, the ME 4C view, mid-esophageal two chamber view (ME 2C) and mid-esophageal long axis view (ME LAX) was used for the diagnosis of left ventricle systolic dysfunction, and mid-esophageal bicaval view (ME bicaval) was used for the volemia evaluation.

Eligibility Criteria:
Inclusion Criteria: patients undergoing liver transplantation

-

Exclusion Criteria:

* None
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms

Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.


Eligibility Criteria:
Inclusion Criteria:

* Presence of papules resulting from insect bites within the last 72 hours
* Presence of symmetric lesions to compare one side to the other
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study
* History of atopy or allergic diseases
* History of allergy of any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility
The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 2

The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.

This study will assess the sensitivity of a wearable device to measure the physiological signals in COPD patients, who have previously experienced hospitalization due to exacerbation of their COPD.

The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy.

Eligibility Criteria:
Inclusion Criteria:

* Any person aged 18 years or over.
* Current diagnosis of COPD.
* Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'.
* Be able to give written consent.
* Able to understand written and spoken English.

Exclusion Criteria:

* Inability to give written informed consent.
* Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
* Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders).
* Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ).
* Based on their medical record if there is any social violence/substance misuse.
* Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
* Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
* Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months.
* Pregnancy
* Patients already involved in an ongoing research study.
* Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life.
* Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons.
* Known allergy to strap.
* On long-term oxygen therapy.
* Acute exacerbation of COPD within 6 weeks prior to inclusion.
Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients

This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Protocol No: TLC599A2003 Name of Finished Product: TLC599

Title of Study:

A Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study for Single dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee.

Study duration:

The trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.

Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female patients, at least 50 years of age.
2. Documented diagnosis of OA of the knee for at least 6 months
3. The study knee has OA with Grade 2 to 3 severity based on the Kellgren Lawrence grades
4. Patients with patient related visual analogue scale (VAS) score of 5.0 to 9.0 at baseline.
5. Willing and able to comply with study procedures and provide written informed consent.

Main Exclusion Criteria:

1. Patients who received systemic corticosteroids within the last 30 days prior to dosing.
2. Patients who use prohibited medications within 7 days prior to study drug administration or any pain control medication including acetaminophen within 48 hours prior to study drug administration.
3. Patients who use prohibited medications other than acetaminophen and oral NSAIDs from screening visit to 7 days prior to study drug administration.
4. Documented history and confirmed autoimmune disease
5. History of post-traumatic knee arthritis, or evidence of intra articular bleeding of the study knee
6. History of infective arthritis
7. Unstable study knee joint
8. Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee within 3 months prior to the screening visit.
9. A history of treated malignancy which is disease free for ≤ 5 years prior to the screening visit
10. Uncontrolled and unstable concurrent medical or psychiatric illness, that will jeopardize the safety of the patient
11. Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to the screening visit.
12. Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, or dabigatran.
13. Abnormalities of laboratory parameters as described below will qualify for exclusion:

    * hemoglobin \< 8 g/dL;
    * total white blood cell count \< 4000/ µL;
    * serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase \> 2 times upper limit of normal (ULN) for the laboratory reference ranges;
    * serum creatinine \> 2 times ULN for the laboratory reference range;
    * serum uric acid \> ULN for the laboratory reference range;
    * prothrombin time/International Normalized Ratio \> ULN for the laboratory reference range.
14. Contraindication to undergoing magnetic resonance imaging (MRI)
Cilostazol and Methotrexate in Rheumatoid Arthritis

This study aims at evaluating the therapeutic effects of Cilostazol as adjuvant therapies to low dose of Methotrexate in patients with Rheumatoid Arthritis and to evaluate their impact on Cyclic adenosine monophosphate(CAMP), Heme Oxygenase-1(HO-1).

Rheumatoid arthritis (RA) is characterized by the presence of hyperplastic synovium in association with immune-mediated inflammatory synovitis associated with chronic production of proinflammatory cytokines, which lead to cartilage and bone degradation .This study is a randomized, controlled double blind placebo-controlled ,prospective study to evaluate the potential therapeutic effects of Cilostazol on synovial inflammation when administered as add-on treatments to the low dose of Methotrexate.

A total of 70 RA patients with active disease will be recruited from Outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the study. They will be diagnosed with RA according to the American College of Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria).

RA Patients who will meet the inclusion criteria will be enrolled in the study.

They will be classified into two groups:

Group 1: 35 RA patients who will receive Methotrexate and placebo for 12 weeks and serve as the control group.

Group 2: 35 RA patients who will receive Methotrexate and Cilostazol 50 mg twice daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria (13) i.e 28 joints disease activity score (DAS-28) \>2.6.
* Age range between 18 and 60 years old.
* Patients receive methotrexate; approximately the same doses of non steroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids (Prednisolone \< 15 mg) will be allowed to enroll the trial.
* Intravenous, intra-articular or intramuscular corticosteroids; intra articular hyaluronate sodium; biological DMARDs and other conventional DMARDs will not be permitted less than 4 weeks before the first dose of cilostazol.

Exclusion Criteria:

* Patients with diabetes, congestive heart failure, other heart disease (arrhythmia, hypertension, ischemic heart diseases), severe anemia, bleeding problems, other inflammatory diseases, active infection, other illness except rheumatoid arthritis.
* Patients on low doses of aspirin
* Patients on anticoagulants.
* Patients with renal or hepatic diseases.
* Patients receiving oral prednisolone greater than 15 mg/day.
* Patients receiving biological DMARDs.
* Patients with hypersensitivity to study medications.
* Patients using antioxidants .
* Pregnant and lactating females.