cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of an Anger and Stress Management Program on Reducing Blood Pressure Levels in Youth

High blood pressure can often be caused by stress or anxiety. This study will evaluate a school-based stress and anger management program that aims to lower blood pressure and anger levels among high school students.

High blood pressure can be caused by many factors, including stress, anxiety, diabetes, kidney disease, or obesity. In many people, there is no identifiable cause for their high blood pressure; this is known as essential hypertension (EH). Increasingly, children are being diagnosed with high blood pressure, which may lead to an increased risk of developing EH as adults. Therefore, the need exists for an effective blood pressure reduction program targeted toward youth. Research has shown that improving people's abilities to manage stress and anger reduces their risk of developing high blood pressure and heart disease. The Williams LifeSkills (WLS) workshop is a program that teaches people to cope with stressful situations. It has been shown to improve heart health, including blood pressure levels, in adults with cardiovascular disease. However, the effect of stress and anger management programs on blood pressure levels in youth has not been widely studied. Study researchers have developed and preliminarily tested a school-based anger and stress management WLS program. This study will evaluate the effectiveness of the school-based WLS program at reducing blood pressure and anger levels in high school students. If successful, this program could be implemented in schools across the country.

This study will enroll high school students. Participants will be randomly assigned to either a 12 lesson WLS program or a control group. Participants in the control group will attend regular high school classes. Participants in the WLS program will attend 12 sessions that will focus on coping skills to help manage stress and anger levels. At baseline, the end of the 12 lesson program, and follow-up visits 3 and 6 months later, participants will complete questionnaires on anger levels; life skills; hostility; stress; self-esteem; and attitudes toward school, teachers, and parents. They will also wear a blood pressure monitor for a 24-hour period.

Eligibility Criteria:
Inclusion Criteria:

* High school student

Exclusion Criteria:

* History of any chronic illness or any chronic health problem requiring pharmacological treatment (e.g., asthma, sickle cell disease, epilepsy)
* Adolescents with ambulatory systolic blood pressure greater than the 95th percentile based on age, sex, and height at screening will be allowed to participate in the workshop but may be excluded from testing
* Unwilling to be assigned into a specific treatment group
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).

Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with uncommon EGFR mutations.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old and above, male or female
2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC
3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
4. At least one measurable lesion
5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
6. A minimum life expectancy of \> 3 months
7. Adequate bone marrow reserve, hepatic, renal, and coagulation function

Other inclusion criteria apply for participating in the study.

Exclusion Criteria:

1. Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2)
2. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives.
3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment
4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment
5. Any unresolved toxicities from prior therapy greater than National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia
6. Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption
7. Active central nervous system metastases
8. Any active infection which has not been controlled at screening

Other exclusion criteria apply for participating in the Study.
Probiotic Influence on Obesity-Related Lipidemia

This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥ 28 kg/m2;
2. Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
3. Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.
4. Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;

Exclusion Criteria:

1. Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;
2. Patients with severe allergies and immune deficiency;
3. Women who are pregnant, breastfeeding or planning to become pregnant;
4. Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
5. People who have used antibiotics in the past two weeks;
6. Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy;
7. Have used laxatives or fiber supplements in the past 6 weeks;
8. Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected.
Alzheimer's Disease Prevention Trial

This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease.

PREventing Postmenopausal memory loss and Alzheimer's with Replacement Estrogens (PREPARE) is a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and progesterone) can delay the onset of memory loss or Alzheimer's Disease in elderly women with a family history of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women 65 or older with a family history of memory problems not currently on estrogen.

Exclusion Criteria:

* Significant neurological impairment
* Current estrogen use
* History of breast cancer
Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.

This study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have Bard totally implanted ports with distally-valved catheters.

This study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially \>28 days for Bard ports with distally-valved catheters.

Reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. Subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port.

A financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. These costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. No financial information will be collected from subject medical records. All required information will be extrapolated from site staff.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 21 years
* Subject has an implanted Bard port with a distally-valved catheter
* Subject has maintenance port flushes with heparin/heparinized saline or normal saline
* Subject is post infusional cancer therapy (solid tumor or hematologic)
* Subject has signed a HIPAA Authorization to use and disclose PHI

Exclusion Criteria:

* Subject is having port maintenance flushes/locks with citrate.
A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects

This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects


Eligibility Criteria:
Inclusion criteria:

* Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
* Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control.

Exclusion criteria:

* Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.
Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus prior to informed consent
* Male and female patients on diet and exercise regimen who are:

  1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
  2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
* HbA1c at Visit 1a:

  1. for patients who are drug naïve: HbA1c \>=7.0 to =\<10.0%
  2. for patients treated with one oral antidiabetic drug: HbA1c \>=6.5 to =\<9.0%
* HbA1c of \>=7.0% and =\<10% at Visit 2 (start of run-in)

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
* Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
* Impaired renal function, defined as calculated eGFR \<60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
* Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
* Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
* Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Effectiveness Study of Different Local Anesthetic Mixtures

Purpose and Background The purpose of this research study is to investigate the benefits of mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two commonly used medications to numb the skin for minor procedures. Lidocaine has a faster onset. Bupivacaine has a longer duration. They are often combined with epinephrine to increase the length of action. These medications are used to control pain at the time of the operation and to decrease discomfort immediately afterward. Participating in the study involves injection of local anesthetic containing lidocaine, bupivacaine, and lidocaine and bupivacain with epinephrine at 4 sites on the forearm. Your participation will potentially improve the administration of these medications in persons undergoing a variety of procedures. You will be one of approximately 25 healthy volunteer subjects in this research study.

Procedures

During your participation the following procedures will be completed:

* You will be asked to read over and sign this consent form, if you choose to participate
* You will be asked demographic information and your medical history will be obtained
* If you are eligible to participate, the palm side of your forearm will be marked for the location of the treatments
* Four small injections will be made into the palm side of your forearms with the local anesthetic mixtures (you will not know which injection is used at each of the four injection sites)
* A small needle will be used for pinprick sensation to determine when numbness begins and ends

Length of Study and Number of Visits This study begins at the time the medications are injected and is completed when sensation has completely returned. The study will last between 6 and 12 hours. During this time, you may perform low intensity tasks including reading, typing, and writing. You must remain in the study location as the sites will frequently be examined.

Exclusions

You should not participate in this study if any of the following apply to you:

* You are pregnant
* You have an allergy to lidocaine or bupivacaine
* You have a history of heart disease (including a prior heart attack, heart dysfunction, or heart failure)

There may be other criteria that you have to meet to be eligible for this study. The study team can discuss these with you to determine whether you qualify.

Discomfort and Risks Risks associated with the injections include temporary discomfort at the injection site and possible infection. It is also possible that you have an allergic reaction or side effect to the medications that are being used.

Benefits There is no direct benefit to you for participating in this study. Your participation will potentially improve the administration of these medications in persons undergoing a variety of procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60

Exclusion Criteria:

* Pregnancy
* allergy to local anesthetics
* history of heart disease or diabetes
Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Diphenhydramine, when injected locally, has been shown to achieve a certain level of local anesthesia. It has been documented for use in simple bedside procedures, however there is a gap in knowledge in its comparison to lidocaine. The purpose of the study is to determine if local infiltration of diphenhydramine is noninferior to the use of lidocaine 1% when trying to achieve local anesthesia for simple laceration repair. Patients who present to the emergency department with a simple laceration will be enrolled in the study. Patients will be evaluated for the pain of the injection as well as the pain of the laceration repair procedure post injection.


Eligibility Criteria:
Inclusion Criteria:

* Lacerations requiring one layer of sutures
* Lacerations appropriate for repair by emergency physicians

Exclusion Criteria:

* Active bleeding from laceration
* Complex lacerations requiring multiple layers
* Lacerations to be repaired by a specialist service
* Patients with allergies to either diphenhydramine or lidocaine
* Laceration repairs would benefit from the use of epinephrine as an additive to the local anesthetic
Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy

This study evaluates the use of robotic rehabilitation with and without transcranial direct current stimulation (tDCS) to improve motor performance in children with hemiparetic cerebral palsy. Half of the participants will receive robotic rehabilitation and half will receive robotic rehabilitation with tDCS. We hypothesize that tDCS may augment the robotic therapy and show greater improvements than robotic therapy alone.

The defining feature of hemiparetic cerebral palsy is motor impairments primarily on one side of the body. Robotic rehabilitation and non-invasive brain stimulation are both emerging technologies that may be beneficial in improving motor performance in individuals with hemiparetic cerebral palsy. Robotic rehabilitation can allow for hundreds of arm movements in the span of an hour, a level of concentrated repetitions that is not possible in traditional rehabilitation. Additionally, robotics can target specific deficits, such as coordinating both arms together, improving accuracy of reaching movements, or improving proprioception, while simultaneously giving the therapist and patient quantitative feedback on performance. Non-invasive brain stimulation using transcranial direct current stimulation (tDCS) can safely modulate activity in regions of the brain and has emerged as a tool to enhance motor learning in typically developing children and augment therapy in children with hemiparetic cerebral palsy.

Children with hemiparetic cerebral palsy will be randomized to receive robotic rehabilitation with tDCS or robotic rehabilitation with sham-tDCS. Participants and the assessors will be blinded to the treatment. All children will complete 10 sessions within 3 weeks of 1.5 hours of robotic rehabilitation. The Kinarm Exoskeleton Robot will be used and children will play games with their affected arm or both arms to target different aspects of sensorimotor control. Children will simultaneously receive real or sham tDCS for the first 20 minutes of the session. tDCS will consist of 1 mA current with the cathode applied over the contralesional M1 area. All children will be assessed before and after the 10 session intervention period using robotic and clinical measures of motor and sensory performance, and at a 3 month follow up.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of hemiparetic cerebral palsy due to unilateral perinatal stroke
* age 6-18 years
* Manual Ability Classification System (MACS) Level I-III
* Modified Ashworth Score in shoulder and elbow \<=3;
* Visual acuity (corrected) better than 20/50 in both eyes
* able to follow instructions and comply with protocol;
* able to give consent/assent;
* able to commit to all assessment and intervention sessions.

Exclusion Criteria:

* significant contractures in the upper extremity;
* other neurological conditions or active medical disease;
* unstable epilepsy;
* contraindications to tDCS;
* botulinum toxin A injections in the upper extremity in the past 6 months;
* upper extremity surgical intervention in past 6 months;
* involvement in another interventional study.
Spinal Clearance Study: Expediting the Spinal Clearance Process in the Major Trauma Patient

The Alfred Hospital receives approximately 40% of the major trauma patients in Victoria, all of whom are at risk for spinal injuries. The potential for spinal injuries necessitates the undertaking of appropriate spinal investigations, and a delay in the completion of these investigations exposes the patient to the risk of a missed diagnosis of spinal instability and of complications of immobility; the potential spinal patient is required to wear a neck collar and be nursed lying flat whilst awaiting the completion and the appropriate documentation of spinal X-ray investigations.

The purpose of this study is to identify the issues causing a delay in the process of the completion of the appropriate spinal investigations and the documentation of the results.

The outcome of the proposed research will be the development of a clinical management protocol to expedite the process, with the aim of optimising patient care and reducing complications.


Eligibility Criteria:
Inclusion Criteria:

* Major trauma patients

Exclusion Criteria:

* Patients not subjected to spinal position restrictions on admission
* Patients deceased prior to spinal clearance
* Patients transferred to another centre prior to spinal clearance
qCTG and Doppler Ultrasound in the Detection of Hypoxia Among FGR Fetuses

To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of fetal hypoxia (pH \< 7.20) among late-onset growth restricted (SGR) fetuses


Eligibility Criteria:
Inclusion Criteria:

* estimated fetal weight below the 10th centile of the reference curve for the Bulgarian population (11);
* absence of sonographic and laboratory evidence of structural anomalies;
* absence of severe maternal complications;
* documented birth weight \< 10th centile;
* full follow-up documentation

Exclusion Criteria:

* multiple pregnancies;
* congenital malformations and any chromosomal malformations known before labor and delivery;
* severe maternal complications;
* documented birth weight \> 10th centile;
* pregnancy loss;
* failure to obtain full follow-up documentation