cyrilzakka/clinical-trials huggingface dataset:
3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases

The purpose of this study is to investigate the auxiliary benefits of three-dimensional printed activating assistive devices for soft-mist inhaler on patients' utilization habit.

Background： The most common treatment for chronic respiratory diseases is inhalation therapy. However, inhalation therapy requires not only correct operating skills, but also exemplary and sustained adherence from the patient. Soft-mist inhaler does not require hand-mouth coordination or minimum inhalation flow rate, and the aerosol release time is longer, which can effectively deliver more medication to the respiratory tract. If the patient is unable to operate the soft-mist inhaler correctly due to abnormal finger joints or weakened hand muscles, it may affect the effectiveness of inhalation.

Study Design： This is a one-year, single-centre, prospective randomized controlled, crossover trial.

Methods： This study will be conducted in the Chest Medicine Education Room on the 2nd floor of Fu Jen Catholic University Hospital. A total of 60 participants will be recruited and randomly assigned into two groups: the control group and the experimental group. Data collection will be conducted after one month of intervention, followed by a crossover trial. Data will be collected again after the second month of intervention, and statistical analysis will be performed.

Effect： This study expect that three-dimensional printed activating assistive devices for soft-mist inhaler will enhance the satisfaction and convenience of elderly patients with chronic respiratory diseases who use soft-mist inhaler, thereby increasing their medication adherence.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-80 years
* Patients diagnosed with chronic respiratory diseases requiring the use of SMI medication by a physician
* Signed informed consent form

Exclusion Criteria:

* Not a first-time user of SMI medication
* Requires assistance from others (primary caregiver or nurse) for the operation of SMI medication
* Refusal to participate in the trial
Study of ABT-888 in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Refractory Myeloma

The combination of PARP inhibitor (ABT-888) with a proteasome inhibitors (bortezomib) have demonstrated significant anti-myeloma effects in preclinical lab and animal studies. The goal of this phase I trial is to evaluate in patients with relapsed or refractory multiple myeloma the safety, toxicity profile and tolerability of ABT-888 (Veliparib) administered on a schedule including twice daily oral dosing for 14 days followed by 1 week rest in combination with standard dosing of Bortezomib.

This is a dose-finding / dose escalation phase I trial of ABT-888 (Veliparib) in combination with Bortezomib and Dexamethasone in patients with relapsed or refractory multiple myeloma. ABT-888 is given orally (PO) twice daily (every 12 hours) for 14 days in a 21 days cycle.

First dose to be given within 1 hour of Bortezomib on day 1. Planned starting dose is 20 mg PO every 12 hours. Starting dose escalation is planned until an MTD is reached.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma.
* Measurable disease, according to the International Myeloma Working Group criteria.
* ECOG performance status 0, 1 or 2.
* Patients must have received prior treatment for MM and have relapsed or progressed on prior therapy; no limit on number of prior treatment regimens, but prior treatment must be completed 2 weeks prior to registration. Prior exposure to Bortezomib is not an exclusion criteria as long as patients did not progress or relapse while receiving or within 3 months of completing trt with bortezomib
* Prior radiation, completed at least 4 weeks prior to registration, is permitted.
* Adequate marrow reserve, liver and renal function

Exclusion Criteria:

* patients with a history of other malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, prostate cancer with stable PSA for \> 3 years, or other solid tumours curatively treated with no evidence of disease for \> 5 years.
* Patients with preexisting grade 2 (or higher) sensory neuropathy or grade 1 sensory neuropathy with neuropathic pain.
* Pregnant or lactating women
* Patients receiving concurrent treatment with other anti-cancer therapy any other investigational agents.
* Active or uncontrolled infections
* Patient with known documented congenital or acquired risk factor for thromboembolic event
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive
Effects of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism

Primary hyperparathyroidism (PHPT) is associated with increased cardiovascular morbidity. The benefit of surgical treatment in this respect is unclear.

This study was performed to evaluate the impact of parathyroidectomy (PTX) on cardiovascular risk profile.

Patients with primary hyperparathyroidism (PHPT) have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of cardiovascular disease in PHPT is not well understood and probably multifactorial. Functional or structural alterations of vascular endothelial and smooth muscle cells may impair the vascular reactivity and lead to accelerated atherogenesis. Several cardiovascular risk factors such as obesity, hypertension, insulin resistance and hyperlipidemia are more prevalent in PHPT compared with controls.Patients with severe form of PHPT had a greater probability of metabolic syndrome (MS) and insulin resistance than patients with mild PHPT and eucalcemic subjects. Although the excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. Some studies suggest that hypertension, dyslipidemia, and derangement of glucose metabolism improve after removal of overactive parathyroid tissue. Others have shown that cardiovascular risk markers remained unaltered after parathyroidectomy (PTX).

The aim of this study was to evaluate whether successful PTX is associated with decreased cardiovascular risk. We investigated indices of metabolic syndrome and insulin resistance as well as various cardiovascular risk factors in patients with manifest PHPT before and one year after successful PTX.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hyperparthyroidism

Exclusion Criteria:

* Individuals with known diabetes mellitus,coronary heart disease, stroke
Nursing Education and Collaborative Learning

Nursing education; It is the process of gaining cognitive, affective and psychomotor skills. Students gain professional competence by equipping them with these skills. Collaborative learning; It not only increases the interaction between the student and the student, but also allows the student to actively participate in the learning process and take responsibility. Thus, it is expected that the quality of health care services will increase with the graduation of nurses who are equipped in terms of knowledge, professional skills and social skills and who have advanced creativity skills. The aim of the study was to examine the effect of the collaborative learning model-based nursing education course on nursing students' creative thinking tendencies and self-regulated learning skills.

The aim of the study was to examine the effect of the collaborative learning model-based nursing education course on nursing students' creative thinking tendencies and self-regulated learning skills. The research is quasi-experimental with a single-group pretest-posttest design. Hypotheses:

1. Students who receive nursing education with a collaborative learning model have a high disposition to think creatively after education.
2. Students who receive nursing education with a collaborative learning model have high self-regulated learning skills after education.

The universe of the research consisted of 3rd year nursing students studying at a university (N:112). The sample consists of all students who enrolled in the 3rd grade, took the nursing education course, volunteered to participate in the research and attend the course. The training program is based on the collaborative learning model. Students participating in the research will take 4 hours of theoretical and 4 hours of clinical practice courses per week for 12 weeks and a patient education plan will be created in clinical practice. The research will be evaluated with the Marmara Creative Thinking Disposition Scale and the Self-Regulated Learning Scale for Clinical Nursing Practices before the education and after the education

Eligibility Criteria:
Inclusion Criteria:

Third-year students who took the course basics of nursing, internal medicine nursing, physiology, pathology, and who voluntarily participated in the study and were not absent were included in the study.

Exclusion Criteria:

* Students in other classes
* Those who do not volunteer to participate in the research
* Students who are absent
Impact of Helmet Use in Preschool Children

* To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution;
* To test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

Current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families.

The magnitude and seriousness of the injury problem in these children in the community could be high. Many injuries may occur that are not treated in emergency departments. Even the occurrence of a minor injury in the face is undesirable. These ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

Eligibility Criteria:
Inclusion Criteria:

* Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program
* The child must possess a bicycle or a riding toy to ride
* The child's caregiver speaks English or Spanish

Exclusion Criteria:

* Age less than two or greater than 5-year olds
* 3-5 year old children that do not own a bicycle or a riding toy to ride
* The child's caregiver does not speak English or Spanish.
MOLAR: Mapping Oral Health and Local Area Resources

The goal of this clinical trial is to test the impact of a screening and linkage intervention for adverse social determinants of health (aSDoH) on oral health linkage to care for emergency department patients. Researchers will compare three groups: Patients in Arm A will receive paper handouts with general oral health and aSDoH resources. Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, an individual must meet all of the following criteria:

  * No evidence of lack of capacity to provide verbal informed consent (as documented in the chart).
  * Willing to comply with all study procedures and be available by phone for the duration of the study (as reported by the patient)
  * Unmet oral health needs as ascertained by the Hope Home (adult) or Gazzaz (pediatric) questions
  * Adult (age ≥18 years old) ED patient or pediatric ED patient (\>1 year of age) presenting with parent or legal guardian. Parent will be the primary study participant but if age \> 7 years, the child will provide assent for medical record review.
  * Ability to communicate in English or Spanish (as reported by the patient)
  * Emergency severity index (ESI) 2-5 (as documented in the electronic medical record)
  * Residence within catchment area of 3-hospital region (defined by MGB home hospital catchment area) at initial enrollment (as reported by the patient)
  * Working phone number

Exclusion Criteria:

* Patients on involuntary holds (per electronic medical record review)
* Presenting from carceral facilities (per electronic medical record review)
* Presenting for acute mental health care under evaluation for Section 12 (per electronic medical record review)
* Patients presenting for assistance with intimate partner violence (IPV) or care following sexual assault
Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers

Goal of this clinical trial is to determine whether Isometric muscle training decrease pain improve function and enhance performance.

Does Isometric exercise improve pain function and performance in bowlers? Researcher will compare the Isometric muscle training with Traditional therapy to examine that isometric exercise work on pain function and performance.

Participants will receive isometric exercises for three days in week and will be followed up after two weeks total four weeks of trial(experimental group).

Participants will receive traditional physical therapy treatment three days of week and followed up after two weeks total four weeks of trail (contril group)

This research is critical for addressing a common health concern and providing evidence-based recommendations for a potentially effective and accessible intervention that can significantly enhance the quality of life and performance of individuals dealing with shoulder pain. Thesis will benefit the bowlers by increasing their performance by enhancing accuracy, speed and consistency and over all shoulder health. Because shoulder discomfort is so common and has such a detrimental influence on everyday activities and performance, research on how isometric muscle training affects shoulder pain, function, and performance is crucial. In a variety of settings, isometric training has demonstrated promise in enhancing musculoskeletal function and pain management; however, its precise influence on shoulder-related problems is yet unknown.

Eligibility Criteria:
Inclusion Criteria:

* Active Male Bowlers
* Age 18 - 30
* Pain that affects performance. Any level of pain that significantly affects a bowler's performance, accuracy, or consistency.
* Pain with psychological impact. Pain that causes emotional distress, anxiety, or frustration.
* Rotator Cuff pain.
* Weekly 6 to 8 hour training

Exclusion Criteria:

* Other than bowlers
A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period

During the COVID-19 pandemic, individuals are having to stay at home in quarantine to reduce the risk of transmission of the virus. Depending on the number of occupants and the dwelling space available, this can lead to household crowding, which can have an effect on mental health. In addition, the closing of leisure facilities, including restaurants, cafes and, with the need to self-isolate and socially distance, has led to loneliness. The focus on "loneliness" has recently been on a rise, and being described as an epidemic, especially when it has been shown to be associated with various diseases as well as increased risk of mortality. Studies conducted on participants in isolation has shown increased mental health issues including anxiety, stress and depression.

Mindfulness intervention has been shown to alleviate mental health issues including loneliness. However, to date, there is limited studies examining the effectiveness of a remote mindfulness intervention. This proposal aims to deliver a remote mindfulness program that can be accessible by participants easily and even during the isolation period. This intervention will investigate the effectiveness and safety in elevating mental health issues faced by the general population.

Loneliness, mindfulness and quality of life will be assessed as the primary outcome of the study. A mindfulness video will be used as the intervention for participants, and is compared with a group with similar video content without mindfulness component. The effect of changes in primary outcome will be assessed between groups after 2-4weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants

Exclusion Criteria:

* None
Palmitate Study: A Method Study of Dietary Lipid Oxidation in Toddlers

The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are.

The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are. These molecules are not dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine samples or more) after drinking the fat molecules, we will be able to measure how fast your toddler is sending out (excreting) these samples in the urine. This will tell us how fast your toddler is using fat for energy. This will also help determine the best urine collection schedule for studies using this technology.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male or female
* Toilet trained or not

Exclusion Criteria:

* Diagnosed metabolic disease
A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers

The recommended treatment for latent tuberculosis infection for adults is a daily dose of isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested the development of a new 300mg isoniazid formulation. The aim of the study is to compare the bioavailability of the isoniazid 300mg new formulation and three 100mg tablets of the reference formulation.

The study is a randomized, single dose, open label, fasting, two-phase crossover bioequivalence study with a wash out period of 7 days (\>7 half-life) in 28 healthy human volunteers. For the determination of isoniazid in human plasma, the investigators developed and validated a sensitive, simple and rapid HPLC-MS/MS method.

This will support the strategy adopted by the Brazilian National Program for Tuberculosis for the treatment of latent tuberculosis. The new formulation will increase patients' adherence to the treatment and quality of life. Medical doctors in Brazil should become aware of the new formulation and the new treatment strategy in order to prescribe the right medication and avoid errors that could result in a high frequency of adverse events. Future research studies should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact on the cure rate.


Eligibility Criteria:
Inclusion Criteria:

* healthy men and women
* aged between 18 and 50 years
* BMI between 18.5 and 29.9 kg/m²
A Phase 1 Study of an Investigational Drug, ALN-AT3SC, in Healthy Volunteers and Hemophilia A or B Patients

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of ALN-AT3SC in healthy volunteers and Hemophilia A or B patients.


Eligibility Criteria:
Inclusion Criteria:

Part A (SAD phase) inclusion:

* Healthy adult males aged 18 to 40 years inclusive at Screening.
* Subjects with adequate complete blood counts and liver function tests.
* Willing to provide written informed consent and willing to comply with study requirements.

Part B \& C (MAD \& MD phase) inclusion:

* Adult male hemophilia patients aged 18 to 65 years inclusive at Screening.
* Patients with adequate complete blood counts and liver function tests.
* Patients with moderate or severe, clinically stable hemophilia A or B (Factor VIII or Factor IX ≤5%).
* Willing to provide written informed consent and willing to comply with study requirements

Part D (MD Phase in patients with inhibitors) Inclusion:

* Same as Parts B/C
* A Bethesda inhibitor assay \> 0.6 BU/mL

Exclusion Criteria:

Part A (SAD phase) exclusion:

* Subjects with a personal history and/or family history of venous thromboembolism (VTE)
* Subjects with a known co-existing thrombophilic disorder
* Subjects with a history of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
* Subjects with a history of serious mental illness that includes, but is not limited to schizophrenia, bipolar disorder, severe depression requiring hospitalization or pharmacological intervention.
* Subjects who have a clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, renal, hematological, lymphatic, neurological, musculoskeletal, genitourinary, immunological including osteoarthritis and other inflammatory diseases, dermatological including rash, eczema, dermatitis, or connective tissue diseases or disorders.

Part B \& C (MAD \& MD phase) exclusion:

* Patients with a current serious mental illness that, in the judgment of the Investigator, may compromise patient safety, ability to participate in all study assessments, or study integrity.
* Patients who have a clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, renal, neurological, inflammatory or other diseases that in the judgment of the investigator precludes their participation in the study.
* Patients with a known co-existing thrombophilic disorder
* Patients with a history of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
* Patients who are known to be HIV positive and have a CD4 count \<400 cells/μL

Part D (MD Phase in patients with inhibitors) exclusion:

* Same as Parts B/C
* Patients who are known to be HIV positive and have a CD4 count \<200 cells/μL