cyrilzakka/clinical-trials huggingface dataset:
Nebulized Hypertonic Saline for Bronchiolitis

This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.

Bronchiolitis is the most common viral respiratory infection in young children and infants. It is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. Hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. Hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. Patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in California between December and April and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. Nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. Patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. Patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. Additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team.

Investigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (RDAI). The investigators will compare rates of being admitted to the hospital in each group. The investigators will also compare RDAI scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of IV fluid needed, and frequency of adverse effects. The investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. Given the significant disease burden of viral bronchiolitis, the potential impact is substantial.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of viral bronchiolitis
* between November and April

Exclusion Criteria:

* prematurity \< 34 weeks
* chronic lung disease
* congenital heart disease
* history of wheezing, asthma or albuterol use
* tracheostomy status
* need for intensive care of assisted ventilation
Impact of Reinforced Education by Video on the Quality of Bowel Preparation

High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by Video on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced education groups received additional education via reminders by video 2 days before colonoscopy. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.


Eligibility Criteria:
Inclusion Criteria:

* outpatients aged 18-80 years
* referred for routine diagnostic colonoscopy
* with access to the educational video themselves or through close family members living in the same household were eligible.

Exclusion Criteria:

1. pregnancy or breastfeeding
2. allergy to purgatives
3. suspected intestinal obstruction, stricture, or perforation
4. hemodynamic instability
5. impaired swallowing reflex or mental status
6. severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
7. illiteracy
8. history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
9. participation declined.
Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.

A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.

Exclusion Criteria:

* The patients were excluded according to the current Summary of Product Characteristics.
Peripheral Insulin Uptake in Type 2 Diabetes Mellitus and in Non-Diabetic Individuals

Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus. It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle interstitium plays a role in this process.

We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria for all participants:

* written informed consent
* hemodynamically stable with a systolic blood pressure \> 100 mmHg
* medical need to undergo a CAG procedure as determined by cardiologist

Exclusion criteria for all participants:

* ongoing myocardial infarction as determined from elevated cardiac markers
* participation in an investigational trial within 90 days prior to present study
* donation of blood (\> 100 mL) within 90 days prior to present study
* serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
* Use or recent use (within 3 months of study participation) of oral glucocorticoids

Inclusion criteria for non-diabetic individuals:

* 30 years ≤ age ≤ 80 years (extremes included)
* fasting glucose level of \< 7.0 mmol/L and HbA1C \< 6.5% (= \< 48 mmol/mol)

Exclusion criteria for non-diabetic individuals:

- known T2DM/use of glucose-lowering medication

Inclusion criteria for T2DM patients:

* 30 years ≤ age ≤ 80 years (extremes included)
* fasting glucose level of \> 7.0 mmol/L, or HbA1C \> 6.5 (= \> 48 mmol/mol) or known T2DM

Exclusion criteria for T2DM patients:

- treatment with insulin preparations
eHealth Usability in Living Kidney Donation

Several web portals for patients are available, but an assessment of their performance is scarce. This is of particular interest among candidates for kidney living donation. A crucial aspect of living donation is to provide standardized information about the risks of the procedure. In 2019 it was launched a personalized digital care path for kidney living candidates, which contains information about the donation process and facilitates the communication between clinicians, transplant coordinators, and patients, enabling telemedicine.

We aim to investigate living donor candidates' experience with the Health Village web portal and the digital care path for living donor candidates. The secondary aim is to investigate their attitude of living donor candidates to eHealth services.

Background. Several web portals for kidney patients are available, but an assessment of their performance is scarce. This is of particular interest among candidates for kidney living donation. A crucial aspect of living donation is to provide standardized information about the risks of the procedure. In Finland, the web portal Health Village contains general information about kidney diseases. In 2019 it was launched a personalized digital care path for kidney living candidates, which contains information about the donation process and facilitates the communication between clinicians, transplant coordinators, and patients, enabling telemedicine. The performance of this eHealth service has not yet been studied.

Objectives. to investigate living donor candidates' experience with the web portal Health Village and the digital care path for living donor candidates. The secondary aim is to investigate their attitude of living donor candidates to eHealth services.

Methods. A prospective cross sectional survey study. Participants will be all kidney donor candidates who have used the digital care path since its implementation in January 2019 up to 1.3.2021 (N=122). The surveys will include general data, the type of electronic devices in possession and the purpose of use. eHealth literacy will be assessed with the eHeals questionnaire. Platform's ease of use will be assessed with the System Usability Scale, and participants´ opinion about the digital path utility with six questions. These items will be answered with a Likert-scale. Finally, we added an open question for qualitative analysis.

Eligibility Criteria:
Inclusion Criteria:

* Living donor candidates from Helsinki area, from 2019 onwards

Exclusion Criteria:

* Living donor candidates from other areas of the country
* non-Finnish speakers
Restoration® Modular Revision Hip System Post Market Study

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for cementless revision of a failed femoral prosthesis.
* Patients willing to sign the informed consent.
* Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
* Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.

Exclusion Criteria:

* Patients with ongoing infection.
* Patients who are severely immunocompromised.
* Patients who are prisoners.
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide

The proposed research addresses the urgent need to reduce suicide rates among teens. This will be the first study that the investigators know of that will examine the feasibility and preliminary effectiveness of augmenting a suicide-focused treatment (Dialectical Behavior Therapy, \[DBT\]) with an evidence-based treatment protocol for insomnia (a digital version of Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). The goal of this clinical trial is to learn providing insomnia treatment in conjunction with suicide-focused treatment leads to greater reductions in suicidality and self-harm than suicide-focused treatment alone.

Participants will be randomly assigned to receive 6 months of DBT plus CBT-I or to DBT alone and will complete research assessments measuring suicidal ideation, self-harm behavior and insomnia symptoms every four weeks over the course of the study, as well as one post-treatment follow-up assessment. Participants will also wear a device on their wrist (like a Fitbit or wristwatch) for 10 days following each assessment to collect data about their sleep.


Eligibility Criteria:
Inclusion Criteria:

1. 12-18 years of age and not yet graduated from high school.
2. Insomnia symptoms, defined as a total score of ≥ 8 on the Insomnia Severity Index .
3. High suicide risk, defined as: \>1 lifetime suicide attempt, b) \> 3 lifetime SH episodes (with at least 1 in the 12 weeks before baseline screening) and c) elevated SI (≥31 on the SIQ-Jr.).
4. If taking medication for psychiatric disorders or sleep, must be on a stable dose (\>2 months).
5. Youth and parent both speak English.
6. At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group.
7. Youth lives at home.

Exclusion Criteria:

1. Significant current mania or psychosis; life threatening anorexia, or other diagnosis of a severe mental or physical condition requiring treatment specific to that disorder and/or that interferes with participation in assessments or treatment.
2. A history of being diagnosed with an Autism Spectrum Disorder.
3. Has a comorbid untreated sleep apnea or a severe circadian sleep-wake disorder with a habitual bedtime after 3 AM or habitual rise time after 11 AM.
4. Insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications.
5. Has conditions that require caution when implementing CBTI, such as bipolar and seizure disorders.
6. Court-ordered to treatment.
Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.

Study Design:

The proposed study is a community-based blinded randomized controlled trial with 2 study arms that will be conducted in two phases:

* Phase I will take place during the dry season (December to April), when malaria transmission rates are lower. Eligible subjects (one per household) will be individually randomized to receive a daily dose of either a powdered vitamin/mineral fortificant containing 12.5 mg of iron (plus ascorbic acid, vitamin A and zinc), or a placebo (containing all micronutrients excluding iron), added to complementary foods, for 5 months.
* Phase II will take place during the wet season (June to October), when malaria transmission rates are higher. Eligible subjects, who did not participate in Phase I, will be individually randomized to one of the two study arms as described above and followed for 5 months.

A dual phase design, with two unique cohorts, was chosen so that preliminary results (at the end of phase 1) could be assessed by an independent Data Safety and Monitoring Committee. It is possible that during the dry season no impact of iron will be detected, while during the wet season, an impact will be observed. With this possible outcome, it is potentially feasible to translate this knowledge into a Ministry of Health Program to only provide iron supplementation (fortification) during the dry months of the year (December to April).

Eligibility Criteria:
Inclusion Criteria:

* Age 6-24 months
* Ingesting weaning food in addition to breastmilk
* Free from malaria or other major illnesses
* Afebrile
* Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up

Exclusion Criteria:

* Severe anemia (hemoglobin \<70g/L)
* Weight-for-height \<-3 z-score(severe wasting)
* Kwashiorkor (defined as evidence of edema)
* Congenital abnormality
* Treatment with iron supplements within the past 6 months
* Presence of any chronic illness
Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence

The goal of this clinical trial is to explore effectiveness on physical activity, function and psychometrics in relation to an exercise intervention in physically inactive middle-aged men and women. The main questions it aims to answer are:

* Is the exercise intervention effective in increasing physical activity, function and motivation towards exercise? Is there an intervention effect in physical activity, function and psychometrics at 6-, 12- and 24 months post baseline?
* Can barriers and facilitators towards increased physical activity be identified in the two groups of the study?

All participants will first receive standard care for physically inactive patients, i.e. Physical activity on Prescription (PaP), followed by allocation to an exercise intervention (EI) group or a control group. The EI group will be offered an additional exercise intervention for 16 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness centre. The control group will be asked to adhere to their PaP.

Researchers will assess physical activity, function and psychometrics in the two groups at 6-, 12- and 24 months to evaluate the intervention effect. Additionally, interviews with the participants in the control and EI groups will be performed in order to explore barriers and facilitators towards increased physical activity in formerly inactive patients.


Eligibility Criteria:
Inclusion Criteria:

* Physically inactive persons as defined as not meeting the current recommendations of at least 150 minutes of moderate to vigorous physical activity per week. This criterion is self-assessed by potential participants.
* Age 40-60 years

Exclusion Criteria:

* Physical disability that affects the ability to perform the exercise intervention.
* Heart failure or severe degenerative disease, e.g. malignant cancer, multiple sclerosis etc.
* Myocardial infarction or stroke during the last 12 months.
* Heart conditions including angina pectoris that is worsened with exercise.
* Neuromuscular, musculoskeletal, or rheumatic conditions that is worsened with exercise.
* Hypertension grade III, i.e. systolic blood pressure above 180 mmHg and/or diastolic blood pressure over 110 mmHg.
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa).

The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes.

UC San Francisco will have oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center.


Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo or have undergone\* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids.
* Able to give informed consent
* Speak English or Spanish

  * Women enrolled at contracted clinical sites must enroll prior to their RF ablation treatment

Exclusion Criteria:

* \<21 years of age
* Plan to undergo hysteroscopic myomectomy
Focused Ultrasound Cavitation Augmented With Aerobic Exercise

This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life.

Abdominal obesity can be treated through invasive and non-invasive procedures. The most common invasive protocol is surgical liposuction, this is mostly useful for removing large volume of fat. Nonsurgical approaches included exercises and selective focus energy which target the subcutaneous adipose tissue including focused ultrasound. Focus ultrasound produce cavitation which results in fat cell lysis through mechanical energy without causing any harmful effect on surrounding nerves and connective tissue.

There is an increasing demand for noninvasive fat reduction methods; there is variety of physical treatments in practice for localized fat reduction such as electrical stimulation, mechanical massage, light based therapies and cold low level laser irradiation but clinically most of them failed to meet expectations. Literature reported that clinically High Intensity Focused Ultrasound (HIFU) is most effective for noninvasive fat reduction therapy. Ultrasound causes cavitation phenomena on fat droplet watery cytoplasm interface and eventually rupture of adipocytes and triglycerides release, this whole phenomena is caused through generation of compression and decompression cycle at specific frequency. Ultrasound Fat cavitation is the technique of handling obesity, specially by destroying fat and shaping a body part. There is a limited literature available on effects of aerobic exercises and focused ultrasound cavitation on obesity but there was no literature available on combine effects of both treatments. This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Overweight (Asian BMI scoring)
* 25 to 40 years of age
* Central obesity

Exclusion Criteria:

* Morbidly obesity
* Hypertension
* Arthritis
* Musculoskeletal disorders
* Cardiovascular disorders
Refinement of Suicide Risk Management Intervention

Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of suicide Ideation
* History of suicide attempts

Exclusion Criteria:

* Geographic location outside the U.S.