cyrilzakka/clinical-trials huggingface dataset:
Clinic-Based Financial Coaching and Family Health and Development

This study will examine the impact of clinic-based financial coaching on parent health-related quality of life and child development measures, as well as family social needs for families with young children receiving pediatric care at a primary care practice in the Los Angeles County safety net.

With an expert group of researchers, financial coaches, and implementation scientists, we will study the impact of clinic-based financial coaching on parent health-related quality of life, child developmental risk, and social needs.We will conduct a clinical randomized controlled trial of financial coaching for low-income families. Parents of infants in a large pediatric primary care safety-net clinic will receive either 1) financial coaching from trained coaches plus social needs screening and resource navigation at all well child visits (intervention) or 2) social needs screening and navigation alone (active control) and will be followed for two years. Aims include:

1a) Examine parent outcomes of overall health-related quality of life (primary parent outcome);

1b) Examine child outcomes of developmental risk scores (primary child outcome) and well-child visit adherence;

1c) Examine family social needs outcomes including incidence of any food insecurity, housing instability, transportation or utilities interruptions (primary family outcome any one or more); and financial metrics.

Eligibility Criteria:
Inclusion Criteria:

* Parents/caregivers in families with children 4 months or under at enrollment receiving care at Harbor-UCLA medical center clinic.

Exclusion Criteria:

* Cognitive impairment or not speaking English or Spanish.
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.

CLIN1001-004 was a randomized, double-blind, placebo controlled, dose-ranging, 7-arm, multicenter study with a gluten challenge. The objects were multiple dose safety and tolerance; efficacy (intestinal permeability \[change in urinary LAMA ratio\] and disease signs and symptoms) following gluten challenge.

Following a 21-day screening period, subjects were randomized to one of seven treatments groups: four groups received larazotide acetate (0.25 mg, 1 mg, 4 mg or 8 mg TID) along with an 800 mg gluten challenge, one group received placebo with an 800 mg gluten challenge, a safety control arm received the highest dose of larazotide acetate (8 mg TID) and gluten placebo and the last group received drug placebo and gluten placebo. The gluten challenge was administered as capsules (800 mg TID) with each main meal for a total of 2.4 g daily. Drug or drug placebo was administered TID 15 minutes prior to each main meal. Subjects received their assigned treatments for two weeks (Day 0 through Day 14) and came to clinic for a follow-up visit one week later (Day 21). Subjects remained on their gluten-free diet for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Must have been diagnosed with celiac disease by biopsy for ≥ 6 months.
* Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology.
* Must be on a gluten-free diet for at least the past 6 months.

Exclusion Criteria:

* Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis).
* Have diabetes (Type 1 or Type 2).
* Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors.
* Consuming oral corticosteroids or immune suppressants.
The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients

Elevated blood pressure is the largest contributing risk factor to all-cause and cardiovascular mortality. According to the U.S. Preventive Services Task Force, hypertension affects nearly 30% of the adult population. Many patients remain undiagnosed, despite the consensus that screening and timely diagnosis is paramount. In this study, 108 ambulatory surgery patients with elevated blood pressure (160/90) that are not yet formally diagnosed with hypertension will be enrolled and alerted of their high blood pressure by a co-investigator MD. They will request permission to follow-up with the patient and the patient's primary care provider 6 months after the initial phone call to check in on the status of their diagnosis and any action taken (lifestyle changes, medication) to alleviate their high blood pressure. Patients will receive a follow-up letter/email at 6 and 3 months to remind them of their potential diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective ambulatory surgery
* Patients with a pre-operative elevated BP defined as greater than 160/90
* Patients above the age of 18
* English speaking

Exclusion Criteria:

* Patients with a pre-existing diagnosis of HTN
* Patients who are taking a hypertensive medication
* Patients who had a pre-operative surgical screening assessment
Epidemiological Study on the Surgical Removal of Third Molars

The aim of this study is to get a clear view on current practice of surgical third molar removal in Belgium and the association with morbidity and complications.

For this prospective cohort study, patients who visit the outpatient department of Oral and Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the Flemish Hospital Network will be participating. All included patients are referred from primary dental providers for the surgical removal of one or more third molars. Before participating, written informed consent will be recorded from all eligible subjects.

Patients consult one of the oral and maxillofacial surgeons or residents working on the department of the University Hospitals Leuven for the removal of third molars. In the standard procedure, patients are not routinely clinically monitored after one week at the department.

Pre-operative, operative and postoperative data will be collected through a questionnaire, extracted data from the patient's medical file and panoramic radiography. The surgeon's individual operation technique will be registered through a one-off questionnaire. The questionnaires are taken at the same time of consultation and includes a maximum of 8 questions per time and are considered as non-invasive and a minimal burden for the patient. Postoperatively, patients record their recovery status and ability to resume daily- and work activities at day 3 and 10 by using a dairy system and, if necessary, revisit the outpatient department of oral and maxillofacial surgery.


Eligibility Criteria:
Inclusion Criteria:

* referred for the removal of one or more third molars

Exclusion Criteria:

* other concomitant oral procedures in the same surgical session
Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance

Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be randomized to one of two arms for imaging navigation to the optimal catheter location for chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be: TACE using C-arm CT supplemented by DSA or DSA only (only DSA images will be used for navigation and tumor vessel tracking). Navigation to subsequent treatment targets in all patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford University Medical Center, and is not part of the study. Vascular complexity, which affects navigation difficulty and thus the need for imaging, will be assessed separately for use in data analysis by two radiologists on a four-point scale.

We hope to learn more about the utility of C-arm CT in patients undergoing TACE for HCC. Data will be evaluated with regards to:

1. Sensitivity and specificity to diagnose additional tumors and its impact on transplantation criteria.
2. The ability to decrease procedural time by aiding navigation through complex arterial anatomy.
3. Impact on radiation dose. Although the patient would receive the radiation during C-arm CT, overall the number of DSA angiograms and fluroscopy may decrease, potentially negating any effect of the additional dose from C-arm CT

Eligibility Criteria:
Inclusion Criteria:

Patients must be affected by HCC

Patients must be 18 years old or older

Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Subjects under the age of 18

Pregnant women
Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)

The main objective of this study is to compare the clinical outcomes of TBI patients receiving only Sterofundin or 0.9% saline as main fluid therapy.

Study Design: Prospective single centre double-blind randomized controlled trial

Study endpoints/outcomes

Primary outcomes:

* 30 day mortality
* Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)

Secondary outcomes:

* Acid-base and electrolyte balance
* Daily mean change in intracranial pressure (ICP)
* Episodes of intracranial hypertension
* Duration of mechanical ventilation
* Length of ICU stay and ICU mortality

Study Duration: 2 years Site: UMMC. Departments involved: Emergency Medicine, Surgery, Anaesthesiology and Pharmacy

Methodology. Investigators will assess patients admitted to the Emergency Department, UMMC, for eligibility.

Randomisation:

Investigators will randomize patients in a 1:1 ratio to either 0.9% saline intravenous fluid group or Sterofundin® intravenous fluid group. An independent statistician not involved with the research will perform a block of eight randomisation using computerised number generator list.

Conduct of study The Department of Pharmacy will identically seal all 0.9% saline and Sterofundin® intravenous fluid bottles and label them, according to their type, as either A or B. The patients, investigators and medical and nursing staff will not be aware of the designation of the letters A and B to the fluids.

Investigators will administer the study fluid will immediately after patient randomisation and this will last for 72 hours.

Other general care of the traumatic brain injury patients from both study arms will continue as per Neurosurgical Unit protocol and Brain Trauma Foundation guidelines.

Data handling

Investigators will collect all data relevant to both primary and secondary outcomes (see also attached proforma):

Statistical analysis Investigators will conduct students t test, Chi squared and the Mann-Whitney U test as appropriate. Investigators will adjust results with univariable and multivariable logistic regression and report their odds ratio. Investigators will present survival analysis using Kaplan Meier curves and compare them using log rank test.

Eligibility Criteria:
Inclusion Criteria:

* Patients age between 18 and 65 years of age
* Non-penetrating moderate (GCS 9-12) or severe (GCS 3-8) traumatic brain injury
* Within 12 hours since the recorded time of injury

Exclusion Criteria:

* Pregnancy
* Polytrauma
* Cardiac arrest at presentation
* GCS of three with bilateral fixed dilated pupils,
* Evidence of severe cardiac, respiratory, renal or liver dysfunction
A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia

Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and functional capacity of patients. There is increasing evidence of the benefits of physical exercise in improving fibromyalgia symptoms, making these interventions part of therapeutic arsenal. Objective: To evaluate the effectiveness of a program of functional exercises in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. Intervention: The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group will perform stretching exercises with the same duration and frequency. evaluation instruments: Visual Analog Scale for pain; Fibromyalgia Impact Questionnaire; Time-up and go test; 1Repetitian Maximum test; Sit and reach test; Berg Balance Scale; and Short Form-36 and amount of analgesics used during the intervention period was evaluated.

Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and the functional capacity of patients. There is growing evidence of the benefits of exercise to improve fibromyalgia symptoms, making these interventions part of the therapeutic arsenal. Objective: To evaluate the effectiveness of a functional exercise program in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. METHODS: This was a randomized controlled trial with blind evaluator. 82 female patients with fibromyalgia were included, aged between 18 and 65 years, randomized into two groups, intervention and control. The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group performed stretching exercises with the same duration and frequency. The evaluation instruments were: Visual Analog Scale for pain evaluation; Fibromyalgia Impact Questionnaire, to evaluate health-related quality of life; Time-up and go test for functional performance assessment; 1Repetitium Maximum, for evaluation of muscle strength; sit and reach test for the assessment of flexibility; Berg Balance Scale, to assess balance; and Short Form-36 to assess overall quality of life. In addition, the amount of analgesics used during the intervention period was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Classification of fibromyalgia based on the criteria of the American College of Rheumatology
* Age 18 to 65 years;
* Pain intensity between 4 and 8cm on a visual analog scale ranging from 0 to 10cm
* Stable medication for at least three months

Exclusion Criteria:

* Uncontrolled cardiorespiratory disease
* Health condition for which physical exercise was contraindicated
* Serious psychiatric disorder
* Uncontrolled diabetes mellitus
* Inflammatory rheumatic disease
* History of regular physical exercise (30min, 3 times a week) in the previous 3 months
A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults with Type-1 Diabetes Mellitus

The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.


Eligibility Criteria:
Inclusion Criteria:

* 1.1nformed Consent signed by the subject
* 1.2 Male and female subjects 18 - 60 years of age (inclusive)
* 1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
* 1.4 Type 1 diabetes diagnosed \> 12 months ago
* 1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months
* 1.6 BMI between 18.5 and 28.0 kg/m2
* 1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom G7)
* 1.8 Willingness to follow the study procedure

Exclusion Criteria:

* 2.1 In female subjects: pregnancy or breastfeeding period (self-reported)
* 2.2 HbA1c of \> 9.0% (based on last measurement by treating physician but not older than 120 days) Note: To be repeated at the study site if measurement is older than 120 days or not available
* 2.3 History of cardiovascular diseases
* 2.4 Irregular 12-lead ECG upon investigator's judgement
* 2.5 Medical history of epilepsy or other neurological disease associated with seizure events
* 2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of tattoos or scars in the measurement area (wrist) that could impair validity of measurement upon investigator's judgement
* 2.7 Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
* 2.8 Not able to understand, write or read German
* 2.9 Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
* 2.10 Enrolment of the PI, his/her family members, employees and other dependent persons
CYCLE Pilot Randomized Trial

Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU.

Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists.

Outcomes: Feasibility: The investigators will study whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether investigators can systematically assess patients' strength.

Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU.

Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).


Eligibility Criteria:
Inclusion Criteria:

* Adults admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and
* could ambulate independently before hospital admission.

Exclusion Criteria:

* Acute condition impairing patients' ability to cycle (e.g., leg fracture),
* proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome),
* unable to follow commands in English pre-ICU,
* temporary pacemaker,
* expected hospital mortality \>90%,
* unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of MV (e.g., cardiorespiratory instability, active major bleeding)
Clinical Validation of Omron WheezeScan

The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.


Eligibility Criteria:
Inclusion Criteria:

Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible.

1. Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis?
2. Is the subject between the ages of 3 months to 8 years old?
3. Is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf.

Exclusion Criteria:

The subjects will be excluded from the study, if they have any of the following criteria.

1. Does the subject have skin rashes or wounds on the chest?
2. Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin?
3. Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)?
4. Does the subject have an allergy to disinfecting alcohol?
5. Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis?
6. Does the subject have a heavy runny nose?
7. Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection?
8. Is the subject having difficulty breathing or having severe symptoms?
9. Was the subject enrolled more than once for the same resulted breath sounds?

   * Note: The subject maybe enrolled once per arm (once wheezing, once non-wheezing).
Is wGRS Associated With DD Recurrence?

Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a significant association between the weighted genetic risk score and Dupuytren disease recurrence. However, a significant dose-response relation was not found. This might be caused by underestimating the recurrence rate, due to the retrospective nature of determining recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to see whether they suffered from recurrent disease.

Objective: We aim to determine whether the wGRS is associated with recurrent DD.

Study design: An observational study, in which the participants of the GODDAF study are followed up.

Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were previously included in another study on the genetic basis of Dupuytren disease.

Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is the presence of recurrent Dupuytren disease.


Eligibility Criteria:
Inclusion Criteria:

* DD patient
* participant in the GODDAF study
* genetic data passed the quality control
* surgical treatment of DD
* written informed consent

Exclusion Criteria:

* Decisionally incapacitated
* Patients treated for DD with collagenase or radiotherapy
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl

The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 18 to 65 years of age
* BMI \>= 19.5 and \<= 37 kg/m2
* No clinically relevant abnormal laboratory values

Exclusion Criteria:

* History or presence of renal or hepatic insufficiency
* Participated in a clinical trial in the past 30 days
* Use of con meds that prolong the QT/QTc taken within 14 days prior to study drug administration
Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

The objective of this case-control intervention study is to explore the effectiveness of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

In the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower third molar which is in vertical or mesiyoangular position and has class I and II ramus relationship and class B and C depth, will included. 75 patient will divided randomly into three groups as CGF, A-PRF and Control. After third molar surgery CGF and A-PRF will prepared and applied to the extraction sockets in CGF and A-PRF groups. nothing will applied to the control group. Post operative pain, edema and trismus will measured at 2nd and 7th days.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting asymptomatic impacted lower third molar tooth in the vertical or mesioanguler position according to the Winter classification, Class I and II ramus relation and class B and C depth according to Pell-Gregory classification
* Patients between the ages of 18-30,
* Non-smokers,
* Patients with ASA I status

Exclusion Criteria:

* Who does not want to be volunteer for the study,
* Do not comply with post-operative recommendations,
* Operation lasting more than 30 minutes,
* During pregnancy or lactation,
* Have a chronic systemic disorder that may affect healing.
* Unable to cooperate,
* Post-operative infection,
* Patients with pericoronitis