cyrilzakka/clinical-trials huggingface dataset:
Cognitive Training to Improve Work Outcomes in Severe Mental Illness

This study will compare the efficacy of two types of supportive treatments for a program called Individual Placement and Support, which helps people with severe mental illnesses find and keep jobs.

Unemployment in people with severe mental illnesses (SMIs), such as schizophrenia, bipolar disorder, and major depressive disorder, has both economic and health-related costs. Unemployed people with SMIs often report an improved quality of life after finding a job, through increases in self-esteem, socialization, opportunities to use skills and abilities, external structure, and income. Supported employment plans, such as Individualized Placement and Support (IPS), help to place and support people with SMIs in jobs available in their community. However, people with SMIs often have difficulties keeping jobs. Research suggests these difficulties are due to cognitive deficits-underlying patterns of thought. This study will test two versions of IPS to see which produces the best outcomes for people with SMIs looking for jobs: one version will be supplemented with cognitive training (CT), which will address cognitive deficits related to work, and the other version will be supplemented with enhanced support (ES), which will increase the support people with SMIs receive with their jobs.

Participation in this study will last 24 months. Participants will first undergo a baseline assessment and then will be randomly assigned to receive IPS with CT or IPS with ES. Participants in both groups will complete one IPS session and one support session-either CT or ES-each week for 12 weeks. The IPS sessions will involve working with a vocational counselor to find a job and then receiving support in training for and maintaining that job. Participants receiving CT sessions will be taught strategies to improve attention, learning and memory, and problem-solving. Participants receiving ES will receive extra sessions of vocational support. All participants will complete assessments at six times: at study entry and after 3, 6, 12, 18, and 24 months. These assessments will include interviews about life circumstances, psychiatric symptoms, and job satisfaction. The first four assessment sessions will involve additional tests-administered with a pencil and paper or on a computer-that measure thinking, learning, memory, and problem-solving abilities.

Eligibility Criteria:
Inclusion Criteria:

* Receiving psychiatric care at UCSD Outpatient Psychiatric Services
* DSM-IV diagnosis of a severe mental illness, including schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder
* Unemployed in the past 30 days, but stating a goal of work
* Fluency and literacy in English

Exclusion Criteria:

* Presence of dementia
* Presence of mental retardation
Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting

The aim of this study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting.


Eligibility Criteria:
Inclusion Criteria:

1. Systematically healthy patient (American Society of Anesthesiology class I and II).
2. Male or female
3. Patients with mucogingival defects scheduled for free gingival graft.
4. Patients with good oral hygiene.

Exclusion Criteria:

1. Patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated.
2. History of recent periodontal surgery at the donor site.
3. Smokers.
4. Pregnancy and lactation.
5. Patients allergic to the used agents,
6. Severe gagging reflex.
7. Inability or unwillingness to provide informed consent.
A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System

The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.

The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models.

Eligibility Criteria:
Inclusion Criteria:

* Children (29 days-18 years old) with anti-infective therapy against infectious disease in central nervous system.
* Clinical symptoms: acute onset, fever (axillary temperature 38 ℃ or higher), headache, altered level of consciousness, vomiting, irritability, sleepiness, low muscle tone, seizures, before the fontanelle full or uplift, positive meningeal stimulation;
* Aboratory examination: CSF appearance change, CSF routine WBC \>100 per ml, CSF routine WBC 10-100 per ml, glucose \<40mg/dl, protein \>100mg/dl), positive detection of etiology (bacterial culture, antigen detection, gram staining).

Exclusion Criteria:

* autoimmune encephalitis;
* central nervous system infection complicated with tumor;
* allergic to carbapenems or glycopeptide antibiotics;
* other cases not suitable for enrollment (small sample size, incomplete clinical data, etc.).
More Relaxation by Deep Breath on Methacholine

Deep inhalation (DI) dilates normal airway precontracted with methacholine. The fact that this effect is diminished or absent in asthma could be explained by the presence of bronchial inflammation. The hypothesis tested was that DI induces more relaxation in methacholine induced bronchoconstriction-solely determined by the smooth muscle contraction-than in exercise induced bronchoconstriction, which is contributed to by both smooth muscle contraction and airway wall inflammation.

Children were referred to the lung function department by their pediatric pulmonologist. Asthma was defined by a complaint of wheezing, cough, dyspnoea or chest tightness at rest or on exercising and a positive response to methacholine or exercise challenge.

The response to exercise was considered positive when Forced Expiratory Volume in 1 s (FEV1) decreased at least 8% from Baseline.

The response to methacholine was considered positive when FEV1 decreased at least 20% or Rrs increased at least 50% from baseline, at or below a cumulated dose of 1,200 μg.

Bronchodilator medications were discontinued at least 12 hours prior to the testing and provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 was larger than 70% pred. Exercise and methacholine groups were matched for age, height, baseline FEV1 z-score, a moderate level of airway response to challenge and DI amplitude ranging 40-60% of the predicted Forced Vital Capacity (FVC). Written informed consent was obtained from the children and their parents for the procedures. Procedures for spirometry, exhaled fraction of NO (FENO), GrsDI (Respiratory conductance response to a deep inhalation) and challenges have been described previously. Acceptable GrsDI's were analyzed at a 10-20% FEV1 decrease from baseline. Statistics were performed using Mann-Whitney, Chi square tests and multiple regression as required. Data are median and interquartile range.

Eligibility Criteria:
Inclusion Criteria:

* Children referred to the lung function department by their pediatric pulmonologist.
* Asthma defined by a complaint of wheezing, cough and dyspnoea.
* Positive response to methacholine or exercise challenge.
* Bronchodilator medications discontinued at least 12 h prior to the testing
* Provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 larger than 70% pred.

Exclusion Criteria:

- Other respiratory diseases than asthma
Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and analgesic effects, so its use may be helpful for patients receiving upper endoscopy.

Unsedated esophagogastroduodenoscopy (EGD) is a useful tool for upper gastrointestinal tract examination and therapy, but it is uncomfortable for many patients. Meperidine has been widely used in colonoscopic examination for many years; however, its use in EGD has not been completely evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.

Exclusion Criteria:

* A therapeutic upper endoscopic procedure, sedated endoscopy, contraindication to Buscopan (hyoscine N-butylbromide)
* Allergy to meperidine
* American Society of Anesthesiology (ASA) risk Class 3 or higher
* Renal failure
* Decompensated cirrhosis
* Aged less than 20 years or more than 65 years
* Pregnancy
* Refusal to provide written informed consent.
Pilot Study of Remote Ischemic Preconditioning in Heart Failure

The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* LV ejection fraction \<40%
* NYHA functional class II-IV
* Non ischemic cardiomyopathy
* Stable

Exclusion Criteria:

* recent cardiovascular hospitalization (within last 4 weeks)
* ischemic cardiomyopathy
* diabetes mellitus
* peripheral neuropathy
* ventricular assist device
* contraindications to exercise stress testing
Testing a New Device to Advance the Use of Social Skills Training With Mental Health Consumers and Clinicians

This study aims to test a new device called the Social Skills Coach that is being created to help mental health consumers with social skills and community functioning. People diagnosed with schizophrenia and clinicians will be included as participants in this study. Mental health consumers (diagnosed with schizophrenia) will be randomly assigned to either test the new device or to participate in a social skills training course. Data will be collected from participants through surveys before participants either use the device or participate the course and afterwards. Individual interviews will be conducted with a sub sample of mental health consumers and clinicians. The study looks to test the credibility and acceptability of the new device to help mental health consumers and clinicians. it will also influence future research.

This phase I pilot study tests the feasibility, credibility, and acceptability of the prototype version of Social Skills Coach in terms of its use among mental health consumers and clinicians. The intervention aims to improve social and daily living skills and community functioning among people diagnosed with schizophrenia spectrum disorder. A mixed methods approach will be taken to collect quantitative data at baseline and follow-up. Quantitative data collection includes the use of surveys that comprise validated instruments. Qualitative data collection will occur at the end of the study and will include the use of semi-structured interviews to capture experiential information. Study participants will be randomly assigned to either a social skills training course (control group) or to a study arm using the Social Skills Coach program (treatment group). The study aims to demonstrate proof of concept for a larger effectiveness trial.

Eligibility Criteria:
Inclusion Criteria:

* Chart diagnosis of schizophrenia spectrum disorder, ability to provide consent, and independent living in the community.
* We will obtain written informed consent, and the consent procedure will include an evaluation of capacity to provide consent

Exclusion Criteria:

* Under age 21 or not able to provide consent.
Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?

Pain during nuclear medicine breast lymphnode detection procedures has been reported as high as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.

In sites other then the breast, using Bicarbonate to make the injection's pH closer to natural, attempts to lower the pain levels will be performed.

Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH 7.40.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for SLN imaging for melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures;
* Patients scheduled to receive two or more injections of Tc-99m SC for the purpose of clinical management of melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures.

Exclusion Criteria:

* Patients presenting for SLN imaging of lesions involving the breast, ear, nose, and genitourinary regions;
* Patients scheduled to receive only a single injection of Tc-99m SC;
* Pregnant or breast feeding women.
A SkeleTal Muscle Recovery Intervention with Dietary Protein in Heart Failure

Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.


Eligibility Criteria:
Inclusion Criteria:

1. Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or N-terminal pro B-natriuretic peptide (NT-proBNP) \>300 pg/mL
2. Age 18 years to 100 years, inclusive
3. Receiving guideline-directed medical therapy (GDMT), unless contraindicated or not tolerated
4. Any of the following markers of severe HF within prior 12 months: i) Inotropic therapy; ii) 1 or more HF hospitalizations; iii) LVEF ≤25%; iv) Peak oxygen consumption (VO2) \<50% predicted or ≤16 mL/kg/min; v) 6-minute walk distance \<300 meters; vi) Unintentional weight loss \>5% of bodyweight over the past year; vii) Moderate or severe muscle wasting on physical examination; viii) NT-proBNP ≥900 pg/mL

Exclusion Criteria:

1. Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-DXA urine pregnancy test before first DXA or randomization
2. History of left ventricular assist device (LVAD), heart transplantation, or estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m2
3. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke)
4. Milk allergy, protein allergy, lactose intolerance, and galactosemia
5. Weight ≥350 pounds and/or BMI ≥40 kg/m2
Canadian Cohort on the Origin and Progression of Airway Disease: Physiology Platform

The Canadian Respiratory Research Network (CRRN) has recently been established to study the origins and evolution of airways disease in the population. The CRRN is funded by the Institute of Cardio-respiratory Health (ICRH), an institute of the CIHR. The Physiology platform will support the other CRRN platforms (biology, imaging, population health, knowledge transfer) by providing a comprehensive characterization of the nature and extent of physiological impairment of respiratory function in smokers at risk for airways disease and in those with early or mild airway obstruction. The planned studies of the physiology group (core sites located at Queen's University, University of British Columbia and McGill University) will initially focus on smoking-related lung injury in those at risk for COPD and in those meeting spirometric criteria for mild airway obstruction, with or without respiratory symptoms. The primary aim of this initial study is to identify and validate sensitive test(s) of peripheral airway dysfunction that may qualify as physiological biomarkers for use in future CRRN studies.


Eligibility Criteria:
INCLUSION CRITERIA:

Stable patients with GOLD grade 1 mild COPD will be included in the study if they have: a post-bronchodilator FEV1≥80 %predicted and an FEV1/FVC ratio \<0.7 and \<LLN; ≥40 years of age; and a cigarette smoking history ≥10 pack-years or ≥10 years of exposure to other inhaled substances (i.e., second hand smoke and/or biomass). Symptomatic (category B) subjects will have a Baseline Dyspnea Index (BDI) total score ≤9, a modified Medical Research Council (MRC) dyspnea score ≥2, or a COPD Assessment Test (CAT) score ≥10. Asymptomatic (category A) subjects will have a BDI\>9, modified MRC\<2 or CAT\<10, no history of seeking medical care for respiratory symptoms, and no history of using respiratory medications. Symptomatic current or ex-smokers (\>10 pack-year history) who do not meet criteria for COPD (e.g., post-bronchodilator FEV1\<80%predicted and FEV1/FVC\<0.7, with both measurements also \<LLN) and who are on no respiratory medication will be included. Symptomatic will be defined as: BDI≤9, modified MRC≥2 or CAT\>10. Healthy, age- and sex-matched, non-smoking (\<2 pack-year history) participants with normal spirometry will be used for comparison purposes.

EXCLUSION CRITERIA:

* presence of clinically significant comorbidities that could contribute to dyspnea or exercise limitation (i.e., unstable heart disease, a pulmonary disease other than COPD, uncontrolled diabetes, neuromuscular or orthopedic impairment);
* history/clinical evidence of asthma;
* contraindications to exercise testing;
* \<40 years of age;
* body mass index \<18.5 or \>=35 kg/m2.
Randomized Trial of LENA Home in A Home Visiting Program

This study evaluates feasibility and efficacy of adding the LENA Home program to the standard Every Child Succeeds (ECS) home visiting curriculum. Half of the participants will receive the standard ECS curriculum during normally scheduled home visits, while the other half will receive this plus LENA Home.

Every Child Succeeds is a program that uses home visiting as a preventive strategy to support low income families in providing stimulating, safe, and nurturing environments for their young children. Most families in home visiting have experienced adversity in their lives, and had inadequate parenting role models as they grew up. Home visitors visit families during pregnancy through the child reaching three years of age, providing information, teaching, and resources to help parents provide the best possible start for their children.

LENA Home is a 13-week curriculum designed to add an early-language focus to existing home visiting or parent education programs for children ages birth to three. It employs LENA wearable audio recorder technology and targeted content to help parents and other caregivers increase interactive talk. There are 13 weekly one-on-one sessions, including modules on parent-child reading and increasing verbal interaction during typical home activities. Sessions include videos, practical techniques, and feedback from LENA recordings via intuitive reports to help parents talk more with their children. LENA Home reports provide data on adult words spoken to the child (AWC) and conversational turns (CTC). LENA Home has been shown to increase interactive talk and child language ability and informs parents how much they are talking with their children in an objective way.

Upon completion of the study, we will have more information regarding whether (1) LENA Home can be successfully integrated into existing home visiting programs (feasibility), (2) children exposed to LENA have larger vocabularies than those who do not receive the intervention, (3) mothers using LENA engage in more literacy-promoting behaviors relative to controls, and (4) LENA improves parent-child interactions (utility).

Eligibility Criteria:
Inclusion Criteria:

1. enrollment in the Every Child Succeeds home visiting program,
2. child age between 6- and 9-months old,
3. English-speaking household,
4. child gestation of at least 32 weeks,
5. child has no known neurobehavioral/genetic syndrome or brain injury likely to cause language delay,
6. maternal age at least 15 years old.

Exclusion Criteria:

Not meeting the above criteria.
Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish

Sometimes when people wear braces, the combination of dental plaque and diets high in sugar and acids can lead to white spots on the teeth surrounding the braces. These are commonly found in people with braces depending on their diet and care of their teeth. The white spots will still be present when the braces are removed. These white spots are the beginning signs of cavities and show that mineral has been lost from the tooth. This study will be testing a new varnish that is painted on the tooth around the braces to prevent these white spots from forming.

This study will enroll patients who wear braces and have planned teeth extractions. A calcium and fluoride releasing varnish will be painted on the teeth planned to be extracted. Braces will then be placed on the teeth. In 3-6 weeks, the extraction will occur and the teeth will be collected for analysis.

This is a randomized split mouth double blinded clinical trial. The CPP-ACP-NaF varnish is commercially available and is used for the treatment of tooth hypersensitivity under FDA 510K K102808. The placebo for this study is the same product without the CPP-ACP-NaF component. Patients with planned orthodontic therapy that include tooth extractions will have orthodontic brackets attached to the to-be-extracted teeth. Each patient will have the CPP-ACP-NaF varnish and the varnish base (without CPP-ACP-NaF) applied to teeth immediately after orthodontic brackets have been applied. The specific teeth (left or right) will be randomly determined as to the application of the varnish or placebo. In this experimental design each patient has CPP-ACP-NaF applied to one side and placebo applied to the other side.

When the teeth are extracted they are transferred to the Carey Laboratory for in vitro evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Patient at the University of Colorado School of Dental Medicine Department of Orthodontics who agree to consent to this study.
* Orthodontic treatment plans that include fixed appliances from the second premolar to second premolar in both arches.
* Orthodontic treatment plans that include extractions of at least 3 bicuspids for orthodontic therapy
* At least 10 years of age
* The patient has adequate oral hygiene

Exclusion Criteria:

* Evidence of decalcification or restorations on any of the premolars planned for extraction prior to orthodontic treatment
* Younger than 10 years of age
* Allergies to cow's milk or cow's milk products
* Any condition that contraindicates orthodontic treatment, or are not willing to consent to the study.