cyrilzakka/clinical-trials huggingface dataset:
Hearing Health for Korean American Older Adults With Mild Cognitive Impairment

The objective of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy of a community-delivered, affordable, and accessible hearing care intervention tailored to the needs of community-dwelling Korean American (KA) older adults with mild cognitive impairment (MCI) and their care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation through a randomized controlled pilot study. Each dyad will consist of the study participant and their care partner.

The study consists of three phases: 1) Phase 1: development of the intervention through exploratory focus groups and/or semi-structured interviews and prototyping via open-labeled trial 2) Phase 2A: randomized, controlled pilot study with study participants randomized to an immediate treatment group, versus a 6-month delayed treatment group of an intervention specific for individuals with MCI, 3) Phase 2B: a non-randomized pragmatic-focused trial of community-dwelling older KAs with hearing loss but without MCI, and 4) Phase 3: qualitative evaluation of the experience and supplemental feedback through exploratory focus groups and/or semi-structured interviews.

Eligibility Criteria:
PARTICIPANT INCLUSION CRITERIA FOR PHASE 2A: MCI-Pilot Trial

* Age ≥ 60 years
* Self-identified as first-generation Korean American
* Self-reported ability to read and speak Korean
* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \> 25 decibel hearing loss in better hearing ear
* Mild cognitive impairment (CDR=0.5 and/or Korean Montreal Cognitive Assessment (MoCA-K) \<23)
* Report not currently using a hearing aid
* Has a care partner able to participate in the study
* Stable medication regimen. Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms

PARTICIPANT INCLUSION CRITERIA FOR PHASE 2B: KA Older Adult-focused Trial:

* Age ≥ 60 years
* Self-identified as first-generation Korean American
* Self-reported ability to read and speak Korean
* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \>= 35 decibel Hearing Loss in better hearing ear
* Report not currently using a hearing aid
* Has a care partner able to participate in the study

CARE PARTNER INCLUSION CRITERIA (same for both Phase 2A and 2B)

* Age 18 years or older
* Able to read and speak Korean
* Lives in the same household with the participant or has at least daily interactions
* Aural-oral verbal communication as primary communication modality
* Able to accompany participant to all study visits

EXCLUSION CRITERIA (same for both Phase 2A and 2B)

Participant exclusion criteria

* Residence in an assisted living facility (ALF) or nursing home (NH)
* Medical contraindication to use of amplification device (e.g., draining ear)
* Currently using a hearing aid or listening device

Care partner exclusion criteria

• Individuals who do not fulfill inclusion criteria
Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial

This study was designed to analyze whether initiation of the NICHD Neonatal Research Network SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery room in non-participants and whether these changes were associated with changes in management and outcomes.

The investigators hypothesized that the investigators would observe following the initiation of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among non-participants preterm infants at Parkland Memorial Hospital.


Eligibility Criteria:
Inclusion Criteria:

* All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010

Exclusion Criteria:

* Infants receiving comfort care
* Those with major congenital anomalies
* Those enrolled in the SUPPORT trial
Hair Repigmentation During Cerebrolysin Therapy

Open-label histological study of scalp biopsies from patients undergoing treatment with Cerebrolysin as therapy for cerebrovascular disease. The aim is to assess by histological techniques the causes of follicular repigmentation that occurs during the Cerebrolysin treatment.

Patients who fulfill the study requirements will receive the standard Cerebrolysin protocol as follows: Intravenous (iv) infusions of 5 vials per week, 2 vials on Mondays and 3 vials on Thursdays for 4 weeks, followed by an 8-week resting period prior to the next cycle of treatment. Each patient will receive 3 cycles giving a total of 9 months of follow-up. For intravenous infusions, each 10 ml vial containing 215.2mg / ml of Cerebrolysin (Ever Pharma) is diluted with physiological saline solution (NaCI 0.9%) to a final volume of 100 mL.

A pre- and post-treatment biopsies will be collected from the achromotrichia area of each patient. Antisepsis of the area will be performed prior to each biopsy with chlorhexidine, followed by local anesthesia with lidocaine 2% and epinephrine. The biopsy will be collected using a 4mm punch and the wound will be sutured with non-absorbable stitches with Prolene 4-0.

Eligibility Criteria:
Inclusion Criteria:

* Known neurologist prescription for Cerebrolysin treatment due ischemic or hemorrhagic stroke, traumatic brain injury or dementia.
* Age-related white or gray hair.
* Above 40 years old
* Voluntarily consents in written informed consent by the principal or legal representative

Exclusion Criteria:

* Patients with a diagnosis of Chronic Kidney Disease (CKD).
* Known history of seizures, epilepsy, or hypersensitivity to one or any drug components.
* Pregnant patients.
* Patients with a history of recent treatment of hair coloring products.
VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors

To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle types as predictors of initial coronary events.

BACKGROUND:

Plasma triglyceride concentration is an independent although relatively weak risk factor for coronary heart disease (CHD). The relative weakness of plasma triglycerides to predict CHD may be due to the substantial diversity of lipoprotein particles that carry the triglycerides, some being related to atherosclerosis and CHD more than others. The investigators have shown in patients who have had a myocardial infarction that the rather weak association between triglycerides and subsequent coronary events is secondary to a stronger relationship with specific types of VLDL remnants, those in the LDL density range that contain apoCIIl.

DESIGN NARRATIVE:

The study will evaluate VLDL and LDL particle types as predictors of initial coronary events in men from the Health Professional Follow-up Study (HPFS) and women from the Nurses Health Study (NHS). A prospective nested case-control design will be used with a total of 1000 CHD cases and 1000 matched controls, with equal numbers of men and women. The investigators will specifically investigate the role of apoCIII containing VLDL and LDL particles in diabetes by over sampling so that 50% of the patients will have type 2 diabetes mellitus. Their previous work shows that LDL apoCIII particles are independent predictors of recurrent CHD in diabetic patients who survived a myocardial infarction. They hypothesize that apoCIII may have a special role in dyslipidemia and CHD in diabetes. Secondary Aims: Besides apoCIII, other small apolipoproteins, apo C1, CII, and All are components of VLDL and LDL and modulate the metabolism of apoB lipoproteins. It is likely that these apolipoproteins have a relationship with human atherosclerosis. They will measure these apolipoproteins in VLDL and LDL and evaluate their relationship to CHD. They will also investigate the associations between these new lipoprotein risk factors and intake of foods and nutrients, physical activity, and other risk factors, including smoking, BMI, age and gender. The results will provide new means to identify nondiabetic and diabetic persons who are at high risk of developing CHD and the environmental determinants, and could form the basis for new lipoprotein targets for lipid management by diet and medicines.

Eligibility Criteria:
Cases having first coronary event
Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

The goal of this clinical trial is to compare the effect of apigenin supplementation in freezing medium with no apigenin supplementation in freezing medium on post-thaw human sperm motility. It will also evaluate the sperm viability, total antioxidant capacity, and oxidative stress markers. The main questions it aims to answer are:

* Does apigenin supplementation in freezing medium improve the post-thaw sperm motility?
* Does apigenin supplementation in freezing medium improve the post-thaw sperm viability, total antioxidant capacity, and oxidative stress?

All normal semen samples from participants who give written informed consent and meet the eligibility requirements will be included in the study. Prepared semen samples were divided into 3 groups.

1. Pre-freezing sperm suspension
2. Frozen-thawed control without apigenin supplementation in freezing medium
3. Frozen-thawed sperm suspension with apigenin 0.2 mM supplementation in freezing medium Baseline sperm motility will be measured in pre-freezing sperm suspension. The last 2 groups will be stored in liquid nitrogen for at least one week. After thawing, the sperm suspensions will be evaluated for motility, viability, total antioxidant capacity, and oxidative stress markers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged 18-45 years who can receive semen analysis services at the Reproductive Biology Unit, Chulalongkorn Hospital, Thai Red Cross Society
* Normal semen analysis results according to the World Health Organization criteria (Volume ≥ 1.4 mL, Sperm concentration ≥ 16 million/mL, Total motility ≥ 42%, Progressive motility ≥ 30%)
* Giving consent

Exclusion Criteria:

* A history of accidents, radiation to the testes, or a history of male reproductive system surgery
* Undescended testis
* Varicocele
* A history of taking certain medications that affect sperm production, such as chemotherapy, hormones
* Currently having sexually transmitted disease
PTSD Treatment and Emotion Regulation Skills Training for Veterans With Military Sexual Trauma (PE+ER)

Prior research has found that Veterans with military sexual trauma (MST) who have more difficulties with emotion regulation were more likely to drop out of PTSD treatment prematurely. The purpose of this pilot study is to determine whether integrating evidence-based emotion regulation skills training with a scientifically validated treatment for PTSD called Prolonged Exposure (PE), will enhance PTSD treatment retention and 'dose received' and subsequently improve treatment outcomes for MST-related PTSD and difficulties with emotion regulation. Results from this project that examine the feasibility of integrating these two treatments will provide methodological evidence and justification for a randomized control trial, if warranted.

The purpose of this study is to learn ways to improve treatments for women with military sexual trauma (MST). The researchers want to learn whether combining evidence-based emotion regulation skills training with a trauma-focused therapy improves treatment outcomes. An evidence-based trauma treatment known as Prolonged Exposure will be used. Emotion regulation skills will also be included in treatment. Veterans with a positive or sub threshold diagnosis of PTSD who experienced a military sexual trauma (MST) will be included. Participants will complete up to twelve 90 minute sessions of PE with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training followed by a post-treatment assessment. All aspects of the project including consent, baseline, treatment and follow-up will be completed either in person or via videoconferencing. Fifteen participants will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* MST-related index event
* Diagnosis of PTSD related to MST assigned on the basis of the Clinician Administered PTSD Scale (CAPS; Weathers et al., 2013)
* Difficulties with emotion regulation as identified by the Difficulties with Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004; although there is no clinical cutoff for the DERS, a total score of 99 is indicative of one standard deviation above average difficulties with emotion regulation for women).

Exclusion Criteria:

* Having a household member who is already enrolled in the study
* Active psychosis or dementia at screening
* Suicidal ideation with clear intent
* Current moderate to severe Substance Use Disorder
* Concurrent enrollment in a clinical trial for PTSD or depression.
Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients

We will evaluate the effect of deep brain stimulation on the depression and quality of life in Parkinson's disease. We aim to compare depression pre-operatively and post-operatively in Parkinson's patients with deep brain stimulation to Parkinson's patients evaluated and approved for deep brain stimulation but who did not complete surgery. We will also compare quality of life measures between patients with and without deep brain stimulation.

Deep brain stimulation is an approved therapy for Parkinson's patients, and this procedure is actively performed at Vanderbilt University Hospital. Questions have been raised concerning the effect of deep brain stimulation on the depression commonly seen in Parkinson's patients. Through this study, we plan to evaluate and compare the incidence and severity of depression in Parkinson's patients with deep brain stimulation to those who did not complete the surgery. Primary literature has indicated a general increase in quality of life of those patients receiving DBS, but no studies have compared these two specific patient populations.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic Parkinson's disease.
* Patients who have received neuropsychological testing in preparation for possible deep brain stimulation.
* Patients are within the age of 50 and 85.

Exclusion Criteria:

* Parkinson's patients not approved for deep brain stimulation on the basis of neuropsychological testing.
* Patients who received deep brain stimulation less than a year ago.
* Patients who do not consent to the study procedures.
Physical Function in Critical Care (PaciFIC)

Impairment in physical function is a significant problem for survivors of critical illness. There is a growing urgency to develop a core set of outcome measures, which can be adopted in clinical and research practice to evaluate efficacy in response to interventions such as rehabilitation.

Phase 1: Development of a new outcome measure. This study aims to examine the development of a single outcome measure which may be able to be utilised across the continuum of recovery of critical illness in the evaluation of physical function. The study will involve examination of two common physical function measures - the Physical Function in intensive care test scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure based on rasch principles which may be able to capture physical functioning changes in individuals with critical illness. Aims: (1) To determine the clinical utility of two physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure to evaluate function in intensive care survivors using Rasch analytical principles.

Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an independent validation sample.

Consecutive eligible patients will be recruited into the study.

Phase 1: Two outcome measures - PFIT-s and DEMMI will be performed within 24 hour period. Order of testing will be randomised to minimise testing bias. Time-points of assessment are: awakening, ICU discharge and hospital discharge. Weekly measures will also be performed if required in ICU and/or ward settings for up to a maximum of 30 days in each setting. The measurement properties of the individual tools PFIT-s and DEMMI will be examined (e.g. validity, responsiveness).

Phase 2: Based on the findings in Phase 1 a new single outcome measure will be developed. In the second phase examination of the measurement properties of the tool will be undertaken including (reliability, validity, responsiveness).

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years of age
* Mechanically ventilated \> 48 hours
* Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)

Exclusion Criteria:

* Premorbid physical or cognitive impairment which would prevent ability to perform functional measures
* New neurological impairment such as stroke or spinal cord injury
* Trauma or orthopaedic injury requiring period of immobilization or non weight bearing status
* Traumatic brain injury with focal neurology
Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.


Eligibility Criteria:
Inclusion Criteria:

* Men or Women with a clinical diagnosis of Probable AD
* MMSE score 16 to 24 inclusive
* Age \>50 and \<90 years
* Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 months
* Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
* No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
* No diagnosis of vascular dementia
* No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for \>6 months may be eligible
* No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
* No cognitive rehabilitation within 6 months of the study
* Subject has a regular caregiver willing to attend all study visits
* Signed informed consent by the subject (and legal guardian, if applicable)

Exclusion Criteria:

* No history of drug or alcohol abuse
* No clinically significant laboratory abnormalities or medical history
* No investigational drug within 30 days of Randomization
* Intolerance or allergy to cholinesterase inhibitors
* Cannot have been on cholinesterase inhibitors for AD for \> 2 years
* If have been on cholinesterase inhibitors for \< 2 years, must have been discontinued \>= 2 months prior to randomization
* Cannot have received memantine within 2 months
* No clinically significant ECG abnormalities prior to randomization
* No history of uncontrolled seizure disorder within 12 months
* Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
* No history of malignancy within 3 years of randomization
* Women cannot be pregnant or breastfeeding
Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery


Eligibility Criteria:
Inclusion Criteria:

* Physical status of ASA 1-2
* Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion
* BMI 17.5-34.9

Exclusion Criteria:

* Allergy to study drugs
* Baseline heart rate \< 70 beat per minute or systolic blood pressure \< 100 mmHg
* Will undergo regional block
* Operation lasting for \> 4 hours or \< 90 minutes
* Consumes opioid routinely prior to operation
Jejunal Ketogenesis and Type 2 Diabetes

The goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. The type of study is an exploratory trial with the participants as own controls. The main questions it aims to answer are: 1. Does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?

The investigators have recently shown that the mucosa in the middle small intestine, the jejunum, in human volunteers produce ketones bodies.This situation is thus contrary to the common view that ketone bodies are formed by the liver during fasting/starvation. Obesity is commonly associated with hyperglycaemic conditions and diabetes mellitus type 2.This has given rise to the question of whether obesity results in disturbances in the intestinal food-induced ketogenesis and whether this influence contributes to the development of type 2 diabetes mellitus?

The project's questions are therefore:

1. Does food intake-induced ketogenesis exist in the small intestine of obese individuals?
2. Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?
3. If no to 2: What is the difference?

Eligibility Criteria:
Inclusion Criteria:

* BMI 35 to 45 kg/m2

Exclusion Criteria:

* Insulin-treated diabetes
* Sequelae of previous diabetes-associated disease (foot, eyes and kidneys, or cardiovascular incident, etc.)
* Diabetes, hypertension, lipid disorder that has not been stabilized for at least 1 month by adequate pharmacological treatment
* Continuous NSAID use
* Preferably otherwise medication-free (exceptions can be made)
* Not operated on in the abdomen (appendectomy excluded)
* Previously known organic gastrointestinal disease, except for gastroesophageal reflux disease (GERD)
* Smokers
* Pregnancy and breastfeeding
* History of drug abuse or other circumstances deemed to jeopardize the patient's ability to participate in the research project
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.


Eligibility Criteria:
Inclusion criteria:

* Must have signed consent for Amendment 5
* Must have completed visit 62 of the core IRIS trial or be in follow-up
* Must be on STI571 treatment
* If on IFN treatment, must be willing to cross over to STI571 treatment

Exclusion criteria:

* Patients who have discontinued from the study and are in follow-up
* Patients who are on IFN treatment and do not want to cross over to STI571 treatment
* Patients who have not consented to amendment 5
* Patients who did not complete the amendment 5 protocol

Additional protocol-defined inclusion/exclusion criteria may apply