cyrilzakka/clinical-trials huggingface dataset:
A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)

This study will evaluate the efficacy and safety and tolerability of 2 dose levels of MK-0653H in Japanese participants. The primary hypotheses are that the administration of MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol (LDL-C) after 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Japanese
* Outpatient with hypercholesterolemia
* Female participant who is of reproductive potential has to agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
* Will maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS 2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Exclusion Criteria:

* Uncontrolled hypertension (treated or untreated)
* Uncontrolled type 1 or type 2 diabetes mellitus
* History of coronary artery disease (CAD), CAD-equivalent disease
* Familial hypercholesterolemia or has undergone LDL apheresis
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption
* History of cancer within the past 5 years (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer)
* Human Immunodeficiency Virus (HIV) positive
* History of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy
* Consumes more than 25 g of alcohol per day
* Currently following an excessive weight reduction diet
* Currently engages in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study
* Hypersensitivity or intolerance to Ezetimibe or Rosuvastatin
* Myopathy or rhabdomyolysis with Ezetimibe or any statin
* Pregnant or lactating
* Taking any other investigational drugs and/or has taken any investigational drugs within 30 days
The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery

The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.

The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice. Currently, this assessment is based on hemodynamic changes, although hypertension or tachycardia is neither sensitive nor specific. An overdose in opioids exposes to many side effects ranging from respiratory depression to phenomena of post-operative hyperalgesia. Conversely, an under-dosage in opioids is at the origin of a nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative morbidity or promote the occurrence of implicit memorization.

Nociceptive influx can not be detected directly. However, its ascent to the somesthetic area of the cerebral cortex leads to physiological reactions that can be evaluated. In particular, there are numerous anatomical and functional interactions between the autonomic nervous system and the nociceptive tract in the brain stem. These interactions are mainly at the level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the solitary tract nucleus and the hypothalamus. The nociceptive influx thus leads to changes in the activity of the ANS. The study of changes in the ANS would therefore be a method of assessing the intensity of the nociceptive influx.

This objective method can be used in the non-communicating or unconscious patient to evaluate the pain and to adapt the analgesic treatment to the best.

Obese patients who receive surgical management often have comorbidities such as restrictive syndrome, or obstructive sleep apnea syndrome. They thus represent a target of choice in perioperative analgesic optimization in order to avoid respiratory complications that may be related to over or under assay of morphine such as atelectasis, alveolar hypoventilation.

It is hypothesized that this device is more effective for the intraoperative evaluation of analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized patients for bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Major Patient Age ≥ 18 years
* Adult patients candidate for planned surgery with BMI\> 30.
* Affiliation to social security.
* Patients who were clearly informed and signed consent.

Exclusion Criteria:

* Patient with a heart rhythm disorder.
* Respiratory rate less than 9 cycles / min.
* Irregular spontaneous ventilation.
* Perioperative use of a drug acting on the sinus node (eg atropine, etc.)
* History of neuropathic pain.
* Patient under morphine until the day before surgery.
* Patients under guardianship or curatorship or deprived of liberty
Voice Quality Analysis of Patients With Laryngotracheal Stenosis

The investigators previously demonstrated that voice changes are common in patients with Laryngotracheal Stenosis (LTS), and patients typically report an improvement in voice outcomes following endoscopic dilation. Recently, NIH based programs such as a Bridge to Artificial Intelligence (Bridge2AI) have highlighted the use of artificial intelligence to identify acoustic biomarkers of disease. Therefore, the investigators hypothesize that progression of LTS scar can be quantified using acoustic measurements and machine learning. The goal of this clinical trial is to remotely monitor patient voice quality in an effort to determine if regularly performed voice recordings can be used as a diagnostic tool in order to predict the need for dilation procedures. The investigators feel that successful use of remote voice recording technology with algorithmic analysis will improve patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of laryngotracheal stenosis
* Patient age 18 - 80 years old
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* The patient must be able to comprehend and have signed the informed consent.
* The patient must have documentation of their date of laryngotracheal stenosis diagnosis and prior medical/surgical history.

Exclusion Criteria:

* Inability to use the app associated with the study.
* Comorbid laryngeal or glottic disease
* Concurrent neurological disease which may impact voice use (such as tremor, parkinsonism, laryngeal dystonia)
Program AACTIVE: African Americans Coming Together to Increase Vital Exercise

Program AACTIVE will enroll 80 African American/Black men with type 2 diabetes and depression. Participants will be randomized to either the intervention arm or the control arm. Participants in the intervention arm will receive counseling (cognitive behavioral therapy) and physical activity sessions over 12 weeks. Counseling and physical activity sessions will take place via a video conferencing platform. There will also be 3 in-person health assessments including baseline, at 12-weeks and 3-month follow up. The investigators are interested in seeing if physical activity and counseling improve A1C outcomes and depression symptoms for participants.

Participants will be randomized to the Program AACTIVE intervention group or an Enhanced Usual Care (EUC) group. The intervention group will receive 10 sessions of cognitive behavioral therapy (CBT) and 6 physical activity sessions over the 12-week period. All Program AACTIVE CBT sessions and exercise sessions will run concurrently and take place virtually.

Eligibility Criteria:
Inclusion Criteria:

* African American/Black males, ambulatory status, diagnosed with type 2 diabetes for one year duration or longer, PHQ-9 score \>=15 with no self-reported psychotic symptoms, live in the Wayne or Washtenaw Counties, have reliable transportation to in-person events, have reliable access to internet and a device that supports video calls.

Exclusion Criteria:

* Stage 2 hypertension as defined by JNCVIII, recent cardiac events, recent laser surgery for proliferative retinopathy, history of stroke, lower limb amputation, peripheral neuropathy, aortic stenosis or other sever valvular heart disease, atrial fibrillation, severe COPD (e.g., basal oxygen), class III or IV heart failure or medical instability.

Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health care provider will be excluded while participants who are currently receiving only medication management from as psychiatrist will be included.
Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease

This will be an open label multicenter study of the safety and efficacy of an active implantable VNS device in patients with Crohn's Disease.

Patients who complete study SPM-007 will be enrolled in this study at the time of the last visit of the preceding study. The assessments at the last visit of the preceding study will also be used as baseline measures for the current study. If the patient has previously discontinued SPM-007 and greater than 30 days have elapsed since the final visit in SPM-007, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies.

The study will continue until the last patient entered has completed 24 months in this study.

Follow-up visits will occur at 3, 6, 12, 18 and 24 months. A final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 24 months on study.

An Interim Visit must be performed a maximum of 1 month after any change in device settings. Interim visits may also be performed at any time at the principal investigator's discretion; either between scheduled visits, or after the patient has completed the Month 24 Visit, if the study is still ongoing.

Eligibility Criteria:
Inclusion Criteria:

Patients must have enrolled in study SPM-007; including patients who either completed that study or withdrew before completion of that study.

Exclusion Criteria:

Inability to provide informed consent Significant psychiatric illness or substance abuse

All patients will be excluded who have developed any of these exclusionary conditions during the SMP-007 study, or in the interim between SPM-007 and the Day 0 of SPM-010:

* History of unilateral or bilateral vagotomy
* History of recurrent vaso-vagal syncope episodes
* Known obstructive sleep apnea
* Known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block.
* Significant pharyngeal dysfunction or swallowing difficulties
* Clinically significant vocal cord damage or hoarseness
* Other implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
* Asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea
* A greater than or equal to 40 pack-year smoking history
* Active peptic ulcer disease
* Patients with a limited life expectancy due to terminal illness
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts

The purpose of this study is to investigate if there is a relationship between the take of fat grafts with and without ADSCs and the presence of specific surface markers on the cells of the stromal vascular fraction.

Two groups of patients will be studied. The control will receive centrifuged fat grafts while the other group will receive centrifuged enriched fat grafts with ADSCs. The performance of both grafts will be assessed through volume measurement employing MRI before and after 6 months post-op.

Eligibility Criteria:
Inclusion Criteria:

* contour irregularities and volume insufficiency in reconstructed breasts no matter the method of reconstruction employed
* local flaps with conditions to receive fat grafts
* good health condition

Exclusion Criteria:

* breast cancer patients under chemotherapy
* smokers
* bad health condition
* patients too thin
* patients that require a new reconstructive surgery (secondary reconstruction)
Single Superior ILM/ERM Flap for the FTMH.

In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.

After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.

Eligibility Criteria:
Inclusion Criteria:

* Full thickness macular hole

Exclusion Criteria:

* Lamellar and pseudo holes
Nutrition Education Program for Cancer Patients Receiving Radiotherapy

Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy

Weight loss is common among cancer patients, and can be attributed to many causes, including mucositis, inability to ingest or absorb adequate calories because of a problem with the alimentary tract, loss of appetite, and metabolic aberrations. Unintentional weight loss may be associated with decreased quality of life (QOL) and a poorer prognosis. Furthermore, for patients who are already in a catabolic state, the increased metabolic demands associated with anticancer treatment (particularly surgery) further worsen the problem. The novel nutrition program might improve the nutrition status and QOL in cancer patients receiving radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are diagnosed with cancer and receive radiotherapy, especially in head and neck cancer, lung cancer, or esophageal cancer.
2. Patients need nutrition support treatment
3. Informed consent

Exclusion Criteria:

1. Critical patients or life expectancy \< 12 weeks
2. Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
3. Unconscious or psychiatric patients
4. Patients with communication problems
The Primary Care Obesity Network (PCON): Incorporating Principles of Self-regulation of Intake

In response to the high prevalence rates of childhood obesity in central Ohio, the Center for Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a partnership between primary care physicians and Nationwide Children's Hospital's Center for Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in Ohio. The overall goal of PCON is to bring an effective and user friendly obesity management program to the community physician's office to prevent and treat the growing number of obese children in the setting of the private office. The predominant nutrition messaging approach to tackling childhood obesity has revolved around the food choices and portion sizes. While this is relevant, an area with significant potential for impact for maintaining optimal growth and a healthy weight for young children is addressing feeding behaviors and self-regulation of intake;. - the "how" of eating. The investigators objective it to investigate whether this self-regulation approach can be employed for an older age group of 6-11 years old.


Eligibility Criteria:
Inclusion Criteria:

* Mother of a 6-11 year old child

Exclusion Criteria:

* Unable to speak and read English
Nutritional Risk Factors for Hip Fracture: a Case Control Study

Low Body Mass Index (BMI) is a risk factor for hip fracture, but it is unknown if it is the low BMI per se that increases risk of hip fracture or if specific micro-nutrients contribute. The investigators want to elucidate this aspect in a case control study studying micronutrients in serum and bone turnover markers of hip fracture patients compared with controls of the same age.


Eligibility Criteria:
Inclusion Criteria:

Cases are admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.

Exclusion Criteria:

* Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable.
* Regarded as moribund at admittance.
* Absence of a valid informed consent or assent.
Options for Navigating Talking About Risk and Adolescent Choices

This study will examine the effectiveness of ON-TRAC (Options for Navigating Talking about Risk and Adolescent Choices), which is an online substance use prevention program that also teaches emotion regulation skills. 200 adolescents, 12-15 years of age, will be randomized to ON-TRAC or a wait list comparison group (who will be offered the intervention at the end of their study participation) to determine impact on substance use, emotion regulation abilities, mental health symptoms, and other risk behavior outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Contact with the Rhode Island child welfare system
* Caregiver who is a parent/guardian of a child who experienced maltreatment
* Caregiver who speaks English or Spanish
* Caregiver who does not have developmental delays
* Adolescent who is between 12-15 years of age
* Adolescent who is fluent in English
* Adolescent who has active follow-up with the Rhode Island child welfare system due to an indicated finding of abuse or neglect in the past year

Exclusion Criteria:

* Adolescent who cannot read at a 4th grade level
* Adolescent who has a sibling who has participated in the program
* Adolescent who has developmental delays
* Adolescent who lacks parental consent for the study
Using Generative Artificial Intelligence (AI) to Create Patient-Friendly Discharge Summaries

This will be an open-label, parallel-group, randomized trial. Patients will be randomized to review the patient-friendly discharge instructions at the time of discharge (intervention group) vs the standard of care. The intervention differs from the standard of care in that patients will be given additional medical documentation in the intervention group.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to Inpatient Medicine unit at NYULH
* Able to read and understand English
* Willing and able to consent to this research

Exclusion Criteria:

* Inpatient Hospice
* Discharged on home hospice
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.


Eligibility Criteria:
Inclusion Criteria:

* Japanese males and females aged 20 or above who have signed the informed consent form
* The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and confirmed by Mini-international Neuropsychiatric Interview (M. I. N. I.)
* The patient has a drinking risk level of High or above (\> 60 g for men and \> 40 g for women) both at the Screening Visit and at the Randomization Visit .

Exclusion Criteria:

* The patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to DSM-IV-TR and confirmed by M. I. N. I.
* The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test
CommunityRx-Cardiovascular Disease

The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:

• What is the effectiveness of community resource information on patient self-efficacy to use community resources?

Participants will be given:

* A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.
* Access to a community resource navigator for support with using the HealtheRx upon request
* 2 text messages with reminders about the HealtheRx and access to the community resource navigator


Eligibility Criteria:
Inclusion Criteria:

* patient
* African American
* age 2 or older
* Have at least one cardiometabolic condition:

  * Overweight (BMI greater than or equal to 25 kg/m\^2);
  * Obesity (BMI greater than or equal to 30 kg/m\^2);
  * ICD-9 or 10 diagnostic code for overweight or obesity
  * Adult prehypertension (SBP 120 to 129 and DBP greater than 80 mmHg);
  * Adult hypertension (SBP greater than or equal to130 or DBP = 80 mmHg);
  * Pediatric Prehypertension (SBP or DBP greater than or equal to 90th but \<95th percentile)
  * Pediatric Hypertension (SBP or DBP greater than or equal to 95th percentile);
  * ICD-9 or 10 diagnostic code for hypertension
  * Adult and Pediatric Prediabetes (Fasting glucose 100-125 mg/dL or OGTT 140-199 mg/dL)
  * Adult and Pediatric Diabetes (FPG greater than or equal to126 mg/dL (7.0 mmol/L) or OGTT greater than or equal to 200 mg/dL (11.1mmol/L) or HgbA1C greater than or equal to 6.5);
  * ICD-9 or 10 diagnostic code for diabetes, pre-diabetes or elevated glucose, or gestational diabetes;
  * Adult and Pediatric Total cholesterol (\>200mg/dL; LDL \>130mg/dL; HDL \< 35 mg/dL; TG greater than or equal to150mg/dL);
  * ICD-9 or 10 diagnostic code for hyperlipidemia

Exclusion Criteria:

* Unable to read, speak or understand English
* Unable to receive text message or email communications
* Living in the same household as someone already enrolled in the CRx-CVD study
* Adults with limited life expectancy (e.g., advanced cancer, end stage liver disease, hospice)
* Adults receiving treatment for cancer
* Adults living in skilled nursing facilities
* Dementia/other significant cognitive impairment