cyrilzakka/clinical-trials huggingface dataset:
SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

The study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. The investigators propose a prospective observational research study of patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for sepsis, severe sepsis or septic shock during their emergency department visit.

After each 1 Liter fluid challenge of IV fluid each outcome measure will be repeated to determine if there is a change in ultrasound measures as patients undergo volume resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* All patients age greater than 18 years who meet criteria of sepsis. Septic shock will be defined as those patients with severe sepsis and persistent hypotension (\<90mmHg systolic blood pressure) despite a fluid challenge of at least 20cc/kg
* Patients will only be considered eligible for enrollment if the treating physician plans to give at least 1-liter of crystalloid after initial US is performed
* A number (approximately 50 patients) with no symptoms of sepsis will be enrolled to assess measurements in healthy patients. These patients will only have one ultrasound performed for each of the desired study measures.

Exclusion Criteria:

* Patients unable to provide consent such as non-English speaking patients or patient/health care proxy unable to give consent
* History of significant trauma
* Incarcerated patients
* Failure to complete fluid challenge
* Pericardial disease or heart transplant. Patients with left bundle branch block, pulmonary hypertension, known systolic dysfunction (Ejection Fraction \<40%), receiving vasopressors, known moderate or severe valvular dysfunction, and irregular heart rhythms will be enrolled but analyzed separately
Brief Behavioral Weight Loss Treatment vs. Weight Watchers

The purpose of this study is to compare the effectiveness of Weight Watchers, brief behavioral treatment, and a combination treatment. We hypothesize that a combination treatment will achieve greater weight losses than Weight Watchers alone.

Weight Watchers is a popular nonmedical commercial weight loss program. Recent studies suggest that people enrolled in Weight Watchers lose approximately 3-5 kg in 6 months of treatment. These outcomes are substantially lower than average weight losses achieved in 6 months if university/hospital-based standard behavioral treatment (approximately 10 kg). However, standard behavioral weight loss programs are expensive and have limited accessibility to most people seeking weight loss. Therefore, the purpose of the current study is to investigate whether enhancing Weight Watchers by adding an 8-week group-based behavioral weight loss program prior to participation in Weight Watchers will improve weight loss outcomes at 6 months.

Comparison: 6 months of Weight Watchers vs. combination treatment (2 months of standard behavioral weight loss treatment followed by 4 months of Weight Watchers) vs. 2 months of standard behavioral treatment.

Eligibility Criteria:
Inclusion Criteria:

Age 21-65 years BMI 27-45 kg/m2 Able to sign informed consent

Exclusion Criteria:

Women who are pregnant, nursing, less than 6 months postpartum, or plan to become pregnant during course of study Individuals who report a medical condition that would affect the safety and/or efficacy of a weight management program involving dietary change and physical activity (e.g., heart disease, cancer) Individuals with major psychiatric illness that would interfere with protocol adherence Individuals who are currently participating in a weight loss program or taking weight loss medication or lost \>=5% of body weight during 6 months prior to screening Recent (within the past 12 months) participation in Weight Watchers
Evaluating Simvastatin's Potential Role in Therapy

The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) cognitive function.

Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects a substance in the spinal fluid around the brain called beta-amyloid-42 which is thought to contribute to Alzheimer's disease. This study also evaluates whether simvastatin improves regional brain blood flow (on magnetic resonance imaging \[MRI\]), reduces inflammation, and improves cognitive function.

The ESPRIT study was a 9-month randomized, controlled clinical trial that randomized 100 middle-aged adults with a parental history of Alzheimer's disease. Participants were randomized to simvastatin 40 mg for one month then 80 mg daily or matching placebo tablets. Fifty of the ESPRIT subjects participated in the MRI sub-study.

Participants had the following data collected: fasting blood tests (baseline and months 3 and 9), medical history and medication questionnaires (each visit), study medication side effect review (all visits), lumbar puncture procedure (baseline and month 9), memory testing (baseline and months 3 and 9), and MRI (baseline and month 9 in 50 sub-study participants).

Eligibility Criteria:
Inclusion Criteria:

* Age 35 to 69
* Parent with Alzheimer's disease

Exclusion Criteria:

* Current use of cholesterol-lowering medication
* Active liver disease
* History of adverse reaction to statins
* Contraindication to lumbar puncture
* Elevated lab values (creatine kinase and creatinine)
* Use of medications known to interact with statins
* History of dementia
* Currently pregnant or planning to become pregnant
* Use of large quantities of grapefruit juice (more than 1 quart per day)
* Current involvement in another investigational drug study
* Contraindications to MRI (for MRI sub-study)
* Ethical contraindication to placebo (persons with high vascular risk)
Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus

One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate or reduce the symptoms of tinnitus.

This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with tinnitus that is severe enough for those persons to seek medical attention will have been seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine that acquires visual images of the brain). A diagnosis of tinnitus will be established after ruling out all other possible causes of the tinnitus.

Subjects will be up to 20 right-handed patients (men and women), 19-65 years of age, with debilitating unilateral or bilateral tinnitus. All subjects must report experiencing the presence of their phantom auditory perception for at least 6 months and have a Tinnitus Handicap Questionnaire (THQ) score \>30. Subjects will be recruited from the Otolaryngology Clinic at UAMS, where routine testing includes a physical exam; pure tone audiometry; and evaluation of middle ear status using tympanometry, stapedius reflex tests, and otoscopy. Patients will undergo a gadolinium-contrast MRI of the head to rule out acoustic neuroma or any other central nervous system pathology. All subjects will be thoroughly informed of the risks associated with the procedures in this study, as described in the Hazards to Subjects section, and written informed consent will be obtained. Subjects will be recruited for this study without regard to race or ethnicity.

Eligibility Criteria:
Inclusion Criteria:

* right-handed subjects
* 19-65 years of age
* debilitating unilaterial or bilateral tinnitus
* Experiencing the presence of phantom auditory preception for \>6 months
* Tinnitus Handicap Questionnaire score of \>30

Exclusion Criteria:

* significant neurological disease
* acoustic neuromas or glomus tumors
* active Meniere's disease
* profound hearing loss
* non English speaking
* personal or family history of epilepsy
* personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines,
* medications that lower seizure threshold and are contraindicated
* individuals who have been taking certain medications
* claustrophobia
* patients who do not exhibit significant cortical asymmetries on PET
Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC

This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
* Age 18-75 years old, Male of Female
* ECOG PS 0-1
* histologically/cytologically or clinically (according to Chinese guidelines for primary liver cancer diagnosis and treatment (2022) criteria) confirmed initial diagnosis of HCC
* Not suitable for radical surgery and/or local treatment, BCLC stage C or stage B who failed local treatment
* Patients who progressed on first-line standard system therapy (Atezolizumab plus bevacizumab, sintilimab combined with bevacizumab, or Camrelizumab and Apatinib, only these three regimenes) or with intolerable toxicity ( except for immunotherapy intolerance)
* Child Pugh A-B7
* Expected survival time≥12 weeks
* At least one measurable lesion (RECIST 1.1)
* Enough organ and bone marrow function

Exclusion Criteria:

* Fibrolamellar sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma.
* Other anti-tumor therapies have been received after first-line systemic anti-tumor therapy.
* Have history of hepatic encephalopathy, or a history of liver transplantation.
* There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion.
* People with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA \> 2000IU/ml or 10\^4 copies /ml; Hepatitis C virus (HCV) RNA \> 10\^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive.
* Central nervous system metastasis.
* Previous bleeding from esophageal or fundus varices due to portal hypertension occurred within 6 months.
* Autoimmune immune disease.
* HIV infection.
* Pregnant women.
* The presence of any serious or uncontrolled systemic disease.
* Other acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the following results: increasing the risk associated with research or drug administration, or interfering with the interpretation of research results. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
cTBS on First-episode Drug Naive Patients With Schizophrenia

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia in accordance with DSM-5
* The course of the disease less then 2 years
* Accepting antipsychotics treatment for less then 2 months

Exclusion Criteria:

* Diagnosed with other mental disease in accordance with DSM-5
* Comorbid with other severe physiological disease
* Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
* Drug or alcohol abuse
* Pregnant or lactating Contraindication to rTMS
Promoting Smoking Cessation in Hospital Patients

To experimentally test methods to promote long-term smoking cessation in hospitalized patients.

BACKGROUND:

Cigarette smoking is a vitally important public health problem. It is a major contributor to cardiovascular disease and one of the leading causes of cancer and respiratory disease. Research in primary care over the last two decades has indicated that smoking cessation interventions in medical settings can be effective. However, there have been few published reports of research examining the effectiveness of smoking cessation interventions in hospital settings. In-patient smoking cessation interventions can potentially reach a large number of smokers. A hospital stay can also be an effective "teachable moment" for smoking cessation advice. Smoking bans in place in hospitals make it a time of enforced abstinence and therefore, an opportunity to overcome the symptoms of physical addiction. Patients are removed from their usual environmental cues for smoking, making initial cessation easier, and they might be particularly receptive to preventive health messages at a time of ill-health. Finally, there is increased access to health care providers whom patients see as valid and knowledgeable sources of health information.

DESIGN NARRATIVE:

All smokers admitted to three hospitals over a 27-month period were identified as part of the admissions process. Those who met eligibility requirements were randomly assigned to one of three treatment conditions: minimal care; a low intensity intervention whose centerpiece was brief firm advice by health care providers and labelling of the smokers' charts (PA intervention); and the PA intervention plus more intensive counseling and follow-up after discharge performed by a research nurse (PA+NC intervention). Intervention components included provision of smoking cessation manuals and training of health care providers (all conditions); structural reminders to health care providers to give smoking cessation advice and provision of smoking cessation advice by a variety of health care providers on several different occasions (PA and PA+NC); and in-hospital counseling tailored to patient characteristics, feedback about a biological marker of smoking, a stepped care approach, and follow-up telephone counseling after discharge (PA+NC only). All participants were followed for twelve months after discharge from the hospital to examine the relative effectiveness and cost-effectiveness of the smoking cessation programs. In addition, information about smoking cessation advice given to study patients by primary care physicians in the twelve months after discharge from hospital was gathered to assess the possible synergistic effects of advice provided in in-patient and out-patient settings.

Eligibility Criteria:
No eligibility criteria
Ketamine + Cognitive Training for Suicidality in the Medical Setting

This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

NOTE: Edits were made to the outcome measures sections to improve clarity regarding the a priori analytic plan with respect to the "Time Frame" of measurements and to reduce redundancies. Timepoints that will be analyzed as trajectories over windows of time and measurements that will be analyzed as composites are now more clearly specified. The previous entries correctly identified all relevant measures and timepoints, but implied incorrectly that each timepoint/measure would be analyzed in isolation.

Eligibility Criteria:
Inclusion Criteria:

Participants who receive ketamine will:

1. be between the ages of 18 and 70 years
2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require follow-up psychiatric care (inpatient or outpatient)
3. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
4. be deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization

Exclusion Criteria:

1. Presence of current/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
2. Mini-Mental State Exam (MMSE) \< 21
3. Current pregnancy or breastfeeding
4. Reading level \<5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
5. Past intolerance or hypersensitivity to ketamine or esketamine
6. Patients taking St John's Wort
7. Patients who have received ECT in the past 1 month prior to intake
8. Patients at ongoing risk for severe substance or alcohol withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
9. Arrested or incarcerated individuals brought in by the legal system for medical stabilization
Contribution of the EyeMAX™ 11Fr (Micro-Tech) Digital Single-Operator Cholangioscope With a Wide Working Channel

Background and aims Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel. A new DSOC (EyeMAXTM 11Fr, Micro-Tech Endoscopy, Nanjing, China) with a 2.0 mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the initial French experience.

Methods A retrospective multicenter observational study on DSOC was conducted across five endoscopy units within the CREGG (French Society of Private Hepato-Gastroenterology). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the SpyglassTM DS II DSOC (Boston Scientific).


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients who were referred to one of the participating expert tertiary endoscopy units for an ERCP for a bile duct stenosis

Exclusion Criteria:

* patients with significant tissue mass that could easily be punctured by EUS-FNB were not included.
* non-accessibility to the bile duct due to a history of Billroth II or Roux-en-Y reconstruction,
* coagulation disorders (such as partial thromboplastin time \> 42 seconds, prothrombin time \[Quick value\] \< 50%, or platelet count \< 50,000/mm³), or treatment with clopidogrel.
Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa

Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.

Background: Up to 20% of patients with anorexia nervosa (AN) die and 50% relapse after the first episode, being its treatment a great challenge for clinicians. Most therapies excessively focus excessively on nourishment, which translates to temporarily restored weight with no improvements in psychosocial life. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a transdiagnostic treatment designed to treat overcontrol, a key aspect in the functioning of patients with AN. To date no clinical trial (CT) has proved its efficacy on these patients or has demonstrated its biological underpinning mechanisms.

Methods: A randomized CT in AN patients will be conducted, where one group will receive treatment as usual (TAU) and the other one TAU with plus RO-DBT, being psychosocial adjustment the main outcome; other secondary variables will be ED symptoms, overcontrol characteristics, autistic traits and neuroimaging changes.

Discussion: The results will fill the a knowledge gap in AN treatment, expecting that patients who receive TAU with RO-DBT will have better social adjustment and less relapses at one year follow up. This is the first study examining neuroimaging changes in RO-DBT to better understand its underlying mechanisms

Eligibility Criteria:
Inclusion Criteria:

* female patients
* aged between 18 to 65 years old,
* having a diagnosis of AN (DSM 5 criteria),
* having had weigh restoration treatment (normal BMI considered \>19 kg/m2)
* having an overcontrol personality style assessed with the styles of coping Word-Pair Checklist scale (ASC-WP)

Exclusion Criteria:

* diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder)
* diagnosis of borderline personality disorder (BPD) or positive result in McLean Screening Instrument for BPD
* mental retardation
* being under standardized psychotherapy at the baseline
* being illiterate or not able to understand Spanish language,
* being left-handed
* being pregnant for MRI requirements.
Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults

The multidimensional self-management intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome. Thus, the purpose of this study was to assess the efficacy of multidimensional self-management intervention program on metabolic syndrome subjects in Taiwan.

The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) \>150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol\<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (6th months and 18th months). All participants complete a structured questionnaire, including basic information, physical activity, and food-frequency.

Eligibility Criteria:
Inclusion Criteria:

* adult women with age ≥ 50 years
* low education, defined as having less than 6 years of education or being primary school graduates
* presence of metabolic syndrome
* community-dwelling
* no hearing and visual acuity difficulties

Exclusion Criteria:

* Unconscious
* Cognitive impairment or dementia