cyrilzakka/clinical-trials huggingface dataset:
Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients

The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions.

Eligible participants will be randomized to stage 1 of treatment which consists of a previously pilot-tested behavioral application (app), the ENGAGE-ALD app, consisting of a knowledge improvement module and a preference-sensitive treatment matching module. Those who do not engage in AUD treatment after randomization ('non-responders') will be re-randomized at 3-months and continue on this in stage two if considered a responder (met treatment engagement). Participants that were not considered to have met "treatment engagement" will be re-randomized at 3-months to a Treatment Facilitation bundle consisting of a barriers to treatment survey followed by a health coaching session.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to comply with all study procedures and availability for the duration of the study
* Willing and able to provide informed consent
* Enrolled at University of Michigan (UM) hepatology clinics or inpatients at UM Hospitals
* Documented diagnosis of alcohol-related liver disease (ALD) (per protocol)
* Recent alcohol use of any amount within the past 6 months as assessed by either patient interview, medical chart review, or positive alcohol biomarker (e.g. blood alcohol level, urinary ethyl glucuronide, urinary ethyl sulfate, or phosphatidylethanol) in the medical record.
* No alcohol use treatment within the past 1 month including, but not limited to:

  * Any professionally lead therapy with a mental health counselor (such as, one-on-one therapy, group therapy, couples or family therapy) with a primary aim of alcohol abstinence or reduction in alcohol use.
  * Community-based alcohol recovery groups (such as, Alcoholics Anonymous, SMART Recovery, Celebrate Recovery, Refuge Recovery)
  * Community-based church support groups primarily focused on alcohol abstinence or reduction in use.
  * Residential (inpatient) alcohol treatment
  * Intensive outpatient programs
  * Any telehealth version of the above options
* Access to a Smartphone or computer for purposes of follow-up. Those who do not have a Smartphone will be provided one along with a calling/data plan at no cost to subject by the study team for the duration of the research stud.
* Ability to speak and comprehend English

Exclusion Criteria:

* Unable to provide voluntary informed consent for any reason
* Substantially cognitively impaired as evidenced by Westhaven grade 2 or higher hepatic encephalopathy or a score \>=10 on the Short Blessed Test for cognitive impairment.
* Unable to read or understand English
* Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation
* Is enrolled in the multidisciplinary ALD clinic at Michigan Medicine
* Any other medical condition or circumstance that precludes safe and meaningful participation in the study
* History of nonadherence to previous clinical or research studies
Sufentanil Pharmacokinetics After Intra Amniotic Injection

The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure.

To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.


Eligibility Criteria:
Inclusion Criteria:

* Termination of pregnancy for fetal malformation
* Gestational age \> 24 weeks of gestation

Exclusion Criteria:

* Multiple pregnancy
* Allergy or contraindication to sufentanil
* Morphinic addiction
* fetal gastroschisis, omphalocele or swallowing disorder
* maternal cardiac or respiratory distress
Web-based Genetic Research on Lupus

The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.

Lupus is a difficult disease to diagnose and one that's difficult to manage, given the lack of specific medicines to treat lupus and the side-effects of current medications. The investigators believe genetics may play a critical role in developing better lupus diagnoses and treatments. If individuals are eligible to participate, the investigators will send a 23andMe DNA saliva kit at no cost. Participants will be asked to take a 15 minute online survey with questions about their lupus experience, symptoms and response to treatments, in addition to five additional bi-monthly short surveys and one final study survey during the 12-month participation. Learn more and join the lupus study today: https://www.23andme.com/lupus/

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with lupus by a qualified physician.
* consents to have 23andMe (via a partner) contact the physician to obtain medical record information
* willing to submit a saliva sample for DNA testing and complete online surveys related to condition
* at least 6 years old (minors under 18 require parental consent to enroll)
* access to the internet
* resides in the United States

Exclusion Criteria:

-
Mindfulness-Based Stress Reduction and the Microbiome

This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota, assessed 8 weeks after enrollment.

The gut microbiota is known to be integral to gastrointestinal health and disease. Psychological stress has been shown to significantly alter the gastrointestinal microbiota of rats, rhesus monkeys, and humans. These studies have consistently shown decreases in lactobacilli among other changes in species that correlate with an increase in diarrheal symptoms. While it is unclear whether stress causes diarrhea leading indirectly to a disruption in the native microbiota, or whether stress leads directly to changes in the microbiota that then lead to diarrhea; there is a growing body of evidence to support the latter. Differences in microbiota have also been shown to be present in irritable bowel syndrome (IBS) and predispose or protect against other forms of diarrhea including bacterial gastroenteritis and radiation-induced diarrhea. In addition, treatment with probiotics containing lactobacillus and other species has been shown to help alleviate IBS symptoms. Stress is hypothesized to act on the microbiota via the brain-gut axis through endocrine, immunological, and/or neurological pathways. This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) \& IBS can lead to a change in the intestinal microbiota, assessed 3 weeks after enrollment. It also seeks to determine if a change in intestinal microbiota correlates with a decrease in IBS symptoms. We propose to use broad-range bacterial 16S rRNA gene PCR with 454 pyrosequencing to characterize the fecal microbiota and correlate changes in bacterial communities to IBS symptoms at baseline and after completion of an 8-week-stress reduction course in 15 patients with PTSD \& IBS and to compare these findings to 5 patients with PTSD \& IBS undergoing usual care without a stress-reduction course.

Eligibility Criteria:
Inclusion Criteria:

* posttraumatic stress disorder

Exclusion Criteria:

* psychosis
* suicidal ideation with intent
SpiroGym App-Aided Cough Rehabilitation

The pilot study by Srp et al. (2021) proved that the SpiroGym app was feasible for supporting expiratory muscle strength training (EMST) in Parkinson's disease (PD) patients. Two weeks of intensive EMST coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control. However, comparative studies were required to verify the possible additional effects of visual feedback on voluntary PCF compared to EMST without feedback.

Goal: To explore the visual feedback effect of the SpiroGym app in EMST on voluntary peak cough

Hypothesis 1: Change in voluntary peak cough flow will be higher in the experimental group than in the active control group after 8weeks and 24 weeks of EMST.

Study Design: A double-blind, randomized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinsons disease
* Stable dopaminergic medication (stable dose for at least 1 month)

Exclusion Criteria:

* Other neurological disorders
* Difficulty complying due to neuropsychological dysfunction (dementia with a score of less - - than 19 on the Montreal Cognitive Assessment)
* Breathing disorders or diseases
* Smoking in the past 5 years
* Uncontrolled hypertension
Study Strategies in Musicians and Their Relationship With Physical and Emotional Variables

The musician profession requires great efforts not only at job level, also social, mental and physical level from the beginning of musical studies.

This study investigates the importance and the relationship between the strategies of study, the artistic level and the motivational level in prevalent musculoskeletal diorders in music students.

The aim of this study is to check the different areas that can influence study strategies, the importance of motivation, music students' deficiencies and assess the contribution of physiotherapy during music studies. To do this, a questionnaire will be sent to students from different conservatories and master's degrees.

Most of the musicians' careers start from childhood, and the demands on both the physical and psychosocial levels entail a large number of occupational diseases and risks to their health. Music students need to dedicate a significant number of hours per day in their different stages of their musical career if they want to achieve success in the studio and turn their studies into their future profession. To meet their objectives, aspects such as motivation, support and adopting good study strategies, among others, are necessary.

The psychological as well as social and physical factors that influence the professional life of the musician. Therefore, working on them from the beginning of the studies, with good practices and strategies, can lead them to success. However, having real information on music students and knowing these aspects would allow us to know the real extent of the motivation and study strategies that the student proposes to improve their musical practice, the discomfort or muscle pain they suffer and the relationship between all of them. Therefore, it is necessary to know the study strategies applied by music students, as well as to know the motivation and how it can affect musical practice and relate to muscular discomfort so frequent in this population group. The main objective of this study is to know the study strategies of conservatory music students, their artistic and motivational level and the possible relationship with musculoskeletal disorders.

Study design. The type of study is a cross-sectional descriptive study that will be carried out through an online questionnaire using the Google Forms platform specially designed for this study. The participating subjects voluntarily, guaranteeing the confidentiality and anonymity of the study participants, as well as their responses. By accessing the questionnaire, the subject has been informed about the purpose and purpose of the study and has given their consent.

This study investigates the importance and the relationship between the strategies of study, the artistic level and the motivational level in prevalent musculoskeletal diorders in music students.

Eligibility Criteria:
Inclusion Criteria:

* Be a music student, either master's or conservatory
* Being over 18 years
* Study an instrument or song

Exclusion Criteria:

* Not studying or having studied any music course
* Be under 18 years of age
Feasibility of the Mindfulness Flow Program (MFP) on Archers

Mindfulness-based interventions have gained popularity among elite athletes, but their effectiveness for enhancing archery performance remains inconsistent. This study examined the feasibility of a 12-week mindfulness flow program (MFP) specifically designed for archers, and assessed the effect of the MFP on shooting performance. The intervention aims to enhance shooting performance, mindfulness, and the flow state, while reducing post-intervention anxiety.

The primary goal of the present study was to test the feasibility of a prototype mindfulness flow program (MFP), with 11 sessions conducted via Zoom video meeting and one in-person session of sport-specific session. Additionally, the program seeks to examine the psychological outcomes associated with the intervention specifically among archery athletes. It is anticipated that the experimental group will show reduced anxiety levels and increased levels of mindfulness and flow when comparing their baseline and post-intervention assessments. This study explores the potential of delivering mindfulness programs conveniently to sport populations via the internet, supplemented by one face-to-face sport-specific session to enhance mindfulness and improve sports performance among athletes.

Eligibility Criteria:
Inclusion Criteria:

* at least one year of archery training experience and training for at least two hours per week

Exclusion Criteria:

* Participants who had previously participated in a mindfulness session were excluded
Long-term Procedural and Device Related Complications of PFO Closure

We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent PFO closure

Exclusion Criteria:

* Unable to complete or adhere to the study
Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities

The current study evaluates the efficacy of Cognitive Behavioral Therapy (CBT) in DUI programs for individuals with a first-time offense. Investigators will utilize a two-group randomized design where individuals enrolled in a DUI program with a first-time conviction will be randomized to Cognitive Behavioral Therapy (CBT; n=150) or Usual Care (UC; n=150). Participants will be assessed at baseline, immediately post-treatment, and 6-months post-treatment. Recidivism data will also be collected using administrative data two years post-treatment.

Enormous unmet needs for alcohol treatment exist among individuals convicted of driving under the influence (DUI) since up to 43% recidivate and 67% meet criteria for alcohol dependence. Investigators will test whether delivering a cognitive behavioral treatment (CBT) for alcohol use disorders (AUDs) as part of a mandated DUI program improves health outcomes, and reduces alcohol use, alcohol-related problems and injuries, and DUI recidivism compared to usual care. The study has the potential to promote the public welfare by providing treatment to individuals with a DUI conviction, while focusing on Latinos, who are disproportionately less likely to access treatment and more likely to be arrested for a DUI, to have higher rates of recidivism, and to die in alcohol-related crashes than their white counterparts. The study is innovative because it would be the first to address effectiveness of treatment for AUDs embedded within a DUI program. Investigators will conduct a randomized trial of a 9-session group-based CBT (n=150) as compared to group-based usual care (UC; n=150) immediately after and 6 months after the end of treatment. Short-term outcomes include alcohol use (rates of heavy drinking, percent days abstinent), alcohol use-related self-efficacy, and intent to drink and drive. Investigators will also examine whether race/ethnicity, gender, acculturation, and alcohol situational norms predict our primary treatment outcomes (rates of heavy drinking, percent days abstinent) and DUI recidivism (alcohol-related violations).

Eligibility Criteria:
Inclusion Criteria:

* meets criteria for at-risk drinking,
* 21 years+,
* English speaking,
* current client in 3-month DUI program

Exclusion Criteria:

* under 21,
* does not speak English,
* does not meet criteria for at-risk drinking
Progesterone and Brain Imaging Study

Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.

The purpose of this study is to learn whether a sex hormone called progesterone is helpful in reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging to measure possible effects of progesterone on certain neurochemicals. These neurochemicals are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and progesterone affect these brain chemicals.

Individuals wishing to participate in this study must be medically healthy men or women who smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental illness or use drugs other than nicotine and marijuana. Participants cannot have any implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants must not have peanut allergies and must never have had a reaction to progesterone. Finally, participants cannot be taking any medications for anxiety, depression or insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Female and male smokers, aged 18 to 50 years;
* History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion);
* Not seeking treatment at the time of the study for nicotine dependence;
* Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a Carbon Monoxide (CO) level greater than or equal to 11 ppm;
* Clean urine drug screen (marijuana is permissible);
* In good health as verified by medical history;
* For women, not pregnant as determined by pregnancy screening, nor breast feeding.

Exclusion Criteria:

* History of major medical illness: including liver diseases, abnormal vaginal bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;
* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder;
* Lifetime history of schizophrenia or other psychotic disorder;
* Lifetime substance dependence disorder, excepting nicotine, alcohol and marijuana, as per SCID interview
* Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview
* Regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;
* Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.

The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.

Eligibility Criteria:
Inclusion Criteria:

* Stable MS disease within 30 days prior to enrollment
* EDSS Score between 2 and 8 inclusively
* Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS.

Exclusion Criteria:

* Women who are pregnant or breast-feeding or who plan to become pregnant during the study
* Has taken immunomodulating drugs within 60 days prior to screening
* HIV positive
Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy

The purpose of this study is to collect data on the incidence, complications, economic burden and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.

The surveillance/recruitment period will take approximately 2 years and once the enrolment of HZ patients has ended, the study will continue for a maximum of 9 months to allow for completion of the follow-up of potential PHN cases.

The data will be captured at protocol specified time-points based on the time of enrolment of each subject.

Eligibility Criteria:
Inclusion Criteria:

* A male or female ≥ 50 years of age at the time of study enrolment presenting with acute HZ.
* HZ diagnosis for this HZ episode:

  * Is his/her first outpatient diagnosis (i.e. initial consultation), OR
  * Took place at another site/centre (e.g. emergency room or Dermatologist/Specialist practice) provided the HZ diagnosis is not more than 7 days before the initial visit for the present study (i.e. secondary consultation).
* Written informed consent obtained from the patient.
* Ability to comply with study procedures.

Exclusion Criteria:

• Patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).
Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery

The investigators investigated the clinical impacts of preoperative nutritional status on mortality in patients undergoing valvular heart surgery. Preoperative nutritional status was evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score. The primary outcome was the association between preoperative nutritional status evaluated by PNI, GNRI, and CONUT score and postoperative mortality. The predictive discrimination ability for mortality between PNI, GNRI, and CONUT were compared. Risk factors for mortality were identified.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent valvular heart surgery from January 2013 to February 2018

Exclusion Criteria:

* Patients younger than 18 years
* Patients undergoing combined congenital heart surgery
* Patients undergoing transcatheter valve replacement
Technique for Localization of Caries Associated Bacteria on Tooth Surfaces.

There is a simple laboratory technique for localization of caries associated bacteria on tooth surfaces by taking an impression of the teeth with a material containing sucrose.

The purpose of this study is to check whether the technique can be incorporated into dental clinics as diagnostic tool comparing to other diagnostic methods available.


Eligibility Criteria:
Inclusion Criteria:

* adult/ patient of the student clinic in Hadassa, Jerusalem.

Exclusion Criteria:

* children/ antibiotic taken in the last month.