cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Best Possible Self Intervention Over Time

This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible Self) over optimism, future expectancies and positive affect at mid-term, in comparison to a control group. The principal hypothesis is that Best Possible Self intervention will enhance significantly the levels of optimism and positive affect in comparison to the control group at short and mid-term.

Over the last fifteen years, research in the field of positive psychology has increased exponentially (Bolier, Haverman, Westerhof, Riper, Smit \& Bohlmeijer, 2013; Sin \& Lyubomirsky, 2009). These studies have shown that positive moods and positive emotions lead people to think, feel, and act in favor of their approach goals, promoting their involvement in them (Lyubomirsky, 2001). One of the main arms of this framework, is the development of exercises and treatment protocols aimed to promote the appearance of different positive emotions and states, called Positive Psychology Interventions (PPIs).

In this sense, Best Possible Self (BPS) has been included as a PPI, since is aimed to enhance wellbeing. Specifically, BPS is a positive future thinking technique, which requires people to envision themselves in the future, after everything has gone as good as it possibly could. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population (Meevissen, Peters \& Alberts, 2011; Sheldon \&Lyubomirsky, 2012; Peters, Flink, Boersma \& Linton, 2010).

Furthermore, the progress of Information and Communication Technologies (ICTs), has allowed the development of technology applications and devices that could enhance the quality of experience and the wellbeing levels. This approach is called Positive Technology (PT) and it can be used as a complement to PPIs. PT can be defined as the scientific and applied approach to improve the quality of our personal experience trying to increase wellness and generate strengths (Riva, Baños, Botella, Wiederhold \& Gaggioli, 2012).

Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of BPS on optimism, mood and affect in young general population. The exercise will be applied through a Positive Technology system and the effects will be analyzed during four months. The design employed in this study is similar to the used in other studies (Meevissen et al, 2011; Renner, Schwarz, Peters \& Huibers, 2014; Sheldon \& Lyubomirsky, 2006).

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 70 years old.
* Be willing to participate in the study.
* Have an e-mail address.

Exclusion Criteria:

* Presence of severe physical illness.
* Presence of psychological disorders.
* Be receiving psychological treatment.
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone

The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
* Performance status score of 0-1
* Patients must sign a consent form before starting the study.
* No evidence of regional disease
* Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
* Non-invasive epidermoid cancers of the skin are eligible.
* The patient must be available for treatments and follow-up visits.
* No evidence of metastatic disease, confirmed by a negative bone scan.

Exclusion Criteria:

* Severe medical or psychiatric problems that may compromise study compliance
* Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase \> 1.5 times the upper normal limit.
Collagen Cross-linking in Keratoconus

Optical Coherence Tomography (OCT) devices are non-contact instruments that can measure the depth of scars, other causes of cloudiness of the cornea, and degree of corneal thinning in patients with keratoconus. Laser Custom Corneal Collagen Cross-linking (CXL) significantly decreases corneal aberrations and improves vision. This study will use OCT-guided setting for the lasers used in the corneal smoothing portion of the laser custom CXL procedure to assess the affect on visual outcomes.

In the U.S., CXL and topography-guided laser ablation were approved independently, but not together. Another variation in technique involves the use of mitomycin-C (MMC), which is effective in reducing corneal haze after the laser surface ablation. Use of MMC during the laser custom CXL was associated with better outcomes, but in separate trials that could not be directly compared. This study will use OCT measurements to evaluate the magnitudes of direct and indirect laser actions after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of keratoconus
* Minimum corneal thickness of 410 microns

Exclusion Criteria:

* Inability to maintain fixation for OCT imaging
* Inability to commit to required study visits
* Inability to give informed consent
* Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
* Mature cataracts if found to limit visual potential to worse than 20/40
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Amiloride vs Triamterene

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1IdoLUI5-bz_1D_0IflZovJO9e1_3kFLc_JLEFM030No/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability).

Inclusion Criteria:

* 1. Aged \> 65 years on the index date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 3. At least two claims with hypertension diagnosis recorded in 365 days prior to cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. Prior use of amiloride or triamterene any time prior to cohort entry date
Role of Supermicrosurgical LVA for Lower Limb Lymphedema

Vascularized lymph node flap transfer (VLNT) was believed to be the treatment of choice for moderate-to-severe lymphedema. Recent publications have supported the use of supermicrosurgical lymphaticovenous anastomosis (LVA) for treating severe lymphedema. This study hypothesizes whether LVA can be performed on post-VLNT patients seeking further improvement.


Eligibility Criteria:
Inclusion Criteria:

* From November 2014 to January 2019
* Lower limb lymphedema patients

Exclusion Criteria:

* Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.
CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP

The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.

To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).

Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.


Eligibility Criteria:
Inclusion Criteria:

* Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
* Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
* Subject is capable of giving written informed consent to participate in the study.

Exclusion Criteria:

* Subject was withdrawn from CONFIRM.
* Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
HPV Vaccine Intervention for Young Sexual Minority Men

This phase III trial studies how well the Outsmart HPV intervention works in increasing HPV vaccine initiation and completion among young individuals who report having a history of same-sex partners, being sexually attracted to males, or identify as gay, bisexual, or queer (i.e., sexual minority males). The Outsmart HPV intervention, which is a population-targeted, individually-tailored mHealth intervention that includes vaccine reminders, may increase HPV vaccine initiation and completion among unvaccinated young sexual minority individuals.

PRIMARY OBJECTIVES:

I. Determine the efficacy of the Outsmart HPV intervention on increasing HPV vaccine initiation and completion.

II. Identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion.

III. Determine if intervention efficacy differs across key demographic and health-related characteristics of participants.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP A: Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.

GROUP B: Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).

GROUP C: Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).

Participants in all study group are followed for 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Cisgender male
* Ages 18-25
* Sexual minority (reports ever having oral or anal sex with a male or being sexually attracted to males; or identifies as gay, bisexual, or queer)
* Lives in the United States (US)
* Has not received any doses of HPV vaccine
* Did not participate in the pilot study
* Read English
* Able to provide informed consent (inferred by completing the screener survey and consent form)
A Prospective Observational Study of TPIAT

Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (TPIAT)

Patients who are undergoing TPIAT at one of the participating center are invited to participate in this observational study, with 450 participants anticipated. The aims of the study are:

Aim 1: To determine (1a) whether patient and disease characteristics are associated with favorable pain and health-related quality-of-life outcomes (HRQOL) after TPIAT; (1b) the optimal timing of the TPIAT intervention to resolve pain and improve HRQOL; and (1c) in a subset of patients, the impact of central sensitization on pain resolution.

Aim 2: To determine (2a) whether patient and disease characteristics are associated with favorable glycemic outcomes from the IAT procedure; and (2b) the optimal timing of TPIAT to obtain post-surgical insulin independence.

Aim 3: To determine the cost-effectiveness of TPIAT.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.

Exclusion Criteria:

1. Partial pancreatectomy
2. TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns

AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.

Neonates undergo a daily randomized music listening program. An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.

AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.

HRV has been previously used to evaluate autonomic nervous system fluctuations in heart rate related to maturation in healthy neonates and in neonates with pathological conditions. This parameter has been used to show how music could improve well-being and the development of the autonomic nervous system in infants.

In this study, neonates (see also inclusion/exclusion criteria), recruited on the basis of birth order, undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between the 23th and the 32nd week
* birth weight \<1500g
* appropriate for gestational age, sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test

Exclusion Criteria:

* genetic anomalies, chromosomal aberrations, congenital heart malformations, intraventricular haemorrhage (\> grade II on ultrasound), periventricular Leukomalacia
* neonates with failed responses to bilateral hearing screening performed by Automated Auditory Brainstem Response testing
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.

The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of acute bacterial sinusitis (sinus infection) in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given by mouth once daily will be compared to a 10-day course of 500 milligrams of levofloxacin given by mouth once daily.

When treating sinus infections (sinusitis) caused by bacteria, the traditional duration of therapy is between 10 and 14 days. In this randomized, double-blind study, 5 days of 750 milligrams of levofloxacin given once daily will be compared to 10 days of 500 milligrams of levofloxacin in the treatment of non-hospitalized adult patients who have acute bacterial sinusitis. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study. Patients will have a sinus specimen collected at the first visit. Safety evaluations will be conducted. The objective of the study is to demonstrate that, in the treatment of acute bacterial sinus infections, a 5-day course of 750 milligrams of levofloxacin given once daily is at least as effective as a 10-day course of 500 milligrams of levofloxacin given once daily and is well tolerated.

Patients will take by mouth 750 milligrams levofloxacin capsules once daily for 5 days followed by placebo capsules once daily for 5 days, or 500 milligrams levofloxacin capsules once daily for 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute bacterial sinusitis, defined by clinical signs and symptoms lasting for less than 28 days and the presence of visible nasal infection, and confirmed by computed tomography (CT) or standard sinus x-rays
* Two or fewer episodes of bacterial sinusitis within the preceding 12 months
* Willing to undergo maxillary sinus puncture or endoscopy

Exclusion Criteria:

* Chronic sinusitis
* Use of systemic antibiotics within the past 72 hours
* Presence or history of serious complications of sinusitis
* Surgery for treating sinusitis
* Required daily use of more than 20 milligrams of prednisone (oral steroid)
* Cystic fibrosis
Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty

The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. Reverse TSA performed by principal investigator

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age
Effects of Menthol in E-cigarettes on Smoking Behaviors

The overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Able to read and write English.
* Smoking at least 1 menthol cigarettes/cigars/little cigars per day
* Report regular menthol cigarette use
* Have at least 200ng/ml urine cotinine
* Willing to abstain from combustible tobacco products 12 hrs prior to each experimental session.
* not planning a smoking quit attempt.
* Have not stopped use due to COVID.
* used e-cigarettes at least 10 times in the past six months.
* Fully vaccinated against COVID-19.
* must report history of JUUL and other nicotine salt/pod devices (i.e., JUUL-like)

Exclusion Criteria:

* Use of psychoactive drugs including anxiolytics, antidepressants, and other psychostimulants unless prescribed and stable for two months.
* Current diagnosis of any severe psychiatric disorder
* Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, pulmonary or hepatic pathology that would increase risk or would interfere with/mimic tobacco abstinence.
* Known hypersensitivity to propylene glycol and nut allergies.
* Pregnant or lactating females.
* current criteria for moderate or severe cannabis and alcohol use disorder per DSM-5 criteria.
* current criteria for other substance use disorders per DSM-5 criteria.
* Seeking treatment to stop smoking.
* individuals who do not want to use e-cigarettes.
* Uncontrolled asthma (defined as \<20 on Asthma Control Test) AND/OR endorsement of "yes" to environmentally induced bronchospasm that requires prescription Epipen)
* blood pressure \>170/\>100 and heart rate \>100
* vaping of CBD/THC or marijuana related products in the past 3 months
* For current THC vapers: Any report of mild or great EVALI-related symptoms (i.e. cough, shortness of breath, chest pain, nausea, vomiting, stomach pain, diarrhea, fever, chills, or weight loss) without non-EVALI reasonable and proximal cause
Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively.

The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls.


Eligibility Criteria:
* Patients from two studies : "Reproducibility of functional tests of the shoulder for the return to sport of patients operated on anterior instability of the shoulder "CPP n ° 2018-A03013-52 and "Validation of the S-STARTS composite score to assess the functions of the shoulder and the patient's ability to return to sport after stabilization of the shoulder by the Latarjet procedure (VAL-S-STARTS)" MR3016020520
* healthy volunteers from two studies : "Reproducibility of functional tests of the shoulder for the return to sport of patients operated on anterior instability of the shoulder "CPP n ° 2018-A03013-52" and "Risk factors for shoulder dislocation in rugby players. Predictive validity of the S-STARTS composite score "MR4612110620

Inclusion criteria:

Patients: o patient between 15 and 45 years old

* Occurrence of the injury requiring surgery during a sports activity
* Reduced shoulder instability by the open Latarjet procedure
* Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)
* Inclusion by decision of the surgeon during the visit 4 months postoperatively

Healthy volunteers :

* volunteer between 15 and 45 years old
* Practice a regular sporting activity

Both groups:

* Patient having signed an informed consent
* Subject affiliated or beneficiary of a social security scheme

Exclusion Criteria:

Patient group:

* Contraindication of the surgeon
* Have another pathology in the upper limbs
* Present a constitutional hyperlaxity
* Have stiffness or recurrence of dislocation of the shoulder post-surgery

Healthy volunteers :

* Medical history of upper limb pain / injury within the past 12 months
* Medical history of orthopedic surgery on the upper limbs

Both groups:

* Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision