cyrilzakka/clinical-trials huggingface dataset:
MyPEEPS LITE Trial

This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=2,500), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

In direct response to RFA-AI-21-018, Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional), we proposed to harness innovative electronic methods to conduct a large, rigorous national study collecting and contextualizing epidemiological HIV incidence data in Young Men who have Sex with Men (YMSM) and testing the efficacy of MyPEEPS Mobile, an evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence. We proposed to establish a large national cohort of 2,500 racially and ethnically diverse YMSM 16-29 years old, the age YMSM are most susceptible to HIV acquisition to identify theoretically-driven correlates of HIV seroconversion among a key population experiencing a disproportionate number of new HIV diagnoses.

Randomized controlled trials (RCTs) are considered the gold standard for estimating treatment efficacy because randomization mitigates risk of bias by balancing measured and unmeasured confounders across treatment groups. However, RCTs are costly, time-consuming, and can be challenging to conduct in certain context. We are therefore integrating the robust epidemiological data that we collected during the UG3 phase into the clinical trial design. That integration is a potentially appealing way to generate an external comparator cohort to increase the power of our RCT to estimate the effect of MyPEEPS Mobile on HIV incidence.

Eligibility Criteria:
Inclusion Criteria:

* Be between 16-29 years of age;
* Sex assigned at birth is male and identify gender as male or non-binary;
* Understand and read English;
* Live within US and its territories;
* Own or have access to a smartphone;
* Self-report anal sex with someone who has a penis in the last 12 months; and
* Be HIV-negative or status unknown

Exclusion Criteria:

* Individuals who identify as transgender
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and above
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete 6 week study period.
Cultural Adaptation of Hap-pas-Hapi (Step-by-Step) for Albanian-speaking Immigrants in Switzerland and Germany

We aim to compare two different levels of cultural adaptation of an Internet- and mobile-based intervention for the treatment of depression called Hap-pas-Hapi among Albanian-speaking immigrants in Switzerland and Germany. One arm will include the generic (minimally adapted) version of Hap-pas Hapi. The other arm will include a version of Hap-pas-Hapi that was adapted to the target population's cultural concepts of distress. Both versions include five sessions and the same therapeutic techniques.


Eligibility Criteria:
Inclusion Criteria:

* Electronic informed consent documented by time-stamped agreement to a set of consent questions
* Albanian-speaking
* Male and female participants aged above 18
* Kessler Psychological Distress Scale (K10), Albanian version score \>15
* Access to Smartphone (iOS or Android) or web-browser

Exclusion Criteria:

* People living outside Germany or Switzerland
* Serious suicidal thoughts or plan (self-assessed with a corresponding question)
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients

In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved exercise tolerance and endothelial function in patients who have undergone the Fontan operation, compared to placebo.

Recent evidence suggests that after Fontan operation, single ventricle patients have impaired function of the vascular endothelium due in part to abnormalities in nitric oxide signaling. Endothelial dysfunction may contribute to the development of congestive heart failure and exercise intolerance that have been well-documented in Fontan patients. Therapeutic interventions to improve endothelial function in adults with heart failure have mainly focused on increasing the synthesis or decreasing the degradation of nitric oxide. We propose a randomized, prospective, placebo-controlled trial of vitamin C, an antioxidant that protects NO deactivation, in subjects with single ventricular anatomy after Fontan palliation. The specific aims of this study are to compare NO signaling, endothelial function and exercise capacity in Fontan subjects to that of a control group that is frequency-matched to case subjects by age and sex, and to assess NO signaling, endothelial function and exercise capacity in Fontan subjects after 4 weeks of oral vitamin C (or placebo) therapy. These results have particular importance because improving the endothelial response in Fontan patients has the potential to reduce the risk of developing congestive heart failure and improve exercise capacity. Furthermore, assessing endothelial function and the effects of therapies aimed at improving vascular health may be generalizable to many other chronic pediatric conditions associated with increased cardiovascular risk such as obesity, diabetes mellitus, and hypertension.

Eligibility Criteria:
Inclusion Criteria:

* 8-25 years of age
* Fontan-palliated patient

Exclusion Criteria:

* New York Heart Association (NYHA) classes III or IV
* Diabetes mellitus
* Family history of premature coronary artery disease
* Use of Sildenafil or other pulmonary artery vasodilators
* Prior cardiac arrest (outside the first 24-hours postoperatively)
* Life-threatening dysrhythmias
* Severe ventricular dysfunction
* Severe AV valve regurgitation
* Pregnancy
* Severe renal or hepatic impairment
RIXUBIS Drug Use-Result Survey (Japan)

The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS.

1. Unexpected adverse drug reactions
2. Occurrence of adverse drug reactions in the actual clinical use
3. Factors that may affect safety and effectiveness
4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency
5. Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia B scheduled to receive treatment with RIXUBIS

Exclusion Criteria:

* Patients not administered RIXUBIS
An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt

The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged \>= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .


Eligibility Criteria:
Inclusion Criteria:

* Women \>= 18 years of age attending a clinic for gynaecological examination.
* Women who agree to provide a cervical sample for human papillomavirus testing.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Referral for abnormal cervical sample at the current visit.
* Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed.
* History of hysterectomy.
* Known diagnosis of immunosuppression, or patient on immunosuppressives.
* Pregnant women.
* Having received one or more doses of HPV vaccine prior to participating in the study.
Anticipating and Tracking: Pack of Gerontological Assessment Embedded

ARPEGE project fits within the general framework of maintaining functional autonomy in the frail elderly. The early identification of elderly people at risk of frailty is essential to be able to make corrective actions to maintain a quality of life desired by the person. ARPEGE offers tracking and monitoring based on a corpus mobile evaluation of frailty, that could be used in various environments (home, prevention center, office of the general practitioner, geriatric consultation), and manipulated intuitively by professionals not specialists.

This four-year project spearheaded by the University of technology of Troyes in partnership with the University of Reims Champagne-Ardenne also brings a set of partners and experts in the region and outside, so that the proposed solution has the qualities necessary for its deployment in terms of value diagnostic, use, acceptability and perfectly controlled ethics.

The Region has made "longevity aging" theme one of its priorities. This image of driver of innovation in this area can only be enhanced by a program like ARPEGE. Beyond the scientific and technological results expected, one can imagine the potential socio-economic benefits if this tracking solution is deployed on a large scale.


Eligibility Criteria:
Inclusion Criteria:

* 70 years or older
* GIR 4, 5 or 6
* Consenting to participate in the study

Exclusion Criteria:

* Severe cognitive impairment ( MMSE \< 10)
* Major neurosensory disorders
* Full hospitalization or not (acute care and rehabilitation..)
* Non- affiliation to a social security scheme
* Major protected by law (guardianship, trusteeship)
* Informed consent not provide
Efficacy of DA-5204 on Gastroesophageal Reflux Disease

This is a single-center, randomized, double-blind, placebo-controlled clinical Study to evaluate the efficacy of DA-5204 and proton pump inhibitor combination therapy compared with proton pump inhibitor alone therapy in patients with gastroesophageal reflux Disease.

Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus causes troublesome symptoms, such as heartburn and acid regurgitation.

Proton pump inhibitors, as acid suppressor, are the agents recommended as the first-line treatment for gastroesophageal reflux disease. However, approximately 20-30% of patients have insufficient effect on this therapy alone.

DA-5204 is a medicine based on Artemisia asiatica 95% ethanol extract. DA-5204 has been administered to treat gastritis and gastric ulcers with antioxidative and cytoprotective actions on gastric mucosal damage. Therefore, we expect DA-5204 to be effective in reflux esophagitis (esophageal mucosal injury).

Eligibility Criteria:
Inclusion Criteria:

* Age is over 20 years old, under 75 years old, men or women
* Patients diagnosed with erosive esophagitis by gastroscopy
* Signed the informed consent forms

Exclusion Criteria:

* Patients who is impossible to receive gastroscopy
* Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding
* Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks
* Patients with surgery related to gastroesophageal
* Patients with Zollinger-Ellison syndrome
* Patients with any kind of malignant tumor
* Patients administered with anti-thrombotic drugs
* Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
* Patients with neuropsychiatric disorder, alcoholism, or drug abuse
* Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
* Women either pregnant or breast feeding
Bruxism and Severity of Temporomandibular Dsyfunction

The aim of the study was to investigate the effect of bruxism on Temporomanbular joint functionality and dysfunction severity in individuals with Temporomandibular Dysfunction (TMD).

The study included 91 individuals aged 20-55 years with TMD. Participants who volunteered to participate in the study signed the Informed Consent Form and completed the Descriptive Data Form including demographic characteristics. The presence of bruxism in individuals with TMD was questioned and the maximum mouth opening measurement was recorded. TMD severity was assessed by Fonseca's Anamnestic Questionnaire (FAQ), pain severity was assessed by Numeric Pain Scale (NPS), and masticatory and TMJ functioning was assessed by JAW Functional Limitation Scale-20 (JFLS-20). The evaluations of the participants were performed only once.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 55 years,
* Diagnosed with TMD,
* volunteer to participate in the study

Exclusion Criteria:

* having a non-reduced disc problem,
* surgical operation due to spine, abdomen and/or TMJ problem,
* trauma, cancer, neurological problems, congenital anomalies, musculoskeletal system problems,
* systemic disease,
* facial paralysis
* Less than 6 months of receiving any treatment related to the spine and TMJ
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data

A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects who participated in SP925 \[NCT00655551\] for treatment of partial-onset seizures

Exclusion Criteria:

* Receiving any study drug or experimental device other than lacosamide
* Meets withdrawal criteria for parent study SP925 \[NCT00655551\]
* Experiencing ongoing serious adverse event
Comparison of Volume Controlled Ventilation and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia

Exclusion Criteria:

1. chronic obstructive respiratory diseases
2. heart failure
3. body mass index (BMI \>30 kg/m2)
Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain

Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour after a lumbar disk surgery.

Patients were treated using patient-controlled analgesia with contramal for 24 hours after a lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein or isotonic saline (placebo).

The primary endpoint was pain intensity measured by the visual analogue scale, and secondary endpoints were contramal consumption and related side effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists 1 or 2 status patients scheduled for elective lumbar disk surgery under general anesthesia

Exclusion Criteria:

* Patients, known allergies to any of the drugs used in this study
* eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to provide informed consent (eg, mental disorders)
Three Good Things (3GT) - Intervention for Transitional Care Patients

Researchers are doing this research study to learn how the Three Good Things (3GT) Positive Psychology journaling activity affects symptoms of stress, depression, resilience, and happiness.

The purpose of this study is to measure, rank and categorize the subject sample of depression, stress, resilience and happiness scores using quantitative surveys. This research aims to learn how a Three Good Things (3GT) journaling activity affects a subject's symptoms of stress, depression, resilience and happiness. The data will allow the project team to gain an in-depth understanding of the impact of the use of resilience strategies from a hospitalized patient's perspective. The project aims to review if there is a correlation between stress, depression, resiliency, and happiness scores to the use of Positive Psychology.

Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 18 years of age.
* Current inpatient at the Mayo Clinic Health System Bloomer Hospital, Bloomer, Wisconsin (a Swing Bed Hospital as defined by the Center for Medicare and Medicaid Services (CMS)).
* Able to speak English.
* Able to answer questionnaires.

Exclusion Criteria:

* Individuals \< 18 years of age.
* Patient unwilling or unable to provide consent to participate in this research study.
* Patient under guardianship.
* As determined through self-report, patient in active psychosis, active suicidal ideation, active substance abuse meeting criteria for substance use disorders except for nicotine (the exception is patients with a history of substance abuse that have been in remission for at least one full year).
* Patient diagnosed with obsessive-compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active Post Traumatic Stress Disorder, or active severe personality disorders.
* Patient with previous participation in this study.
Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry

Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.

Investigators aim is to create a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.

Such a set of standards would increase the quality of single and multi-center studies, national registries as well as aggregation syntheses such as meta-analyses. It will also be of utmost importance in tiring times of public health emergencies and will help understand practice variability and outcomes during COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 PCR positive (within 7 days)
* COVID-19 PCR pending
* COVID-19 high clinical suspicion

Exclusion Criteria:

* Patient without Prior Research Authorization (applicable to Mayo Clinic sites)
* Non COVID-19 related admissions
* Repeated Admission to ICUs/Hospital
Spanish Validation and Cross-cultural Adaptation of the QoR-15E

The satisfactory recovery of the patient after a surgery with an anesthetic request is very important for a quality and excellence assistance. The quality of recovery questionnaire QoR-15 was validated by their authors in 2013 with the study titled development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. This questionnaire allows a comprehensive assessment by associating the physiological parameters until then assessed with the subjective personal perception of the patient of his state of health. With the consent of its original author, this study is carried out to validate the questionnaire in Spanish and adapted to our environment.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Comprehensive and sign informed consent.
* Knows and understands the Spanish language.
* Undergo a scheduled surgical intervention under any type of anesthetic procedure from the specialties of general surgery, urology and gynecology.
* Score \> 26 points in the Mini Mental State Examination (MMSE) test.

Exclusion Criteria:

* Patients under 18 years old.
* Not having signed the informed consent.
* Not knowing or understanding the Spanish language.
* Surgical intervention from other specialties than general surgery, urology and gynecology.
* Score \< 27 points in the Mini Mental State Examination (MMSE) test.
Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients

Periodic leg movement disorder is defined as periodic episodes of repetitive limb movements during sleep that mainly occur in the lower limb, including the hips, knees and toes and sometimes affects the upper limb. It may be accompanied by frequent nocturnal arousals, and if so, this sleep disturbance may cause excessive daytime sleepiness. Chronic kidney disease patients are at risk of periodic leg movements and common causes are iron deficiency, anemia, raised serum calcium and central and peripheral nervous system disorders.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease

Exclusion Criteria:

* diabetic, hepatic and chrest disease patients
CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

The purpose of this study is to compare CT perfusion parameters to RECIST 1.1 and mRECIST assessment for advanced HCC treated by systemic immunotherapy, and to evaluate perfusion parameters as predictive factors of response on baseline and on early follow-up


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Proved HCC
* Advanced HCC, defined as Barcelona Clinic Liver Classifications (BCLC) stage B non eligible for loco-regional therapy and stage C
* No prior systemic therapy
* Measurable disease per Response Evaluation Criteria for Solid Tumour (RECIST) v1.1
* Child-Pugh Score = A
* Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2

Exclusion Criteria:

* Absence of CT perfusion before treatment initiation more than a two-month delay between treatment initiation and first post-treatment CT perfusion
* Uninterpretable CT perfusion
* Definitive contraindication to CT perfusion (allergy or advanced renal disease)