cyrilzakka/clinical-trials huggingface dataset:
Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change

Although measurement-based care (MBC) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. Questions remain regarding MBC's unique added value compared to usual care.

Thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. This study implemented MBC in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework.

Researchers will compare three groups: 1) the Measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. Participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.

Measurement-based care (MBC) is an evidenced-based practice, involving routine completion of patient-reported outcome measures and collaborative discussions between clinician and client to inform clinical decision-making and facilitate improvement. Despite its known benefits, such as reduced dropout rates and improved treatment outcomes, questions remain regarding MBC's unique effectiveness compared to standard care. Furthermore, mechanisms of change on how MBC actually works in treatment have yet to be fully investigated. Thus, the current study aims to conduct a randomized control trial to evaluate the added value of MBC, by comparing an MBC+psychotherapy group, a psychotherapy-only group, and a waitlist group with no interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Primary concern and referral reason for seeking psychotherapy are either depressive- or anxiety-related symptoms and/or psychological distress, using minimum scores as follows: PHQ-9 (score \> 4), GAD-7 (score \> 4), and BASE-6 (score \> 18), and
2. being 18 years old or older.

Exclusion Criteria:

1. Severe physical or psychiatric conditions that would hinder the treatment (e.g., clients with acute psychosis, intellectual disability, or neurocognitive disorders who do not have the capacity to undergo informed consent and participate in the study);
2. currently receiving psychotherapy through another source;
3. significant suicidal/homicidal risk that would need immediate intervention;
4. do not have ability complete Patient-Rated Outcome Measures (PROMs) either in person or remotely
Survival Outcomes in Metastatic Prostate Cancer in the Brazilian Population - Analysis of Individual Characteristics and Treatment Modalities in Different National Health Institutions.

Survival outcomes in metastatic prostate cancer in the population Brazilian - analysis of individual characteristics and modalities of treatment in different national health institutions


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of castration-resistant metastatic prostate cancer diagnosed in the period between January 2014 and December 2017.

Exclusion Criteria:

* Diagnosis of localized or locally advanced or metastatic disease sensitive to castration;
* Patients with medical records filled with incomplete data that make it impossible to evaluate the treatment received.
Partial Posterior Hyaloidectomy in Macular Surgery

To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal breaks related to induction of a posterior vitreous detachment

The induction of a posterior vitreous detachment (IPVD) during vitrectomy have been suggested as one of the etiologies of iatrogenic retinal break related to vitrectomy.The iatrogenic retinal breaks related to IPVD usually develop near or anterior to the equatorial region.

Thus, the investigators hypothesized that this complication could be prevented by restricting the extent of IPVD, and planned a modified procedure of vitrectomy in which the extent of IPVD and removal of vitreous cortex was restricted to about slightly beyond the margin of temporal major vascular arcade.

The investigators have termed this procedure, partial posterior hyaloidectomy. Unlike RRD or proliferative diabetic retinopathy, lesions are localized within the major vascular arcade in macular disorders so that macular disorders could be an eligible indication for this procedure.

Eligibility Criteria:
Inclusion Criteria:

* Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively

Exclusion Criteria:

* history of previous intraocular surgery
Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders

1. Current research has found that tDCS has a positive effect on improving the negative attention bias of AD patients, and this study uses HD-tDCS intervention to improve the cognitive function and neural mechanisms of AD patients in the OFC to provide a theoretical basis for AD neural mechanism research. Verify Hypothesis 1: HD-tDCS cathodal stimulation of the left OFC reduces the excitability of this region, modulates its connectivity with the attentional function network, and thus changes the emotional experience of social threat.
2. Currently, there is no consensus on the stimulation parameters for tDCS in the treatment of AD, and more evidence is needed to prove and explore. It is hoped that the HD-tDCS intervention protocol will become an effective treatment method for improving cognitive function and clinical symptoms in AD patients. Hypothesis 2: The HD-tDCS with intensified stimulation parameters (2mA, twice a day, with a 20-minute interval, for 5 consecutive days) has an impact on the main and secondary clinical variables of AD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the DSM-5 AD diagnostic criteria;
2. The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screening meets the diagnosis;
3. Age: 18-55 years old;
4. The patient participated voluntarily, obtained the consent of the family members, and signed the informed consent form;
5. Scale score criteria: 14 points on the Hamilton Anxiety Scale (HAMA) and 17 points on the Hamilton Depression Scale (HAMD).

Exclusion Criteria:

1. Neurological diseases or other psychiatric disorders;
2. severe somatic diseases;
3. received medical treatment including medication, psychotherapy, electroconvulsive therapy, and physical therapy within the first half months of enrollment;
4. tDCS examination contraindications, such as intracranial metal or electronic implants, skull plate, or other skull implants.
5. Pregnancy and lactation.
Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas

To evaluate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas

Surgical assessment for staging of endometrial carcinoma during primary surgery remains one of the most varied practices worldwide, as it may include no nodal assessment, sentinel node mapping, and complete pelvic and aortic lymphadenectomy up to the renal vessels. Since lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, gynecologists agree that pelvic and aortic lymphadenectomy should be routinely performed in high-risk patients (grade 3, deep myometrial invasion, type 2 cancer). However, whether lymphadenectomy is required in patients with endometrioid endometrial cancers of grade 1 or 2 and with less than 50% myometrial invasion is controversial. Then, the investigators conducted this prospective cohort study to investigate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas (grade 1 or 2, \< 50% myometrial invasion, and a tumor diameter ≥ 2 cm) as well as their outcomes.

Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. No contraindication to surgery.
3. Signed and dated informed consent.
4. Intermediate-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).
5. Without any suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.

Exclusion Criteria:

1. Low-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter \< 2cm (in intraoperative frozen section examinations).
2. Grade 3 endometrioid cancer (in preoperative pathological diagnosis or in intraoperative frozen section examinations).
3. Deep muscular infiltration (in intraoperative frozen section examinations).
4. Cervical invasion and/or ovarian/tubal invasion (in intraoperative frozen section examinations).
5. With suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.
Reliability of Hammersmith Examination in Prediction of Neurological Outcomes (REHAPENO)

In this study workers are trying to test the correlation between Hammersmith Infant Neurological Examination and MRI brain/cranial ultrasound with early prediction of neurological developmental outcome of preterm neonates. This study is prospective cross-sectional collecting the data of patients according to daily standard medical practice

The primary aim of this study is to evaluate the neurobehavioural performance of infants born preterm using the Hammersmith Infant Neurological Examination (HINE) in standard medical practice and compare it with the gold standard MRI and ultrasound imagings. It would be possible to check do we need to use all the 3 examinations or Hammersmith examination would be enough reliable predictor. Secondary aim is to explore the relationships between MRI brain /cranial us abnormalities and HINE at term-equivalent age in infants born preterm in prediction of neurological outcome at 1 year of chronological age.

This study will be only single arm/single group. This group would receive the regular practice of MRI, Ultrasound (US) and Hammersmith assessments. The 3 assessments would be compared in relationships with the neonatal developmental outcomes (developmental milestones).

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<37 weeks' GA at birth admitted to the neonatal nurseries at the Abha Private Hospital in Kingdom of Saudi Arabia. This project aims to recruit 50 infants \<37weeks at birth over a 1-year stating from march 2018

Exclusion Criteria:

* -infants with congenital or chromosomal abnormalities
Social Media Based Peer-Led Intervention for HIV Prevention

The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV prevention and to increase linkage to primary care.

This study examines a social media based peer-led and delivered intervention focused on increasing PrEP adoption in young men of color who have sex with men (YMCSM). While prior efficacy trials have included YMCSM 18-29, we will focus on PrEP in YMCSM outside clinical trial settings. Rather than an alternative medium for implementation of existing interventions designed for in-person contact, social media may be a true 'game changer' to engage hard to reach individuals. While many online behavioral interventions exist, including some that use social media, this will be one of the few studies to use and test social media to facilitate uptake of a biomedical intervention. E-PrEP will connect the target population (YMCSM) to a new prevention tool (PrEP) through rapid linkage to medical care, accelerating diffusion of PrEP. Given the paucity of data regarding social media-based interventions to change health-related behavior, E-PrEP may have a marked impact on future bio-behavioral interventions, especially those that include diffusion of innovation. Social media offers the power of scale and efficiency for large potential impact, even with relatively low-intensity interventions. Similarly, PrEP, if widely adopted in high-risk populations and offered with behavioral interventions, could markedly decrease HIV infection rates. Social media-based, peer-led approaches like E-PrEP could be used to enhance efforts by community-based and other organizations that employ internet-assisted or peer-outreach strategies to improve health.

Primary Aim: To test the feasibility and preliminary efficacy of E-PrEP for increasing PrEP adoption in a cluster-randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or Transgender individual; Ages 18-29; Have had unprotected anal sex with a male partner in the prior 12 months; Fluent in English or Spanish; Are HIV-negative or unknown status (self-report); Identify as Black and/or Latino

Exclusion Criteria:

* YMCSM who do not consent/assent to study; not currently using at least one of 2 social media sites that will be used for the E-PrEP intervention (not using Facebook, or Instagram), and do not live in New York City.
The Inselspital Surgical Cohort Study

Personalizing surgical care is of enormous clinical relevance, when considering the number of patients undergoing surgery in Switzerland every year. Currently, personalization is based on underlying or coexisting disease or alterations of laboratory values, but there is no accepted biological test available that may predict success or failure of surgery. Surgical site infections are the most common form of hospital-acquired infections. While the relevance of bacteria, antibiotics and intensive care support is well accepted, the impact of the individual host response remains poorly understood. The Investigators hypothesize that postoperative alterations of the metabolome allow identification of predictors of surgical complications in general, and surgical site infections in particular.

The investigators will conduct a prospective cohort study aiming to identify the metabolic and genetic signature that is associated with surgical site infections. Secondary aims and outcomes include the influence of metabolome on response to anesthetic drugs and acute and chronic pain, surgery- and anesthesia-factors related to short- and long-term oncological outcome, metabolic response effect on infectious complications and rejection after transplantation, bacteria-specific immune responses to major surgery after 2-4 weeks after surgery, metabolomics and macrobiotic markers for postoperative ileus or anastomotic leakage, and the effect of the presence of multidrug resistant bacteria on surgical outcome. All patients undergoing surgery in the investigators' clinic and who gave informed consent will be included. A blood sample will be taken before surgery, on the first postoperative day and after 3-8 weeks. A Urine sample will be taken after surgery and after 3-8 weeks. Sink and rectal swabs will be acquired before surgery. The samples will be stored in a Biobank. Additionally, all data routinely captured during the treatment of the patient from the different data collection systems in use in the investigators' hospital will be coded and centralized in a single, cohort database

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
* Who gave General consent
* Study-specific written informed consent

Exclusion Criteria:

* None
A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures \[POS\] with or without secondary generalization \[SG\] or for primary generalized tonic-clonic seizures \[PGTCS\] associated with idiopathic generalized epilepsy \[IGE\] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of epilepsy
2. History of POS with or without SG or PGTCS associated with IGE
3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
4. Previously treated with 1 or 2 AEDs as monotherapy
5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency

Exclusion Criteria:

1. Episode(s) of status epilepticus within the past 6 months before Screening
2. Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)
3. Previous or current use of perampanel

   Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days
4. Hypersensitivity to perampanel or any of the excipients
VX-950 and Peginterferon for Hepatitis C

VX-950 is an investigational drug , which is being tested in combination with a known treatment for hepatitis C, peginterferon.


Eligibility Criteria:
Inclusion Criteria:

* infected with Hepatitis C virus

Exclusion Criteria:

* contraindications to peginterferon therapy
Internet-delivered Cognitive Behaviour Therapy (ICBT) for Post-secondary Students

Post-secondary students are at an elevated risk for anxiety and depression, with approximately one in three students experiencing clinical levels of symptoms at some point during their academic career. Despite the high prevalence of these mental health concerns, many students do not receive adequate treatment. Internet-delivered cognitive behaviour therapy (ICBT) is an alternative to face-to-face service that is effective for improving symptoms of anxiety and depression in general adult populations. Recently, there has been increasing interest in the use of ICBT in post-secondary populations, however high drop-out rates and small effect sizes suggest that current ICBT programs are not fully meeting students' specific needs. Additional research is necessary to ensure that ICBT is delivered to students in a manner that is both acceptable and effective.

The proposed study will be an implementation trial to examine whether the efficacy of an ICBT course for post-secondary students is improved by offering a motivational interviewing component at pre-treatment and a booster session 1-month after completing treatment. Follow-up assessment will be conducted as 3-month post-treatment. Primary outcomes are anxiety, depression, and academic functioning. Implementation outcomes will include measures of the acceptability, adoption, and fidelity (assessed by number of modules completed) of the ICBT course.

The aims of the study will be to: assess the efficacy of the UniWellbeing Course in reducing symptoms of anxiety and depression and increasing adjustment to academic and social responsibilities; to assess the impact of a pre-treatment motivational interviewing component on attrition, engagement, and outcomes (depression, anxiety, and academic functioning); to assess the impact of a booster session on anxiety, depression, and academic and social adjustment at three-month follow-up; and to assess the combined effect of including both a motivational interviewing component and booster session on outcomes.

Eligibility Criteria:
Inclusion Criteria:

* registered as a student at a post-secondary institution in Saskatchewan; over the age of 18;endorse symptoms of depression and/or anxiety; be able to access computers and the Internet and be comfortable using them; and willing to provide a physician as an emergency contact

Exclusion Criteria:

* high risk of suicide or hospitalization for mental health in previous 12 months
* unmanaged alcohol or drug use problems
* severe psychiatric illness that is not managed (e.g. psychosis or mania)
Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.


Eligibility Criteria:
Inclusion Criteria:

* The healthy children in mental and physical aged between 18-24 months, and the guardians agree and fully understand the protocol.
* No Hepatitis A disease and contraindication of vaccination
* No history of Hepatitis A Vaccine
* The subjects can follow the requirements of experiment project.
* Do not vaccinate other vaccine in one months.
* Axillary's temperature≤37℃

Exclusion Criteria:

* Having severe diseases.
* Allergy to the components in Vaccine
* Immune abnormalities
* The people who do not agree with the Inclusion Criteria
* Have a serious chronic disease
* Any conditions which researcher think will influence the results or the subjects.
Investigation of Wearing Compliance of Spectacles for Myopia Control

The goal of this observational study is to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers.

This unmasked, multi-center, observational study will evaluate the wearing patterns of established (use of ≥3 months) juvenile spectacles wearers. Wearing pattern will be measured via the use of temperature sensors fitted to the sides of the participant's spectacles. Data from the final week of the 1-month study will be used for analysis to minimize 'unusual' wear patterns which may occur early in the study.

Eligibility Criteria:
Inclusion Criteria:

1. They are aged between six and 15 years old.
2. Their parent or guardian understands the rights of the subject and are willing to sign a statement of informed consent.
3. They understand the study at a level appropriate for their age and are willing to sign a statement of assent.
4. They and their parents or guardians are willing and able to follow the protocol.
5. They currently use spectacle lenses for myopia control and have done so for at least three months.
6. They agree not to participate in other clinical research for the duration of this study.

Exclusion Criteria:

1. They have an unusual ophthalmic history, which in the opinion of the site investigator or Principal Investigator might impact on the successful conduct of the study.
2. They are amblyopic.