cyrilzakka/clinical-trials huggingface dataset:
Telerehabilitation for Post COVID-19 Condition

Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of patients with COVID-19 report persistent symptoms up to 8 months after the infection. There are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate the acceptability and the potential impact of the program on treating patients with functional limitations and persistent fatigue symptoms. It's a pre and post-study without a control group.

Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of patients with COVID-19 report persistent symptoms up to 8 months after the infection. There are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate the acceptability and the potential impact of the program on treating patients with functional limitations and persistent fatigue symptoms. It's a pre and post-study without a control group. The intervention will be based on cardiopulmonary rehabilitation principles and will be administered for 12 weeks. Fatigue, post-exertional malaise, and functional/exercise capacities will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Living in the community
* Living near Sherbrooke (\<50km)
* Having a diagnostic of COVID-19 confirmed (PCR) and post-COVID syndrome (according to the World Health Organization criteria)
* Being aged between 25 and 65 years old
* Having access to internet at home
* Living with a family member/caregiver or having a telephone or a medical alert system (in case of emergency)
* Reporting persistent fatigue symptoms according to the Fatigue Severity Scale (FSS) (score≥4/7)
* Reporting functional limitations according to the Post-COVID-19 Functional Status scale (PCFS (score ≥2/4);
* Being able to give free and informed consent (adequate understanding of the study protocol);
* Agreeing to perform a pulmonary function test, an exercise stress test, and an ergospirometric exercise test (adequate understanding of steps and procedures);
* Having a low exercise capacity and moderate-to-severe cardiovascular risk \<7 metabolic equivalent of a task (MET) or ≤9 if significant reduction of self-reported exercise tolerance according to the stress test performed on a treadmill - Cornell protocol);
* Having no other potential explanatory causes for fatigue or reduced exercise capacity according to medical evaluation

Exclusion Criteria:

* Cognitive impairment: Mini-Mental State Examination (MMSE) ≤24/30
* Inability to perform or understand study procedures
* Medical contraindication
Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer

The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.

The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.

Specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on:

1. patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer,
2. measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process,
3. the treatments selected, and
4. 3-6 and 9-12 month outcome assessments of clinical status, decision regret, cancer-related quality of life including worry, functional status, and treatment side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 to 85 years
* Sex: male
* Race/ethnicity: no restrictions
* Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either:
* localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values \< 10 ng/ml, OR
* Intermediate risk prostate cancer, defined as Gleason score = 7, T2b-T2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or PSA 10-20 ng/ml
* Willing to participate and able to give informed consent
* Able to adequately see the study intervention which is an interactive decision dashboard \& complete study-related questionnaires
* Able to understand English language adequately to use the decision dashboard and complete study-related questionnaires

Exclusion Criteria:

* Unable to complete study-related tasks due to cognitive deficits or English non-fluency
* Unwilling to participate.
* Deemed clinically unsuitable for active surveillance as a prostate cancer management option
Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth

Non-constipated irritable bowel syndrome is a common disorder that may be related to small intestinal bacterial overgrowth. Saccharomyces boulardii CNCM I-745 is a probiotic yeast that has proven efficacy for the treatment of acute gastroenteritis and antibiotic-associated diarrhea. However, its efficacy for the treatment of diarrhea-predominant irritable bowel syndrome with small intestinal bacterial overgrowth has not been assessed. Hence, an exploratory randomized, open label trial comparing the efficacy and safety of Saccharomyes boulardii CNCM I-745 plus diet administration versus diet administration only for 15 days among adult patients with the aforementioned condition was conducted.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Diagnosis of Irritable Bowel syndrome according to Rome III criteria
* Diagnosis of concomitant small intestinal bacterial overgorwth (SIBO) by breath test

Exclusion Criteria:

* Pregnancy
* Diagnosis of Celiac disease
* Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions
* Immunosuppression
* Diagnosis of active cancer
Safe, Healthy, Adolescent Relationships and Peers

The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the factors that contribute to the behaviors and health of teen girls, such as girl's friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about how to make healthy choices. This study will inform us on ways to help teen girls engage in safe and healthy relationships and adjustment.

Initiation of drug use and participation in sexual-risk behaviors such as having multiple sexual partners, unprotected sexual intercourse, and intercourse with drug users are all too common among girls with at-risk histories, such as those who have experienced poverty, abuse, neglect, or been in the juvenile justice system. Studies consistently find that these girls have disproportionately high rates of these problems that, in addition to increasing risk for negative outcomes, have other costly sequelae such as drug addiction, early pregnancy, sexually-transmitted infections (STIs) and HIV contraction, delinquency, and early mortality (e.g., Santelli et al., 2001; Stueve et al., 2005). In our prior work, the investigators showed that the investigators could prevent early onset sexual intercourse and tobacco and marijuana initiation in pre-teen girls in foster care. Although this intervention, delivered to girls who were 11-years old and had not yet entered middle school, demonstrated efficacy, the investigators know very little about how to prevent the more serious and costly sexual-risk and illicit drug use behaviors in at-risk girls during the high school years, a period of risk for engagement in such behaviors. This study builds from this prior work to develop a new intervention for teenage girls with early adversity.

Eligibility Criteria:
Inclusion Criteria:

* reside in Lane County and within 70 miles of the University of Oregon
* have a current caregiver
* both girl and caregiver are fluent in English

Exclusion Criteria:

* are medically fragile
* have a significant developmental disability
* have graduated from high school or have a General Educational Diploma (GED)
Algorithm for Vertical Placement of Implantable Collamer Lens

The objective is to develop and evaluate an algorithm for implantable collamer lens (ICL) sizing that uses high frequency ultrasound biomicroscopy (UBM) for vertical placement.

This study is a single-arm, clinical evaluation study of vault height and refraction, after successful ICL implantation. Subjects will be assessed pre-operatively, operatively, at 1 week postoperatively, and 1, 3, and 6 months post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and vault height.

Eligibility Criteria:
Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in each study eye.

Inclusion Criteria:

* Presenting for uncomplicated ICL implantation, either toric or non-toric lens, with vertical placement of the ICL
* Gender: Males and Females.
* Age: 23 or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
* Potential postoperative visual acuity of (20/25 Snellen) or better in the study eye

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or study eye, the subject should not be enrolled in the study.

* Irregular astigmatism (e.g. keratoconus)
* Unstable refractive error
* Low endothelial cell count
* Anterior chamber depth \<2.8mm
* Any cataract in operative eye or nontraumatic cataract in the fellow eye
* Narrow anterior chamber angles (Grade 2 or less)
* Difficulties comprehending written or spoken language
* Patient with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate)
* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
* Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Motor Control Training in Individuals With Subacromial Pain Syndrome

The porpusose of this study is to evaluate the repercussions of a motor control exercise protocol in patients with subacromial pain syndrome without indication of surgical repair.

Methods: This is a randomized controlled trial which will be composed of volunteers of both genders, aged between 35 and 60 years. All volunteers will undergo pre-assessment (Av1): pain sensation, pain and function, shoulder range of motion, muscle strength, electromyographic activity and kinematics of the shoulder complex. After the initial evaluation, the volunteers will be randomly divided into two groups to carry out the intervention: exercises (GE - conventional exercises with elastic band) and motor control (GCM - motor control training). The intervention protocol will last eight weeks. After four weeks, the second assessment (AV2), similar to AV1, will be performed and the global change perception questionnaire will be added. At the end of the intervention protocol, the third evaluation (AV3), similar to AV2, will be performed. A follow-up will be performed after 4 weeks of the end of the intervention protocol, with the assessment being equal to AV3.

The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov. The study will only begin after approval of the ethics and research committee. All volunteers should read and sign the terms of free and informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Present subacromial pain with a score greater than or equal to 2 (Visual Analog Scale) for more than 2 months;
* Positive Neer test;
* Positive Hawkins test;
* Positive Jobe test (pain);
* Positive Patte test (pain);
* Involvement of the supraspinatus and / or infraspinatus tendon (without degenerative characteristics) confirmed by Magnetic Nuclear Resonance (MRI) examination.

Exclusion Criteria:

* Intense pain during the evaluations;
* Fail to properly perform the evaluation procedures;
* Two consecutive or five alternating absences during the training protocol.
Follow-up Study on Recipients of Treatment at the Jerusalem Center for the Treatment of Psychotrauma

Researchers examined perceived satisfaction and perceived increase or decrease in symptoms among recipients of treatment at the Jerusalem Center for the Treatment of Psychotrauma, using self report methods. Researchers hypothesized that a significant number of recipients would report a decrease in their symptoms and general satisfaction with the treatment they received.

Researchers conducted a follow-up study of clients of Meytiv, the clinical branch of the Jerusalem Center for the Treatment of Psychotrauma. Researchers plan to use the results of the study to better understand the demographics of those who come to the Center, and to improve the services offered to our clients. Before beginning treatment, every Meytiv client filled out a questionnaire in which information is requested regarding demographics, trauma history, symptoms, and various levels of functioning. Researchers administered a similar self-report questionnaire to all clients upon completion of treatment. The follow-up questionnaire contained the following several indices: the Traumatic Events Screening Inventory (TESI), which requests a client's trauma history; the Multidimensional Scale of Perceived Social Support, which measures level of family, friend, and other support; the Brief Symptom Inventory, which measures level of various psychiatric symptoms, including somatic complaints, depressive symptoms, anxiety, and paranoid or hostile thoughts; the Self-Efficacy Scale, which measures level of self-reliance and confidence in one's ability to cope with stressors; and PDS, which measures subjective response to trauma, symptoms, and and level of functioning. This questionnaire, which mirrors one completed by all Meytiv's clients before treatment, was administered to those clients who completed treatment within a year of the study. Clients completed the follow-up questionnaire on condition that if they were in need of further treatment, Meytiv would refer them to the appropriate provider. Responses will be coded and analyzed to check significance among potentially related variables, including demographic variables. Most importantly, results of the follow-up questionnaire will be compared to its parallel from the beginning of treatment in order to examine what effects our treatment has on one's symptoms, and whether our clients have been satisfied

Eligibility Criteria:
Inclusion Criteria:

* All clients who were exposed to a traumatic event within the last 2 years and completed treatment at the Trauma Center within the last year

Exclusion Criteria:

* Clients under the age of 12
Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty

Background

Bone irrigation is essential in cemented total knee arthroplasty surgical technique in order to improve cement penetration and interdigitation into cancellous bone, that is going to determine the strength of the bone-cement interface.

Purpose

To report the effect of high-pressure pulsatile lavage versus manual rinsing on bone cement penetration in total knee arthroplasty.

Methods

This is a single-centre, prospective, randomized, controlled clinical trial. The study included 100 patients undergoing primary total knee arthroplasty. All patients meeting inclusion criteria were randomly assigned to the pulsed lavage or non-pulsed lavage group. The cumulative bone cement penetration was radiologically assessed in antero posterior and lateral radiograph views in 10 zones according to the Knee Society Scoring System. A statistical analysis was performed between both groups comparing bone cement penetration cumulative scores.


Eligibility Criteria:
Inclusion Criteria:

* Age \>60 years
* Age \<89 years
* Clinical symptoms of knee osteoarthritis
* Failed conservative treatment

Exclusion Criteria:

* Metal allergies
* Active or latent knee sepsis
* Extensor mechanism dysfunction
* Morbid obesity
* Several peripheral vascular disease
* Noncompliance due to major psychiatric or neurological disorders.
Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy

The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Has body weight ≥50 kg for men and ≥45 kg for women
* Must have diagnosis of neuropathic PLSR
* Has duration of neuropathic (leg) pain of at least 6 months before Screening
* Has an intensity of ≥4 and ≤9 on the Numerical Rating Scale based on a paper-based question at Screening and on Day 1 that asks for the average pain intensity of neuropathic (leg) pain due to PLSR over the last week

Key Exclusion Criteria:

* Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)
* Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
* Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)

Background:

Eating Disorders (ED) are mental health conditions, characterized by pathological behaviors toward food intake or a persistent obsession with weight control. EDs have a high prevalence among pre-adolescents in developed countries and pose a significant economic burden. Preventive interventions targeting at-risk populations for ED have proven effective. The use of Information and Communication Technologies (ICTs) facilitates access to larger population groups while also reducing costs.

Objectives:

* Develop and validate a universally applied intervention, mediated by ICTs, for the Primary Prevention of Eating Disorders (PRETA), through cultural adaptation and adjustment of the POtsdam Prevention at Schools (POPS) Program to preadolescents.
* Assess the efficacy of the PRETA Program through a randomized controlled trial (RCT).
* Evaluate the efficiency of the PRETA Program from a social perspective. Methodology The PRETA Program uses 9 online sessions with interactive activities for pre- adolescents, plus education for their families and teachers.

Its content includes addressing key factors in the development of ED, such as eating habits, beauty standards, and media literacy, as well as activities aimed at strengthening psychological dimensions (self-esteem, emotional regulation, problem-solving, psychological flexibility, and resilience) and social skills, including communication styles and distinguishing between jokes and bullying.

The study involves schools being randomly assigned to either the PRETA Program or regular health activities. The effect of the intervention will be evaluated 3 months after its start.

A matched-pair cluster random allocation will be used, with schools being asigned as clusters. Five schools will be assigned to each group.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the fifth or sixth year of primary education.
* Informed consent provided by the student's legal guardians and responsible teacher to participate.

Exclusion Criteria:

* Significant comprehension difficulties that limit adequate participation in the program and questionnaires.
Cognitive Remediation in Early Phase Psychosis

The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).


Eligibility Criteria:
Inclusion Criteria:

* Early phase schizophrenia, schizoaffective disorder, psychosis NOS
* Less than 5 years since start of adequate treatment for psychotic disorder
* Age between 18-40
* Norwegian speaking (sufficiently to understand and complete assessments)

Exclusion Criteria:

* Traumatic brain injury
* Neurological disorder as determined by medical history
* IQ below 70