cyrilzakka/clinical-trials huggingface dataset:
The Long Term Effect of MRI Before Radical Prostatectomy.

A randomized clinical trial conducted by Oslo University Hospital between 2010 and 2012 included 438 patients with prostate cancer to the non-MRI group (216) or the MRI group (222) before robot-assisted radical prostatectomy (RALP). The primary endpoint was to compare the nerve-sparing surgery types and the proportion of positive surgical margins (PSM) in each group. The MRI group underwent more non-nerve sparing surgery, whereas the proportion of PSM was similar in both groups (p=0.4) \[1\]. Since the long-term effects of preoperative MRI are unknown, we aimed to assess the variations in the long-term functional and oncological outcomes between the groups.

The aim of this study was to evaluate the oncological and functional outcomes in a 12-year follow-up after RALP in patients preoperatively randomized to no-MRI or MRI.

Material: a total of 438 consecutive patients were referred to RALP. Of these, 222 were randomized to preoperative MRI (intervention group), and 216 were randomized to no MRI (control group). All underwent radical prostatectomy between 2010 and 2012.

Study design: An experimental interventional study with 12-years follow-up

Endpoints: PSA recurrence (PSA ≥0.2ng/ml) Predictors for PSA recurrence (PSM, DÁmico risk group, Gleason score, T-stage) Overall survival (OS) Predictors for OS (PSM, DÁmico risk group, Gleason score, T-stage) MRI predictors for PSM, PSA recurrence and OS

Erectile function (IEEF-5) and urinary continence (IPSS-10) Urinary incontinence rates (≥1daily pads)

Statistics: Before RALP, included patients were randomized to the i) non-MRI group and ii) MRI-group. Kaplan Meier curves express the RFS and OS in the two groups, and the Log-rank test assesses any difference. Cox regression analyses is used to calculate the effect of MRI (Hazard ratios with 95% CIs). Chi-square test is used to assess the difference in incontinence rates, and the Mann-Whitney U test for assessing the difference in median IIEF-5 and IPSS-10 scores. Binary and Cox regression analysis is used to assess the predictive value of a positive surgical margin on PSA recurrence, and the effect of MRI variables in predicting RFS and OS (ADC, tumor volume, and radiological T-classification).

Data collection and handling of data: All patients were included in the study "Clinical impact of MRI in patients with prostate cancer." The urological and/or oncological clinic have followed these patients as part of routine clinical practice. Relevant clinical data are recorded in the "Radical prostatectomy registry ." All patients have already answered appropriate questionnaires during their regular follow-up.

PhD project: The study is a PhD project for radiologist Daniyal Noor at Oslo University Hospital

Eligibility Criteria:
Inclusion Criteria:

Prostate cancer scheduled for prostatectomy. All participated in the previous RCT

Exclusion Criteria:

Patients who did not sign the consent paper for any reason or did not accept the study premises.

Patients who underwent MRI prior to randomization. Patents who withdrew their consent for any reason during the study.
Relationship of Trunk Control and Endurance with Balance and Functional Mobility in Cerebral Palsy

It is predicted by studies that the motor and cognitive performance disorders seen in children with Cerebral Palsy (CP) may lead to loss of balance, postural control and mobility. At the same time, trunk muscle fatigue seen in children with CP is a critical motor problem and may cause deficits in adjusting the proper connection between the trunk and pelvis stabilizers.These deficits can lead to impairments in balance, postural control and mobility. Considering the relationship between the deficits seen in children with CP and postural control and postural control with the trunk, the idea that there is a need for studies that evaluate the trunk in every way and reveal its relationship with balance, postural control and mobility in order to organize the rehabilitation program effectively in children with CP. Therefore, in the planning of our study, it was aimed to evaluate trunk control and endurance in children with CP and to examine their relationship with balance and functional mobility parameters, as well as to reveal their relationship with functional health and quality of life.


Eligibility Criteria:
Inclusion Criteria:

Being diagnosed with Cerebral Palsy Volunteer Be between the ages of 6-18 Being at level 1 and 2 according to Gross Motor Function Classification System (GMFCS) (Level 1-2).

To have the cognitive skills to understand and apply the evaluation parameters.

Exclusion Criteria:

Participants diagnosed with Cerebral Palsy having cognitive disorders Participants diagnosed with Cerebral Palsy having vision or hearing problems Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.
Efficacy of Silymarin for Acute Hepatitis

The overall objective of this project is to assess whether Silymarin therapy shortens illness or prevents complications in patients with acute hepatitis. We will specifically compare responses in acute hepatitis patients treated with Silymarin to those given a control preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled trial.

The study is designed as a double-blinded placebo controlled trial. We compare a 4 week course of therapy with silymarin tablets and a low-dose vitamin preparation (placebo) and then follow-up for a total of 8 weeks to assess treatment response. Outcomes of our randomized controlled trial are improvement in symptoms and signs, normalization of liver functions, time to resuming normal activities, and and sense of well-being. This protocol follows the standard therapeutic care for acute hepatitis except that the patients will receive either a herbal supplement (silymarin), which many patients are taking anyway, or a vitamin placebo.

Freshly collected serum will be tested for anti-HAV IgM, anti-HBc Igm, anti-HBs, HBs Ag, anti-HCV antibody, HCV-RNA, anti-HDV IgM, anti-HEV IgM, CMV and EBV and for alanine aminotransferase (ALT), AST, direct and total bilirubin.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis.
* Recent (\<1 month) history of illness.
* Elevation of ALT \> 2.5 normal.
* At least 13 years old.

Exclusion Criteria:

* History suggestive of severe drug-induced acute hepatitis.
* Children 12 years and younger.
* Pregnant or breastfeeding women
* Suspected hypersensitivity to Silymarin or vitamin preparations.
* Evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy.
* Patients who are critically ill, with multisystem failure or cancer.
* Substance abuse such as IV drugs.
* Any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.
Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer

On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients.

The hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (PSM) and biochemical recurrence of the disease (BCR), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).


Eligibility Criteria:
Inclusion Criteria:

* Signature of the informed consent and consent to the use of personal data
* Prostate Specific Antigen (PSA) \< 20 ng/mL
* Unilateral organ-confined disease on MRI (performed according to ESUR recommendations and reported according to PiRads V.2) or PET-PSMA (performed according to the recommendations of the EANM and reported according to "EANM standardized reporting guidelines v1.0 for PSMA-PET")
* Histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and/or standard biopsy with ISUP \< 3 and ipsilateral on imaging investigations
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Life expectancy ≥ 5 years
* Availability of the patient's pre-operative clinical data
* Patients must be available to carry out the follow-up visits defined by the protocol
* Absence of retroperitoneal, lymph nodal, bone or visceral metastatic lesions
* Patients eligible for robot-assisted radical prostatectomy

Exclusion Criteria:

* Special histotypes of prostate cancer
* Patients with PSA \> 20 ng/ml at diagnosis
* Impossibility to perform MRI (with pacemakers, claustrophobia...) or PET-PSMA
* Previous prostate surgery (TURP, adenomectomy)
* Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
* Serious underlying disease or uncontrolled medical condition including active and uncontrolled infections
* Patients with dementia or psychiatric illness that limit compliance with study requirements or that could prevent understanding and/or signing the informed consent.
The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy

This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills.

In a systematic review, evaluated the effectiveness of multimedia education program (MLEP) and confirmed that MLEP reduced cost significantly and improved patient participation in enterostomy care and self-care ability. However, research was insufficient for whether a multimedia education program (MLEP) interventions can improve patient self-care and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 20
* Operation with ostomy

Exclusion Criteria:

* Dementia, mental illness, and central nervous system diseases
* Unable self-care
* Visual or hearing impairs
User-friendly HIV Testing and Counseling Services

Multicenter cohort study of individuals reporting behavioral risks of HIV acquisition, recruited among those presenting for testing for HIV and other sexually transmitted infections.

Overarching goal: to study factors associated with uptake of HIV prevention and (re)testing services in medium-sized cities in Thailand.

Primary objective: To estimate the incidence of HIV and other sexually transmitted infections (syphilis, chronic hepatitis B and C) among individuals presenting for retesting.

Secondary objectives:

* To evaluate the uptake of pre-exposure prophylaxis
* To assess retention in the study
* To evaluate client HIV knowledge
* To describe HIV prevalence and characteristics of individuals newly diagnosed with HIV
* To describe characteristics of individuals at risk of HIV infection
* To assess the quality of the testing and referral services.

Testing and counseling for HIV, syphilis and other sexually transmitted infections is provided to consenting individuals.

Components: interactive counseling program, self sampling (finger prick) under supervision, questionnaire (on a tablet computer) to assess risks of HIV acquisition, understanding of HIV transmission routes and pre-exposure prophylaxis, willingness to take pre-exposure prophylaxis if at risk of HIV, and satisfaction with regard to services provided.

Referral to appropriate care facility of participants diagnosed with infection. HIV negative participants with significant risk of HIV are advised to come back for HIV retesting within 3 to 6 months and informed about pre-exposure prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 15 years or more
* Willing to be tested for HIV and other sexually transmitted infections
* Able to understand the study and its procedures

Exclusion Criteria: None
REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study

This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.

Eligibility Criteria:
Inclusion Criteria:

* Participant's age ≥ 22 years.
* Participant presents with a Rutherford category of 2 to 6.
* Participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with DABRA Laser System.
* Participant is able and willing to be anti-coagulated.
* Ability and willingness of participant to give written informed consent and comply with follow-up.

Exclusion Criteria:

* Pregnant, breastfeeding, planning to become pregnant - If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
* Endovascular interventions within 90 days prior to study enrollment (on leg to be treated).
* Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study.
* Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast.
* Inability or unwillingness of the patient to comply with study examinations.
* Necrosis necessitating major amputation.
* Subject has an anticipated life span of less than one (1) year.
* Medically non-compliant subjects, based on Investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels).
* No run-off vessel is present when treating above the knee. A run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.
A Team-Based Care for Hypertension Management (TBC-HTA)

The purpose of this study is to determine whether a team-based care (TBC) intervention, combining physician, nurse and pharmacist care improves BP control compared to usual care at 6 months among outpatients with uncontrolled hypertension.


Eligibility Criteria:
Inclusion Criteria:

* treated patients with uncontrolled hypertension (defined as daytime systolic/diastolic ambulatory blood pressure monitoring (ABPM) ≥135/85mmHg) taking one or two antihypertensive medications;
* speak and understand French;
* agree to use the same pharmacy's services for the whole duration of the study.

Exclusion Criteria:

* unable to understand the study aim;
* pregnancy and lactating;
* livimg in a nursing home;
* hospitalization during the recruitment period;
* participation in another study;
* daytime ABPM\>180/110 mmHg.
The Treatment of Depression With Botulinum Type A Toxin

A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.

Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead

Eligibility Criteria:
Inclusion Criteria:

1. Male/Female between the ages of 18 and 65
2. Major Depression Disorder as defined by DSM IV criteria and diagnosed by a psychiatrist. DSM (Diagnostic and Statistical Manual) IV criteria for depression are: a depressed mood or anhedonia for at least a two week period. This mood must represent a change from the person's normal mood; social, occupational, educational or other important functioning must also be negatively impaired by the change in mood. Major depressive disorder cannot be diagnosed if a person has a history of bipolar disorder or if the depressed mood is better accounted for by substance abuse or a psychotic disorder. In addition, the patient must have 5 of the following symptoms:

   * Significant weight loss or weight gain.
   * Insomnia or hypersomnia
   * Psychomotor agitation or retardation
   * Feelings of worthlessness or excessive guilt
   * Poor Concentration
   * Fatigue or loss of energy
   * Suicidal thoughts
3. History of depression for at least 6 months
4. Initial score 14 or higher on initial Hamilton Depression rating scale.
5. Melancholic facial expressions amenable to treatment with Botox. Photos will be taken of potential participants and ranked independently by two investigators, on a scale of 1-10 based on how negative they look, 10 being the highest. Patients with an average score of 6 or above will be included in the study

Exclusion Criteria:

1. Active substance abuse
2. Bipolar Depression
3. Subjects who are pregnant, nursing or trying to become pregnant during study participation
4. Subjects who are currently on more than 3 psychiatric medications at the time of enrollment
5. Current medications used to treat depression must be stable for at least 60 days prior to enrollment
6. Previous Botox treatment
7. The Principle Investigator has determined that this study is not in the best interest of the subject and therefore the subject will not be enrolled.
Berberine Treat Metabolic Syndrome in Schizophrenia

In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia.

This study is an open lable clinical intervention trial, include 30 female subjects with diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（ 300mgTID） as an add-on therapy lasting 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ;
2. Female subjects aged 18-60 years;
3. monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine；
4. subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007;
5. the subjects and their guardians sign the informed consent agreement.

Exclusion Criteria:

1. subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5;
2. chronic organic diseases involving any central nervous system, such as tumors and inflammation, brain trauma, active seizures, vascular diseases, Parkinson's disease, myasthenia gravis, and other degenerative diseases;
3. a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation;
4. used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months;
5. serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc;
6. currently receiving anti-inflammatory or immunosuppressive treatment, including oral steroids;
7. a history of chronic infection, including tuberculosis, AIDS and hepatitis;
8. allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase deficiency;
9. pregnant women, lactating women；
10. participants were involved in other clinical trials within 1 months prior to the signing of informed consent
11. other reasons judged by the researchers to be inappropriate for the clinical study.
Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath

This is a two-arm, cluster randomized trial designed to to evaluate the effectiveness of an e-cigarette curriculum \[called the CATCH My Breath (CMB) program\] in delaying the onset of e-cigarette use in middle schoolers. Schools will be assigned to either the CMB program or usual care, which is Texas Education Agency (TEA) required tobacco prevention program. 10 schools will be assigned to each arm arm, and each school will include 70 students in the study, for a total of 700 students per arm and 1400 total students in the study. Both programs will be administered to participating students over 3 years.

The goal of this research is to empirically assess the three year immediate effects and 12 year follow-up of the CATCH My Breath (CMB) program on delaying the onset of e-cigarette use with a 6th-9th grade cohort, using a 20-school group randomized controlled trial (RCT), with 1,400 students. E-cigarettes are the most commonly used tobacco product by US youth. Recent research, strongly suggests that youth who only smoke e-cigarettes exhibit symptoms of addiction, and are more likely to experiment combustible tobacco. Unfortunately, few e-cigarette prevention programs exist, and none have been tested for longer-term efficacy. Although some tobacco prevention programs have included an e-cigarette add -on component, to our knowledge, none of these revised programs have been formally evaluated. The lack of e-cigarette specific program content, and lack of rigorous evaluation, warrants the proposed project. CMB was developed with input from school administrators, health education coordinators, tobacco prevention educators, classroom teachers, students, and parents. CMB has been formatively evaluated and pilot tested at 59 middle schools in 7 states, resulting in positive feedback from over 100 middle school teachers and 9,578 6th-8th grade students. Our second pilot pretest-posttest controlled experiment (2017-2018), and resulted in an treatment-control difference of 3.8% in ever smoking over a 16-month period. Given CMB's current popularity with schools as a 'best practice' program, and with initial positive results, a full scale randomized control trial is needed to determine longer term, 6th-9th grade efficacy.

Eligibility Criteria:
School Inclusion Criteria:

* enrollment of at least 70 students in each of the 6th, 7th, and 8th grades
* school location is 100 miles of research site

School Exclusion Criteria:

* schools that have participated in the previous 2 pilot tests
* currently implementing CMB

Student Inclusion Criteria:

* enrollment in the 6th grade at a study school
* willingness to complete the measurements six times during the study

Student Exclusion Criteria:

- severe disabilities that limit their participation

Parent Inclusion Criteria:

* ability to communicate in English or Spanish
* caretaker of a 6th-grade child.

Parent Exclusion Criteria:

-inability to communicate in English or Spanish