cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation

The aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. Physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later.

Renal transplant recipients have to integrate preventive behaviours into their everyday lives. From the literature it is known that patients can only partially adhere to the recommended behaviours. An evidence-based self-management program to support patients in behaviour change was developed with a main focus on prevention of weight gain and increasing physical activity and medication adherence.

The aim of this study is to investigate the effectiveness of the program in patients in the first year after renal transplantation.

The specific aims of this study are:

1. Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).
2. Compare differences in the amount of physical exercise between subjects in the IG group and the CG.
3. Compare differences in self-reported medication adherence between the subjects of the IG group and the CG.

Secondarily, differences in self-reported quality of life, anxiety and depression, and differences in patients' perception of health care provision regarding chronic illness between the subjects of the IG group and the CG will be compared.

Design: Randomised controlled trial, not blinded

Setting and time: The study will take place at the Nephrology Clinic, University Hospital Zürich, from 1 May 2012 through 31 April 2015.

Variables and Measurement: Physical, behavioural, and clinical outcomes will be measured at baseline, before randomization and then 8 and 12 months later. Medication adherence, physical activity, symptoms of depression and anxiety, quality of life and patients' perception of health care provided will be measured with validated questionnaires. Body weight, height, waist to hip ratio and body composition (BCM Fresenius) will be measured at the Nephrology Clinic. Physical activity will be measured with the pedometer StepWatchTM.

Intervention

Eligibility Criteria:
Inclusion Criteria:

* received a kidney or a kidney-pancreas transplant in the University Hospital Zürich

Exclusion Criteria:

* unstable psychiatric disorder
* cognitive impairment
* multi-organ transplantation with lung
* liver or heart
* illiteracy
* not able to speak and understand German
Patient Perceptions and Experiences Following Multiple Sessions of Simulated or Genuine HVLA Manual Chiropractic Adjustments

Our primary aim with this trial is to measure participant blinding following two simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments to assess if participants are able to identify their un-disclosed treatment group. Our secondary aims with this trial are to utilize electrocardiography (ECG), impedance cardiography (ICG), and gait analysis before either treatment session and after both treatment sessions to assess if there are any changes with the participants' measurements before and after a sham or genuine HVLA chiropractic treatment.

The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments. Briefly, 60 eligible participants will be randomized (1:1 ratio) to receive two sessions of either simulated/sham or genuine/real chiropractic spinal adjustments with a 1 week washout between each treatment. The participants will be given a brief survey immediately following their first and second sessions, as well as immediately prior to the second session. This survey captures their perceptions and experiences regarding the intervention they received. The participants will also complete a pre- and post-electrocardiogram (ECG), impedance cardiography (ICG), and gait analysis. The participant will wear electrical diodes to assess ECG and ICG. Additional sensors will be placed on the participant to assess gait patterns while walking on a treadmill.

Eligibility Criteria:
* No history of stroke or transient ischemic attack or current symptoms including: Dizziness or vertigo; Tinnitus (ringing in the ears); Visual, sensory, or motor disturbances
* No new pattern headache complaint
* No recent whiplash injury (within 3 mo)
* No spinal fractures/dislocations
* No disc problems with radiating symptoms to the arms or legs
* No severe degenerative joint disease in the spine
* No connective tissue disorders
* No primary fibromyalgia
* No metabolic or metaplastic bone disease
* No history of cervical, thoracic, or lumbar spine surgery
* No uncontrolled high blood pressure or vascular disease
* No current use of anticoagulant therapy
* Not a DC or a DC student enrolled 4th quarter or above
* No present, self-reported pregnancy
* No chiropractic care in the 2 weeks prior to participation
* Did not participate in the feasibility study for this pilot (Perceptions and experiences following a single session of simulated or genuine high velocity, low amplitude (HVLA) manual chiropractic adjustments)
Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication

The purpose of this study is to determine the influence of moderate FiO2 and the lung protective ventilation on postoperative pulmonary complications following hepatic resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1\~2,Planned intrabdominal hepatic resection surgery;
* Expected duration 2 hours to 6 hours;
* Age 40 yr to 70 yr);
* BMI 18-26.9kg/m2
* Risk of postoperative pulmonary complications (Arozullah score ≥2);

Exclusion Criteria:

* Noninvasive ventilation in the last 30 days;
* Recent history of pneumonia, ALI/ARDS (in the last 30 days);
* History of pulmonary resection;
* History of neuromuscular disease;
* Child-Pugh\>A grade；
* Patient refusal;
Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)

The overall purpose of this observational Post Market Clinical Follow Up (PMCF) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

To comply with Medical Device Regulation (MDR) Post Market Clinical Follow Up (PMCF) requirements through proactive ongoing assessment of the safety, efficacy, and performance of the commercially available Glycar Pericardial Patch in patients undergoing cardiovascular repair or reconstruction surgery.

This real-world evidence retrospective data collection single-arm multicentre, observational, non-interventional study will enrol up to a minimum of 50 consecutive participants who meet inclusion criteria, in 2-3 centres. The study is aimed at providing real-world evidence of the Glycar Pericardial patch.

Retrospective data analysis will include collected clinical data from consecutive participants with a minimum of 2 years follow up, meaning from 30 June 2020 and going back in time. The quality of medical history being recorded is believed to be more reliable and complete in the most recent years. Therefore, it was decided to start enrolling consecutive participants in a reverse chronological order.

Eligibility Criteria:
Inclusion Criteria:

* If no waiver has been granted by the Ethics committee: Participants (all age) or legal guardian has signed the informed consent
* Participant has undergone a cardiac or vascular procedure which falls within the indications for use and required the use of Glycar Pericardial Patch

Exclusion Criteria:

- There are no study specific exclusion criteria. Participants have already been treated per standard clinical practice.
Group Acceptance and Commitment Training (ACT) With Healthy Older Adults

The current study aims to explore the impact of a two-session group Acceptance and Commitment Therapy (ACT) intervention compared to an assessment-only control on psychological outcomes in healthy older adults. The proposed study has two main objectives.

1. Examine the impact the intervention on targeted ACT processes over time
2. Examine the impact of the intervention on aspects of eudaimonic well-being over time

Older adults are a growing segment of our population, and this period of life presents a variety of physical, emotional, environmental, and cognitive changes, even for healthy individuals. The current study aims to explore the impact of a two-session group Acceptance and Commitment Therapy (ACT) intervention compared to an assessment-only control on psychological outcomes in healthy, community-dwelling older adults.

Participants will be randomly assigned (stratified by sex) to the ACT group condition or to an assessment-only control group. After randomization, those in the assessment-only control group will be asked to complete four assessments via mail (baseline, one-month, three-month, and six-month). The intervention group will participate in a brief group ACT intervention occurring over two sessions (90 minutes each, approximately one week apart). Intervention participants will also complete assessments at baseline and at one-month, three-months, and six-months post-intervention.

The specific aims and hypotheses of the current study are:

Specific Aim #1: To examine longitudinal between-group differences in targeted ACT processes including psychological flexibility (openness to experience, behavioral awareness, and valued action) and satisfaction with social roles and activities from baseline to follow-up. We hypothesize that there will be significant time by group interaction, such that psychological flexibility and satisfaction with social roles and activities will increase significantly more in the intervention group relative to the assessment-only control group.

Specific Aim #2: To examine longitudinal between-group differences in eudaimonic well-being (purpose in life and personal growth) from baseline to follow-up. We hypothesize that there will be significant time by group interactions, such that purpose in life and personal growth will increase significantly more in the intervention group relative to the assessment-only control group.

Eligibility Criteria:
Inclusion Criteria:

* healthy, community-dwelling older adult (age 65-99)

Exclusion Criteria:

* significant primary psychiatric disease
* medications that have the potential to affect cognitive functioning
* neurological events
Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

This study included cataract patients who underwent toric intraocular lens (IOL) implantation, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

This study included cataract patients who underwent the implantation of toric intraocular lens (IOL) with haptic design, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

Eligibility Criteria:
Inclusion Criteria:

* Cataract

Exclusion Criteria:

* • small pupil

  * zonular dehiscence
  * preexisting corneal pathology
  * glaucoma
  * uveitis
  * a history of ocular trauma or surgery
  * severe intraoperative and postoperative complications
Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer

This phase II trial evaluates Fluorine-18 radiohybrid prostate-specific membrane antigen (18F- rhPSMA)-7.3 positron emission tomography (PET)/computed tomography (CT) scans with and without furosemide for the reduction of bladder activity in patients with prostate cancer that has come back (recurrent) based on elevated levels of prostate-specific antigen (PSA) in the blood (biochemical) after prostate surgery (prostatectomy). Furosemide is a diuretic substance that increases the urine flow into the bladder, thereby decreasing the level of radioactivity within the bladder, which may help to see any abnormal areas that could be masked by the radioactivity within the bladder. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, rhPSMA ligand. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Adding furosemide to 18F-rhPSMA 7.3 PET/CT scans may help to better detect and treat patients with biochemically recurrent prostate cancer.

PRIMARY OBJECTIVE:

I. To determine if administering 20 mg furosemide intravenously (IV) at the time of radiotracer injection significantly reduces bladder activity compared with the same patient scanned without furosemide as internal control.

SECONDARY OBJECTIVES:

I. To compare detection rates of recurrent disease in blinded interpretations between the furosemide and non-furosemide 18FrhPSMA-7.3 PET/CT scans, with patients serving as their own internal controls.

II. To compare reader confidence in identifying prostate bed and other recurrent lesions on a 18F-rhPSMA-7.3 PET/CT with furosemide compared with 18F-rhPSMA-7.3 PET/CT without furosemide.

OUTLINE:

Patients receive 18F-rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate, post-prostatectomy
* Biochemical recurrence of prostate cancer following radical prostatectomy (RP) with or without adjuvant or salvage therapy: PSA \>= 0.2 ng/mL followed by a subsequent confirmatory PSA value \>= 0.2 ng/mL
* Age over 18
* Ability to provide written informed consent
* Patients with standard of care creatinine =\< 1.3 mg/dL performed within 90 days prior to enrollment

Exclusion Criteria:

- Inability to undergo 18F-rhPSMA PET-CT, contraindications to furosemide or urinary incontinence
Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)

Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence

Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

Eligibility Criteria:
Inclusion Criteria:

1. -Signed informed consen
2. -Good general state of health according to the findings of ythe clinical history and the physical examination
3. -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide
4. -Women having rejected de rehabilitation treatment or in which the treatment had failed
5. -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution

Exclusion Criteria:

1. -Pregnant or lactating women
2. -Active urine infection
3. -Presenting an infravesical obstruction
4. -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
5. -Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years
6. -Cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study
7. -Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
8. -Subjects with congenital or aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
9. -Anesthesic allergy
10. -Major surgery or severe trauma in the previous 6 months
11. -Administration of any drug under experimentation in the present or 3 months before recruitement
Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial

The study aims to test the hypothesized non-inferiority of a self-guided digital intervention compared to a therapist-guided variant for people with atopic dermatitis (AD). Both interventions are based on Cognitive behavioral therapy. Participants will be recruited from advertisements in social media. Measurements of AD symptoms and psychological well-being will be conducted at pre-treatment, post-treatment as well as 6-month and one-year follow-up.

Background: Digital self-care based on Cognitive-behavioral therapy (CBT) could be an effective alternative to guided CBT for people with atopic dermatitis (AD) and has the theoretical potential to significantly increase access to psychological treatment for patients with AD, whilst being cost-effective for health care organizations.

Aim: To investigate whether a shortened digital self-care intervention is noninferior to, and cost-effective compared with, a comprehensive and therapist-guided CBT treatment for AD.

Intervention: Participants randomized to guided care will receive internet-delivered cognitive behavior therapy for 12 weeks. Participants randomized to digital self-care will have access to a self-guided intervention for 12 weeks_

Design, setting, and participants: This is a single-blind, randomized clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. 174 adult participants with AD will be recruited through self-referral. Participants will be randomized 1:1 to the two experimental conditions. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analyzed intention-to-treat.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported AD diagnosed by physician (potential participants will disclose the circumstances of their diagnosis)
* No new types of medications introduced for six months prior, with no intention of future change
* Able to understand Swedish
* Access to the internet and a smartphone

Exclusion Criteria:

* Other disease or condition that has immediate treatment priority over AD. This could be an ongoing demanding treatment of a severe somatic or psychiatric condition. No specific diagnoses are inevitably a cause for exclusion, as potential participants will rather be evaluated on a case-to-case basis.
Peribulbar Block Versus Subtenon's Injection in Redo Vitreoretinal Surgery

To compare the efficacy and efficiency of peribulbar block versus sub-Tenon's capsule injection of local anesthetic in redo vitreoretinal surgery

Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.5% bupivacaine with 60 IU hyalouronic acid.

The primary outcome measured was intraoperative eye pain, which was rated by patients in both groups using an 11-point (0-10) numerical visual analogue scale immediately after.

The surgeons indicated whether they perceived patient discomfort during 4 different stages of the operation: opening of the conjunctiva, vitrectomy (if performed), placement of scleral buckle (if performed) or using the laser probe, and closing of the conjunctiva.

The need for supplemental local anesthesia, and use of IV sedation for additional pain control intraoperatively were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80

Exclusion Criteria:

* Uncooperative patients
* Bleeding disorders
* High axial length (30mm) with previous buckle surgery
Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease

The investigators hypothesize that text message reminders to girls diagnosed with pelvic inflammatory disease (PID) in the emergency department (ED) will improve follow-up to their primary care provider (PCP) after being discharged from the ED.

The Centers for Disease Control (CDC) recommends that patients diagnosed with pelvic inflammatory disease (PID) receive follow-up care within 72 hours of diagnosis. However, recent studies show that the majority of teenage girls diagnosed with PID do not receive this follow-up care within 72 hours. We hypothesize that text message reminders to girls diagnosed with PID in the emergency department (ED) will improve follow-up to their primary care provider (PCP) after being discharged from the ED.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 15 years and older
* New diagnosis of PID, as defined by the 2006 CDC minimum criteria for diagnosis of PID, on current ED encounter
* Determined by attending physician to be appropriate for outpatient treatment

Exclusion Criteria:

* Patient does not have a cell phone that is capable of receiving text messages
* Developmental disability
* Non-English speaking
* Pregnancy
* Patient who was enrolled in this study on a prior ED visit
Comparison of Interventions for Developmental Dyslexia

The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of an intervention resulting from the combination of two yet validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific Stimulation (VHSS) and the Action Video Game Training (AVG). Finally, the effectiveness of the administration of only AVG is intended to be compared to other treatments. All interventions are administered for 13 hours over 9 days to a group of Italian students with DD aged 8-12.


Eligibility Criteria:
Inclusion Criteria:

* having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice

Exclusion Criteria:

* presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
* having been involved in previous reading intervention programs