cyrilzakka/clinical-trials huggingface dataset:
Integrating Safer Conception Counseling to Transform HIV Family Planning Services

This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family planning (FP) program that incorporates a structured, multi-component safer conception counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2; less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by The AIDS Support Organization (TASO) Uganda.

Family planning (FP) services for people living HIV/AIDS (PLHA) focus on preventing unplanned pregnancies and mother-to-child-transmission (PMTCT), and currently provide no services to support safer conception, despite \~40% of HIV+ women in sub-Saharan Africa (SSA) becoming pregnant post HIV diagnosis. Antiretroviral therapy (ART) greatly reduces the transmission risks associated with childbearing, but many PLHA are either not on ART or not adequately adherent; hence the need for using safer conception methods (SCM) such as manual self-insemination and timed unprotected intercourse. This cluster RCT will compare (1) a comprehensive FP program that incorporates a structured, multi-component SCC intervention (SCC1) versus (2) an SCC training workshop for FP nurses (SCC2; mimics approach used by Ugandan MoH to integrate new services), and (3) existing FP services (usual care) at 6 HIV clinics operated by TASO Uganda. The 3-arm design, together with the planned cost-effectiveness analysis, allows us to examine two models for integrating SCC into FP services that differ on level of intensity, thereby informing MoH policy and resource allocation. Sixty clients in HIV serodiscordant relationships who express childbearing desires at recruitment will be enrolled at each site (n=360) and followed for 12 months or completion of pregnancy (if applicable). The primary outcome is use of either SCM (for those trying to conceive) or dual contraception (those who decide against pregnancy).

Eligibility Criteria:
Inclusion Criteria:

1. HIV+ client of TASO
2. Client if of reproductive age (males age 15-60; females age 15-45).
3. Has a partner with whom the client is considering having a child.
4. If client or their partner is age 15-17, the couple must be "married", defined as cohabitating and the parents of the minor(s) are reported to be aware of the relationship.
5. Partner with whom the client is considering having a child is HIV-negative.

5. Client reports that their partner is aware of the client being HIV-positive.

Exclusion Criteria:

1. Female client (or partner of male client) is pregnant
Motor Imagery Training Football Players With Anterior Cruciate Ligament Repair

Volunteer participants who have undergone anterior cruciate ligament surgery at Bursa Çekirge State Hospital and meet the inclusion criteria will be included in the study. The study will select a sample group from the universe using the probability sampling method (simple random sampling). Participants will be divided into 2 groups: Conventional Physiotherapy + Kinesthetic motor imagery training group and Conventional physiotherapy group with randomization software (https://www.randomizer.org/). Conventional physiotherapy practices created by the physician will be applied by physiotherapists working in the hospital. Knee functions will be evaluated with the IKDC scale, reaction time will be assessed with video recording supported by the Kinovea program, kinesiophobia will be assessed with the Tampa kinesiophobia scale, and finally, autonomic functions will be evaluated with the polar device. Measurements will be repeated after 6 weeks of interventions.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with anterior cruciate ligament repair,
* Individuals who have no experience in this type of training,
* Not having any vision, hearing, or speech problems that would prevent the tests from being performed.
* Individuals who agree to the purposes of this study and to participate voluntarily.

Exclusion Criteria:

* Have previous experience in Motor Imagery techniques or training,
* Having any orthopedic problem that prevents walking,
* Having a history of neurological disease,
* People being treated with any medication that affects the central nervous system
Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet

Multicenter, Prospective, randomized, comparative and controlled study about the beneficial effects in behavior and brain connectivity of different dietary patterns in 100 children with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.

We collect electroencephalogram (EEG), event related potentials (ERP) data, and behavior parameters in ADD/ADHD children that not take stimulants or other drugs during study. They would only follow some nutritional recommendations based on increasing the amount of dietary protein and fast carbohydrates decrease. The duration of the study will be 6 months, 3 months for recruitment and 3 months for dietary treatment.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosed 12 months before
* no take medication
* BMI above the 25th percentile
* Wiesel score between 80 and 100 (about 120)
* Patients who agree to participate and whose guardians signed the informed consent form

Exclusion Criteria:

* eating disorders
* psychosis, bipolar disorder or depression
* kidney or liver failure
* diabetes
* diuretic or cortisone treatment
* haematological problems
* suprarenal diseases
* cancer
* Brain injury
* Cardiovascular or arrhythmia problems
Genetic Causes of Familial Hypercholesterolemia

Familial hypercholesterolemia (FH) is a common disease. The genetic background to FH is not yet fully understood. In the present prospective cohort study we aim to study the association between different clinical characteristics, gene mutations and prognosis.

In this prospective observational cohort study of patients with high clinical suspicion of familial hypercholesterolemia (FH) we aim to study the association between different clinical characteristics, gene mutations and prognosis.

The included patients will undergo physical examination and extended blood sampling. DNA will be extracted and used for both whole genome sequencing and investigation of both known- , unknown- and suspected mutations associated with FH.

The patients will be followed in for 15 years in the Swedish patients registry and the Swedish cause of death registry.

Eligibility Criteria:
Inclusion Criteria:

1. Age 8 years or older.
2. Clinical suspicion of FH
3. Dutch Lipid Clinic Network Score of at least four or a first grade relative with a genetic deviation that may be associated with FH.

Exclusion Criteria:

1) Age below 8 years.
Improved Discrimination Of Central And Obstructive Apnoeas In Infants

Referral of infants to the respiratory sleep disorders breathing team with apnoeas \[pauses in their breathing\] and apparent life-threatening episodes are frequent. While the majority of such episodes do not have a significant underlying problem a potentially life threatening condition accounts for a significant proportion of cases.

In order to fully assess an infant, a full-scale overnight polysomnography study would be required. Unfortunately due to the complexity of such studies and because the equipment is generally fully booked for many weeks ahead it is extremely difficult to arrange timely assessment. Hence, currently, we are largely reliant on simple screening with pulse oximetry (measuring oxygen levels in the blood with a simple probe). This is able to identify potentially significant problems, but it is does not help to determine whether this is because the baby simply stops breathing for a period due to disturbance of its control of breathing, or whether it is experiencing obstructive episodes, for which there are a number of causes. This new equipment to be assessed would potentially provide a simple, robust means of undertaking definitive studies simply and effectively on the medical wards with assessment of chest and abdominal wall movement being linked to pulse oximetry.

This is likely to provide a substantial and significant improvement on our current practice. The benefits will be that, for those with no significant underlying problems, we will be able to provide much greater reassurance for the parents, which is clearly very valuable, while in those with a problem we will be able to distinguish those with central or obstructive apnoea with a degree of certainty that will greatly streamline further assessments and treatment.


Eligibility Criteria:
Inclusion Criteria:

•Infants between 36 weeks post conception and one year old referred to the respiratory and sleep team for central or obstructive apnoea or apparent life threatening events.

Exclusion Criteria:

•Chest wall deformity on injury that precludes the use of the Volusense paediatric device.
Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique

The traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. Instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. Respectively 20% and 50% of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result, and complain of residual symptoms. A newer, more physiological technique for implanting a total knee prosthesis, known as kinematic alignment, aims to recreate the unique native anatomy and laxity of each patient\&#39;s knee. The kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient\&#39;s experience of his or her prosthetic knee. As a result of the emergence of the kinematic alignment technique, two manufacturers have developed total knee prosthesis implants specifically for this new insertion technique. A "made-to-measure" total knee prosthesis (ORIGIN® - Symbios, Yverdon-les-Bains, Switzerland) was developed with the aim of reproducing the unique contour of each implanted knee. Another manufacturer opted to develop a generic total knee prosthesis implant (SPHERIKA® - Medacta, Castel San Pietro, Switzerland), but with a design optimized for the kinematic alignment technique. These two models of total knee prosthesis each offer advantages and limitations that need to be assessed. The main aim of this study is therefore to compare the joint perception of these 2 prostheses. It will also look at the clinical and imaging results, the biomechanics of the prosthetic knee during gait, and the muscular strength of knee extension, obtained for these 2 total knee prostheses.


Eligibility Criteria:
Inclusion Criteria:

* Patient with indication for initial total knee replacement
* Patient affiliated to a social security scheme
* Patient informed of the study and formally included (informed consent signed) before the first research examination.

Exclusion Criteria:

* Patient with complex osteoarthritis (e.g. bone loss, history of patellar instability)
* Patient with contralateral knee prosthesis
* Patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip or contralateral knee
* Patient with another condition (acquired pathology) of the lower limbs and/or nervous system that may significantly affect gait quality
* Patient deprived of liberty by judicial or administrative decision,
* Patient of legal age under legal protection or unable to express consent.
Dane County Safety Assessment for Elders (SAFE) Research Study

This 3-year collaborative project will develop, implement, and test a comprehensive approach to the prevention of falls among high-risk older adults in Dane County, Wisconsin through two complementary strategies:

1. a targeted strategy of an individualized multifactorial intervention for community-living high-risk older adults. Older adults are defined as aged 65 and older. High risk is defined as two or more falls in the year prior, one fall with injury, or one fall with gait and balance problems, as per recent guidelines from the American Geriatric Society (AGS). The multifactorial intervention consists of an in-home assessment followed by recommendations to the participant and his/her physician, a prescription for physical therapy, other referrals (optometry, podiatry, occupational therapy, etc.) based on the assessment, monthly phone follow-up for 11 months, and a prescription for long-term exercise after physical therapy.
2. a program to educate primary care physicians, physician assistants, nurse practitioners, and physical therapists in Dane County in the current diagnosis and treatment recommendations for fall prevention.

The purposes of the project are:

1. To test, in a randomized, controlled, single-blind study design, whether a multifactorial intervention for high-risk older adults will decrease the rate of falls compared to a control group receiving a home safety and nutrition booklet by mail;
2. To enhance existing health professional knowledge base to support fall prevention;
3. To test, in a quasi-experimental study design, the ability of a community-wide health professional educational program to decrease the rate of fall-related hospitalizations among older adults (both high and low-risk) in Dane County compared to control counties in Wisconsin.

We hypothesize that:

The rate of falls will be 40% lower over one year among high-risk older adults randomized to the individualized multifactorial intervention (combined with health professional education), compared to those randomized to home safety and nutrition booklets (combined with health professional education) in Dane County.

A health professional education program about fall prevention will decrease the rate of fall-related hospitalizations among older adults (both high and low-risk) in the intervention county by 10%, compared to an anticipated no change from baseline in control counties.

Eligibility Criteria:
Inclusion Criteria:

* Community-residing in Dane County or surrounding communities.
* Seniors living in assisted-living senior apartments
* Aged 65 and older
* At high risk for falls as defined by AGS criteria (two or more falls in the past year, or one fall with injury, or one fall with abnormal gait or balance)

Exclusion Criteria:

* Reside in a community-based residential facility (i.e. group home)
* Are unable to give informed consent and have no related, in-home caregiver
Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance. Mucus volume (mL) measured by Functional Respiratory Imaging (FRI). FRI is a quantitative endpoint that identifies mucus plugs in the segmented airways. Mucus volume will be assessed based on movement of mucus plugs and/or clearance from segmental airways. CT scans are obtained to determine FRI and will be obtained and assessed at baseline and after the 4-week treatment period to assess changes in mucus volume within the airways, associated with the Volara treatment. The study will also provide insight into the mechanism of action of the therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of COPD with or without bronchiectasis.
2. Age ≥ 21 years.
3. Naive to Volara therapy.
4. FEV1 \< 80% predicted (based on pulmonary function tests within the past 12 months).
5. Daily sputum production over the prior 2 weeks.
6. Signed informed consent.
7. Stable pulmonary disease defined as no change in disease status.
8. Stable medication regimen for 30 days prior to visit 1, defined as no change in prescribed medications and adherence to their prescribed medications for pulmonary disease

Exclusion Criteria:

1. Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
2. History of pneumothorax within the past 6 months prior to visit 1.
3. History of haemoptysis requiring embolization within the past 12 months prior to visit 1.
4. Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
5. Inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol.
6. Inability to complete a 6-minute walk.
7. Actively participating in another clinical trial involving an investigational medication or device.
8. Pregnant females as verified by point of care human chorionic gonadotropin test.
9. Current Intrapulmonary Percussive Ventilation and/or oscillation and lung expansion users.
10. Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.
11. Participant requires mechanical ventilation.
12. Participants with artificial airways
Effectiveness of Online Therapy to Prevent Burnout

This study aims to address the reliability and validity of the Empowerment for Participation (EFP) batch of assessments to measure Burnout risk in relation to the efficacy of online interventions to provide proactive rehabilitation using Cognitive Behavioral Therapy (CBT) and floating to achieve improved mental health and wellbeing.

An Empirical design using raw EFP psychometric data to measure the effectiveness of online therapy to reduce the risk for Burnout between a control group and an online therapy group. The aim is to test whether or not there is a statistically significant difference in the effectiveness on online therapy to reduce the Risk for Burnout compared to that of a Control Group. Fifty participants were randomly selected. The rehabilitation and control Group consisted of twenty-five normally distributed employees (N25) each. The rehabilitation group received therapy, and the control had not yet received any form of therapy. SPSS was used to analyze the data collected, a Repeated Measure ANOVA, an ANCOVA, a Discriminant analysis, and a Construct Validity analysis were used to test for Reliability and Validity.

The group was randomly selected from a list of employees within the My-E-Health ecosystem. The group (N50) normally distributed group met all assumptions and consisted of a Control Group (N25) and a Therapy Group (N25). The post assessment value was used as the dependent variable.

The Burnout measure (30 questions) is obtained from the Empowerment for Participation (EFP) batch of assessments (110 questions). All assessments and CBT were done digitally online and floating was done at a designated location. The full EFP assessment is integrated into a digital ecosystem designed for this purpose and therapy. The online digital system is an integrity-based platform offering both the employee and caregiver a secure and encrypted ecosystem or secure data tunnel or channel between the therapists and patients.

Eligibility Criteria:
Inclusion Criteria

Employees assessed on the EFP Burnout Scale as having:

* a Moderate Risk of Burnout
* a High Risk of Burnout
* A Burned out Risk (Mental Health Exhaustion)
* Employees with a current Bunrout diagnosis from a hospital, outpatient or psychiatric cllinic
* A fully employed person with a member organization
* No other inclusion criteria.

Exclusion Criteria:

Employees assessed on the EFP Burnout Scale as having:

* No evidence of Burnout
* Low Risk of Burnout.
* Unemployed persons
* No other exclusion critera was used.
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial

Rationale: Glaucoma is a group of diseases characterized by progressive neuropathy of the optic nerve associated with visual field loss. Current glaucoma management aims to preserve visual function throughout life by reducing the intraocular pressure. This can be achieved by medical therapy or by surgical procedures such as implantation of a glaucoma drainage device (GDD). Conventionally, the tube of such a device is positioned in the anterior chamber (AC). Unfortunately, the presence of the tube in the AC may have a significant negative impact on the number of endothelial cells of the cornea and may even lead to corneal decompensation. Alternatively, the tube can be positioned in the posterior chamber (i.e. behind the iris). In this study, both procedures will be compared.

Objective: Primary: to determine the loss of corneal endothelial cells after implantation of a Paul GDD with its tube either anterior or posterior of the iris. Secondary: to compare efficacy and safety of both procedures.

Study design: Prospective, randomised, treatment controlled clinical trial. Study population: Pseudophakic patients with glaucoma who need a GDD. Intervention: Implantation of a Paul GDD with its tube anterior/posterior of the iris. Main study parameters/endpoints: Endothelial cell loss of the cornea.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: At present potential benefits and drawbacks of positioning the Paul tube behind the iris are insufficiently known, successful positioning of the tube may require slightly more surgery time and the risk of hyphaema may be higher. It is expected, that in the long run damage to the corneal endothelium is less. Risks of study-related assessments are negligible, burden is low, extra time is about 35+15+35+35 minutes (total 2h).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Informed consent
* Pseudophakic
* Open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or angle closure glaucoma with sufficiently deep anterior chamber
* Endothelial image at baseline of fair or good quality

Exclusion Criteria:

* Iridocorneal endothelial syndrome or posterior polymorphous dystrophy
* Eyes with a history of penetrating trauma
* Eyes with a history of (intra)ocular surgery other than uncomplicated cataract surgery
* Eyes with corneal disease
* Synechiae posterior
* Pregnant and lactating women
Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.

Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
Caffeine and the Autonomic Nervous System

Caffeine consumption has been linked to dysfunction of the autonomic nervous system. In this study the investigators analyze the effects of caffeine containing drinks (including energy drinks and coffee) on ECG based parameters of the autonomic nervous system.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* \> 18 years

Exclusion Criteria:

* known cardiovascular disease
* other diseases which may influence the autonomic nervous system
* medication which may influence the autonomic nervous system
* prior caffeine consumption (\<24 hours)