cyrilzakka/clinical-trials huggingface dataset:
Links Between Cognitive Functions and Clinical, Biological and Neuroradiological Outcomes in Adults with Sickle Cell Disease.

Sickle cell disease (SCD) is an inherited blood disorder. Symptoms include acute and chronic complications. Due to progress in SCD care, patients with SCD are living longer than before and we focus more attention in chronic complications.

Children with SCD experience worse cognitive functions than healthy children, and fewer is known about cognitive functions in adults. Studies suggest lower cognitive performance in SCD, mostly in executive functions and processing speed, but the biological and anatomical substrates of cognitive decline are not yet well established in SCD. Often times, cognitive impairments and cerebral disorders are not diagnosed and treated in adults with SCD.

The main objective of this study is to propose a deep neuropsychological assessment in adults with SCD and cognitive complaints and to highlight links between cognitive functions and clinical, biological and neuroradiological markers. The hypothesis of this study is that cognitive functions are associated with severity of the SCD, with bood abnormalities, with MRI markers and Transcranial Doppler (TCD) markers of cerebrovascular disease. The secondary objective of this study is to validate a brief cognitive assessment tool (BEARNI tool) in adults with SCD.

This study is an observational cross-sectional study that will enroll adults with SCD and cognitive complaint.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Sickle cell anemia (homozygous SS or heterozygous SC, Sβ0, S/C, Sβ+)
* In steady state (without vaso-occlusive crisis or acute chest syndrome at the time of measurements)
* Presence of spontaneous cognitive complaint or requested by the physician.
* Good command of the French language (native language or not)
* No objection to participate in the study
* Affiliated patient or beneficiary of social security scheme

Exclusion Criteria:

* Patient not compliant in the management of his disease
* Patient participating in another interventional research protocol that may interfere with this protocol (according to investigator's judgment)
* Language barrier
* Pregnancy or breast feeding
* MRI contraindication
* Patient under guardianship , curatorship or justice
* Inability to express non-opposition
Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.

The study in order to evaluate the effect of virtual reality glasses during splint in children on pain and anxiety due to the procedure.

The study was carried out as a randomized controlled experimental study in order to evaluate the effect of virtual reality glasses during splint in children aged 6-12 years on pain and anxiety due to the procedure.

The sample of the research consisted of 80 childrens who came to Karabuk University Training and Research Hospital orthopedic policlinic and emergency between 1 May and 31 October 2021 for the splint application. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.

The "Participant Information Form", the "Wong Baker Pain Scale", the "State Anxiety Inventory for Children", virtual reality glasses and pulse oximeter were used to collect data. The pain, anxiety and vital signs of the children in the experimental and control groups were recorded before, during and after the splint.

The video chosen by the children in the experimental group was shown with virtual reality glasses during the splint application. In the control group a video wasn't shown during the splint application. Chi square, Mann Whitney U, Bonferroni and Friedman tests were used in the analysis of data.

Eligibility Criteria:
Inclusion Criteria:

* The child should be between the ages of 6 and 12 age old.
* Acceptance of the research and giving written consent by the family and the child.
* Ability of the family and child to speak Turkish.
* The child should not wear glasses.
* The child should be at a cognitive level able to choose videos.

Exclusion Criteria:

* The child should have chronic diseases.
* The child should take analgesics with in the last 24 hours.
* The child should have physical, mental and neurological disabilities.
* The child has a febrile illness.
* Fainting of the child during the procedure.
Multiparametric MRI in Men With Prostate Cancer Undergoing Active Surveillance

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Men with localized prostate cancer (PCa) with small tumor burden may be followed on active surveillance (AS) rather than active treatment. AS is an attempt to avoid over-treatment of PCa, which is estimated to be insignificant at the time of diagnosis, and therefore unlikely to affect patient morbidity and mortality. AS include close monitoring with PSA measurement (blood test), digital rectal exploration (DRE) and trans-rectal ultrasound-guided prostate biopsy (TRUS-bx) at regular intervals, so that active treatment can be initiated if the cancer becomes more aggressive. It is crucial that patients undergoing AS are staged correctly, to avoid underestimating more aggressive disease and patients mistakenly are enrolled into AS instead of active treatment.

Previously, a PhD study conducted at Herlev Hospital revealed that multiparametric MRI (mp-MRI) of the prostate can improve the detection and staging of PCa and may add additional information about tumor aggressiveness compared to the traditional methods DRE and TRUS-bx. Mp-MRI at the inclusion of AS may detect missed significant tumors and potential areas of higher aggressiveness than detected by the traditional biopsies. Additional targeted biopsies from these suspicious areas can then be performed with a re-evaluation of the treatment plan, if more advanced disease is identified. Conversely, mp-MRI has a high negative predicted value for significant disease and can be used to rule out significant PCa, reassuring patients and physicians to go on with AS. Mp-MRI has been used at the Urology Department, Herlev Hospital, since 2013 in the diagnosis of PCa and in the evaluation of patients undergoing AS. The main objective of this study is to retrospectively investigate, whether mp-MRI can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patients with low risk localized prostate cancer enrolled in active surveillance

Exclusion Criteria:

* Metastatic prostate cancer
* No mp-MRI data present
* Prostate cancer treatment
* Known allergic reaction to Gadolinium-based MRI contrast agent
* Prostate biopsy during the last 21 days
* Impaired renal function with GFR \< 30 ml / min
* pacemaker
* Magnetic metal residues in the body
* Claustrophobia
* Psychiatric disorders
* Age under 18 years
The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention

Mixed-method observational study: the impact of pandemic related changes in healthcare on quality of life and experiences with healthcare in Dutch patients undergoing surgery or another intervention during the covid pandemic (2020-2021).

Phase 1: qualitative study to gain insight in relevant themes in Patient Reported Experiences Measures (PREMs) by conducting focus groups Phase 2: creating and validating a questionnaire based on themes identified in phase 1 Phase 3: questionnaire study among Dutch patients who underwent an intervention in 2020-2021 using the validated questionnaire of phase 2. The answers will be linked to data from national patients registries in surgery, cardiology, orthopedics and neurology.


Eligibility Criteria:
Inclusion Criteria:

* undergoing surgery or intervention in the Netherlands in 2020 or 2021

Exclusion Criteria:

* participation language restricted to Dutch
Red Cell Distribution With to Lymphocyte Ratio in Cardiac Surgery

It is aimed to investigate whether red cell distribution with (RDW) to lymphocyte ratio (RLR) can predict early comorbidity among cardiac surgery patients.

There are important developments in the field of cardiac surgery due to advances in medical treatments, surgical techniques, intraoperative anesthesia management, and postoperative intensive care. On the other hand, the proportion of high-risk patients has increased due to the increasing number of elderly patients with comorbidities presenting for cardiac surgery. It is important to analyze outcomes such as postoperative morbidity and mortality, due to concerns about the quality of life of patients after cardiac operations, the recommendations of current ERAS protocols, and the shortening of intensive care unit length of stay. Complications such as cardiac, pulmonary, renal, and neurological disorders, infections such as pneumonia or sepsis, and prolonged stay in the intensive care unit and hospital are indicators of not only the quality of care but also the quality of life after cardiac surgery. Therefore, it is important to determine the perioperative risk factors that cause postoperative morbidity. Various outcome prediction models are used for cardiac surgery, such as the Cardiac Anesthesia Risk Assessment score, Tuman score, Tu score, and the European System for Cardiac Operative Risk Assessment score, which uses preoperative factors to predict the postoperative outcomes. It is known that intraoperative factors such as CPB duration, aortic cross-clamp time, surgical technique, and serum lactate levels are associated with postoperative morbidity. Recent studies suggest that inflammatory and immune imbalance may play an important role in postoperative complications. Studies point to new parameters derived from preoperative complete blood count as potential biomarkers of inflammation and oxidative stress. Many markers such as Neutrophil/Lymphocyte ratio, Mean platelet volume (MPV) or RDW alone have been studied in cardiac surgery. The ratio of red cell distribution width (RDW) to lymphocyte (L) has been popular in recent years as an indicator of poor prognosis, especially in oncological patients. However, this marker has not yet been evaluated in terms of morbidity or mortality in cardiac surgery patients.

The main purpose of this study; To investigate the RDW/L ratio as an early morbidity marker in cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing open-heart surgery with cardiopulmonary bypass

Exclusion Criteria:

* Re-operations
* Emergency operations
* Patients with preoperative renal failure
* Patients with preoperative hematological problems
* Patients with preoperative infection
* Patients with preoperative immunological disease
* Patients using preoperative steroids
The Effect of Simulation-Based Training on Physiotherapy Student's Self-Confidence and Satisfaction Level

The goal of this clinical trial is to investigate the effect of simulation-based training in the cardiac rehabilitation course on the confidence and satisfaction of physiotherapy and rehabilitation students.

The main questions it aims to answer are:

Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the confidence levels of physiotherapy students? Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the satisfaction levels of physiotherapy students? Does simulation-based training in blood pressure and electrocardiography in cardiac rehabilitation have an effect on the theoretical knowledge levels of physiotherapy students?

This study is planned to be conducted with 39 individuals who are enrolled in the course and taking it for the first time.

The study will be conducted at the Acıbadem University CASE Laboratory using surveys administered before and after simulation training on blood pressure and electrocardiography (ECG). The sociodemographic characteristics of the participants will be recorded using an information form. The level of experience, theoretical knowledge, and competency in blood pressure and ECG measurement will be assessed with a 'Pre-Test' prepared for this purpose. The same parameters, along with satisfaction with the simulation training, will be assessed with a 'Post-Test' using a self-assessment survey method after the training. The prepared surveys, detailed below, will be completed separately for blood pressure and ECG training.


Eligibility Criteria:
Inclusion Criteria:

* Being a student of Physiotherapy and Rehabilitation at Acıbadem University
* Being enrolled in the Cardiac Diseases and Rehabilitation course
* Having completed the consent form

Exclusion Criteria:

* Repeating the Cardiac Diseases and Rehabilitation course
* Refusing to participate in the study
FINGER Robot Therapy Study

The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.

Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to "slack", not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years of age
* Have history of stroke affecting the arm, at least 6 months prior to enrollment
* have arm and/or hand weakness as measured on a standard clinical scale
* do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
* do not have active major brain disease other than the stroke
* have absence of pain in the stroke-affected arm and hand

Exclusion Criteria:

* severe stiffness of the arm or hand as measured on a standard clinical scale
* severe problems speaking or understanding speech as measured on a standard clinical scale
* severe reduced level of consciousness
* severe loss ability to sense movement of your limbs as measured on a standard clinical scale
* currently pregnant
* difficulty in understanding or complying with the instructions given by the researcher
* inability to perform the experimental task that will be studied
* increased pain with movement of the stroke-affected arm or hand

Exclusion criteria that will prevent subjects from participating in the MRI:

* Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials,
* Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan
* Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up
* Subjects who have claustrophobia
* Subjects who are currently pregnant or breastfeeding.
Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This form of presenting Ang II to the immune system induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against angiotensin II may offer a valuable alternative to conventional drugs for the treatment of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140-179 mmHg and/or mean sitting office DBP = 90 -109 mmHg on 2 consecutive visits (screening and V1).
* Daytime blood pressure above threshold for definition of hypertension in the baseline ABPM measurement (SBP \>135 mmHg).
* Stable baseline blood pressure confirmed on 2 consecutive visits (screening and V1). (Changes \<20mmHg for sitting office SBP and \<10mmHg for mean sitting office DPB).
* Patients without current antihypertensive therapy. Patients on previous mono-antihypertensive therapy, who can safely stop their medication
* Patient is willing and able to comply with all trial requirements and procedures.

Exclusion Criteria:

* Patients with "very high added risk" according to 2007 Guidelines for the Management of Arterial Hypertension (Journal of Hypertension, 2007, 25:1105- 1187), i.e. those with:grade III hypertension (mean sitting office SBP

  * 180mmHg and/or meansitting DBP ≥110mmHg/history or presence of established cardiovascular or renal disease (Ischemic stroke, cerebral hemorrhage, transient ischemic attack)/ Myocardial infarction, angina pectoris, coronary re-vascularization/ clinically relevant heart failure (NYHA class II-IV)/ Peripheral artery disease/ Diabetic nephropathy
* Electrocardiographic confirmed left ventricular hypertrophy
* Increased plasma creatinine
* Diabetes mellitus type I, history, presence or new diagnosis of diabetes mellitus type II.
* Postural hypotension at screening
* Arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure.
* Known autoimmune disease.
* Severe allergy.
* Pregnancy or breastfeeding.
* Women in childbearing age that are not surgically sterilized.
* Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C.
* Current diagnosis or history of malignancy.
Evaluation of Excellence in Italy's Residence for Execution of Security Measure

The model of care for forensic psychiatry in Italy was changed by law (Law 81/2014) so that the six legacy secure forensic hospitals (Judicial Psychiatric Hospitals, OPG) were closed and new secure community residences for the execution of security measures (REMS) were opened in each of the 20 regions of Italy. This transition was in place by 2015. This observational study evaluates the health gains for patients both previously in OPGs and those admitted first to REMS. Health gains assessed include recovery measured by symptoms, function, need for therapeutic security and recovery of legal autonomy.

All those detained in REMS in the twelve month period 2019 to 2020 form the reference population. Samples are assessed for symptom severity (BPRS), global function (GAF), cognitive function (MMSE), risk and protective factors for violence (HCR-20, SAPROF), personality factors (PCL-R), measures of need for therapeutic security (DUNDRUM-1), treatment response relevant to violence and mental illness (DUNDRUM-3) and forensic recovery (DUNDRUM-4).

Outcome measures include violent and challenging behaviour (MOAS), length of stay, conditional (legal) discharge.

Eligibility Criteria:
Inclusion Criteria:

* admitted to REMS
* voluntarily consents to participate

Exclusion Criteria:

* MMSE less than 19
Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan

Aims:

1. To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and
2. To describe its enabling intervention packages and components to be delivered at the Basic Health Units in Thatta district.

The proposed study will be a pilot implementation with nested qualitative component. The study will also involve situational analysis for proposed study site and Theory of Change workshops with key stakeholders.

This study is a replication of the methods used in the development of a district mental healthcare plan in Uganda (Kigozi et al., 2016).

Mental neurological and substance use (MNS) disorders contribute significantly to global burden of disease. The WHO Mental Health Action Programme (MhGAP) taking a life course approach has developed an intervention guide to scale up services in low and middle income countries (LMICs) focusing on priority mental health conditions in adults and older adults.

The gap between the individuals in need of mental health interventions and those who actually receive such care remains very large. To reduce the treatment gap, the WHO Mental Health Action Plan (WHO, 2017) strongly recommended assessment, diagnosis and treatment of MNS in community settings and primary healthcare (PHC). Central to this agenda is the WHO Mental Health Gap Action Programme (mhGAP) and intervention guide (IG) (WHO, 2010) which is an evidence based tool.

The proposed project aims to integrate the adapted WHO-mhGap-IG for depression, self-harm and suicide prevention into the community and primary settings in Thatta (situated in the province of Sindh, Pakistan).

Depression and self-harm are selected priority conditions for the proposed study.

In order to collect information and detailed cross-sectional data on health and factors that can influence health of Thatta district, a situational analysis tool will be used.

Both one to one in-depth interviews as well as focus groups will be conducted with stakeholders to explore possible barriers and facilitators of testing the feasibility of adapted mhGap-IG for depression and self-harm in Thatta.

Pilot study will be conducted using the mhGAP-Intervention Guide (mhGAP-IG) (two modules: Depression, self harm and suicide prevention)

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 and above presenting to recruiting health facilities will be assessed by the research team for depression (positive) and/or history of self-harm (positive

Exclusion Criteria:

* Patients below 18 years of age,
* Patients taking medication for/ having a diagnosis of substance abuse, severe mental/physical disability/ comorbidity, whereby they are unable to participate in the interview.
Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

The study will compare 2 treatment modalities. One group will receive the routine protocol of intermittent pitocin induction for 6 hours and the second group will receive continous pitocin infusion for 16 hours.

The primary aim is to observe which protocol leads to the fastest delivery and evaluate the time in each group from induction to delivery.

After singing an informed consent, and prior to IOL initiation, study participants were randomly assigned (1:1) to receive either intermittent or continuous Oxytocin infusion. Both groups received the same primary infusion dose of Oxytocin 1.0 with an incremental increase of 2.5 every 30 minutes until 20, titered to a target of 3-5 contractions in a 10 minute period. During Oxytocin infusion, fetal heart rate was continuously monitored. Artificial ROM was performed according to the accepted indications, local protocol and by the staff physician discretion who was in charge on the labor ward at that time, regardless of oxytocin initiation time. In the intermittent Oxytocin infusion group, Oxytocin was discontinued after 8 h if the patient did not go into active labor during by that time, and renewed 4 h later. In the continuous infusion group, patients received a continuous Oxytocin infusion for 16 h. If they did not go into active labor within this frame time, Oxytocin was discontinued for 4 hours and then resumed. In addition, during Oxytocin infusion, sodium levels were monitored every 8 h.

Eligibility Criteria:
Inclusion Criteria:

1. Women with a singleton pregnancy that are admitted for induction or augmentation of labor.
2. Women at gestational age 370/7 or more.
3. Vertex presentation.

Exclusion Criteria:

1. Age under 18 or over 45.
2. High order gestation.
3. Women with contraindication for vaginal delivery.
4. Active labor.
5. Women with a uterine scar.
6. Multiparity(\> 5 deliveries).
7. Documented fetal anomalies.