cyrilzakka/clinical-trials huggingface dataset:
TheEffect of a Solution-FocusedApproach on Breastfeeding

The Effect of a Solution-FocusedApproach on Breastfeeding Self-efficacy:

A RandomizedControlledStudy It is a single-blind, randomized controlled study with a pre-test post-test design.

In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature.

Question 1: Is a solution-oriented approach effective in increasing mothers' breastfeeding self-efficacy?

Solution-Focused Approach (COS) is a therapeutic counseling method developed by Steve de Shazer and Insoo Kim Berg et al. in the mid-1970s. This postmodern approach method focuses on the solution itself rather than going to the root of the problems, revealing the individual's past achievements and positive experiences. aims to remove.

One of the most important advantages of the Solution-Oriented Approach is that it is effective in a short time. Studies have shown that CFS can achieve the desired results between 6 and 10 sessions. It is important that the sessions and techniques of the Solution-Oriented Approach are used in harmony and that the sessions are structured. Particular attention is paid to the first session as it initiates the change and contributes to the process. In Solution-Oriented Approach, sessions are conducted as "first session" and "second and other sessions".

In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old, literate,
* Can speak Turkish,
* Primiparous and at term and healthy delivery (38-42 weeks, 2500-4000g born, 5th minute APGAR score of 7 and above, no known congenital disease),
* Women who do not have a chronic disease that prevents breastfeeding in their baby or in themselves
* Does not have a systemic disease,
* Those who have never received a planned breastfeeding training before,
* Having a healthy pregnancy,
* Planning to breastfeed,
* Women who have internet access, devices with internet usage (smartphone, computer, tablet, etc.), who have Zoom and Google Meet video conferencing applications on these devices.
* Women who can be reached within one week at the latest after giving birth

Exclusion Criteria:

* Women who do not want to breastfeed
* Women who have a disability to breastfeed
* Expressing that they cannot continue to work until the end,
* Women who did not participate and did not answer the post-test of the questionnaires.
ReCoUPS: Post-Concussion Patient Reports

Physical and cognitive rest are recommended as treatment for concussion, but debate persists about the utility of this recommendation for patients recovering from concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. This study will measure and compare symptom and activity reports in the days and weeks after a concussion among patients randomly assigned to different incentive-based arms.

Although physical and cognitive rest are recommended as the hallmark treatment for concussion, debate persists about the utility of this recommendation for patients recovering from a concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. Objective and timely measures of physical and cognitive activity will aid in defining the relationship between physical and cognitive rest and clinical outcomes, such as symptom status, in the days and weeks after a concussion. Random assignment to incentive-based arms will be used to measure patient engagement with the study protocol and a dedicated research platform that involves ecological momentary assessment (EMA), in which participants report their real-time symptoms and daily activities in response to randomly timed prompts, will be used to help assess the rest and recovery process among pediatric and adult patients after concussion.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 13 to 64 years.
* Presents with head injury concerning for concussion in line with criteria specified in the most recent Consensus Statement on Concussion in Sport, defined as head trauma with neurologic impairment, including, but not limited to somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability) symptoms.
* Within approximately 5 days of injury.
* Ownership of a smartphone to report symptoms and activities.
* Speak English.
* Informed consent or parental/guardian permission and child assent for those under 18 years of age.

Exclusion Criteria:

* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Eculizumab to Prevent Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation

The purpose of this study is to try to determine if the drug eculizumab can help prevent antibody-mediated rejection in patients undergoing a kidney transplant from a living donor with a different blood type than their own.

Kidney transplantation is considered the best therapy for patients with end-stage renal disease. In some instances, the only suitable living kidney donor is ABO blood group incompatible. This usually presents a barrier to successful transplantation because most recipients have circulating serum antibodies that bind to incompatible blood groups that will bind and damage the kidney allograft early after transplantation. Fortunately, over the past decade, we and others have developed protocols involving the pretransplant removal of anti-blood group antibodies using multiple plasmapheresis treatments that allow for the successful transplantation of ABOi LDKTx. Thus, this therapy enables patients to receive a living donor with its advantages rather than having to wait \>5 years for a deceased donor kidney.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Have end stage renal disease (ESRD) and is receiving a kidney transplant from a living donor to whom he/she has a baseline anti-blood group titer \>1:32
* Be vaccinated against N. meningitides (quadrivalent vaccine), H. Flu, and pneumococcal disease at least two weeks prior to beginning desensitization.

Exclusion Criteria:

* Has an unstable cardiovascular condition
* Has had a previous splenectomy
* Has any active bacterial or other infection
* Has a known or suspected hereditary complement deficiency
* Has known hypersensitivity to the treatment drug or any of its excipients
* Has history of illicit drug use or alcohol abuse within the previous year
* Has history of meningococcal disease
* Has any medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, pose an added risk for the patient, or confound the assessment of the patient (e.g. severe cardiovascular or pulmonary disease)
Variable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease

This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would have significant clinical implications in the management of Freezing of gait (FOG) in these PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could have better effect on FOG than HFS and low frequency stimulation (LFS).

HFS of STN provides consistent, long-term improvement of the cardinal motor signs of PD, such as bradykinesia, tremor and rigidity. FOG has responded poorly to HFS and tends to continue to deteriorate over time, but this can be alleviated by relatively LFS. Evidence has indicated that LFS-STN can improve axial signs in some but not all PD patients, but most of them experienced loss of efficacy in the short term. Then comes to the little improvement or even worse of tremor, rigidity and bradykinesia, which consists of the three main symptoms of Parkinson's disease. Thus even if axial problems could be solved by LFS in a long way, it could also be hard to tolerate by those patients. The effect of VFS on FOG will be studied. The investigators hypothesize that VFS could have better effect on Freezing of gait than HFS and LFS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were receiving bilateral STN stimulation for more than six months.
2. They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait.
3. Subjects had an ability to walk at least 10 meters independently during ON DBS condition.

Exclusion criteria:

1. gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease.
2. any change in the HFS DBS settings, three months prior to participation in the study.
3. complete inability to walk despite assistance while DBS ON.
4. Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing).
5. Subjects could not tolerate prolonged OFF medication condition.
Inflammation During ECMO Therapy and ECMO Weaning

The goal of this interventional clinical trial is to compare patients who undergo ECMO therapy for treatment of acute respiratory distress syndrome (ARDS) and a randomized into one of two possible weaning strategy groups.

Group 1: Weaning from ventilator occurs before ECMO weaning.

Group 2: Weaning from ECMO occurs before weaning from ventilator.

This study investigates which one of these strategies is more indulgent for the lung, and leads to less inflammation and therefore less potential side effects and an overall more favourable clinical course.

As a primary criterion, measure of IL-6 in blood samples will beused. As secondary criterions, SOFA score at various time points, ventilation pressures, lung injury score (LIS), length of stay in the intensive care unit, and ventilator-associated pneumonia as well as levels of inflammatory cells and cytokines in both blood samples and bronchoalveolar lavage at different time points will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory distress syndrome (ARDS) according to the Berlin Definition (PaO2/FiO2 \< 100) and treatment with veno-venous ECMO (vvECMO)
* Hemodynamic stability
* Lung compliance did not change/improved during the last 24 hours
* Tidal volume did not change/improved during the last 24 hours with a PEEP of 10 cmH20 or above
* Consent of the patient or their legal representative

Exclusion Criteria:

* Age \< 18 years
* Artificial ventilation for more than 7 days prior
* Patient, legal representative or doctors decided against an unrestricted intensive care treatment
* Positive pregnancy test at time of screening
* Cardiac failure requiring veno-arterial ECMO therapy
* Chronic respiratory insufficiency requiring long-term oxygen treatment
F 18 T807 Tau PET Imaging of Alzheimer's Disease

A single-center, open-label baseline controlled imaging study designed to assess whether brain tau fibril uptake of flortaucipir as measured by PET correlates with cognitive status of individuals with and without brain tau fibrils.

This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in individuals with and without brain tau fibrils. The primary goal is to develop tau imaging technique as an antecedent biomarker of cognitive decline. The investigators propose to obtain preliminary data that will support the possibility of detecting cognitive decline in its earliest stages, before the occurrence of dementia.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants, at least 18 years of age.
2. Cognitively normal, or with mild dementia, as assessed clinically
3. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
4. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.

Exclusion Criteria:

1. Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
4. Has hypersensitivity to F 18 T807 or any of its excipients.
5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
6. Severe claustrophobia.
7. Currently pregnant or breast-feeding.
8. For those electing to undergo the optional lumbar puncture: currently on anticoagulant of any form -
Acute Heart Failure - COngestion Discharge Evaluation

Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .

Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised for acute heart failure.
* Patients considered clinically discharging from hospitalisation for acute heart failure.
* Age ≥18 years
* Patients having received complete information regarding the study design and having signed their informed consent form.
* Patient affiliated to or beneficiary of a social security scheme.

Exclusion Criteria:

* Comorbidity for which the life expectancy is ≤ 3 months
* Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion.
* History of lobectomy or pneumonectomy lung surgery
* Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
* Pregnant woman, parturient or nursing mother
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Adult person who is unable to give consent
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Exploration of Possible Reasons for the Discrepancy Between Expectation and Indication of Subjective Perceived Exertions

The 6-minute walk test is a test of physical performance in physiotherapy with lungs and heart patients (Pollentier 2010). However, only 8 and 11% of patients in everyday test situations report a score of 7 or higher on a scale of 0-10 for effort (Jehn 2009). This study is intended to explore, based on grounded theory, why the majority of patients do not assess themselves according to the almost maximum performance.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease undergoing in-patient cardiovascular rehabilitation; over 55 years of age. Patients underwent a 6-minute walk test with assessment of the intensity of the exercise

Exclusion Criteria:

* no understanding of the German language
* Patients would not be able to perform a 6-minute walk test, e. g. surgery on the large joints of the lower extremities, unstable heart disease or predominant neurological symptoms.
Conventional Versus Point-of-care Based Coagulation Management

The purpose of the study is to determine the efficacy of two different algorithms for coagulation management in patients undergoing cardiac surgery suffering from increased bleeding tendency. Algorithm 1 is based on conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration,...) and Algorithm 2 is based on thrombelastometry using the ROTEM-device and impedance aggregometry using the Multiplate device.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years, combined surgical procedures (ACB \& valve surgery), double valve surgery, aortic surgery, Re-Dos

Exclusion Criteria:

* none
Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis

The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.

This is a multicenter, randomized, parallel group, double-masked, active- controlled study. Subjects will be enrolled and randomized to either 8 % or 15% DSP-Visulex with placebo drops or Vehicle-Visulex (V-Visulex) with prednisolone acetate 1% eye drops. All subjects will receive concomitant treatment with cyclopentolate.

Eligibility Criteria:
Inclusion Criteria:

* Non-infectious anterior uveitis

Exclusion Criteria:

* lntraocular pressure \> 25mm Hg OU.
* Previous occurrence of an acute episode of anterior uveitis in affected eye(s) within 4 weeks prior to Visit 1.
* Historical or active intermediate or posterior uveitis in affected eye(s).
* Clear systemic causes of uveitis that may require or have required systemic treatment
* Uveitis suspected to have resulted from recent surgery or trauma.
* Use of ocular medication of any kind in affected eye(s) more than 2 days prior to Visit 1, excluding artificial tears, topical allergy medications, eyelid scrubs.
* Current use, or anticipated initiation during the study, of a corticosteroid or an immunosuppressant agent by any route (oral, inhaled, ocular, dermal). Current stable use is allowed.
PIMR and Pulmonary Vascular Disease

The findings from this innovative, first-in-man, prospective pilot study will elucidate the role of PIMR and RV-IMR in pre-capillary PH. The study cohort will consist of patients with pulmonary pressures ranging from normal (advanced lung disease patients undergoing lung transplant evaluation) to severe PH (PAH and CTEPH patients), and thus will allow for identification of a PIMR cutoff. Participants will include: 1) advanced lung disease patients undergoing bilateral heart catheterization as part of their pre-lung transplant work-up, and 2) newly referred patients to PAH and CTEPH clinics undergoing bilateral heart catheterization as part of standard of care work-up. All participants will undergo PIMR testing, and those with pre-capillary PH will also undergo pulmonary OCT and measurement of RV-IMR. The study seeks to define the relationship between PIMR and PH and to establish the PIMR threshold that identifies pulmonary microvascular dysfunction as well as to evaluate the association of PIMR and pulmonary vascular remodeling on OCT in patients with pre-capillary PH. In addition, the study will assess the relationship between RV-IMR and RV pressure overload among patients with pre-capillary PH.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Able to provide informed written consent.
* Patients with 1) advanced lung disease requiring standard-of-care bilateral heart catheterization as part of lung transplant evaluation in whom mPAP \< 20 mmHg on RHC, or 2) PAH/CTEPH (i.e. pre-capillary PH) undergoing standard-of-care bilateral heart catheterization as part of their work-up/treatment

Exclusion Criteria:

* Contraindicated to undergo fluoroscopy and/or coronary angiography (e.g. pregnancy)
* Chronic kidney disease (serum creatinine ≥ 2.0 mg/dL)
A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate

This study will evaluate the impact of rapid acceleration in the heart rate on the QT prolongation of quizartinib.

This is a QT assessment study of quizartinib when given as a single oral dose of 90 mg in 70 healthy subjects.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female subjects 18 to 55 years of age (inclusive), with a BMI of 18 kg/m2 to 32 kg/m2 (inclusive) with a minimum body weight of 40 kg at Screening.
2. Has vital signs (measured after subject has been supine for at least 5 minutes) at Screening within the following ranges: heart rate: 50-100 beats per minute (bpm); systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once.
3. Liver function test results (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and total bilirubin \[TBil\]) must be equal to or below the upper limit of normal.
4. Hemoglobin levels must ≥11.5 g/dL for female subjects and ≥12.5 g/dL for male subjects.
5. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum and estradiol \<40 pg/mL \[\<147 pmol/L\] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the protocol-approved means of contraception from Screening until 7 months after the dose of quizartinib.
6. In males, documented surgical sterilization, or sexual abstinence, or agreement to use 1 of the protocol-approved means of contraception from Screening until 4 months after the single dose of quizartinib.

Key Exclusion Criteria:

1. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality) that could interfere with subject's safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
3. History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant and/or a QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 milliseconds (ms) at Screening
4. Females who are pregnant or breastfeeding
5. Laboratory results (serum chemistry, hematology, and urinalysis) outside the normal range, if considered clinically significant by the investigator. Estimated creatinine clearance (CrCl) \< 90 mL/min (calculated by Cockcroft-Gault equation) at Screening.