cyrilzakka/clinical-trials huggingface dataset:
Goals of Care Communication

This study proposes to evaluate, among adults with advanced heart failure (HF) and their health care providers, the effects of a communication intervention designed to improve patient-provider communication about goals of care (GoC). Patient activated GoC conversations can result in providers' better understanding their patients' preferences for end-of-life care. GoC conversations that occur over time may allow patients and providers to consider a wider range of options earlier in the HF illness trajectory. Preliminary data suggests that the proposed GoC intervention increases the occurrence and quality of patient-provider communication about end-of-life care for advanced COPD. The proposed study will test the effects of the GoC intervention compared to usual care, using a randomized, 2-group (N = 80, n = 40/arm), repeated-measures design. Measures will be taken at a patient's baseline study entry and after the next scheduled clinic visit. Specific Aim 1 is to evaluate change in number of GoC conversations between patient and provider between the two groups. Specific Aim 2 is to examine whether the intervention increases patient quality of life, referrals to palliative care, advance care planning, decreases depression and anxiety. Specific Aim 3 is to describe the feasibility, acceptability, perceived benefits, burden, and implementation success of the intervention in the heart failure clinic setting. Patients will be randomized to the GoC intervention or to receive usual care. Patients in the GoC intervention group, telephone coaching by a research nurse to help patients role-play talking with their HF providers. Both patients and their providers, will be provided with summaries of individualized, patient-centered information about patient preferences for communicating about end-of-life care and patient self-identified barriers to and facilitators of communication about end-of-life care with tips on how to initiate goals of care discussions. Providers of patients in the intervention group will also be provided with patient-specific prognostic information based on the Seattle Heart Failure Model. The GoC intervention will be tested in a real-world clinic setting. This intervention is expected to be relatively cost-effective and easily translated into general cardiology practice in the future. The study is expected to make significant contributions to provision of earlier access to palliative care in the advanced HF disease trajectory.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of HF from either systolic or diastolic dysfunction, with an ejection fraction of ≤ 40%
2. Completion of an outpatient HF visit within the past 6 months
3. Ability to read, write, and speak in English

Exclusion criteria:

1. Short BLESSED cognitive score \> 10 to rule out significant cognitive impairment;82
2. Diagnosis of any additional terminal illness with life expectancy of ≤ 1 year not related to heart disease
3. Psychiatric illness that required hospitalization in the past year; and (4) age less than 18 years
A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour

In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was 21 % and 16% to 38% in case of dystocia.

The definition of " dystocia " is traditionally based on the research led by Friedman in the 1950's on a restricted population sample. Several studies over the last years seem to indicate that the different phases of labour are longer than originally described by Friedman.

Our current hypothesis is that the application of a new definition of dystocia would enable a more appropriate management of labour.

The main purpose of this study is to show a significant decrease of the CS rate with the use of the new partograph developed by Neal and Lowe.

Secondary purposes are

* To reduce the use of oxytocin during labour without increasing maternal or neonatal morbidity;
* To decrease immediate per-operative complications and post-operative complications associated with CS

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

* Affiliation to a social security insurance
* Written consent given
* Singleton pregnancy
* Cephalic presentation
* ≥37 gestational weeks
* Spontaneous onset of labour

Exclusion Criteria:

* Previous cesarean section
* Induction of labour
* Intrauterine growth restriction
* In utero fetal death
* Congenital malformation
* Chorioamnionitis
* Placenta praevia
* Need for an emergency delivery (fetal heart rate abnormalities at admission)
* Contra-indication for vaginal delivery
* Patient under temporary guardianship, guardianship or judicial protection
* Patient included in another study which could interfere with the results of this study
Prevalence of COPD: First Epidemiological Data From a Large Region of Turkey

The study was designed to obtain some baseline data on COPD in Malatya region of Turkey.

Sixty clusters from urban and rural regions were randomly selected. Ten and seven consecutive houses were included in the study from each urban and rural cluster respectively. A validated questionnaire on epidemiology of COPD was completed for each household over 18 by a pulmonary physician. Each subject performed the standard spirometric measurement and early bronchodilation testing.

Eligibility Criteria:
Inclusion Criteria:

* All households over 18 were included in the study

Exclusion Criteria:

* Age \<18 years
Long-term Follow-up After Stroke (The LAST-long Trial)

Despite the improved treatment of acute stroke over the past decades, those suffering from stroke still are at an increased risk of functional and cognitive decline in the long term. The most common consequences of stroke are functional impairments, cognitive impairments, depression and fatigue. These are also regarded as barriers to achieve optimal adherence to the guidelines regarding secondary prevention. The primary aim of this project is to evaluate the effectiveness of a multimodal individualized intervention to prevent functional decline in the long term after stroke.

In a clinical randomized controlled trial, participants randomized to the intervention arm will be followed with monthly meetings by a stroke coordinator for 18 months.

The stroke coordinator will assess the patients risk factors within the domains of physical function, cognitive function, social function, medication and lifestyle factors and make a treatment plan targeting the individual needs for further follow-up.

Those randomized to the control group will receive standard care.

Patients living in the municipalities of Trondheim, Lørenskog and Skedsmo admitted to Akershus University Hospital or St. Olavs University Hospital will be included at the outpatients clinic 3 months after the stroke.

All patients will be re-assessed at 6, 12 and 18 months after inclusion. Primary outcome will be modified Rankin Scale at 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of first ever or recurrent stroke (ischemic stroke or hemorrhage)
* mRS \< 5
* Living in Trondheim, Skedsmo or Lørenskog municipality
* Less than 10 points on Short Physical Performance Battery (SPPB) OR less than 26 points on Montreal Cognitive Assessment (MoCA) OR more than 27 points on the 7 item version of the Fatigue Severity Scale (FSS-7) OR more than 7 points on the depression or anxiety items on Hospital Anxiety and Depression Scale (HADS) OR reduced hand function (i.e. fails on Motor Assessment Scale - Advanced arm- and hand function, item 3)
* Able to understand Norwegian
* Able and willing to sign informed consent.

Exclusion Criteria:

* Life expectancy \< 12 months
* Other serious diseases, judged by the medical doctor to make it difficult to comply with the intervention (i.e. serious neurological diseases or drug abuse).
MSC-Exos Promote Healing of MHs

Purpose: To assess the safety and efficacy of mesenchymal stem cells (MSCs) and MSC-derived exosomes (MSC-Exos) for promoting healing of large and refractory macular holes (MHs).

Hypothesis: MSC and MSC-Exo therapy may promote functional and anatomic recovery from MH. MSC-Exo therapy may be a useful and safe method for improving visual outcomes of surgery for refractory MHs.

Based on the purpose and hypothesis,the participants with large and longstanding idiopathic MHs underwent vitrectomy, internal limiting membrane peeling, MSC or MSC-Exo intravitreal injection, and heavy silicon oil, air, 20% SF6, or 14% C3F8 tamponade. MSCs were isolated from human umbilical cord, and MSC-Exos were isolated from supernatants of MSCs via sequential ultracentrifugation. At the time of study enrollment, as well as physical examinations, best-corrected visual acuity (BCVA) and intraocular pressure will be measured and fundoscopy be performed. All diagnoses of MH are going to confirmed via spectral-domain optical coherence tomography (OCT), and the minimum linear diameter (MLD) of each MH will be measured parallel to the retinal pigment epithelium.The participants are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, and physical examinations.

Eligibility Criteria:
Inclusion Criteria:

1.Clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns

Exclusion Criteria:

1. Only one functional eye
2. In other clinical trials.
3. Other diseases which can affect visual acuity, such as cataract, diabetic retinopathy, glaucoma, corneal diseases, etc.
4. Eye had undergone vitrectomy or scleral buckling, cataract surgery, Nd:YAG laser less than one month ago.
5. Contralateral eye has poor prognosis than the study eye.
6. Idiopathic or autoimmune uveitis history.
7. Aphakic eye
8. Physical condition is poor that can not keep prone position.
9. Secondary macular lesions
10. The equivalent spherical diopter of the study eye before any refractive correction or cataract surgery, which is greater than 6.0d or above 26mm of the ocular axis of the study eye.
11. Intraocular pressure is higher than 25mmHg
12. Within ocular inflammation, such as eye blepharitis, scleritis, keratitis and conjunctivitis.
13. Systemic condition is poor, such as the poor control of diabetes and hypertension, myocardial infarction, cerebrovascular accident, renal failure and so on,and the researchers assessed those who are unable to complete the trail.
Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia

The purpose of this study is to investigate the effect of amblyopia therapy on cases who will receive Interactive Binocular Treatment (IBiTTM) without patching compared with those who will receive standard patching of the dominant eye with placebo IBiTTM.

In this randomized clinical trial, 40 unilateral amblyopic children (3 to 10 years old) will be studied. All unilateral functional amblyopic children with best corrected visual acuity (BCVA) worse than 0.30 LogMAR at least in one eye or a difference of two BCVA lines of Snellen between the two eyes will be included and randomly will divide into the case (n=19) and control (n=21) groups. Cases will play I-BiT™ games, while controls will have standard patch therapy and will play with placebo IBiTTM for one month. All subjects will be underwent comprehensive ophthalmic examinations at baseline and at one-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Functional amblyopia with BCVA less than 20/30 (0.3 LogMAR) at least in one eye
* A difference of two BCVA lines of Snellen between the two eyes

Exclusion Criteria:

* A history of penalization one month prior to the study
* Bilateral amblyopia
* BCVA less than 20/200
* Eccentric fixation
* Nystagmus
* Ocular deviation more than 10 prism diopter (pd)
* Organic amblyopia
* Uncooperative children those with
* Mental and physical disability
* Systemic diseases
Pelvic Inflammatory Disease in COVID-19 Era

The goal of this retrospective cohort study is to to scrutinize the impact of coronavirus disease 2019 (COVID-19) on incidence, demography and patient characteristics in Pelvic Inflammatory Disease comparing with the equal time duration, before and after lockdown was initiated in the country.

The main aim of this study was to compare the demographic and clinical parameters between two cohorts before the onset of lockdown and within the pandemic.


Eligibility Criteria:
Inclusion Criteria:

Pelvic Inflammatory disease

Exclusion Criteria:

Pregnancy Oncologic disease
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)

This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.

MS affects at least 400,000 people in the US alone, and its incidence has increased in the past 50 years, likely due to changing environmental risk factors. Recent research suggests that diet may be a critical factor in the development of MS. The "Western diet", high in sugar, fat, and salt, may influence MS risk and progression by directly affecting the immune system, altering gut bacteria, and changing metabolism.

Studying patients with MS who are overweight and obese may be relevant as obesity can cause chronic low-grade inflammation, potentially worsening MS symptoms. Diet modification represents an interesting potential therapy for MS, particularly calorie restriction and fasting, which have been associated with reduced markers of inflammation. In addition to these direct effects, weight optimization may lead to improvements in MS-related symptoms, like fatigue, and overall quality of life.

This is a single-blinded randomized trial of adherence to a dietary intervention in patients with MS who are receiving monthly natalizumab infusions. The study will evaluate how use of technology may help patients with MS adhere to a calorie restricted diet. It will also evaluate the effect of weight loss on fatigue and quality of life in patients with MS. A second part of the study will evaluate if shortening the period during the day in which people consume their typical food amounts leads to improvements in patient-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 25 kg/m\^2 for calorie restriction study
* BMI \< 25 kg/m\^2, or ≥ 25 kg/m\^2 if participant was unwilling to enroll in calorie restriction study
* Smartphone with the ability to download and use the LoseIt! application (calorie restriction only)
* Smartphone with the ability to take and store photos (calorie timing only)

Exclusion Criteria:

* History of diabetes requiring medication
* Currently pregnant or breastfeeding
* History of an eating disorder
* Currently taking warfarin
* History of major surgery within past 3 months
Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia

To demonstrate the efficacy of ranibizumab in combination with reduced-fluence verteporfin photodynamic therapy (RF-PDT) in patients with subfoveal choroidal neovascularization secondary to pathologic myopia (PM).

Sixty patients received ranibizumab 0.5 mg combined with reduced fluence (RF) verteporfin PDT. Ranibizumab was first administered to patients followed after seven days by RF-PDT. Subsequently intravitreal ranibizumab (IVR) was injected as needed (pro re nata). All patients were evaluated every 4 weeks for 48 weeks.

Main Outcome Measures: Mean change in best-corrected visual acuity (BCVA) from baseline at 48 weeks, reduced mean central foveal thickness (CFT) analyzed by optical coherence tomography (OCT) and improved macular sensitivity registered at microperimetry (MP) evaluation.

Eligibility Criteria:
Inclusion Criteria:

* pathologic myopia, defined as spherical equivalent greater than 6 D and axial length more than 26 mm (Carl Zeiss IOLMaster V 4.07; Carl Zeiss Meditec, Dublin, California, USA);
* posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
* fluorescein angiography (FA) detection of the subfoveal or juxtafoveal CNV (CNV was classified as juxta-foveal if the lesion was closer than 200 mm but not under the geometric center of the foveal avascular zone);
* clear ocular media;
* duration of symptoms no longer than 4 weeks before enrollment.

Exclusion Criteria:

* prior treatment for CNV including previous intravitreal drugs injection or PDT-V;
* presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion;
* history of recent myocardial infarction or other thromboembolic events;
* ongoing uncontrolled hypertension or glaucoma;
* refractive media opacities;
* eye surgery.
Continuous Glucose Monitoring in Infants

The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.

We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.

Eligibility Criteria:
Inclusion Criteria:

* Mother at least 18 years of age
* Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA)
* Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers

Exclusion Criteria:

* Infants born small for gestational age (SGA)
* Infant birth weight \<2.5 kg
* Infant BMI \<10th percentile on Olsen chart
* Infants born \<38 weeks gestation
* Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound
* Mother is non-English speaking
Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients

The objective of this study is to detect the evidence on the immune response following acute SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after infection for both symptomatic and asymptomatic patients.

A total of 30 COVID-19 patients for the study will be enrolled. All the patients enrolled were confirmed to be infected with SARS-CoV-2 by RT-PCR assay for nasal and pharyngeal swab specimens.

For the study, serum samples of the 30 patients will be collected and will be investigated for the detection rate for immunoglobulin G (IgG). The first sample will be collected 2 weeks after the second negative RT-PCR assay for nasal and pharyngeal swab specimens and 6 samples will be collected after that for 6 months later; one serum sample tested every month for 6 months after.

The following questions will be addressed:-

1. What proportion of confirmed cases develops specific IgG antibodies to SARS-CoV-2?
2. How long is the duration of detection of serum IgG antibodies and antibody titres over time following infection with SARS-CoV-2?

Eligibility Criteria:
Inclusion Criteria:

* patients with recent COVID- 19 infection(2 weeks after the second negative RT-PCR assay)

Exclusion Criteria:

* patients on immune-suppressive therapy
* patients with immunological disease
COVID-19 Vaccine Responses in PIDD Subjects

The goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines.

Individuals with primary and secondary antibody immunodeficiency are at higher risk for severe COVID-19 disease. Humoral immunity is thought to be the predominant protection against COVID-19, however mRNA vaccines have been shown to elicit both antibody and cellular responses.

The goal of our study is to assess the cellular immune responses of participants with antibody deficiency diseases, including X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID), and secondary hypogammaglobulinemia, before and after immunization with SARS-CoV-2 mRNA vaccines.

Our aim is to examine SARS-CoV-2 spike-specific T cell immune responses before and after immunization with mRNA vaccines in a cohort of individuals with antibody deficiencies compared to healthy volunteers. Our secondary objectives include (1) detecting cellular immune response differences between immunized and infected participants, (2) observing cellular immune responses over time, and (3) comparing clinical outcomes between vaccination, infection, and underlying antibody deficiency. The results will show whether antibody deficiency individuals can mount T cell responses to SARS-CoV-2 vaccination or infection, data that are expected to inform health policy of SARS-CoV-2 implementation in immunocompromised individuals. Findings will further provide foundation for larger cohort studies of SARS-CoV-2 vaccination in other immunocompromised populations.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of antibody deficiency with confirmatory lab or genetic testing
2. Stable on immunoglobulin replacement therapy
3. Age \>6 months and able to provide consent, or assent with parental consent if \<18 years
4. Willing and able to receive the Pfizer BioNTech BNT162b2 mRNA or the Moderna mRNA-1273 vaccines

Exclusion Criteria:

(1) History of other chronic disease with depressed immune function or immune suppressive medication
A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease

The goal of this pilot randomized trial is to assess the feasibility and preliminary efficacy of an advanced care planning (ACP) video decision support tool for improving patients' knowledge regarding their goals of care options and end of life (EOL) decision-making in patients with end-stage liver disease (ESLD).


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age with an established diagnosis of end-stage liver disease
2. Patient must have either 1) primary hepatologist at the MGH Liver Center or an MGH-affiliated primary care physician, or 2) a previous inpatient admission at MGH
3. Deemed ineligible for liver transplantation as determined by the primary hepatologist
4. Ability to communicate in English and provide informed consent
5. A score ≥ 7 on the Short Portable Mental Status Questionnaire

Exclusion Criteria:

1. Severe hepatic encephalopathy which the primary hepatologist believes prohibits informed consent or participation in the study
2. Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary hepatologist believes prohibits informed consent or participation in the study
3. Prior history of liver transplantation
4. Patient has been referred to or enrolled in hospice care
5. Patients who have been referred to palliative care
Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients (AML)

The objective of this study is to evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry. A special emphasis will be focused on monitoring expression of CD200 as well as PGP-170 (MDR1) on blasts cells.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* No pregnant woman
* Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia
* Presence of a monitored serum blastose
* Patient who can obtain free and informed consent (speaks French, no guardianship or curatorship)

Exclusion Criteria:

* Minor Patient (\< 18 years old)
* Medical or psychological Condition that could interact with the ability to understand the study,
* Pregnant or lactating women,
* Major persons under guardianship or under the protection of justice
* Persons deprived of their liberty by a judicial or administrative decision
* Lack of information and opposition to its participation in the study