cyrilzakka/clinical-trials huggingface dataset:
Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients

In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT) Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological findings in thrombocytes and anti-body patterns is going to be investigated.

The investigators examined the frequency of anti-PF4/heparin antibodies (IgG/M/A; EIA) and their functional activity (HIPA) in 38 whole organ deceased donor liver transplant recipients. Additionally, demographic, clinical, donor- and recipient-specific parameters and laboratory findings (ALAT, ASAT, cholinesterase) were investigated.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive liver transplant recipients between 01/2010 and 08/2011 who
* were transplanted at our center after allocation of a liver graft via Eurotransplant

Exclusion Criteria:

* patient's refusal to participate in prospective observation
The Effect of Psychological First Aid Intervention on Stress and Resilience in Volunteers Working in Kahramanmaraş Centered Earthquakes

Purpose: It was aimed to compare the effectiveness of online psychological first aid intervention on stress and psychological resilience in volunteers who took part in earthquakes.

Method: This is a single-blind randomized controlled experimental study conducted to determine the effect of online psychological first aid intervention on the stress and resilience levels of volunteers who took part in the earthquake.

In this study, it is aimed to compare the effectiveness of the online psychological first aid intervention on stress and psychological resilience given to the volunteers working in various provinces (11 provinces) affected by the Kahramanmaraş Centered Earthquakes.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering in the earthquake zone,
* Not having a perception disorder that will prevent communication,
* To volunteer to participate in the research.

Exclusion Criteria:

* Having a communication barrier,
* Not wanting to be involved in the study.
Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram

Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).

Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET). The following hypothesis will be tested: Antidepressant response or remission in depressed BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed patients.

Eligibility Criteria:
Inclusion Criteria:

* Current age 18-64 years; DSM-IV diagnosis of BPD, type-I, or type-II; Enrolled in the Citalopram Study at Tufts Medical Center

Exclusion Criteria:

* Current pregnancy, or inability to utilize contraception, The presence of any metallic implants, History of claustrophobia
Endocrown and 90° Shoulder Endocrown

Use chairside Computer-Aided Design \& Computer-Aided Manufacturing(CAD/CAM) system (computer aided design / manufacture), using glass ceramic zirconia enhanced lithium silicate glass ceramics (VITA, SUPRINITY, VS) material, compare the difference of firmness, comfort and durability between two kinds of root canal restoration methods:endocrown and 90° shoulder endocrown. Objective to establish the optimal method and material for the restoration of the teeth with root canal therapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18-60 year old patients with healthy body, the tooth is molar, root tip no obvious damage, no root fracture by X-ray;
2. after complete root canal therapy, the remaining 4 wall intact tooth tissue;
3. after complete root canal therapy, the remaining 3 wall intact tooth tissue;
4. have good oral hygiene habits;
5. agreed to participate in the trial and signed the informed consent form;
6. patients who are not participating in other clinical trials;
7. after completion of the repair, compliance with the USPHS evaluation criteria of marginal density class A cases

Exclusion Criteria:

1. obvious destruction of the apical tissue and large cysts;
2. severe periodontitis patients;
3. oral malignant tumor patients;
4. radiotherapy patients;
5. pregnant women;
6. patients with mental illness or systemic diseases;
7. people who can not take care of themselves;
8. the researchers believe that is not suitable for the test.
National Survey on the Lockdown of Children With Disabilities

During the COVID-19 pandemic, lockdown measures were established in France affecting the life course of children with disabilities. This study aimed at identifying the experiences, main difficulties and needs of these children and their parents during the lockdown period.


Eligibility Criteria:
Inclusion Criteria:

-children (age 0-18 years) with motor disabilities (with and without associated impairement), living in France.

Exclusion Criteria:

-
Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia

RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia.

PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.

OBJECTIVES:

* Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.
* Attempt to correlate the incidence of specific, nonrandom combinations of molecular genetic lesions with clinical outcome in these patients.

OUTLINE: Patients are stratified by risk (standard vs high).

Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Patients are followed for at least 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed acute lymphoblastic leukemia (ALL)
* Meets criteria for 1 of the following:

  * Standard risk, as defined by the following:

    * 1 to 10 years old at diagnosis
    * WBC less than 50,000/mm\^3
  * High risk, as defined by the following:

    * Less than 1 year old or over 10 years old at diagnosis
    * WBC greater than 50,000/mm\^3
* Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL)

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence

This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* If female, must be of nonreproductive potential
* If male, must agree to use acceptable contraception
* Symptoms of overactive bladder with urinary urgency incontinence
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive bladder caused by neurological condition (eg, spinal cord injury, multiple sclerosis)
* History of bladder surgery
* Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks
* Previous treatment with botulinum toxin therapy of any serotype for any urological condition
Physiology & Optical Coherence in STEMI

The objective of this study is to prospectively evaluate the outcomes of different treatment pathways using a Physiology \& Imaging guided PCI in patients with STMEI.

A multi-centre study that will prospectively enrol consecutive STEMI patients who don't receive primary PCI within 48 hours after symptom onset because of different reasons.

STEMI patients with culprit lesion stenosis between 0%-90% will be included in this study and randomized to angiography-guided, FFR-guided or OCT guided PCI groups.


Eligibility Criteria:
Inclusion Criteria:

- Age ≥18 years STEMI for 7-30 days Have not undergone PCI because: Stabilization in a non-PCI hospital followed by transfer to a tertiary hospital for further evaluation;Previous emergent angio without ballooning or stenting;Previous emergent Thrombus Aspiration without ballooning or stenting;Pharmacoinvasive therapy Stenosis between 0%-90% TIMI flow grad 3

Exclusion Criteria:

- Left main disease or bypass disease Intolerance to a study drug, metal alloys, or contrast media Life expectancy less than one year Previous PCI or CABG history Cardiogenic shock or LVEF\<35% Severe renal or hepatic dysfunction, hemodynamic instability \>90% stenosis in culprit lesion TIMI flow ≤ grade 2 Planned surgery within 6 months after index procedure Clinical indications of inability to tolerate DAPT for 12 months Inability to provide written informed consent Participation in another trial before reaching the primary endpoint
The Effects of Group Exercise and Basketball on Obese Children

This study aimed to compare the effects of group exercises under physiotherapist control and basketball program on body composition and motor skills of obese children. 45 obese children aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and control group (n:15). The children were assessed before and after 12-week study duration. Body Mass Index (BMI), the percentage of body fat, and circumference values of the children were recorded. Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) was used to determine motor skills of children.

The roles of active physiotherapy programs and sport programs on the management of the problems arising from childhood obesity should be determined. Although the effects of exercise and various sport branches on decrease obesity and obesity related problems, the effects of group exercises managed by physiotherapists and team sports on body composition and motor skills of obese children are not clear so health professionals may have difficulties while suggesting better physical activity for this population.

Thus, body composition and motor skills of the included children were recorded at the beginning. They were then grouped into three in order to compare the effects of group exercises and basketball. Children in the control group did not participate in any of them. Intervention lasted 12 weeks so they were then taken to the assessments at the end of this duration.

Eligibility Criteria:
Inclusion Criteria:

* children who were born in 2006 (10 years old),
* children whose BMI values were ≥95. Percentiles,
* a report which was given by a doctor to state that the child could participate in aerobic exercise,
* children who had not continued to a diet program for 3 months,
* children who had not participated regularly in any sport or exercise for 6 months.

Exclusion Criteria:

* children who had any disease requiring use of medicine,
* children who had any pain to prevent doing exercise or sport,
* children who had any neuromuscular disease
Outcomes of Patients With COVID-19 in the Intensive Care Unit

The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit.

A Multicenter Observational Study.

As of 23 March 2020, a cumulative total of 332,930 confirmed cases of coronavirus disease 2019 (COVID-19) were reported in 189 countries and territories worldwide. As of this time, there had been 367 total confirmed cases of COVID-19, including four deaths in Mexico. The clinical manifestations of patients with COVID-19 are wide, asymptomatic infection, mild upper respiratory tract illness, and approximately 5% of critically ill patients with COVID-19 have presented rapidly progressive respiratory failure, development of acute respiratory distress syndrome (ARDS), and intensive care unit (ICU) admission. On March 24, 2020, the Secretary of Health of Mexico, formally declared the beginning of phase 2. It has been estimated that many confirmed cases of COVID-19 would occur, thus would result in a significant increase of hospital and ICU admissions.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed case: Critically ill patient who meets the operational definition of a suspected case and who has a confirmed diagnosis by the National Network of Public Health Laboratories recognized by the Institute of Epidemiological Diagnosis and Reference (Indre) (Mexico).

Exclusion Criteria:

* If a negative for SARS-CoV-2 result is obtained from a critically ill patient with a high index of suspicion for COVID-19 virus infection.
* Patients who had participated in another observational study in the last 30 days prior to inclusion.
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression


Eligibility Criteria:
Inclusion Criteria:

1. Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug
2. Can understand the nature of the trial and protocol requirements and provide signed informed consent

   * from patient, if deemed competent to provide consent
   * from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
3. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
4. Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
5. Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study
6. The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

1. Patient was significantly non-compliant in Study ACP-103-032
2. The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior
3. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
4. Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures
5. Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
6. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment
Telenursing System by Providing Health Education and Lifestyle Modification Among Diabetic Patients in Bangladesh

The global burden of chronic diseases is increasing and becoming a public health issue throughout the world. The use of telenursing is increasing significantly during and after the COVID-19 pandemic to treat and prevent chronic diseases. Study objectives: The objective of this study is to apply the self-management telenursing program and telenursing system developed by the researchers to Bangladesh and to evaluate its feasibility and efficacy (improved diabetes control in participants). Method: This is a pilot, quasi-experimental pre- and post-intervention study. Diabetes patients who will attend the Grameen Primary Health Care Centers (PHCs) in Bangladesh will be enrolled. Investigators include patients who have been diagnosed with type 2 diabetes, both sexes, age above 18-75 years old, all types of treatment, and willing to participate / give consent. Investigators exclude patients who have been diagnosed as gestational diabetes, diabetes as a secondary cause, complication of CKD stage 5, HbA1c is less than 7.0% for past 1 year with CKD stage 1 or 2, no complications or complications with good control, having enough knowledge (had education before) and implemented good practice regarding diabetes management assessed by the research nurses, and disabled persons who need other person's support for daily living. The sample size was calculated and found 70. Patients who meet the eligibility criteria will be introduced by physicians at the PHCs, and the nurses will contact the patients at the PHC. Written informed consent (ICFs) will be obtained from all the participants. Protocol including ICFs got approval from the Institutional Review Board of Bangladesh Medical Research Council (BMRC/NREC/2022-2025/336) on September 08, 2024. The outcome of this study is to evaluate the effects of telenursing intervention by controlling HbA1c. Investigators set various secondary endpoints including feasibility. By making self-supported decisions, the patients will be able to manage their diet, exercise and medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed as type 2 diabetes
* Both sexes
* Age18-75 years old
* Who will have a smartphone or mobile phone
* Who are willing to participate / give us the consent

Exclusion Criteria:

* Patients who have been diagnosed as Type 1 and gestational diabetes
* Patients whose diabetes is secondary causes
* Patients who have complication of CKD stage 5
* Patients whose HbA1c is less than 7.0% past 1 year with CKD stage 1 or 2, no complications or complications with good control, having enough knowledge (had education before) and implemented good practice regarding diabetes management assessed by the research nurses (hereafter "the nurses")
* Disabled persons who need other person's support for daily living
'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.

Exclusion Criteria:

* No specific exclusion criteria
High Definition Profiling of Ovarian Cancer Ascites

This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients.

High Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.

The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid.

HGSOC is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.

In recent years, new therapeutic regimens are being tested to improve the care of HGSOC patients. These approaches include the use of poly-ADP-ribose polymerase inhibitors (PARPi) targeting Homology Directed Repair deficiency, anti-angiogenic drugs, such as anti-VEGF monoclonal antibodies, and immune checkpoint inhibitors, that target immune modulation induced by tumor and tumor-associated cells and inflammatory signals. Unfortunately, the outcome of such therapies has been to date either erratic or dismal.

This points to the acute need to identify new biomarkers predictive of treatment response, effectively geared to the clinical setting.

The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid. This will allow to define tumoral archetypes, reflecting HGSOC's endophenotypes, associated with prognosis in patients, possibly guiding future refined therapeutical paradigms for ovarian cancer patients and endowing researchers with a well-characterized multilayered dataset for future reference in the context of molecular dissection and target discovery paradigms.

Indeed, the combination of origin- and archetype-based stratification of HGSOC patients, will allow to better identify patients for which existing therapeutical regimens could be beneficial, such as the use of checkpoint inhibitors and anti-angiogenic drugs, that have been so far erratic in ameliorating patient's survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery
* Diagnosis of high grade serous ovarian cancer confirmed by histopathology assessment
* Patients who provided written informed consent

Exclusion Criteria:

* HIV-positive patients
* HBV-positive patients
* HCV-positive patients