cyrilzakka/clinical-trials huggingface dataset:
Investigation of Immune Amnesia Following Measles Infection in Select African Regions

The goal of this observational study is to investigate the effects of measles virus (MeV) infection on pre-existing immunity, vaccine response, and susceptibility to subsequent illness in children aged 1-15 either with or without acute MeV infection.

This is a prospective, observational, longitudinal study to be conducted in West Africa. Eligible children will be enrolled into 1 of 2 arms: acute MeV infection (cases) or no acute MeV infection (controls) as assessed using upper respiratory specimens and blood samples. Blood samples will be collected at screening/enrollment (Day 0) and follow-up visits on Day 14, Week 13, and Week 52, and tested for humoral and cellular immune responses to endemic pathogens to determine changes in antibody diversity and antibody secreting cells (ASCs). All children in each arm will receive rabies vaccination (standard 3-dose series given as pre-exposure prophylaxis \[PrEP\]), with the first dose randomized to either Week 8 or Week 47 after enrollment. Biological samples will be collected after vaccination to assess if the immune stimulus (rabies vaccine) response differs: 1) between children with and without MeV infection, and 2) based on the timing of the receipt of the rabies vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1 to 15 years.
* Ability of the participant's legal or culturally acceptable representative to provide informed consent.
* Ability to give assent, as appropriate.
* Stated willingness of parent/guardian and participant as appropriate, to comply with all study procedures.
* Willingness to receive rabies vaccine.
* Meet the criteria for assignment to Group 1 or Group 2, as follows:
* Group 1, cases (acute MeV infection):
* Clinical signs and symptoms suggestive of acute MeV infection (Koplik spots or skin rash) AND
* Laboratory confirmed measles:
* Upper respiratory specimen (swab) PCR for measles positive, OR
* Serum IgM for measles positive.
* Group 2, controls (no acute MeV infection):
* No clinical signs and symptoms suggestive of acute MeV infection (Koplik spots or skin rash) AND
* Upper respiratory specimen (swab) PCR negative for MeV AND
* Serum measles IgM negative AND
* Serum measles IgG positive and previously vaccinated for measles (2nd dose will be offered if appropriate). If serum measles IgG is negative, participant must be willing to be vaccinated regardless of prior measles vaccine history to meet this criterion.

Exclusion Criteria:

* HIV infection or any other immunosuppressive condition or medications.
* Pregnant or lactating.
* History of prior measles or immunologic evidence of prior measles in the absence of prior measles vaccination.
* Severe anemia, defined as hemoglobin less than 8 g/dL.
* Any acute or chronic condition which, in the opinion of the investigator, constitutes a contraindication to participation in this study.
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Safety and immunological efficacy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged over 65 years old
* Informed consent form has been signed and dated

Exclusion Criteria:

* Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barre syndrome(GBS)
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills

The purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.

Sixteen volunteer patients will be recruited. Two titanium mini-implants will be installed in the distal segments of the maxilla in recipient sites prepared with either a sonic device or conventional drills. Biopsies containing the mini-implants will be retrieved after 2 weeks in eight patients, and after 6 weeks in the other eight patients. Histomorphometric analyses will be performed

Eligibility Criteria:
Inclusion Criteria:

* presence of an edentulous atrophic zone in the posterior segment of the maxilla
* height of the sinus floor ≥10 mm
* ≥ 25 years of age;
* smoking ≤10 cigarettes per day
* good general health
* no contraindication for oral surgical procedures
* not being pregnant.

Exclusion Criteria:

* presence of systemic disorders
* chemotherapy or radiotherapy
* smokers \>10 cigarettes per day
* previous bone augmentation procedures in the same region.
A Retrospective Study on the Outcome of Different Fixation Methods After Olecranon Osteotomy

Humeral intercondylar fractures are very challenging in clinical treatment. There are many problems not clear. One of the important problems remained to be solved is which fixation method can achieve the best effects after olecranon osteotomy. Therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.

Humeral intercondylar fractures are very challenging in clinical treatment. Because the humeral intercondylar fracture is comminuted and often occurs in elderly patients with osteoporosis, it is difficult to achieve rigid fixation during the operation and failure of fixation occurs from time to time after the operation. Nonunion and reoperation have brought great sufferings to the patients.In recent years, both surgical methods and technique of internal fixation have been greatly improved, but there are still many problems not clear. Olecranon osteotomy has been proven to be an effective approach for comminuted intercondylar fractures and there are different fixation methods to fix the proximal ulna after intercondylar fixation. However, it is not clear which method can achieve the best effects. Therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years old;
2. Distal humerus fractures.

Exclusion Criteria:

1. Pathological fractures;
2. Combined with fractures of ipsilateral upper limb;
3. Fracture over 2 weeks;
4. Patients who refused surgical treatment;
5. Patients who were unable to obtain the 1 year follow-up data after the operation.
Determination of Optimal Sleep Treatment Elements - Pilot

Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed.

In this pilot study, a smartphone and web application developed to treat insomnia using these treatment components will be tested.

Two future studies will investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia by means of the Multiphase Optimization Strategy (MOST), and verify this intervention's effect in a randomized controlled trial (RCT).

As a pilot study for a Multiphase Optimization Strategy (MOST) study, the current study will assess the effects of a newly developed smartphone and web application for digitized cognitive behavioural therapy for insomnia (eCBT-I). All treatment components, i.e., sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy, will be tested in order to receive feedback on the functioning of the application as well as to get an initial impression of possible treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* Individuals who report moderate-to-severe insomnia symptoms (a score ≥10 on the Insomnia Severity Index, ISI)
* Individuals with access to a smartphone or computer with internet connection
* Individuals who report sufficient technological proficiency (e.g., ability to download apps)

Exclusion Criteria:

* Children (\<18 years)
* Individuals who report mild or no clinically relevant insomnia symptoms (a score \<10 on the ISI)
* Individuals who have a shift-work schedule or are on maternity/paternity leave, if this impacts their sleep quality or amount of sleep
* Individuals who are unable to read Danish
* Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cardiovascular disease, cancer, COPD)
* Individuals who report other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
* Individuals who have previously used the "Hvil®"-app, e.g., during the beta test phase
Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction

The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.

The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.

Eligibility Criteria:
Inclusion Criteria:

* Female adolescent patients with an age range 11- 14 years.
* Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
* Normal vertical growth pattern.
* Fully erupted maxillary first premolars and first permanent molars.

Exclusion Criteria:

* Previous orthodontic treatment.
* Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
* Active periodontal affection or severe gingival inflammation.
De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients

Over 21 million surgical procedures take place among adults aged 65 and older in the US each year, and most older surgical patients in the US now receive benzodiazepines (e.g., midazolam, lorazepam) during anesthesia care. This occurs despite recommendations to avoid these medications in older patients due to associated medical risks and lack of demonstrated benefit. In other words, routine benzodiazepine administration to older surgical patients is likely to represent low-value care that is a suitable target for de-adoption. In this study, we will evaluate a United States Anesthesia Partners (USAP, Dallas, TX) quality improvement initiative using peer comparison feedback to clinicians and/or mailed informational letters to patients as strategies to encourage physician de-adoption of routine preoperative benzodiazepine administration to older surgical patients. In partnership with USAP, this study will be conducted using randomization to evaluate its effect.


Eligibility Criteria:
Inclusion Criteria:

* All anesthesia clinicians employed by USAP will be included in the evaluation. Patients will be included if they are at least aged 65 and undergo an elective (scheduled) surgical or endoscopic procedure under general anesthesia.

Exclusion Criteria:

* Patients will be excluded if they are unscheduled (urgent/emergent) cases due to inability to reliably deliver study interventions to this group; if they did not receive general anesthesia; or if they received a nerve block procedure.
Study on the Impact of Stem Cell Donation and Bone Marrow Harvesting on Unrelated Donors

Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. The principal objective of the research is to study any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood stem cell donors.

The study subjects will be Retrospective and Prospective voluntary unrelated donors on the Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free Hospital and BUPA Glen Vale in Bristol.

All participants in the Prospective Arm will be asked to donate one 5-10ml sample of blood at study entry prior to stem cell donation and further samples at 120 and 360 days post donation. Those found to carry aneuploid cell clones at these time points will be asked for a further 5-10ml blood sample at least twice - at the end of 24 months and 36 months respectively. The Retrospective and Positive Control group will be asked to supply one 5-10ml sample of blood.

The aim of this study is to detect any genetic differences between bone marrow and PBSC unrelated donors, post donation and confirm or refute the observations of "long-term genetic or epigenetic effects" published by Nagler et al\[Nagler,A. et al. Exp.Haem (2004) 32;122-30\]. The employment of more sensitive methods such as iFISH and gene array analysis to assess any permanent genetic changes, our primary objective, will make our study more robust.

There will be two arms:

i) Retrospective arm - the peripheral blood of unrelated donors who donated 3 to 5 years previously will be screened.

ii) Prospective arm - peripheral blood of unrelated donors will be examined prior to donation and at 120 and 360 day's post-donation. In those found to have aneuploid changes at these time points, there will be additional sampling at 24 and 36 months and if necessary these donors will be followed up.

Each arm of the study will include 50 BM unrelated donors and 50 PBSC unrelated donors giving a total sample population of around 200 unrelated donors. There will be one positive control group of 50 patients with a range of haematological malignancies. The blood samples taken from both BM and PBSC donors prior to donation will act as internal negative controls.

Eligibility Criteria:
Inclusion Criteria:

Donors of peripheral blood stem cells

Exclusion Criteria:

Relatives suffering from blood cancer
Correlation of Platelets Count With Endoscopic Findings in a Cohort of Egyptian Patients With Liver Cirrhosis

Portal hypertension is a common complication of liver cirrhosis that can lead to development of esophageal varices (EV). They are abnormally dilated veins within the wall of the esophagus that lead to haemorrhage (1). Majority of patients with cirrhosis will develop EV at some point, and about third of these patients will have at least one bleeding episode because of rupture of a varix . For this reason, screening endoscopy for detection of the presence of EV should be part of the diagnostic work-up in patients with cirrhosis. This is a very important preventive step for identification of those patients with variceal bleeding risk and furthermore, identification of patients in urgent need for prophylactic treatment.

All guidelines stress on screening endoscopy for early detection of EV in cirrhotic patients with portal hypertension. However this approach is limited by its invasiveness and cost effectiveness issues of screening endoscopy .

Recent research has focused on the use of noninvasive methods to detect patients with the intention of avoiding endoscopy in low-risk cases . Thrombocytopenia (platelet count \< 150,000/μl) is a common complication in patients of chronic liver disease (CLD) . So, the investigators in this research formulated this study to determine whether platelet count can predict the presence of EV or varices which need prophylactic therapy (medium or large size EV) in a cohort of Egyptian patients with liver cirrhosis and can identify patients with the intention of avoiding endoscopy in low-risk cases.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis based on history, physical examination, laboratory tests, ultrasound scans and liver biopsy in some occasion.

Exclusion Criteria:

* Hepatocellular carcinoma.
* Portal vein thrombosis.
* Parenteral drug addiction.
Uremic Toxins in the ICU: Patients After Cardiac Surgery

Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)


Eligibility Criteria:
Inclusion Criteria:

* ICU patients after cardiac surgery with acute renal failure
Chaplain Family Project Trial

Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Based on their score the surrogate will be put into one of two groups, and then randomized to either the control or intervention group. Control group members will receive usual care, while intervention group members will meet with our study chaplain, who will provide the SCAI (Spiritual Care Assessment and Intervention) framework.

Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice.

The specific aims of this proposed study are:

1. To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress.
2. To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative).
3. To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS).
4. To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital.
5. To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.

Eligibility Criteria:
Inclusion Criteria:

Cognitive Requirements

1. Patient is not decisional due to:

   * Intubation (other than surgery- see exclusion criteria below)
   * Sedation
   * Unresponsive
   * otherwise unable to communicate (AMS, dementia, delirium, etc.)

   Decision Support Requirements
2. Patient has a qualified surrogate decision maker

Exclusion Criteria:

* Intubated for surgery and expected to be extubated within 24 hours
* Imminently dying as evidenced by patient notes
* Patient and/or family have a care contract or other restriction due to complicated or volatile situation
* Patient is a prisoner
* Patient is being followed by Adult Protective Services (APS)
* Patient meets cognitive criteria but does not have a qualified surrogate decision maker
Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several degenerative diseases, including retinopathies and glaucoma, however no previous safety study involving humans has been conducted. The objective of this study is to evaluate effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence tomography, and retinal ganglion cells function.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Advanced Bilateral Open-Angle Glaucoma;
* Best corrected visual acuity less than 0,1 in the better eye;
* Social and cognitive ability to participate.

Exclusion Criteria:

* Severe systemic morbidities;
* Other ocular blind conditions associated;
* Impossibility in performing any of the proposed examinations.