cyrilzakka/clinical-trials huggingface dataset:
COVID Vaccine Immunity in Kidney Transplant Recipients

50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

50 ESRD patients on peritoneal dialysis or hemodialysis or not on immunosuppression, no prior transplant, no known history of COVID infection, whom have had at least 2 doses of mRNA vaccine, and undergoing transplantation at UAB will be enrolled, after signing the informed consent. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

Eligibility Criteria:
Inclusion Criteria:

* End Stage Renal Disease patients on peritoneal dialysis or hemodialysis or not on immunosuppression
* no prior transplant
* no known history of COVID infection
* had at least 2 doses of mRNA COVID vaccine
* undergoing transplantation at the University of Alabama at Birmingham
* multi-organ transplant allowed

Exclusion Criteria:

* active COVID infection
* participant is not vaccinated against COVID
Nutrition in Pediatric Oncology in Central America

This study investigates nutritional status, at predefined points in therapy, and the association with outcomes in children and adolescents undergoing treatment for cancer in institutions under Asociación de Hemato-Oncología Pediátrica de Centro América (AHOPCA) consortium in Central America. The aim of the study is to examine the effects of the newly-established nutritional program aimed at improving the delivery of nutritional care and outcomes in children undergoing treatment for cancer in Central America.

In low and middle-income countries, children with cancer are simultaneously dealing with malnutrition in high proportions. Without proper access to care and a minimal or basic level of care, these children are exposed to worse conditions. Studies have shown that more than half of the children with cancer are also malnourished at diagnosis. This increases children's risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates. With an established nutritional education and clinical intervention program, the outcomes of these children can be improved, especially in Central America where the cancer rates and malnutrition is high, as shown by several studies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of childhood cancer (Solid tumors, Acute Lymphoblastic Leukemia (ALL), other Lymphomas)
* Recruited at diagnosis
* Under the age of 18 years

Exclusion Criteria:

* Other cancer diagnosis
* Palliative care patients
Occupational Therapy in Complex Patients: a Pilot Study

To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient. For this reason, the investigators propose one randomized controlled trial that will compare the group receiving the intervention of OT and the control group, to quantify the level of performance and satisfaction in the activities of interest of the patient, identified through the COPM. The hypothesis is that the benefit may be higher, as clinically relevant, in the group of complex patients treated with the proposed intervention of OT compared to those receiving the usual rehabilitation therapy.

The investigators already implemented an observational pilot study, aimed at defining the characteristics and needs of the population in question and the OT intervention characteristics. These information will now be used to implement this randomized controlled trial, designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.

This study will be set with exploratory purposes, with appropriate high number, which will allow the investigators to quantify the difference between the two groups in terms of performance scores derived from the COPM (COPM_p). From the results of this part it will then depend on the planning for the subsequent study with the correct sample size.

Eligibility Criteria:
Inclusion Criteria:

* complex inpatient

Exclusion Criteria:

* primary psychiatric disorders,
* language barriers,
* severe cognitive impairment
* communication disability
Serum Uric Acid Levels and Onset of Cardiovascular Diseases: a CALIBER Study

Serum uric acid level is a commonly measured biomarker. The association between serum uric acid level and the risk of developing cardiovascular diseases has been observed in some studies, while others showed controversial results. Estimation of this association may help to predict cardiovascular outcomes and may guide new treatment strategies. The hypothesis is that increased serum uric acid level is associated with a range of cardiovascular diseases.

Smaller observational studies suggested that increased serum uric acid level is associated with increased incidence of several cardiovascular diseases. Associations with specific initial presentations of cardiovascular diseases have not been studied in large cohort from the general population, but may be of interest for use in risk prediction or to guide therapeutic strategies.

The aim of this study is to estimate associations between serum uric acid level and initial presentation of a range of cardiovascular diseases.

The study will use data from the CALIBER dataset of clinically collected electronic health record data from England. Patients enter the study when they have a blood urate measurement recorded in the dataset, and they are followed up until they experience one of the cardiovascular endpoints, death or transfer out of the participating primary care practice.

This study is part of the CALIBER (Clinical disease research using linked bespoke studies and electronic records) programme funded from the National Institute for Health Research (NIHR) and Wellcome Trust. The central theme of the CALIBER research is linkage of the Inpatient Hospital Episode Statistics (HES) with primary care (Clinical Practice Research Datalink) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* Patients registered with a participating general practice during the study period
* Age 30 years or older at study entry
* No record of previous diagnosis of cardiovascular disease
* Follow up for at least one year before the index date.

Exclusion Criteria:

* Patients without a measurement of blood urate level during the study period.
Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia

Meeting people's needs is positively correlated with their recovery. However, recovery services rarely include nurse-led programs tailored to the needs of these people. This study aimed to evaluate the effectiveness of a new needs-tailored recovery program by using a cluster-randomized controlled trial design.

First year, investigators used the pilot study to test the needs tailored recovery program feasibility, acceptability and preliminary usefulness of the needs-tailored nurse-led recovery program. In the second year, based on the findings of the pilot study, a cluster randomized controlled trial was conducted to assess the effectiveness of the needs-tailored nurse-led recovery program in two psychiatric centers in northern Taiwan. The treatment group receive the needs-tailored nurse-led recovery program by their home-care nurses over 6 months. The control group receive the usual community psychiatric care only. Data were collected before the intervention, after the intervention, and at a follow-up session three months after the end of the intervention period. The outcomes were recovery, needs, hope, empowerment, psychotic symptoms, and medication adherence. The investigators used repeated measures ANOVA tests to examine the effect of the group × time interaction.

Eligibility Criteria:
Inclusion Criteria:

* were living in the community and had a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* were aged 20-64 years
* were able to communicate in Mandarin or Taiwanese.

Exclusion Criteria:

* were living in a community institution such as a recovery home, community rehabilitation center, nursing home, or day hospital
* had a neurocognitive disorder, substance abuse disorder, or comorbidity.
Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma

This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral load and molecular characterization of EBV in plasma.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven nasopharyngeal carcinoma - WHO type 3 (recurrence or metastases)
* metastatic disease or locally recurrent disease not amendable curative therapy
* Patients must have measurable disease
* least one (not more than a total of three prior lines of chemotherapy for metastatic or recurrent disease). This must include at least 1 prior line of platinum-containing chemotherapy.
* An ECOG performance status of 0-2
* Absolute neutrophil count (ANC) ≥1500/mm3
* Hemoglobin 8g/dl (blood transfusion is allowed to correct hemoglobin level).
* PLT ≥ 75,000/mm 3
* Total bilirubin ≤ 2 x upper normal limit (UNL)
* Serum ALT ≤ 5 x UNL
* Serum creatinine ≤ 2 mg/dL
* Serum albumin ≥ 2.5 g/dL
* No known history of brain or leptomeningeal metastasis.
* ≥ 18 years of age.
* Estimated life expectancy ≥ 24 weeks.
* For sexually active women of childbearing potential, negative pregnancy test within 21 days of enrolling on trial.
* must be able to give informed written consent

Exclusion Criteria:

* Patients who have not had at least 1 or more than 3 previous lines of treatment for metastatic or recurrent NPC
* Prior BORTEZOMIB therapy
* Immunotherapy ≤ 4 weeks have elapsed prior to study entry
* Biologic therapy ≤ 4 weeks have elapsed prior to study entry
* Radiation therapy ≤ 4 weeks have elapsed prior to study entry
* Major surgery, or significant traumatic injury ≤3 weeks prior to study entry
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
* Evidence of CNS involvement
* Presence of \> grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology.
* Patients with significant local symptoms from metastases which is amenable to radiotherapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to BORTEZOMIB.
* History of other malignancy ≤ 3 years prior to study entry, except for adequately treated basal cell, squamous cell skin cancer or cervical intraepithelial neoplasia.
* Uncontrolled intercurrent illness
* Patients who are pregnant or breast feeding (Sexually active men and women of childbearing potential must use contraception during course of therapy and within 3 months of completion of trial) Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
* Known history of HIV
Comparison of Clinical and Radiological Results of Using Only Screws and Plate Use in Latarjet Operation in Shoulder Instability

Randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability

Randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability

2 groups will be determined in the study, while the first group will include the group in which corocoid fixation with cannulated screws was performed, while the second group will include the group that underwent osteosynthesis with plate and screw

The results will be evaluated statistically based on clinical scores (constant, vas) and radiological findings (a angle).

Eligibility Criteria:
Inclusion Criteria:

- Recurrent shoulder dislocation; 18-65 age

\>%10 glenoid loss or Hill Sacs Lesion

Exclusion Criteria:

- \<18 age \<%10 glenoid loss shoulder dislocation due to epilepsy Dislocations associated with other upper extremity injuries
Innovations in Hearing Accessibility and Technology (IHAT) Study

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

The aim of the proposed project is to evaluate the effectiveness of emerging over-the-counter (OTC) service delivery models with the gold standard traditional prescription hearing aids fit by hearing care professionals (HCP) using audiology best practices. OTC service delivery models include OTC HA fit to individual users using best practices with in person HCP support (OTC-HPC), via remote consultation (OTC-R) and self-fit OTC HAs without any clinical support (OTC-SF). The study will use a prospective four-arm randomized controlled trial design with longitudinal repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation
* Aged 40 years or older
* No previous HA experience greater than 3 months
* Able to read and understand patient education materials
* Willing to be randomized to one of the four groups, and
* Owns a smartphone

Exclusion Criteria:

* Hearing loss that is too severe for OTC HAs
* Middle ear disorders or conductive pathology present
* Asymmetrical hearing loss
* Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the MOCA
* Non-English speaking as it may impact the ability to complete our test battery
Serum Neurofilament Light (NFL) in Surgery Under General Anaesthesia (GA) Compared to Surgery With Hypno-analgesia (Hyp)

Experimental studies have shown that inhalational anesthetics may be neurotoxic by for example causing amyloid beta deposition. Otherwise a pre-clinical study reported an increase in tau phosphorylation with the use of propofol.

Whether anesthesia and surgery contribute to the development of long-term cognitive decline remains however controversial. A meta-analysis concluded that general anesthesia could increase the risk of postoperative cognitive decline (POCD) compared with regional or combined anesthesia but this was not shown for Postoperative delirium (POD). This conclusion should be interpreted with caution as these studies showed many shortcomings.

Currently no study has compared the release of Neurofilament Light, a biomarker of neuronal injury, in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs.

POD and POCD are manifestations of cognitive dysfunction occurring in the perioperative period. Whether surgery and specifically anesthesia contribute to the development of perioperative cognitive dysfunctions is not clear.

Cell culture and animal studies have suggested detrimental effects of anesthetic exposure.1,2,3 Otherwise, it has been shown in animals that surgery plus anesthesia produced worse POCD than anesthesia alone.4 Proinflammatory cytokine levels increase during surgery. These elevated levels of inflammatory markers associated with the activation of microglial cells may induce neuroinflammation enhancing ongoing neurodegeneration.5 However, anesthetics may be capable of modulating inflammation and may alter the neuroinflammatory response.

Clinical studies associating the effects of general anesthesia with POCD and POD are conflicting.6 These varying results could be due to heterogeneity of patients' baseline status (e.g. cognitive status, education, associated diseases), type of surgery, as well as methods used to determine POCD and POD.

The use of serum neurobiomarkers, sensitive and specific for neuronal cell injury will address the hypothesis of general anesthesia neurotoxicity. Serum Neurofilament Light (NFL) is such a neurobiomarker.Currently no study has compared the release of Neurofilament Light, a biomarker of neuronal injury, in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs. Our hypothesis is that surgery under GA compared to hypnosis does not statistically increase the risk of neuronal injury as measured by serum NFL.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing thyroid or breast cancer surgery and necessitating one night of hospital stay

Exclusion Criteria:

* Renal insufficiency with a GFR \< 30 mL/min
* Mammectomy
* Preoperative psychiatric problems
* Patients not speaking fluently French
* Patients at risk of postoperative hyperalgesia (Kalkman score \> 4/15)
* Allergy to local anesthetics, NSAID and to Rocuronium
* Patients undergoing one day surgery
Effect of Dietary Salt Supplemantation in Vasovagal Syncope Prophylaxis: A Clinical Trial

Syncope is a syndrome consisting of a relatively short period of temporary and self-limited loss of consciousness caused by transient diminution of blood flow to the brain (most often the result of systemic hypotension). The objective of this study was to evaluate the effect of salt supplementation in vasovagal syncope prophylaxis.

Healthy volunteers without use of medicines with except contraceptives orals that met the exclusion criteria were consecutively enrolled in a randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Use medicines
* Previous diseases
* Incapacity of to understand and to sign the term consent
Smoking Cessation Intervention for Women Living With HIV

As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as cardiovascular diseases and cancers on these people have consistently increased. Smoking is one of the major contributing factors to these health problems and rates of cigarette smoking in this group are substantially higher than those of the general population: 40-70% vs. 17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative consequence of smoking than their male counterparts. They are also less likely to see tobacco dependence treatment for dual stigma associated with both conditions: HIV infection and nicotine addiction. This is a pilot study to develop smoking cessation intervention for these women.

Women are at high risk of becoming HIV positive due to biological vulnerabilities, low socioeconomic status, dominant sexual practices of males and epidemiological factors. For example, the risk of being infected with HIV during unprotected sex is two to four times greater for women than for men. With the use of combined antiretroviral therapies, these women now live longer than ever before which now faces the healthcare community with the need for evolving understanding of HIV and aging. However, the burden of non-AIDS related health problems such as cardiovascular diseases and cancers on people living with HIV/AIDS while aging has considerably increased. Smoking is one of the major contributing factors to these health problems. Rates of current cigarette smoking are substantially higher among people living with HIV/AIDS than the general population: 40-75% versus 19%. Women smokers living with HIV have a 36% higher risk for developing AIDS and 53% higher mortality when compared to non-smoking women with HIV. This study is a pilot randomized controlled trial (RCT) testing the feasibility and acceptability of a videoconferencing smoking cessation intervention (video arm) for women with HIV in comparison with a telephone-based smoking cessation intervention (telephone arm). Both arms will receive 8, 30-minute weekly cessation counseling sessions plus 8-week nicotine replacement therapy. Participants will be followed up at 1, 3 and 6 months from the target quit day. Self-reported abstinence will be verified with a saliva cotinine test using an Nicotine Alert test strip and the testing process will be monitored via mobile-phone video call.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Diagnosis of HIV infection
* Age 18 or older
* Smoking at least 5 cigarettes a day
* Having access to a mobile-phone with Internet connection
* Willing to quit smoking within the next 4 weeks

Exclusion Criteria:

* Inability to speak English
* Involvement in another cessation program
* Being pregnant or lactating
* Having an active skin disease
* History of serious mental illnesses (e.g., schizophrenia and bipolar disorder)
* Serious alcohol use problem
* Use of any illegal substances excluding marijuana
Progesterone in Patients With Placenta Previa

This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.

Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg \[Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt\], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age 26-28 weeks of gestation.
2. Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan.

Exclusion Criteria:

1. Multiple pregnancy.
2. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM).
3. Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
4. Women who have been maintained on progestin therapy since early pregnancy for whatever reason.