cyrilzakka/clinical-trials huggingface dataset:
Impact of Age and BMI on Liver Transplant Outcomes

Prospectively enrolled retrospective chart review and Liver Transplant database review to determine the modifiable and nonmodifiable risk factors specifically relating to Living Donor Liver Transplants. To observe the impact of age and BMI on graft outcomes and whether they impact the intraoperative management, post-operative length of stay, and complications.

There has been a great deal of research into the characteristics of the donor for organ transplant, with older donors and those with more comorbidities having worse function once the organ is implanted. There has not been a great deal of research in the United States about the recipient's characteristic including age and BMI and the effects on donor organ function. With increasingly expanded criteria for organ recipients especially in the field of living donor organs the investigators plan to show the impact of older age and increased BMI on newly transplanted organs.

Eligibility Criteria:
Inclusion Criteria:

* All patients who received a liver transplant at UPMC- Montefiore Hospital Age\> 18

Exclusion Criteria:

* Excludes Children (\<18 years old) as they do not receive their operation under the same protocols Lost to follow-up prior to 1 year Participation in alternate research protocol that significantly altered the care they received in the perioperative period that may make their inclusion skew results.
Identifying Tissue-of-origin in Transplant Patients and Patients with Malignancies.

the investigators are developing a method for diagnosing cell death in the body using blood and urine tests. The test is based on two well-known phenomena in biology. First, when cells in the body die, short fragments of their DNA, about 150 bases long, find their way into the bloodstream for a short period of time of about fifteen minutes to an hour, before being eliminated in the liver and kidney. The details of this process are not fully known, but it is clear that the phenomenon exists. Already today, this phenomenon is widely used clinically for prenatal diagnosis of chromosomal aberrations in the DNA of the fetus that is found in large quantities in the mother's blood. Liquid biopsies from cancer have already been developed, based on the identification of somatic mutations originating from a cancerous tumor in the free DNA found in the serum or plasma. In the case of cancer, liquid biopsies may be a convenient way to monitor the genetic evolution of the tumor, response to treatments, and more. This approach of detecting cell death using free DNA in the bloodstream has a severe limitation when it comes to the death of cells whose genome is not different from the genome of the other tissues in the body, and therefore the DNA cannot be associated with the tissue of origin based on sequence analysis.

The duration of the sample collection period is estimated to be five years. Work in the laboratory will continue for another 3 years. The laboratory work will be carried out in the laboratories of Prof. Eithan Galun at Hadassah Ein Kerem and Prof. Nir Friedman at the Hebrew University of Givat Ram. Access will be given to Prof. Galun and his team. Since genetic variation is not tested in this study, there is no fear of revealing the subject's personal genetic information. In this study we use an identified sample, on which identifying details for the participant are indicated, for example: name, social security number or code number that can be given to the sample. The identified information and the information that will be extracted from the sample will be saved in coded excel sheets. In this way, only authorized researchers and research staff will be allowed access. The samples will be preserved as coded identified samples in the laboratory of Prof. Eithan Galun, Hadassah Ein Kerem, Jerusalem in a freezer in a locked room with limited access to researchers and the authorized research team only, and also, in the laboratory of Prof. Nir Friedman, the Hebrew University of Givat Ram, Jerusalem under similar conditions with access to the research team only. the investigators also ask the liver and kidney transplant recipients to collect a urine sample, with the thought that it might be possible to save a blood test and be satisfied with a urine sample.

Eligibility Criteria:
Inclusion Criteria:

Kidney and liver transplant recipients Patients with malignant tumors

Exclusion Criteria:

Pregnant women Minors Incompetent Chronic background disease.
Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation

The purpose of this study is to evaluate the consistency of quantitative peak stress myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2 minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson) injection. It is anticipated that there will be no or minimal difference between the four delay times.


Eligibility Criteria:
Inclusion Criteria:

* Recent normal clinically-indicated exercise myocardial perfusion SPECT, treadmill maximal exercise test or exercise echocardiographic study
* No change in symptoms between the exercise study and PET study
* Capable of providing written informed consent
* BMI 25-32 kg/m2

Exclusion Criteria:

* Diabetes mellitus
* Coronary Artery Calcium Score \>25
* Second and Third Degree Atrioventricular Node Block
* Sinus Node Dysfunction
* Recent Syncope of unknown etiology
* Left ventricular hypertrophy per ECG or echocardiography
* Slowed circulation times
* Active wheezing or with acute asthmatic or bronchospastic attacks requiring changes in therapy within the past 30 days.
* Patients that have experienced a previous hypersensitivity reaction thought to be related to Lexiscan
First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation

Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy.

Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy. The primary endpoint is progression-free survival, and the incidence of radiation-induced lung injury.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 75 years
* Pathologically documented NSCLC
* Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI
* Positive EGFR mutation confirmed by ARMS
* At least 3-month life expectancy
* KPS ≥ 70
* Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L
* Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN
* Written informed consent before patient registration and any protocol-related procedures

Exclusion Criteria:

* Previous radiotherapy
* Received other investigational systemic drugs within 4 weeks prior to study entry
* Severe or uncontrolled systemic disease
* Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant
* Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
* Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Trial of a Secondary Stroke Prevention Program

The purpose of this study is to determine whether an outpatient program can reduce the risk of recurrent stroke.

Stroke is a major cause of death and disability. A history of stroke is the strongest predictor of a future stroke. Control of risk factors lowers the risk of future stroke, yet most persons with stroke do not have their risk factors controlled.

In this randomized-controlled trial, we will test whether an outpatient stroke prevention program consisting of group clinics, patient self-management, and telephone care coordination can lower the risk of recurrent stroke by improving patient knowledge, medication adherence, and lifestyle habits. If successful, this program may be adapted to other settings.

Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke within the past 30 days
* transient ischemic attack within the past 30 days
* person receiving care at VA Long Beach Healthcare System

Exclusion Criteria:

* unable to understand informed consent
* already enrolled in another research study
Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine.

The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).

The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.

The study included:

* A screening visit of up to 21 days prior to randomization
* Randomization at baseline
* A Treatment period (initiated within 3 days of randomization), which included 28-day treatment cycles in both arms until predefined treatment discontinuation criteria were met
* A follow-up visit 30 days after discontinuation of treatment,
* A post study treatment follow-up period until death or the study cutoff date.

The criteria for treatment discontinuation were:

* Participant (or legal representative) chose to withdraw from treatment
* The investigator thought that continuation of the study would be detrimental to the participants well-being, such as:

  * Disease progression
  * Unacceptable AEs not manageable by symptomatic therapy, dose delay, or dose modification
  * Intercurrent illness that prevented further administration of study treatment
  * Noncompliance with the study protocol
* Participant was lost to follow-up
* Unblinding of the participant's investigational treatment

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas
* Metastatic disease
* No prior chemotherapy for pancreatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Adequate renal, liver and bone marrow functions

Exclusion Criteria:

* Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of randomization
* Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors
* Uncontrolled hypertension
* Pregnancy or breastfeeding
* Participant with reproductive potential (M/F) without effective method of contraception

The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Eligibility Criteria:
Inclusion Criteria:

* Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
* Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
* Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
* Willing to follow contraception guidelines

Exclusion Criteria:

* Clinically improving pulmonary status over the month prior to screening
* Undergone a previous stem cell infusion unrelated to this trial
* Pregnant or breast feeding or planning for either during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection
* History of a splenectomy, lung transplant or lung lobectomy
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Gamified Fitness Training to Promote Children's Physical Activity

The study aimed to introduce gamified physical fitness training in health education with the goal of enhancing physical activity levels and assessing its feasibility within a small-scale context involving 11-12-year-old children.

A cluster experimental design was conducted in a small-scale context of school children. Participants were recruited by inviting two elementary schools located in the same district area for testing the physical fitness training effects. Two schools were randomly assigned to either the training group (TG; n = 47) receiving physical fitness training or the control group (CG; n = 44) without the training. Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team from the TG school. PA outcome indicators were assessed using AI-wireless sensors attached to participants' wrists over 12 weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified physical fitness training in health education classes. Data collection occurred during school days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week (T3). Generalized estimating equation statistics were used to assess the program effects.

Eligibility Criteria:
Inclusion Criteria:

* school children in 5th grade

Exclusion Criteria:

* physical deformity, mental disability, limited higher density physical activity such as asthma, cardiovascular disease, and bone fracture.
Puberty, Sex Hormones and Pain Sensitivity in Adolescents With Migraine

The purpose of this research study is to investigate the relationships between sex hormone levels and experimental pain sensitivity and migraine severity will be examined.

This study will investigate how puberty and variability in sex hormone levels impact pain sensitivity and migraine symptoms.

Hypothesis 1- A significant reduction in pain sensitivity from early to late pubertal status will be found only for adolescents without but not with migraine during pubertal maturation.

Hypothesis 2- Experimental pain sensitivity will be negatively correlated with testosterone levels in adolescents in both groups (with and without migraine).

Exploratory Hypothesis 1- In adolescents with migraine, higher migraine severity (headache frequency and migraine disability) will be associated with lower testosterone levels.

Exploratory hypothesis 2- Adolescents with migraine will have lower testosterone levels than those without.

Eligibility Criteria:
Inclusion criteria

1. Age between 11-15
2. Males and females
3. English speakers
4. Migraine group: diagnosed with migraine
5. Control group: Healthy, with no first degree relative with migraine

Exclusion criteria:

1. Pregnancy or breastfeeding,
2. Chronic pain (except for migraine for the migraine group), neurological or psychiatric syndromes or syndromes associated with pubertal maturation
3. Use of medications that impact sex hormone levels (i.e., contraceptive pills)
Effect of Virtual Glasses on Pain and Comfort During ESWL

The aim of this study is to examine the effect of virtual glasses application on the patient's pain and comfort level during ESWL.

The data obtained in the research will be analyzed using the SPSS 23.0 "Statistical Package for Social Sciences" for Windows program. Descriptive statistical methods when evaluating data; number, percentage, mean, frequency, standard deviation will be used. As hypothesis tests, analysis will be made with Mann Whitney U, student t test, and chi-square tests. The findings will be interpreted with a significance level of 0.05 at the 95% confidence interval.

After obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce himself to the patient who is admitted to undergo ESWL procedure and explain the purpose of the research. Informed consent will be obtained from patients who volunteered to participate in the study. The data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical characteristics of the patients will be recorded from the patient file. Data will be collected from the first patient who will undergo the ESWL procedure. Pain with VAS and comfort level with General comfort scale will be checked 5-10 minutes before the procedure. According to the randomization, the patient in the virtual glasses group will first be explained to the patient by the researcher that he will wear the glasses for 30 minutes during the procedure and watch the video. When the 30 minutes are up, the patient will be informed by the researcher and the glasses will be removed. No intervention will be performed on the patient in the control group. The first patient will go to the operation room. Patients in the virtual glasses group will use the virtual glasses for 30 minutes after the patient goes to the operating table and the preparation is completed. No intervention will be performed on the patient in the control group. All patient groups will be checked for pain with VAS and comfort level with general comfort scale 30 minutes after the end of the procedure. At the end of the procedure, the patient will come to the service. No intervention will be done to the patients in the control group, and the routine care protocol of the clinic will be applied.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* Absence of hearing and perception problems,
* Absence of any visual impairment,
* ESWL procedure will be performed for the first time,

Exclusion Criteria:

* Using any analgesic or anxiolytic before the procedure,
* Having a psychiatric disorder
Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

Encephalitis and meningitis are serious central nervous system diseases. There is currently a lack of comprehensive and accurate diagnosis and treatment pathways. Therefore, we conducted this multicenter, prospective, and randomized controlled study. It was designed to evaluate the diagnostic performance and its impact on the outcomes of the patients enrolled. As such, we came to the results of the optimal process of diagnosis and treatment strategy of encephalitis/meningeal syndromes with improved effective treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected meningitis : the patient has a new fever (\>38.5℃), accompanied by ≥1 of the following manifestations：

  1. Stiff neck
  2. Change in state of consciousness
  3. Other signs of meningitis: such as meningeal irritation.
* Patients with suspected encephalitis: Unexplained changes in the state of consciousness for more than 24 hours (including lethargy, agitation, personality changes, etc.) or accompanied by recent memory impairment, with the following ≥1 manifestations:

  1. Fever during the course of the disease (≥ 38℃); (oral temperature)
  2. Convulsions or focal neurological symptoms;
  3. Increase in the number of cerebrospinal fluid cells (\>4\*10\^6/L);
  4. Abnormal EEG that meets the manifestations of encephalitis and cannot be attributed to other reasons
  5. Imaging suggests encephalitis (CT or MRI)
* Have not received effective anti-infective treatment yet
* Have an identifiable address and live in the area during treatment.
* Suspected encephalitis/meningitis patients who are willing to participate in trial treatment and follow-up and can give informed consent (if the subject is illiterate, sign or hearing consent is required).
* Willing to comply with follow-up research procedures.

Exclusion Criteria:

* Known breastfeeding or pregnancy
* Failure to comply with treatment or follow-up time;
* The researcher believes that there are any conditions (social or medical) that allow subjects to participate in unsafe;
* Participating in other clinical studies
* Insufficient cerebrospinal fluid or blood samples
* Clinically diagnosed infections, tumors or other neurological diseases
Glucagon Efficiency After High and Low Carbohydrate Diet

No studies have investigated if the dietary composition of carbohydrate influences the glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further, the recommended diet composition to patients with type 1 diabetes has not been thoroughly validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated. The purpose of this study is to determine, whether diet composition of carbohydrate affects the glycogen stores in the liver and affects the glucose response of glucagon during hypoglycaemia.

HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of low-dose glucagon is not associated with diet carbohydrate content.

AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet influence the glycaemic response of low-dose glucagon in patients with insulin pump treated type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose excursions.

DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After participants have given an informed consent, they will go through four steps: 1) screening visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study visit and 4) second meal intervention for one week finalizing with another study visit.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 70 years
* T1D ≥ 3 year
* BMI 20-27 kg/m2
* CSII ≥ 1 year
* HbA1c \< 69 mmol/mol (8.5 %)
* C-peptide negative (\< 60 pmol/l)
* Hypoglycemia awareness (self-reported)
* Use of carbohydrate counting and the insulin pump bolus calculator for all meals

Exclusion Criteria:

* Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
* Impaired renal function (eGFR \< 60 ml/min/1.73m2)
* Liver disease with ALAT \> 2.5 times the upper limit of the reference interval
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* Known or suspected alcohol or drug abuse
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
* Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
* Inability to understand the patient information and to give informed consent.