cyrilzakka/clinical-trials huggingface dataset:
Immune Monitoring and Assay Development in Organ Transplant Recipients

The purpose of this study to develop a well-characterized library of blood, biopsy tissue, and urine samples from transplant patients. Subjects without transplants will also be enrolled for comparison. Samples will be used to study the characteristics of patients undergoing transplantation that influence their response to transplant therapies and their reactions to drugs used in transplantation. This knowledge is important as it helps physicians design new drugs and tailor transplant therapies to the individual thereby reducing the side effects. In this study, people will be asked to donate blood, biopsy tissue and urine. Donation of these samples will not influence patients' treatments. These samples will be tested using a variety of biological tests to better understand how immunosuppressive drugs change the various components of the immune system. The tests will be for research only; no changes in an individual's treatment will be based on the results of tests performed in this study. If there is extra sample, the sample will be stored for use in other testing at a later date. The ultimate goal is find the right combination of medications for each individual patient while keeping their new organ working well. This study is a first step in that direction by perfecting tests used to characterize a patient's immune system


Eligibility Criteria:
Inclusion Criteria:

* Recipients of or candidates for organ transplantation or organ donors for recipients under evaluation at Emory University or CHOA
* Normal volunteers to include individuals without any known end-stage organ disease who are not on any immunosuppressive medication, and individuals with conditions requiring immunosuppression (i.e. dermatological diseases) that do not require transplant therapies
* Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of minors, ability to give minor assent (children older than 5 years of age), in conjunction with written guardian consent

Exclusion Criteria:

* Patients who fail to meet the criteria for transplantation or post-transplant follow-up by Emory or Children's Healthcare of Atlanta physicians
* Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy or technical considerations that would prevent acquisition of sufficient tissue on biopsy for clinical use, or medical urgency preventing timely administration of the consenting process.
Etiology and Prevalence of Peripheral Arterial Disease

To determine the prevalence of peripheral arterial disease in a defined population by non-invasive techniques; to evaluate the association of cardiovascular disease risk factors with peripheral vascular disease; to determine whether non-invasive tests of peripheral arterial disease can be utilized as markers for coronary heart disease; to determine the status of the microvasculature using conjunctival photographs and to compare the results with risk factors and the peripheral arterial disease testing results.

BACKGROUND:

Atherosclerosis is frequently generalized, affecting blood vessels in various parts of the body. Previous studies had noted the strong association between peripheral arterial disease and coronary heart disease and the similarity of risk factors, particularly diabetes and cigarette smoking for both diseases. The natural history of peripheral arterial disease had not been delineated because of the lack, until recently, of accurate and reliable non-invasive testing.

DESIGN NARRATIVE:

All 624 subjects were initially studied under a Lipid Research Clinic protocol that involved two evaluations, visit 1 and visit 2. At visit 2, half of the subjects were from a random sample of the LRC visit 1 cohort and others were selected from the visit 1 cohort for hyperlipidemia, defined as being at or above age- and sex-specific 90th percentiles for cholesterol or 95th percentiles for triglycerides or taking lipid-lowering medications. At visit 2, the subjects were characterized as to age; sex; drug, diet, alcohol and smoking history; personal and family history of cardiovascular disease; Rose questionnaire; and electrocardiogram and examination by a cardiologist. The subjects were given a traditional manual examination for peripheral arterial disease and four non-invasive tests including segmental blood pressure, flow velocity by Doppler ultrasound, postocclusive reactive hyperemia, and pulse reappearance half-time. The subjects were categorized into large vessel peripheral arterial disease, isolated small vessel peripheral arterial disease or normal based on the results of non-invasive testing and followed for an average of four years.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.

The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants.

The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

* non-smoking mother
* healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone),
* normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection)
* single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days)
* expected vaginal delivery with cephalic presentation
* mother should be able to master Swedish well enough to participate in the study
* mother should live close enough to the hospital to be ready to return for follow up after four months.

Exclusion Criteria:

* Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures
Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs) after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the prevention of pseudophakic cystic macular lesions

344 Patients undergoing uncomplicated standard phacoemulsification at Kyungpook National University Hospital from 2013 to 2015 were reviewed. CMLs, which is any cystic fluid collections after cataract surgery, were confirmed by preoperative and postoperative optical coherence tomography(OCT) on preoperative, postoperative 1month and 3months examinations. CMLs were classified into two groups: cystic macular edema(CME) and microcystic macular edema(MME).

Eligibility Criteria:
Inclusion Criteria:

* patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015.

Exclusion Criteria:

* patients had complicated cataract surgery (eg, significant corneal edema, posterior capsule rupture, vitreous loss, dropped nuclear material, retained cortical material, or an IOL not placed in the capsular bag)
Patient Reported Outcomes in Pulmonary Arterial Hypertension

Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.

This study will use the Clinical Impact Method to develop a patient reported outcome for use in patients with pulmonary arterial hypertension Clinical personnel at the study sites will approach and discuss possible participation in Phase I and II of the study with subjects from the existing pool of patients currently receiving usual and customary care at the site.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent
* Subjects aged \>=18 who have documented PAH
* Speak English
* Subjects who provide written informed consent to participate in the study before being screened for the study.

Exclusion Criteria:

* Patients with non-PAH Pulmonary Hypertension
* Physical inability to complete the interview process
* Subjects who are currently enrolled in an experimental drug study
Factors Affecting Therapeutic Efficacy of Vaginal Laser Therapy for Female Stress Urinary Incontinence, and the Effect of Vaginal Laser Therapy on Overactive Bladder Syndrome and Sexual Function

The main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy.

Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence. However, factor affecting treatment efficacy of vaginal laser therapy remains unknown. Thus the main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy. Besides, the durability of vaginal laser therapy will be assessed. The above knowledge should be helpful for clinical decision making.

Eligibility Criteria:
Inclusion Criteria:

* \>20 years old female
* had stress urinary incontinence symptoms
* Sexual behavior
* No urinary tract infection
* At their own expense for vaginal laser therapy

Exclusion Criteria:

* Abnormal vaginal bleeding
* Vaginal fistula
Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma

A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent should be signed before implementing any trial-related procedures
* Male or female, 18 years old ≤ age ≤ 75 years old
* Histopathologically or cytologically diagnosed as locally advanced intrahepatic cholangiocarcinoma
* No previous systemic treatment, More than 6 months after the end of postoperative adjuvant therapy was allowed
* Expected survival time \> 3 months
* At least ≥ 1 measurable lesions per RECIST 1.1
* ECOG PS scores 0-2
* Sufficient organ and bone marrow function
* Urine or serum pregnancy test is negative

Exclusion Criteria:

* Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ)
* Ampullary tumor
* Received treatment from other clinical trials within 4 weeks before the first dose
* Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
* Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction
* Uncontrollable pleural effusion, pericardial effusion or ascites
* Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment
* Allergic reactions to the drugs used in this study
* HIV antibody positive, active hepatitis B or C (HBV, HCV)
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* other conditions that the investigator deems inappropriate for enrollment.
Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease

This study consists of four parts, Parts A, B, C, and D.

* Part A is a single dose pharmacokinetic (PK) study in pediatric participants with Sickle Cell Disease ages 6 to 17 years.
* Part B is a multiple dose, safety, exploratory, efficacy, and PK study in adolescent participants with Sickle Cell Disease ages 12 to 17 years.
* Part C is a multiple dose, safety, tolerability, and PK study, which includes the assessment of hematological effects and the effect on TCD flow velocity of voxelotor in pediatric participants with Sickle Cell Disease ages 4 to 17 years.
* Part D is a multiple dose, safety, tolerability, and PK study, which examines the hematological effects of voxelotor in pediatric participants with Sickle Cell Disease ages 6 months to \< 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants with homozygous hemoglobin SS (HbSS) or hemoglobin S beta0 thalassemia (HbS β0thal)
* Age:

  * Part A - 6 to 17 years of age
  * Part B - 12 to 17 years of age
  * Part C - 4 to 17 years of age
  * Part D - 6 months to \<4 years of age
* Hydroxyurea (HU) therapy:

  * Parts A, B, and C: A participant taking hydroxyurea (HU) may be enrolled if the dose has been stable for at least 3 months with no anticipated need for dose adjustment during the study and no sign of hematological toxicity.
  * Part D: A participant taking HU may be enrolled if the dose has been stable for at least 1 month. Titration to the maximum tolerated dose (MTD) is allowed during the study.
* Hemoglobin (HB):

  * Part A - No restriction
  * Parts B, C, \& D - Hb ≤ 10.5 g/dL
* For Part C only: Participants 12 to 17 years of age must have a TCD velocity of ≥ 140 cm/sec measured anytime during screening.

Exclusion Criteria:

* Any one of the following requiring medical attention within 14 days of signing the Informed Consent Form (ICF):

  * Vaso-occlusive crisis (VOC)
  * Acute chest syndrome (ACS)
  * Splenic sequestration crisis
  * Dactylitis
* Requires chronic transfusion therapy
* History of stroke or meeting criteria for primary stroke prophylaxis (history of two TCD measurements ≥ 200 cm/sec by non-imaging TCD or ≥185 cm/sec by TCDi).
* Transfusion within 30 days prior to signing the ICF

Exclusion Criteria for Part D Only:

* Body weight \<5 kg for 1 month prior to the screening visit and at the screening visit.
The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients

Testing the effect of providing an antidepressant and anxiety-type escitalopram for patients with glioblastoma on patient's quality of life including the effect of treatment on mood and cognition during treatment.Two subgroups will fill questionnaires :

* Questionnaire mini mental state exam (mmse) which is the maximum score of 30. A score of below 24 indicates a flaw in the level of dementia
* Questionnaire depression / mood PHQ9P(Pa t i e n t H e a l t h Qu e s t i o n n a i r e - 9)
* The M. D. Anderson Symptom Inventory (MDASI)
* Evaluation of the hospital situation awareness (clinical assessment and questionnaire)
* Cognitive assessment which will be carried out by the Department neuropsychological and include:

  * Executive function (Stroop)
  * Abstract Reasoning (similarities)
  * -Auditory and Spatial Attention (Digit span, Spatial span) visual memory and remembering Literature
  * Memory function - visual and auditory (ROCF, RAVLT)
  * Language function: Naming and verbal fluency
  * Mindstreems Neurotrax

This study is planned as prospective randomized, controlled, double-blind study.

Patients will undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age,Karnofsky score, extent of tumor resection), for two research groups:

Group number 1 will include 50 patients, who will receive Escitalopram or Placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months. . The dose study is fixed and is not aimed at symptomatic treatment of anti-depressant (such as major depression).

Eligibility Criteria:
Inclusion Criteria:\* men and women

* Aged 18-80
* who signed an informed consent form
* patients that underwent biopsy or resection of brain glioblastoma.
* KPS≥70
* Patients that are stable in terms of seizures who take only one antiepileptic drug

Exclusion Criteria:

* Patients who suffered from depression within five years,
* Patients treated with antidepressants
* Are not able to answer the questionnaires because of an inability to communicate
* Patients treated with inhibitors (MAOI) such as: nialamide , isocarboxazid , iproniazid, phenerzine, tranylcypromine
* Patients who suffer from epilepsy.
* Patients who suffer from Parkinson's
* Patients who suffer from cardiac dysfunction or heart attack recently.
* Patients with eye problems in expanding pupils - can result in the development of glaucoma and closed angle.
* Severe renal dysfunction. (creatinine clearance \<30 mL / min). , Creatinine less than 1.5 times the upper limit of normal or end-stage renal disease
* Hepatic insufficiency -bilirubin General\> 1.5 times the upper limit of normal, Hepatic Enzymes less than 2.5 times upper limit of normal
* Pregnant women
* a score of less than 24 test The mini-mental state examination (MMSE)
* allergy to any component of the drug- Talc, croscarmellose sodium, Microcrystalline Cellulose silicified, Magnesium stearate, Hypromellose, Macrogol 400, Titanium Dioxide
Evalution of Nurse's Abilities in ICU Setting

The assessment of nurses' skills is of fundamental importance in order to predict their performance, this is true in all areas of care but especially in the critical area. The aim of the single center prospective observational study is to provide the organization and specifically the nursing coordinator with an evaluation form that is as specific and complete as possible for evaluating the performance of nurses in ICU.

The nursing coordinators of 4 UOCs of intensive care for adults in the IRCCS Gemelli Polyclinic Foundation in Rome will be involved in the use of an evaluation scale for nurses. In each UOC, 10 nurses will be randomly selected for which to carry out the evaluation, subject to informed consent and compliance with the inclusion criteria in the study.

Results Certify the reliability of the Scale for evaluating the performance and attitudes of nurses working in intensive care.

It is hypothesized that an objective assessment tool of nurses' skills allows for an adequate allocation of resources not only in quantitative terms but also and above all in qualitative terms.


Eligibility Criteria:
Inclusion Criteria:

* Intensive care nurses present for at least 12 months in the relevant unit,

Exclusion Criteria:

* Newly hired or newly transferred nurses (\<12 months of presence in the relevant ICU).
A Novel Approach for Horizontal Augmentation: A Split Box

The goal of this clinical study is to investigate the effectiveness of the split-box technique in systemically healthy, non-smoking, over 18 years of age, participants with narrow crests (\<5mm bone width) and adequate bone height (\>12mm). The main questions it aims to answer are:

* The primary objective of the present study is to investigate the effectiveness of the split-box technique by evaluating the change in width and height of the alveolar bone.
* The secondary objective is to evaluate the superiority of the split-box technique and its modifications in terms of the amount of bone gain.

According to the 3D topography of the alveolar ridge of the patients before augmentation, split box or one of its modifications, reverse split box or sliding split box techniques were selected and applied. (split box was applied if the bone thickness was more than 3 mm at the top of the crest and did not increase towards the lower border at the alveolar bone, reverse split box technique was applied if the bone thickness was more than 3 mm at the top of the crest and increased towards the lower border at the alveolar bone, sliding split box was applied if the bone thickness was less than 3 mm at the top of the crest but the bone thickness increases towards the lower border at the alveolar bone.)


Eligibility Criteria:
Inclusion Criteria:

* To be older than 18 years of age
* To be systemically healthy
* To be non-smokers
* Having narrow crests (\<5 mm bone width)
* Having adequate bone height (\>12 mm)
* Having cone-beam computed tomography scans before surgery and five months after augmentation

Exclusion Criteria:

* Having bone diseases,
* A history of neck or head radiotherapy
* Receiving steroids, bisphosphonates or chemotherapeutic drugs
* Being pregnancy
* Having narrow bone thickness in the crest (\<3 mm), those in whom this thickness did not increase toward the lower border of the alveolar bone
* Patients with a history of infection or exposure after augmentation
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Primary Objective:

- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

* To assess the effect of the 2 lixisenatide regimens on:

  * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24
  * Fasting Plasma Glucose (FPG)
  * 7-point Self-Monitored Plasma Glucose (SMPG) profiles
  * Body weight
* To assess the safety and tolerability of the 2 lixisenatide regimens

The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Eligibility Criteria:
Inclusion criteria:

* Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit
* Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

Exclusion criteria:

* Screening HbA1c \< 7.0% and \> 10.0%
* Fasting plasma glucose at screening \> 250 mg/dL (\> 13.9 mmol/L)
* Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
* Participants who usually did not eat breakfast
* Type 1 diabetes mellitus
* Body Mass Index (BMI) ≤ 20 kg/m\^2 and \> 40 kg/m\^2
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
* Amylase and/or lipase \> 3 times the upper limit of the normal laboratory range ( ULN) at screening
* Alanine aminotransferase (ALT) \> 3 ULN at screening
* Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
* Any contra-indication related to metformin
* Any previous treatment with lixisenatide

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems

In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.

Comparison of the post operative pain with two rotary systems including Reciproc and One shape.

Confounding factors were neutralized and the rotary systems were compared.

Eligibility Criteria:
Inclusion Criteria:

* Systematically healthy patients
* First or second molars with irreversible pulpitis without periapical pathosis.
* Single visit endodontic treatment

Exclusion Criteria:

* Root canal retreatment
* Pregnancy
* The presence of a difficult root canal anatomy
* Internal or external resorption
* Teeth with open apices
* Any accident of complication occurred during treatment
* Presence of periapical lesion, abscess or sinus tract