cyrilzakka/clinical-trials huggingface dataset:
Erector Spina Plane (ESP) Block in Pediatric Patients

In this study, we aimed to evaluate the erector spina plane (ESP) block method that we used in our clinic with ultrasonography in pediatric cases between 1 month and 2 years of age who underwent laparotomy.

36 patients who will undergo laparotomy between the ages of 1 month and 2 years in ASA ( American Society of Anesthesiologists) I-II class will be included in the study. patients will be divided into 2 groups. Intraoperative erector spina plane block will be applied to the 1st group (group E) and intraoperative local anesthetic infiltration will be applied to the 2nd group (group L). Postoperative pain will be evaluated with the FLACC (face, legs, activity, crying, consolation) scale.

Eligibility Criteria:
Inclusion Criteria:

* 1 month and 2 years of age
* ASA (American Society of Anesthesiologists) I-II class
* Patients who underwent nephrectomy, pyeloplasty, adrenal tumor excision with unilateral paramedian incision

Exclusion Criteria:

* Patients who underwent laparotomy with a midline incision
* Local infection at the injection site,
* Anatomical anomalies
* Allergies to local anesthetics,
* Coagulopathy,
* Liver, kidney failure patients
Opiophobia in Postsurgical Adults With Cancer

To learn how people who underwent surgery feel about their prescribed opioid medication after they leave the hospital.

To explore the barriers and fears related to use of opioids among a population of adults who underwent surgery for cancer who were prescribed opioids for home use during the first week following hospital discharge for a surgical treatment of a malignancy.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient with cancer admitted for cancer-related surgery
2. inpatient surgical hospital stay lasting at least 23 hours
3. discharged home with a prescription for opioid analgesics
4. able to read, speak, and consent in English.

Exclusion Criteria:

1. Age less than 18 years
2. not discharged with a prescription for opioid analgesia to manage pain
3. individuals for whom there is documentation of inability to provide consent in the medical record.
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults

The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, 18 to \<60 years old
* Subjets willing to provide written informed consent and able to comply with the requirements for the study

Exclusion Criteria:

* Subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine
* Subjects with a history of Guillain-Barré syndrome
* Subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study
* Subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection
* Subjects who have had an acute febrile (at least 38.0°C) episode at some time during the 72 hours before enrollment
* Subjects who have received a vaccination within 7 days before enrollment or who are scheduled for another vaccination (excluding the study vaccine) during the study
* Immunocompromised subjects with immunodeficiency diseases or those who are receiving immunosuppressive or immunomodulatory therapy, e.g., azathioprine, cyclosporin, interferon, granulocyte-colony stimulating factor, tacrolimus, everolimus, sirolimus
* Subjects who have received high-dose corticosteroids in the 3 months before vaccination or who will be administered a cumulative dose of 700 mg of corticosteroids during the study. Inhaled, intranasal, and local application of corticosteroids is permitted, regardless of dosage, and corticosteroids such as prednisolone at a maximum dose of 15 mg/day are allowed
* Subjects who have been administered immunoglobulins or blood-derived products 3 months before enrollment or who are scheduled for the administration during the study
* Subjects who have received an influenza vaccine within 6 months of enrollment
* A female subject who is pregnant or who is breast-feeding. Subjects of childbearing potential without an appropriate contraceptive measure within 30 days before enrollment and who do not agree to use a clinically acceptable method of birth control during the study (e.g., oral contraceptives, condom, diaphragm or intrauterine device, or vasectomy of male partner)
* Subjects who have participated in any other clinical trials within 30 days of the administration of the study vaccine
* Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study
The Effect of Book Reading on Comfort, Hope, Anxiety and Vital Signs of Intensive Care Unit Patients

This study was planned to investigate the effect of reading aloud books on comfort, hope, anxiety and vital signs in patients hospitalized in intensive care unit. This study was designed as a randomized controlled clinical trial. Data will be collected by using the Descriptive Characteristics Questionnaire, General Comfort Scale, Dispositional Hope Scale, State-Trait Anxiety Inventory, and the Vital Signs Monitoring Form.

This study was planned to investigate the effect of reading aloud books on comfort, hope, anxiety and vital signs in patients hospitalized in intensive care unit. This study was designed as a randomized controlled clinical trial. Data will be collected by using the Descriptive Characteristics Questionnaire, General Comfort Scale, Dispositional Hope Scale, State-Trait Anxiety Inventory, and the Vital Signs Monitoring Form. Individuals in the intervention group will be read a storybook for 3 nights in the intensive care unit. The control group will not be subjected to any practice other than the routine practices of the clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age,
2. Stable clinical condition after intensive care unit admission,
3. Have no physical or mental impairment in answering the questions,
4. No verbal communication disability (hearing and speech),
5. No diagnosed psychiatric disorder,
6. With a Glasgow Coma Scale score of 15,
7. Not receiving sedation for at least 12 hours,
8. Will be hospitalized for at least 3 days from the time of enrollment in the study,
9. Individuals who agree to participate in the study will be included in the study.

Exclusion Criteria:

1. People with hearing or vision problems,
2. Intubated,
3. Any diagnosed neurological or psychological disorder,
4. Transferred to another unit or exitus before the specified period,
5. Individuals who do not agree to participate in the study will not be included in the study.
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis

To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis

JKB-121 is a long-acting small molecule that is efficacious as a weak antagonist at the TLR-4 receptor. It is a non-selective opioid antagonist which has been shown to prevent the lipopolysaccharide (LPS) induced inflammatory liver injury in a methionine/choline deficient diet fed rat model of nonalcoholic fatty liver disease. In vitro, JKB-121 neutralized or reduced the LPS-induced release of inflammatory cytokines, deactivated hepatic stellate cells, inhibited hepatic stellate cell proliferation, and collagen expression. Inhibition of the TLR4 signaling pathway may provide an effective therapy in the prevention of inflammatory hepatic injury and hepatic fibrosis in patients with nonalcoholic steatohepatitis. This study will evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Provision of written informed consent
3. Biopsy-proven NASH within 12 months or at screening
4. ALT \> 40 U/L for women and \> 60 U/L for men at screening and at least once in the previous 12 months.
5. HBA1C of ≤ 9.0

Exclusion Criteria:

1. Any chronic liver disease other than NASH
2. Cirrhosis, as assessed clinically or histologically
3. Presence of vascular liver disease
4. BMI ≤ 25 kg/m2
5. Excessive alcohol use (\> 20 g/day) within the past 2 years
6. AST or ALT \> 250 U/L.
7. Type 1 diabetes mellitus
8. Bariatric surgery in the past 5 years.
9. Weight gain of \> 5% in past 6 months or \> 10% change in past 12 months.
10. Contraindication to MRI
11. Inadequate venous access
12. HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C virus (HCV) RNA positive.
13. Receiving an elemental diet or parenteral nutrition
14. Chronic pancreatitis or pancreatic insufficiency
15. Any history of complications of cirrhosis
16. Concurrent conditions:

    * Inflammatory bowel disease
    * Significant cardiac disease
    * chronic infection or immune mediated disease
    * Any malignant disease
    * Prior solid organ transplant
    * Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data.
17. Concurrent medications which may treat NASH
18. HbA1C \> 9.0%
19. Pregnancy or breastfeeding.
Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer

The primary purpose of this study is to determine if we can identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells.

* This study is designed to determine the feasibility, safety amd dosing for indocyanine green and near-infrared fluorescent light in order to maximize the near infrared-guided detection of tumor-specific sentinel lymph nodes during the routine surgery for early stage lung cancer when the tumor and nearby lymph nodes are removed.
* At the time of surgery, the indocyanine dye will be injected into or around the patient's tumor. We are using a dose approximately 10,000 times lower than previously approved for injection in the blood. After a few minutes, the surgeon will remove the lymph nodes near the tumor, as is standard for lung surgery, and we will look at these lymph nodes with near-infrared fluorescence.
* The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lymph nodes most likely to contain tumor cells. If the lymph node is not found in the group of nodes usually removed, we will use the near-infrared light to look near the tumor for the sentinel lymph nodes and guide the surgeon so that the sentinel nodes can be removed and studied. The surgeon will then continue with the operation and remove the tumor. The lymph nodes are processed for special analysis tailored to finding metastasis in sentinel lymph nodes.
* Since the first question of this study is to determine the smallest dose of indocyanine green that can be used safely for near-infrared detection of the lymph nodes, not all subjects will receive the same dose. The most any person will receive is 1/3 of a teaspoon.
* A five year observation period begins following the operation during which surgeons and physicians will examine the patient and order certain studies to look for evidence of regrowth of the tumor.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or histologically documented new non-small cell carcinoma that have agreed to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as recommended by their thoracic surgeon for treatment
* Surgically resectable lung cancer
* N2 lymph nodes negative on PET scan or mediastinoscopy
* Age \> or equal to 18 years of age
* Men, women of non-child bearing age or women with a negative pregnancy test

Exclusion Criteria:

* Patient does not want to undergo subsequent surgical resection
* Medical condition such as uncontrolled infection or cardiac disease that, i the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient.
* T4 or N2 disease
* Pre-operative spirometry that suggests they cannot undergo resection of their primary tumor by segmentectomy, lobectomy, bilobectomy, or pneumonectomy
* Iodide or seafood allergy
* Pregnant or lactating women
Long-Term PF-06651600 for the Treatment of Alopecia Areata

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.

A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.


Eligibility Criteria:
Inclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study:

* Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
* De novo participants \>=12 to \<18 years of age: \>=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
* De novo participants \>=18 years of age and participants from Study B7931005 or B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study: \>=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
* No evidence of terminal scalp hair regrowth within 6 months (de novo only)
* Current episode of terminal scalp hair loss \<=10 years (de novo only)

Exclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study:

* Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
* History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
* History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
* Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Exclusion criteria for all participants:

- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose \>12 weeks prior to the screening visit
Tonus, Stiffness and Elasticity of Hand and Wrist Muscles in Smartphone Addiction

The aim of this study was to investigate the tonus, stiffness and elasticity of the hand and wrist muscles in intensive smartphone use.

Consent was obtained from the students with the 'Informed Voluntary Consent Form' and the sociodemographic data of the students were recorded on the previously prepared Descriptive Data Form. The students were asked to fill out the Smartphone Addiction Scale-Short Form. Before starting the clinical evaluation, anamnesis was taken from the students and their general health status, phone usage time (minutes) and exclusion criteria were questioned. Myotone evaluations of the tenar region, flexor carpi radialis, flexor carpi ulnaris, extensor digitorum, extensor carpi radialis and extensor carpi ulnaris muscles were performed. Then, the standard grip strength of the dominant and non-dominant side hand was evaluated with Saehan hand dynamometer and the lateral grip strength of the thumb was evaluated with Saehan pinchmeter.

Eligibility Criteria:
Inclusion Criteria:

* To study at Bandirma Onyedi Eylül University
* Students between the ages of 18-30 years, whose voluntary consent was obtained and who use smartphones

Exclusion Criteria:

* Individuals with musculoskeletal system problems such as fractures of the hand, fingers and upper extremities, rheumatoid disease with evidence of systemic, specific pathological conditions
* Individuals who have undergone any surgical operation related to hand, finger and upper extremity problems
* Individuals who have received hand, finger and upper extremity related physiotherapy and rehabilitation services in less than 6 months
* Individuals with diagnosed psychiatric illness.
Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.

This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.

Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Having end-stage renal disease (ESRD) on maintenance hemodialysis
* Aged between 18 and 70 years at enrollment
* Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
* Willing to adhere to the study protocol

Exclusion Criteria:

* Being pregnant
* Acute cytolysis in the last three months before enrollment
* Any vaccination during the month preceding enrollment
* Intolerance or allergy to any component of the vaccine
* Ongoing opportunistic infection
* Hepatitis C virus infection
* Hematological disorder
* Cancer
* Unexplained fever the week before enrollment
* Immunosuppressive or immunomodulating treatment in the last six months
* Renal transplantation or upcoming renal transplantation
* Liver disease
* Other immunocompromised condition not related to ESRD
* An expected survival of \< 6 months
The Effects of Angiotensin II Receptor Blockade on Kidney Function and Scarring After Liver Transplant

This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

This study is a double-blinded, placebo controlled trial to help determine the pathogenesis of chronic renal dysfunction in patients undergoing liver transplantation. It will examine the renal function and renal morphology in patients on calcineurin inhibitors and the effects of Cozaar (losartan) following liver transplantation. Participants will have blood, urine and iothalamate clearance test, to look at kidney function prior to transplant. At the time of transplant, kidney biopsies will be performed in the operating room under anesthesia. Participants will be in the study for one year. At three weeks following liver transplant, participants will be randomly assigned to receive either a placebo (inactive drug) or the study drug (losartan). The participant will need to continue to return to the clinic at the normal scheduled intervals. During these times blood and urine tests will be done. A kidney biopsy will be performed at the yearly exam and study pills will be stopped. The researchers will continue to follow participant's creatine measurements for the next 10 years.

Eligibility Criteria:
Participants who will be undergoing a liver transplant and are between the ages of 18 to 70 years of age.
68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients

Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the most widely studied 68Ga-PSMA-11. This pilot study was evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.

Prostate cancer (PC) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. Due to low levels of glycolysis in prostate cancer cell, the uses of 18F-FDG PET/CT to detect prostate cancer and its metastases are limited. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga-labeling have been developed. 68Ga-PSMA PET/CT has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by CT, MRI and bone scan. 68Ga-P16-093, a novel radiopharmaceutical modified based on 68Ga-PSMA-11, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was prospectively designed to evaluate the diagnostic performance of 68Ga-P16-093 compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed untreated primary prostate cancer patients;
* 68Ga-PSMA-11 and 68Ga-P16-093 PET/CT within a week;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.