cyrilzakka/clinical-trials huggingface dataset:
Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.

Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.

Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.

Eligibility Criteria:
Inclusion Criteria:

* Between 20aged and 45aged in healthy males
* Over 55kg and BMI: 18.5\~25 kg/m2
* Agreement with written informed consent

Exclusion Criteria:

* Subject with symptoms of acute disease at the time of screening
* Clinically significant cardiovascular system, pulmonary system, renal system, endocrine system, blood system, gastrointestinal system, nervous system, mental disease or malignant tumor
* Subject with known for gastrointestinal disease or surgical history which affect on absorption of drug
* An impossible one who participates in clinical trial by result of screening tests
* Inadequate result of laboratory test AST/ALT \> 1.5 x UNL Total bilirubin \> 1.5 X UNL
* Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
* Subject with known for hypersensitivity reaction to imatinib analog
* Subject with known for history which drug abuse or show positive for it in screening tests
* Previously participate in other trial within 60 days
* Previously make whole blood donation within 60 days or component blood donation within 30 days
* Previously have blood transfusion within 30 days
* Not able to taking the institutional standard meal
* Subject who have had abnormal eating which affect on the ADME of drug
* Not able to taking the grapefruit-containing foods
* Taking ETC(ethical the counter)medicine including oriental medicine within 14 days or taking OTC(over the counter)medicine or vitamin preparations within 7 days
* Continued to be taking caffein(caffein\>5cup/day), drinking (alcohol\>30g/day) and severe heavy smoker(cigarette\>1/2pack/day)
* An impossible one who participates in clinical trial by investigator's decision including for reason laboratory test result
Ketamine as an Adjunctive Therapy for Major Depression

Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

Pragmatic, randomised, controlled, parallel-group, pilot trial. Trial participants will be patients admitted to St Patrick's University Hospital for treatment of a depressive episode. The investigators aim to recruit up to 20 participants who will be eligible for this study and randomly allocate 10 patients to each group. The participants will undergo usual inpatient care as prescribed by their treating team for the index acute depressive episode. Both participants and assessors will be blind to treatment allocation. Consented participants will be randomly allocated in a 1:1 ratio to a four week course of either once-weekly ketamine or midazolam infusions. Block randomisation will be independently performed. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions. Blood samples will be taken at four time-points in the first infusion session and before the final infusion for neuroplasticity biomarker studies. Both groups will continue treatment as usual. Participates will also be followed up over a three month period.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Hamilton Rating Scale for Depression-24 item version (HRSD-24) score of ≥21
* Voluntary admission for treatment of an acute depressive episode
* Meet Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)

Exclusion Criteria:

* Current involuntary admission
* Medical condition rendering unfit for ketamine/midazolam
* Active suicidal intention
* Dementia
* History of Axis 1 diagnosis other than major depression
* Electroconvulsive Therapy (ECT) administered within the last two months
* Alcohol/substance dependence in previous six-months
* Pregnancy or inability to confirm use of adequate contraception during the trial
* Breastfeeding women
Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation

Objective: To evaluate the diagnostic concordance between multislice computed tomography (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of patients after cochlear implantation.

Study Design: Prospective, randomized, single-center, interventional, pilot study on the diagnostic performance of a medical device.

Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan after cochlear implant surgery.

Interventions: Nine patients were implanted with electrode arrays from three different manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed, and 2 experienced radiologists blinded to the imaging modality evaluated the randomized images, twice.


Eligibility Criteria:
Inclusion Criteria:

* CI surgery for severe to profound bilateral deafness
* affiliated with the French health insurance

Exclusion Criteria:

* pregnancy
* Patients weighing more than 160 kg
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of \> 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients.

This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned
* Obese - defined as a Body Mass Index (BMI) ≥ 35 kg/m2 as calculated in the Epic computer record

Exclusion Criteria:

* Known true tape allergy
* Sensitivity to silver
* History of intolerance to Negative Pressure Wound Therapy
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
* Subjects who are at least 18 years of age
* Subjects whose anatomy can accommodate the Relay device
* Subjects who consent to participate
* Subjects who agree to comply with follow-up schedule

Exclusion Criteria:

* Subjects with non-aneurysm lesions
* Subjects with less than 1 year life expectancy
* Subjects who are pregnant
* Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.)
* Subjects participating in another investigational study
Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer

The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Metastatic disease
* Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
* At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
* Completed at least one cycle of the treatment
* Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
* Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
* Progression was documented,
* Preferentially radiologically by tumor growth or new lesions, or by
* Clear symptomatic deterioration supported by at least two of the following clinical criteria: ≥ 10% worsening in KPS or ≥ 1 worsening in ECOG; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression.
* KPS \>/= 70
* Adequate bone marrow function
* Adequate hepatic function
* Adequate renal function

Exclusion Criteria:

* CNS metastatic disease
* Bulky disease (any single mass \>10 cm).

  -\>Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.
* Prior external beam irradiation to a field that includes more than 30% of the red bone marrow.
* Patients with clinically significant severe cardiorespiratory disease.

Please consult with the clinical trial site for the full detailed list of specific inclusion/exclusion criteria.
Persistent COVID-19 Symptoms in Minia

Objective This study aims to identify the nature and prevalence of persistent symptoms in patients discharged from Minya University hospitals in Egypt after recovery from COVID-19, the severity of these symptoms, and the possible risk factors associated with them.

This is a cross-sectional observational retrospective study. The study population included patients, both hospitalized and non-hospitalized, who were diagnosed with COVID-19. Demographic information, symptom severity, present comorbidities, and persistent COVID-19 symptoms were collected. SPSS software was used for the statistical analysis, and p-values less than 0.05 were considered significant.

Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria Patients were included in this study if they tested positive for COVID-19 at the time of their illness (positive COVID-19 polymerase chain reaction \[PCR\] test) or if laboratory, clinical, and radiological criteria suggested the infection with COVID-19, and the severity of their symptoms ranged from asymptomatic to severe. Both hospitalized and non-hospitalized patients were included.

Exclusion Criteria:

Exclusion criteria Patients excluded were frail or at the end of their life or had severe cognitive dysfunction, as well as patients \<18 years of age.

-
Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.


Eligibility Criteria:
Inclusion Criteria

* Patient between 18 and 85 years old
* Patient currently on hemodialysis or pre-dialysis and planned creation of an upper extremity AV fistula with suitable anatomy
* Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
* Life expectancy of at least 24 months

Exclusion Criteria

* Malignancy or treatment for malignancy within the previous 6 months
* Immunodeficiency including AIDS / HIV or Active autoimmune disease
* Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
* Pregnancy or breast feeding
* Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF
* Employees of the sponsor or patients who are employees or relatives of the investigator
* History of failed organ transplant on immunosuppression
ERAS Protocol in Laparoscopic Hysterectomy

ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay. This study aimed to investigate the impact of implementing ERAS protocols on healthcare costs in patients undergoing a laparoscopic hysterectomy.

ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay in various kinds of surgical procedures. This study aimed to investigate whether ERAS protocol has an impact on healthcare costs in patients undergoing a laparoscopic hysterectomy. Patients scheduled for laparoscopic hysterectomy will be allocated to one of the study groups: ERAS group patients will receive ERAS protocol during the perioperative period; Conventional care groups will undergo standard abdominal hysterectomy without the implementation of ERAS protocol. The groups will be compared with respect to the length of hospital stay, rehospitalizations, and healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled for laparoscopic hysterectomy

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) class IV
* Development of complications during surgery
* Body mass index \> 40 kg/m2
Proximal Humerus Fractures: A Retrospective Analysis

The purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of open reduction, internal fixation surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. open reduction internal fixation surgical management of a proximal humeral fracture

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age
3. Greater Tuberosity Fractures
Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population

In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures


Eligibility Criteria:
Inclusion Criteria:

* Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (\>4 uterine contractions in 20 minutes):

  1. Cervix \> 2 cm in dilation or 80% effaced
  2. Positive fetal fibronectin (if performed).
  3. Demonstrated cervical change between two exams within 90 minutes.

Exclusion Criteria:

* Negative fetal fibronectin
* \> 5cm dilatation
* Multiple gestations
* Known fetal anomalies or chromosomal abnormalities
* Ruptured membranes
* Significant vaginal bleeding
* Suspected chorioamnionitis
* Preeclampsia or uncontrolled hypertension
* Non-reassuring fetal heart tracing
* Placenta previa and/or accreta
* Placenta abruption
* Intrauterine growth restriction
* Maternal renal disease
* Underlying maternal cardiac condition
* Symptomatic hyperthyroidism
* Significant maternal disease
* Contraindication to nifedipine or magnesium
* Cerclage presence
* Tocolytic use within the last 12 hours
* Hypotension (defined as average blood pressure of \<70/40's unresponsive to 1000 cc fluid bolus
Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens.

The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.

The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022.

Data from five visits will be collected:

* Baseline preoperative (maximum 30 days prior to surgery)- retrospective
* IOL implantation Day 0 - retrospective
* Postoperative visit at Day 1 (+/- 0 days) - retrospective
* Postoperative visit at 1 month (+/- 2 weeks) - retrospective
* Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females above 18 years of age;
* Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 2022);
* Diagnosis of cataract and/or ametropia (hyperopia, myopia);
* Subject who has signed an informed consent form.
* Patients who have participated in all visits that are subject to retrospective data collection.

Exclusion Criteria:

* Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
* Patients with the following condition(s) at the time of the baseline visit:

  * Corneal astigmatism \> 1.5 D
  * Uncontrolled diabetic retinopathy
  * Iris neovascularization
  * Congenital eye abnormality
  * Uncontrolled glaucoma
  * Pseudoexfoliation syndrome
  * Amblyopia
  * Uveitis
  * AMD (advanced AMD)
  * Retinal detachment
  * Prior ocular surgery in personal medical history
  * Previous laser treatment
  * Corneal diseases
  * Severe retinal diseases (dystrophy, degeneration)
  * High myopia
  * Inadequate visualization of the fundus on preoperative examination
  * Patients deemed by the clinical investigator because of any systemic disease
  * Pregnancy
  * Eye trauma in medical history
  * Current use of systemic steroids or topical ocular medication
* Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.)
Theater in School Sex Education - a Randomized Controlled Study

The study evaluated if interactive theater in school sex education affects student knowledge, attitudes and behavior regarding condom use. The intervention group got a play, value exercises, chlamydia games, condom school and interactive replay with professional actors and staff from a youth guidance center. The control group got standard sex education from school staff, based on the education guidelines of the Swedish National Agency for Education.

The spread of chlamydia indicates that current preventive work with condoms is insufficient. Research shows that reasons behind increased chlamydia include youths taking more sexual risks, due to altered attitudes and sexual behaviors. Since only condoms protect against both sexually transmitted infections (STIs) and unwanted pregnancy, the goal of the World Health Organization (WHO) chlamydia prevention program is to increase condom use. Research suggests that school is the most important arena for sex education, reaching all youths early in life, when many values on sex and relationships are instilled. International studies on theater in sex education indicate effects like increased knowledge on the topic, and partially changed attitudes and behaviors among youths. Furthermore, several studies show that youths feel theater is a good method for sex education and a supplement to standard education.

Eligibility Criteria:
Inclusion Criteria:

* students in eighth grade
* could read and understand Swedish

Exclusion Criteria:

* students in special education.
Individualized Treatment of Acute Achilles Tendon Rupture

To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.

The study includes two control groups of non-operative and operative treatment.


Eligibility Criteria:
Inclusion Criteria:

* Appointment in the Outpatients Department within 4 days of injury.
* Total Achilles tendon rupture.
* Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
* The patient must be expected to be able to attend rehabilitation and post-examinations.
* The patient must be able to speak and understand Danish.
* The patient must be able to give informed consent.

Exclusion Criteria:

* Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
* Previous rupture of the Achilles tendon in any of the two legs.
* Treated with Fluoroquinolones or corticosteroids within the last 6 months.
* In medical treatment of diabetes.
* Suffers from rheumatic disease.
* Other conditions prior to the injury resulting in reduced function of any of the two legs.
* Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
* Inability to lie in prone position on the operating table.
* Terminal illness or severe medical illness: ASA (American Society of Anesthesiologists) score higher than or equal to 3.