cyrilzakka/clinical-trials huggingface dataset:
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
* Information on data collection provided to the patient or legally authorized representative and signed informed consent.
* Aneurysm diameter ≤10mm .
* Age range of 18 - 90.

Exclusion Criteria:

* Aneurysm previously treated.
* Aneurysm AVM related or dissecting.
* Participation in a clinical investigation of other aneurysm treating or related devices.
* Any condition that would preclude the conduct of protocol follow-up.
* Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.
DNA Methylation Testing for the Screening of Uterine Cervical Lesion

In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years or older
* Signed an approved informed consents
* Feasible to be followed up
* Available residual cytology samples for methylation analysis

Exclusion Criteria:

* Without history of cervical disease, including cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
* No requirement of cervical cancer screening of cytology or high-risk human papillomavirus
Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa

A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).


Eligibility Criteria:
Inclusion Criteria:

1.Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Informed Consent Form; 4.Subjects who are confirmed with variants of RPGR ;

Exclusion Criteria:

1.Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.
Artificial Pancreas in Latin America

The purpose of this study is to use closed-loop systems with the algorithms designed by the University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).

Aims:

1. To test University of Virginia closed-loop algorithm with meal announcement for 36 hours at our facilities.
2. To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm without meal announcement to maintain glucose control for 2 periods of 12 hours

In both cases, the adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time .

Eligibility Criteria:
Inclusion Criteria:

* Patient have been diagnosed with T1DM at least two years ago and have been using an insulin pump and a CGM for at least 6 months prior to the trial first visit.
* Patient is \>18 and \<65 years.
* Patient has HbA1c \> 6.5 % and \< 10%.
* Woman in premenopausal age agrees to use contraceptive methods.
* Woman in premenopausal age has negative B-HCG in the tests performed in the trial.
* Patient is trained in carbohydrates counting.
* Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits.

Exclusion Criteria:

* Patient has been hospitalized for diabetic ketoacidosis in the last 12 months.
* Patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months.
* Patient has a history of coronary disease or cardiac failure.
* Patient with uncontrolled arterial hypertension.
* Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia.
* Patient has symptoms compatible with an active infectious disease.
* Patient has Cystic Fibrosis.
* Pregnant women, or women with the intention of getting pregnant; women breastfeeding.
* Patient has been hospitalized for psychiatric treatment in the last 6 months.
* Patient with a diagnosis of an adrenal disease.
* Patient has abnormal laboratory values for liver function: transaminase \> 2x upper limit of normal.
* Patient has abnormal laboratory values for renal function: GFR \< 60 ml/min/1.73m2
* Patient has active gastroparesis.
* Patient is under oncological treatment.
* Patient has taken acetaminophen 72 hours previous to the study.
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain

The purpose of this study is to evaluate the safety and effectiveness of immediate release tapentadol hydrochloride for the relief of moderate to severe acute non-cancer pain among Filipino patients.

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes). The study will enroll approximately 100 patients who will be taking immediate release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored at baseline (Day 1) and throughout the 28-day treatment period of tapentadol IR (Day 7, Day 14 and Day 28) for effectiveness with the help of short form Brief Pain Inventory questionnaire. Safety evaluations will include assessment of adverse events, clinical laboratory tests, and co-morbid conditions. The total study will be conducted for 3 years and the duration of treatment will be for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Filipino patients with moderate to severe non-cancer pain with an onset of 12 weeks or less from the baseline visit Patient is experiencing either an acute exacerbation of non-cancer pain or pain that has progressed to the point with the duration of at least 7 days and in the prescribing physician's judgment requires treatment with a Schedule II opioid
* Medically stable on the basis of routine physical examination, medical history, and vital signs at the time of baseline visit

Exclusion Criteria:

* Refuse to protocol-defined use of effective contraception
* Pregnant and lactating women
* Patients with severe renal and hepatic impairment, and having or suspected paralytic ileus
* Patients with conditions where drugs with mu-opioid receptor agonist activity are contraindicated
* Patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs or receiving other mu-opioid receptor agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, and sedatives
* Patients who are receiving Monoamine oxidase (MAO) inhibitors or who have taken them within the last 14 days
* Patients with documented history of increased intracranial pressure, impaired consciousness, coma and seizure
A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients

To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026 concentrations and outcome/toxicity.

All patients will receive an initial loading dose of WR 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of WR 6026 taken in a fasting state for 3 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Any medications not listed as excluded will be permitted on study.

\[ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.\]

Patients must have:

* Documented HIV infection.
* Documented PCP.
* On a room air ABG, the PO2 value greater than or equal to 70 mm Hg and the (A-a) DO2 less than 35 mm Hg.
* Signed informed consent from parent or legal guardian for those patients less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity to quinolines.
* If patient is unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study.

Concurrent Medication:

Excluded:

* Any patient unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study (e.g., TMP/SMX, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine).
* Methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites).

Patients with the following prior conditions or symptoms are excluded:

* History of G6PD deficiency, hemoglobin M abnormality, or NAD methemoglobin reductase deficiency.

Prior Medication:

Excluded:

* More than 24 hours receipt of anti-PCP treatment for the current episode of PCP. Receipt of prior PCP prophylaxis is permitted, as long as it is discontinued at study entry.
Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice

The main objective of this post-marketing observational study is to collect data from the use of general anesthesia in patients undergoing any surgery to create local recommendations. These data will be based on the evaluation of volatile induction and maintenance anesthesia (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on cardiovascular system in common clinical practice in Kazakhstan.

This post-marketing observational study will be conducted in a prospective, multi-centre format. It is a non-interventional, observational study in which Sevorane is prescribed for adult patients undergoing general surgery for induction and maintenance of anesthesia in the usual manner in accordance with the terms of the local marketing authorization. Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist. No additional procedures (other than standard of care) shall be applied to the patients. Each patient will be observed from the start of anesthesia through anesthesia end. Markers of myocardial ischemia will be detected up to the first 24 hours after anesthesia (if available). Additionally the correlation between the experience and training background of anesthesiologists and patient related outcomes of general anesthesia with Sevorane as a single anesthetic will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist
* Age greater than or equal to 18 years

Exclusion Criteria:

* Known sensitivity to sevoflurane or other anesthetic containing halogen
* Known or suspected genetic susceptibility to malignant hyperthermia
* Receiving regional anesthetic techniques
* Receiving intravenous anesthesia
* A history of unexplained moderate/severe hepatic dysfunction with jaundice, fever, and/or eosinophilia in association with halogenated anesthetics
Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.


Eligibility Criteria:
Main Inclusion Criteria:

* Healthy male volunteers
* Negative urine drug screen
* Have signed the informed consent.

Main Exclusion Criteria:

* History of serious adverse reactions or hypersensitivity to any drug.
* Use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. Permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.
Hypnotic Intake and Motor and Cognitive Performances at High Altitude

This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep, cognitive and motor performances and on acute mountain sickness symptoms at high altitude. Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms, cognitive and motor performances will be assessed to determine potential residual effects of Zolpidem within such conditions.


Eligibility Criteria:
Inclusion Criteria:

* No sojourn above 2500 m during the past 2 months
* Coffee intake \< 3 cups per day
* Non-smoker

Exclusion Criteria:

* Respiratory, cardiovascular, metabolic or neuromuscular diseases
* Psychiatric disorders
* Use of hypnotics within the past year
* Dependence syndrome (alcool, drugs, etc)
* Severe insomnia or somnolence
Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumors (Part A, B)
* Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
* Unresectable, advanced or recurrent colorectal cancer(Part D)
* Life expectancy of at least 3 months
* Patients with ECOG performance status 0 or 1

Exclusion Criteria:

* Patients with severe complication
* Patients with multiple primary cancers
Point of Care Testing for Presence of Current and or Previous T. Gondii Infection

This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant.

This is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver.

This allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.

This study will determine the feasibility of using the point of care Toxoplasma ICT IgG-IgM BK test produced by LD Bio Diagnostic to detect Toxoplasma gondii in clinical settings. The result of testing from Toxoplasma ICT IgG-IgM BK test will be compared with the standard predicate test. These results will be provided to FDA for consideration for clearance of this test.

Eligibility Criteria:
Inclusion Criteria:

* any adult who is willing to participate in the study

Exclusion Criteria:

* pregnant women who are in their 17-27 weeks of gestation.
Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it lacks objective evaluation methods.

The aim of this study is to evaluate the changes in reaction time task according to the presence or absence of reward stimulation and to assess the relation between these performances and apathy scales.

MATERIAL: 13 patients with Mild Cognitive Impairment (MCI), 15 patients with Alzheimer's disease (AD) and 91 elderly healthy subjects were enrolled. A computerized test using the experiment software E-prime® was designed to assess reaction times (in ms) in different experimental conditions after a training trial (neutral, stimulation, stress, stimulation after stress, extinction) and relation between the performances to the test and the Apathy Inventory (AI) scores (lack of initiative, lack of interest, emotional blunting) were observed.

METHOD: Using a computerized test, each patient is asked to press a button (mouse of the computer) each time the screen of the computer becomes completely white. After pressing the button, a randomized colorized geometric figure appears on the screen, and disappears automatically after a few seconds, replaced by a new white screen. Reaction time (in ms) between a white screen and a press of the button is analysed. After a training trial, reaction times are analysed in different experimental conditions: neutral - stimulation1 (patient gets points when pressing the button) - stress (alarm) - stimulation2 (patient gets points when pressing, after the stress trial) - extinction (similar to neutral condition).

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with diagnosis of Alzheimer's Disease according to DSM-IV criteria
* MMSE \>20

Exclusion Criteria:

* None
* Motor or psychiatric disorders
Extent of ILM Removal and Its Impact on Outcomes of MH Surgery

Eligible patients who were scheduled for surgery for idiopathic macular hole (MH) were equally randomized to small extent group or large extent group depending on the extent of internal limiting membrane (ILM) to be removed. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter according to the group. The primary analysis was conducted to identify the difference of functional and anatomical outcomes between the two groups. Subsequent analysis was performed to reveal the relationship between the functional and anatomical outcomes.

This randomized clinical trial was performed at a single center. Patients who were scheduled for surgery for idiopathic macular hole (MH) were enrolled. Eligible patients were equally randomized to small extent group or large extent group depending on the extent of ILM to be removed. Random numbers were generated through computerized block-randomization.

A standard 3-port pars plana vitrectomy was performed by a single surgeon using 23-gauge vitrectomy system, with a 1-step scleral tunnel incision. After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of indocyanine green dye. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter centering at the center of the MH according to the pre-assigned group. This was followed by a complete fluid-gas exchange, and all patients were encouraged to maintain a face-down position for at least 5 days postoperatively.

Postoperative measurements of BCVA and M-score were conducted at 2- and 6-month follow-up visits by independent masked observers. The first postoperative SD-OCT scanning was usually conducted at 1 to 2 weeks after operation according to the intraocular gas status. Then, OCT scans were conducted at follow-up visits 2, and 6 months postoperatively. The same experienced examiner conducted all the OCT scans on all subjects.

Comparison of anatomical closure, BCVA, M-score, Δ BCVA, and Δ M-score were primarily performed between the two groups. Then, the parameters measured from OCT scans with changes in ETDRS visual acuity and M-score were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic macular hole

Exclusion Criteria:

* macular hole associated with other causative diseases