cyrilzakka/clinical-trials huggingface dataset:
Platelet Adhesion in the Pathobiology of Aortic Stenosis

Aortic stenosis (AS) is a serious and common condition that affects 2-3% of the population \>65 years of age in Western countries. It is also responsible for extraordinarily high healthcare expenditures, estimated to be over $6 billion annually,2 in part because the primary treatment for severe AS is aortic valve replacement (AVR) which is resource-intensive. Valve abnormalities are frequently recognized before AS becomes severe, or before there is need for guideline-directed procedural intervention, thereby providing an opportunity for pharmacologic intervention to slow disease progression. Yet, all attempts to prevent AS progression in those with degenerative non-congenital forms of disease have failed. The only non-procedural intervention that benefits patients with moderate or greater AS is the aggressive treatment of hypertension, which reduces net left ventricular (LV) afterload (valvulo-arterial impedance \[Zva\]) and can slow secondary LV remodeling. The overall goal of this proposal is to integrate advanced imaging and vascular biology to study how von Willebrand factor (VWF) and platelet adhesion promote AS progression through many parallel pathways, thereby representing a potential therapeutic target. We are hypothesizing that blood markers of abnormal VWF proteolysis and platelet-derived factors, and abnormal valve shear patterns which can be detected by advanced analysis of spectral Doppler on echocardiography are predictors for progressive AS.


Eligibility Criteria:
Inclusion Criteria For AS group

* Age \>25 years of age
* Mild or moderate calcific, non-congenital aortic stenosis by echocardiography within the prior 3 months defined as:

  * aortic valve area 1.0 cm2 - 1.9 cm2 and either
  * peak velocity of \>2.5 m/s and \<4.0 m/s with normal or mildly reduced stroke volume index (\>25 ml/m2), or
  * VTI ratio (LVOT:AoV) of \<0.5 and \>0.25 with abnormal stroke volume (\<35 ml/m2 or \>60 ml/m2).
* Age and sex-matched control subjects undergoing echocardiography with no aortic stenosis, and no more than mild severity disease of other valves.

Inclusion criteria for Control Group

Exclusion Criteria:

-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RDX5791 in Healthy Volunteers

A Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-and multiple-ascending doses of RDX5791 in healthy male and female subjects.

In the single-ascending dose (SAD), 5 separate cohorts received RDX5791 at various doses once po fasting. Each cohort of 8 subjects (6 RDX5791, 2 placebo) received a diet standardized fro Na+ content wile in the clinical pharmacology unit (CPU).

The PK data from the 50-mg dose and the safety data from the 150-mg dose of the SAD study were evaluated prior to proceeding with the multiple-ascending dose (MAD) phase. Doses of RDX5791 are 3, 10, 30, and 100 mg administered once daily po fasting. Four cohorts of 10 subjects each (8 RDX5791, 2 placebo) received a diet standardized for Na+ content while in the CPU.

Safety assessments including clinical assessment and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring were performed at regular intervals. Plasma was collected at regular intervals for PK analysis. The PD assessment included stool frequency and consistency, as well as changes in urinary Na+ excretion. All bowel movements were collected and analyzed for Na+ content outside this study protocol.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 29.9 kg/m², inclusive
* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
* Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization

Exclusion Criteria:

* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
* Any surgery on the small intestine or colon, excluding appendectomy
* Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days
* Hepatic dysfunction (\[ALT\] or \[AST\]) \>1.5 times the upper limit of normal or renal impairment
* Any evidence of or treatment of malignancy, excluding non-melanomatous malignancies of the skin
* Use of diuretic medications, medications that are known to affect stool consistency and/or GI motility
* Use of an investigational agent within 30 days prior to Day -2
* Positive virology, alcohol, or drugs of abuse test during screening
* Use of any prescription medication within 7 days before admission to the CPU
* Have had significant blood loss (\>450 mL) or have donated 1 or more units of blood or plasma within 8 weeks prior to study entry
A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes

In order to determine if speech-language therapy has positive effect, reliable measurement tools are required to document outcomes. Currently, there is very limited information concerning the measurement of changes in speech production as a result of treatment for acquired apraxia of speech and aphasia. This study will obtain information concerning the reliability of several speech production measures over time. Thirty persons with chronic aphasia and apraxia of speech will be asked to provide speech samples in response to commonly used assessment tools on three sampling occasions so that the stability of measurements may be examined.

After establishment of appropriate outcome measures, a small, pilot treatment study will be conducted with four participants. The participants will receive a new treatment for aphasia and acquired apraxia of speech and outcomes will be measured relative to speech and language production.

A single group, repeated measures design will be used to obtain repeated speech samples from 30 persons with chronic acquired apraxia of speech and aphasia. Speech samples will be elicited using commonly employed motor speech assessment protocols; an initial sample, a sample one week following the initial sample, and a sample at four weeks following the initial sample. The following measures will be obtained from the samples: percent consonants correct, percent fluent utterances, and duration of utterance. Stability of the measures will be examined.

After the preceding measures have been analyzed, a series of four, single-subject experimental designs will be conducted. Four participants with chronic aphasia and apraxia of speech will receive a new treatment for aphasia and apraxia of speech applied sequentially to two sets of experimental picture picture stimuli. Outcomes will be measured in terms of speech production (measures described above) as well as in terms of language production.

Eligibility Criteria:
Inclusion Criteria:

* Veterans or non Veterans with aphasia and apraxia of speech who reside in the Salt Lake City region (commutable),
* 12 months or more post stroke or other focal brain injury, no other neurological conditions,
* native English speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35dB at 500, 1K, 2K Hz),
* non linguistic cognition within normal limits

Exclusion Criteria:

* less than 12 months post stroke,
* insufficient hearing, insufficient non linguistic cognitive skills,
* neurological conditions other than stroke,
* more than one stroke or brain injury
* unable to attend treatment in the Salt Lake City vicinity
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies

A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center Study to Assess the Efficacy of BRCX014 Combined with Standard-Of-Care Treatment in Subjects with Glioblastoma Multiforme, Multiple Myeloma, and GI Malignancies

Several studies have shown a potential anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, and overcoming chemotherapy resistance. In phase I trials, cannabinoids have been shown to enhance the uptake of chemotherapy into malignant cells without affecting normal cells. The investigators seeks to demonstrate that the combination of chemotherapy with BRCX014 will have a greater anti-tumor and anti-proliferative activity when compared to standard of care alone.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent
2. Male and Females age 18 to 80 years old at the time of screening
3. Confirmed tissue diagnosis of Multiple myeloma, GI malignancy by a licensed pathologist
4. A performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
5. Females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device \[IUD\])
6. Male study subjects must be willing to use two approved forms of contraceptives (e.g., physical barrier-condoms, abstinence, spermicidal lube)

Exclusion Criteria:

1. Subject is pregnant or plans to become pregnant or actively lactating/nursing
2. Hypersensitivity to any ingredient in the study product
3. Initial laboratory values as determined by the principal investigator to be clinically significant
4. A substance abuse history within the last five years
5. Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
6. .Close affiliation with the investigational site (e.g., a close relative of the investigator), dependent person (employee or student of investigational site, or sponsor's staff)
7. Currently enrolled in another investigational clinical study
8. A known history of severe depression or psychiatric disorders or active suicidal ideation
9. Inability or unwillingness to cooperate with the study procedures for any reasons
Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure, will be compared. The primary outcome of the study is dysplasia-free resection margin rate, secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention time, postoperative pain, intra- and postoperative complications, the resected cone volume and users satisfaction.

Conization is the method of choice in therapy for cervical dysplasia. Beside the risk of preterm delivery, the risk of a local relapse in patients with dysplasia-affected resection margin is high.

The Goldstandard standard technique in conization for women with cervical dysplasia is the large loop excision of the transformation zone ("LLETZ"). Nevertheless other techniques such as the excision of the abnormal tissue with the so called "Fischer Cone Biopsy Excisor" could provide advantages and is yet not enough investigated. The loop excision technique uses a circular electrode, in contrast Fischer Cone Biopsy Excision is done by a triangular electrode.

It is unknown, whether the use of the circular or the triangular electrode is superior regarding the dysplasia-free resection margin rate and other outcome parameters such as the resected cone volume, postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, comparing the two electrosurgical techniques, "LLETZ-conization" and "Fischer Cone Biopsy Excision". The primary outcome of the study is the dysplasia-free resection margin rate independently proved by a pathologist, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 11 step VAS scale, time to complete hemostasis measured in seconds, duration of the intervention measured in minutes, resected cone volume, users satisfaction according to a 11 step VAS scale and intra- and postoperative complications, defined as necessity to intervene surgically up to 14 days postoperatively.

The study Population consists of women undergoing conization for histologically proven cervical dysplasia.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven cervical dysplasia
* colposcopy Prior to conization
* informed consent
* no known hematologic disorder

Exclusion Criteria:

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate
TransPERineal Fusion Biopsy Versus transrECTal

Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

Interventional, comparative, randomized, controlled study in 2 parallel groups, open-label, longitudinal, multicenter, aimed at demonstrating the non-inferiority of targeted transperineal biopsies compared to targeted transrectal biopsies in terms of diagnostic efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Patient having had a multiparametric prostatic MRI with the realization of 3 sequences (T2, diffusion, perfusion) interpreted by a local referent radiologist in prostate MRI or whose PI-RADS score is confirmed by rereading by a local referent radiologist in prostate MRI in case prostate MRI performed outside the center;
* Patient with at least one PI-RADS 4-5 lesion on MRI;
* Patient eligible for prostate, transperineal and transrectal biopsies, targeted and systematized;
* Patient with negative pre-biopsy antibacteriological urine examination ;
* Patient with prostate specific antigen (PSA) level ≤ 20 ng / mL;
* Patient capable of understanding the information related to the study, answering questionnaires in French, reading the instructions and having expressed their consent to participate in the study.

Exclusion Criteria:

* Patient who has already had a prostate biopsy;
* Patient with stage ≥ cT3a prostate cancer according to TNM classification version 8
* Patient with negative MRI or whose lesions have a PI-RADS score \<4;
* Patient with impassable rectal stenosis;
* Patient with a dermatological disease preventing perineal access;
* Patient with rectal amputation;
* Patient presenting with a urinary tract infection;
* Patient on anticoagulant treatment at an effective oral dose, not relayed;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial
Validity and Reliability of the Two-Minute Step Test in Traumatic Meniscal Tear

This study is designed to explore the validity and reliability of the two-minute step test as an assessment method for functional capacity in patients diagnosed with traumatic meniscal tear. The objective is to determine the effectiveness of this test in accurately measuring the functional abilities of individuals with traumatic meniscus tears. By focusing on patients who have been diagnosed with such injuries and employing the two-minute step test, the study aims to provide valuable insights into the suitability of this evaluation tool for assessing functional capacity in this specific patient population. The findings of this research have the potential to contribute significantly to the clinical understanding and management of traumatic meniscal tears, offering clinicians a reliable and valid method for evaluating the functional capabilities of affected individuals.

The study is planned as a cross-sectional clinical study. Fifty-five patients diagnosed with traumatic meniscal tear who apply to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital clinics will be included in the study. Patients must have a previous diagnosis of traumatic meniscal tear based on magnetic resonance imaging.

Sociodemographic data such as age, height, weight, body mass index, marital status, education level, and occupation will be recorded. The level of impairment in daily activities of patients with meniscal tear will be assessed using the Western Ontario Meniscus Evaluation Questionnaire. Pain intensity will be evaluated using the Visual Analog Scale, a linear scale of 10 cm. The Pain Catastrophizing Scale will be used to assess the patient's level of distress due to pain. The patient's confidence level in performing different activities due to pain will be evaluated using the Pain Self-Efficacy Questionnaire.

The patient's physical function will be assessed using the 2-Minute StepTest. This test, to be administered by the same evaluator, requires the patient to have rested for at least 30 minutes before starting, and there will be a minimum of 1 hour of rest between the tests conducted. Before starting the tests, the patient's blood pressure, oxygen saturation, and heart rate will be measured, and if results are outside the normal range, the test will not proceed.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 50 who have previously been diagnosed with traumatic meniscal tear through magnetic resonance imaging will be included in the study

Exclusion Criteria:

* Patients under the age of 18 and over the age of 50
* Patients with accompanying knee osteoarthritis
* Degenerative meniscal tears
* Uncontrolled hypertension
* Decompensated cardiac failure
* Presence of systemic diseases affecting lower limb functions
* Presence of degenerative diseases affecting lower limb functions
* Peripheral artery disease causing vascular claudication
* Psychiatric illness
* Neuromuscular disease
Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?

Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO\> 5%) and smokers ( SpCO\> 10%).

Currently, the use of e-cigarettes is democratizing. Unfortunately, the threshold for toxic SpCO is not defined for this patient profile.

The risk is treating in excess or worse than underestimating carbon monoxide poisoning in e-cigarette users who would be exposed to carbon monoxide exposure.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting to adult emergency department
* Age ≥ 18 years

Exclusion Criteria:

* Passive exposure to tobacco
* Mixed exposure (tobacco / e-cigarette)
* Patient having objected to the processing of his data
Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis

OBJECTIVES:

I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.

Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.

Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Mildly to moderately severe ulcerative colitis
* Patient age: 18 to 80
Evaluating the Effect of Chronic Antihypertensive Therapy on Vasopressor Dosing in Septic Shock

Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock

This will be a retrospective four-cohort study. The four cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or chronic angiotensin-converting-enzyme inhibitor (ACE-Inhibitor), 2) on chronic β-blocker, 3) on ACE-Inhibitor, and 4) on both chronic β-blocker and ACE-inhibitor

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older
* Diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin)
* Admitted to an intensive care unit (ICU) at Rush University Medical Center (RUMC)
* Time frame: 01/01/2012 to 07/1/2016

Exclusion Criteria:

* Pregnant patients
* Transfer from outside hospital on vasopressors
* Admitted in cardiopulmonary arrest
* Prior arrest within 24 hours of admission to RUMC
The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment（Retrospective Research）

The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after intravenous or inhalation anesthesia by a ambispective cohort study.

Gesell development scale contains five subscales including adaptability, fine motor, gross motor, language, and social skill evaluation. Developmental quotient (DQ) = (development age/actual age)×100. Total DQ is the average of five DQ of subscales. DQ≥86 is normal, 76≤DQ≤85 is suspicious, 55≤DQ≤75 is mild neurological damage, 40≤DQ ≤54 is moderate neurological damage, 25 B DQ B 39 is severe neurological damage, and DQ\< 25 is very severe neurological damage.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing cochlear implantation under general anesthesia
* 6 to 36-month-old child
* Normal body weight
* Children with normal structures of the inner ear and auditory nerve
* Children without contraindications to anesthesia and surgery
* Patients who have not participated in other clinical trials
* Without any acute infectious diseases or systematic diseases

Exclusion Criteria:

* The participants with a Gesell score (fine motor and gross motor) lower than 86 after preoperative evaluation.
* With other illness which could affects curative effect of recovery, such as inner ear malformations (except for large vestibular aqueduct syndrome), auditory vestibular nerve dysplasia, dysgnosia and mental disease;
* Inability to cooperate with the hearing evaluation and the language training
* Cute and chronic otitis media and mastoiditis, unhealed tympanic membrane perforation
* Abnormal structure of brain, including white matter dysplasia, Demyelinating Diseases
Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm

The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.

The details of the proposed study are as follows:

1. Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
2. Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
3. Methods:

   1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
   2. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.
   3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
   4. The polyp as well as well as the two biopsies are reviewed by a pathologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Polyps 4-9mm

Exclusion Criteria:

* Pregnant
* Inflammatory bowel disease
* Polyposis syndromes