cyrilzakka/clinical-trials huggingface dataset:
A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards

The study team will collect data for this study from participants who are having surgery and recovering postoperatively on 2 pre-designated hospital units. The study team will use vital signs data from a portable device that participants wear on their wrists as well as conventional vital signs data that is collected when a health care provider comes into their room and collect this information.

A substudy is also being performed with the distribution of surveys to the nursing staff on the floors who are utilizing the ViSi hemodynamic monitors within our institution.

This proposed study will provide the necessary preliminary data for a National Institutes of Health Research Grant Project (NIH R01) application that will test the utility of continuous portable hemodynamic monitoring in a large-scale randomized trial. Two separate post surgical hospital units will be randomized to utilize the Sotera ViSi monitoring system or to not utilize the Sotera ViSi monitoring system for a 4 week period of time alternating over the period of 1 year. The study team will assess the effect of unblinded continuous monitoring and the associated alerts on the cumulative duration (min/hour) of each of hypotension, tachycardia, and desaturation. The study team will assess the effect of continuous monitoring and associated alerts on the ordinal clinical intervention outcome which measures the single most extreme/elevated clinical intervention incurred by a patient for any of the 3 outcome variables of interest (hypotension, tachycardia, hypoxia) during the study period with response by staff. The study team will assess the treatment effect on myocardial injury after non-cardiac surgery (MINS) during the study period.

A substudy involving the the medical center nursing staffs' impressions of the device as well as their confidence in its utilization in keeping their assigned patient's safe will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 65 years of age
* \>/= 45 years of age with at least 1 cardiovascular risk (hypertension, diabetes)
* Requiring a general or regional anesthetic as part of their surgical procedure.
* Requiring (or anticipated to require) at least a 48 hour hospital stay after surgery.
* All subjects aged 18 and older who are patients receiving ViSi monitoring on the 2 nursing units involved.

Exclusion Criteria:

* \< 48 hour hospital stay
* Receiving local anesthetic for their surgical procedure
* troponins not ordered if \<65 years of age without a single cardiovascular risk factor or \<45 years of age
Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy

Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. Thus, it is important to set up a model to predict the quality of bowel preparation individually.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-90 years old who undergoing colonoscopy

Exclusion Criteria:

* failed colonoscopy because of technical chanllenge or poor tolerance of patients
* history of colorectal surgery
* prior finding of severe colonic stricture or obstructing tumor
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction or ileum
* known or suspected bowel obstruction or perforation
* pregnancy
* unable to give informed consent
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386

The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
* Healthy volunteer must have regular bowel movements (at least once daily)

Exclusion Criteria:

* History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
* A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
* Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia

PURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation combined with hyperthermia instillation is associated with elevated prostate specific antigen (PSA). MATERIALS AND METHODS: We will treat 25 consecutive patients with bladder cancer with a 6-week course of Synergo therapy, followed by cystoscopy at 6 weeks. Blood samples for PSA determination will obtain before each synergo therapy application and at cystoscopy with each patient also serving as a control.

Evaluating changes in PSA level in patients undergoing treatment with Synergo delivered local hyperthermia combined with intravesical instillation of Mitomycin C for adjuvant treatment or pt. with recurrent tu of bladder post TURT with BCGtreatment.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent transitional cell carcinoma of urinary bladder post endoscopic resection
* PSA Prior synergo therapy application\<10
* Normal rectal examination
* Patients willing to sign informed consent according

Exclusion Criteria:

* History of prostate cancer
* Previous history of TCC stage T2 or higher
* Invasive tu of bladder
* Prior pelvic radiotherapy or systemic chemotherapy
* Active prostatitis
* Active tuberculosis
Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports

The overall goal of the Lumbar Image Reporting with Epidemiology (LIRE) is to perform a large, pragmatic, cluster randomized controlled trial to determine the effectiveness of a simple, inexpensive and easy to deploy intervention - insertion of epidemiological benchmarks into lumbar spine imaging reports - at reducing subsequent tests and treatments. The investigator's main hypothesis is that for patients referred from primary care providers, inserting epidemiological evidence in lumbar spine imaging reports will reduce subsequent diagnostic and therapeutic interventions, including cross-sectional imaging (MR/CT), opioid prescriptions, spinal injections and surgery.

The long-term public health significance is that a simple, inexpensive intervention has the potential to substantially reduce unnecessary and expensive care for back pain patients. Importantly, this approach could be applied to a wide range of other conditions and other diagnostic tests (e.g. other imaging tests, laboratory tests, genetic testing). If this study is positive, adding epidemiologic benchmarks to diagnostic test reporting could become the dominant paradigm for communicating all diagnostic information.

To test this hypothesis, the investigators propose to conduct a pragmatic cluster, randomized controlled trial, randomly assigning primary care clinics at four large health systems to receive either standard lumbar spine imaging reports or reports containing epidemiological benchmarks for common imaging findings. The investigators will use a novel stepped wedge randomization scheme that temporally randomizes sites, allowing within-site before/after comparisons in addition to between-site comparisons, while assuring that all sites will eventually receive the intervention. The primary outcome will be a metric of back-related intervention intensity. The primary analysis will occur at the clinic level and not the patient level.

This pragmatic trial will demonstrate both the feasibility of randomly assigning clinics within large health systems as well as the feasibility of passively collecting outcomes data up to two years after enrollment using the robust electronic medical records systems available at each health system.

Eligibility Criteria:
Inclusion Criteria:

* Imaging of lumbar spine requested by primary care provider

Exclusion Criteria:

* Age \< 18years
Oral Versus Vaginal Misoprostol for Induction of Labor

The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.

Induction of labor is widely carried out all over the world in cases where continuation of pregnancy is hazardous to both the mother and/or fetus. The induction in a ripe cervix is not difficult but complications are significantly increased when the cervix is unripe. The only agent approved for cervical ripening and induction of labor in patients with an unripe cervix is dinoprostone(PGE2). Misoprostol is a synthetic PGE1 analogue marketed for the prevention and treatment of gastro-duodenal ulcers. Misoprostol costs much less than dinoprostone and does not require refrigeration and has few systemic side effects.In addition, it is rapidly absorbed orally and vaginally. Although misoprostol is not registered for such use, it has been widely used for obstetric indications such as induction of abortion and of labor. Misoprostol for induction of labor in preceding literatures mainly prescribed in multiple dosing regimen. The adverse effects on uterus potentially occur owing to the frequent administration of misoprostol. The objective of this study was to compare a single dose oral misoprostol with vaginal misoprostol.

Eligibility Criteria:
Inclusion Criteria:

* A live singleton pregnancy at a gestation of \>37 weeks, with obstetric or medical indications for induction, and unfavorable cervix (the initial Bishop score of \<717), vertex presentation, reactive fetal heart rate pattern, absence of labor, and intact membranes without previous stripping. Post-term inductions were considered when gestational age was \>41 weeks.

Exclusion Criteria:

* Suspected cephalo-pelvic disproportion, estimated fetal weight of \>4000 grams, maternal age of \<18 years, parity of \>5, previous cesarean delivery or history of uterine incision, any contraindication for vaginal delivery or prostaglandins administration and suspected chorioamnionitis.
Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

This study evaluates whether a scent applied during exposure therapy and during subsequent sleep will increase the durability of treatment effects for individuals with fear of spiders, contamination, and enclosed spaces.

Newly acquired memories encoded during wakefulness are spontaneously re-activated during sleep, resulting in synaptic potentiation and strengthening of the re-activated traces. Targeted memory reactivation (TMR) typically involves a period of initial learning in the presence of an olfactory or auditory contextual cue, coupled with later presentation of the cue during sleep to ostensibly facilitate memory reactivation and consolidation. Numerous studies have found evidence of improved task performance subsequent to cue-induced neuronal replay, however application of TMR to treatment of naturally acquired, clinically significant fear has been limited.

The present study will will provide a rigorous test of TMR's efficacy as an augmentative strategy for exposure therapy. It is hypothesized that participants who sleep in the presence of the same odor that they are exposed to during exposure therapy will exhibit reduced fear at follow up, relative to participants who sleep in the presence of a different odor, or a non-odorous control.

Eligibility Criteria:
Inclusion Criteria:

* Marked anxiety in at least one fear domain (spiders, contamination, or enclosed spaces), as determined by the presence of both:

  1. self-reported peak anxiety of at least 50 on a 100 point scale in response to two behavioral approach tasks
  2. self-report measures meeting the following cutoffs for the target fear:
* Fear of Spiders Questionnaire ≥ 50
* Obsessive-Compulsive Inventory-Revised (Washing Subscale) ≥ 4
* Claustrophobia Screener ≥ 2

Exclusion Criteria:

* Diagnosed sleep disorder
* Current sleep medication usage
* Inability to differentiate two different odors from an indoor scent diffuser
* Current psychotherapy for fear of spiders, snakes, enclosed spaces, or contamination
* Current use of air fresheners, scented candles, or other items with odors related to those used in the study
A Study of Vitamin D in Subjects With Alopecia Areata

The objective of this study is to assess the parathyroid-vitamin D-calcium axis in subjects with alopecia areata. The hypothesis behind this study is that hypovitaminosis D might contribute to the pathogenesis of alopecia areata.

Alopecia Areata (AA) is a T-Cell mediated, non-scarring, polygenic, autoimmune disease of the hair follicle. It has been reported to be associated with other autoimmune diseases, especially autoimmune thyroid disease and vitiligo. It is more common in females. Recently, vitamin D deficiency has been claimed to contribute to the pathogenesis of multiple autoimmune disease. There is a strong inverse correlation between the level of 25-hydroxyvitamin D levels and the autoimmune disease in adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are at least 18 years old
* Subjects with newly diagnosed with alopecia areata

Exclusion Criteria:

* Subjects who take supplemental Vitamin D, by itself or as a part of a multivitamin
The Effects of Horse-back Riding on Core Muscles in Adolescents

The aim of the study is to examine the effects of riding on the core muscles, balance and muscle strength of the extremities in healthy adolescents.

Core strength, core endurance, balance, upper extremity and lower extremity strength assessments were performed on the study group before and after the riding training.

Twenty participants, aged between 10-19 years, research (n=10) and control (n=10) groups, were included in the study. The study group (n=10) received riding training for eight weeks. The study group was evaluated twice before and after riding.The control group only participated in the assessments at the start of the study. Demographic information of all volunteer participants were recorded.

Core strength was evaluated with a stabilizer pressure biofeedback device, and core endurance was evaluated with isometric endurance tests. Balance was evaluated with Star Excursion Balance Test, upper extremity strength was evaluated with hand dynamometer and lower extremity strength was evaluated with back-leg dynamometer.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 10-19 years
* No previous horse-back riding experience
* Individuals with no health problems

Exclusion Criteria

* Any history of surgery intervention
* Individuals who do not regularly participate in horse-back riding
Gonadotropin Type in Ovarian Stimulation

A key challenge facing reproductive biologists is the integration of the knowledge about oocyte-secreted factors into coherent physiological mechanisms of how oocytes govern folliculogenesis, cumulus cell function, and oocyte and embryo development. Although key oocyte-secreted factors have been identified, understanding their modes of action is complicated by multiple interactions between maternal and oocyte signaling molecules, as well as the constantly changing state of physical interactions between the oocyte and its companion somatic cells during folliculogenesis. Thus, the investigators study aimed to determine if there is any relationship between different gonadotropin preparations and oocyte-secreted factor secretion, the endocrine pattern in follicular fluid, and the apoptotic rate in cumulus cells during controlled ovarian stimulation.

The follicular environment is primarily influenced by the type of gonadotropin the follicle is exposed to during the follicular phase. The role of gonadotropins has been especially important in improving the efficiency of in vitro fertilization. Several studies comparing the use of human menopausal gonadotropin (hMG) with recombinant follicle-stimulating hormone (rFSH) have found significant differences in the endocrinological profile and the follicular dynamics. These differences have been related to the human chorionic gonadotropin (hCG)-driven luteinizing hormone (LH) activity added to hMG. Moreover, differences in the proportion of acid residues in FSH molecules should be considered.

On the other hand, the main physiological regulatory hormones of follicular survival are the gonadotropins. Suppression of serum gonadotropins leads to massive apoptosis of granulosa cells in developing follicles resulting in atresia; whereas, gonadotropin treatment of early antral and pre-ovulatory follicles prevents this unplanned apoptosis. However, studies using cultured rat granulosa cells have shown that treatments with FSH or LH/hCG are ineffective in preventing spontaneous apoptosis, suggesting neighboring theca cells and local factors produced in the ovary are important for regulation of follicle growth and atresia.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* regular menstrual cycles
* no hereditary or chromosomal diseases normal karyotype negative for sexually transmitted diseases
* at least seven antral follicles per ovary

Exclusion Criteria:

* PCO
Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping

Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome.

Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG.

The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.


Eligibility Criteria:
Inclusion Criteria:

Group 21

* Brugada Type 1 syndrome
* Age : 50-60 years old
* Asymptomatic
* Signed informed consent

Group2

* Brugada Type 1 syndrome
* Age \>18 years old
* Implantable defibrillator
* Having received at least 1 appropriate shock or a sudden sudden death
* Signed informed consent

Groups 1 and 2

Exclusion Criteria:

* Brugada Type 2 or 3 syndrome
* Contraindication to electrophysiological exploration
RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will be comparative efficacy measured as the change from baseline in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
* Fecal elastase \<100 mcg/g stool
* Good disease control with porcine PERT prior to enrollment
* Good nutritional status

Exclusion Criteria:

* History or diagnosis of fibrosing colonopathy
* Distal intestinal obstruction syndrome in 6 months prior to screening
* Receiving enteral tube feedings
* Chronic diarrheal illness unrelated to pancreatic insufficiency
* Liver abnormalities, or liver or lung transplant, or significant bowel resection
* Forced expiratory volume in 1 second (FEV1) \<30%
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.

The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a 1-week follow-up Period. Subjects eligible for the study will be randomized to receive either NYX-783 (4-weeks) or placebo (4 or 8-weeks).

Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of PTSD \[Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)\] with the primary traumatic event occurring ≥12 months prior to screening.
* PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
* CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

Exclusion Criteria:

* Complex PTSD.
* Trauma focused psychotherapies.
* Primary traumatic event occurred prior to 2001.
* Primary traumatic event was followed by further major traumatic life episodes.
* Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
* Current use of medications with primarily central nervous system activities
* Other clinically significant medical histories that may interfere with completing the study.
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

Primary Objective: To determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of Lymphoseek and Indocyanine Green.

Secondary Objective: (1) To determine the overall detection rate of sentinel lymph nodes with concurrent use of Lymphoseek and Indocyanine Green (2) To determine location and number of Lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (SPECT/CT imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) To determine the concordance of Lymphoseek-positive sentinel lymph nodes with intraoperatively detected Indocyanine Green-positive sentinel lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

* The patient has histological diagnosis of cancer of the endometrium of any histology or grade.
* The patient should have received no prior treatment for her endometrial cancer.
* The patient has clinically uterine confined disease.
* The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care.
* The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2.
* If age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
* The patient has provided written informed consent.
* The patient is at least 18 years of age at the time of consent

Exclusion Criteria:

* The patient has clinical or radiological evidence of metastatic disease.
* The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix.
* The patient has participated in another investigational drug study within 30 days of scheduled surgery.
* The patient has an iodine allergy.
* The patient is pregnant or lactating.