cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.

Eligible participants had a history of HE, a Conn score of 0 to 2 at enrollment, and either had successfully participated in a previous HE study with rifaximin (that is, RFHE3001 \[NCT00298038\]), or were new participants enrolled with ≥1 verifiable episode of HE (equivalent to a Conn score of ≥2) associated with cirrhosis or portal hypertension within 12 months of screening.

Successful participation in a previous rifaximin study was defined as having received ≥80% and ≤120% of the expected tablets, having been reasonably compliant with study procedures, and having not been discontinued from the previous study due to study drug-related Adverse Events. Participants who experienced HE or associated symptoms during or after the RFHE3001 study were considered eligible for entry into this open-label study if the participant and Investigator did not perceive study medication as a possible cause of the HE episode or associated symptoms. Participants who did not participate in a previous HE study with rifaximin were eligible if this open-label study was the only rifaximin HE study available at an individual site.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent Form
* In remission from past HE
* Appropriate birth control measures
* More than or equal to 18 years of age
* Must be potential for benefit from treatment
* Recent HE episodes
* Capable and willing to comply with all study procedures
* Participant has support network

Exclusion Criteria:

* Significant medical conditions or Investigator decision not to include the participant
* Allergies to the study drug or similar drugs
* Laboratory abnormalities
* Recent participation in another clinical trial
* Problems experienced in a previous HE trial
* Pregnant or at risk of pregnancy
* Recent alcohol consumption
* Active or latent bacterial or viral Infections
* Bowel issues
* Recent Active Cancer
* On a prohibited medication
The Effect of Peer Comparison Emails on Oncologists' Documentation of Cancer Stage

Documenting cancer stage is the most important determinant of treatment approach and survival for cancer patients. However, oncologists do not routinely document a patient's cancer stage in the structured field in electronic health records. This quality improvement pilot study evaluated the impact of sending an email to physicians at a cancer center of a large academic hospital with individualized data on their rates of cancer stage documentation using a structured field. The investigators assessed patient-level documentation and physician-level rates of staging documentation over 15 months including a three-month pre-period, a six-month pilot phase and a six-month follow-up period. The investigators also estimated staging documentation rates separately for each physician's new versus established patients.


Eligibility Criteria:
Inclusion Criteria:

* Attending physicians who had been at one of three sites of hospital between January - August 2018

Exclusion Criteria:

* Physicians treating cancer patients where American Joint Committee on Cancer (AJCC) staging modules were less clinically relevant
* Physicians with low clinical volume (\<5 patients over 3 months)
* Physicians without any outpatient visits
GLP_1 RA Ultrasound Study

The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index over 35
* Type 2 Diabetes
* Currently taking GLP01 RA agonist (for GLP 1 group)
* Not taking GLP-1 RA agonist (for control group)

Exclusion Criteria:

* Diagnosis of gastroparesis
* patient refusal to participate
* Previous gastric bypass or any other gastric surgery
* Currently on peritoneal dialysis
* Abdominal pathology
* Gastro-intestinal obstruction
* Pregnancy
Modified Ramped Position for Intubation of Obese Females.

The aim of this work is to investigate the feasibility of using the modified a ramped position for intubation of obese females in comparison to the traditional ramped position.

Adequate conditions for endotracheal intubation require appropriate positioning of head and neck. The sniffing position had been described as the most appropriate head position for endotracheal intubation. Sniffing position is achieved through two main components: flexion of the neck by 35° (achieved by head elevation) and extension of the head by 15° 2 to have the sternum at the same level of external auditory meatus 34. Sniffing position has the advantage of alignment of the three axes: oral, pharyngeal, and laryngeal axes for reaching the optimal laryngeal visualization.

In obese patients, it is recommended to put the patient in the ramped position (back-up position with the tragus of the ear is at the level of the suprasternal notch) in addition to the sniffing head-and-neck position. Some commercially available pillows were introduced to facilitate laryngoscopy in obese patients such as: Troop elevation pillow and Rapid airway management positioner.

In addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese females; that is impedance of laryngoscopy by large breasts. This problem commonly hinders the intubation process and might lead to serious hypoxia. Most of the positions described in literature were concerned with facilitating laryngeal visualization. No position to the best of our knowledge was applied to aid the introduction of the laryngoscope in the presence of large breasts.

The investigators hypothesized that using a special pillow to achieve a modified ramped position (by slight extension of the neck) at the beginning of the laryngoscopy would bring the breasts away from the laryngoscope. After successful introduction of the laryngoscope in the oral cavity, the head will be elevated using a head rest to achieve ordinary ramped position if laryngeal visualization was not adequate.

The aim of this work is to investigate the feasibility of using the aforementioned modified ramped position for intubation of obese females in comparison to the traditional ramped position.

Eligibility Criteria:
Inclusion Criteria:

* female patients
* obese (with body mass index above 30 kg per squared meter)
* Scheduled for surgery under general anesthesia.

Exclusion Criteria:

* Patients with scars in the face or neck.
* Edentulous patients.
* Patients with airway masses.
Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning

To assess the impact of an e-learning course in neuromuscular monitoring on the frequency of application of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia and secondarily on the incidence of residual neuromuscular blockade after anesthesia.

We will collect data prospectively from 6 Danish anaesthesia departments from the time of intervention, using data from the Anaesthesia Information Management System (AIMS). Baseline data is obtained from another study based on the same data extraction procedure (NCT02914119).


Eligibility Criteria:
Inclusion Departments We will include the 6 largest anaesthesia departments in the Zealand Region of Denmark.

Anaesthetists We will include the following anaesthesia personnel as anaesthetists: nurse anaesthetists in training, nurse anaesthetists, first year residents in anaesthesiology, residents in the last 4 years of training in anaesthesiology, and specialist consultants in anaesthesia.

Patients We will include and collect data from all patients undergoing general anaesthesia with neuromuscular blockade in each data collection period. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses with a case for every general anaesthetic received.

Exclusion criteria We will exclude personnel without clinical functions, i.e. administrative personnel.
Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock

The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.

Till date, no studies are available that have evaluated the incidence of relative adrenal insufficiency in preterm very low birth weight (VLBW) infants with shock. The focus had been on stable preterm and critically ill preterm infants. Given that steroid treatment improves blood pressure and stabilizes cardiovascular status in preterm infants with volume and pressor-resistant hypotension,it becomes essential to examine the incidence of adrenal insufficiency in this cohort (rather than a broad group of critically ill preterm infants). Moreover, there are no studies on adrenal function in Indian neonates.

The purpose of this study is to compare the levels of basal and stimulated (using low dose \[1µg/k\] ACTH) cortisol levels in preterm (28-34 weeks gestation) very low birth weight (birth weight 750 gm to 1500 gm) infants with shock in the first week of life requiring vasopressor therapy and matched (gestation, birth weight, postnatal age-matched) hemodynamically stable infants ('control group').

Eligibility Criteria:
Inclusion Criteria:

* All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following criteria would be enrolled.
* Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of \> 10 mcg/kg/min)
* Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age.

Exclusion Criteria:

* Major congenital malformations
* Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)
* Postnatal corticosteroid treatment
* Refusal to give consent
Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok

The goal of this diagnostic test is to compare the results of refraction and amblyopia risks between using 2WIN-S portable refractor and cycloplegic refraction in pre-school age.

All participants will be tested by 2WIN-S portable refractor.


Eligibility Criteria:
Inclusion Criteria:

* corrected visual acuity 0.1 logMAR (Snellen 20/25) or better
* Age 3-6 years old who studies in the kindergarten school that joins the study
* Parents sign informed consent form about allowing their child to join the study

Exclusion Criteria:

* other eye conditions causing visual and 2WIN-S portable refractor working disturbance such as media opacity, history of ocular surgery, strabismus, etc.
Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.

Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education \& increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects are ≥ 18 years of age
2. English or Spanish speaking
3. Patient scheduled for pelvic floor surgery

Exclusion Criteria:

1. Unable to speak English or Spanish
2. Using long acting opioids (e.g. MS Contin, Fentanyl patch)
3. Primary or Pain Healthcare Provider recommends against study participation (eg. If the patient has a history of opioid use disorder or other confounding problems, we will contact the Primary Care Provider or Pain Healthcare Provider for their recommendations regarding study participation)
Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer

The primary purpose of this sub study is to assess the safety, tolerability and determine recommended Phase 2 dose (RP2D) of GSK3901961 in HLA A\*02:01, HLA-A\*02:05 and/or HLA A\*02:06 positive participants with New York esophageal squamous cell carcinoma (NY ESO 1) and/or Cancer testis antigen 2 (LAGE 1a) positive previously treated metastatic Non-Small Cell Lung Cancer (NSCLC) and previously treated, advanced (metastatic or unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma SS/MRCLS.

This study is a substudy of the Master record - (209012) NCT04526509.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be \>=18 years of age and weighs ≥40 kg on the day of signing informed consent
* Participant must be positive for HLA-A\*02:01, HLA-A\*02:05, and/or HLA-A\*02:06 alleles
* Participant's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a expression by a GSK designated laboratory
* Performance status: Eastern Cooperative Oncology Group of 0-1
* Participant must have adequate organ function and blood cell counts 7 days prior to leukapheresis
* Participant must have measurable disease according to RECIST v1.1.
* Participant has advanced (metastatic or unresectable) SS or MRCLS confirmed by local histopathology with evidence of disease-specific translocation
* Participant has completed at least one standard of care (SOC) treatment including anthracycline containing regimen unless intolerant to or ineligible to receive the therapy.
* Participants who are not candidates to receive anthracycline should have received ifosfamide unless also intolerant to or ineligible to receive ifosfamide. Participants who received neoadjuvant/adjuvant anthracycline or ifosfamide based therapy and progressed will be eligible
* Participant has histologically or cytologically confirmed Stage IV NSCLC
* Participant has been previously treated with SOC for Stage IV NSCLC

Exclusion Criteria:

* Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in NSCLC as specified in the protocol
* Any other prior malignancy that is not in complete remission
* Clinically significant systemic illness
* Prior or active demyelinating disease
* History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments
* Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1 vaccine or NY-ESO-1 targeting antibody
* Prior gene therapy using an integrating vector
* Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant
* Washout periods for prior radiotherapy and systemic chemotherapy must be followed
* Major surgery within 4 weeks prior to lymphodepletion
* Pregnant or breastfeeding females
The Effects of Newcomball Training on Physical Fitness and Mood State of Middle Age Women in Israel

Habitual physical activity was found to be positively related to better health and well-being. One of the most popular physical activity forms is ball games. In Israel, there is a growing popularity in a new ball game - Newcomball - which is being played by many middle age, non-athlete, women. However, so far, no study had evaluated the contribution of the game to improvement in the participants' physical fitness. The aim of this study, therefore, is to evaluate the effects of six month two weekly Newcomball training sessions to the physical fitness of middle age women.

Physical fitness will be evaluated by six different physical tests: 1. agility T test, 2. "shuttle run" test for aerobic capacity, 3. vertical jump, 4. power ball throw, 5. "sit and reach" flexibility test , 6. 20 m all-out run speed test.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults women

Exclusion Criteria:

non healthy, using drugs, competitive athletes women-
Examining the Impact of Family Connectors

The purpose of this study is to understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults.

The study objectives are to examine the association between involvement in Family Connectors, a manualized peer-to-peer support and education program for family members of adolescents or young adults with symptoms of first episode psychosis, and feelings of empowerment, self-efficacy and social support.

Eligibility Criteria:
Inclusion Criteria:

* English speaking, due to the study materials not being validated in other languages.
* 18 years of age or older,
* Family member of adolescents/young adults with first episode psychosis who participated in OnTrackNY.

Exclusion Criteria:

* Does not provide informed consent.
Long-Term Outcomes of LSG in Pediatric Patients

This project aims to assess the short- and long-term safety and efficacy of bariatric surgery in children and adolescents compared to adults.

Obesity affects children and adults across all age groups. More than 30% of children and adolescents in the United States are currently overweight or obese, whereas the prevalence of obesity is as high as 21.4% in young children.This increase in prevalence is associated with significant short- and long-term health implications and necessitates effective interventions that induce significant weight loss and ameliorate associated conditions.

The results of weight loss surgery in children and adolescents are still scarce, despite recent studies suggesting favorable short- and intermediate-term outcomes that are comparable to those in adults. Although evidence continues to emerge, this solution is still denied to young children.

Bariatric surgery has proven safety and efficacy in inducing significant weight loss and co-morbidity resolution in children and adolescents. However, long-term evidence in this age group is yet to be reported. This project aims to study long-term weight loss, cardiovascular risk factors, growth and morbidity in severely obese children and adolescents (aged 5-21 years) who undergo laparoscopic sleeve gastrectomy (LSG).

This study aims to narrow the current evidence gap by studying the long-term effects of bariatric surgery in children and adolescents with severe obesity.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 5 to 21 years
* BMI higher than the 140% of the 95th percentile for age and gender
* failure to lose satisfactory weight during a period of at least 6 months
* Supportive psychological evaluation
* Presence of a dedicated caretaker from the patient's family
* Motivation, realistic expectations
* Informed consent or assent with concomitant parental consent for patients aged \< 17 years
* Absence of medical and surgical contraindications

Exclusion Criteria:

* Cardiac failure
* Respiratory failure
* Immune deficiency
* GI disease
* Age greater than 21 years
* Inability to sign informed consent / assent
3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)

The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS).

This is an open-label, non-randomized, non-comparative expanded access study. Up to 25 patients with clinically proven paraneoplastic or primary autoimmune LEMS per EMG and positive voltage-gated calcium channel antibody serology, OR patients with clinically proven CMS per electromyogram (EMG), biopsy or genetic testing who meet the selection criteria outlined in sections 3.1 and 3.2 will be enrolled in this study. Subjects will receive 3,4-diaminopyridine (3,4-DAP) starting with a low dose and titrating up per efficacy and patient tolerance to a maximum daily dose of 100mg . Treatment will continue until the subject experiences a treatment-limiting toxicity, voluntarily withdraws consent, transfers to another site, dies, becomes lost to follow-up, is no longer receiving clinical benefit from 3,4-DAP (in the opinion of the subject and/or the investigator), or the Jacobus Pharmaceuticals or the FDA discontinues the study.

Eligibility Criteria:
Inclusion Criteria:

* LEMS diagnosis OR Pre or Post Synaptic CMS diagnosis
* 18 years or older
* Females must have negative pregnancy test and be willing to practice an effective form of birth control
* No prolonged QT syndrome as indicated by baseline EKG

Exclusion Criteria:

* Known sensitivity to 3,4-DIAMINOPYRIDINE
* History of seizures and/or severe asthma
Acute Management of Humeral Shaft Fractures: Sling vs. Splint

When people break their arm and arrive at Oregon Health and Science University's Emergency Department (OHSU ED), they are treated with a short-term means of immobilizing their broken arm. The two most common ways of stabilizing the broken parts of the arm are 1) with a plaster-based coaptation splint, or 2) with a soft cloth sling and swathe. These hold the arm steady until the patient can schedule an appointment with the OHSU Orthopaedic Trauma clinic where they will receive definitive evaluation and stabilization/fixation. In much of the orthopaedic literature coaptation splints are the default immobilization method. The investigators hypothesize however, that sling and swathe immobilization may be equally effective for short term stabilization, while being faster to apply, and more comfortable for the patient. This randomized, unblinded prospective study will follow the satisfaction, quality of life and limited functional outcomes of all enrolled participants during the first week following their injury.


Eligibility Criteria:
Inclusion Criteria:

* age 18-80
* acute midshaft humeral fracture within 48 hours

Exclusion Criteria:

* ED presentation more than 48 hours after injury
* Head injury
* Open fracture
* Pathological fracture
* Known pregnancy
* Inmate or prisoner
* Non-English speaking
* Sexual Assault (SA) victim
* Patient and Legally Authorized Representative unable to provide consent