cyrilzakka/clinical-trials huggingface dataset:
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)

The objective of this trial was to establish the dose-response of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch,T1) in Japanese and Caucasian participants. Part A: Japanese Participants

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex (Org 25969) has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium-induced neuromuscular blockade. The current trial P05956 was conducted in Japan and set up to establish the dose-response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Japanese participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Is of American Society of Anesthesiologists (ASA) class 1 - 3;
* Is at least 20 years but under 65 years of age;
* Japanese participants;
* Is scheduled for elective surgery in supine position and under sevoflurane anesthesia, in need of administration of neuromuscular blocking agents (NMBAs), with an anticipated duration of about 1.5-3 hours;
* Has given written informed consent.

Exclusion Criteria:

* Participants in whom a difficult intubation because of anatomical malformations was expected;
* Is known or suspected to have neuromuscular disorders impairing the effect of NMBAs and/or significant renal dysfunction (for example a creatinine level \> 1.6 mg/dl) and/or severe hepatic dysfunction.
* Is known or suspected to have a (family) history of malignant hyperthermia;
* Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
* Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
* Females who were pregnant;
* Females not using birth control or using only oral contraception as birth control continuously;
* Were breast-feeding;
* Has already participated in P05956, or in another trial with sugammadex;
* Has participated in another clinical trial within 6 months of entering into P05956
Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. Analgesic mechanisms of mindfulness will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Seeking treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by medical staff to interfere with study involvement.
Comparison of Whole Body DWI to FDG PET

This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.

PRIMARY OBJECTIVE:

I. Correlation of DWI and FDG to detect disease.

SECONDARY OBJECTIVE:

I. Inter-reader variability of DWI interpretation by region.

OUTLINE:

Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI within 60 days of receiving a non-FDG PET (either PET/CT or PET/MRI). There will be an optional PET/MRI performed within six months of the original study. Participants will be followed up through a medical records review for up to two years.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
3. Ability to understand a written informed consent document, and the willingness to sign it.
4. Diagnosis of metastatic cancer.

Exclusion Criteria:

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
2. Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel
Clinical Outcomes With Bilateral Implantation of Odyssey IOLs

This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.


Eligibility Criteria:
Inclusion Criteria:

• Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.

Exclusion Criteria:

* Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
* \< 2 weeks post YAG capsulotomy.
* Best corrected distance visual acuity worse than 20/25.
Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)

Obesity is a significant and growing problem in the US that negatively impacts health and well-being of racial and ethnic minorities, people of low socioeconomic status, and persons living in rural communities and in the South. Obesity is a major concern in Arkansas, where the obesity rate for adults is higher than the rate for other adults in the nation. However effective weight loss programs are not typically available in these communities. Research has shown that the Diabetes Prevention Program (DPP) lifestyle intervention is effective in promoting weight loss in high risk individuals through changes in diet and physical activity that significantly reduce the chances of type 2 diabetes. Effective methods are desperately needed to translate the DPP to community settings, where obesity is a compelling public health burden. A major step in translating the DPP is to examine the efficacy of health professionals and community health workers (CHWs) in delivering the program in real-world settings. This is an important issue from the perspective of how evidence-based weight loss interventions can be provided to underserved, and resource constrained communities that typically may not have access to trained professionals for program delivery. The current project is a 5 year randomized controlled trial that examines DPP delivery and weight outcomes for individuals randomly assigned to either: (1) the DPP intervention delivered by CHWs or (2) the DPP intervention delivered by health professionals or (3) the Self Help condition. The study population consists of overweight adults (body mass index (BMI) \> 25) who reside in communities with a high proportion of African Americans. Primary outcome is change in body weight at 16 months. Cost effectiveness and lifestyle behaviors are also evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Non-institutionalized men and women aged 18 and older
2. BMI \[weight (kg)/ height (m2)\] \> 25
3. Able to walk for exercise
4. Able to provide informed consent
5. Willing to accept random assignment

Exclusion Criteria:

1. Currently pregnant or nursing, or pregnant within previous 6 months
2. Recent heart attack or stroke (in past 6 months)
3. Congestive heart failure (NYHA Class 3-4)
4. History of bariatric surgery or weight loss in excess of 10% in past 6 months
5. Current use of weight loss medications
6. Another member of household enrolled in study
7. Presence of significant impairment that might interfere with participation, such as underlying disease likely to limit lifespan, infectious disease (e.g., HIV, tuberculosis), substantial cognitive impairment, renal dialysis, diagnosis of schizophrenia, psychosis or substance abuse, or other condition that might compromise participation or for which weight loss is not recommended
8. Plans to move from the area within the study period
Ultrasonographic Measurement of Internal Jugular Vein as a Predictor of Hypotension Following Spinal Anesthesia

Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.

Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65 Patients who read and accept the consent form of the study Patients undergoing elective surgery under spinal anesthesia

Exclusion Criteria:

* under 18 years old, ASA scores 3-4, presence of any significant hepatic, renal, cardiavasculary, or respiratory disease, having left ventricular ejection fraction less than 40%, and allergy to study medications.
Complement (C1q) Binding to HLA Antibodies in a Solid-phase Immunoassay and Clinical Effect on Platelet Transfusion

Background:

Platelets are blood cells that help blood clot. Some people have what is called thrombocytopenia. This means they have a low blood platelet count. They need platelet transfusions very often. Human leukocyte antigen (HLA) alloimmunization occurs for a lot of these people. They become refractory. This means their platelet levels no longer increase after transfusions. Researchers want to study a procedure that detects HLA antibodies. They want to test how well it predicts how a person will respond to a transfusion. They want to see if it does this better than the procedure that is usually used.

Objective:

To study the effect of C1q-binding of Class I HLA antibodies on platelet refractoriness in people who get platelet transfusions. To test if this method better predicts response to platelet transfusion than the IgG solid phase immunoassay method.

Eligibility:

People enrolled on protocols 11-C-0136, 08-H-0156, 03-C-0277, 01-C-0157, or 01-C-0129 who:

Agreed to have their specimens and data used for future research

Had Class I HLA antibodies detected by the IgG method

Had one or more platelet transfusions at NIH after the first positive HLA IgG antibody result

Design:

For each participant, researchers will look at a small portion of their archived plasma sample. The samples were left over from prior HLA antibody tests.

Participants samples will be analyzed. They will be tested to see if C1q-binding HLA antibodies are present. This will be done by solid phase immunoassay. Results will be compared with the past results of the IgG method.

Participants data will be stored in database that s protected by password.

...

Human leukocyte antigen (HLA) alloimmunization is common in patients undergoing frequent platelet transfusion, and is the most important cause of immune platelet refractoriness. Management strategies in HLA alloimmune platelet-refractory patients include transfusion with HLA-matched or crossmatched platelets; however, in broadly-sensitized patients, or in patients with uncommon HLA types, antigen-negative or epitope compatible donors may be difficult to find.

The Luminex immunoglobulin (Ig)G single-antigen-bead (SAB) solid phase immunoassay is now commonly used to detect HLA antibodies. However, an assay that specifically detects C1qbinding to HLA antibodies has been reported to identify a clinically relevant subset of HLA antibodies in solid organ transplantation; one group has studied the utility of this assay in platelet transfusion of HLA-alloimmunized platelet refractory patients. We intend to evaluate the ability of this C1-binding immunoassay to predict response to platelet transfusion in HLA alloimmune patients.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Class I HLA antibodies detected by the IgG solid phase immunoassay method
  2. Greater than or equal to 1 episode of platelet transfusion at NIH after the first positive HLA IgG antibody result

EXCLUSION CRITERIA:

1) Hyperproliferative thrombocytopenia
Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470

A study on whether ACT-1014-6470 has an effect on how the body takes up, distributes and gets rid of omeprazole and midazolam in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
* Healthy male participant aged between 18 and 45 years (inclusive) at Screening.
* Body mass index of 18.5 to 28.0 kg/m2 (inclusive) at Screening.
* Systolic blood pressure 100-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive), measured on either arm, after 5 min in the supine position at Screening and on Day -1.

Exclusion Criteria:

* Previous exposure to ACT-1014-6470.
* Known hypersensitivity to ACT-1014-6470, omeprazole, substituted benzimidazoles, midazolam, or treatments of the same pharmacological classes, or any of their excipients.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed if performed more than 12 weeks prior to administration of \[first\] study treatment, cholecystectomy not allowed).
* Previous treatment with any prescribed medications (including vaccines \[Vaccination regimen against COVID-19 completed less than 2 weeks prior to first study treatment administration or any vaccination against COVID-19 planned before end-of-study\]) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration.
* Legal incapacity or limited legal capacity at Screening.
* Participant with rare inherited issues of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with visual impairment due to macular edema following CRVO
* Diagnosis of CRVO at maximum 6 months prior to Screening
* BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion Criteria:

* Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
* Central retinal thickness (CRT) \< 250 µm in the study eye
* Prior episode of RVO in the study eye
* Active formation of new vessels in the study eye
* Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
* IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
* Improvement of \> 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of 18 years of age or under
* Diagnosis of glaucoma
* IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria:

* Require surgery for acute angle closure
* Have had prior cyclodestructive procedures
* Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit
Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

The purpose of this study is evaluating the efficacy and safety of generics caspofungin in the treatment of the patients with neutropenic and fever.Another purpose of this study is comparing the pharmacokinetic characteristics of generics caspofungin and original medicine(Cancidas®) for providing a basis for clinical rational administration.

Caspofungin, a member of the new echinocandin class of compounds，had been proved as effective as and generally better tolerated than liposomal amphotericin B when given as empirical antifungal therapy in patients with persistent fever and neutropenia，and It was approved by FDA in 2001.The generics caspofungin of Chia Tai TianQing Pharmaceutical Group Co. , Ltd. (CTTQ) will be approved by CFDA.The purpose of this study is evaluating the efficacy and safety of this generics caspofungin in the empirical antifungal therapy in patients with persistent fever and neutropenia.

This is a prospective,multicenter,randomized,controlled,open label study,the designed cases are 60 subjects.This study is divided into two stages,one is pharmacokinetics study stage ,the purpose of this stage is comparing the blood concentration of generics caspofungin and original medicine(Cancidas®) ,24 of 60 subjects will participate in this stage,the randomization in a 1:1 ratio will be performed at each group.The other 36 subjects will participate in another stage that is a single study,all subjects will use generics caspofungin.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old
* The neutrophil counts of the patients with leukemia, lymphoma or other tumors undergoing chemotherapy or receiving hematopoietic stem cell transplantation are below 500 million/L for 96 hours at least,as well as the body temperatures are over 38.0 °C;
* It is ineffective using intravenous broad-spectrum antibacterial therapy lasting at least 96h;
* Estimated survival period \> 3 months;
* Subjects voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

* The subjects did not receive adequate antibacterial therapy;
* The subjects were received other antifungal medications within 14 days (except for fluconazole prophylaxis);
* It was confirmed or clinically diagnosed as invasive fungal infection;
* Subjects with liver dysfunction (ALT, AST exceeds the upper limit of normal value by 2 times);
* Subjects with renal insufficiency (Cr, BUN exceeds the upper limit of the normal value of 1.5 times);
* Subjects are allergic to the investigational product;
* Pregnant or lactating women;
* Simultaneous treatment with cyclosporine, tacrolimus, rifampicin, efavirenz, nevirapine, dexamethasone, phenytoin or carbamazepine;
* Other circumstances that investigators believe unsuitable for enrollment; （criteria 8 does not apply to Phase 2）
Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients

This study was aimed to evaluate whether speaking valve combined with airway pressure could predict upper airway patency non-invasively in prolonged tracheostomized patients, identify candidates who need following endoscopy examination.

Tracheotomy is an effective means of treating critically ill patients, but its postoperative management faces many challenges, especially in the assessment and monitoring of upper airway patency. Although the indwelling tracheostomy tube plays an important role in maintaining airway patency and assisting breathing, it may also cause a series of complications, including airway stenosis, granulation tissue hyperplasia, airway collapse, and laryngeal dysfunction. The patency of the upper airway after tracheotomy is directly related to the patient's spontaneous breathing ability and quality of life. Although the existing bronchoscopy provides accurate diagnostic information, its invasiveness and high cost limit its application in extensive and high-frequency monitoring. Finding a non-invasive, easy-to-operate and accurate alternative method is of great clinical significance.The speaking valve is a one-way valve placed at the end of the tracheostomy tube that directs airflow to the upper airway when the cuff is deflated. Airway pressure measurement is a simple, non-invasive method that measures the pressure inside the tracheostomy tube to infer airway patency and resistance levels. Combining the two for a systematic assessment of upper airway patency in tracheostomy patients may provide a new, efficient, non-invasive monitoring tool for the clinic. By comparing the results of speaking valve combined with airway pressure measurement with the "gold standard" bronchoscopy results, its sensitivity and accuracy in assessing upper airway patency are verified, which is expected to not only provide a non-invasive, easier-to-use bedside assessment tool, but also improve the quality of patient care and their quality of life. Our hospital's respiratory rehabilitation center has the appropriate infrastructure and professional staffing to conduct research safely and in a standardized manner.

Eligibility Criteria:
Inclusion Criteria:

* Weaned from ventilator more than 48 hours
* No any organ failure
* No sepsis
* Stable heart rate and blood pressure
* Lung infection under control
* PCO2\<60mmHg
* Patient and family sign informed consent form

Exclusion Criteria:

* Serious dysfunction of vital organs
* Unable tolerance of cuff deflated
* Laryngopharyngeal trauma
* Known severe upper airway obstruction before referrer to our department
* Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known