cyrilzakka/clinical-trials huggingface dataset:
A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants

This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has been specially prepared to contain radiolabeled carbon \[¹⁴C\]. \[¹⁴C\] is a naturally occurring radioactive form of the element carbon. This study will help determine how the drug appears in the blood, urine, and stool after it is administered by mouth to healthy people. Information about any side effects that may occur will also be collected. This study will last about 10 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²), inclusive

Exclusion Criteria:

* Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product
* Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy
* Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
* Have participated in a \[¹⁴C\] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous \[¹⁴C\]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe: less than 5000 millirem (mrem)/year whole body annual exposure
Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Women's Views

This is a prospective, single-institution observational study to be conducted at 4 clinics within the Southern California Permanente Medical Group. Pregnant women who present for prenatal genetic counseling at the designated clinics and who meet study eligibility criteria will be offered the option of the verifi® prenatal test by a trained, licensed and certified genetic counselor (GC) . Women who elect the verifi® prenatal test will have a blood sample drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited clinical laboratory (Redwood City, CA). Results will be reported to the ordering health care provider by the laboratory within 8-10 business days and will be shared with the subject by their provider. Subject care and decision-making following NIPT result will be clinically managed by the provider with his/her subject and is not dictated by the study protocol. All eligible women who provide informed consent, whether they elect or decline NIPT will be asked to complete a short questionnaire on their views of prenatal testing. The uptake of invasive prenatal procedures (CVS and/or amniocentesis) by the total prospective cohort will be collected through review of electronic medical records (EMR). A historical cohort with matched demographic and pre-test indications to the prospective cohort will be identified from the EMR for comparison in the primary analysis.


Eligibility Criteria:
Inclusion Criteria

* Age 18 years or older at enrollment
* Clinically confirmed singleton pregnancy
* Gestational age between 10 weeks, 0 days and 20 weeks, 0 days
* Referred for prenatal genetic counseling due to increased risk for fetal aneuploidy (advanced maternal age (AMA ≥ 35 years at delivery, high-risk prenatal screen result, abnormal fetal ultrasound finding consistent with fetal aneuploidy, and/or history of prior affected pregnancy for fetal aneuploidy)
* Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and infant hospital discharge exam)
* Able to provide consent for participation using language-appropriate forms

Exclusion Criteria

* Invasive prenatal procedure (amniocentesis or CVS) already performed
* History of demised or vanished co-twin (spontaneous or following in vitro fertilization)
Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Neostigmine

Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio threshold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.

Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by an anticholinesterase agent (neostigmine). Neostigmine will be injected once four muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with the clinical practice worldwide admitted.

Two questions have to be investigated. First, is this dose of neostigmine sufficient to allow a complete recovery of tetanus stimulations ? Second, due to the pharmacological properties of neostigmine, does a recurarisation phenomenon occur following repeated tetanus stimulations ? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.


Eligibility Criteria:
Inclusion Criteria:

* ASA clinical status 1 to 3 informed consent obtained before anesthesia induction

Exclusion Criteria:

* ASA clinical status 4 emergency surgery scheduled surgery in prone position hepatic or renal disease BMI higher than 35 allergy to rocuronium or neostigmine
Digital Interventions to Treat Hazardous Drinking

There has been a significant increase in the prevalence of stress- and alcohol- related disorders during the COVID-19 pandemic. This project aims to conduct a feasibility study to evaluate the preliminary efficacy of a digital intervention designed to reduce stress and alcohol use. Additionally, this study will examine the impact of stress, including COVID-19 related stress, on the risk of alcohol misuse and the outcomes of the intervention in risky social drinkers.

This project proposes a feasibility study to evaluate the preliminary efficacy of a digital intervention aimed at addressing stress-related drinking in risky drinkers with emotional stress. This digital intervention combines telehealth- and smartphone app- based approaches, allowing concurrent intervention and participant-initiated daily exercise in a real-life setting. This program integrates alcohol intervention with breathing-based stress reduction and focuses on developing emotion regulation skills to manage stress, craving, and alcohol misuse. After the 4-week intervention, all participants will be prospectively followed for 30 days to monitor stress, alcohol use, and other health-related behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Heavy or binge drinkers
* Either high or low COVID-19 related stress

Exclusion Criteria:

* Current or past substance use disorder other than mild alcohol, tobacco, marijuana use disorder
* Psychiatric disorders except for mood and anxiety disorders
* Any significant current medical conditions
Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty

A randomized, controlled, clinical trial on the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery

Objective to evaluate the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery

Participants: Patients undergoing elective laparoscopic colorectal surgery over 18 years old.

The research intervention was ERAS exercise

The study design was a randomized, parallel controlled trial

ERAS exercise in perioperative period as the experimental group. No ERAS exercise group was the control group.

The sample size was estimated according to the main efficacy index ( the attenuation of frailty after 7 days surgery) of this study. It was assumed that the attenuation of frailty in the ERAS exercise group was better than that of the control group. The parameters were set as test level (alpha) of 0.050 using a two-sided two-sample unequal-variance t-test, β = 0.9, according to the results of previous clinical trials and combined with literature, the population mean difference was 0.6 with standard deviations of 0.8 for the experimental group and 0.8 for the control group. the experimental group: the control group was 1:1, 39 cases in each group, considering the 20% shedding rate, 49 cases in the experimental group and 49 cases in the control group were selected.

1. The experimental group The patients take ERAS exercise from hospitalization to 30 days after operation.
2. The control group The patients do not take ERAS exercise in perioperative period.

Efficacy evaluation

1. The primary endpoint of the study was the attenuation of frailty via Frailty Phenotype (FP) between before surgery and 7days, 30 days after surgery.
2. Secondary endpoints included the 6-minute walk test (6MWT),nutritional risk screening (NRS2002), anxious and depressive states, activities of daily living (ADL),postoperative complications and mortality,short-term recovery quality,postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving elective laparoscopic colorectal surgery.
* 18≤age≤100 years old, no gender limit;
* The ASA score is between I and Ⅲ;
* Clearly understand and voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria:

* Emergency surgery;
* Those with a history of cognitive dysfunction;
* Those with a history of neuromuscular diseases,;
* American Society of Anesthesiologists class ⩾IV;
* Those with a history of spontaneous pneumothorax, coagulation dysfunction,
* Acute and systemic infectious diseases, moderate or higher fever;
* Pregnant women;
* History of drug abuse;
* Those who judged by the physician in charge to be unsuitable for ERAS-exercise;
* Other severe cardio-pulmonary diseases that would affect the 6MWD
* Those failure to obtain informed consent.
PremCry Study : Study of Ontogeny of Crying in Preterm Infants.

Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.

Very few longitudinal studies have been produced on preterm's crying. As the term approaches, the characteristics of preterm babies' crying are similar to those of term infants. But these studies date back more than 30 years and are obsolete in terms of the quality and performance of sound recording equipment and signal processing.

No study has looked at the genesis of the cry itself and the varieties of the cry of the preterm baby, depending on whether it was in a situation of hunger, pain, discomfort (bath).

This longitudinal study recordings of crying babies from 26 amenorrhea week to 33 amenorrhea week, 24 hours per week, each week until the return home. In the same time, parents will be asked to know the situation of the baby (hunger, pain, bath).

Eligibility Criteria:
Inclusion Criteria:

* Infant born between 26 and 33 amenorrhea week
* Live infant at birth
* Parent affiliated or entitled to a social security scheme
* Parent who received informed written information about the study

Exclusion Criteria:

- Intubated infant
Virtual Reality in Electrophysiology Laboratory (EP)

The purpose of this study is to evaluate the use of virtual reality (VR) technology as adjunct to routine anesthesia care for patients undergoing electrophysiology (EP) procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Patients scheduled for electrophysiology procedure with MAC.
* Subject willing to participate and able to provide informed consent.

Exclusion Criteria:

* Age \< 18 years old.
* History of motion sickness or blindness.
Electroacupuncture is Effective in Cardiac Deconditioning Induced by Head-down Bed Rest

To investigate the changes of cardiovascular function during short-term simulated weightlessness after electroacupuncture (EA) treatment．

Spaceflight is associated with cardiovascular deregulation. However, the influence of microgravity on the cardiovascular system and the underlying mechanisms and countermeasures remain largely unknown. Our previous studies have demonstrated that electroacupuncture (EA) is effective at improving orthostatic tolerance (OT). The purpose of this study was to determine if EA treatment can attenuate cardiovascular deconditioning induced by a 4-day -6° head-down bed rest (HDBR). Fourteen healthy male subjects were randomly allocated into a control group (Con, n=6, 4 days HDBR without countermeasure) and an EA treatment group (EA, n=8, 4 days HDBR with EA at Neiguan \[PC-6\] for 30 min daily for 4 consecutive days during HDBR). OT was estimated with a combination of +75°/20 min head-up tilt and lower body negative pressure test before and after HDBR. Plasma hormones and heart rate variability were assessed before and after HDBR. Cardiac systolic functions and cerebral blood flow were measured before, during, and after HDBR. The data showed that EA treatment applied daily for 30 min during a 4-day HDBR prevented OT and cardiac systolic function from decrease, prevented autonomic dysfunction (a decrease in the activity of the parasympathetic nervous system), and increased the concentrations of plasma angiotensin II (Ang II) and aldosterone (Ald). These results indicate that 30 min of daily EA treatment at PC-6 is highly effective in partially maintaining OT and cardiac systolic function. Activation of the peripheral sympathetic nervous system and increased plasma hormones is largely responsible for maintaining OT after a 4-day HDBR. Therefore, EA treatment appears to be an effective countermeasure against cardiovascular deconditioning induced by HDBR.

Eligibility Criteria:
Inclusion Criteria:

* The subjects were healthy and physically fit but were not athletes.Comprehensive physical, psychological and routine blood chemistry examinations were performed to select qualified subjects for this research.No medication, smoking, alcohol, or caffeinated drinks were allowed during the study.

Exclusion Criteria:

* skeleton-muscle diseases, visual or acoustic dysfunction, organic and functional diseases of psychiatry and neurology as well as sleep disorders
Optimizing DBS Electrode Placement and Programming

Deep brain stimulation (DBS) has become the primary surgical therapy for the treatment of motor symptoms associated with Parkinson's disease (PD), and for essential tremor (ET). Although an effective and relatively safe procedure with expanding indications, opportunities exist for the optimization of the current procedure.

The investigators therefore propose, in a group of patients undergoing DBS surgery for the treatment of PD or ET, to use a combination of high-field imaging modalities, intraoperative electrophysiology, external sensor interfaces, and computational modeling, to gather information on the utility of using these techniques to optimize DBS electrode placement and programming.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of idiopathic Parkinson's disease or essential tremor
* Ability to provide informed consent

Exclusion Criteria:

* Claustrophobia or other conditions that prevent undergoing MR imaging
* MMSE score \< 23
* Significant neurological diagnosis other than PD or ET.
* Idiopathic dystonia
The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability

An altered permeability has been proposed to play an important role in the pathogenesis of several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel disease. Nutrients derived from food are able to influence the permeability of the intestine and can therefore also affect gastrointestinal symptoms. In this study, the investigators will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot peppers and cinnamon, respectively, on gastrointestinal physiology.

Objective:

To obtain more information about the effects of capsaicin and cinnamaldehyde on the intestine, these substances will be infused directly in the duodenum. Hereafter, the permeability of the intestine, gallbladder motility and the effects on satiety will be assessed.

Hypothesis:

Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin from enterochromaffin cells as determined by the multi sugar permeability test


Eligibility Criteria:
Inclusion Criteria:

1. Based on medical history and previous examination, no gastrointestinal complaints can be defined.
2. Age between 18 and 65 years. This study will include healthy adult subjects. Subjects over 65 years have an increased risk for comorbidities, therefore, subjects over 65 years will not be included. Furthermore, age has an influence on the homeostasis of the intestinal mucosa \[21\], which can potentially influence outcome parameters of the study.
3. BMI between 20 and 30 kg/m2

Exclusion Criteria:

1. History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
2. Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
3. Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
4. Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
5. Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic), pregnancy, lactation
6. Excessive alcohol consumption (\>20 alcoholic consumptions per week)
7. Smoking
8. Blood donation within 3 months before the study period
9. Self-admitted HIV-positive state
SHARE Approach Evaluation

The SHARE Approach Evaluation study was meant to evaluate the SHARE Approach, designed by AHRQ and updated by UCD. The SHARE Approach is a training program for clinicians on shared decision making.

This research group has been selected by the Agency for Healthcare Research and Quality (AHRQ) to evaluate its SHARE Approach Model. This model is designed to improve shared-decision making (SDM) between providers and patients, and teaches clinicians skills that are applicable to SDM in the context of preference-sensitive treatment choice and problem-solving. It remains one of the only freely available SDM toolkits that provides clinician-facing resources for comprehensive SDM training. This study will assess the effectiveness of the SHARE model training using training evaluation surveys, card survey data with providers who have received the SHARE training, and their patients, and audio recordings of clinician/patient encounters. The training and evaluations will be done at a total of 12 health care practices (10 primary care practices and 2 cardiology practices). All research data will be de-identified and kept confidential.

Eligibility Criteria:
Inclusion Criteria:

* Population to be enrolled include clinicians and any practice staff who participate in the SHARE Approach training in 12 practices to be recruited across Colorado.
* Patients will also be enrolled for the card surveys and audio recordings if they are meeting with a clinician who has taken the SHARE Approach training.
* 18 to 89 years old

Exclusion Criteria:

* Children
* Decisionally challenged
* Prisoners
Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis

Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.

Study population: Cirrhosis with portal vein thrombosis within 6 months of diagnosis of portal vein thrombus Study design - A prospective, randomized, single center open label study Block Randomization, block size - 10 Study site - Department of Hepatology, ILBS, New Delhi from The study will be conducted on the consecutive patients with liver cirrhosis with portal vein thrombosis.

Study period -1 year Monitoring and assessment

* At enrollment:

  1. Complete history and physical examination
  2. Etiology of cirrhosis
  3. Presenting symptoms
  4. Severity of ascites, Jaundice
  5. Pattern and number of prior decompensation
  6. UGIE and variceal status
  7. Complete physical evaluation
  8. Hemogram, Kidney function test, Liver function test, INR
  9. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
  10. Fibroscan-liver and spleen
  11. 2D-ECHO, ECG
  12. AFP At follow-up (1month, 3 month, 6 month, 9 month 12month)

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  1. Complete history and physical examination
  2. Pattern and number of decompensation
  3. MELD, CTP, APRI, ALBI Score
  4. Hemogram, Kidney function test, Liver function test, INR
  5. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.

Exclusion Criteria:

1. Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
2. CTP \>10
3. Hepatocellular carcinoma
4. Tumoral PVT
5. Isolated gastric varices with red colour signs
6. Peptic ulcer disease with large ulcers
7. Pregnant or breastfeeding women
8. Thrombocytopenia (platelet count \<50,000/μL)
9. Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
10. Those not giving consent for therapy