cyrilzakka/clinical-trials huggingface dataset:
Critical Care Anxiety and Long-Term Outcomes Management

The aims of this study are to (1) test the benefits of a non-pharmacologic anxiety management approach with patients who are critically ill and/or traumatically injured during intensive care hospitalization and (2) test whether this approach reduces anxiety and improves engagement in rehabilitation therapies, shortens duration of hospitalization, and improves psychological and quality of life outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Ability to read, write, and speak English
* Alert (Best RASS ICU sedation score ≥-2)
* Current CAM-ICU test negative
* Expected ICU stay ≥48 hours
* Anxiety Visual Analog Scale (VAS-A) score ≥30
* Prescribed rehabilitation therapy at eligibility

Exclusion Criteria:

* Inability to communicate (verbally, or via hand writing/gestures)
* Greater than 90% probability of mortality in hospital
* Anticipated discharge to hospice or transition to end-of-life care
* Pre-existing cognitive impairment (e.g., dementia, pervasive developmental disorder)
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment
* Men and woman, 20 years of age and above

Exclusion Criteria:

* Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments
* Inability to swallow oral medication
* Uncontrolled or significant cardiovascular disease
* Inadequate bone marrow function
* Inadequate hepatic function
* Inadequate renal function
* Pancreatitis
Stress Reduction Training for Emotion Regulation and Well-Being

This study will examine whether stress reduction training - which a growing body of research indicates has manifold benefits for behavior regulation, emotion regulation, and other salutary outcomes of relevance to this proposal - predicts lab-based and daily life-based neural and behavioral outcomes indicative of reduced stress, including emotions, desires, and reactions to adverse events such as social conflict.

This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions, desires, and reactions to adverse events such as social conflict. The full research project will be conducted over approximately 4-6 weeks, and will consist of two data collection sessions on the Virginia Commonwealth University (VCU) campus, one before and one after a 14-day stress reduction training course conducted via mobile phone (SmartPhone). The two courses entail instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or an active coping course. Both of these courses - mindfulness training (MT) and coping training (CT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas CT emphasizes established emotion regulation techniques to reduce stress and promote well-being.

Some study details are purposely omitted at this time to preserve scientific integrity.

Eligibility Criteria:
Inclusion Criteria:

1. English speaking (will not be advertised but screened)
2. Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened)
3. Free of major, uncorrected sensory impairments and cognitive deficits
4. Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day).
5. Personal SmartPhone (Android or Apple operating systems).

Exclusion Criteria:

1. non-English speaking
2. are unwilling or unable to complete study assessments or treatments
3. present fMRI safety risks (e.g., ferromagnetic implants, body weight \> 300 lbs)
4. report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
5. report a hospitalization over the last 3 months
6. report current drug abuse (e.g., recreational drug use, smoke more than ½ pack per day, alcohol intake in excess of 2 drinks per day)
7. are prisoners or pregnant women
8. no personal SmartPhone (Android or Apple operating systems)
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)

This study evaluates the accuracy of a comprehensive venous Doppler echography including the portal vein pulsatility index (PVPI) to quantify invasively measured right-sided venous pressures. A substudy will correlate invasive and non-invasive hemodynamic measurements to ballistocardiography and seismocardiography with the Kino-cardiograph (Kino) device (HeartKinetics, Waterloo, Belgium).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 year old and able to provide informed consent;
* Consecutive patients scheduled for right heart catheterisation by a dedicated heart failure specialist at the Centre of Cardiovascular Diseases (University Hospital Brussels, Jette, Belgium).

Exclusion Criteria:

* Major anatomical variations of the portal veins (agenesis of left and right portal vein) and/or arterio-portal vein fistula;
* Patients with Child-Pugh B or C liver cirrhosis or liver transplant;
* Body Mass Index \< 20 kg/m².
Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.

This is an open-label, Phase I-II study of post injection pain and inflammation after intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive patients ( new onset Neovascular AMD with no history of intravitreal injections).

The treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with Lucentis will switch to Eylea for study purposes and vice versa.

Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed. Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenclature (SUN) working group classifications.

Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent and comply with study assessments for the full duration of the study
2. Age \>/= 65 years
3. New onset Neovascular Age-Related Macular Degeneration or (See No.4)
4. Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
5. Visual Acuity of 20/400 or better
6. No history of Post injection pain or inflammation with prior treatments -

Exclusion Criteria:

1. History of Endophthalmitis in either eye
2. Uncontrolled or symptomatic Dry Eye Syndrome
3. History of Anterior or Posterior Uveitis
4. History of Post injection pain or inflammation with prior treatments
5. Recent thromboembolic event(\<3 months)
6. Pregnancy(positive pregnancy test) or Lactation/Premenopausal women not using adequate contraception -
Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for pregnant and lactating women (PLW) or infants and young children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of LNS and MNP offered to PLW and IYC will be consumed by them.

The study will be conducted in three steps. Step 1 will be a test-feeding to compare the acceptability of each "version" of the LNS-child (LNS-child with cardamom flavor, LNS-child with no added flavor),LNS-PLW (LNS-PLW with cumin flavor, and LNS-PLW with no added flavor) and MNP to the others in terms of taste, smell and texture, as well as amount of the test-dose consumed. In Step 2, participants in the Phase 1 trial will receive a 2-week supply of one of the LNS products or MNP, which they will consume daily in their homes for 14 days under real-life conditions. In Step 3, focus group discussions will be held with participants to discuss different aspects of infant and child feeding and discuss best ways for the LNS or MNP product to be used in the context of Bangladesh.

Eligibility Criteria:
Inclusion criteria for LNS-PLW arm:

* Pregnant women in their second or third trimester (in case of third trimester pregnancy, the expected date of delivery is not within three weeks) or lactating women with a child between 3 days and 6 months of age
* At least 18 years of age
* No life-threatening pregnancy-related complications (e.g., pre-eclampsia, antepartum hemorrhage)
* Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
* Living in the study area for at least 6 months
* Planning to remain in study area for at least the following three weeks.

Exclusion criteria for LNS-PLW arm:

* Known allergy to peanuts or other food products (as reported on the screening questionnaire)

Inclusion criteria for LNS-Child and MNP-Child arm:

* Children 6-24 months of age
* Consuming solid foods for at least the past 30 days
* Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
* No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver)\[LNS-Child only\]
* Planning to remain in study area for at least the following three weeks.

Exclusion criteria for LNS-Child and MNP-Child arm:

* Severely malnourished \[mid-upper arm circumference (MUAC) \< 115 mm\]
Melatonin vs Pregabalin for Anxiolysis and Sedation

preoperative melatonin, pregabalin or both will be given to all patients preoperative

On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Sedation score (ramsay sedation score)(10) will be recorded on arrival to OR An 18-gauge cannula will be inserted in a peripheral vein and a warmed (37°C) lactated Ringer solution infusion was started. Ondansetron 4 mg will be administered intravenously as a prophylaxis against nausea and vomiting. Thereafter the patient will be supported in the sitting position. Intrathecal anaesthetic (room temperature hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 mL) will be given under complete aseptic technique . The patient was returned to the supine position for 15 min then to lateral position with operative side up.

HR and blood pressure will be measured every 2.5 minutes intraoperatively, however, the values will be recorded in the anesthesia chart only every five minutes for 2 hours then every 15 minutes for 3 hours. Durations will be calculated considering the time of spinal injection as time zero.

Hypotension (SAP\<100 mmHg or \<80% of the baseline measured before spinal anaesthesia) will be treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. If bradycardia (HR≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate HR (≥60 bpm).

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* patients undergoing hip arthroplasty
* patient consent for spinal anaesthesia
* patient alert, concious and good mental condition

Exclusion Criteria:

* Patients with any neurolgical or psychiatric history before the procedure
* Patients with a history of chronic pain
* patients with known allergy to any of this study drugs
* patients have Any contraindication to neuraxial block.
The Association of Warfarin Dosage and Plasma Enantiomer Concentration With the Gene Polymorphisms of CYP and VKOR

Oral warfarin anticogulation for the prevention and treatment of patients with venous thromboembolism is one of the most used therapies in clinical practice. Patients require different dosage to achieve the target therapeutic anticoagulation. Optimal dosage and bleeding complication are two most clinical concerns. Besides of multiple individual factors (e.g. age, dietary intake, vitamin supplement, drug compliance etc.), some genetic factors may determine the drug requirement and safety.

The cytochrome P450 CYP2C9 is a liver enzyme required for the oxidative metabolism of warfarin. The vitamin K epoxide redutase (VKOR) is a liver enzyme associated with the reuse of the oxidative hydroquinone form of vitamin K. The VKOR enzyme is the target of warfarin. Recent studies revealed both genes may determine the pharmacodynamic of warfarin anticogualation. To date, there are more than thirteen identified polymorphism at CYP2C9 gene. Majority of those variant polymorphisms may decrease the warfarin requirement. The VKOR complex subunit 1 (VKORC1) is a newly identified gene. Some polymorphisms also were reported.

As we know, the Chinese patients need a lower dosage of warfarin in comparison with the Caucasian patients. We are interested in finding the genetic causes of Taiwneses Chinese patients. In our study we will first identify the polymorphism patterns of these two genes in normal population. Then, we will try to find the association between these polymorphism and patient warfarin requirement. Our pharmacogenetics study will be valuable for prevention of bleeding complication of warfarin treatment in Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Use warfarin therapy for at least two months before study
* Stable INR value during recent three months

Exclusion Criteria:

* higher age(\>80 y/o)
* liver and renal dysfunction
* alcohol abuse
* BMI\<18kg/m2
* coadministered medicine that can affect pharmacokinetics or pharmacodynamics of warfarin
Cooling the Uterus in C-section After Dysfunctional Labor

The objective of the study is to demonstrate whether cooling the uterine smooth muscle during cesarean section (following delivery of the fetus) will promote better uterine contraction and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section for dysfunctional labor.

Two hundred patients will be drawn from all pregnant women who require a cesarean delivery for dysfunctional labor. Dysfunctional labor will be defined as cervical dilation of 3 or more centimeters, in active labor without cervical change for 2 or more hours. Patients will be randomly assigned to the study group or the control group, and each group will have 100 patients.

Following the delivery of the fetus, patients in the control group will have IV Pitocin administered per the usual protocol and the uterus will be wrapped in lab sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. Additional utero-tonic medications may be given to improve uterine contraction.

In the study group, following the delivery of the fetus, the uterus will be externalized in the usual fashion, except the uterus will be wrapped with lap sponges saturated in sterile, iced normal saline. Additional utero-tonic medications may also be given in the study group to improve uterine contraction.

Immediately after the delivery of the fetus and prior to the delivery of the placenta, the amniotic fluid and blood on the surgical field will be aspirated into the suction canister. This amount of fluid in the suction canister will be noted and subtracted from the amount of fluid in the canister at the conclusion of the surgery.

At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. Post surgical vaginal bleeding will be monitored and calculated until the patient is discharged from the labor and delivery unit. Use of utero-tonic medications will be recorded.

At the conclusion of the study, the amount of blood loss and utero-tonic drugs between the control and study groups will be compared. The need for additional surgeries, such as a hysterectomy or D\&C, will be compared between the two groups.

Eligibility Criteria:
Inclusion criteria:

* pregnant women of any age
* gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study.

Exclusion criteria:

* Women who refuse to be in the study
* women who are unable to consent due to emergent nature of the cesarean section
* women who are unable to understand the nature of the study due to mental illness, mental retardation, medical condition, or other communication barrier will be excluded.
A Non Interventional Pilot Study on Machine Learning for ILD Detection Based on the Patient Data From Digital Devices in Unresectable Stage III Non-Small Cell Lung Cancer Patients Receiving Durvalumab

Objective in this study is to investigate feasibility of developing machine-learning based model for the identification of future development of diagnosed Grade 2 and higher ILD and of disease progression in patients with unresectable Stage III NSCLC receiving durvalumab

Study design: Multicentre, prospective, non-interventional pilot study

Data Source(s): Medical records, wearable devices, and mobile application.

Study Population:Patients treated durvalumab following chemoradiation therapy for stage III unresectable NSCLC in Japan from the June 2021 to June 2022. They must fulfil all of the inclusion /exclusion criteria.

Exposure(s): dulvalumab

Outcome(s): Disease progression, ILD including radiation pneumonitis.

Sample Size Estimations : 150 patients

Statistical Analysis: Continuous variables will be reported as mean, median, standard deviation, IQR, maximum, and minimum. Categorical variables will be summarized as absolute frequency and percentage. Ninety-five percent confidence intervals (CIs) will be presented where appropriate. Time-to event for ILD/Disease progression will be estimated by Kaplan-Meir method. Also, in the process of developing model, data production such as per-patient plots of the physiological data(multivariate time series) and physiological data before and after (in a shorter time-scale) the ILD event per event will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Patient who provided written signed informed consent prior to the first study-specific procedures.
* Patient who receives durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy
* Patient whose performance status showed 0 or 1 prior to durvalumab treatment
* Patient who is able and willing to wear the devices daily for up to 6 months as instructed

Exclusion Criteria:

* Patient under immunotherapy treatment other than durvalumab.
* Patient had received prior immunotherapy
* Patient under the interventional clinical studies using unapproved drugs or off-label use of drugs
* Patient who showed ILD (including radiation pneumonitis) of Grade 2 and higher, after consolidated chemoradiation therapy.
* Patient who is judged as not suitable for the study by the study site investigators, in terms of fitting wearable devices, presence of silicone or metallic allergy
Randomized Trial of EUS Neurolysis in Pancreas Cancer

This is a clinical trial to determine more effective methods of controlling the pain in pancreatic cancer. Although narcotic pain medication are effective, they have many side effects and are underutilized due to social stigma and fear of addiction. Celiac plexus neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be more effective and have fewer side effects than pain medication alone. We are evaluating the effectiveness of this standard pain medications with or without celiac plexus neurolysis in a randomized controlled trial. One half of the participants will receive pain medications only and the other half will receive pain medications plus neurolysis, delivered via an endoscopic ultrasound device placed in the stomach.

This is a phase III randomized blinded sham controlled trial of endoscopic ultrasound guided celiac plexus neurolysis. Patients with pancreatic cancer who are unresectable and who have significant pain (\> 3 on 0-10 scale) will be enrolled. At the time of a staging endoscopic ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same medication into lumen of stomach). Neurolysis will be performed using standard bupivicaine and ethanol. Patients will be followed for at least 3 months for pain, quality of life and narcotic usage.

Eligibility Criteria:
Inclusion Criteria:

3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the CT scan information.

3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day.

3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not required unless clinically indicated due to known warfarin use or suspected coagulopathy.

3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation \>90%.

3.5 \> 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances.

3.8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy.

3.9 Life expectancy \> 3 months 3.10 Signed and dated informed consent.

Exclusion Criteria:

Unable to sign informed consent