cyrilzakka/clinical-trials huggingface dataset:
Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.

Subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study will be recruited. Subjects will be randomized to receive either Dabigatran 150mg daily for three days or standard treatment. Vital signs, CBC, inflammatory markers and BMP, and bleeding complications will be evaluated daily for the next 7 days of until discharge whichever is sooner.

Eligibility Criteria:
Inclusion Criteria:

* Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase \>3 times UNL and AP on images)
* 18-75 years old
* Willingness to sign the informed consent
* Symptom onset within 72 hours

Exclusion Criteria:

* Under 18 years of age or over 75 years of age
* Pregnancy or lactating
* Presence of pseudo aneurysm on CT
* Predicted severe acute pancreatitis
* Unwilling or unable to sign the informed consent
* Had recent surgery or sphincterotomy
* Active pathological bleeding
* Concurrent use of anti-coagulation
* Known serious hypersensitivity reaction to Dabigatran
* CrCI \<30mL/min or on dialysis
* Mechanical prosthetic valves
* Liver disease
* Cancer
* On Chemotherapy or immunosuppressant
* Persistent ALT, AST, Akl Phos \>2 x ULN
* Active hepatitis C, active hepatitis B, and active hepatitis A
* Anemia (hemoglobin \<10g/dL)
* Thrombocytopenia
* Concomitant use of P-gp inhibitors
Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue

The investigators hypothesize that Guaraná, a native plant from the Amazon, might improve chemotherapy-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, the investigators randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the cycles of Chemotherapy.

The aim of this study is evaluate the favourable effects of Guaraná in quality of life and Fatigue in patients undergoing Chemotherapy treatment for Breast Cancer. After approval by our Institutional Review Board, we included consenting patients with a histological diagnosis of Breast Cancer for whom Chemotherapy was indicated.

Patients who agreed to participate in the study were submitted initially to a screening interview with the Brief Fatigue Inventory questionnaire from MD Anderson. If the patient presented with a severe fatigue, anemia (HB\<11.0), hypothyroidism or psychiatric disorders she was excluded. If she presented with a mild or moderate fatigue the follow up continued and the patient was assessed 21 days later after her first cycle of chemotherapy with the same questionnaire. If an increase in fatigue levels occurred from mild to moderate, mild to severe or moderate to severe the patient was randomly assigned to receive either Guaraná 50mg or a placebo p.o. q12 for 21 days. At this moment the patient answered a General questionnaire, FACIT-F, FACIT-ES, HADS, Pittsburgh Sleep Quality Index and Chalder Fatigue Questionnaire (Day 1).

After the second cycle of chemotherapy the patient underwent a "wash out" period of 7 days without any intervention, and after that period she received placebo or Guaraná according to the cross over design after answering for the second time the questionnaires above (Day 29) and also the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). After 21 days (Day 42) she was assessed again with the same questionnaires used in the second interview.

The patient's cancer diagnosis, treatment history, concurrent medication was recorded during the pretreatment and The Brief Fatigue Inventory was answered before each assessment.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of Breast Cancer
* Patients undergoing Chemotherapy (First Cycle)
* 18 years old or older

Exclusion Criteria:

* Hypothyroidism
* Clinical Depression
* Prior Chemotherapy
* Anemia
* Unable to sign informed consent
* Severe Fatigue
Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta

The purpose of this study is to examine the efficacy and costs of this patient-centered approach ("Choice" between two cervical cancer screening modalities) in adherence to cervical cancer screening as compared to the current standard of care within the public health system in Mississippi (Pap test at the local department -"Pap") among un/under-screened African American women in the Mississippi Delta using a theory-based, culturally relevant intervention implemented by Peer Health Educators (PHEs).

OBJECTIVE: Our objective is to examine the efficacy and costs of a patient-centered approach ("Choice" between self-sampling and Pap test) in adherence to cervical cancer screening as compared to Pap test at the local health department ("Pap") among un/under-screened African American women in the Mississippi Delta.

HYPOTHESES: Women in the "Choice" arm will have a higher cervical cancer screening adherence as well as higher satisfaction than women assigned to the "Pap" arm; (2) Within the "Choice" arm, more women will choose and complete self-sampling than Pap test; and (3) The "Choice" intervention will be on average less costly and more cost-effective than the "Pap" intervention.

SPECIFIC AIMS: (1) To compare the impact of these two intervention approaches, "Choice" versus "Pap", on cervical cancer screening adherence through a group randomized controlled trial; (2) To compare patient satisfaction between the two intervention approaches; and (3) To compare the costs and cost-effectiveness of these two intervention approaches, "Choice" versus "Pap".

STUDY DESIGN: 12 towns will be randomized to either "Choice" or "Pap" (180 women/arm). Peer Health Educators (PHEs) will identify African American women who report not having undergone cervical cancer screening in the past three years and deliver a brief theory-based, cultural relevant educational session on cervical cancer and screening using a door-to-door approach. Women randomized to the "Pap" arm will be provided with information on how to schedule an appointment at the local health department. Women randomized to the "Choice" arm will be given the choice of attending the health department for a Pap test or self-collecting their own sample at home to be sent for HPV testing. PHEs will follow-up with women in either arm who have a positive test in order to assure diagnostic evaluation and care.

Eligibility Criteria:
Inclusion Criteria:

* no personal history of cervical cancer
* not have engaged in cervical cancer screening in the past four years

Exclusion Criteria:

* none
Effect of PCV and VCV on Extravascular Lung Water

Volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) are the common ventilatory modes during OLV undergoing thoracic surgery. A controversy regarding which ventilation mode is better for oxygenation during OLV with PCV enhances oxygenation more than VCV ;given its initial high peak inspiratory flow rates and its rapidly decelerating flow pattern. However, this high peak inspiratory flow rate might also provoke lung injury via shearing and traction forces on the alveoli. Extravascular lung water describes water within the lungs but outside pulmonary vasculature. Lung ultrasound (LUS) assessment of EVLW by B-lines provides a reliable and easy alternative.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged (18-60 years), undergoing elective thoracoscopic surgery with one lung ventilation

Exclusion Criteria:

* Emergency surgeries.
* Left Ventricular ejection fraction less than 40%.
* Any patient known to have pulmonary hypertension
* Patients with preoperative congestive heart failure, cardiogenic shock, preoperative pulmonary edema
* Hepatic patients (liver functions double the upper reference range)
* Morbid obesity (BMI \> 40).
* Renally impaired patients with creatinine more than 2 mg/dl.
* Any patient with respiratory dysfunction (FEV1\<60% of the expected).
* Any patient with previous thoracic surgery.
* One lung ventilation more than 2 hours
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
2. Cohort 5: naive to the use of oral contraceptives.

Exclusion Criteria:

1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
Effect of Metformin, Dapagliflozin, Combination of Metformin and Pioglitazone in Patients With Type 2 Diabetes

Although, a number of drugs are promising treatment strategies for insulin resistance, a critical question arises to which drug benefits patients with type 2 diabetes more from reduced insulin resistance and consequent glycemic control. In this study, we aim to evaluate the effect of metformin, dapagliflozin and the fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone) on insulin sensitivity and glycemic control in overweight patients with newly diagnosed type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in this present study;
* Regular diet and exercise;
* Age 18 to 60 years;
* Screening glycated hemoglobin (HbA1c) \> 9.0%;
* Body mass index (BMI) ≥ 24.0 kg/m2

Exclusion Criteria:

* Other forms of diabetes;
* Insulin allergy or intolerance of metformin, pioglitazone and dapagliflozin;
* Renal dysfunction (estimated glomerular filtration rate \< 45 mL/min);
* Severe liver disease or elevated transaminases (2.5-fold the upper limit);
* History of alcohol dependence or drug abuse in the past 5 years;
* Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
* Acute infection or stress state 1 month prior to this study;
* Pregnancy or lactation;
* History of diabetic ketoacidosis (DKA) within the previous year;
* Psychiatric disease;
* Other comorbid serious condition including severe heart and pulmonary disease, heart failure of New York Heart Association class IV, and tumors.
Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors

This study is a prospective exploratory study to explore the application value of gallium 68 labeled-fibroblast activation protein inhibitor-04 Positron Emission Tomography（68Ga-FAPI-04 PET）imaging in patients with endometrial cancer and compare it with the imaging agent with better imaging effects to study its advantages. After patient enrollment, 68Ga-FAPI-04 Positron Emission Tomography/Computed Tomography（PET/CT） and Positron Emission Tomography/Magnetic Resonance Imaging（PET/MRI） examinations are performed, with the imaging agent administered intravenously at a dose of 0.02 to 0.04 mCi/Kg×patient weight (Kg), and a whole-body scan is performed 30-60 minutes later, with images processed as usual. Within 1 week before and after the examination, Fluorine18 labeled-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography（18F-FDG PET/CT） is completed, along with medical history collection and necessary laboratory tests. Subsequently, patients undergo surgical resection of the lesion and suspicious metastatic lymph nodes shown by FAPI PET/CT to obtain the corresponding pathological results. Finally, the diagnostic value of all patients in 68Ga-FAPI-04 PET/CT and PET/MR is analyzed and compared with 18F-FDG PET/CT to study the differences in diagnostic efficacy between the two.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Obtaining written informed consent
* Being able to accept follow-up
* Feasible surgery or biopsy to obtain the final result

Exclusion Criteria:

* Pregnant and lactating female patients
* Patients who are difficult to receive further diagnosis and treatment due to their severe condition
* Any patients with contraindications to magnetic resonance imaging
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject (male or female) between the ages of 18 and 55 years.
* Subject with a body weight of \> 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and 32.0 kg/m2(both inclusive).
* Subject with a total IgE level of ≤ 100 IU/mL.

Exclusion Criteria:

* Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.
Prospective Stratification of Infectious Risks in Multiple Sclerosis

This monocentric study is to identify factors that increase the susceptibility for infections and establish a questionnaire-based infection score that allows a prospective stratification for infectious risks in patients with multiple sclerosis (MS) (InRIMS-Study). The study will utilize a validated, MS-adapted questionnaire and infection diary from the Airway Infection Susceptibility (AWIS) study in a regularly followed, prospective cohort of MS patients. It is a nested project of the prospective observational Swiss MS Cohort (SMSC) and SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF) for the InRIMS-study and Swiss MS Cohort (SMSC) and/or Serially Unified Multicenter Multiple Sclerosis Investigation (SUMMIT) study

Exclusion Criteria:

* Not able to sufficiently understand the patient information and questionnaire (German language)
* MS Patients with long-term antibiotic prophylaxis
* MS Patients with known primary immunodeficiency, under chemotherapy due to any malignancy or HIV infection.
High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 y.o
* Aggressive Large B-Cell Lymphoma (CD20+)
* Ann Arbor stage III, IV
* IH or high adjusted IPI
* signed inform consent

Exclusion Criteria:

* Age \< 18 ou \> 60 y.o
* other type of lymphoma
* serology VIH +
* other neoplasms apart from basal cell carcinoma or situ carcinoma
Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of the efficacy or safety of specific anti-seizure medications or overall management strategies.

This is a single-center prospective observational study. The investigators aim to: (1) track critically ill patients undergoing clinically indicated EEG monitoring and seizure management to identify risk factors for electrographic seizures, (2) create prediction models guiding EEG monitoring resources to the patients at highest risk for seizures, and (3) evaluate our current management strategy in terms of safety.

Context: Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of specific medication selections or overall management strategies. The Children's Hospital of Philadelphia (CHOP) has a formal ICU EEG Monitoring Pathway aiming to standardize EEG monitoring and seizure management. This is a single-center prospective observational study of patients undergoing clinically indicated EEG monitoring to identify risk factors for electrographic seizures and create prediction models guiding limited EEG monitoring resources to the patients at highest risk for seizures, and also to evaluate the current seizure management strategy in terms of safety.

Objectives: The primary objective is to identify risk factors for electrographic seizures in critically ill patients and use these risk factors to create and validate a seizure prediction model. The secondary objective is to evaluate the safety of a targeted and timely electrographic seizure identification and management strategy among critically ill patients guided by a CHOP ICU EEG Monitoring Pathway.

Study Design: Single center observational study of consecutive patients undergoing clinically indicated EEG monitoring.

Setting/Participants: Single-center study of critically ill children in the Pediatric ICU at CHOP undergoing clinically indicated EEG monitoring and seizure management.

Eligibility Criteria:
Inclusion Criteria:

1. Care in the Children's Hospital of Philadelphia Pediatric ICU.
2. Clinically indicated continuous EEG monitoring.
3. Age \> 1 month to 18 years.

Exclusion Criteria:

1. Admitted for Phase 2 (intracranial) EEG monitoring.
2. Intensivist expects to discontinue technological support in the next two days given underlying medical or neurological problems.
Addressing Proven Factors in HIV Prevention for Latino Youth

This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.


Eligibility Criteria:
Inclusion Criteria:

* youth attend school selected as study site
* youth in 6-7th grade

Exclusion Criteria:

* parent/youth non-English or Spanish speakers
FLO for Discogenic Pain

Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.


Eligibility Criteria:
Inclusion Criteria:

* subject (male or female) is at least 18 to 70 years of age
* diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines
* Diagnosis of disc degeneration with Pfirrmann score of 1-3
* Subject has failed at least six months of conservative care
* Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of \>6/10 concordant or partially concordant
* The subject is able to comply with all post-operative standard of care and follow instructions.

Exclusion Criteria:

* Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome
* Subject had previous surgery at the disc level
* Patient has previously received injection of FLO within 3 months of screening
* The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision
Dose Tapering Study of Adalimumab in Psoriasis

The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did not add clinical response. Based on this therapeutic window, the introduction of dose adjustments based on Ctroughs (therapeutic drug monitoring) will be further validated in a prospective randomized-controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab Ctroughs, dose reduction is able to maintain favorable clinical outcome.

Patients will be included after signing informed consent and randomized in either a standard dose arm or a concentration based arm based on prior Ctrough measurements. In the concentration based arm, dosing frequency will be lowered to once every 3 weeks. If patients still have supratherapeutic Ctroughs of adalimumab, these patients will continue adalimumab self-administration every 4 weeks. In the standard based arm, patients will continue on standard dosing schedule. During each study visit blood will be taken in order to quantify Ctroughs. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit. In addition, in a subset of patients in each treatment arm, additional sampling will be collected by dried blood spot sampling in order to build a PK(PD) model for adalimumab.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis for at least 6 months prior to inclusion
2. Participants must have a stable disease during maintenance on adalimumab (absolute PASI \< 3)
3. Participants are not allowed to use topical steroids from 7 days before randomization until the end of the study (week 48).
4. Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

1. Participants who have currently a predominant nonplaque form of psoriasis
2. Participants who are pregnant, nursing or planning a pregnancy while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
3. Participants who are unable or unwilling to undergo multiple venapunctures
4. Participants who are treated according to a different dosing schedule than standard dosing of adalimumab (regular dose regimen every 2 weeks; 40 mg)