cyrilzakka/clinical-trials huggingface dataset:
Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

The goal of this project is to characterize changes in emotion regulation pathways associated with healthy behaviors in people who have recently lost weight and are seeking to maintain weight loss over a 1-year period.

Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for overweight and obesity which substantially increase risk for chronic conditions such as heart disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise in obesity threatens to reverse recent gains in life expectancy and account for a large percentage of premature deaths in the U.S. Although there is evidence for the short-term efficacy of a number of methods for initiating health behavior change to lose weight, these interventions have shown only limited ability to affect significant, long-term behavioral changes in the majority of adults. In part this may be because they fail to adequately address how psychological factors that lead to relapse to unhealthy behaviors and failure to maintain long-term behavior change.

The purpose of the study is to understand brain changes that accompany participation in programs that foster healthy behaviors in people seeking to maintain weight loss. We will use MRI scans to study brain function in men and women 25-60 years old who have lost weight in the last year without surgery. Participants will be assigned to one of two programs to help them maintain weight loss and will be compensated for their time. Our goal is to gain a better understanding of the brain changes that lead to long-term success in keeping weight off, in the hope that this knowledge will assist in the development of improved treatments.

Eligibility Criteria:
Inclusion Criteria:

* 25 to 60 years old
* Healthy individuals who have intentionally lost at least 5% of their body weight over the past year
* BMI \>20.5 kg/m2 at study entry and \>25 in past 2 years

Exclusion Criteria:

* Weight-loss surgery or medications
* Serious Psychiatric or medical conditions
* Substance abuse
* Ineligible for MRI
* Pregnant
* Eating disorder
The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Chemotherapy

The purpose of this randomized trial will evaluate whether providing clinicians with daily reports from a well-validated, standardized, patient-centered electronic symptom survey tool (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm with standard of care daily clinician interviews or (2) standard of care plus daily electronic symptom surveys, the results of which will be sent to clinicians electronically.

The primary objective of the study is to compare peak symptom burden between the two study arms (autologous transplant vs. allogeneic transplant). Peak symptom burden will also be compared between the two study arms within both subgroups of patients (myeloablative vs. reduced intensity conditioning). Secondary outcomes that will also be compared between the two arms include: changes in patient-reported quality of life, time to supportive care treatment changes, length of hospital stay, thirty day readmission rate after discharge, days alive and out of the hospital in the 100 days since admission, and overall survival. Additionally, measures of physical activity will be captured through physiological monitoring in order to explore associations with patient-reported symptom measures. Patient and clinician satisfaction will also be evaluated.

In this study, the investigators will use an electronic survey to assess 16 patient-reported symptoms to calculate a symptom score that may range from 0-61 each day. This symptom score represents the symptom burden for the patient on that particular day. Symptom burden is anticipated to peak between days 7 and 14, so the investigators will define peak symptom burden as the average of the symptom scores on days 7, 10 and 14. In both arms, symptoms will be assessed on these days in order to compare peak burden.

Eligibility Criteria:
Inclusion Criteria:

* Verification of access to a functioning email account
* \>= 18 years of age
* \<= 75 years of age
* Able to read in English
* Assessed as competent based on discretion of study personnel
* Willing and able to provide signed, informed consent

Exclusion Criteria:

* Concurrent participation in LCCC1234
Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents

Endoprosthesis treatment of aortic pathologies has become the reference in the vast majority of situations. The success of this treatment is conditioned by the choice of the endoprosthesis which must be as adapted as possible to the anatomy. This choice is currently based on manual geometric measurements performed on the preoperative scanner using conventional image processing software.

The morphological result of the implantation of the endoprosthesis in the aorta is obtained by a CT scan carried out postoperatively. This scanner makes it possible to define the positioning of the endoprosthesis, the apposition surfaces between the aorta and the endoprosthesis and to predict the long-term result.


Eligibility Criteria:
Inclusion Criteria:

- Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder

Exclusion Criteria:

* Patient who has objected to the use of their data.
* No preoperative scanner available or insufficient injection quality
* Preoperative scanner with slice thickness greater than 3 mm
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients

Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients

Prospective clinical monocentric study in ICU with sedated ventilated obese patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line BMI \>30

Exclusion Criteria:

* Acute kidney injury BMI \<30 Sevoflurane anaphylaxia
Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis

Primary objective: To describe the evolution of cerebral lesions in IE patients (number of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).

Introduction:

Infectious endocarditis (IE) is a rare disease (1500 cases per year in France) with a poor prognosis (20 % of mortality). Neurological complications participate in the initial morbimortality but their long-term impact is poorly known. The acute neurological complications are symptomatic in approximately a quarter of patients. Neurological lesions are frequently observed using systematic cerebral imaging. In the IMAGE study, systematic cerebral MRI in 130 patients performed during the acute phase of IE allowed found cerebral lesion in 82 % of the patients and in 79 % of patients without neurological symptoms. The evolution of cerebral lesion, including brain micro-bleedings and their impact prognosis are not known.

Hypothesis: Cerebral lesions detected by MRI during the acute phase of infectious endocarditis may involve and may have an impact on functional prognosis.

Primary objective: To describe the evolution of cerebral lesions in IE patients (comparing the proportion of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).

Secondary objectives:

* To compare frequency of different brain damages in acute phase of IE and during follow-up.
* To analyse the relationship between functional and cognitive status and cerebral lesions.
* To analyse the relationship between initial and follow-up cerebral lesions and initials characteristics (microorganisms, anticoagulation, echocardiographic characteristics, valve replacement surgery, type of valvular substitute, mycotic aneurysm embolization)
* To collect plasma during follow-up of IE
* To compare patient characteristics between patients who accept the functional exploration and those who patient refuse
* To describe oral health and oral condition

Eligibility Criteria:
Inclusion Criteria:

* History of Infective endocarditis treated in Bichat Claude Bernard hospital
* Cerebral MRI performed during the acute phase of endocarditis
* Resident in Metropolitan France
* 18 years old or more

Exclusion Criteria:

* Refusal to participate
* Contra indication to MRI scan
* History of allergy to gadolinium
* Pregnancy or lactating female
* Lack of Social Security or CMU (recipient or beneficiary)
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants

The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18.0 to 30.0 kilograms/square meter.
* Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception.
* Male participants must either agree to abstinence or use of a condom plus an effective method of contraception.

Exclusion Criteria:

* Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months.
* History of any drug or alcohol abuse in the past 2 years; current tobacco/nicotine user or within the last 12 months; positive drugs of abuse test result.
* Clinically significant laboratory abnormalities.
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder.
* History or family history of meningococcal infection.
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
* Presence or history of clinically significant allergy requiring treatment.
* Donation or loss of greater than 400 milliliters of blood within the previous 3 months.

Note: Other inclusion/exclusion criteria may apply, per protocol.
Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties

Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Sedation occurrence during titration and a VAS score higher than 60/100mm are two independent risk factors for postoperative pain during hospitalization.

The association of NB and multimodal analgesia constitutes the reference in evidence-based recommendations. An adductor or femoral triangle block, alone or associated with periarticular infiltration, is recommended during TKA. During THA, NB associated with surgical periarticular infiltration improves analgesia and rehabilitation This study aims to identify the incidence and risk factors of morphine titration in PACU after lower limb arthroplasty performed by 5 experienced surgeons and using a multimodal analgesic procedure


Eligibility Criteria:
Inclusion Criteria:

* Total hip arthroplasty
* Total Knee Arthroplasty
* Uni-compartmental knee arthroplasty (UKA)

Exclusion Criteria:

* Bilateral surgery Surgical revision Hip fracture surgery Other osteoarticular procedure(s) associated to hip/knee arthroplasty Refusal to use data Contra-indication of paracetamol, ketoprofen and dexamethasone
First in Man Study of Implantable Alginate Hydrogel

The objective of this clinical research is to evaluate the safety and effectiveness of Implantable Alginate Hydrogel to reconstruct the left ventricle in the treatment of heart failure


Eligibility Criteria:
Inclusion Criteria:

1. The patients must have been able and willing to give written informed consent
2. The patients should be adult (age≥ 18 years and \<75 years) males or females
3. The patients must have been on stable, evidence-based therapy for HF
4. The Patients have a LVEF ≤35%
5. NYHA is classified as grade III or IV
6. If female, the patients must have been (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of the study device.

Exclusion Criteria:

1. Have undergone any therapeutic traumatic heart surgery within 30 days.
2. Hemodynamic instability or cardiogenic shock.
3. Right-sided HF.
4. Patients who presented with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis.
5. History of Constrictive pericarditis.
6. History of stroke (within 60 days prior to the surgical procedure).
7. History of myocardial infarction (within 30 days prior to the surgical procedure).
8. An LV wall thickness of the LV free-wall, at the mid-ventricular level, of \< 6 mm.
9. Serum creatinine \> 2.0 mg/dL, or calculate creatinine clearance rate \<25 mL/min
10. Clinically significant liver enzyme abnormalities, i.e., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal.
11. Had been receiving concurrently an investigational product in another clinical trial or had received an investigational product in another clinical trial in the 30 days prior to enrollment.
12. A life expectancy of \< 1 year due to comorbidities .
13. Unfit for the minimal invasive treatment.
Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling

Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity pathologies derived from neurological ischemia disorders using the combination of Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS) therapies.

Although there are a number of pain disorders, associated with back, or lower extremity pain and swelling, the American Association of Sensory Electrodiagnostic Medicine (AASEM/ DTSC) study programs will accumulate received data following a protocol of treatment performed for the purpose of eliminating pain, reducing swelling, and accelerating recovery periods as well as to record the success or failure and/or improvement of the malfunctioning body part.

* Condition: Neuropathic Pain, Tingling or Numbness derived from neurological Ischemia
* Intervention: Treatments of Monochromatic Infrared Photo Energy (MIRE) in combination with Electronic Signal Treatment (TENS) therapy
* Study Type: Interventional
* Study Design:

  1. Allocation: Non-Randomized
  2. Endpoint Classification: Efficacy Study
  3. Intervention Model: Single Group Assignment
  4. Masking: Open Label
  5. Primary Purpose: Scientific record of treatment success or failure

Eligibility Criteria:
Inclusion Criteria:

* In the investigator's judgment, a high probability of 5 year survival and compliance with the study visit schedule.

Ability to comprehend and sign an informed consent document prior to study enrollment.

Exclusion Criteria:

* Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of minimum 37 weeks.
* Birthweight of minimum 2500 g (5.5 lb.).
* Age of greater than 3 weeks and less than 12 weeks at enrolment.
* Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording \>3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period \& for duration of study).
* Participant Informed Consent form signed by parent or legal guardian.
* Infant is considered healthy following physical exam.
* Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits

Exclusion Criteria:

* Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
* Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
* Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
* Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
* Failure to thrive.
* Known lactose or gluten intolerance.
* Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.
* Known other causes for abdominal pain (e.g., pyloric stenosis).
* Participation in any other interventional clinical study.
* Immuno-compromised participant or participant with other severe chronic disorder.
* Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.
* Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.
* Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
The Glycocalyx in COVID-19 Patients. A Pilot Study

The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.

The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.Circulating plasma syndecan-1 is measured as surrogat parameter for the extent of the glycocalyx damage.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 detected by PCR measures going along with clinical symptoms
* age \> 18 years

Exclusion Criteria:

* refusal of study participation
Androgen Receptor mRNA Expression is Positively Associated With Live Birth in Women Undergoing IVF Independently of the Type of Ovarian Response

AR is a steroid hormone receptor that regulates various genes' expression and affects cellular proliferation and differentiation. Androgens interact with AR, exert their paracrine action on granulosa cells and regulate gonadotropin synthesis, follicle development, oocyte maturation and corpus luteum function. Estrogens increase AR mRNA and testosterone binding site in uterine endometrium and leiomyoma. In human cancer cells, low estradiol increases AR levels, suggesting the estrogen/androgen ratio as a predictor of sex steroid response. AR mRNA expression is, also, regulated by progesterone. Although AR mRNA is expressed in the female reproductive tissues, its expression has never been studied in peripheral blood.


Eligibility Criteria:
Inclusion Criteria:

* Women with poor ovarian response according to bologna criteria

  1. Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response
  2. A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
  3. Abnormal ovarian reserve test, (AFC ˂5-7 follicles or AMH ˂0.5-1.1 ng/ml).
* Women with normal ovarian response with normal menstrual cycles, normal astral follicle count and normal hormonal assay.

Exclusion Criteria:

* Not more than 43 years old.
* No history of malignancies, endometriosis or polycystic ovary syndrome.
* Underlying genetic cause of infertility
* History of severe cardiac, hepatic or renal disease.
* History of systemic disease or treatment during the last three (3) months
* Participation in another interventional study and a likelihood of being unavailable for follow-up.
Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

The purpose of this study is to determine whether coronary artery computed tomography scanning is a more rapid, less expensive and safe alternative to standard diagnostic evaluation of patients with acute chest pain in the emergency room.

Over 6 million patients per year visit hospital emergency departments for evaluation of chest pain, with diagnostic costs estimated to be in excess of $10 billion. Standard diagnostic evaluation often includes 8-12 hours of serial laboratory tests followed by stress imaging studies requiring an additional 4-8 hours.

Multi-slice coronary artery computed tomography scanning (MSCT) has been shown to be a highly accurate diagnostic method in comparison to invasive angiography. Because of its speed and high negative predictive value, MSCT could rapidly screen patients for the presence of coronary disease, which may expedite their care.

This study compares the length of stay and cost of care in emergency chest pain patients randomly assigned to initial evaluation by MSCT compared to patients randomly assigned to a standard diagnostic evaluation including single photon emission computed tomography scanning. The study follows these patients to detect major adverse cardiac events including unstable angina, acute myocardial infarction or death over a 90-day period.

Eligibility Criteria:
Inclusion Criteria:

* Chest pain or angina equivalent symptoms.
* Age ≥ 25 years.
* Low risk of infarction and/or complications by Goldman/Reilly criteria.

Exclusion Criteria:

* Known coronary artery disease.
* Electrocardiogram diagnostic of acute cardiac ischemia and/or infarction.
* Elevated serum biomarkers including creatine kinase (CK) MB, myoglobin, and/or cardiac troponin I on initial testing.
* Contraindication to iodinated contrast and/or beta blocking drugs.
* Atrial fibrillation or markedly irregular rhythm.
* Pregnancy.
* Renal insufficiency, creatinine \> 1.5 mg/dL.
* Iodinated contrast within prior 48 hours.