cyrilzakka/clinical-trials huggingface dataset:
Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France

The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France. This registry is a requirement of the Haute Autorité de Santé (HAS).

Data Collection on patients who have been implanted with an E-vita OPEN PLUS Stent Graft System from 15th July 2014 until 31st May 2019. The E-vita OPEN PLUS Stent Graft System was implanted at the discretion of the treating physician. Participating physicians provided their observations collected during routine care for patients he/she had decided to treat with the E-vita OPEN PLUS Stent Graft System.

The period of data collection was three years starting from the intervention of each patient. Data verification was performed.

Eligibility Criteria:
Inclusion Criteria:

None

Exclusion Criteria:

None
A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy

To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

1. To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.
2. Establishment of risk assessment model for Grade B fistula.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery.
* Surgery performed by the same surgical team.

Exclusion Criteria:

* PD or LPD combined with another organ resection.
* PD or LPD performed due to trauma.
* PD or LPD for emergency treatment, such as the rupture and bleeding of tumor.
* Palliative resection.
* Patients with severe organ dysfunction before surgery.
* Patients treated with preoperative neoadjuvant chemotherapy or other treatments (Radiotherapy, targeted immunotherapy, etc.).
* Patients with missing data for clinical or radiographic variables.
A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously

The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.

This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention) study to evaluate the clinical use, safety and ease of care of two patient-controlled analgesia (PCA) systems to deliver pain medication either through the skin or intravenously. The fentanyl hydrochloride PCA system, which delivers the medication through the skin, and morphine intravenous (IV)- PCA, which requires injection into a vein, are used for management of moderate to severe acute pain in postoperative patients who have undergone elective major abdominal or orthopedic surgery. These patients, who are expected to require postoperative pain relief with strong opioids for at least 24 hours, will control the delivery of medication for up to 3 days. Assessment of effectiveness include: patient's global assessment of pain control (poor, fair, good, excellent); Pain Intensity, measured on a visual numerical rating scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain; Ease-of-Care questionnaires including Patient Ease-of-Care questionnaire, Nurse Ease-of-Care questionnaire, and Physical Therapist Ease-of-Care questionnaire; and, total number of doses delivered by patients in the fentanyl transdermal PCA or morphine IV PCA treatment groups. Safety evaluations include vital signs (pulse, blood pressure) and oxygen saturation, respiratory function, and the incidence of adverse events. The study hypothesis is that fentanyl transdermal PCA is not inferior to morphine IV PCA treatment in patient's global assessment of method of pain control during the first 24 hours after surgery. Transdermal PCA: 40 micrograms fentanyl per on-demand dose, each delivered over 10 minutes for a maximum of 6 doses/hr for 24 hours (maximum of 80 doses, 3.2milligrams). Morphine IV PCA: morphine doses with a maximum of 20 milligrams per 2 hours for 24 hours (maximum 12 doses, 240 milligrams).

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the criteria of American Society of Anesthesiology (ASA) pre-operative physical status I, II, or III
* Patients expected to have moderate or severe pain after a major abdominal or orthopedic procedure
* Patients expected to remain hospitalized for at least 24 hours postoperatively

Exclusion Criteria:

* Known allergy or hypersensitivity to fentanyl, morphine, or to skin adhesives
* Known or suspected to be dependent on strong opioids or to have abused any drug substance or alcohol
* Severe respiratory symptoms
* Chronic pain disorder
* Pregnant or nursing women, or those lacking adequate contraception
Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer

To look at what types of measures can be used to predict how an older person will tolerate chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw to look at the different measures.

Purpose: To identify baseline predictors of change in function over the course of treatment with chemoradiotherapy in patients with head and neck cancer.

Participants: Patients 65 or older who have an appointment at the North Carolina Cancer Hospital (NCCH) or other participating sites, have planned chemoradiotherapy for head and neck cancer

Procedures (methods): Consenting subjects will complete a Geriatric Assessment, Functional Assessment of Cancer Therapy - Head and Neck and give a blood sample for CBC and p16INK4a at the start of their chemoradiotherapy, at week four, at the end and 90 days post therapy. They will also complete a health behavior questionnaire at baseline.

Eligibility Criteria:
Inclusion Criteria

* Patients will be eligible for this protocol provided they have an appointment at the North Carolina Cancer Hospital (NCCH), have planned chemoradiotherapy for head and neck cancer (any histology) and consent to complete the Geriatric Assessment. No exclusions will be made based on gender, ethnicity, performance status or race. Patient must be able to read and speak English.
* Signed, IRB approved written informed consent.
* Age of at least 65 years.
* Enrollment in other studies, both therapeutic and observational, will not result in exclusion.

Exclusion Criteria

* Inability to read and speak English.
* Inability to comply with study for any other reason than language
AI Support in Novice's Decision-making for Ultrasound Fetal Weight Estimation

The SCAN-AID study is a prospective, randomized, controlled, and unblinded study that compares the performance of novices in ultrasound fetal weight estimation. The study evaluates the impact of two levels of AI support: a straightforward black box AI and a more detailed explainable AI.

The goal of this randomized controlled clinical trial is to learn which type of artificial intelligence (AI) effects the diagnostic accuracy of ultrasound estimation of fetal weight (EFW), when performed by novices, in this study represented by medical students.

The study's objectives are:

* Which type of artificial intelligence support system works for novices in improving the ultrasound fetal weight diagnostic accuracy?
* Does the artificial intelligence improve image quality, evaluate the cognitive load placed on participants when utilizing AI support, and is the AI system usable for novices?

Participants will be tasked with conducting an ultrasound Estimated Fetal Weight (EFW) using either a simple black box AI or a detailed explainable AI feedback system. The AI systems will assist participants in determining if they have captured the appropriate image for EFW. The outcomes will then be compared to those of a control group.

Ultrasound procedures will be performed on pregnant women with fetuses at a gestational age of 28-42 weeks, who have previously undergone an EFW by an expert sonographer or doctor at the clinic within 5 days days leading up to the examinationday. One participant of each randomization arm, will perfrom an EFW on the same pregnant woman.

Eligibility Criteria:
Ultrasound novice participants:

Inclusion Criteria:

* Medical students with no former fetal or abdominal ultrasound training.
* The participants will have to understand spoken and written Danish or English.

Exclusion Criteria:

• Medical students who received formal fetal or abdominal training prior to the inclusion in this study.

Pregnant women;

Inclusion Criteria:

* The participants will have to understand spoken and written Danish or English.
* BMI \< 30
* Gestational age: 28-42

Exclusion Criteria:

* Age \> 40 years
* Fefal anomaly
* Oligohydramnion
* Gestational Diabetes, Diabetes type 1 or 2.
Assessment of Novel Metabolic Imaging Modalities as A Predictor Of Therapeutic EfficacyiIn Glioblastoma (GBM)

The goal of this study is to evaluate the prognostic capacity of DMI in a trial assessing the efficacy of adding BPM31510, a lipid nano dispersion of CoQ10 to standard treatment of Glioblastoma (GBM).


Eligibility Criteria:
Inclusion Criteria:

* Any participant that consents to entry into the Phase II BPM31510 parent study (BPM31510IV-11)
* Women of childbearing potential must have a negative pregnancy test
* Ability to understand and the willingness to provide written informed consent.

Exclusion Criteria:

* Refuse to have an IV
* Allergy to MRI contrasts
* Diabetic patients who are taking insulin
Investigation of the Effects of Physiotherapy in Patients With Platelet Rich Plasma (PRP) Applied Knee Osteoarthritis

This study evaluates effects of PRP and physiotherapy on pain, physical function and quality of life in patients with knee osteoarthritis.

PRP has been reported to have a low to moderate level of evidence in patients with knee osteoarthritis (OA) in reducing pain and improving function. Similarly, in individuals with knee osteoarthritis, exercise has been reported to be effective in reducing the pain and improving physical function of the knee OA patient in the short term, and may be even more effective with individual exercise programs. However, there is no study examining the effect of PRP and exercise together. PRP and exercise can be more effective together. The aim of our study was to investigate the effects of physiotherapy on pain, physical function and quality of life in patients with knee OA who underwent PRP injection.

Eligibility Criteria:
Inclusion Criteria:

* Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
* Patients with knee osteoarthritis who underwent PRP injection at least three days ago,
* Being volunteer

Exclusion Criteria:

* Any intra-articular application and / or physiotherapy and rehabilitation in the last 6 months,
* Have any other orthopedic problems involving the lower extremities
* Having cognitive problems,
* Having additional neurological, rheumatologic and / or oncological problems
Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.

The purpose of the study is to validate potential biomarkers for the aid in the diagnosis of PCOS in adolescent and young adult women in the age range of 15-25 years. Female subjects included in this study will have one visit where clinical data for assessing PCOS will be collected and a blood draw will be performed to collect serum for measurement of parameters relevant to PCOS will be performed. Study subjects that receive a PCOS diagnosis will have two follow up visits for follow up on treatment where additional serum and clinical data will be collected. The first visit will be 3 months after receiving the diagnosis and the second visit 6-12 months after the initial visit.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects age 15-25 years
* Signed written informed consent

Exclusion Criteria:

* Less than 1 years from onset of menarche
* Use of hormonal contraceptives
* Documented ongoing pregnancy
* Major ovarian abnormalities, including subject with only one ovary, cysts and solid masses \> 2 cm as detected by transvaginal ultrasound
* Malignancy ( documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)
ITBS-Neurosplasticity for Female Youth with Depression

TBC

TBs

Eligibility Criteria:
Inclusion Criteria:

1. are assigned female sex at birth;
2. are 14yo to 24yo;
3. outpatients;
4. are competent to assent (those age 14-18) or consent to participate (those age 19-24);
5. have a Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM 5) diagnosis of Major Depressive Episode by Mini-International Neuropsychiatric Interview (MINI) version 7.0.0 for participants aged 18-24 and Adolescents (MINI-KID) for participants aged 14-17;
6. have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item) or Depressive symptom severity as shown by a total Children's Depression Rating Scale Revised (CDRS-R) score 40;
7. have not changed dose or initiated a new regular antidepressant or antidepressant augmentation treatment(s) for 4 weeks prior to starting TMS treatment;
8. are able to adhere to the treatment schedule;
9. pass both the TMS and MRI adult safety screening questionnaires.

Exclusion Criteria:

1. have Moderate or Severe Substance Use Disorder (except tobacco) within the last three (3) months;
2. have a concomitant major unstable medical illness;
3. have active suicidal intent;
4. have not responded to 2 or more adequate trials of antidepressant medication in the current episode as meassured by the ATHF form
5. are pregnant or planning to become pregnant during the study period;
6. have a lifetime (MINI) diagnosis of any psychotic disorder;
7. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDE;
8. have previously had ECT or rTMS;
9. have any significant neurological disorder or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging.
10. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
11. have history of epilepsy
12. are participating in standardized regular psychotherapy provided by a psychiatrist or a registered psychologist for less than 3 months prior to study entry or planning to start during the course of rTMS treatments;
13. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);
Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice

This study was designed to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with ARBs, other than azilsartan, in daily medical practice.

Patient enrollment will be started on April 1, 2014. The usual dosage for adults is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the participant's age and condition. The maximum daily dose is 40 mg.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension who meet all the following criteria will be enrolled:

  1. Patients who has complications of diabetes mellitus
  2. Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1\* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets)
  3. Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution
  4. Patients who is an outpatient
  5. Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m.

     \*For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).

     Exclusion Criteria:
* Patients with contraindications to azilsartan
Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI).

MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP.

fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal).

PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using MRA and fMRI.


Eligibility Criteria:
Inclusion Criteria:

* Healthy migraine patient without aura
* Age 18-40
* Weight 50-100 kg
* Fertile women must use safe contraceptives

Exclusion Criteria:

* Tension type headache more than 5 days per month
* Other primary headaches
* Daily use of medication except contraceptives
* Drug taken within 4 times the half life for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Hypotension or hypertension
* Cardiovascular or cerebrovascular disease
* Mental illness or substance abuse
* Other significant conditions determined by the examining doctor
* Contraindications to MRI scan
* Headache within the last 48 hours before start of trial
Early Oral Feeding After Total Gastrectomy for Cancer

The aim of this study is to evaluate the possibility of shortening postoperative hospital stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol (ERAS).


Eligibility Criteria:
Inclusion Criteria:

* Total gastrectomy for cancer
* Age 18 - 80 years
* Informed consent

Exclusion Criteria:

* Numerous hepatic and peritoneal metastases
* Extended resections (pancreas, colon)
* Preoperative malnutrition requiring total parenteral nutrition
* Emergency surgery
Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant.

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant. The participant will continue to be tested for Hepatitis C for 12 weeks post-treatment.

The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before and after transplant will prevent the establishment of HCV infection in the recipients of kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the objective of the study is to evaluate the safety and efficacy of 2 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.

Eligibility Criteria:
Recipient Inclusion Criteria:

* Participants ≥ 18 years old
* On the deceased donor kidney waitlist at Johns Hopkins Hospital
* Awaiting a first or second kidney transplant
* No available living kidney donors
* On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate \<15 ml/min for ≥ past 90 days
* HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis
* Calculated panel reactive anti-human leukocyte antigens (anti-HLA) antibody (flow cPRA) below 80%

Recipient Exclusion Criteria:

* Plan to receive a multi-organ transplant
* Plan to receive a dual kidney transplant (including en bloc)
* History of prior solid organ transplant other than first kidney transplant
* Participating in another study that involves an intervention or investigational product
* Plan to receive a blood type incompatible kidney
* History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA
* Unable to safely substitute or discontinue a medication that is contraindicated with the study medication
* Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study