cyrilzakka/clinical-trials huggingface dataset:
Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester

Investigators measured the placenta, fetal liver and ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices in the second trimester.Investigators aimed to correlate measurements with maternal/fetal outcomes and evaluate their success in predicting poor obstetric outcomes

GDM screening may not always be possible with OGTT performed in limited weeks of gestation. In addition, mid-trimester ultrasound scanning is done in all pregnancies. Therefore, measurement of placental volume and fetal liver volume may be an alternative method for the diagnosis of GDM. In order to predict GDM in the second trimester, the use of 3D sonography and VOCAL (Virtual Organ Computer Aided Analysis) technology in high-risk pregnant women and their cost-effectiveness rates should be investigated further. Multicenter randomized controlled studies with more patients are needed to be able to say more clearly.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* diagnosed with GDM

Exclusion Criteria:

* multiple pregnancy
* congenital anomalies
* gestational hypertansion
* preeclampsia
Palliative Care Unit Transfert Announcements

The course of care of a patient with a cancer whose evolution is pejorative, is marked by difficult announcements, called "bad news". In the palliative phase, prognostic announcements are at the forefront. Of these, the announcement of a transfer to the Palliative Care Unit has not been the subject of any specific studies to the best of our knowledge. It therefore seemed interesting to us to explore the stakes of this particular announcement, a source of upheaval for the doctor and the patient, by gathering the point of view of each one.

The objective of our study is to analyze the methods of announcing a transfer to the Palliative Care Unit and the perception of this announcement by the doctor and his patient with an incurable cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old with solid cancer or malignant haemopathy in palliative phase transferred from a HUS service to the HUS UnASP and informed of this transfer by the originating doctor .

HUS senior hospital doctors, supporting patients with solid cancers or malignant hemopathies.

Exclusion Criteria:

* Patients whose clinical state does not allow for maintenance (tiredness, confusion) or difficult communication.
Cerebral Bases Bodily Representations

Bring elements of understanding to the study of brain organization bodily representations. The body is organized into multiple, distinct levels of representation. The body schema is an unconscious and dynamic representation of his body, updated constantly, resulting from the convergence of multiple sensory information, which articulates with the motor systems to participate in the genesis of the action. The self-image corresponds to a more abstract representation of the body, covering symbolic and imaginary aspects drawn from the emotional life of the individual. Finally, the body of another person engages simultaneously shared and differential representational systems that allow understanding the actions of others while preserving the identity of the agent responsible for the action. These various bodies represented subtly interacting and participating in equilibrium, the self-awareness building as being curious, social and acting. Brain organization bodily representations remains a fundamental question still poorly explored that is of major scientific interest because of its influence on identity and social construction, and the serious repercussions that are their problems, also for the individual and society. This project aims to deepen this hypothesis using a methodology combining functional imaging and awake surgery. The richness of this project lies in the innovative methods of investigation, and in the plurality of disciplines (neuropsychology, neurophysiology, neuroimaging and neurosurgery) and teams (clinical and research) grouped for wear.

The subjects enrolled in this study are all candidates in patients with awakened provided surgery for therapeutic reasons, and volunteer to participate in this experiment. Awake neurosurgery is for patients with glial tumors, but also brain metastases and intra-parenchymal cavernomas. A first experimental session will be held in pre-operative period. Patients realize a functional magnetic resonance imaging (fMRI) brain to define a precise functional mapping of cortical structures, including lateral occipital, involved in body representation. The second experimental session will be conducted in the neurosurgical intervention, practiced one to four weeks later.

This dual approach that combines the functional stimulation of a cortical area (imaging) and functional inhibition (in surgery) allows you to make extremely robust scientific arguments about the causal relationships linking structure and function


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Candidate awake in a long surgery
* Carrying on an original tumor glial parietal or temporal
* Normal global cognitive efficiency score greater than or equal to 27

Exclusion Criteria:

* Patient ambidextrous or left
* Non glial tumor
* Tumor not involving the temporal or parietal lobes
* Consumption of non-drug substance
* Visual perceptual disorder and or space
* Global Cognitive Impairment
Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens

The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.


Eligibility Criteria:
Inclusion Criteria:

* An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility

Exclusion Criteria:

* A positive (reactive) HIV and/or HCV and/or HBV test
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial

This open-label, non-comparative, extension trial will enroll subjects with genetically confirmed PMD who have completed the End-of-Study Visit in the SPIMM-202 trial. Subjects who do not discontinue or withdraw from the trial will receive treatment with 40 mg SC elamipretide for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD.

Eligibility Criteria:
Inclusion Criteria:

* Investigator determines the subject can, and subject agrees to, adhere to the trial requirements for the length of the trial including self-administration (by subject or trained caregiver) of the study drug
* Subject completed the End-of-Study Visit in SPIMM-202

Exclusion Criteria:

* Subject has any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all trial requirements
* Subject has received any investigational compound (excluding elamipretide) and/or has participated in another interventional clinical trial within 30 days prior to the SPIMM-203 Baseline Visit (excluding SPIMM-202) or is concurrently enrolled in any non-interventional research of any type judged to be scientifically or medically incompatible with the trial as deemed by the Investigator in consultation with the Sponsor
* Subject experienced an adverse reaction attributed to study drug resulting in permanent discontinuation of study drug in the SPIMM-202 trial.
* Female subjects who are pregnant, planning to become pregnant, or lactating
* Subject has undergone an in-patient hospitalization within the 1 month prior to the SPIMM-203 Baseline Visit
Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent prior to participation
* Willing and able to comply with all study requirements
* Receiving standard doses of RIF and INH
* HIV antibody negative
* Male or non-pregnant, non-breastfeeding female
* Study participation will not extend length of ATT by more than 4 weeks

Exclusion Criteria:

* \< 18 years
* Body weight \< 50 kg
* eGFR \< 60 mL/min
* Abnormal LFTs including ALT \> 2.5 ULN
* HIV antibody positive
* Non-standard TB regimen (containing RHZE)
* Women of childbearing age unless using effective contraception
* Family history of sudden cardiac death
* Prior history of cardiac disease that precludes the use of low dose digoxin
* Medical or psychiatric condition that might affect participation in the study based on investigator judgement
* Regular consumption of grapefruit or grapefruit juice
* ECG abnormalities that preclude the use of low dose digoxin (intermittent complete heart block, second degree AV block, supraventricular arrhythmia associated with conducting pathways, ventricular tachycardia or fibrillation)
Testing the Efficacy of a Post-discharge Call Program on the Rate of Readmission

NYU Langone Health patients receive a call from a clinical care coordinator after they are discharged from the hospital (within 1-3 days). The current study is testing the efficacy of this program.


Eligibility Criteria:
Inclusion Criteria:

* All patients discharged from NYU Langone Health who are eligible to receive a call from a clinical care coordinator after they were discharged from the hospital.

Exclusion Criteria:

* N/A
Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes

Preterm premature rupture of membrane is associated with increased oxidative stress and inflammatory process, enhancing the activity or the availability of antioxidants may modulate the inflammatory response associated with PPROM, thereby reducing oxidative stress and the risk to the fetus. In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal) oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores

In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal )oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients
* admitted with PPROM
* between 24-32 weeks of gestation

Exclusion Criteria:

* Women with contractions
* abruption
* monochorionic multiple pregnancy
* abnormal (non-reassuring) cardiotocogram
* meconium-stained amniotic fluid
* signs of intrauterine infection
* major fetal anomalies
* hemolysis
* elevated liver enzymes
* low platelets (HELLP syndrome); or severe preeclampsia.
Glucocorticoid Administration After Traumatic Birth

This study has two components, an observational and a trial component. The observational part is being done to screen for postpartum posttraumatic stress disorder by collecting mental health assessments in women who are immediately postpartum for up to 6 weeks.

Additionally, the project has a small number of subjects that will participate in a clinical trial in which they would self-select to receive one dose of hydrocortisone intravenously while they are in the hospital. This pilot of up to 20 participants in the trial arm is designed to create a first indication of whether this could become an effective early intervention to prevent PTSD if given while trauma memories are first being formed.

This registration will list the observational part (number of participants =100) as well as the clinical trial (number of participants =20).


Eligibility Criteria:
Inclusion Criteria (for observation and hydrocortisone treatment groups):

* Screening positive for PTSD Diagnostic and Statistical Manual of Mental Disorders-5 Criteria A (felt a threat to life or injury to self or neonate)
* Postpartum hemorrhage or emergency cesarean delivery
* Owner of a smart phone or email account

Exclusion Criteria (for observation and hydrocortisone treatment groups):

* Active uncontrolled psychological disturbances identified by current psychiatric admission
* Psychiatric consult during admission, or need for hospital appointed sitter during admission
* Non-English speakers requiring a translator
* Current corticosteroid use or corticosteroid use during the study period (including betamethasone for promoting fetal lung maturity)
* Cognitive impairment identified by medical chart review or patients requiring a legal guardian for medical decision making

Exclusion Criteria: (additional criteria for participants that will receive hydrocortisone)

* Self-reported hypersensitivity to hydrocortisone
* Inability to consent patient and administer study drug within 12 hours of a traumatic event
* Weight \< 45 kilograms (kg) or \>120kg
* Subjects with systemic active infections (e.g. viral, bacterial, fungal, protozoan, or helminthic)
* Subjects with uncontrolled hypertension, renal insufficiency, or decompensated congestive heart failure
* Subjects with inflammatory bowel disease
* Subjects with active or latent peptic ulcers
Usefulness of Wireless pH Monitoring in GERD Diagnosis

Gastroesophageal reflux disease (GERD) is extremely common in our environment. Its diagnosis is complex. The Lyon Consensus defined, based on 24-hour pH monitoring, that an acid exposure time greater than 6% is definitely abnormal, less than 4% is normal, and between 4 and 6% is a gray area.

The objective of this study is to describe the change in therapeutic behavior based on the result of prolonged pH recording performed with a 96-hour wireless pH measurement capsule in patients with GERD symptoms and an acid exposure time measured by impedanciometry/pH of 24 hours in the gray area. Also, describe the therapeutic outcomes.

Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.

A 96-hour off IBP wireless pH monitoring capsule will be performed. The worst day, the average of the 4 days and the presence of 2 or more days with AET\>6% and the 4 days with AET\<4% will be recorded.

Patients will be categorized into GERD, reflux hypersensitivity, and functional heartburn. A treatment will be established based on these categories and the GERDq will be measured at 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age, with symptoms of gastroesophageal reflux, who have undergone a 24-hour impedance pH study without proton pump inhibitors (PPIs), whose AET is between 4 and 6% will be included consecutively. .

Exclusion Criteria:

* Patients with severe comorbidities: Liver cirrhosis, oncological disease, autoimmune diseases, cognitive impairment, psychiatric diseases, bleeding diathesis or anticoagulation
* Pregnant women
* Patients with severe esophagitis, esophageal varices, esophageal strictures, Barrett's esophagus, anti-reflux surgery
* Patients with history of pacemaker or defibrillator, since they can interfere with the signal.
* Patients with nickel allergy
* Patients that refuses to sign the informed consent.
3D Printing Models in Surgical Planning of Osteotomies in Kienbock´s Disease Stages II-III

Ischemic necrosis of lunate bone, osteonecrosis or Kienböck´s disease was described by Kienböck in 1910. Numerous surgical procedures for this disease had been proposed. These surgical options, that depends of the radiological stage and anatomical risk factors, can be classified into lunate unloading procedures, lunate revascularization, replacement procedures and salvage procedures. These procedures, except the salvage procedures, has been successful in reconstructing and maintaining the height of the carpus, avoiding progression of the disease and with reduction of the pain.

The lunate unloading procedures are surgical treatments that make a radial osteotomy for modify differents anatomical risk factors associated with the osteonecrosis.

The anatomical factors associated with Kienböck´s disease are morphology of the lunate type I by Antuña-Zapico, cubitus minus, radial inclination angle greater than 23º, and little coverage of the lunate by the radius.

The types of radial osteotomy for Kienböck´s disease stages II, IIIA, IIIB or IIIC, depends to the anatomy of the patient and its anatomical risk factors. For patients with cubitus minus the indication is usually a radial shortening osteotomy. For patients with zero variant and an increase in the radial inclination angle the indication is usually a closed wedge radial osteotomy. The dorsolateral biplane radial osteotomy is used for zero variant cases such as a modification of the technique proposed by Nakamura et and Miura et al. It decompresses the lunate on the frontal plane and reduces dorsal radiolunate impingement on hyperextension. Dorsolateral radial osteotomy ensures a reduction of the radial inclination angle and a corresponding lunate decompression on the anteroposterior and sagittal plane.

Eligibility Criteria:
Inclusion Criteria:

* Kienbock´s disease in the wrist estages II, IIIA, IIIB or IIIC by Lichtman classification

Exclusion Criteria:

* Pre-radiological stages-Lichtman stage I
* Radiocarpal and midcarpal osteoarthrosis, Lichtman stage IV
* Kienböck in children: less than 18 years
* Adults years greater than 85 years old
Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness

The primary objective of the trial is to compare the impact and safety of delayed salvage therapy (dSRT, i.e., SRT initiated at PSA values of 0.4-0.5 ng/ml) to those of early salvage therapy (eSRT, i.e., at PSA levels of 0.2 ng/ml) in patients with biochemical relapse after radical prostatectomy.

The secondary objective of the trial is to perform analysis of the subgroups of patients to determine which patients are most likely to benefit from dSRT

Exploratory objective of the trial is to determine whether selected molecular genetic parameters (172 candidate genes and molecular alterations) and known clinical parameters can be used to identify potential predictors of worse prognosis in patients with known risk factors for relapse after radical prostatectomy, thereby augmenting and refining patient stratification, optimizing their therapy, and clarifying the proper timing of multimodal therapy


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Pathologically confirmed invasive prostate carcinoma with minimal 1 risk factor (RF) after radical prostatectomy (RP)
* Patient refuses the adjuvant therapy after normalization of urinary function within 6 month after RP
* Signed informed consent to participate in the study and (where necessary) consent to participate in the translational part of the research (not a requirement)
* ECOG 0 - 1
* pT2 and minimal 1 risk factor (RF):

  * R1 (PSM), and/or
  * Gleason score (4+3=7) 8-10 and/or ISUP grade group 3-5
* pT3a /pT3b with or without one RF
* No evidence of suspicious pelvic lymph nodes by initial diagnostic: cN0 and/or pN0
* No evidence of suspicious distant metastases by initial diagnostic: M0
* Patient with decline of PSA level to undetectable PSA levels (\< 0,1 ng/ml) or around 0,2ng/ml and with another decreasing trends so that the PSA level decline within 12-24 weeks after RP to undetectable levels (\< 0,1 ng/ml) and with renewed increase of PSA \>0,2 ng/ml (BCR= biochemical relapse) without any clinical relapse on PSMA PET/CT
* No hormonal therapy prior and /or after the radical prostatectomy
* Patient suitable and fit for subsequent radiotherapy with high likelihood of good compliance to the follow-up

Exclusion Criteria:

* Life expectancy (based on Charlson comorbidity index) \< 10 years
* Patient not fit for the therapy
* History of other cancer (other than a radically removed non-melanoma skin carcinoma)
* Previous pelvic irradiation
* Active immunosuppressive medication
* History of hormone therapy prior to randomization
* cN1 and/or pN1 and M1
* PSA-persistence after RP (PSA 12-weeks after RP \> 0.1 ng/ml or no decreasing trend described in Inclusion criteria)
Tecfidera and MRI for Brain Energy in MS

The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS by 2010 McDonald criteria
* Relapsing clinical course
* Ages 18-55
* Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)

Exclusion Criteria:

* Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease)
* Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan.
* Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant
* Prior treatment of greater than 1 month at any time with DMF
* Inability to tolerate MRI procedures
* Pregnant/breastfeeding
Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

Must have X-ray confirmed successful hip fracture repair; Must have completed surgical wound healing; Ability to walk a specified distance with or without a walking aid; Must weigh at least 35 kg.

Exclusion Criteria:

Must not have history of any other lower limb fractures in the past 6 months; Must not have certain cardiovascular conditions; Must not have a chronic active infection (e.g. HIV, hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at least 3 months in the past year;