cyrilzakka/clinical-trials huggingface dataset:
Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth

Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. Follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related.

In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose.

Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in Humans.

The BETADOSE project consist in a randomized, multicenter, double blind placebo-controlled non inferiority trial comparing a standard dose regimen (24 mg) to a reduced dose regimen (12 mg) of betamethasone given to prevent the neonatal complications associated with very preterm birth.A betamethasone course consists in 2 injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg.

The first injection will be unmasked in both group. In both group, women will receive a first 12 mg injection of betamethasone according to local protocols.

Randomization will be performed after the first injection. Women will then receive either a placebo injection (reduced dose regimen, 12 mg only from the first injection) or a second 12 mg betamethasone injection (standard dose regimen, 12 mg from the first injection and 12 mg from the second injection=24 mg). This protocol allows women sent from level 1 and 2 to level 3 perinatal centers after having already received their first injection to participate.

In case of multiple antenatal betamethasone courses, women will receive their second course according to the same design as in their first course.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Patient Having receipt the first injection of betamethasone and pregnancy term \< 32 weeks of gestation
* Age \> 18 years
* Patient affiliated to a social security regime

Exclusion Criteria:

* Chromosomal aberrations and major fetal malformations
* Cervical dilatation ≥ 4 cm and of cervical length ≥20mm.
* Patient who have already received a first course of betamethasone
* first intravenous injection of betamethasone
Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)

Precise assessment of postoperative volume status is important to administrate optimal fluid management. Bioelectrical impedance analysis (BIA) which measures the body composition using electric character. Extracellular water (ECW) ratio by BIA represented as the ratio of ECW to total body water (TBW) and is known to reflect the hydration status. Based on this, we aimed to determine whether aggressive fluid control using ECW ratio could improve clinical outcomes through a single blind, randomized controlled trial.

Critically ill patients admitted to an intensive care unit (ICU) after surgery have commonly experienced a large amount of wide organ injury and profuse bleeding resulting in vessel damage during surgery. Severe systemic inflammatory reactions and pathophysiological stress could consequently occur in these patients. For patients in an acute postoperative phase, it is important to maintain organ perfusion by correcting hemodynamic instability through fluid resuscitation.

Bioelectrical impedance analysis (BIA), a non-invasive method, is useful for quantitatively measuring body composition such as body fat and muscle mass. It is also useful for evaluating volume status based on resistance and reactance of cells known to have different electrical conductivity according to biological characteristics of body composition. In our previous study using BIA, the results showed that changes in ECW ratio after surgery were related to conventional parameters of overhydrated status such as daily fluid balance or capillary leak index (CLI). In addition, overhydration with value of ECW ratio above 0.390 on 3rd postoperative day appeared to be a risk factor for postoperative morbidity and mortality.

Herein, we aim to set the ECW ratio as a guideline for postoperative volume status and confirm a hypothesis that active intervention with fluid management to control the ECW ratio by BIA could lower clinical outcomes in patients with fluid imbalance through a prospective randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the surgical ICU after surgery under general anesthesia regardless of the type of surgery
* Patients who showed abnormal range of baseline ECW ratio by BIA (less than 0.390 or more than 0.405) that measured at the time of ICU admission

Exclusion Criteria:

* aged under 18 years
* underwent surgery under local or regional anesthesia
* pregnant
* had bone fixation or underwent limb amputation
* had any prosthetic medical devices such as pacemaker or metallic intravascular device
* stayed in ICU for less than 48 hours
* readmitted within 48 hours after ICU discharge
* diagnosed with renal failure and receiving renal replacement therapy
* underwent extracorporeal membrane oxygenation treatment before surgery
* agreed for do-not-resuscitate
68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer

This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.


Eligibility Criteria:
Inclusion Criteria:

Group A: Adenocarcinoma of the prostate gland suitable for radical Tx.

* Adenocarcinoma of Prostate
* Gleason score 4+3 and above, or PSA \> 20 ng/mL or clinical stage \>T2C.
* Suitable for surgical tx
* No Hormone Therapy in last 3 months

Group B: PCa and a diagnosis of BCR, previously treated with radical prostatectomy, being considered for radical salvage therapy (with curative intent).

* Original diagnosis of PCa, treated with radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on:

  1. Post RP: two consecutive rises in PSA and final PSA \>0.lng/ml OR Post RP: three consecutive rises in PSA. This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).
  2. Post RP: PSA doubling time of \~15 months OR PSA level 0.5 ng/ml.
* No previous recurrences of PCa.
* Consideration for radical salvage therapy.
* Should not have received androgen-deprivation therapy within 3 months of screening.
* No Hormone Therapy in last 3 months

Group C: PCa and a diagnosis of BCR, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent).

* The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of:
* Increase in PSA level \~2.0 ng/ml above the nadir level after radiotherapy (RT) or brachytherapy, no previous recurrences of BCR.
* The subject is being considered for radical salvage therapy.
* Should not have received androgen-deprivation therapy within 3 months of screening.
* No hormone therapy within the past three months.

Exclusion Criteria:

Group A:

* Prior Tx for Prostate Tumours
* Gleason \< 4+3
* Hip prostheses
* eGFR \<20

Group B:

* Hormone Therapy in the last 3 months
* Hip prostheses
* eGFR \<20

Group C:

* Hormone Therapy in the last 3 months
* Hip prostheses
* eGFR \<20
Weight Based Enoxaparin in Trauma Patients

Hospitalized trauma patients frequently suffer from blood clots in the legs or lungs. To minimize the risk of these blood clots developing, patients may be given a blood-thinner drug such as enoxaparin.

Until now, a set dose of enoxaparin has been given to a patient, regardless of his or her weight. However, a recent study suggests that for obese patients, the set dose may be inadequate. The purpose of this study is to evaluate whether or not a dose of enoxaparin that is based on the patient's weight will help to prevent the formation of blood clots.

The information gathered through this study will help doctors to understand the best way to prevent blood clots in future trauma patients. The potential risks of participating in this study include the minor risks of blood draws and ultrasounds, as well as the more significant risks of bleeding as a side effect of the enoxaparin.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Body Weight \>60 kg
* Admitted to the trauma services at Intermountain Medical Center
* Have received 1 standard dose of enoxaparin for VTE prophylaxis during current hospital admission.

Exclusion Criteria:

* Significant bleeding injury such as solid organ laceration or intracranial bleed at discretion of attending physician
* Renal insufficiency (GFR \<30)
* Platelet count \<100 thousand per cubic ml
* Hypersensitivity to heparin or prior documented heparin induced thrombocytopenia (HIT) by patient report or in medical record
* Pregnant or breast feeding
* Hemorrhagic stroke in proceeding 3 months
* abnormal baseline coagulation characterized by an INR \>1.4, obtained at the discretion of the treating clinician
* Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve
* Treatment with concomitant antiplatelet agent other than aspirin 326 mg or more daily
* Subjects with a life expectancy less than 1 month
* Subjects hospitalized more than 72 hours prior to randomization.
Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia

The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.

Preeclampsia (PE) is a multi-system progressive disorder affecting up to 8% of pregnancies. Epidemiologic studies have shown a significant association between PE and future cardiovascular disease (CVD) in women. Despite recognition of this relationship, there are no good markers to help determine which women are at highest risk, in particular as this relates to long-term cardiovascular risk, the number one cause of mortality in U.S. born women. As such, the study of PE and cardiovascular outcomes, in particular to identify early markers for the development of late CVD, provide insight into critical opportunities for early treatment and modification of disease trajectory in women.

The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.

The investigators hypothesize that preeclampsia with severe features confers a much higher risk of cardiovascular impairment compared to milder form of preeclampsia and healthy controls. If the hypothesis proves correct, these findings may change clinical practice by warranting routine echocardiogram for these patients for early recognition, intervention and treatment of cardiac dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Females older than 18 years of age
* Singleton pregnancy
* The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
* Able to speak English
* Must meet one of the population categories, until each group has reached 20 subjects

Exclusion Criteria:

* Multiple gestation
* History of chronic hypertension or cardiac disease including but not limited to history of heart arrhythmias, congenital heart disease, and use of any cardiac medication (such as beta blockers, ACE inhibitors, calcium channel blockers) prior to pregnancy.
* History of medical problems that may contribute to cardiac dysfunction, including but not limited to chronic hypertension, poorly controlled hyperthyroidism and diabetes mellitus.
Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH

The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage

Research Question:

Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?

Eligibility Criteria:
Inclusion Criteria:

1. Women undergoing elective caesarean section
2. Patient having one or more risk factor for PPH

   * Multiple pregnancy
   * Polyhydramnios (AFI \>25cm)
   * Macrocosmic baby (\>4.5 Kg)
   * Prolonged , augmented and obstructed labour
   * Obese patients(BMI \>30)
   * Premature rapture of membranes
   * Previous history of PPH
3. Age ≥18 years
4. Gestational Age ≥ 35 Weeks
5. Informed Oral Consent From The Patient

Exclusion Criteria:

1. History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)
2. History of epilepsy or seizure
3. Any Known Cardiovascular , renal or liver Disease
4. Autoimmune Diseases
5. Sickle Cell Disease
6. Severe hemorrhagic Disease
7. Placenta Previa.
8. Morbidly adherent Placenta
9. Abruptio placenta
10. Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome
11. Administration Of low molecular weight heparin or Anti platelets the week before delivery .
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)

Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
* No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
* Caregiver required.

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant medical condition.
* Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Empowerment and Burnout of Midwives at the End of Health Emergency From COVID-19

As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations.


Eligibility Criteria:
Inclusion Criteria:

1. Midwives registered in the orders of Friuli Venezia Giulia (FVG) region
2. Midwives in practice for at least one year
3. Midwives practicing in FVG region

Exclusion Criteria:

1. Consent not granted
2. Midwives in retirement for more than a year
A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.

Open label phase 1/2 study of ascending multiple oral doses of HKI-272 in combination with IV trastuzumab in subjects with advanced human epidermal growth factor receptor 2 positive (HER2+) breast cancer. Three to six subjects will be enrolled in each dose group. Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 21. When the maximum tolerated dose (MTD) of HKI-272 plus trastuzumab is determined, an additional 30 subjects will be enrolled at that dose level, and followed for progression free survival for approximately 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy
* Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)
* HER2 positive breast cancer
* At least one measurable target lesion
* Adequate performance status
* Adequate cardiac, kidney, and liver function
* Adequate blood counts
* Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control

Exclusion Criteria:

* More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
* Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1
* Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2
* Extensive visceral disease
* Active central nervous system metastases
* Pregnant or breast feeding women
* Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
* Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)
* Significant cardiac disease or dysfunction
* History of life-threatening hypersensitivity to Herceptin
* Inability or unwillingness to swallow HKI-272 capsules
* Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
Study of Enzyme Supplements to Treat Celiac Disease

The purpose of this study is to examine whether a cocktail of two common food-grade enzyme supplements leads to decrease of serum activity markers in celiac disease patients insufficiently treated by previous gluten exclusion.

Celiac disease is genetically determined abnormal immune response to gluten, a component of wheat, rye and barley proteins that cause damage to the villous structure in the small bowel. The active disease is characterized by the induction of gluten-dependent autoantibodies to transglutaminase type-2, which are sensitive and specific non-invasive markers of gluten-sensitivity. Gluten-free diet normally leads to clearance of antibodies from serum in 6-12 months. Persistent seropositivity is a problem in patients who only incompletely exclude gluten or frequently transgress the diet. In such cases, damage of the small bowel may persist and complications may occur at higher frequency. The central hypothesis to be tested is that enzyme treatment designed to degrade a certain amount of gluten before absorption in the gastrointestinal tract will lead to a clinically meaningful decrease in auto-antibody levels in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Celiac disease diagnosed by small intestinal biopsy
* More than 12 months elapsed since initial diagnosis and start of the dietary treatment
* Evidence for ongoing active disease as verified by seropositivity or dermatitis herpetiformis rash
* Subject agrees to follow a gluten-free diet

Exclusion Criteria:

* Other gastrointestinal or hepatic disease besides celiac disease
* Selective IgA deficiency
* Use of dapsone or diaphenylsulfone
* Pregnancy and breast-feeding
Stereotactic Body Radiotherapy for Liver Tumors

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.

This study is a single site, non-randomized, prospective, phase IV trial.

Composed of 4 patient groups:

1. Oligometastases (1-3) with aggregate tumor diameter \< 6 cm
2. Metastases from neuroendocrine tumors with functional endocrine syndromes
3. Unresectable hepatocellular carcinoma (HCC)
4. Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \>= 18 years
* Zubrod performance status of 0-3
* Oligometastases (1-3) with aggregate tumor diameter \< 6 cm
* Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation
* Unresectable hepatocellular carcinoma (HCC)
* Unresectable intrahepatic cholangiocarcinoma (IHCC)
* Maximum tumor diameter \< 6 cm
* Adequate liver function:

Total bilirubin \< 3 mg/dL Serum albumin \> 2.5 g/dL Serum levels of liver enzymes \< 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication

- Signed study-specific consent form

Exclusion Criteria:

* Maximum tumor diameter \> 6 cm
* Prior radiotherapy to the liver
* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent