cyrilzakka/clinical-trials huggingface dataset:
Management of the PDA Trial

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.

This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment.

Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate will be left to the clinical team.

The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA).

Eligibility Criteria:
Inclusion Criteria:

* Postnatal age 48 hours -21 days
* Infant 22 0/7 to 28 6/7 weeks gestation at birth
* sPDA, as defined as:

  1. Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram
  2. Mild or Moderate Clinical Criteria with Large PDA on echocardiogram

Exclusion Criteria:

* Cardiopulmonary compromise
* Known congenital heart disease (besides atrial septal defect or ventricular septal defect)
* Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation)
* Any condition which, in the opinion of the investigator, would preclude enrollment
A Study to Determine Eligibility for CAH-301 (A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH) [NCT04783181])

This pre-screening study is designed to determine potential eligibility of adults with classic CAH due to 21-hydroxylase deficiency (21-OHD) for participation in the CAH-301 \[NCT04783181\] gene therapy trial with BBP-631.

Adult participants diagnosed with classic CAH due to 21-OHD and who are taking glucocorticoids as treatment for CAH will undergo assessments to determine their potential eligibility for participation in the adult CAH-301 treatment trial with BBP-631.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and non-pregnant females with classic CAH (simple virilizing or salt-wasting) due to 21-OHD
* Screening/baseline 17-OHP levels \> 5-10 × ULN
* Is on a daily regimen of glucocorticoid
* Naïve to prior gene therapy or AAV-mediated therapy

Exclusion Criteria:

* Positive for anti-AAV5 antibodies
* History of adrenalectomy and has no significant liver disease
EVA: Evista Alendronate Comparison

The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures


Eligibility Criteria:
Inclusion Criteria

* 50-80 years of age, inclusive
* 2 years since last menses
* Dx femoral neck osteoporosis
* No vertebral fractures

Exclusion Criteria

* Poor candidate for study drugs
* Hx of diseases affecting bone metabolism
* Hx of breast/estrogen-dependent cancer
* Current use of osteoporosis drug therapy
* Hx/high risk of VTE
Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study

In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. 25 patients will receive the iPure and 25 patients will receive the standard IOL. Study hypothesis: The iPure IOL shows better rotational stability compared to the standard IOL. A clinically relevant difference for rotational stability is defined as 2°.

Although there may be no direct benefit to the subjects under study, the investigation will assess the stability which determines the efficacy for future toric optics and the amount of glistening and PCO formation of the IPure and ZCB00 hydrophobic acrylic IOLs.

25 eyes of 25 patients will be recruited for each IOL, that is 50 eyes of 50 patients. The randomization will be done with a binomial law. The IOL have a priori the same IOL constants which eliminates the necessity to know which IOL is going to be implanted at the preoperative time. A clinically relevant difference for rotational stability will be 2°. The reasonable standard deviation of the position of an IOL in the eye is 2.4°. A total of 48 patients is necessary for a probability of 80% to measure a clinically relevant difference concerning the IOL stability.

In the week before surgery, the eye to be operated is examined at the slit-lamp and by indirect fundoscopy and measurement of intraocular pressure (IOP) will be performed routinely. Additionally, routine biometry is performed using the IOLMaster (Zeiss Meditec AG, Jena, Germany) for axial length measurement, K-readings and anterior chamber depth (ACD) measurements.

Randomisation will be performed using online randomisation and patients will be allocated 1:1 either to the study group (iPure group), or to the control group (ZCB00).

A self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed in a standardised fashion. The IOL is implanted via injector into the capsular bag. Following the implantation of the IOL, the viscoelastic substance is aspirated thoroughly from the anterior chamber, as well as retro-lentally, to assure complete removal of the OVD.

Any deviation from the standard protocol will be recorded peroperatively. Follow-ups will be performed 1-2 hours, 1 month, 12 months and 24 months after cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract
* Age 21 and older
* Visual Acuity \> 0.05
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.

Exclusion Criteria:

* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
* Previous ocular surgery or trauma.
* Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
Ventilation Distribution After Bariatric Surgery

Obese patients have an increased risk of developing post-operative respiratory complications due to their comorbidities. They have a restrictive ventilatory defect with reduction of lung volumes and expiratory flow limitation, higher airway resistance and collapsibility of the upper respiratory tract. These abnormalities are worsened by general anesthesia and opioid administration. It has been proved that oxygen therapy with HFNC (high flow nasal cannula) increases lung volumes through a continuous positive airway pressure (CPAP)-effect. This also improves gas exchange and decreases anatomical dead space. At the present time, CPAP represents the gold standard for the prevention of postoperative pulmonary complications. The purpose of this study is to evaluate lung ventilation, gas exchange and comfort with HFNC compared with CPAP during the post-operative period in patients who undergo laparoscopic bariatric surgery.

Immediately after bariatric surgery, patients will follow a pre-determined schedule of oxygen therapy with conventional facemask (from the beginning to minute 10), HFNC (with a flow of 40 L/min from minute 11 to 20, 60 L/min from minute 21to 30, 80 L/min from minute 31 to 40, 100 L/min from minute 41 to 50, 80 L/min from minute 51 to 60, 60 L/min from minute 61 to 70, 40 L/min from minute 71 to 80), conventional facemask again (washout, from minute 81 to 90) and CPAP (10 cmH2O, from minute 91 to 100). Lung ventilation will be evaluated with electrical impedance tomography (EIT), which measures thoracic impedance variations related to changes in lung aeration. At the end of each 10 minutes-period the following data will be collected: electrical impedance tomography data (to calculate the global inhomogeneity index, Δ end-expiratory lung impedance and tidal impedance variation), hemodynamic parameters, respiratory rate, SpO2, pain (numerical rating scale), level of sedation (Ramsey score) and patient comfort (modified Borg scale). An arterial blood gas will be collected at the end of the following steps: baseline facemask, HFNC 40 and 100 L/min, washout facemask and CPAP. Data about anesthetic/analgesic drugs and ventilation parameters will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patient's consent to the trial
* Candidate to laparoscopic bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass)
* BMI 35-50 kg/m2
* ASA class 1-3

Exclusion Criteria:

* Obesity hypoventilation syndrome
* Contraindication to EIT (e.g. implantable cardioverter-defibrillator)
Effect of Meal Composition on the Responses to Meal Ingestion

Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility Criteria:
Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Serial sampling of venous blood

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers, greater than 50 kg, able and willing to sign informed consent

Exclusion Criteria:

* Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

The purpose of this study is to determine the treatment efficacy of CYH33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma harboring PIK3CA hotspot mutation, who received prior systemic anti-tumor treatment.

The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.

Eligibility Criteria:
Main Inclusion Criteria:

1. Female patients ≥ 18 years of age
2. Provide informed consent voluntarily.
3. Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
4. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status.
5. Patients must have failed standard chemotherapy.
6. ECOG-PS ≤ 1.
7. Patient must have adequate organ and bone marrow function measured within 28 days of screening.

Main Exclusion Criteria:

Patients are ineligible for this study if they meet any of the following criteria:

1. Patient has received any anticancer therapy
2. Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
3. Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
4. Any toxicities from prior treatment that have not recovered to baseline.
5. Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
6. Patients who have symptomatic CNS metastasis.
7. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
8. Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C.
9. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
10. Patients with clinically significant cardiovascular disease
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.

The mavaCamten ObservationaL evIdence Global cOnsortium in hypertrophic cardiomyopathy (COLLIGO-HCM) is a global observational research initiative aiming to describe the real-world outcomes of treatments for obstructive hypertrophic cardiomyopathy (HCM), including mavacamten.

This retrospective study uses data from existing medical records and electronic registries from HCM centers around the world.

Eligibility Criteria:
Inclusion Criteria:

* Source Cohort

  - Have at least one recorded encounter with a Hypertrophic Cardiomyopathy (HCM) diagnosis during or after 2018 (the first is defined as the index) and aged ≥18 years on the index date.

  - Disease-specific patient history documented in the medical record.
* HCM Sub-Cohort

  - Participants in the source cohort with a known HCM diagnosis
* Mavacamten Sub-Cohort - Participants who have their first mavacamten prescription after the index date

Exclusion Criteria:

• HCM Sub-Cohort

- HCM phenocopy (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis) observed after the first observed HCM-associated encounter in the medical record.
The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in healthy man.

Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.

On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.

Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)will be measured to evaluate channel activity in the nephron.

Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.

The vasoactive hormones aldosterone, renin, angiotensin II, atrial natriuretic peptide (ANP), brain natriuretic (BNP) and endothelin is measured in plasma

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 18-40 years
* Body Mass Index (BMI) 18,5-30 kg/m2

Exclusion Criteria:

* Arterial hypertension (\>140 mmHg systolic and/or 90 mmHg diastolic)
* Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
* Neoplastic disease
* Alcohol abuse,
* Drug abuse
* Medical treatment except oral anticontraceptive
* Smoking
* Pregnancy or
* Abnormal blood and urine sample
* Abnormal ECG
* Blood donation within a month before examination
Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure

Heart failure is a complex and heterogenous disease with mortality and morbidity that equals more cancers. Numerous studies have examined the ability to improve prognostication from heart failure, ranging from basic statistical methodologies to machine learning, with impressive improvements in both predictive indices. However, no study to date has examined, in a randomized fashion, the impact of providing prognostic information on provider behavior and downstream clinical outcomes. It is for this reason that the investigators plan to perform the Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure (REVeAL-HF) Trial within the Yale New Haven Health System. REVeAL-HF is a randomized, single-blind intervention trial that is testing the clinical impact of providing prognostic information to the provider on heart failure outcomes in the inpatient settings. The study hypothesis is that electronic alerting about prognostic information on heart failure patients along with links to guidelines will lead to reductions in all-cause mortality and 30-day HF hospitalizations via improved use of guideline directed medical therapy and more adequate decongestion.

Heart failure is the major cause of mortality and morbidity in the United States and Western Europe and prognosis in individual patients is highly variable. Quantifying a patient's survival prospects based on their overall risk profile has the potential to help identify those patients in need of more intensive monitoring and help target appropriate populations for therapies. In fact, several comprehensive risk scores in patients with heart failure are currently available for both reduced and preserved ejection fraction but their applicability to contemporary heart failure populations is unknown. Additionally, the impact of knowing a patient's prognostic information on treatment decisions in heart failure has never been studied. Therefore, guidelines do not recommend using risk assessments to decide on therapeutic decision making in heart failure due to a lack of data for this strategy. The investigators have proposed a randomized controlled trial be conducted of an electronic alert system that informs practitioners about their patients risk of inpatient mortality and 1-year predicted mortality using data from the electronic health record (EHR). The primary outcome for the trial will be a composite of all-cause mortality and 30-day risk of heart failure rehospitalization. The secondary outcomes will be length of stay, discharge doses of heart failure therapies, palliative care referral, referral for advanced therapies like transplant or mechanical circulatory support, referral to electrophysiology, and change in weight during hospitalization (aggressiveness of diuresis). The investigators will enroll into the trial across the hospitals that comprise the Yale New Haven Health System.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* NTproBNP levels of \>500pg/mL within 24 hours of admission
* Intravenous diuretics within 24 hours of admission

Exclusion Criteria:

• None
Visual Stress of the Open Urban Environment

Background and objectives: There is a general agreement that some types of urban environment could be the source of psychological stress as opposed to natural-relaxing environment. A number of aesthetical researches found out that the main cause for stress appearance can be explained by the complexity and order of the environment. There are also some indications that the stressing influence of the open environment can be measured by evaluating eye movements, in particular saccadic movements.

The objective of this study is to characterize eye movements - mainly saccades -while presenting visual material of different complexity and order and to evaluate the possible relationship between eye movements and parameters of psychological and physiological stress.

Methods: The research is based on systematic gradual experiments on healthy volunteers, who will be tested while viewing series of abstract figures and pictures of natural and urban areas with different level of complexity and order. Each figure or picture will be showed to subjects for 7 seconds. During the whole experimental session the investigators will measure:

1. Saccadic and other eye movements using the magnetic scleral search coil technique. The magnetic scleral search coil technique is the most sensitive and accurate technique used in modern ocular motor research for measuring horizontal, vertical and torsional eye movements. The coils are easy to apply and well tolerated over a wearing period of up to 45 minutes per recording session.
2. Heart rate pulse will be measured using a commercial pulse-meter.
3. Aesthetical evaluation: Following each figure or picture 7 seconds presentation; subjects will rate it in a scale from 1 (very relaxing) to 10 (very stressful).

Possible relationship between saccadic eye movements, heart rate and aesthetical rate will be analyzed using WIN 11 SPSS and MATLAB in statistically accepted ways.

Population: A total of about 60 healthy subjects aged 18-60 years old will be recruited for the study from students, faculty and staff of Tel Aviv University and of Meir Medical Center.

Criteria for inclusion: Healthy subject with normal vision

Criteria for exclusion: Eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* Normal vision

Exclusion Criteria:

* Eye disease such as corneal or scleral abrasion or disease, glaucoma
* Refractive errors greater than 2 diopters
* Concurrent medication with CNS-active agents
Suturing vs Biological Adhesive in Simple Lacerations of Hand

To assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive.


Eligibility Criteria:
Inclusion Criteria:

* Any age
* Hand laceration distal to the volar wrist crease.

Exclusion Criteria:

* Fracture , tendon, artery involvement, more than 8 hours from laceration to trx,
* Immunosuppression
* Anticoagulation therapy
* Diabetes
* Unable to achieve homeostasis in more than 15 minutes
* Unwilling to participate in the study
* Unable to participate in the follow up or bite of any kind.
The Radiation Oncology Registry and Biosample Repository

The goal of this study is to establish a registry and biosample repository (defined as blood, urine, and tumor specimens) in patients with a cancer and/or benign tumor diagnosis undergoing radiotherapy.


Eligibility Criteria:
* Anyone age 18 and above with a cancer and/or benign tumor diagnosis undergoing radiotherapy
* Able to sign consent