cyrilzakka/clinical-trials huggingface dataset:
Phthalate and Bisphenol Exposure During Minipuberty

Phthalates and bisphenols have been detected in a range of infant care products. This pilot study will test whether intervening on these sources of exposure during the critical period of minipuberty affects infants' body burden of phthalates and bisphenols. Investigators will recruit 10 participants from the ongoing NYU Children's Health and Development Study (CHES) cohort study who are \>=37 weeks gestation, carrying a male fetus, and intending to breastfeed. Investigators will randomly assign them to use either conventional baby products or phthalate- and bisphenol-free baby products for the first three months of their children's lives. Toward the end of the intervention, investigators will collect maternal breast milk and infant urine, and assay samples for phthalate metabolite and bisphenol concentrations.


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in NYU CHES study at the NYULH-Brooklyn campus
2. 18 years of age or older
3. At least 37 weeks gestation
4. Carrying a male singleton fetus
5. Intending to breastfeed
6. English or Spanish speaking
7. Intending for pediatric care for infant to occur at the Sunset Park Family Health Center at NYU Langone

Exclusion Criteria:

1. Not enrolled in NYU CHES study from the NYULH-Brooklyn campus
2. Under 37 weeks gestation
3. Carrying a female fetus
4. Carrying multiples
5. Not intending to breastfeed
6. Not comfortable communicating in English or Spanish
7. Not intending for pediatric care for infant to occur at NYULH Sunset Park Family Health Center
8. Under 18 years of age
Mindfulness and Cognition in Schizophrenia

Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia (men only)
* aged 18-55
* with no change in antipsychotic medication and clinical status within four weeks prior to the study
* affiliates or entitled to a social security scheme
* who have given their informed consent before participating in the study.

Exclusion Criteria:

* History of head trauma, neurological disease or not stabilized serious physical illness
* Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months
* Beta blocking and anti-arrhythmic medications.
Cosmetic Appeal, HRQoL and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer

The therapeutic efficacy of three types of orchidectomy was ascertained as well as the QoL and scrotal cosmetic satisfaction of patients in the three surgical arms. Two of these surgeries produced a pseudotesticle (BSCO, BESO) while one (BSO) did not.

Patients with prostate cancer (PCa) were grouped into three surgical arms: BSO (bilateral simple orchidectomy), BSCO (bilateral subcapsular orchidectomy) and BESO (bilateral epididymal-sparing orchidectomy). Preoperatively, baseline serum testosterone, PSA, Quality of life (QoL) and pre-operative testicular volumes were obtained. Timed interval sampling for serum testosterone and PSA variation was done post-operatively. By three months post-op, the cosmetic appeal of the scrotal appearance, post-operative pseudotesticular volumes and QoL were also assessed.

The therapeutic efficacy of the surgeries was determined by the rates of decline of serum testosterone and PSA, as well as the nadirs achieved. The variations in the pre-and post-operative QoL was analysed.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy

Exclusion Criteria:

* Patients who have had bilateral orchidectomy
* Those who opt for medical castration
The Glittre Activities of Daily Living Test in Chronic Low Back Pain

The aim of our study is to investigate the validity and reliability of the Glittre activities of daily living test in individuals with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic low back pain
* Chronic low back pain for at least the last 3 months
* Being aged 18-65
* Voluntary participation in the study

Exclusion Criteria:

* Having orthopedic or neurological impairments
* History of surgery due to chronic low back pain in the last 6 months
* Being pregnant
* Participating in regular physical activity in the past 3 months
Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device

Collect patient data and to monitor the clinical use (safety and efficacy) of the device


Eligibility Criteria:
Inclusion criteria:

- Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure

Exclusion criteria

The device is contraindicated for patients known to have any of the following:

* Known coagulation dysfunction
* Leak reversal with separate or significant residual or recurrent leak
* Acute infection
* Known intra-cardiac thrombi
* Recent pelvic venous thrombosis
* Recent myocardial infarction or a surgical bypass operation in the last 30 days
* If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally
* Intolerance of contrast agent
A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum

Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent position, irrigated water and blood may prevent visual field of ESD.

Generally, whole precutting around the lesion during the ESD is performed prior to dissection. However, it is expected that partial precutting method for the lesion located in the antrum of the lesser curvature may improve the visibility of ESD because it can help us the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time of ESD for the lesion located in the antrum of the lesser curvature according to the precutting methods (whole precutting vs. partial precutting).


Eligibility Criteria:
Inclusion Criteria:

1. Over 19 years old
2. Patients with gastric adenoma or early gastric cancer

Exclusion Criteria:

1. Patients who has undergone subtotal gastrectomy
2. Patients who has undergone gastrostomy
3. Patients with local recurred gastric adenoma or early gastric cancer
Evaluation of California's Armed and Prohibited Persons System

This study evaluates exposure to California's Armed and Prohibited Persons System (APPS) and risk of future violence and other important outcome events among individuals who legally purchased firearms in the past but have since become prohibited from owning them. The main hypothesis is that APPS will be associated with a significant reduction in risk for future violence among individuals who are directly affected.

Violence remains an important public safety and public health problem. Prior research has shown that denying firearm purchases by individuals who are at high risk for committing violent crimes, thereby restricting their access to firearms, is an effective violence prevention strategy. The Armed and Prohibited Persons System (APPS) is a new violence prevention initiative undertaken by the California Department of Justice (CalDOJ). APPS is used by law enforcement to systematically identify persons who, having legally purchased firearms in the past, have become prohibited persons in the present-usually as the result of a criminal conviction. Such individuals are at increased risk for future violence.

APPS uses existing data to identify firearm owners among persons who have become prohibited from owning or possessing firearms under California or federal law. CalDOJ then uses this information to contact and attempt recovery of firearms in the possession of prohibited individuals.

This controlled prospective longitudinal evaluation of APPS relies principally on data collected by CalDOJ in the course of APPS operations or on data in the public domain, such as community characteristics published by the U.S. Census Bureau.

To maximize fairness during the implementation of APPS, approximately 1,000 California communities will be stratified by region, population, and violent crime rate and randomized into two groups that will be exposed to APPS at different times during the study period. Hierarchical analysis will examine outcomes for individuals clustered at the community level. The principal analysis will be on an intent to treat basis. A secondary per protocol analysis will also be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Adults with records of firearms ownership who have experienced a prohibiting event. Prohibiting events are based in Federal and California state law. Among others, they include criminal convictions for felonies and selected violent misdemeanors; emergency hospitalization for dangerousness associated with severe mental illness, as specified in statute; and status as respondent to a domestic violence restraining order.

Exclusion Criteria:

* None.
Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain

Administration of midazolam with morphine in patients with severe acute pain is a routine practice in the management of pre- and post-operative patients but has not been evaluated in pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam in the pre-hospital management of traumatic patients with severe acute pain.

In a multicenter prospective randomized double-blind placebo-controlled trial, the investigators would like to compare the analgesic effect and safety of the intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a validated numeric rating scale (NRS).

The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.

Patient will be included in pre-hospital setting. They must have an acute pain NRS greater than or equal to 6 from a traumatic origin. The participation of the study for each patient will be the time of the pre-hospital setting. The study will stop when the patient arrives at the hospital.

Patient will be randomized after obtaining an informed consent. Then, the nurse will administered intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg or intravenous morphine 0.10 mg/kg and placebo.

Only the nurse will be aware of the treatment received by the patient. Every 5 minutes, life constants and pain score will be recorded on the case report form.

Assessment will be done at the baseline using a validated numeric rating scale. The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old
* conscient with spontaneous ventilation
* acute pain with an traumatic origin : pain escape superior or egal to 6/10
* taking care by French reanimation and urgency mobile services (Smur).

Exclusion Criteria:

* younger than 18 years old or older than 70 years old
* chronical respiratory insufficiency
* severe hepatocellular insufficiency,
* myasthenia
* known allergy to morphine or benzodiazepin,
* already treated for a chronical pain,
* pregnant women
* treated by morphine
* patient unable to evaluate his/her pain
* any acute and severe hemodynamic, respiratory or neurologic deficiency
* needed an local analgesia
* patient who received an other antalgic treatment
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering

GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed.

The investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.

The investigators will use Decapeptyl on day 2 of menstruation followed by antagonist protocol.

Hormonal proflie including E2, P, LH, FSH will be measured. LH surge and the rest of the hormonal profile will be compared to day after ovulation triggering.

Eligibility Criteria:
Inclusion Criteria:

* patients that undergo fertility preservation

  * patients planned to freeze embryos due to PGT or surrogacy --patients at high risk for OHSS

Exclusion Criteria:

* Poor ovarian response
* known hypothalamic- pituitary dysfunction
Levosimendan Administration in Pulmonary Hypertension

The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function.

Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.

In this study, Levosimendan will be administered in patients with pulmonary hypertension undergoing cardiac surgery. The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function. The drug will be administered in different doses to define the dose at which Levosimendan administration reduces pulmonary vascular resistance and pressure without causing significant reduction of systemic vascular resistance and pressure. The anti-inflammatory effect of the perioperative use of Levosimendan in cardiac surgery will also be studied.

In this setting, 45 patients with PH caused by left sided heart disease, will be assigned into three groups:

GROUP A: Administration of Levosimendan at a dosage of 3mcg/kg after anesthesia induction.

GROUP B: Administration of Levosimendan at a dosage of 6mcg/kg after anesthesia induction.

GROUP C: Administration of Levosimendan at a dosage of 12mcg/kg after anesthesia induction.

Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used. The anti-inflammatory action of Levosimendan will also be evaluated by interleukin-6 (IL-6) measurements.

This study will lead to conclusions regarding the effectiveness of Levosimendan administration in the treatment of right heart failure and PH in cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
* elective cardiac surgery

Exclusion Criteria:

* primary pulmonary hypertension
* thromboembolic disease
* chronic obstructive pulmonary disease
* emergency surgery
* redo surgery
* inability to consent to the study
Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program.

Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas.

Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect.

The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy.

If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a positive result in fecal immunochemical test within the population-based colorectal cancer screening program.
* Complete colonoscopy with cecal intubation.
* Inform consent signed.

Exclusion Criteria:

* Personal history of colorectal cancer.
* Family history of colorectal cancer: ≥2 FDR or ≥1 FDR diagnosed before 50 years of age.
* Family history of hereditary colorectal cancer syndromes: Lynch syndrome, FAP, etc.
* Personal history of inflammatory bowel disease.
* Terminal illness.
* Personal history of total proctocolectomy.
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 45-64 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) 20.0-29.9 kg/m\^2 (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
* Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
* Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening.
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults

The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.

To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.

To evaluate safety of GC3111 in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged above 19 and under 64 at the time of screening
2. Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug
3. Subject who provided informed consent and assent forms

Exclusion Criteria:

1. Subject who received vaccine within 4 weeks prior to receiving study vaccine
2. Subject who received Tdap vaccine prior to receiving study vaccine
3. Subject with chronic cough history within 12 weeks before receiving study vaccine
4. Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
5. Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine
6. Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures