cyrilzakka/clinical-trials huggingface dataset:
Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects

The aim of the project is to assess brain network dynamics, self-referential information processing and prosociality and learning following the modulation of the serotonin-system by serotonergic-psychoactive compounds.


Eligibility Criteria:
Inclusion Criteria:

* Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
* Little or no previous experiences with psychedelic substances
* Body mass index (BMI) between 18.5 and 25
* Willing to refrain from drinking caffeine 3 days and alcohol the day before testing session, from drinking alcohol and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
* Able and willing to comply with all study requirements
* Informed consent form was signed
* Good knowledge of the German language

Exclusion Criteria:

* Previous significant adverse response to a hallucinogenic drug
* Participation in another study where pharmaceutical compounds will be given
* Self or first-degree relatives with present or antecedent psychiatric disorders
* History of head trauma or fainting
* Recent cardiac or brain surgery
* Current use of medication or psychotropic substances (including nicotine addiction)
* Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
* Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction, coronary spastic angina)
* Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
* Liver or renal disease
MRI Assessment of Placental Health

The ultimate goal of this project is to develop methods that allow informed decision-making on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies. Although there is no specific correspondence between a single type of pathology and IUGR, the common result of these pathologies is placental insufficiency, which limits the maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and inflammation in the villous and intervillous space (villitis). Thus one potential approach to distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental transport. Based on the hypothesis that efficiency of oxygen transport is representative for overall oxygen and nutrition transport in placenta, the investigators propose to characterize the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use it as an index for better stratification in the IUGR risk group. The investigators will also consider alternative MRI approaches such as structural, diffusion and spectroscopy measurements inside the placenta, which might reflect the state of placental transport and reveal the status of placental health.

Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency from normal placenta transport with histopathology data of the placenta. 2) To correlate the MRI metrics that reflects placental insufficiency with fetal outcome


Eligibility Criteria:
Inclusion Criteria:

1. The pregnant mother with twin gestation with diagnosis of selective IUGR based upon obstetrical US findings as following:

   * Proven monochorionicity / dichorionicity
   * Discordance in estimated fetal weight (EFW). Growth restriction (\<10 percentile of norm) in one or both fetus(es) AND/OR growth discordance (\> or = 20%) between twin fetuses.
2. The pregnant mother with singleton gestation with diagnosis of IUGR based upon obstetrical US findings as following:

   * Proven singleton gestation
   * Growth restriction of fetus (\<10 percentile of norm)
   * Doppler measurements that indicates placental insufficiency: umbilical artery, middle cerebral artery, uterine artery; or oligohydramnios.
3. Gestational age: Bigger than 18 weeks.
4. Pregnant mother is between age 18 to 45, clinically stable and can safely tolerate fetal MRI study.

Exclusion Criteria:

Fetuses/infants with the following features will be excluded.

1. Fetus/infant with chromosomal anomalies or known genetic disorders.
2. Fetus/infant with other major congenital malformation.
3. Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient, quality or completeness of the data.

Pregnant mothers with the following features will be excluded.

1. Mothers with contraindication to MRI (with pacemaker, metal in body, oversize).
2. Mothers with claustrophobia
3. Mothers medically unstable for the MRI study
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD\[s\]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
* May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (\>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[\<=\]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
* May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

* Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
* Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
* Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids \>10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
* Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment
A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia

This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age.
* Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH secreting pituitary tumor).
* Have previously had pituitary surgery and/or pituitary radiation with the intent of curing or treating Cushing's disease.
* Have clinical symptoms and signs of hypercortisolism.
* Are able to provide written informed consent.
* Are expected to complete the study.

Exclusion Criteria:

* Are surgical candidates for pituitary surgery or have had pituitary surgery within 8 weeks before screening.
* Have taken any medication that may interfere with protocol testing procedures within 30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine, primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz, neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral contraceptives).
* Have received investigational treatment (drug, biologic agent or device) within 30 days of screening.
* Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or therapeutic use of ACTH.
* Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such as those with severe obesity, major depression or a history of alcoholism.
* Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
* Have renal failure as defined by a serum creatinine of 202 mg/dL.
* Elevated total bilirubin (\>1.5x ULN), elevated ALT(\>3x ULN) or AST (\>3x ULN).
Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors

Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.

This will be a prospective, non-interventional long term data collection study. Adult healthy unrelated stem cell donors receiving Sandoz' filgrastim according to the stem cell mobilization protocols of the respective apheresis centers will be monitored for safety and efficacy during the mobilization period, and a systematic safety data follow-up will be implemented for up to 10 years after mobilization.

Eligibility Criteria:
Inclusion Criteria:

Volunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization

Exclusion Criteria:

* Donors of age \<18 years
* Related to recipient
* Chronic significant organ diseases
* Systemic autoimmune diseases
* Chronic infectious diseases
* History of malignant disease
* Pregnant and breastfeeding women
* Hypersensitivity to E. coli derived proteins
* Hypersensitivity to the active substance or to any of the excipients of Sandoz' filgrastim
* Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim
* Participation in previous stem cell mobilization procedures
* Previous or concurrent use of other mobilizing agents, e.g. plerixafor
* Informed consent was not signed prior to beginning of documentation.
Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies

Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by activation-induced marker expression.


Eligibility Criteria:
Inclusion Criteria

All Participants:

* Aged 18-75 years old MS Patients
* Diagnosed with MS based on 2017 McDonald criteria

Exclusion Criteria

All Participants:

* Participants with a known history of COVID-19 Healthy Adults
* Immunocompromised or on immunosuppressive therapy MS Patients
* None specified
Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery

In this prospective, randomized trial, including patients scheduled for a major open or laparoscopic abdominal surgery (duration \>2 hours) under general anesthesia , the investigators will compare 2 strategies of protective mechanical ventilation: a fixed intraoperative PEEP of 6 cmH2O and an individualized intraoperative PEEP according to the driving pressure.

Patients will be randomized into 2 groups:

* Fixed PEEP group: will receive protective intraoperative mechanical ventilation: tidal volume: 6 ml/kg of PBW, recruitment maneuvers every immediately after tracheal intubation and every 2 hours and a fixed PEEP of 6 cmH2O
* Individualized PEEP: protective mechanical ventilation with the same modality with an individualization of PEEP levels hourly in order to achieve the lowest driving pressure. PEEP levels will be adjusted after intubation and hourly by increasing or decreasing PEEP levels every 10 respiratory cycles.

The primary outcome: incidence of post operative pulmonary complications during the first post operative days.

Eligibility Criteria:
Inclusion Criteria:

* BMI\<35, ARISCAT score \> 26, patients scheduled for major abdominal surgery

Exclusion Criteria:

* unplanned post operative ICU stay and mechanical ventilation
Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery

This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery.

After CABG surgery, a condition known as hyperglycemia or high blood sugar often occurs even in patients who have never been diagnosed with diabetes. This high blood sugar can lead to complications after surgery such as infections at the site of the incision. Additionally, if there is any cardiac muscle injury either prior to or during surgery, the injured cardiac muscle can not use glucose (the body's fuel and energy source) as well as it did prior to the injury. This reduced ability to use glucose slows the cardiac muscles ability to repair itself and provide the normal pumping force and function needed to circulate the blood throughout the body. This inability to repair itself and/or provide the normal pumping force and function can make it difficult for the patient as well as increase the length of stay required in the CSICU.

GLP-1 has the ability to lower blood sugar and help cells use glucose for fuel and energy but when the blood sugar becomes low its glucose lowering ability decreases. In this study, we want to see we want to see if GLP-1 may help keep the blood sugar within normal limits and reduce or eliminate the need for insulin. We will also see whether it will help the heart recover more quickly.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females age \> 18 years of age
* Able to consent
* Scheduled for non-emergent coronary artery bypass graft (CABG)
* Have an ejection fraction \< 35%
* Ischemic patients with Left Ventricular Dysfunction (LVD) who need a valve procedure with their CABG

Exclusion Criteria:

* Emergency coronary artery bypass graft surgery
* Patients with an ejection fraction \> 35%
* Repeat or redo CABG patients
* Patients with a history of pancreatitis
* Pregnant or lactating females
Mesenteric Ischemia in the Emergency Department: a Retrospective Multicenter Study

Acute mesenteric ischemia is a life-threatening condition characterized by high mortality if unrecognized early. This multicenter retrospective observational study will review the emergency departments's (ED) notes of all patients discharged from hospital with a diagnosis of acute mesenteric ischemia in 2014-2015 comparing it with those admitted to the ED for abdominal pain in the same timeframe.

Acute mesenteric ischemia is a condition characterized by non-specific presentation (typical clinical presentation is considered "abdominal pain out of proportion to examination") that may be under-recognized in the Emergency Department. Early identification and treatment is essential to improve outcome as mortality rate is attested around 80% if untreated within few hours from onset. The investigators aim to review the emergency department's clinical notes of patients discharged from hospital in 2014 and 2015 diagnosed with acute mesenteric ischemia. Furthermore the investigators will consider patients admitted for "abdominal pain" in the same time frame without acute mesenteric ischemia and we will compare presentation symptoms, medical history, medications, vitals, laboratory markers and imaging finding of the two groups. From this comparison, the investigators will be able to clarify the incidence among general population and among patients presenting acute abdominal pain. Finally, using multivariate analysis, the investigators may identify those variables predictive of acute mesenteric ischemia. This study will be held in three university hospitals and all data analyzed together.

Eligibility Criteria:
Inclusion Criteria:

* ICD-9 diagnosis of acute mesenteric ischemia in 2014 and 2015
* Admitted to hospital after Emergency Department assessment
* age\>18

Exclusion Criteria:

* age\<18
* post-traumatic or post-surgery related acute mesenteric ischemia
* lack of assessment in the Emergency Department
Recurrent Atrial Fibrillation

This study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses.

Eligible individuals with no previous history of atrial fibrillation or flutter who develop a limited episode of atrial fibrillation during a hospital stay for an acute medical illness or non-cardiothoracic surgery or procedure. Patients will be monitored for a period of 1 month using Medtronic SEEQ monitors for recurrence. Subjects will self assign to wear the SEEQ monitor or standard of care. Individuals with implanted cardiac devices capable of detecting atrial fibrillation will also be included.

Eligibility Criteria:
Inclusion Criteria:

* Development of atrial fibrillation or flutter during a hospital stay following a non-cardiac procedure or acute medical illness
* CHADS2VASc score of 2 or more

Exclusion Criteria:

* Prior history of atrial fibrillation of flutter
* Requiring ventilator support or in shock
* Acute decompensated heart failure or EF =/\< 40%
* Greater than mild valvular heart disease
* Other structural heart disease such as more than mild LVH, constrictive or restrictive cardiomyopathy
* Hyperthyroidism uncontrolled at the time of diagnosis if known
* Pulmonary embolism that requires thrombolysis or resulted in shock
* Use of antiarrhythmic drugs (class I or III) at the time of discharge
* Cardiothoracic surgery in the last 6 months
Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?

Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the body has a balanced ying-yang or the qi flows in correct strength and quality along the meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in the channels and is able to regulate and restore yin-yang balance.However, there are some drawbacks associated with acupuncture which may limit its applications. These include transmission of infectious disease, pneumothorax and other problems associated with organ punctures, cardiac tamponade, and broken needles with remnants migrating to other locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is effective in reducing dyspnoea in patients with chronic obstructive pulmonary disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4) and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the subject could experience distinct sensation as deqi.

Eligibility criteria: Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese.

Outcome Measures: Heart rate, Mean arterial blood pressure, Heart rate variability

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese were recruited for study

Exclusion Criteria:

* history of cardiopulmonary, neurological and psychologic disorders or they required taking drugs within one week that might affect the cardiovascular and neurological status
Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury

The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.

Severe Traumatic Brain Injury, when not leading to mortality, is a major cause of morbidity in early adulthood.

Recent studies have demonstrated a previously unappreciated association between Severe Traumatic Brain Injury and endocrine dysfunction.

The current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must be between the ages of 18-65
* Documented moderate to severe Traumatic Brain Injury (TBI) at less than 4 months post injury.
* Glasgow Coma Scale (GCS) equal to or greater than 12
* Patients volunteer to participate in the study, with a written informed consent signed
* BMI between 17 kg/m2 - 30kg/m2
* Affiliation to a national health insurance program

Exclusion Criteria:

* Glasgow Coma Scale (GCS) ≥13
* History of TBI ≥4 months
* Anterior hypopituitarism documented
* History of radiotherapy
* Liver dysfunction: total bilirubin \<20µmol/l and/or factor V\<60%)
* Renal dysfunction: creatinine clearance \< 30 ml/mn (Cockcroft \& Gault)
* Anyone who is currently taking or who has taken corticotherapy in the last 4 weeks before TBI
* Pregnancy
* Contraindications to MRI:
* Patients who have a heart pacemaker
* Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
* Patients with severe claustrophobia
Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

Data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse.

This is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity undergoing coronary angiography are prospectively enrolled.All patients underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5 hours.All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure, and in hospital major adverse cardiac events (MACE). All patients are also followed-up for 12 months in order to assess their long-term risk of MACE, compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* history of aspirin hypersensitivity
* acute coronary syndrome or known/suspected stable coronary artery disease
* intent to undergo percutaneous coronary intervention

Exclusion Criteria:

* withdrawal of consent