cyrilzakka/clinical-trials huggingface dataset:
Study of PET Scans and Serotonin in Hot Flashes Treatment

The purpose of this study is to determine in a preliminary manner whether successful therapy of hot flashes can be associated with changes in the serotonin transporter in the brain. The serotonin transporter is important in delivering serotonin into certain portions of the brains (serotonin is a chemical that is important in the control of body temperature, mood, sleep, and other functions).

Hot flashes represent the most common complaint among peri- and postmenopausal women. Over 60% of postmenopausal women experience hot flashes, and 10-20% of all postmenopausal women find them nearly intolerable. Despite the prevalence of hot flashes, their pathophysiology is not well understood. Treatment options include non-pharmacological approaches, hormonal interventions, and non-hormonal pharmacological agents. The most effective treatment for hot flashes is estrogen. The most promising non-hormonal treatments for hot flashes are selective serotonin or noradrenergic reuptake inhibitors (SSRI/SNRI). Although estrogen withdrawal is implicated in the initiation of hot flashes, and serotonin's role is well established in thermoregulation, the relationship between estrogen and serotonin is not known. Preclinical studies suggest that both estrogen and SSRI down regulate the serotonin transporter. Clinical studies that further delineate the relationship between effective treatments for hot flashes and the serotonin transporter may shed a new light into the pathophysiology of these symptoms and more importantly, into design of new-targeted treatments.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* 7 or more hot flashes per day for at least 3 months
* Must be able to undergo magnetic resonance (MR) and PET imaging
* Must be able to receive either paroxetine or estrogen

Exclusion Criteria:

* No treatment with hormone therapy or other medications that affect estrogen within the past 3 months
* No evidence of a currently active cancer
Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care

The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.

Investigators assess the general and personal knowledge of epilepsy, compliance of antiepileptic drugs (AED), and self efficacy scale. Participants be asked to use the mobile application (Brain4U) and record seizure type, frequency of seizures, aggravating factors, and adverse events related to antiepileptic drugs for 2 month period.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 1-99.
* Participants must attend Seoul National University Bundang Hospital Pediatric Neurology Outpatient Clinic.
* Participants under age 18 must have an adult guardian give informed consent.
* Participants must have a functioning smartphone (iOS or Android) which can download the and perform Brain4U application.
* Participants must be able to use mobile application skillfully.

Exclusion Criteria:

* Person who does not have smartphone nor restricted to use mobile application can not participate this study.
* Person with intellectual disability or unable to use mobile application can not participate this study.
Electronic Registry of Male Patients With Congenital Adrenal Hyperplasia 21-hydroxylase Deficiency

Observational, retrospective, prospective, single-center cohort study. Participation in the registry will be offered consecutively to any patient with the disease, newly diagnosed or with documented diagnosis made at another center, at any stage of the disease. Laboratory tests, imaging study for patient monitoring and care procedures all will be conducted in accordance with normal clinical practice.

Observational, retrospective, prospective, single-center cohort study conducted at the UOC of Endocrinology and Diabetes Prevention and Treatment of IRCCS AOU of Bologna. Participation in the Registry will be offered consecutively to any patient with the disease, newly diagnosed or with documented diagnosis made at another Center, at any stage of the disease. Laboratory tests, imaging study for patient monitoring, and care procedures all will be conducted in accordance with normal clinical practice.

For the retrospective phase, patients whose diagnosis of CAH was made on or after 01/01/1960 will be enrolled, and observation related to this phase will be extended until this study is approved.

The study population is partly from direct access at the U.O.C. of Endocrinology and Diabetes Prevention and Treatment, as the regional referral center for this rare disease (congenital adrenal hyperplasia).

The potentially involved cohort is estimated to be about 30 patients at the time the registry was established. It is assumed that both retrospective and prospective phases can be completed in 15 subjects and retrospective alone in the remaining 15 subjects.

The registry may become the reference for calculating incidence and prevalence in Emilia Romagna of the disease under study.

Eligibility Criteria:
Inclusion Criteria:

* Male gender;
* Age 18 years or older;
* Newly or previously diagnosed patients with CAH from 21-hydroxylase enzyme deficiency, in whom CYP21A2 gene analysis for determination of pathological mutations and genotype has already been performed;
* Obtaining informed consent.

Exclusion Criteria:

* Patients with an unsure diagnosis of CAH;
* Patients with CAH caused by (or with the co-presence of) pathogenic molecular alterations other than mutations in the CYP21A2 gene.
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


Eligibility Criteria:
Key Inclusion Criteria:

* Heterozygous for F508del and an MF mutation (as defined in the protocol)
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply
Evaluation of the Interest of a Specialist in Dermatology for Dermatopediatric Consultations

Dermatologic diseases, of very different etiology and variable severity, represent a major motivation for consultation (in private consultations and in emergency departments), thus leading pediatricians to frequently turn to dermatologic advice.

The principal aim is to estimate the degree of concordance of the main diagnosis between a pediatrician and a pediatric dermatologist.

The secondary aims is to estimate the degree of concordance of the treatment, advices and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Under 18 years old
* consultating for dermatologic problem in emergency department (1 department) or private pediatric center (1 center)
* signed consent
* consécutives consultations

Exclusion Criteria:

* no consent
Brain Effects of Memory Training in Early Psychosis

Background: People with psychosis show profound deficits in memory. A new cognitive remediation therapy using an app on a computer or mobile phone to improve memory has been effective in this population, but the neurobiological effects are unknown.

Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes during a working memory task before and after a 12 hour memory training intervention on a computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter connecting prefrontal and parietal lobe before and after training.

Methods: 46 people with psychosis will be randomized to a computerized training of either memory training or a control condition of non-memory games (language/card games) and will self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app http://www.peak.net. Imaging data will be gathered with a 3 Tesla scanner pre and post training.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female and between the ages of 18 and 40
2. Able to understand and sign an informed consent document in English.
3. Meet diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychosis not otherwise specified.

Exclusion Criteria:

1. Impaired intellectual functioning (full-scale IQ\<70).
2. Past or current history of a clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment.
3. Current severe substance use disorder.
The Development of Younger Siblings of Children With Autism Now at 10 Years of Age

Background: Autism is a complex developmental disorder involving difficulties in verbal and nonverbal communication, social-emotional functioning, and markedly restricted interests and activities. Strong evidence from research conducted with family members of children with autism supports the role of genetic factors in its etiology. Thus, some family members are characterized by the broad autism phenotype (BAP) which involves a clinical picture of milder but qualitatively similar difficulties.

Working hypothesis and aims: Researchers recently initiated prospective longitudinal studies investigating the early developmental profiles of young siblings of children with autism (SIBS-A). Such longitudinal SIBS-A study is currently conducted at the Hebrew University and includes the oldest siblings studied to date. Our main aim is to identify siblings who manifest any autism or BAP characteristics.

Methods: Two groups, SIBS-A (n = 42) and siblings of children with typical development (SIBS-TD, n = 62), were seen at ages 4, 14, 24, 36, 54 months and 7 years. We plan to continue the investigation at age 10 years, a time when school related abilities and social/emotional competences are more consolidated and to investigate the developmental trajectories of children's abilities from age 4 months to 10 years using growth curve analyses.

Expected results: We expect that compared to SIBS-TD, significantly more 10-year-old SIBS-A will display difficulties related to ASD or BAP related difficulties. We also expect to identify different patterns of stability and/or change in the development of children's abilities from age 4 months to 10 years, between the two groups.

Importance: This study provides a useful approach for the examination of the main research hypothesis regarding the development of SIBS-A. One of the main advantages of using the growth curve analysis is the identification of early predictive markers for future development.

Probable implications to Medicine: This research has significant implication for early identification and the search into the causes of autism and the BAP, as well as for implementation of early treatment and prevention programs. By highlighting expressions of ASD and the BAP in siblings, we may identify early clinically predictive behavioral markers associated with their onset and contribute to the investigation of underlying genetics mechanisms.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the SIBS:

* A group comprised intact families who had a child with autism.

Inclusion criteria for families in the SIBS-TD group:

* Intact families with a newborn and an older child who exhibited typical development with no history of any learning and/or emotional difficulties according to parental report
Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)

The noradrenergic system plays a known role in attentional systems and suspected causal role in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as a inhibitor of norepinephrine transporter(SLC6A2). The investigators hypothesis is that norepinephrine transporter polymorphism is associated with responses and adverse effects of OROS-methylphenidate in treatment of ADHD.


Eligibility Criteria:
Inclusion Criteria:

* ADHD
* Physically healthy

Exclusion Criteria:

* Neurological illness
* Concurrent additional psychiatric treatment
* \< IQ 70
* Psychotic disorder
* Major mood disorder needed other psychiatric medication
* Significant suicidal ideation
* Pervasive developmental disorder
Minimally Invasive Pancreatico-duodenectomy

Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary and pancreatic diseases including malignant and benign conditions. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care. Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited. In this prospective randomized study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD compared to conventional open PD.

Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary and pancreatic diseases including malignant and benign conditions. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care . Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited despite several improvements in surgical devices and techniques that have allowed surgeons to approach the pancreas laparoscopically, laparoscopic PD remains challenging. LPD represents one of the most advanced abdominal operations owing to the necessity of a complex dissection and reconstruction. Recent reports note that complete laparoscopic PD including laparoscopic resection and reconstruction is both technically feasible and safe. In this prospective randomized study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD compared to conventional open PD

Eligibility Criteria:
Inclusion Criteria:

1. Age from less than 70 years.
2. Tumor size less than or equal 3cm.
3. No vascular invasion.

Exclusion Criteria:

1. Multiple prior abdominal surgeries.
2. Body mass index \>40.
3. Locally advanced tumors .
4. Inability to withstand prolonged anesthesia.
5. Tumor size more than 3 cm.
6. Patients who received chemoradiotherapy.
7. Pregnant females.
8. Patients with cirrhotic liver.
Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2

The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).

The TRACK-LVO registry is an observational study conducted across multiple centers with the aim of improving the detection and treatment of large vessel occlusion (LVO) in acute ischemic stroke (AIS) patients. LVO is a major predictor of unfavorable outcomes in stroke patients, and the most effective imaging modalities for its detection remain a topic of debate.

To address this, the investigators will enroll consecutive AIS patients with LVO screened under different imaging modalities and compared the efficacy of endovascular therapy (EVT) and best medical management (BMM). The registry defines LVO as an occlusion of the intracranial ICA with or without the involvement of the terminal bifurcation, M1 and/or M2 segment of the MCA, A1 and/or A2 segment of the ACA, VA, BA, or P1 and/or P2 segment of the PCA. Patient information, including basic demographic profiles, imaging characteristics such as volume of ischemic core and occlusion site, and treatment-related complications will be collected for both EVT and BMM groups. For patients in the EVT group, detailed information on the EVT procedure and angiographic images will also be collected.

The study aims to identify the optimal imaging modalities for LVO detection and to compare the prognosis of AIS patients with LVO receiving EVT versus BMM. This academic, real-world, multi-center, observational registry will contribute valuable insights to improve the detection and treatment of LVO in AIS patients, ultimately improving patient outcomes and reducing the burden of stroke on public health and socio-economic development.

Eligibility Criteria:
Inclusion Criteria:

1. Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
2. Age ≥ 18;
3. Ischemic stroke confirmed by head CT or MRI;
4. Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
5. Patients receiving either endovascular therapy or best medical treatment;

Exclusion Criteria:

- None
Effectiveness for Interventions to Minimize Surgical Site Infections

The purpose of this study is to evaluate two different simple and inexpensive extra treatments during colorectal surgeries to see if this will reduce the rate of post operative infections

The population for inclusion for this study will be drawn from the patients undergoing elective transabdominal colorectal surgery. This population was chosen due to its inherently high rate of superficial-incisional infection.Colorectal procedures stand out as a particularly highrisk surgery with respect to SSI. Several studies have reported rates of infection of 25% or more making colorectal surgeries an excellent opportunity for testing new strategies to reduce SSI.

This pilot project seeks to preliminarily evaluate two new strategies that are inexpensive and could be readily incorporated into current practice. The strategies are pressurized irrigation of the superficial surgical wound (above the fascia) and subcutaneous injection of gentamicin into the surgical wound prior to initial skin incision. Comparison will be made between prospectively enrolled patients and historic controls.The hypothesis to be tested is that these interventions will significantly reduce superficial incisional infection rates compared with historic control.

Eligibility Criteria:
Inclusion Criteria:

* VA patients getting transabdominal,elective colorectal procedures
* willing and capable of giving self informed consent

Exclusion Criteria:

* patients unable to give informed consent
* emergency colorectal procedures
* transanal procedures
* patients who have contaminated or dirty wounds that would preclude attempts at skin closure at the conclusion of the procedure
* patients undergoing appendectomy
* patients undergoing intraabdominal procedures not including surgical resection of the colon or rectum (ie.procedures involving small bowel , stomach)
* patients with pre/op creatinine clearance less than 20ml/min
* patients with known allergy or hypersensitivity to gentamicin
* patients that have received gentamicin within 2 weeks of potential study date
Probability of Optimal Target Attainment of Amikacin in Patients With Febrile Neutropenia During Treatment for a Hematological Disorder

The present trial is a single center, prospective, observational pharmacokinetics and pharmacodynamics (PKPD) cohort study investigating whether patients suffering from a hematological disorder and treated with amikacin due to febrile neutropenia (FN) achieve the predefined amikacin target concentration (Cmax ≥60 mg/L).

Amikacin is an aminoglycoside (AG) that exerts a rapid bactericidal effect against many Gram-negative pathogens. Its pharmacological effect depends on the peak concentration achieved. However, a common side effect of AG is dose-dependent acute kidney injury (AKI), especially when administered over several days due to an accumulation of the drug in the proximal renal tubular cells. In patients in advanced stage of a hematological disease, low body weight influences amikacin pharmacokinetics and pharmacodynamics (PKPD) and increases its clearance. However, there is little known about amikacin PKPD in patients with febrile neutropenia (FN). Whereas the therapeutic efficacy is associated with the peak concentration of AG, toxicity of AG depends on the area under the curve (AUC) or trough level of the drug. When using the AUC to predict renal toxicity, an AUC between 200 and 300 mg/L \* h of amikacin has been proposed as a potential threshold for renal toxicity. At the University Hospital Basel (USB), amikacin is administered intravenously (iv) as once daily infusion combined with cefepime or piperacillin/tazobactam immediately after the occurrence of a fever spike in patients with FN. After the iv administration of amikacin, peak concentration is achieved after 30-60 min. The in-house guidelines recommend the administration of lower amikacin dosages compared to other published studies (15 mg/kg body weight vs. 20 mg/kg or up to 30 mg/kg). It remains unclear if adequate peak concentrations are achieved in patients with FN, when lower amikacin doses are administered. The aim of this study is to investigate the probability of optimal pharmacological target attainment (Cmax ≥60 mg/L) during amikacin treatment among patients with FN treated for hematological disorder in order to evaluate the in-house amikacin dosage recommendations. The current project includes the sampling of biological material during hospital admission and the collection of health-related personal data.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Informed consent (IC) as documented by signature
* Documented hematological disorder
* Hospitalization at the USB due to the treatment for a hematological disorder (e.g. chemotherapy, stem cell transplantation)
* Being at risk of developing FN during the hospital stay (e.g. because of chemotherapy)

Exclusion Criteria:

* Previous enrolment into the current study
* Outpatients
* Patients undergoing hemodialysis
* Women who are pregnant (special pharmacokinetic)