cyrilzakka/clinical-trials huggingface dataset:
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders

This clinical trial is a single center, single dose study of the acute effects of intranasal insulin on energy metabolism and cognitive function in patients with schizophrenia, schizoaffective and bipolar disorders, compared and healthy controls.

Psychotic disorders are common and severe psychiatric disorders. Despite advances in understanding the pathophysiology of these disorders, more effective and tolerable treatments are still needed. Evidence suggests that energy metabolism is altered in psychotic disorders. The investigators recently developed non-invasive MRI-based techniques to quantify redox balance and ATP generation in the brain. Targeting insulin pathways in the brain may allow for modulating abnormalities in energy metabolism. The investigators seek to examine whether intranasal insulin can modulate energy metabolism and improve cognition in patients with psychotic disorders. The study will use magnetic resonance spectroscopy (MRS) technology to measure in vivo energy metabolism processes in the brain, before and after the administration of intranasal insulin. Investigators will also measure changes in cognition with the administration of intranasal insulin.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses of schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features OR
* Healthy Controls (no history of DSM psychiatric diagnoses, nor history of the same in first-degree relatives)

Exclusion Criteria:

* Psychiatric hospitalization within the last 4 weeks
* Unstable/active disease or potential contraindications, such as liver disease, kidney disease, uncontrolled hypertension, significant or unstable medical illness
* Currently prescribed: antidiabetic agents, including oral antidiabetic medications and insulin, intranasal medication, steroids, weight loss agents
* Pregnant or breast-feeding, not using an effective form of contraception for at least 3 months, and/or not abstinent for 1 month prior to enrollment
* History of significant head injury
* Contraindication to MRI scans (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal-containing IUDs).
* Medical conditions preventing blood draws
* History of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months
* BMI \> 35 or body weight \> 350 lbs or BMI \<18
* DSM diagnosis of substance use disorder in the past month
* For Healthy Controls:
* Taking medication other than birth control
Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.


Eligibility Criteria:
Inclusion Criteria:

-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.

Exclusion Criteria:

-N/A
A Psychological Intervention to Promote Acceptance and Adherence to NIV in People With COPD

This study aims to analyze the impact of a brief psychological support intervention in the promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of this intervention on both physical and psychological well-being, and consequently, a reduction of health costs.


Eligibility Criteria:
Inclusion Criteria:

* age\> or =18 years
* the voluntary participation to the Study
* inpatients or outpatients
* subjects with Chronic Obstructive Pulmonary Disease (COPD), from moderate (GOLD 2- 50% ≤ FEV1 \<80% pred.) to severe (GOLD 3- 30% ≤ FEV1 \<50%pred.) (FEV1= Forced Expiratory Volume in the 1st Second)

Exclusion Criteria:

* refusal of the Informant Consent
* pregnancy
* subjects affected by oncological or psychiatric illnesses
* immune depressive condition as the principal condition
* usage of antidepressant drugs
Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema

Up to 30 participants with mild to moderate atopic dermatitis/eczema will be enrolled to apply study Investigational Product for 4 weeks.

This will be a 4-week single arm study. This study will be executed by one clinical research company in one research center accruing 30 subjects with mild to moderate Eczema/atopic dermatitis. Patients ages 18-75, will be enrolled. Subjects that are enrolled will be placed on Locus's Over The Counter cream "Arctiva" twice per day for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female;18-75 years of age
* Have a clinical diagnosis of Mild to Moderate Eczema or Atopic Dermatitis
* Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedure

Exclusion Criteria:

* Patients using topical corticosteroids steroidal creams and other agents within 7 days prior to first dose of trial Eczema treatment.
* Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment.
* Active bacterial, viral, or fungal skin infections
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding

The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.

The study will be conducted using a randomized, double-blind, crossover study design. Thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. Two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. Participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. On the day of experimental testing, subjects will arrive to the laboratory in a fasted state. Subjects will rest semi-supine for multiple blood sampling. Following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). Thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. Study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. After three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be male or female between the ages of 18-35 years;
* Participants have not been consuming any nutritional supplements for the preceding 6-week period;
* Participants have not been consuming any ergogenic aids for the preceding 6-week period;
* Participant has provided written and dated informed consent to participate in the study;
* Participant is willing and able to comply with the protocol;
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire;

Exclusion Criteria:

* Participant is allergic to any ingredient in the nutritional supplement or placebo;
* Participant is not pregnant or trying to become pregnant, nor breast feeding;
* Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;
* Participant currently ingests nicotine or has quit within the last 6 months;
Evaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement

The aim of the present study was to compare, a standard efficient technique in accelerating OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT in an attempt for further acceleration of OTM.

The study design was a randomized split mouth design to compare, clinically and radiographically, between the two interventions (Corticotomy and Laser versus Corticotomy only) by assessing the rate of maxillary canine retraction achieved in 4 months. Secondary outcomes were to evaluate 1st maxillary molar anchorage loss, changes in tipping, torque and rotations values of maxillary canine and 1st molar. In addition, the impact of both interventions on root resorption was assessed. The present study was carried on 16 female patients. All patients required maxillary 1st premolar extraction and subsequent maxillary canine retraction.

Eligibility Criteria:
Inclusion Criteria:

1. Post pubertal patients with age more than 17 years.
2. Class I or Class II (Angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage.

Exclusion Criteria:

1. Patients having missing permanent canine teeth in maxillary arch.
2. History of trauma or root canal treatment in maxillary canines.
3. History of previous orthodontic treatment.
4. History of hormonal disorder or syndrome.
Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).

The OMELETTE study is a randomised, controlled, unicentric, open-label study to prove the noninferiority of reduced prone position (PP) sessions (more tan 16 hours) versus prolonged PP (48 hours).

This is a non-comercial, investigator-driven clinical study developed in a single critical care unit.

The study is coordinated by the main investigator from Hospital Universitario 12 de Octubre in Madrid; The sponsorship is performed by Dr. Ignacio Sáez (Hospital Universitario 12 de Octubre).

The study was planned according to the Good Clinical Practices. Omelette study has been approved by the Ethics Committee. All participating Patients must give informed consent before any study procedure occur.

Eligibility Criteria:
Inclusion Criteria:

* Patient above 18 year-old.
* Diagnosis of severe ARDS due to COVID-19 under invasive mechanical ventilation,
* Meet criteria for PP: PaO2/FiO2 \< 150 millimeters of mercury column (mmHg), PEEP ≥ 5 Centimeters of Water (cmH2O), FiO2 ≥ 60.

Exclusion Criteria:

* No consent for the study.
* PP contraindicated (( elevated intracranial pressure, massive hemoptysis, recent tracheal surgery or sternotomy, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy).
Suspension of Falciform Ligament During Mini Gastric Bypass

The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension

The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patient with BMI more than 40 with or without co-morbidity
* Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria:

* Unfit patients for laparoscopic sleeve gastrectomy
* Patients refuse to share in the study
* Patients that already on PPI due to any indications
* Revisional surgery for obesity
* Previous upper abdominal surgery
Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics

Comparison between multiple approaches of laparoscopic hernia ( percutaneous assisted laparoscopic hernia, purse string closure of hernial sac, total dissection of hernial sac).

In pediatric age, indirect inguinal hernia represents more than 95% of the hernial disease. It is a congenital type, in contrast with adulthood in which acquired forms are more frequently found.

Inguinal hernia repair is one of the most frequently performed surgical procedure in infants and young children. Laparoscopic hernia repair in infancy and childhood is still debatable. There are many techniques available for laparoscopic hernia repair in pediatrics.

Laparoscopic hernial repair is increasingly adopted even for neonates and has achieved a high success rate with low recurrence rate with long-term follow-up. The main advantages of laparoscopy are no incision of the fascia, exploration of the other side in case of bilateral hernia, and visualization and safeguarding of the vas deferens and the spermatic vessels. Moreover, it is advantageous over open technique in case of recurrent hernia. Different modalities of techniques have been used for repair such as needlescopic disconnection of hernia sac, flip flap technique, muscular arch repair, and ring closure.

Eligibility Criteria:
Inclusion Criteria:

* patients in the age limit with congenital inguinal hernia

Exclusion Criteria:

* recurrent hernias
* cases inwhich laparoscopic surgery is contraindicated
* cases with collagen defect diseases
Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)

This observational study aims to evaluate the outcomes of patients with early-stage epithelial ovarian cancer who are treated with minimally invasive surgery (such as laparoscopic or robotic surgery). Specifically, the study will look at:

1. Post-Surgery Complications

   * What is the rate of complications within 30 days after surgery?
   * How often do patients require readmission to the hospital, re-operation, or conversion to open surgery?
2. Cancer Outcomes

   * What is the rate of cancer upstaging (when the cancer spreads to a more advanced stage during surgery for example because of an intra-operative ovarian cyst rupture)?
   * What are the overall survival and disease-free survival rates for patients treated with minimally invasive surgery?

Researchers will compare two groups of patients:

Group 1: Patients with early-stage ovarian cancer treated with minimally invasive surgery.

Group 2: Patients with early-stage ovarian cancer treated with open surgery. The goal is to see if there are any differences in post-surgery complications, recovery, and cancer outcomes between the two groups.

Fertility-Sparing Treatment:

The study will also compare patients who are undergoing fertility-sparing treatments for early-stage ovarian cancer. Two subgroups will be looked at:

* Patients receiving fertility-sparing surgery through a minimally invasive procedure.
* Patients receiving fertility-sparing surgery through an open surgery. The same outcomes (complications, survival, etc.) will be assessed and compared between these two groups as well.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with apparent early-stage epithelial ovarian cancer at preoperative evaluation
2. Patients who underwent surgery between January 2014 and December 2023
3. Patients who underwent open or minimally invasive surgical staging (Laparoscopic or Robotic-assisted approach) or restaging procedure
4. Patients with final pathology report of Epithelial Ovarian Cancer

Exclusion Criteria:

1. Patients who have not performed a complete surgical staging
2. Patients who underwent neoadjuvant chemotherapy
3. Patients with invasive synchronous tumor
4. Patients with no informed consent
5. Patients with ASA class score of 4 or 5
Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes

This research aims at analysing the profile of the elderly with cognitive impairment (IC) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence).

The objectives of these studies are to determine the presence of IC and the profile of users who suffer from it in 8 nursing homes in the province of Pontevedra of new admission in 2017, as well as the identification of the frequency of underdiagnosis in the filiation of the mental pathology that causes IC and if that underdiagnosis is related to the presence of doctors or nurses specialists in geriatrics. Sociodemographic, clinical (with special relevance in cognitive assessment and the presence of mental disorders) and functional variables will be analyzed. In addition to providing information that can improve the DC early detection as well as the scarcity of studies in this field, the importance of this research is justified by developing treatment guidelines for people with IC in the future

Eligibility Criteria:
Inclusion Criteria:

* Vounteer
* Elderly Admitted to Nursing homes
* From 60 years old

Exclusion Criteria:

* Elderly without cognitive assessment at admission
* Existence of doubts about the presence of IC
Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score

IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score.

Patient eligibility: adult patients ≤ 82 y with HD vintage \> 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.

Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.

Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 82 years
* hemodialysis vintage more than 6 months
* two of the following markers of malnutrition:
* body mass index (BMI) \<= 20 kg/m2
* body weight loss within 6 months \>= 10 percent
* serum albumin \<= 35 g/L
* prealbumin \<= 300 mg/L

Exclusion Criteria:

* weekly dialysis time \< 12 h
* urea Kt/V index \< 1.2
* serum albumin \> 38 g/L
* prealbumin \> 330 mg/L
* hypertriglyceridemia \> 2.5 mmol/L
* associated comorbidities compromising the one-year survival
* treatment by oral, enteral or parenteral feeding during the last 3 months
* hospitalization at time of randomization
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation

The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.

The occurrence of apoptosis in liver ischemia/reperfusion injury has been well characterized in animal models. In this context apoptosis has specifically been observed in sinusoidal endothelial cells and hepatocytes, and this has also been associated with an increase in activated caspase-3 in liver tissue extracts. The use of caspase inhibitors to prevent apoptosis during liver storage and transplantation may reduce ischemia/reperfusion injury and hence improve graft function after transplantation. Suppression of apoptosis by caspase inhibitors may also allow for longer ischemic times allowing organs to be transported greater distances. In addition, suppression of apoptosis may lower the risk involved in using suboptimal donor organs.

Eligibility Criteria:
Inclusion Criteria:

* Minimum adult age

Exclusion Criteria:

* Fulminant hepatic failure (UNOS Status I patients)
* Previous liver transplantation
* Patients undergoing split liver grafts
* Extrahepatic malignancy
* If female, pregnant or lactating