cyrilzakka/clinical-trials huggingface dataset:
The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes

The study will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm.

Previous studies have reported that oxytocin administration intranasally and orally (spray on the tongue) can modulate neural and behavioral responses during processing of face emotions and can influence top-down attention to social stimuli. However, no research has directly compared the neural and behavioral effects of the two different administration routes on the processing of emotional scenes. In the current randomized, double-blind, between-subjects, placebo-controlled study, 160 healthy male subjects will be recruited and receive treatment either oxytocin (24IU, orally/intranasally) or placebo (orally/intranasally). Prior to treatment, all subjects will complete a number of questionnaires to control for potential group differences in potential confounders in terms of personality traits and mood, including: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), Interpersonal Reactivity Index (IRI). Additionally, the Positive and Negative Affect Schedule (PANAS) is administered before the treatment and before and after completing the implicit emotional scanning task to measure any changes in mood. Forty-five minutes after receiving treatment, subjects will be required to undergo and MRI scanning session including structural scans and resting-state fMRI followed by an implicit emotional scene processing task (picture source: Nencki affective picture system, including positive, neutral, and negative-valence social and non-social scenes). After fMRI scanning, subjects will be required to rate emotional stimuli presented during the scan on valence, intensity, and arousal using 1-9 point Self-Assessment Manikin (SAM) scales.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

* 1. History of brain injury 2. Head trauma 3. Substance abuse 4. Medication
Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia

This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.

Antimicrobial stewardship is defined as any activity that promotes the appropriate selection, dosing, route and duration of antibiotic therapy. Antimicrobial stewardship programs usually include pharmacists and/or doctors with expertise in infection diseases management. Prospective chart review and physician feedback is a common intervention used by antimicrobial stewardship programs to improve antibiotic utilization and patient outcomes.

Pneumonia is the most common reason for antibiotic utilization in hospitals. Significant variation in antibiotic utilization for patients with pneumonia has been repeatedly demonstrated in published studies despite the existence of best-practice treatment guidelines. Treatment variation from these guidelines has been demonstrated to result in worse outcomes such as increased mortality. Antimicrobial stewardship programs can help reduce the treatment variation from guidelines.

Despite improvements in certain outcomes, antimicrobial stewardship programs have not demonstrated any impact on the length of stay of patients admitted to hospital with pneumonia. Part of this absence of evidence may be due to poor study design and failure to recruit sufficient patients. This study will include the implementation of an antimicrobial stewardship program across many hospitals and the study design and analysis will account for the design problems of the previous studies.

Eligibility Criteria:
Inclusion Criteria:

* Community-acquired pneumonia
* Immunocompetent
* Age \> 18 years

Exclusion Criteria:

* Admitted to an intensive care unit or high intensity unit
* Requiring invasive or non-invasive ventilation
* Life expectancy less than 3 months
* Hospitalization within the previous 3 months for at least 48 consecutive hours
* Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count \<=200, splenectomy or on cytotoxic chemotherapy
* Neutropenic \[defined as a PMN count\<=0.5x109 cells/L\] from any cause
* Receiving immunosuppressants \[defined as \>=40 mg prednisone daily (or steroid equivalent) for \>=2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life expectancy of at least 12 weeks
* History of histologically documented r/r Grades 1 to 3a FL, or r/r DLBCL
* Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
* Have a clinical indication for treatment as determined by the investigator
* Must have at least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters \[cm\] in its largest dimension by CT scan or Magnetic Resonance Imaging \[MRI\])

Exclusion Criteria:

* Prior use of any monoclonal antibody, radio-immuno-conjugate or antibody drug conjugate within 4 weeks before study start
* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
* Adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to Grade less than equal to (\</=) 2 prior study start
* Completion of autologous stem cell transplant (SCT) within 100 days prior study start
* Prior allogeneic SCT
* Eligibility for autologous SCT (participants with r/r DLBCL)
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Current or past history of central nervous system lymphoma
* Current Grade \>1 peripheral neuropathy
* Vaccination with a live vaccine within 28 days prior to treatment
Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients

The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.

After screening all of 280 patients under regular HD in Faghihi Hospital Hemodialysis Center, 80 stable patients in the age range of 18-80 years old were found to be eligible for enrollment and gave their informed consent to participate in this trial. Subjects were excluded if they were prescribed any multivitamins or immunosuppressive drugs or taking antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study or if they had been hospitalized in the previous month, we also excluded the ones who were pregnant or had active infections. The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients were randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and were followed for 12 weeks.In order to determine the nutritional statuses of all patients, at the baseline, the questions of SGA and MIS questionnaire were read to the patients and completed in person by the main investigator. The questions of SGA and MIS were also asked by the same person at the end of treatment phase.Before the onset of the treatment and after the end of the treatment phase of the study, 10cc blood samples were taken from each patient.The blood was taken from the patient's arm used for hemodialysis cannula just before the beginning of the hemodialysis procedure. The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C. Serum levels of malondialdehyde (MDA), interleukin-6 (IL-6), high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium , phosphate, parathyroid hormone (PTH), albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels were measured in all patients at the baseline and at the end of treatment phase of study.The aim of this study was to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were dialyzed three times a week at least for 3 months or more

Exclusion Criteria:

* Patients who took any multivitamins or immunosuppressive drugs within 2 months prior to enrollment in the study
* Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid,omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study
* Patients who were Hospitalized in the previous month
* Patients who had active infections
* Being pregnant
Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion

The aim of the study is to investigate pain, function and quality of life before and 10-12 months after surgical repair and/or rehabilitation of hamstrings avulsion


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for treatment of hamstring avulsion

Exclusion Criteria:

* Conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions
* Patients that do not speak or understand Danish
Intracranial Aneurysms and Cognitive Function

The prevalence rate of intracranial aneurysms in the adult population is close to 5%. Rupture risk of such aneurysms causing subarachnoid hemorrhage (SAH) can be substantial.Most patients suffering from an aneurysmal SAH are in their mid life, i.e., 30 to 60 years old. Aneurysmal SAH may cause disability and mortality. The present study includes a follow-up study and a cross-sectional fMRI study. The purpose of the follow-up study is to monitor patients receiving prophylactic surgical treatment of their un-ruptured aneurysms to examine whether such treatment is associated with cognitive, psychosocial and/or neurologic sequela. The purpose of the cross-sectional fMRI study is to examine the relationship between memory function and brain activity among SAH patients. Memory impairment is often found among aneurysmal SAH patients. Using fMRI can possibly shed some light on whether such memory impairment may be caused by diffuse cerebral damage or a focal damage at the aneurysm site.


Eligibility Criteria:
Inclusion Criteria:

* Patients with un-ruptured aneurysms in the anterior communicating artery and the middle cerebral artery.
* A subgroup of patients suffering aneurismal subarachnoid hemorrhage.

Exclusion Criteria:

* History of earlier cerebrovascular, psychiatric or neurological disease.
* Age older than 75 years
* Lack of fluency in Norwegian
* Alcohol or Substance abuse
* Aphasia
* Substantial vision or hearing deficits
Bevacizumab for Neovascular Age-related Macular Degeneration

Age-related macular degeneration (AMD) is one of primary blinding eye disease among people over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the effective therapeutic approach that the majority of patients in China can bear establishing a suitable treatment for China.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of neovascular Age-related macular degeneration
* Signed informed consent

Exclusion Criteria:

* No other ocular fundus diseases
Coronavirus: Ventilator Outcomes Using Artificial Intelligence Chest Radiographs & Other Evidence-based Co-variates

We will determine ventilator outcomes to Coronavirus Infectious Disease 2019 (COVID-19) using artificial Intelligence with inputs of chest radiographs and other evidence-based co-variates.

The chest radiograph (chest x-ray) has emerged as the United Kingdom's National Health Service (NHS) frontline diagnostic imaging test for COVID-19, in conjunction with clinical history and key blood markers: C-reactive protein (CRP) and lymphopenia. Typically, every suspected COVID-19 patient presenting to the emergency department is undergoing blood tests and a chest radiograph. Therefore, it has become critical for radiologists to review and "hot" report the chest x-ray urgently.

Primary Objective: Use chest radiographs and clinical data to determine whether patient can survive with a ventilator

Eligibility Criteria:
Inclusion Criteria:

Admitted to intensive care unit (ITU) or equivalent COVID-19 polymerase chain reaction (PCR) positive

Exclusion Criteria:

No imaging prior to ITU admission
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT

This study is a single-center, non-randomized, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft-versus-host disease (GVHD) prophylaxis. The primary objective is to assess the safety and feasibility of abatacept/tacrolimus/mycophenolate mofetil GVHD prophylaxis following omidubicel HCT.

Target enrollment is 10 participants. Subjects are adults with a diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing. Patients will be followed for a total of 18 months and will have research blood draws and Abatacept pharmacokinetics, as well as standard of care assessments that will be reviewed for this study.

It is estimated that 36 months of accrual will be necessary to enroll the targeted sample size with an accrual rate of approximately 1 participant every 3 months. Accrual will be reported by race, ethnicity, gender, and age. Descriptive analyses are planned given the sample size.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing
2. Adult patients (≥18 at the time of enrollment)
3. Adequate organ function for transplant defined as:

   1. Left ventricular ejection fraction ≥ 40%;
   2. DLCO, FEV1, FVC \> 50% predicted;
   3. Total bilirubin ≤ 2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis, and ALT, AST, and alkaline phosphatase all \< 5 x upper limit of normal (ULN);
   4. Serum creatinine within normal range, or if serum creatinine outside normal range, must have measured or estimated creatinine clearance \> 40 mL/min/1.73m2;
   5. Karnofsky performance score ≥ 70; and
   6. If applicable, \> 6 months since a previous autologous transplant.
4. Female patients (unless postmenopausal or surgically sterilized) and male patients (even if surgically sterilized) must agree to practice two effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse from the time of signing informed consent through 100 days post-transplant. Fertility preservation method will be left to treating physician's discretion.

Exclusion Criteria:

1. Patients with known sensitivity to dimethyl sulfoxide, dextran 40, gentamicin, human serum albumin or bovine material
2. Presence of a donor-specific antibodies with MFI \>2000
3. Uncontrolled bacterial, fungal or viral infection
4. Treatment with any other investigational medical product (medications without any known FDA approved indication) needs to be discussed with the PI for patient eligibility.
Fetoscopic NEOX Cord 1K® Spina Bifida Repair

To fetoscopically use cryopreserved human umbilical cord allografts, named NEOX Cord 1K®, as a spinal cord cover of spina bifida defects. This procedure will be performed to create a watertight seal covering over the spinal cord in order to decrease the incidence rates of postnatal morbidities. For larger skin defects, NEOX Cord 1K® may be used as a skin cover.


Eligibility Criteria:
Inclusion Criteria:

Maternal inclusion criteria:

* Singleton pregnancy
* Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
* Maternal age: 18 years and older
* Body mass index \< 40 kg/m2
* No preterm birth risk factors (short cervix, history of previous preterm delivery)
* No previous uterine incision in the active uterine segment
* Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful

Fetal inclusion criteria:

* Spina bifida defect between T1 to S1 vertebral levels
* Chiari II malformation
* No evidence of kyphosis (curved spine)
* No major life-threatening fetal anomaly unrelated to spina bifida
* Normal karyotype, or normal Chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance

Exclusion Criteria:

Maternal exclusion criteria:

* Non-resident of the United States
* Multifetal pregnancy
* Poorly controlled insulin-dependent pregestational diabetes
* Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
* Current or planned cerclage or documented history of an incompetent cervix
* Placenta previa or placental abruption
* Short cervix of \< 20 mm
* Obesity as defined by a body mass index of \> 40 kg/m2
* Previous spontaneous singleton delivery prior to 37 weeks
* Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
* HIV or Hepatitis-B positive status
* Known Hepatitis-C positivity
* Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery
* Other medical conditions which are contraindication to surgery or general anesthesia
* Patient does not have a support person
* Inability to comply with the travel and follow-up requirements of the trial
* Patient does not meet psychosocial standardized assessment criteria
* Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
* Maternal hypertension
* Zika virus positivity
* Allergy/history of drug reaction to Amphotericin B

Fetal exclusion criteria:

* Major fetal anomaly not related to spina bifida
* Kyphosis in the fetus of 30 degrees or more
* Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints
A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients

The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.


Eligibility Criteria:
Key Inclusion criteria:

* Male and female patients 18 to 65 years of age inclusive (at the time of the screening visit), and who passed screening examinations by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
* Presence of atopic dermatitis confirmed by itchy skin condition in the past 12 months (must have), plus three, or more, of the following:

  1. History of involvement of the skin creases (fronts of elbows, behind knees, fronts of ankles, around neck or around eyes)
  2. Personal history of asthma or hay fever
  3. History of generally dry skin in the past year
  4. Onset before age of 2 years
  5. Visible flexural dermatitis
* Patients with an EASI score of ≥20 at screening and stable AD (not currently experiencing an acute flare of their AD or had a significant change in the extent of their disease or their treatment regimen in the month prior to enrollment)
* Patients with a Total IgE in the range of 30 to 5000 IU/mL inclusive

Key exclusion criteria:

* Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means unless they were using a highly effective method of birth control:
* Total abstinence
* Male/female sterilization
* Combination of any two of the following (a+b or a+c or b+c):

  1. Use of oral, injected or implanted hormonal methods of contraception
  2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
  3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment.

Exclusion Criteria:

* Age less than 18 years
* Treatment with other postoperative adjuvant chemotherapy
* Survival is less than 3 months after liver transplantation
* Inability to provide written informed consent prior to study entry