cyrilzakka/clinical-trials huggingface dataset:
Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

prospective longitudinal measurements of nutritional status parameters (body composition by BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality data collection over 2 year period in patients receiving chronic hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age \> 18 years, in chronic hemodialysis treatment at least 3 months
* Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V \> 1.2 and/or hemodialysis performed 4 hours 3 times weekly
* Patients with normal hydration status (edema-free), with no neuro-muscular diseases
* Informed consent obtained before any trial-related activities

Exclusion Criteria:

* Patients with edema, pleural effusion or ascites at their initial assessment
* Patients with active malignant disease or liver cirrhosis
* Patients with neuro-muscular diseases
* Patients on chronic treatment with steroids on doses \> 10 mg/day Prednisone (or equivalent)
* Patients treated with immunosuppressive agents
* Patients suffering from

  * Acute vasculitis
  * Severe systemic infections
  * Heart failure (NYHA class III-IV)
* The receipt of any investigational drug within 1 month prior to initiating of this study
Patent Foramen Ovale Closure Reduce in SCUBA-divers

It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO).


Eligibility Criteria:
Inclusion Criteria:

* catheter-based PFO-closure because of DCI

Exclusion Criteria:

-
Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria


Eligibility Criteria:
Inclusion criteria:

1. Patients \> 16 years of age.
2. Histologically documented diagnosis of DSRCT, unresponsive or in no complete remission after any conventional multimodality approach.
3. Immunohistochemical documentation of activated PDGF-R expression by tumor
4. At least one measurable site of disease
5. Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group)
6. Adequate end organ function

Exclusion criteria:

1. Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
2. Patient is \< 5 years free of another primary malignancy
3. Patient with congestive heart failure or myocardial infarction within 6 months of study
4. Female patients who are pregnant or breast-feeding.
5. Severe and/or uncontrolled medical disease
6. Known brain metastasis.
7. Chronic active hepatitis or cirrhosis
8. Known diagnosis of human immunodeficiency virus (HIV) infection.
9. Chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
10. Previous radiotherapy to \> 25 % of the bone marrow
11. Major surgery within 2 weeks prior to study entry.

Other protocol defined inclusion/exclusion criteria may apply.
Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device

Thermoplastic devices are used in orthodontic treatment and consists of a series of nearly invisible, removable aligners. However, every device used in the mouth can change the buccal flora and increase the number of bacterias. This is a risk factor for enamel demineralization. The treatment can vary in time of use per day. The patient under orthodontic treatment has to use the device for 22 hour each day. When the period of retention comes, it is reduced to 8 hours. The investigators want to know if the concentration of bacterias in saliva and dental plaque will increase, and if the material can cause damage on gingiva.

The orthodontic thermoplastic devices became more affordable and with simple techniques, due to the technological advancement. The main advantage of this appliance is that it is nearly invisible, seen that patients do not want to show braces. Others reasons for searching this kind of treatment is because it is removable. While eating, brushing the teeth or even in a important social event, there is the facility to remove the appliance. In the other hand this appliance, according to the american board association, does not finish the treatment as well as the conventional braces. Another problem is that every device placed in the mouth is more plaque retentive, increasing the risk of enamel demineralization. Also, this device disrupts the normal flow of the saliva, preventing the buffering. This study will analyse the amount of streptococcus mutans and lactobacillus in the saliva and in the biofilm of the teeth and of the appliance, seeded in culture medium. Another point, is check the prognosis of the gingival health owing to the contact with the device during the hole treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have stabilized their growth between 16 and 40
* Who have agreed to participate in the study if elected and to sign informed consent
* Residing in the metropolitan area of Curitiba and have the opportunity to attend recall appointments

Exclusion Criteria:

* Periodontal status deteriorated
* missing teeth
* Cleft lip and palate
* History of orthognathic surgery
* History of dental or skeletal open bite
* Presence of some habit oral tongue thrusting, mouth breathing, thumb sucking even after termination of orthodontic treatment
Assessment of the Psychosocial Impact of the COVID-19 Pandemic on the MD Anderson Cancer Center Workforce

This study investigates the impact of the COVID-19 pandemic on the psychosocial health of employees of MD Anderson Cancer Center. Epidemics have been shown to promote psychological stress among medical staff in high risk areas, which may lead to mental health problems. Assessing how the pandemic is affecting employees may allow for more comprehensive actions to be taken to protect the mental health of employees.

PRIMARY OBJECTIVE:

I. To assess psychosocial and stress-related outcomes in employees at MD Anderson Cancer Center during and post the COVID-19 pandemic.

SECONDARY OBJECTIVE:

I. To identify demographic and occupational factors associated with COVID-19 related psychosocial and stress outcomes.

OUTLINE:

Participants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.

Eligibility Criteria:
Inclusion Criteria:

* MD Anderson employees
Dichoptic Video Treatment for Amblyopia

1. To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children
2. To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)

Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. However, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. To provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. Families will have the option to continue with the vdeos for up to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 3 to 7 years old
* Amblyopic eye visual acuity 20/32-20/125
* Fellow eye visual acuity 20/16-25
* Interocular visual acuity difference of at least 2 lines
* Anisometropia or corrected strabsimus (\<5pd)
* in glasses at least 8 weeks or no change in visual acuity over two visits
* no prior binocular treatment
* must be able to see full video screen

Exclusion Criteria:

* prematurity of 8 weeks or more
* coexisting ocular or systemic disease
* developmental delay
* poor ocular alignment (\>=5 pd)
Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication

Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.

The hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.

People with the selection criteria for the study, coming to the nuclear medicine department in order to benefit from a Gallium-68-DOTATOC PET/CT exam as part of a diagnostic or pre-therapeutic assessment of a neuroendocrine tumor will be offer to participate in the study After sign consent, patients were install in a room to have blood drawn for Troponin Ic, BNP and CRP and after Gallium-68-DOTATOC infusion Gallium-68-DOTATOC PET/CT will be recorded and immediately the cardiac record in Gated mode

Eligibility Criteria:
Inclusion Criteria:

Persons who have received complete information on the organization of the research and who have signed the informed consent and:

* Age ≥ 18 years old.
* Having read and understood the information document.
* Affiliated to a social security scheme.

Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumour.

Exclusion Criteria:

Person with

* Hypersensitivity during previous use of 68Ga-DOTATOC
* Impossibility of performing a PET-CT (patient agitated, confused, etc.).
* History of heart disease,
* Severe arrhythmia that does not allow the PET synchronized with the ECG
* Severe renal insufficiency (GFR \<30 ml/min/1.73 m2)
* Treated with a somatostatin analogue.
* Cushing's syndrome
* Pregnant woman, likely to be or breastfeeding
* Adult subject to a legal protection measure (guardianship, curators, legal safeguard)
* Person of legal age unable to express their consent
* Person deprived of liberty by a judicial or administrative decision
* Person, subject to psychiatric care under articles L. 3212-1 and L. 3213-1
Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with STEMI
2. Informed, written consent

Exclusion Criteria:

1. Age \< 18 years or Age \> 90 years
2. Active bleeding; bleeding diathesis; coagulopathy
3. Increased risk of bradycardic events
4. History of gastrointestinal or genitourinary bleeding \<2 months
5. Major surgery in the last 6 weeks
6. History of intracranial bleeding or structural abnormalities
7. Suspected aortic dissection
8. Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, unconsciousness, known malignancies or other comorbid conditions with life expectancy \<1 year)
9. Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
10. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
11. Known relevant hematological deviations: Hb \<10 g/dl, PLT\<100x10\^9/l
12. Use of coumadin derivatives within the last 7 days
13. Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
14. Known severe liver disease, severe renal failure
15. Known allergy to the study medications
16. Pregnancy
17. Human immunodeficiency virus treatment
18. The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days).
19. If the patients cannot sign percutaneous coronary intervention (PCI) informed consent for any reason.
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)

It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.


Eligibility Criteria:
Inclusion criteria for T2DM

* Diagnosis of T2DM
* Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin
* Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration
* Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%

Inclusion criteria for healthy subjects:

* Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)

Inclusion criteria for all subjects:

* Subjects with (eGFR ≥ 60 and ≤ 160 mL/min/1.73m² and urinary albumin excretion \< 300 mg/g creatinine)
* Body Mass Index (BMI) of 18 to 38 kg/m²
* Men and women, ages 18 to 65 years, inclusive

Exclusion criteria for all subjects:

* Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus
* Subjects with T2DM with fasting plasma glucose \> 200 mg/dL, healthy subjects with fasting plasma glucose \> 105 mg/dL
* Subjects with T2DM with HbA1C \> 10.0%, healthy subjects with HbA1C \> 6.8%
The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Pilot)

The purpose of the study is to evaluate of the relationships between fractionated exhaled nitric oxide, disease activity, and symptom severity in patients with eosinophilic esophagitis compared to those without eosinophilic esophagitis.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patient who will undergo esophagogastroduodenoscopy with biopsies at Children's Memorial Hermann Hospital, as part of the standard of care in the evaluation of EoE
* Able to perform the single-breath exhalation for the hand-held analyzer, NIOX MINO (Aerocrine, Sweden)
* Signed informed consent by a parent or legal guardian
* Signed assent form by the child/adolescent subjects 7-18 years of age

Exclusion Criteria:

* Past medical history of asthma, allergic rhinitis, IBD, parasitic infection, hay fever and any exposure to smoking (including secondhand smoke) because these disorders are known to affect the FeNO levels
* Active respiratory tract infections at the time of FeNO evaluation because this can affect the result of the FeNO as well
* Asthma questionnaire and/or Spirometry test consistent with asthma
Topical Application of Essential Oils to Treat Onchomycosis

Patients with documented onychomycosis of one or more toe nails will be treated with a daily application of a topical lacquer containing several essential oils.

The topical lacquer contains the following components:

Active ingredients:

Hydroxypropyl Chitosan OLEOZON(r) - natural, ozonized sunflower oil. Vitamin E Tea Tree Oil Cannabidiol

Vehicle:

Nanoparticle medium chain triglyceride oil

Eligibility Criteria:
Inclusion Criteria:

Clinician observation consistent with probable onychomycosis of one or more toenails.

Positive polymerase chain reaction (PCR) for fungal infection or Positive Periodic Acid Schiff, Biopsy, KOH or Culture for fungal infection -

Exclusion Criteria:

Unwlling to discontinue current anti-fungal medication, oral or topical

-
An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

This prospective observational study aims to evaluate safety, application and onset of effect of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the first 6 months (in case of re-therapy: 12 months).


Eligibility Criteria:
Inclusion Criteria:

* No pretreatment with rituximab
* Age 18 years or older
* Patients with active, severe rheumatoid arthritis with prescription of rituximab according to German Summary of Product Characteristics (SmPC - "Fachinformation")
* Patients with signed informed consent
* Female patients with secure contraception

Exclusion Criteria:

* Violation of Selection criteria:

  1. Active severe infection
  2. Severe heart failure (NYHA class IV) or severe, uncontrollable heart disease
  3. Participation in an interventional study within the last 3 months before therapy start with rituximab
  4. Pretreatment with rituximab
  5. Age \<18 years
  6. Known intolerability of monoclonal antibodies or chimeric monoclonal antibodies
  7. Known pregnancy or breastfeeding
* Data of patients without approval of data by the physician
* Patients without informed consent
* Double documentation
Pharmacologic Treatment in Legal Offenders With Schizophrenia, a Prospective Observational Mirror Image Study.

Considering the vulnerability of patients with schizophrenia in forensic treatment, we have designed a prospective-observational trial. The purpose of our study, notably its focus on selecting the appropriate medication, developing clinical profiles, and determining the grounds of clinical judgment, is relevant for treating patients with schizophrenia.

Patients with a schizophrenia spectrum disorder who commit violent crimes appear to have some distinguishing characteristics. The current view is that crime committed in the course of a psychiatric illness, particularly schizophrenia, is treatable and preventable. Nonetheless, treatment options for this patient group are sparse. The evidence regarding the efficacy and safety of such treatments is practically nonexistent. In practice therapeutic options are limited to medication and even here there is only one antipsychotic (clozapine) which has The current view is that crime committed during a psychiatric illness, particularly schizophrenia, is treatable and preventable. Nonetheless, treatment options for this patient group are sparse. The evidence regarding the efficacy and safety of such treatments is practically nonexistent. In practice, therapeutic options are limited to medication; even here, almost no controlled clinical trials are investigating this issue.

In clinical practice, selecting specific psychopharmacological treatments for patients with schizophrenia showing violent or aggressive behavior is particularly demanding. The lack of evidence regarding treatments for this particular group is partly attributable to their dual vulnerability and the consequent restrictions on clinical and experimental trials. Paradoxically, the efforts to ensure the safety and rights of these patients put them at a disadvantage, as they have no access to evidence-based treatment for their condition. Therefore, at best, they experience limited or slow improvement in their condition or, at worst, receive potentially ineffective or deleterious treatment.

To address the lack of evidence regarding the efficacy and safety of antipsychotic treatment options for this particular population, the investigators have designed a prospective observational study with evaluation in a mirror image design. This reduces confounders at the level of a randomized controlled trial, allowing for robust statistical analysis.

Eligibility Criteria:
Inclusion criteria

* Participants are competent to give informed consent.
* Participants are between 18 and 65 years of age.
* Diagnosis of schizophrenia DSM-5
* Violent crime in the course of a psychotic episode.
* German language proficiency

Exclusion criteria

* Low intelligence
* Current neurological disorder
* Substance induced psychotic disorder
Genetic Influence on Statin Pharmacodynamics

The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)


Eligibility Criteria:
Inclusion Criteria:

* recently (within past 3 months) started taking atorvastatin, lovastatin, or simvastatin

Exclusion Criteria:

* concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)

This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of \>/=33 on the PCL-5 at screening
* The index trauma event must have occurred in adulthood, i.e., when the participant was \>/=18 years old
* The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening
* At baseline, either taking a stable dose of a single antidepressant (SSRI or SNRI) for management of PTSD and have been on that medication for \>/=6 weeks at that stable dosage and demonstrating residual symptoms of PTSD or prior demonstrated lack of tolerability or lack of efficacy and not taking an antidepressant medication at baseline for \>/=6 weeks
* Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
* For women of childbearing potential: agreement to remain abstinent or use contraception

Exclusion Criteria:

* Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening
* Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug
* Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
* Substance use disorders during last 12 months
* Significant risk for suicidal behaviour
* Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
* Clinical diagnosis of peripheral neuropathy
* Within the last 2 years, unstable or clinically significant cardiovascular disorders
* Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
* Moderate or severe hepatic or renal impairment
* History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic)
* Medical history of malignancy, if not considered cured
* Participants who have received treatment with investigational therapy within 8 weeks prior to randomization
* Known hypersensitivity to balovaptan, its components, or any of the excipients used in the formulation
Outcomes of Stem Cells for Cerebral Palsy

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy of any types caused by oxygen deprivation.

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections