cyrilzakka/clinical-trials huggingface dataset:
Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial

In this study, we aim to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

Sepsis and Septic Shock are common and highly morbid clinical conditions without any specific therapy aside from antibiotics. A recent quasi-experimental study (Marik et. al., PMID 27940189) demonstrated a remarkable benefit when the combination of Ascorbic Acid (Vitamin C), Corticosteroids, and Thiamine (Vitamin B1) were given to patients with sepsis. In particular, patients who received this combination of medications required a shorter amount of time on vasopressors, suffered less organ failure, and had improved mortality. Vitamin C has long been suggested for treatment of patients with severe infection as it exerts significant anti-oxidant effects and reduces endothelial permeability. Corticosteroids, a mainstay of therapy for refractory shock in sepsis, have also been shown to enhance the beneficial cellular effects of vitamin C. Finally, thiamine has been shown to be an effective mitochondrial resuscitator in sepsis, especially for the \~30% of septic shock patients who present with thiamine deficiency (Donnino et. al, PMID 26771781).

In this study, we aim to reproduce the findings of Marik et. al. using a more rigorous study design (i.e. a blinded, randomized clinical trial) and focus on the important clinical outcomes of organ failure and death.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient (age ≥ 18 years)
2. Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection
3. Receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin)

Exclusion Criteria:

1. Member of a protected population (pregnant, prisoner)
2. Known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging)
3. End stage renal disease (ESRD) requiring dialysis
4. Known Glucose-6-Phosphate Dehydrogenase deficiency
5. Known Hemachromatosis
6. Comfort Measures Only status
7. Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician)
8. Receiving supplemental thiamine in a dose greater than that contained in a multivitamin
9. Clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug
10. Clinical indication for thiamine as determined by the clinical team providing this drug
11. Clinical indication for ascorbic acid as determined by the clinical team providing this drug
12. Known allergy to vitamin C, hydrocortisone, or thiamine
The SIR-POBA Bypass Trial

The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.

This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options (plain old ballon angioplasty versus sirolimus coated balloon angioplasty). The recruitment phase is calculated for two years with a planned follow-up of 2 years. Follow-up data will be collected to answer the endpoints and will include all available follow-ups to monitor the bypass up to 2 years after the procedure. Typically, follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the procedure.

Eligibility Criteria:
Inclusion Criteria

* Age at least 18 years
* Informed consent with signature
* Rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (Rutherford 4-6)
* Venous bypass stenosis requiring intervention
* Confirmed inflow
* At least 1 crural outflow vessel

Exclusion Criteria:

* Pregnant or lactating women
* Active infection or sepsis
* Patients currently participating in another clinical trial
* Unconfirmed inflow
* Intolerance to sirolimus
* Coagulopathy
* Radiotherapy
* Patients on immunosuppressive therapy
* Non-dialysis renal insufficiency (eGFR \< 45 ml/min/1.73m2)
* Use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).
Reliability and Validity of the Dutch Language Version of the CFCS-NL and the VSS-NL in Flanders, Belgium

The study aims to determine the reliability and validity of the CFCS-NL and VSS-NL (both speech and language-related classification scales for children with cerebral palsy) for Flanders so they can be implemented within the CP-referencecentre at UZ Leuven, amongst the classification scales that are already being used.

Within the CP-referencecentre, the gross motor (GMFCS), fine motor (MACS) and swallowing (EDACS) skills have of children witch cerebral palsy (CP) have long been classified. In the speech and language pathology field, the Communication Function Classification Scale (CFCS) and the Viking Speech Scale (VSS) were recently developed. The CFCS maps communication as a whole and is a five-point scale. The CFCS is analogous to the aforementioned scales. The VSS focuses on speech intelligibility and is a four-point scale.

This research is based on determining the reliability and validity of the above scales for Flanders so that they can be implemented within the CP-referencecentre. In addition, the mutual relationship between the scales and the relationship between the CFCS-NL and the other classification scales for CP (GMFCS, MACS \& EDACS) will be determined. The VSS will also be translated into Dutch beforehand, this is a collaboration with the VU University Amsterdam (dr. Joke Geytenbeek).

The study is a cross-sectional study. The patients (n = 20) will be recruited during the consultations at the CP-referencecentre between February 1, 2019 and April 30, 2019. The selection criteria consist of: diagnosis of CP, age of 4 t.e.m. 10 years, single language education in Dutch, no diagnosis of ASD and a signed Informed Consent Form.

A questionnaire bundle will be given to the parents of the participating patients (completion time approx. 30 to 45 minutes). This includes a few questionnaires about characteristics of the child / filler, two questionnaires about the social communication skills and the social interaction skills of the child, and the CFCS and VSS scales which the parents have to score. This questionnaire bundle (with the exception of the questionnaires concerning social communication skills and social interaction skills) will also be given to the child's teacher and a treating paramedic. In addition, an appointment will also be made at the patients house where a video recording (2x15min) will be made in which the child interacts with a trusted person and an untrusted person (the researcher) so that the CFCS- NL and the VSS-NL scores of the child can be determined by the student and the speech therapists of the CP-referencecentre. During that appointment one of the parents will also be interviewed using the subdomain "Social Functioning" of the PEDI-NL.

After data collection, a quantitative data analysis is performed to obtain an answer to the research questions.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy
* GMFCS I-V

Exclusion Criteria:

* Bi- or multilinguism
* Diagnosis of autism
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least one year
* HbA1c 7-11% (both inclusive)
* Treated with insulin for at least six months - any regimen

Exclusion Criteria:

* Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation
* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product
Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome

Prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births.

assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal respiratory distress syndrome and NICU admission as a result

Term neonates born between (37-39 wks) by elective cesarean section are likely to develop respiratory distress syndrome more than neonates born by vaginal delivery, and this risk increases for the subgroup of neonates born after elective caeserean section , i.e. before onset of labour , , with potentially severe implications The risk is decreasing with advanced gestational age and neonates born in 37 weeks are at 1.7 times more than those born at 38 weeks , which in turn are at 2.4 times more than those born at 39 weeks If the pregnant female is given four intramuscular injections of 6 mg of dexamethasone , 48 hrs before elective caesarean section decreases the neonatal respiratory morbidity. Five studies lasting between 3 to 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid , neither through infection of the fetus or mother nor in long term neurological or cognitive effect According to Cochrane Database of Systematic Reviews 2018 , prophylactic administration of antenatal corticosteroids appeared to reduce the rate of RDS by approximately 52%. It also reduced the need for NICU admission, both due to respiratory morbidity (by approximately 58%) and for any indication. The reduction of NICU admissions due to respiratory reasons is consistent with the reduction of respiratory morbidity after corticosteroid administration

Eligibility Criteria:
Inclusion Criteria:

* Gestational age (37-39wks).
* Singleton pregnancy.
* Didn't receive any steroid treatment during pregnancy.

Exclusion Criteria:

* Undetermined gestational age
* Maternal chronic diseases (e.g: hypertension, DM-2) to avoid any side effects of steroid use and to keep the pregnant 's case from getting worse.
* Congenital fetal malformations
* Emergency CS
* Pregnant refusing to participate in the study or unable to consent
Bariatric Surgery and Pharmacokinetics of Losartan

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on losartan are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Vitamin D on Prevention and Treatment of COVID-19

The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.


Eligibility Criteria:
Inclusion Criteria:

* Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.

Exclusion Criteria:

* Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms

Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography \[PET\] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy. Screening consists of a Fluorodeoxyglucose Positron Emission Tomography \[FDG-PET\] and tumor imaging, medical history, physical examination, Eastern Cooperative Oncology Group \[ECOG\] performance status, blood draws, a pregnancy test for female patients of childbearing potential. Treatment consists of PF00562271 tablets continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic malignancies who have tumor appropriate for serial biopsy.
* Adequate organ function, including bilirubin less than 1.5 x ULN, and \[Eastern Cooperative Oncology Group\] ECOG performance status of 0-2.

Exclusion Criteria:

* Clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent CYP 3A4 inhibitors, and history of clinically significant cardiac or pulmonary disorders.
Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

Collection of tissues for analysis from patients undergoing elective neck dissection.

The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.

The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection.

The specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.

Eligibility Criteria:
Inclusion Criteria:

* All patients with biochemical evidence of squamous cell carcinoma of the head and neck.

Exclusion Criteria:

* Patients without biomedical evidence of squamous cell carcinoma.
Improving Primary Care in Patients With Mental Disorders

This study will determine the effectiveness of medical case management in improving the medical care of people with mental disorders or substance abuse problems.

Poor quality of care may contribute to impaired health status and increased mortality in individuals with serious mental disorders and substance abuse problems; interventions designed to improve medical care for this population need to be developed. This study will develop a population-based medical case management model for improving the primary medical care of patients at an inner city community mental health center.

This study will last 2 years. Participants will be randomly assigned to receive medical case management or standard of care (typically drug and behavioral therapy) for 2 years. Participants in the case management group will receive help in overcoming barriers to receiving primary care. Participants will also undergo 5 interviews over the 2-year study duration, and have annual chart reviews. Results of the interviews will be used to assess quality of primary care, service use, health outcomes, psychiatric symptoms, and substance use.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mental illness or substance abuse
* Patient at Florida Hall (Grady Health Systems)

Exclusion Criteria:

* Current use of medical case management
Effect of Formula on Infant Behavior

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health as determined from subject's medical history by parent report
* Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
* Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* Subject is between 7 and 42 days of age
* Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
* Infant is exclusively formula-fed at time of study entry
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
* Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

Exclusion Criteria:

* An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
* Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
* Subject participates in another study that has not been approved as a concomitant study
* Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment
* Subject has been treated with oral antibiotics within 7 days prior to study enrollment
* Mother intends to use a combination of breast and formula feeding
The Effect of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy

The purpose of this study is to research more reasonable and safe methods of nutritional support to improve the nutritional status of tumor patients, which guarantees the anti-tumor treatment such as chemotherapy.

This study is a prospective, randomized, controlled clinical trials. 300 patients were randomly divided into 2 groups for its own control study.

Test group: Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g,Bid), a total of 150 people, are used for 42 days continuously.

Placebo group: Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g, Bid), a total of 150 people, are used for 42 days continuously.

The subjects were randomized to AB or BA parallely, and the two groups were given chemotherapy and nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 70 years old
* Breast or lung cancer was diagnosed by pathology or cytology
* ECOG score: 0-2 points
* PG-SGA: 2-8 points, while the weight loss within 3 months less than 5%
* The organ function is good, with chemotherapy index. ANC is equal to or over 1.5 \* 10\^9/L, PLT is equal to or over 100\* 10\^9/L, HGB is equal to or over 90g/L
* Bilirubin is equal to or less than 1.5 times of the normal upper limit, AP, AST, ALT is less than or equal to 2 times of normal upper limit
* Ccr is equal to or over 50mL/min
* Life expectancy is equal to or over 12 weeks

Exclusion Criteria:

* Complete or incomplete intestinal obstruction
* A severe infection or difficult to control diabetes
* History of organ transplantation, or current use of immunosuppressive agents
* An intervention in nutritional supplements, or a metabolic disorder
* Parenteral nutrition must be applied
* Alcoholism or drug addiction
* Pregnancy or lactation, or women of childbearing age refuse contraception
* There are potential factors that interfere with the mental, psychological, family, social or geographical and other factors of the research project
* There are other diseases that may interfere with the results of this study, such as the second primary tumor
* For any other reason, the researchers were unable to complete the study
Gastric Cancer Prevention for Indigenous Peoples

The incidence of gastric cancer in local indigenous peoples is higher than the non-Indigenous counterpart in Taiwan. How to design an effective prevention strategy for gastric cancer is of importance. The present study aimed to identify the causes that may account for the health inequalities, allowing generation of a plan of action on the whole population scale.

Owing to the continuing gap in cancer burden between Indigenous and non-Indigenous peoples, reducing health disparities has drawn worldwide attention. Evidence indicates that the gastric cancer incidence and mortality rates in Indigenous peoples are much higher than those of non-Indigenous counterparts living in the same areas. Exposure to more risk factors from social habits, lifestyle, and Helicobacter pylori infection has been considered the cause. However, even though gastric cancer has been repeatedly shown to be preventable by eliminating risk factors, eradication policies are rarely designed for Indigenous peoples. Possible obstacles may include the lack of Indigenous health statistics, inadequate access to care, difficulty in modifying social habits and lifestyles, and the presence of environmental and cultural barriers. Developing and implementing a preventive strategy following the evidence-based principle remains a challenge.

In Taiwan, the number of Indigenous peoples has grown; however, their life expectancy remains substantially lower than that of the non-Indigenous population. Cancer is the most prevalent cause of death for Indigenous peoples and a disproportionate prevalence of certain kinds of cancer is noted for Indigenous peoples. These observations provide an opportunity to establish a plan of action, in which a specific intervention is developed to decrease the threat from each specific cancer so that the overall disparate burden can be reduced in a stepwise manner.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-60 years
* Mentally competent to be able to understand the consent form
* Able to communicate with study staff for individuals

Exclusion Criteria:

* Pregnancy
* Individuals with major comorbid diseases