cyrilzakka/clinical-trials huggingface dataset:
S Protein and COVID-19: a Monocentric Prospective Study

The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients.

Non-pharmacological, non-interventional, prospective, monocentric study involving the use of biological materials.

There will be two cohorts:

* COVID + cohort: 50 patients with positive nasopharyngeal swab and / or BAL.
* Control Cohort: 20 patients with non-SARS-CoV-2 related pneumonia.

The study involves analyzing biological samples collected for normal clinical practice.

In particular:

* blood samples will be used for PROS and Sflt1 assay, haematological, biochemical and coagulation tests.
* Samples deriving from nasopharyngeal swab or from Broncho-Alveolar Lavage (BAL) liquid will be used for Real time PCR analysis to evaluate the viral load of SARS CoV-2.

Eligibility Criteria:
Inclusion Criteria:

Cohort COVID + :

* Subjects aged ≥ 18 years.
* Signing of the informed consent.
* Positivity for SARS-CoV-2 by RealTimePCR from nasopharyngeal swab or bronchial wash.

Cohort Control:

1. Subjects aged ≥ 18 years.
2. Signing of the informed consent.
3. Diagnosis of pneumonia not related to SARS-CoV-2, demonstrated by negative swab.

Exclusion Criteria:

* Patients with a diagnosis of congenital S Protein deficiency.
* Patients who are taking oral anticoagulant therapy (TAO) or new oral anticoagulants (NAO).
* Chronic liver failure (\> 5 points on the Child-Pugh score).
* Female subjects who are pregnant or on estrogen-progestogen replacement therapy.
The Clinical Safety of Alcoholic Extract Sahastara Remedy of Extract Capsule in Healthy Volunteers

The clinical safety of Sahastara remedy alcoholic extract in healthy volunteers. Investigators will investigate safety of 100 and 200 mg of Sahastara remedy extract capsule in healthy volunteers. This is Clinical trial Phase I.

The sahastara remedy (SHT) is a Thai traditional medicine that is use to relieve pain of musculoskeletal problem. There is study shown that SHT extract was not found acute and chronic toxicity in rat. However, there is no study regarding safety in human. Thus, this study is a clinical trial Phase I that investigate clinical safety of SHT alcoholic extract in healthy volunteers. The clinical safety will monitor for 28 days in continuously use of 100 and 200 mg SHT extraction 3 time a day and after stop intervention for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* No pregnancy
* No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
* No Supplementary food and/or Vitamin during the study
* Able to follow suggestion during the study

Exclusion Criteria:

* Uncontrolled Hypertension (BP\>140/90 mm.Hg.)
* BMI \> 30
* Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
* On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage

Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.

IVH is one of the most common complications in preterm infants. Nearly 60% of preterm infants with grade III-IV IVH develop severe neurodevelopmental outcomes. There are currently no effective treatments to prevent preterm infants with IVH from developing ventricular dilation or serious neurological disabilities. Recent studies have shown that EPO could improve neurodevelopmental outcomes in preterm infants with grade III-IV IVH. However, the dose and course of EPO in preterm infants is still uncertain. The purpose of the study was whether repeated low-dose EPO (500 U/kg, every other day, for 2 weeks) given to very preterm right after the diagnosis of IVH could improve long-term neurological outcomes. Very preterm infants with gestational age of ≤ 32 weeks who are diagnosed with IVH within 72 hours after birth in NICU are eligible for enrolment. After informed consent is obtained, infants will be randomly assigned to EPO group or vehicle group. The primary outcome is whether EPO improves mortality and neurological disabilities in very preterm infants with IVH at 18 months of corrected age, and the secondary outcome was whether EPO decrease the incidence of cerebral palsy, MDI\<70, blindness, and deafness.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants admitted to NICU ≤ 32 weeks gestation at birth
* Birth weight less than 1500 g
* Less than 72 hours of life at time of enrolment
* Diagnosed as IVH by head ultrasound
* Written informed consent of parent or guardian

Exclusion Criteria:

* Genetic metabolic diseases
* Congenital abnormalities
* Polycythaemia (Hct \> 65%) within first 24 hours of life
* Thrombocytopenia (platelets \< 50K cells/microL) within first 24 hours of life
* Unstable vital signs (such as respiration and circulation failure)
Inadequate Protein Intake at Specific Meals and Functionality in Middle to Older Aged Mexican Adults

This study sought to determine if the inadequate protein intake per meal (defined as eating \<30 g protein or 0.4 g protein/kg body mass) at specific meals (breakfast, lunch, dinner) is associated with functionality in middle to older aged Mexican adults. Functionality was evaluated with self-reported questionnaires to assess their functionality score for different activities of daily living.

Detailed dietary information was obtained for each participant to estimate dietary protein intake per meal (breakfast, lunch, dinner). One meal was considered with inadequate protein intake if its content was \<30 g or 0.4 g/kg.

Functionality was assessed with two validated questionnaires. One for instrumental activities of daily living (Lawton) and another for activities of daily living (Barthel). We calculated a score according to each author's scales. This score was divided into three possible groups as "low", "middle", and "high" scores.

To analyze the association between inadequate protein intake per meal and functionality, we used multinomial logistic regression. The outcome variable was functionality ("High" was the reference group, "middle" and "low" scores were considered as impaired functionality), and the predictive variables were inadequate protein intake at breakfast, lunch, and dinner. They were adjusted for age, BMI categories, number of diagnosed diseases, sex, and inadequate protein intake per day (\<1.2 g/kg/d).

Eligibility Criteria:
Inclusion Criteria:

* Subjects able to stand up and walk independently or with walking sticks only.
* Subjects able to answer questionnaires independently or with minimum caregivers' assistance.

Exclusion Criteria:

* Subjects reporting any kind of hospitalization within the last year.
Study Evaluating MST-997 in Advanced Malignant Solid Tumors

MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered intravenously (IV). This phase 1 dose escalation study is designed to evaluate the safety and tolerability of if IV MST-997 formulated in Polysorbate 80 Diluent can be safely administered on a weekly basis.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of malignant solid tumor with measurable disease
* Life expectancy of at least 12 weeks
* ECOG (Eastern Cooperative Oncology Group) performance status of 0,1,or 2

Exclusion Criteria:

* Recent major surgery, radiation therapy or anti-cancer treatment
* History of any other prior malignancy within last 5 years
The Relationship Between Cerebral State and Emotion in Anesthesiologist and Surgeon

This study was designed to observe the cerebral state obtained via wavelet analysis (HXD-I,Beijing Easymonitor Technology Co.Ltd, China) and evaluate the emotion in various states in anesthesiologist and surgeon. And we also explore the association between the characteristic of cerebral state and the emotion.

A total of 20 anesthesiologist (A group) and 20 surgeon(S group) in Ruijin hospital were enrolled for this study. Except had a medical history of mental illness or emotional disorder and pregnant woman. A group and S group completed emotional self-perceived questionnaire and then observe the characteristic of cerebral state via cerebral state monitor. They also completed anonymous questionnaire, including Maslach Burnout Inventory-General Survey(MBI-GS), Self-reporting Inventory-90(SCI-90), Burnout Measure(BM).

Eligibility Criteria:
Inclusion Criteria:

* A total of 20 anesthesiologist (A group) and 20 surgeon(S group) in Ruijin hospital were enrolled for this study.

Exclusion Criteria:

* had a medical history of mental illness or emotional disorder and pregnant woman.
Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with pain secondary to osteoarthritis of the knee
* Age of 18 years and up
* Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation

Exclusion Criteria:

* Patients who are incapable of judgment and/or to give informed consent
* Patients who are pregnant
* Patients who are under 18 years old
* Patients who have allergies to local anesthetic
* Patients with platelet dysfunction or bleeding disorders
* Patients who are currently mentally unstable
* Patients who have a diagnosis of fibromyalgia
Characteristics of Renal Blood Flow in AKI Patients in ICU and Its Clinical Significance

To study the changes in the renal artery and renal vein with renal cortical and medullary microcirculatory blood flow in patients with sepsis; to study the relationship between renal arteriolar and renal vein with renal cortical and medullary microcirculatory blood flow and renal function; and to find the value of ultrasonographic assessment of renal blood flow indices for evaluating prognosis in patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-85 years old; Control group: patients with non-acute kidney injury after ICU general surgery; Observation group: patients who met the diagnostic criteria of AKI: Scr elevation ≥26.5 umol/L within 48h; Scr elevation exceeding 1.5 times and more than the basal value within 7d; and decrease in urine output (\<0.5 ml/kg/h) with a duration of 6h or more.

Exclusion Criteria:

* Those who did not meet the inclusion criteria or refused to be enrolled; patients with underlying end-stage renal disease or requiring long-term dialysis; renal transplant patients; patients with other underlying systemic diseases causing renal dysfunction (SCr \> 88.4 umol/L); those who were unable to obtain a clear renal ultrasound view; those with suspected contrast allergy; those with pulmonary arterial systolic blood pressure ≥ 90 mm Hg; and those who were pregnant or breastfeeding women.
Managing Side Effects in Clinical Practice

This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).

The purpose of this study is to evaluate patients' reported experiences with regularly prescribed medications. No medications are prescribed as part of this study. Rather, if a patient are prescribed a new medication during their regularly scheduled clinic visit, he/she may be eligible to participate.

Patients who agree to participate and who are prescribed a medication in clinic will be contacted by telephone or email 3 weeks after their appointment to evaluate positive and negative experiences with the medication.

Eligibility Criteria:
Inclusion Criteria:

* Patient is seen in the Division of Gastroenterology at BIDMC
* Patient is prescribed a medication for the treatment of functional gastrointestinal disorders that has not previously been tried by the patient

Exclusion Criteria:

* Patient is not seen in the Division of Gastroenterology at BIDMC
* Patient has previously taken the drug that is prescribed
Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.

A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.


Eligibility Criteria:
Inclusion Criteria:

Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.

Exclusion Criteria:

Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.
Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation

Avoiding warm ischemia time during vascular anastomosis of the renal allograft is important to prevent damage. The investigators are studying a cooling device that may control the temperature of the renal allograft during transplant surgery; attempting to keep temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys.

Warm ischemia can damage a renal allograft in many different ways often leading to early failure of the kidney transplant and sometimes even death of the transplant recipient. For this reason every effort is made to keep the allograft cold during the removal and transportation, and protocols have been developed to ensure this. Although kidneys are kept below 5°C during transportation, they re-warm rapidly during the transplant surgery. On average, kidneys are exposed to 40 or more minutes of dangerously warm temperatures during transplant surgery.

To avoid damage, it is important to reduce the amount of time it is exposed to warm temperatures. Currently, there are no devices or standardized protocols available to ensure a kidney stays cold during the transplant surgery.

The Principal Investigator has developed Kidney Skinn, a device that may control the temperature of the renal allograft during transplant surgery; keeping allograft temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys. The device may also potentially provide retraction and support for the kidney during the transplant operation, making the surgery easier to perform. Additionally, the device may be found to be easily removed once the transplant is complete.

A previous study was conducted with the Kidney Skinn in animals; the next step is to investigate whether the device can perform in the human clinical setting. This study will be done in 2 steps. Part A: a series of consecutive consenting patients to determine device initial safety, and Part B: a single-centre randomized-controlled pilot study of kidney transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age at time of transplant
2. Slated to receive a single cadaveric organ
3. Donor declared by traditional neurological determination of death (NDD)
4. Standard criteria donor (SCD) or Extended criteria donor (ECD)
5. Consent obtained prior to the transplant operation

Exclusion Criteria:

1. Living donor (LD)
2. Donor after cardiocirculatory death (DCD)
3. Highly sensitized patients (those with Panel-reactive antibody or PRA \>80%)
4. Recipient of a previous kidney transplant
Evaluation of TEACH (Training Early Achievers for Careers in Health) Research

The conceptual framework underlying the TEACH Research Program is based on a specific theoretical approach designed to influence adolescent career choice, in this case towards a career in clinical research. The factors responsible for influencing career choice that form the foundation for our investigation are: 1) the importance of role models in career choice; 2) acquisition of knowledge in order to align ambitions; and 3) the participation of students in activities that actively challenge and engage them. These three factors are addressed by the following three components of the TEACH Research Intervention: 1) participation in a research team consisting of a multi-tiered structure of mentors; 2) classroom instruction of clinical research knowledge and career strategies; and 3) a hands-on clinical research experience through an internship on the Hospitalist Project.

The evaluation of TEACH Research (Teaching Early Achievers for Careers in Health) aims to rigorously evaluate a precollege enrichment program in clinical research targeting high school students particularly underrepresented minorities, in order to increase the entry and success of these students into careers in clinical research. Through these measures, the TEACH Research Program will educate high achieving minority students and in turn hopefully encourage and promote these students to think about a career in clinical research.

This projects aims to rigorously evaluate a precollege enrichment program in clinical research targeting high school students, and particularly underrepresented minorities, in order to increase the entry and success of these students into careers in clinical research.

Through the components listed in the brief summary, we hope to promote a career in clinical research among high achieving minority students. To determine whether TEACH research generates these benefits, we will recruit a larger number of candidates interested in the TEACH research than we have spots, then randomly assign students to TEACH Research or the standard more didactic enrichment programs already included in the Collegiate Scholars Program. In addition to determine the overall efficacy of the program, we will study how aspects of the program, including the didactic components, mentored research experience, and work experience, and characteristics of the student affect the development of the knowledge, attitudes, and behaviors needed for a career in clinical research.

Eligibility Criteria:
Inclusion Criteria:

* Junior high school students in the Collegiate Scholars program

Exclusion Criteria:

* Students other than junior high school students
Reduction of Bacteria in MRSA Positive Ulcers

The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent
* Must be 19 years of age or over
* Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.
* Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover

Exclusion Criteria:

* Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)
* Is \< 19 years of age
* Has a clinically infected ulcer
* Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.
* Has been using systemic antibiotics during 7 days prior to enrolment into this study.
* Has an Ulcer / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)
* Has an Ulcer / Lesion size beyond the inner borders of the wound cover
* Is septic or has other signs of an invasive infection
* Has used any other investigational product within 30 days preceding study participation.
* Suffers from a condition, which, in the opinion of the Investigator,would compromise his or her safety.
* Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data.
* Has a known allergy to any of the products that are part of this protocol
* Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection.
* Is using any of the prohibited concomitant medications or treatments
Helicobacter Pylori and Body Iron in Adults

This study is an etiologic trial to test the hypothesis that predicts that Helicobacter pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body iron. The study will assign and aims to complete the follow-up of 240 subjects half of them assigned to a highly effective FDA approved 14-day course of a 3-1 capsule containing bismuth subcitrate, metronidazole and tetracycline plus omeprazole which is now OTC. We have tested the effectiveness of this therapy in the study population and it seems to yield almost 100% eradication on PP analysis. We need the best possible, near 100% eradication rate, which we have already obtained in a pilot, to make comparisons on ITT basis and safely conclude that H pylori leads to a deficit of body iron.

This etiologic double-blind randomized trial in non-anemic mostly asymptomatic/mildly dyspeptic Hp-infected adults will assess whether Hp eradication results in improvements in the levels of iron stores. Iron stores will be assessed by (i) SF as primary outcome, and the following secondary outcomes: (ii) serum transferrin receptor (sTfR), (iii) the ratio of sTfR to SF or R/F, which will be used to estimate body iron, (iv) transferrin saturation (TS), (v) zinc protoporhyrin (ZPP) and (vi) hemoglobin (Hb) at baseline and at 6 months of follow-up. This study is a double-blind randomized clinical trial (RCT) of Hp eradication allocating 400 Hp-infected asymptomatic/mildly dyspeptic adults 18-65 years of age of El Paso, Texas, to receive either (i) a 14-day quadruple Hp eradication therapy described above or (ii) placebo. We expect that at least 240 will complete the study medications and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65, men and women, residents of the geographic target area in El Paso, Texas, who consent to participate and complete at least 10 days of the study medication.

Exclusion Criteria:

* Unsure if they stay in the area, have a history of allergic reactions to any antibiotic, lack adequate specimen for culture, phenylketonurics, women who are pregnant or unwilling to use 2 modern contraceptive methods during the 2-weeks they take the medications, with a history of heavy menses, anemic, history of peptic ulcer disease or had received Helicobacter eradication therapy or have abnormal lab results for kidney and liver functions tests. Will hold the enrollment for 4 weeks to those taking PPI, bismuth salts and antibiotics, and for 3 months since last blood transfusion or receiving intravenous iron preparations.