cyrilzakka/clinical-trials huggingface dataset:
Effect of Proton Pump Inhibitors on Endothelial Function

In this randomized controlled crossover study, the investigators propose to test the hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric dimethylarginine (ADMA), which is a marker of endothelial dysfunction. The authors propose to evaluate ADMA concentrations and vascular function analysis in healthy volunteers and adults with a history of cardiovascular disease given PPI vs placebo for four weeks each.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers aged 18 to 75 years (n=10) or male or female volunteers with a history of coronary or peripheral artery disease (n=10)
* Able to understand the nature of the study and to give written informed consent
* Able to communicate well with the investigator himself or his/her representatives
* Body Mass Index between 18 kg/m\^2 and 35 kg/m\^2 at the screening visit
* Creatinine \<1.5, and liver enzymes \<2x normal, with all laboratory tests considered normal or of no significant clinical relevance to the study by the investigator

Exclusion Criteria:

* Contra-indication to proton pump inhibitor treatment
* Current treatment with PPI or H2 antagonist, and not able to tolerate withdrawal or washout of medication.
* Current or historical evidence of clinically severe cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease.
* Any other acute or chronic disease which could influence the volunteer's health and/or the study results
* Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or hernia repair
* Use of enzyme inducers or enzyme inhibitor drugs within the last three months before the first drug administration
* Participation in another ongoing clinical trial
* Past or current drug exposure amounting to drug abuse or addiction
* Past or current alcohol exposure amounting to alcohol abuse or addiction (i.e. \> 28 units per week for males, where 1 unit = one measure of spirit (25 mL), one glass of wine (125 mL) or 1/2 pint beer)
* Donation of blood or any other major blood loss (\>500 mL) within three months before the study
* Unwilling or unable to comply with the study protocol for any reason or in the opinion of the investigator should not participate in the study
* Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV-1 or HIV-2 antibody at screening
* Known allergy or intolerance to any other compound in the study drug or any other closely related compound
Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema

The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema.

Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Everyone in the trial will use delgocitinib cream.

The trial will last up to 7 weeks and there will be 6 visits and a phone call. There will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above at screening.
* Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
* Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
* Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
* Subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.

Exclusion Criteria:

* Concurrent skin diseases on the hands, e.g. tinea manuum.
* Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet.
* Active psoriasis on any part of the body.
* Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
* Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
* Use of tanning beds, phototherapy (e.g. ultraviolet B \[UVB\], ultraviolet A1 \[UVA1\], psoralen ultraviolet A \[PUVA\]), or bleach baths on the hands within 28 days prior to baseline.
* Cutaneously applied treatment with immunomodulators (e.g. phosphodiesterase 4 \[PDE-4\] inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline.
* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
* Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth

The present study is a randomized, placebo-controlled, double blinded study to evaluate efficacy of EB-PA as protein amplifier for skeletal muscle strength \& growth in males with active lifestyle. Approximately 160 subjects aged between ≥ 20 and ≤ 35 years will be screened and 138 participants are to be randomized. Both the IP and placebo study arms will have at least 40 completed subjects after accounting for the screening failure and dropout/withdrawal rate of 14% and 13 % respectively (Total 120 completers). The treatment duration for all the study subjects will be 30 days. The sustained effect of the product will be observed for next 7 days, wherein, the subjects will be abstaining from the protein and IP supplementation and will exercise at their ease.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 20 - 35 years with active lifestyle with moderate physical activity level as per International Physical Activity Questionnaire.
* Recreationally gym goer with history of at least 1 month of endurance training (E.g.: functional exercises)
* Not participating in resistance type training (E.g.: external or body weight training) for ≥3 months prior to screening.
* Body mass index (BMI) 22 - 29.9 kg/ m2.
* Individuals with a 1-RM strength defined by Upper Body ≥ 25 Kgs and Lower Body ≥ 100 Kgs will be included in the study.
* Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs prior to the exercise lab visit.
* Fasting Blood Glucose ≤ 110 mg/ dl.
* Systolic Blood Pressure ≤ 129 mmHg and Diastolic Blood Pressure ≤ 89 mmHg.
* TSH (thyroid stimulating hormone) ≥ 0.4 and ≤ 4.9 mIU/L.

Exclusion Criteria:

* Engaged in structured weight training for more than 3 months prior to screening.
* Presence of chronic disease.
* Changes in body weight more than 4.5 kg (10 pounds) in the past three months as assessed by history.
* Subjects diagnosed with hypertension.
* Subjects who are diagnosed with Type I Diabetes Mellitus and Type II Diabetes Mellitus.
* History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
* Allergy to whey protein or herbal ingredients.
* Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put them at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
* Subjects who have been part of a clinical study within 90 days prior to the screening.
* Subjects who have used whey or other supplemental proteins anytime in last 3 months.
Evaluation and Follow-up of People With Tick-borne Diseases

Background:

Lyme disease is the most common tick-borne disease in the United States, but other diseases transmitted by ticks have also been on the rise in recent years. Early symptoms of a tickborne disease include fever, headache, fatigue and possible rash. Researchers want to collect information and samples from people with Lyme disease and other tick-borne illnesses to better understand and diagnose these diseases.

Objective:

To evaluate and follow people with tick-borne diseases to help researchers learn more about these infections.

Eligibility:

People ages 18 and older who have or are suspected of having a tick-borne infection.

Design:

Participants will have an initial visit, and visits about 1, 6, and 12 months later. The visits can include a physical exam, blood tests, collection of blood, urine and saliva samples for research, and filling out health-related questionnaires. Participants who have the rash of Lyme disease may be invited to have up to 3 skin punch biopsies of the rash for research.

Lyme disease is a multisystem illness caused by the spirochete Borrelia burgdorferi and it is the most common vector-borne illness in the United States. Tick-borne disease cases reported to the Center for Disease Control and Prevention (CDC) have been on the rise with over 59,000 cases reported in 2017. This protocol is designed to collaborate with University of Maryland School of Medicine for the purpose of recruiting and enrolling patients with Lyme disease and other tickborne illnesses. This is a natural history study which has the objective of developing a rigorously defined population of patients with Lyme disease and other tick-borne illnesses, per CDC case definitions, to serve as the basis for research in multiple aspects of the infections. These research sub-projects have emphasis in exploring the biological markers of tick-borne infections, developing new diagnostic tests for these infections, assessing the clinical course and outcome of patients with these tick-borne infections, and defining the immunological response to the pathogens.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Clinical diagnosis of suspected, confirmed, or probable LB or other TBD per CDC case definitions.
* Has not received antibiotic therapy for tick-borne disease for more than 2 weeks.
* Age \>=18 years.
* Able to provide informed consent.
* Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other disorders.

EXCLUSION CRITERIA:

* Post-treatment Lyme disease syndrome
* Women who report they are pregnant.
* Any other condition or history of unacceptably poor compliance that, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the study.
Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).

Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.

Eligibility Criteria:
Inclusion Criteria:

* Suffering a cancer
* Evaluated within a cardio-oncology program

Exclusion Criteria:

* None
Evaluation of a Device That Separates Blood Cells From Serum/Plasma

There are many instances where there is no access to a centrifuge (Emergency wards, EMT truck, battle field, etc.) or when a result is needed immediately (myocardial infarction); a new collection tube which could separate serum and plasma from whole blood immediately upon, if not during, collection, would be extremely beneficial. Such a new tube could save time and cost by eliminating centrifugation steps that are currently required to obtain serum and plasma.

A new blood collection tube has recently been developed; the tube separates serum/plasma from the whole blood while the blood flows into the tube. This is accomplished by a filter set inside the tube; the filter set may be impregnated with an anti coagulant agent, such as sodium citrate (blue top) or may be virgin (red top). The serum collection part of the tube is disconnected from the filtering part upon completion of the serum collection, capped with a lid, and forwarded to a bed-side instrument or to a test analysis laboratory. The filter part is discarded in a hazardous waste container. Blood Separation free of red cell damage is achieved by controlling blood flow rate into the device. A 30 second flow intake is typical. The flow rate controller in use in this experiment is an element added in line to the standard blood drawing needle set.

This study is being conducted to compare concentrations of routine clinical chemistries (analytes and electrolytes) measured in serum/plasma obtained from routine standard blood collection tubes to novel blood collection tubes that separate blood cells from whole blood while the blood is being drawn. Routine clinical labs will be performed on the serum and the plasma obtained from the standard and the novel tubes to evaluate the efficacy of the novel tubes to recover cell-free serum for measuring various routine blood analytes as compared to standard tubes.

Procedure Plasma, as well as serum, will be collected and analyzed in the study. While the blood collection procedures for each of these are the same, collection of blood into the standard tube differs from that into the serumSTAT tube; the subsequent post-treatment of the blood/serum/plasma differs from one to the other. The serum will be ready for analysis after completion of the steps. The procedure for how to draw the blood using the new device will be explained and demonstrated to the phlebotomist to ensure (s)he is comfortable using the device.

The following routine clinical chemistry shown in the metabolic panel below shall be measured ;

1. Albumin
2. AlkalinePhosphatase
3. ALT (Alanine Transaminase)
4. AST (Aspartate Transaminase)
5. BUN (Blood Urea Nitrogen)
6. Creatinine
7. Glucose
8. Total Bilirubin
9. Total Protein
10. Calcium
11. Carbon Dioxide
12. Chloride
13. Potassium
14. Sodium
15. Troponin I

Furthermore, the BUN/Creatinine ratio shall also be presented in the data set.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 y/o

Exclusion Criteria:

* NONE
Investigation on the Role of Corticosteroids and Beta-Agonists on Cytokine Production in COPD Patients

Research on the synergistic effect of corticosteroids and beta-agonists on the cytokine production in COPD patients. Blood will be obtained from healthy volunteers and COPD patients and blood monocytes will be stimulated to produce cytokines with or without the prementioned drugs.


Eligibility Criteria:
Inclusion Criteria:

* clinical COPD
* smoking
* age \> 40 years

Exclusion Criteria:

* age \< 40 years
* use of antibiotics, corticosteroids or beta-agonists
Effect of PBM on Functional Capacity and Fatigability in Post Covid-19 Elderly

Participants had randomly divided into two equal groups. Group (A) which is the study group will receive photobiomodulation session two times per week for four weeks. Group (B) will be the control group that will receive placebo photobiomodulation two times per week for four weeks.

group (A):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. submaximal exercise capacity using time up and go test will be assessed.
3. fatigability will be assessed using fatigue assessment scale.
4. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed.
5. After one month all the assessment procedure will be repeated again.

r group (B):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. submaximal exercise capacity using time up and go test will be assessed.
3. fatigability will be assessed using fatigue assessment scale.
4. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed.
5. After one month all the assessment procedure will be repeated again.

Eligibility Criteria:
Inclusion Criteria:

* 60 to 75 years of age
* past history of covid 19 in the last year

Exclusion Criteria:

* ( history of a histologically demonstrated malignant carcinoma , hyperthyreosis , epilepsy, light sensitivity )
Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers

In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.

The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is considered as a critical factor in the development of multiple sclerosis.

This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at Screening and confirmed at Day -1 who have signed the informed consent.
* Aged from 18 to 55 years, both inclusive.

Exclusion Criteria:

* History of serious adverse reactions or hypersensitivity to any drug.
* Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis that requires no treatment may be tolerated).
* Need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study.
* Participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study

Despite COVID-19 pandemic having started more than one year ago, there are still limited treatment options for these patients, and over 145 million cases and 3 millions deaths have ensued worldwide. Fortunately, SARSCoV2 vaccines have been developed at an unprecedented pace. While the vaccination programs are still ongoing, early reports on efficacy are mainly centered on healthy population. In Chile most people have received the inactivated Coronavac vaccine. Data on the immune response after vaccination in immunocompromised patients is lacking. Therefore, this study aims to evaluate the immune response after Coronavac vaccine in 5 cohorts of immunocompromised patients and healthy controls. We will include patients with cancer, HIV, solid organ transplant and patients receiving immunomodulatory agents for rheumatic diseases.


Eligibility Criteria:
General Inclusion Criteria:

* Eastern Cooperative Oncology Group \< 3
* Vaccination with 2 doses of Coronavac vaccine

General Exclusion Criteria:

* Previous SARS-CoV-2 infection
* Vaccination with Coronavac more than 12 weeks before informed consent
* Intravenous immunoglobulin therapy 60 days before informed consent
* Any condition, that could interfere with the participant's participation during the study in the opinion of the treating investigator.

Cancer Cohort

Inclusion Criteria:

* Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for other condition.

Bone Marrow Transplant Cohort

Inclusion Criteria:

* Bone marrow transplant between January 2019 and December 2020

Exclusion Criteria:

* Other cancer diagnosis during the last 5 years, solid organ recipient, HIV, immunosuppressant treatment for other condition.

Solid Organ Recipient Cohort:

Inclusion Criteria:

* Liver, kidney or heart transplant between January 2019 and December 2020
* Active immunosuppressant treatment

Exclusion Criteria:

- Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV

HIV Cohort:

Inclusion Criteria:

* CD4 \<= 500 cels/mm3 documented one year before study enrollment
* Active antiretroviral therapy
* Viral load \< 200 copies/ml

Exclusion Criteria:

* Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, immunosuppressant treatment.

Rheumatic Disease Cohort

Inclusion Criteria:

* Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, relapsing polychondritis, Behcet disease or juvenile idiopathic arthritis
* Chronic immunomodulatory treatment with anti-TNF, anti-IL6 or anti-IL17 agents

Exclusion Criteria:

* Treatment with more than one biological agent.
* Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, HIV diagnosis.
The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.

To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.

This study collected patients used standard neoadjuvant therapy (TCbHP/THP/EC-THP/AC-THP) among stage II-III HR+/HER2+ early breast cancer, and to describe patient clinical characteristics and clinical outcomes of them in real world settings.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or older
* HR+/HER2- breast cancer diagnosis based on local standards
* Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time
* Standard Therapy, determined at the discretion of the investigator, including （TCbHP/THP/EC-THP/AC-THP）
* Complete medical history was available
* Karnofsky Performance Status (KPS) Scale score ≥ 70

Exclusion Criteria:

* Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
* Pregnant or breast-feeding women
* Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer
* Those who have stage IV breast cancer