cyrilzakka/clinical-trials huggingface dataset:
Work-related Respiratory Symptoms in Champagne Vineyard Workers

Work related asthma and rhinitis are frequent diseases with a significant morbidity and a social and economic impact. Farmers are highly exposed to various inhaled agents such as organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to pollen allergy, especially gramineae pollen. They can also be related to the use of pesticides or exposure to mites .

Aim of the study were :

to determine the prevalence of work related respiratory symptoms in workers of Champagne vineyard in France to analyze the relationships between respiratory symptoms, occupational exposure and sensitization profile in workers of Champagne vineyard in France

Eligibility Criteria:
Inclusion Criteria:

* workers of Champagne vineyard
* aged \> 18 years
Tea-beetroot-venous Occlusion Plethysmography

In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.

Based on data from previous studies, this physiological response is blunted in obese subjects, and the investigators expect these responses to be restored when the glucose load is combined with tea or beetroot juice in obese, insulin resistant men.

Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Aged 30-70 years.
* Obesity (BMI\>30 kg/m2)
* insulin resistance as fasting glucose levels \>6.1 mmol/L.
* Reported intense sport activities \>10 h/w.
* Reported alcohol consumption \>28 units/w
* Signed Informed consent
* Currently not smoking and being a non-smoker for at least 3 months prior to the start of the study.

Exclusion Criteria:

* BMI ≥ 40 kg/m2.
* Presence of cardiovascular disease.
* Presence of sudden cardiac death in a 1st degree relative at an age \<50 years.
* Presence of diabetes mellitus type 2.
* Regular tea drinker (\> 2 cups per day)
Surgical Treatment for Degenerative Scoliosis

The study aims to analyze the surgical treatment of low back pain due to degenerative kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of back pain and functional ability before and after the surgical treatment will be performed by administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be matched to a purely objective and radiological assessment according to international guidelines. A psychological analysis will be also performed in order to evaluate co-morbidity from this field, considering that the concept of "shared decision-making" for the therapeutic approach to low back pain requires the evaluation of all these parameters.


Eligibility Criteria:
Inclusion Criteria:

* Female or male
* Age 40-75 years
* Patients capable of understanding and willing
* Lumbar or thoraco-lumbar degenerative kyphoscoliosis
* Chronic low back pain from more than 6 months and/or presence of neurological deficits at lower limbs
* Failure to respond to conservative therapy

Exclusion Criteria:

* Infections in place
* Coagulation deficits
* Serious psychological comorbidity
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* HIV positive at least one year
* Clinically stable on ART for at least six months
* Documented viral load less than 50 copies/mL for the last six months
* Documented prestudy CD4 cell count equal or more than 400x10exp6/L
* Nadir CD4 cell count equal or more than 200x10exp6/L
* Signed informed consent

Exclusion Criteria:

* Reported pre-study AIDS-defining illness within the previous year
* Malignant disease
* On chronic treatment with immuno-suppressive therapy
* Unacceptable values of hematology and clinical chemistry parameters
* Current chronic infection such as HCV and HBV or active tuberculosis
* Pregnant or breastfeeding women
* Not using safe contraceptive methods
* Participation in other clinical trial
* Incapability of compliance
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients with Primary Immune Thrombocytopenia

A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period.

Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case.

3a. Agree to use contraceptives consistent with local regulations and the following:

• Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.

In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply:

4. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).

5. Participant has completed a 52-week treatment period.

Exclusion criteria:

1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines)
2. Use of any other investigational drug or participation in any other investigational trial
3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners

The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood biochemical parameters in male recreational runners.

1. Male recreational runners would be recruited by community websites or email. After completely introducing the study, the participants would be requested to sign informed consent.
2. The participants would perform maximal oxygen consumption test prior to the supplementation. The participants would be supplemented with either Danggui Buxue Tang or placebo for a week before performing the 13-km run. A total of 4 times blood collection (before supplementation, immediate after running, 1 day and 3 days after running) would be performed for evaluating the effect of Danggui Buxue Tang on blood biochemical parameters.

Eligibility Criteria:
Inclusion Criteria:

* The participants should have the experience finishing 10-km run but without the experience of attending a marathon run.

Exclusion Criteria:

* Participants suffering from anemia (Hb \<13 g/dL), taking usual supplements, medication, alcohol or not feeling comfortable.
Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

Acute pulmonary embolism (PE) is a serious disease associated with high mortality rates despite advanced therapeutic options. The treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition

Acute pulmonary embolism (PE) is a serious disease associated with high mortality rates despite advanced therapeutic options. The treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition.

Initial risk stratification of patients with PE could be based on clinical indicators. The presence of shock and hypotension is the most important clinical sign of poor prognosis. Other clinical variables, associated with poor prognosis are age over 70 years, history of bed rest over five days, cancer, chronic obstructive pulmonary disease, renal failure, heart failure, and tachycardia .

Echocardiography represents the most useful imaging tool in everyday clinical practice to show right ventricular dysfunction (RVD) because of its noninvasive nature and relative low cost. RVD assessed on echocardiography has been described as one of the strongest predictor of early mortality in PE .

Currently, computed tomography pulmonary angiography (CTPA) represents the diagnostic gold standard for PE. Additionally, CTPA was used to evaluate the prognosis by determining the distribution and severity of vascular obstruction of clots in pulmonary circulation; this is called computed tomography pulmonary artery obstruction index (CT-PAOI). CTPA was also suggested as a predictor of RVD .

In addition to the clinical findings and the imaging abnormalities, there are several biomarkers and indicators that can be used to predict severity and prognosis in patients with PE. These biomarkers include troponin and brain natriuretic peptide (indicators of RVD and myocardial damage), D-dimer, C-reactive protein, arterial blood gases parameters and complete blood count (CBC) parameters. However, some of these biomarkers have not been widely studied and are not commonly used although they are readily available and cheaper for developing countries.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years) who will be diagnosed as acute pulmonary embolism based on computed tomography pulmonary angiography (CTPA) and not yet treated.

Exclusion Criteria:

1. Age less than 18 years.
2. Patients with known hematological disorders.
3. Patients with history of recent blood transfusion (within 3 weeks).
4. Patients receive anti-platelet and/or anticoagulant medications.
5. Patients receive immunosuppressive drugs.
6. Patients with known cardiopulmonary diseases other than the pulmonary embolism.
7. Patients with known active infectious diseases or immunological diseases
A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
* Diagnosis of psoriatic arthritis meeting Classification Criteria for Psoriatic Arthritis (CASPAR)
* Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count \[SJC\]) and ≥5 tender joints (from a 68 tender joint count \[TJC\]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
* Have had a history of documented plaque psoriasis or currently active plaque psoriasis
* If using cDMARD therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
* If using non-drug therapies (including physical therapies), thse should be kept sable during screening
* Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol

Key Exclusion Criteria:

* Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
* Prior use of more than one TNF inhibitor, at any time.
* Use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to Baseline;
* Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
* Use of more than 1 NSAID or cyclooxygenase-2 (COX-2) inhibitor.
* Have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening
* Presence of very poor functional status or unable to perform self-care.
* Administration of a live or attenuated vaccine within 12 weeks prior to baseline
To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames

Doxil or Doxorubicin to be administered was administered in a dose of 50 mg/m2 as infusion over 15 minutes. Blood samples to be obtained at 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours

Comparison of AUC in a single dose of Doxorubicin vs single dose of Doxil \[ Time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days) The primary objective of this study is to determine the pharmacokinetic equivalence of Doxorubicin and Doxil as a single dose in patients with carcinomas, lymphomas and leukemia's. The outcome measure will be determined by analyzing the concentration from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (C max)to determine % variability between doxorubicin and Doxil within each patient.

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria

Inclusion Criteria:

Have confirmed diagnosis of lymphomas. leukemia's and carcinoma to be treated with Doxil or Doxorubin Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.

Be \>/= 18 and \</= 75 years of age Sign a written Institutional Review Board (IRB)-approved informed consent form Have a negative pregnancy test, if patient is of child-bearing potential. Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential) Have acceptable liver function, renal function and hematologic status based on the institution.

Exclusion criteria Any Medical related exclusion criteria as per the institution. Are unwilling or unable to comply with procedures required in this protocol Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor Are currently receiving any other investigational agent Have exhibited allergic reactions to doxorubicin or a similar structural compound
Measuring Accuracy of Wristband for Registration of ECG RR-Intervals for One Hand, SenceBand in Comparison to Holter

The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd).

Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand in real-world condition during 24-hours of routine duties in comparison to a predicate device (Holter monitor). For monitoring HRV each subject will put heart rate monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed in standard configurations places. Data will be collected during routine duties. SenceBand will collect data from 5-minutes intervals each 30 minutes, Holter will collect data continuously over 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has given written informed consent;
2. Subject is male or female, aged 18-75;
3. Subject has understood and complied with the requirements of the study protocol and;
4. Subject is fluent in Ukrainian.

Exclusion Criteria:

1. Subject has cardiac pacemakers;
2. Subject is a pregnant woman;
3. Subject has an allergy on polyurethane;
4. Subject refers to vulnerable groups of the population;
5. In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol.
Harm Reduction Services

The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria
* English or Spanish speaking
* able to provide informed consent.

Exclusion Criteria:

* inability to provide informed consent or participate in the study procedures as proposed in the consent
* active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder)
* an unwillingness to be randomized.
* are prisoners
Sexual Dysfunction, Disability and Quality of Life in Patients With Multiple Sclerosis (MS)

This is an observational, prospective, non-interventional, non-controlled study planned to be conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).

The purpose of this observational study is to determine the correlation between the degree of disability and sexual dysfunction; and between the sexual dysfunction and the quality of life (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.

Multiple sclerosis, like most of the chronic diseases, can affect the sexuality of those who suffer from it. This situation has an evident and marked impact on the QoL of the subjects and his/her partner, and causes conflict in the relationship, with high levels of mutual dissatisfaction.

The impact that the duration of the disease or the degree of disability have on the level of sexual dysfunction is not clear. However, the possible organic and state of mind causes of the sexual dysfunction makes us think that the degree of disability is a crucial factor in the genesis and duration of the symptoms in the sexual area. The frequency with which the sexual dysfunction is detected or referred in these subjects is variable.

The sexual dysfunction in subjects with MS is typically characterized by a decreased libido, erectile dysfunction and ejaculation disorders in men, and decreased lubrication and anorgasmia in women. The most commonly detected problems are the erectile dysfunction and/or lack of sexual interest in men and lack of interest, decreased libido and orgasmic disorder in women.

This observational study aims to assess a population of subjects with MS that show symptoms of sexual dysfunction, in order to determine the relationship, if any, between the severity of the general disability and the incidence of sexual dysfunction. At the same time, this epidemiologic study aims to measure the impact the sexual dysfunction generates in the quality of life of subjects with MS.

The data to be obtained could contribute to a better understanding of the relationship between the studied variables and, eventually, to alert the treating doctors about the incidence of these morbid associations.

The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.

Eligibility Criteria:
Inclusion Criteria:

* Men and women \> 21 years of age
* Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
* Subjects with a diagnosis of RRMS for more than one year
* The subject who have signed the Informed Consent

Exclusion Criteria:

* Subjects with no sexual experience
* Subjects with other diseases associated to MS
* Subjects with psychiatric diseases that could cause sexual dysfunction
* Subjects with one relapse during the previous month
* Use of antidepressants and/or corticosteroids during the previous month