cyrilzakka/clinical-trials huggingface dataset:
Biodiesel Exhaust, Acute Vascular and Endothelial Responses

Exposure to particulate air pollution has been shown to increase cardiovascular mortality and morbidity, and in previous controlled exposure studies has been shown to have acute cardiovascular and respiratory effects. The last decade has seen an unprecedented drive towards finding a bioeconomical and renewable source of fuel in order to reduce our dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders for future fuels, biodiesel remains as the strongest contender within European markets. In 2007 researchers at the EPA released a commentary, which concluded that the assumed correlation between the chemical composition of biodiesel exhaust and a reduction in health effects was only hypothetical. They suggested that there was a clear need for the study of health effects in humans regarding biofuel exhaust. In this project the investigators aim to investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust exposure in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 20 healthy, non-smoking subjects, age 20-55 year old, both genders.

All subjects undergo a general health examination and are required to have:

Normal clinical examination Normal EKG Normal routine blood tests Normal lung function

Exclusion Criteria:

* Cardiovascular disease
* Diabetes Mellitus
* Asthma and/or allergy
* Respiratory infection within 3 weeks of the study
* Antioxidant- and/or vitamin supplementation within 2 weeks prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
* Female subjects will take a urinary pregnancy test before each exposure and will be excluded if this is positive.
Clinical Study of Liposomal Paclitaxel in Chinese Patients

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.

There are clinical trials show that paclitaxel is common option for the treatment of solid tumors. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional paclitaxel. However,the tolerance of this new dosage form of paclitaxel (liposomal paclitaxel) has never been studied in Chinese cancer patients. This study is designed to find the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age: from 18 to 70
2. Patients with solid tuomors at advanced stage must be histologically or cytologically confirmed ,and be suitable for treating with Paclitaxel Liposome solo
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS)is from 0 to 2
4. Patients who are expected to live at least 3 months
5. Laboratory tests before the study: white blood count (WBC)≥4,000/mm³,absolute neutrophil count (ANC) ≥1,500/mm³, platelet count ≥100,000/mm³, hemoglobin≥9.0 g/dL, aspartate aminotransferase AST (sGOT) and alanine aminotransferase ALT(sGPT)≤2.5 times of normal value upper limit，serum creatinine≤1.0 time of normal value upper limit，total bilirubin≤1.5 times of normal value upper limit
6. Not using chemotherapeutics (including test drug)before the study trial at least 4 weeks
7. No obvious functional disturbance diseases of internal organs
8. Complying with the study protocol
9. Sign informed consent
10. No Previous anaphylactic reaction to hormone

Exclusion Criteria:

1. Allergy to any medication or foods; History of hypersensitivity reactions to the conventional dosage form of paclitaxel or correlate excipients
2. Active uncontrolled central nervous system metastasis
3. Severe complications that obviously influence the compliance of patients
4. Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
5. Taking other study medications or participating other clinical trial within 4w
6. Having radiation therapy or operation within 4w
7. Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin)
8. Pregnant or lactant women; fertile patients not using effective contraception during study
9. No chief organ functional disturbance or diseases:

   * abnormal liver and renal functions
   * myocardial infarction
   * active heart disease
   * neuropathy or mental diseases including dementia or epilepsy
   * blind、deaf、dumb or extremity disability
   * known infection
   * active diffuse intravascular coagulation
10. Others whom researchers regard not eligible for the study.
A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer

Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.


Eligibility Criteria:
Inclusion Criteria:

- Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy

Exclusion Criteria:

- Patients with a contraindication for prescription of Firmagon®
NeuroReAlign Therapy for Cognitive Rehabilitation in Patients with Stroke

The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on cognition in stroke survivors in the chronic stage (\>6 months). The study will include male and female participants aged 18-70 years.

The main questions it aims to answer are:

Does NeuroReAlign Therapy improve cognition in stroke survivors compared to conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional cognitive therapy to determine its effects on cognition.

Participants will:

Undergo NeuroReAlign Therapy or conventional cognitive therapy for 4 weeks. Have their cognition evaluated using the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Trail Making Test (TMT), Stroop Test, Digit Span Test, and Verbal Fluency Test (VFT).

Complete outcome assessments at baseline and after the intervention (week 4).


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic or hemorrhagic stroke
* Have a stroke more than 6 months
* Age between 18 and 70

Exclusion Criteria:

* Patients with severe cognitive impairments
* Patients cannot walk independently
Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy

The purpose of this research is to compare two different approaches for treating patients with achilles tendinopathy: eccentric exercise, stretching and manual therapy VS Electric dry needling, eccentric exercise, stretching and manual therapy. Physical therapists commonly use all of these techniques to treat achilles tendinopathy. This study is attempting to find out if one treatment strategy is more effective than the other.

Patients with achilles tendinopathy will be randomized to receive 8-10 treatments (1-2 treatments per week) over 6 weeks (10 treatments max) of either: (1)Eccentric exercise, stretching, manual therapy and electrical dry needling or 2. eccentric exercise, stretching and manual therapy

Eligibility Criteria:
Inclusion Criteria:

1. Adult \>18 years old that is able to speak English.
2. Report of at least 3 months of Achilles pain clinically diagnosed as Achilles tendonitis or Achilles tendinopathy
3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for Achilles pain in the last 6 months:
4. Diagnosis of noninsertional tendinopathy, defined as the following

   * Subjective report of pain located 2-6 cm proximal to the insertion of Achilles tendon to the calcaneus, particularly with running or jumping
   * Tenderness to palpation of the Achilles tendon while the clinician gently squeezes the tendon between the thumb and index finger in a proximal to distal direction
   * Positive Arc Sign - Intratendinous swelling moves relative to the malleoli with the tendon during active dorsi/plantar Flexion
   * Royal London Test - Tenderness to palpation decreases significantly or disappears with max dorsiflexion

Exclusion Criteria:

1. Report of red flags to manual physical therapy to include: hypertension infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe vascular disease, malignancy, etc.
2. History of previous Achilles tendon surgery, ankle arthrodesis, hind foot fracture, or leg length discrepancy of more than one half inch.
3. History of arthrosis or arthritis of the ankle and/or foot.
4. History of significant ankle and/or foot instability
5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   1. Muscle weakness involving a major lower extremity muscle group
   2. Diminished lower extremity patella or Achilles tendon reflexes
   3. Diminished / absent sensation in any lower extremity dermatome
6. Involvement in litigation or worker's compensation regarding foot pain
7. Any condition that might contraindicate the use of electro-needling
8. The patient is pregnant.
China Atopic Dermatitis Registry Study

This regestry study is aimed to characterize the medical care and drug treatment under real-life conditions among Chinese patients with moderate to severe Atopic Dermatitis who are not well controlled by topical therapies.

Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.

Among topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.

The goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.

Eligibility Criteria:
Inclusion Criteria:

* Age≥12;
* AD according to Williams diagnosis criteria (see Appendix 1);
* Moderate to severe AD that inadequately controlled by topical therapy
* Moderate-to-severe: SCORAD score≥25; or
* Inadequately controlled by topic therapies: Determined by physicians.

Exclusion Criteria:

* No.
A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.

This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document；
2. Aged ≥18 years old;
3. Histologically or cytologically confirmed advanced or metastatic malignant tumor;
4. Presence of at least one measurable lesion in agreement to RECIST criteria;
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
6. Life expectancy ≥3 months;
7. Adequate organ performance based on laboratory blood tests;
8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

1. Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose;
2. Previous received experimental medication or therapy within 4 weeks before the first dose;
3. Previous therapeutic surgery within 4 weeks;
4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
5. Known allergic to any compound of SHR-A2102;
6. Patients with uncontrolled or active brain metastasis；
7. Patients with clinical significant lung disease;
8. Patients with history of autoimmune diseases;
9. Known active hepatitis B or C infection;
10. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
Appetite Responses to Breakfast Bar Product

The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-70 years
* Habitual snack bar consumers (at least several times per month)
* Body mass index 18.5-29.9 kg/m2 (based on self-reported weight and height)
* Understand and willing to follow the study procedures
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
* Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day
* Willing to provide informed consent to participate in the study

Exclusion Criteria:

* Pregnant or lactating women, or women who are planning to become pregnant during the study
* Known food allergies, sensitivities, or intolerance to any food or food ingredients
* Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
* Taking medications that affect appetite, metabolism or blood pressure
* Presence of acute diseases or infection
* Presence or history of chronic diseases
* Diagnosed with an eating disorder
* Restraint eaters as determined by a score \>4 from the Dutch Eating Behavior Questionnaire
* Lost or gained 5 or more pounds in the past 3-months
* On a weight loss diet or undergoing intermittent fasting
* COVID-19 infection within the past 3 months
* Subjects who do not eat bar products
Evaluation of a Flu Vaccination Program Directed at Pregnant Women Assisted at a Research Hospital in Italy.

Influenza is a serious Public Health problem, which causes a high number of cases and deaths worldwide each year. In Italy, about 8 million cases were reported in the 2018/2019 flu season, 809 of which were severe, with 198 deaths. Pregnant women are considered one of the most at-risk groups, as infection can lead to serious complications for the mother and fetus. The Italian Ministry of Health recommends free flu vaccination for pregnant women in the second or third trimester, as the vaccine is safe and effective in protecting the mother, fetus and newborn.

During the 2018-2019 flu season, the Fondazione Policlinico Universitario A. Gemelli IRCCS (FPG) held an educational session on maternal and childhood vaccinations in the context of the Childbirth Preparation Course held monthly at the FPG, offering the on-site flu vaccination to participants and their partners, if present.

The objectives of this study are: to improve knowledge and attitudes regarding vaccination in the course participants, assessing their changes through a pre-post anonymous questionnaire; to evaluate the impact of the flu vaccination strategy implemented, through the analysis of vaccination coverage.


Eligibility Criteria:
Inclusion Criteria:

* Attendance to the educational session about vaccination in the context of the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS

Exclusion Criteria:

* None
Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic

Subjects will be recently discharged patients from Sunnybrook Inpatient Psychiatry Unit. Subjects will be randomized in a 1:1 ratio to either the Caring Contact intervention or usual care. 75 subjects will be enrolled in each arm. In additional to usual discharge-related care, subjects in the caring contact group will receive brief emails that convey a message of hope and provide resources. These emails will be sent on days 4, 21, and 56 post-discharge. The specific content of these emails will be pre-determined varying slightly by time point. In contrast, the control group will only receive usual discharge-related care, including discharge planning and also a sheet of resources normally provided to patients. A widely used and validated measure will be employed to assess depression and anxiety symptoms. The 25-item self-report Hopkins Symptom Checklist will be emailed to all subjects at baseline, day 4, 21, and 56 post-discharge, along with the Caring Contact communication. It is hypothesized that there will be a significantly greater reduction in mental health symptoms among patients receiving Caring Contacts compared to those who receive usual care.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Inpatient status in Sunnybrook Inpatient Psychiatry Unit at time of recruitment
* Have an email or mailing address
* Ability to read and understand English
* The ability to understand and comply with the requirements of the study and capable of providing informed consent

Exclusion Criteria:

* A primary Major Neurocognitive Disorder diagnosis
Retrospective Evaluation of Adult and Pediatric Transfusion-dependent Patients Treated With Deferasirox Therapy

Iron overload is a leading cause of morbidity and mortality in transfusion-dependent patients. Deferasirox is the most promising iron chelator agent in several clinical scenarios. The investigators propose a retrospective study (chart review) to evaluate comprehensive iron overload management in transfusion-dependent patients treated with deferasirox for up to 5-10 years in a real clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Transfusion- dependent patients (\> 2 years);
* Ongoing deferasirox therapy during the study period;
* ≥ 2 Magnetic Resonance scans (one at baseline and at least one post baseline - as per clinical need) during study period (this criteria is not mandatory for patients undergoing only the endocrine subanalysis and participating only to the cardiac analysis);
* Available medical history including relevant clinical and laboratory data (e.g serum ferritin, liver function tests, renal function tests, endocrine parameters ) at baseline before starting deferasirox treatment

Exclusion Criteria:

* Non transfusion- dependent patients;
* Other chelation therapy than deferasirox;
* Absence of complete medical history as above specified
A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People

The purpose of this trial is to investigate the effects of delgocitinib, taken as a capsule, on the heart rhythms of healthy people, compared to a placebo.

The trial will be performed in two parts.

* Part 1: Group 1 (dose 1 or placebo) and Group 2 (dose 2 or placebo)
* Part 2: Group 3 (dose 3 or placebo) and Group 4 (dose 4 or placebo)

The doses in Part 2 may be adjusted depending on the results of Part 1.

Participants will be screened within 28 days of their dose. Participants will stay in the clinic from Day -1 to Day 2 (1 day postdose) and will be dosed on Day 1. A follow up phone call will take place 2 week (±2 days) after dosing.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index of ≥18.0 and \<30.0 kg/m2.
* In good health, as judged by the investigator based on: medical history, physical examination, vital sign assessment, clinical laboratory evaluations .
* ECG without any clinically relevant abnormal findings at both screening and baseline
* No history of additional risk factors for torsades de pointes (for example, heart failure, hypokalaemia, family history of long QT syndrome).
* Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must be willing to use highlly effective methods of contraception.

Exclusion Criteria:

* Any disorder which is not stable and could:

  * Affect the safety of the subject throughout the trial.
  * Influence the findings of the trial.
  * Impede the subject's ability to complete the trial.
* Use of any medication known to prolong the QT/QTc interval within 3 months or 5 half-lives of the drug, whichever is longer, prior to randomisation.
* Any medications, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to dosing.
* Current use of combined hormone contraceptives or combined hormonal replacement therapy.
* Subjects who have smoked (use of any type of tobacco and nicotine containing products) within the last 3 months prior to screening.
* History of chronic alcohol or drug abuse within 12 months prior to screening.
* Receipt of any vaccine approved for SARS-CoV-2 within 4 weeks prior to baseline and/or 2 weeks after dose.
* Receipt of live, attenuated vaccines within 4 weeks prior to baseline.
Supragingival Plaque Removal With and Without Dentifrice

Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by brushing with and without conventional toothpaste. Settings and Design: Twenty-four students aged 17 to 28 years old participated in this randomized clinical trial.

Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of cessation of oral hygiene, Quigley \& Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by paired sample t test.


Eligibility Criteria:
Inclusion Criteria:

* students of both genders systemically healthy.

Exclusion Criteria:

* individuals who exhibited gingivitis (presence of gingival bleeding at any site);
* probing depth \> 3mm and/or attachment loss \>3mm at any site;
* using orthodontic appliance devices, dental prostheses, dental implants;
* presence of abrasions, restorations and/or carious lesions at cervical region;
* individuals who had less than 20 natural teeth.
Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion

Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion injury.

Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory markers in the circulation

Healthy volunteers are included in the study to investigate endothelial function and platelet activation after preconditioning by sevoflurane in subanesthetic concentrations.

Forearm perfusion, endothelial function and leukocyte/thrombocyte activation after tourniquet-induced ischemia/reperfusion injury of the forearm are measured using healthy volunteers in a cross-over design.

Eligibility Criteria:
Inclusion criteria: male

* Non-smoker
* No asthma
* NPO
* Volunteer

Exclusion criteria:

* Female
* Chronic medication
* Asthma
* Smoking