cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode

Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram + Trichilia catigua Dry Extract (LABCAT TCJUSS) in the average alteration on depression score measured by the Hamilton Scale (HAM-D).

Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram + LABCAT TCJUSS in the following aspects:

1. Alteration on the average score of anhedonia symptoms through the Shaps-C Scale;
2. Alteration of average scores of Global Clinical Impression carried out by the investigator (CGI-S e CGI-I);
3. Average scores of the Patient Global Evaluation

Eligibility Criteria:
Inclusion Criteria:

* Subjects from both sexes aged between 18 and 65 years;
* Patient diagnosed with mild depression episode confirmed by psychiatric and psychometric evaluation, presenting basal scores above 08 and below 24 measured by the Hamilton Rating Scale (HAM-D);
* Capable of understanding the nature and objective of the study, including risks and adverse effects and intended to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which comes to be confirmed by signing the informed consent.

Exclusion Criteria:

* Have a known hypersensitivity to Trichilia catigua or history of serious adverse reactions;
* Shows risk of suicide, assault, murder or moral exposure;
* Clinical history of bleeding disorders;
* Drug addiction, including alcohol;
* Known or suspected neoplasia;
* Knowledge positive test result for the human immunodeficiency virus;
* Patient not willing to adhere to the procedures of the Protocol;
* For women, can not be pregnant or nursing and must be in use of a contraception method during the participation in the study;
* Patients using other drugs with sedative or antidepressant action, which can not be suspended for 15 days (wash out);
* Diabetics;
* Hyperthyroidism;
* Participation in any experimental study or use of any experimental drug three months before the start of this study;
* Has any condition which the investigator deems relevant to the non-participation of the study.
Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data

The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:

* The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.
* The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.

Participants will:

* Receive or not receive TTFields.
* Concomitantly or adjuvantly receive TTFields.

The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:

* The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.
* The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.

Participants will:

Step 1:

* Treatment arm I: Patients receive standard RT + TMZ, followed by maintenance TMZ, with Optune® starts during peri-radiotherapy period (2 month before to 3 months after radiotherapy). The duration of TTFields lasts for at least 2 months.
* Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant.

Step 2:

* Treatment arm I: Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment. The duration of TTFields lasts for at least 2 months. If the subject is assigned to this treatment arm, Optune® therapy will begin no later than the 7th day of RT and TMZ treatment.
* Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune® within 3 months after radiotherapy for at least 2 months.

Researchers will compare the overall survival of each arm to see if TTFields demonstrates an improvement in survival outcomes within the Chinese population in real-world practice, and whether this efficacy is further enhanced when combined with RT and TMZ.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of GBM according to WHO classification criteria.
2. Age ≥ 18 years.
3. Recovered from maximal debulking surgery.
4. Karnofsky performance status ≥ 60.
5. Planned treatment with RT/TMZ followed by maintenance TMZ.

Exclusion Criteria:

1. Progressive disease (per investigator's assessment).
2. Infratentorial or leptomeningeal disease.
3. Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment.
4. Any serious surgical/post-operative condition that may risk the patient according to the investigator.
Effects of Personalized Training Program on Coronary Flow Reserve in Healthy Volunteers

This study investigates whether an individualized exercise program, including a personal trainer, can improve cardiovascular status quantified with ultrasound to assess coronary flow reserve and other non-invasive techniques. The subjects in the study will be divided into two groups; one group will have a personalized exercise- and nutrition program and the other group will have acess to a gym membership, but no personal trainer.

Coronary heart disease is one of our most common diseases that causes significant morbidity and mortality. Because the risk of serious cardiovascular events, such as myocardial infarction and death, is evident in this patient population, it is of utmost importance to develop diagnostic methods to identify patients at risk. The most appropriate diagnostic methods are those that are safe to implement for both patient and physician, but also accessible and cost-efficient.

By using non-invasive techniques such as ultrasound, coronary artery function can be examined as coronary flow reserve (CFR). In the platform of non-invasive techniques used by the investigators for examinations of cardiovascular status, other methods are included, such as measurement of intima-media thickness in the carotid and radial arteries. The investigators goal is to compare the group with the personalized program with its placebo, and to compare the two study-groups with each other, to investigate whether the personalized program provides greater health benefits.

Eligibility Criteria:
Inclusion Criteria:

* non-smokers
* no current medication,
* no known diseases that require regular medication
* no known risk factor for cardiovascular disease (hypertension, hyperlipidemia, diabetes, heredity, obesity, peripheral vascular disease)
* no physically fit athletes.

Exclusion Criteria:

* ongoing treatment with medicine containing dipyridamole (asasantin, persantin)
* known hypersensitivity to adenosine
* chronic obstructive pulmonary disease
* atrial fibrillation or other obvious arrythmias
* AV-block grade 2 or higher
* other serious illness
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).


Eligibility Criteria:
Inclusion Criteria:

* High cholesterol

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Impacts of Clean Cookstoves and Empowerment Training on Women's Health in Refugee Settings

The main objective of this study is to understand the links and outcomes of adoption of a cleaner cookstove/fuel and exposure to a personal empowerment training on women's health outcomes in a Congolese refugee camp in Rwanda, with a focus on gender-based violence (GBV).

This randomized controlled trial examines the impacts of a phased-in integrated technology -behavior change intervention on women's health with a focus on gender-based violence. In a population of approximately 1500 Congolese households in Kigeme refugee camp in Rwanda, two interventions are randomly deployed in the camp. The first intervention is the Inyenyeri cookstove/pellet fuel system, a Tier 4 clean cookstove system; the second intervention is a behavior change intervention (referred to as I-ACT, Individual-Agency-Centered Training) designed to foster personal agency and empowerment, given to women and, if applicable, their male partner. Analyses will be done with interviews on 1500 women (ages 18-45) from these households that may have received one, both or none of the interventions, either as the full sample or the sub-sample of partnered-only women.

Eligibility Criteria:
Inclusion Criteria:

* Study participants are between the ages of 18 years - 45 years of age
* Reported as currently living in a refugee camp with no intention to relocate
* Has lived in any refugee camp for at least 1 year and can be interviewed in private
* Has the ability to give informed consent

Exclusion Criteria:

* Inability to provide informed consent
* Individuals having evidence of significant illness and/or are not able to engage fully in the surveys
* Women younger than 18 or over 45 years of age
* Those who have not lived continuously in a refugee camp setting for the past 12 months
* If two or more women live in a household, only one of these will be included in the study. The one responsible for fuel purchase/collection will be selected. If more than one woman is responsible for fuel collection, we will randomly choose one woman to participate in the study.
Blood Biomarkers from Internal Jugular Vein for the Diagnosis of Alzheimer's Disease

The goal of this observational study is to explore the diagnostic performance of blood biomarkers from the internal jugular vein for the diagnosis of Alzheimer's disease (AD) in patients with cognitive symptoms or concerns. The main question it aims to answer is:

Whether blood biomarkers from the internal jugular vein outperform those from the median cubital vein which is the routine site for venous blood collection?


Eligibility Criteria:
Inclusion Criteria:

1. age: 40-90 years old (including 40 and 90 years);
2. patients with cognitive complaints or concerns;
3. Willing and able to comply with all aspect of the protocol and provide written informed consent. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations).

Exclusion Criteria:

1. Severe medical conditions which are not stably and could affect the subject's safety;
2. Presence of contraindications for PET examination, cerebrospinal fluid or blood collection;
3. Unwilling and refuse to participate in this study.
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects

The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects between the ages of 18-45 years
2. Have no reproductive potential; or agree to use a highly effective method of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing
3. Have signed the informed consent form approved by the IRB

Exclusion Criteria:

1. Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, viral hepatitis, AIDS and syphilis
2. Have a history of or current allergic disease
3. Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
4. Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
5. Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
6. Pregnant or breastfeeding female subjects
7. Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period
Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation

To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV) in preterms with respiratory disease syndrome(RDS) after extubation.

To very low birth weight infant(VLBW) with respiratory disease syndrome(RDS) who need mechanical ventilation,early extubation may have more benefits.Early extubation may decrease the ventilation-associated pneumonia(VAP),sepsis and decrease the incidence of severity bronchopulmonary dysplasia(BPD).But often fail attempts at extubation because of apnea,atelectasis,hypercapnia,hypoventilation or other illnesses.

High frequency oscillatory ventilation is benefit to lung.Initial ventilation with HFOV in preterm with RDS may reduce the incidence of BPD and improve the neurodevelopment.Compared HFOV with conventional ventilation in preterm infants showed that HFOV had superior lung function when 11 to 14 years age.Whether nasal high frequency oscillatory ventilation(NHFOV) also have those advantages in non-invasive mode? Null D M et al do a experiment on preterm lambs,the result suggest that NHFOV may promotes alveolarization.But there was no clinical trials to prove.

The nasal intermittent positive pressure ventilation (NIPPV) group fail definition：1、 Fraction of inspired oxygen (FiO2)\>40%、MAP\>12 centimeter water column (cm H2O),but arterial oxygen saturation (SaO2)\<90%.2、significant abdominal distension.3、PaCO2\>60millimeter of mercury(mmHg)or partial pressure of arterial oxygen (PaO2)\<45 millimeter of mercury(mmHg).4、severe apnea( definition:\>6 episodes requiring stimulation in 6 hours or requiring \>1 episodes of positive-pressure ventilation) 5.potential of hydrogen (PH)\<7.2 The

The NHFOV group fail definition：1、FiO2\>40%、MAP\>14 mbar,but SaO2\<90%.2、significant abdominal distension.3、PaCO2\>60millimeter of mercury(mmHg) or PaO2\<45millimeter of mercury(mmHg).4、severe apnea 5.PH\<7.2.

Eligibility Criteria:
Inclusion Criteria:

1. birth weight\>1000g
2. gestational age \>28 weeks
3. have respiratory distress syndrome and need invasive ventilation

Exclusion Criteria:

1. birth wight\<1000g
2. gestational age \<28 weeks
3. infants wiht abnormalities of upper and lower airways
4. infants have contraindications of non-invasive ventilation -
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
* Male or Female, ≥12 years of age
* Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
* Patient must have history of at least 1 asthma exacerbation including one of the following:

  * requiring treatment with systemic corticosteroids
  * an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
* Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Exclusion Criteria:

* Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
* Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
* Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
* An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
* Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
* Patient must not meet unstable asthma severity criteria as listed in the protocol
* Peak expiratory flow must not be below 50% o predicted normal
* Pregnancy, breast-feeding or planned pregnancy during the study
A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST)

This is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (REST) to usual care for reducing stress in individuals with COPD.

This is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (REST) to usual care for reducing stress in individuals with chronic obstructive pulmonary disease (COPD). The intervention is based on the breathing techniques of Pranayama. It was developed with patient and stakeholder input and is targeted for individuals with COPD who have moderate levels of stress and symptom burden. The intervention is a 15-minute breathing protocol which will be taught to participants and subsequently evaluated in a clinic setting with surveys, lung function, and cardiac assessments. This intervention will be pre-tested in 6 individuals, revised, and piloted in 30 individuals (15 in intervention group, 15 in control group). This study will answer the question of 1) whether a controlled breath protocol is feasible, acceptable, and safe for patients with COPD and 2) whether any modifications to the intervention are needed for a future multicenter trial to be proposed and conducted after the completion of the pilot trial. We will also 3) obtain sufficient estimates of variability in stress measures to inform statistical planning of a future trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spirometry confirmed COPD (FEV1/FVC \<0.70 + FEV1\<80%)
* Perceived Stress Scale \> 13
* Age \>40 years old
* Able to read, write, and speak in English
* Able to attend 1 in person training session and 1 in person trial sessions

Exclusion Criteria:

* Current regular practice of breathing exercises or pranayama
* No access to internet or telephone
* Recent hospitalization for COPD exacerbation or any reason in the past 30 days
* Other primary lung disease (ILD, asthma, bronchiectasis) by self-report or chart review
* Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids)
* Severe cognitive impairment
Pharmaco-Economic Study of Treatment Options in Patients With Advanced RCC

This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of clear-cell renal cell carcinoma
* Patients with evidence of metastatic disease
* Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib
* Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease

Exclusion Criteria:

* Patients enrolled in any clinical trial involving anti-cancer therapy
* Pregnant woman
Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

The administration of Janus kinase (JAK) inhibitors as well as biological disease-modifying anti-rheumatic drugs has dramatically improved even the clinical outcomes in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX). The dysregulation of JAK-signal transducer and activator of transcription (STAT) pathways via overproduction of cytokines, such as interleukin-6 (IL-6) is involved in the pathogenesis of RA. Filgotinib is a selective JAK1 inhibitor to be approved for use in RA. Filgotinib is effective in suppressing disease activity and preventing the progression of joint destruction due to inhibition of the JAK-STAT pathway. IL-6 inhibitors such as tocilizumab also inhibit the JAK-STAT pathways due to inhibition of IL-6 signaling. We will evaluate whether the effectiveness and safety of filgotinib monotherapy is non-inferior to those of tocilizumab monotherapy in RA patients with inadequate response to MTX.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following requirements to be considered for entry into the study:

  1. ≥20 years old
  2. with the diagnosis of RA based on the ACR/EULAR 2010 RA Classification Criteria
  3. with at least moderate disease activity defined as a DAS28-ESR ≥3.2 at the eligibility evaluation
  4. treated with MTX for ≥8 weeks prior to the providing consent, including 4 weeks or more at the same doses of 8 to 16 mg per week (stable doses of \<8 mg per week are allowed only in the presence of intolerance to higher doses)
  5. ability and willingness to provide written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

* The exclusion criteria are as follows:

  1. concurrent use of a corticosteroid equivalent to \>5 mg/day of prednisolone
  2. applicable an item for the contraindication of filgotinib or tocilizumab
  3. a previous use of a JAK inhibitor or IL-6 inhibitor
  4. treatment with a corticosteroid and csDMARD and change of dose within 4 weeks prior to the providing consent
  5. treatment with a biologic DMARD or a biosimilar DMARD (ie, infliximab, biosimilar of infliximab, adalimumab, biosimilar of adalimumab, golimumab, certolizumab pegol or abatacept) within 8 weeks prior to the providing consent
  6. treatment with a TNF inhibitor (ie, etanercept or biosimilar of etanercept) within 4 weeks prior to the providing consent
  7. use of a prohibited drug or therapy, other than the agents noted above, within 4 weeks prior to the providing consent
  8. a complication causing musculoskeletal disorders other than RA (ie, ankylosing spondyloarthritis, reactive arthritis, psoriatic arthritis, crystal-induced arthritis, systemic lupus erythematosus, systemic scleroderma, inflammatory myopathy, or mixed connective tissue disease)
  9. current pregnancy, breastfeeding, or noncompliant with a medically approved contraceptive regimen during and 12 months after the study period
  10. inappropriateness for inclusion in this study as determined by the investigator