cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Comparative Study of GB221 Pharmacokinetics

The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.


Eligibility Criteria:
Inclusion Criteria:

To be enrolled in the study, subjects must meet the following criteria

1. Males aged 18 to 45 years.
2. Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
3. Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
4. Normal or non-clinically significant ECG.
5. Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
6. Willingness to give written and informed consent prior to any studyrelated procedures being conducted

Exclusion Criteria:

Subjects will be ineligible for the study if any of the following criteria apply:

1. Receipt of any investigational agent or drug within 4 weeks of entry to the study.
2. Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
3. Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
4. Clinically significant drug allergy or sensitivity to any medication.
5. A history of chronic or recurrent infections.
6. A recent history of surgery.
7. History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
8. Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
9. A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
10. A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
11. Vaccination of any type within the previous month.
12. A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
13. Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
14. Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
15. History of asthma or other chronic respiratory disease in the past 5 years.
16. History of neurological or neuromuscular disease.
17. History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
18. History of bladder or urethral disease.
19. Smoking cigarettes \> 10 per day.
20. Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.
The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment

For this study, 213 individuals with Mild Cognitive Impairment were recruited. The study period ran from June 2018 to October 2021. The procedure involved a combined screening and baseline examination, including oral, medical, cognitive, and quality-of-life examinations. Re-examinations followed this at 6, 12, and 24 months. The examinations were performed at a university research clinic, and all participants received their usual medical and dental care during the study. At baseline, each participant received a powered toothbrush. Participants were carefully instructed on how to operate the powered toothbrush and were asked to brush for at least two minutes in the morning and evening. No restrictions were given against the use of other oral care products. Compliance with the powered toothbrush was followed by a participant survey conducted at each examination.. Facilitating and improving life by introducing a powered toothbrush as part of oral hygiene may benefit individuals with MCI. This study aimed to investigate whether the use of a powered toothbrush could maintain or improve oral health by reducing dental plaque (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD)≥4mm in a group of individuals with MCI for an observation period of 24 months. Furthermore, to study how oral health changes affect QoL aspects.


Eligibility Criteria:
Inclusion Criteria:

* Being 55 years or older
* Having experienced memory problems in the last six months before inclusion
* Having a Mini-Mental State Examination score of 20-28
* Are not receiving any formal care
* Having at least ten teeth of their own

Exclusion Criteria:

* Having a terminal illness with less than three years of expected survival
* Having another known significant cause of disease explaining cognitive impairment
Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night time blood pressure between healthy control subjects and patients with adrenal insufficiency. No intervention will be administered and the study is observational only.

We propose to use a case control design to test the main hypothesis that as compared to healthy control subjects matched for sex, age, adiposity and race/ethnicity, patients with adrenal insufficiency, whether primary or secondary, have disturbances of the circadian system that are associated with high day to day variability of sleep time as well as elevated markers of cardio-metabolic risk, including abnormal oral glucose tolerance and reduced nocturnal blood pressure dipping.

A secondary hypothesis of the study is that adrenal insufficiency patients on a replacement regimen (as part of their standard of care ongoing treatment) that results in daytime cortisol profiles approximating the normal diurnal variation will have better cardio-metabolic function than adrenal insufficiency patients who have grossly abnormal cortisol profiles.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary adrenal insufficiency, Healthy matched controls, acute or unstable health conditions age 18 or older

Exclusion Criteria:

* Diabetes, Tertiary adrenal insufficiency
Implementing the Transcultural Social-Ethical-Care Model -TEC-MED for Older People in the Mediterranean Basin

Implementation of the TEC-MED model of social and health care in the elderly population of the Mediterranean basin through a quasi-experimental trial. Participants will be assigned to the intervention group and will receive comprehensive care and assessment under the TEC-MED care model. Participants in the control group will receive usual care during the data collection phase, but will be offered care under the TEC-MED model at the end of the project.


Eligibility Criteria:
Inclusion Criteria:

* 60 years or more
* Living in the Mediterranean Basin countries

Exclusion Criteria:

* None
Ethaselen for the Treatment of Thioredoxin Reductase High Expression Advanced Non-small Cell Lung Cancers

Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200 mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately 50% non-small cell lung cancers harbored high thioredoxin reductase expression(IHC result ++ or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg ethaselen per day was safety and tolerated by Chinese malignant tumor patients.In pre-clinical research, our group found that, elevated of thioredoxin reductase activity was associated with the expression of thioredoxin reductase tested by immunohistochemistry, which means high expression of this enzyme may be a favourite predicted factor of ethaselen, the specific inhibitor of thioredoxin reductase.

This phase 1c study will include patients pathologic diagnosis advanced non-small cell lung cancer who had received more than two lines standard treatment, according to NCCN Non-small cell lung cancer guideline, there were no standard treatment scheme for these patients. Approximately 40 patients will be included in the study, patients will received oral ethaselen dispersible tablet, 600 mg bid dose, primary endpoint of this study is 6 week disease control rate(DCR, CR+PR+SD), secondary endpoints include progression free survival(PFS), overall survival(OS), quality of life(QOL) and drug safety.

Eligibility Criteria:
Inclusion Criteria:

* advanced non-small cell lung cancer, stage IIIB/IV who had received more than 2 standard treatment scheme
* 18-75 years old, anticipate overall survival more than 3 months, ECOG 0-2
* within 4 weeks, not receive chemotherapy, radiotherapy or surgery
* HB≥90g/L； ANC ≥1.5×109/L；PLT ≥80×109/L
* EGFR/ALK mutation negative
* immunohistochemistry test of cancer tissue showed ++ or +++ of thioredoxin reductase
* brain metastasis without symptoms

Exclusion Criteria:

* according to NCCN non-small cell lung cancer guidelines (2014 v3), there were standard treatment scheme for the patients
* pregnancy or breast-feeding women
* any serious disease which could not be controled
* urine protein≥++, or 24h urine protein\>1g
* received any anti-cancer treatment within 4 weeks
E-intervention on Subclinical Fear of Cancer Recurrence

The present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based self-management intervention, namely eConquerFear-HK and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local Chinese cancer survivors with subclinical fear of cancer recurrence.

A pilot randomised controlled feasibility trial will used to test the feasibility, utility, and potential effectiveness of an internet-based self-management intervention for fear of cancer recurrence among local Chinese cancer survivors with subclinical fear of cancer recurrence.

The following hypotheses will be tested:

1. There will be a greater FCR improvement in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
2. There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
3. There will be greater improvements in secondary outcomes (psychological distress and quality of life) in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
4. Cancer survivors receiving eConquerFear-HK intervention will perceive the intervention useful for managing their FCR and be satisfied with the intervention.
5. Cancer survivors receiving eConquerFear-HK intervention will show high completion rates.

Eligibility Criteria:
Inclusion Criteria:

* Cantonese- or Mandarin-speaking Chinese cancer survivors
* recently diagnosed with potentially curable (stage 0 to III) colorectal or breast cancer
* had recently completed surgery as primary treatment
* have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past six months
* scored 13 to 21 on the fear of cancer recurrence-short form will be recruited.

Exclusion Criteria:

* non-Chinese ethnicity
* metastatic cancer
* with current diagnosis of depression or psychosis or are currently receiving psychological treatments
* language or intellectual difficulties that prevent them from understanding the intervention content
* having limited or no Internet access.
Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery.

As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered.

Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.

Main goals

1. Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia
2. Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival.

Secondary objectives

1. Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer
2. Evaluation of the influence of lidocaine on postoperative inflammatory response
3. Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery

Exclusion Criteria:

* • persistent chronic pain

  * chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
  * Contraindications for any of the study medications
  * Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.)
  * Significant hepatic (ALAT and/or ASAT \> 2 normal values) or renal (plasma creatinine \> 2 mg/dl) disorders
  * Convulsive disorders requiring medication during the last 2 years
  * Planned regional analgesia/anesthesia (spinal or epidural)
  * Corticoid dependent asthma
  * Autoimmune disorders
  * Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
  * Refusal for study participation
The Effect of XSurge Supplementation on Biomarkers and Performance From High Intensity Resistance Exercise

Part one of this study will consist of baseline (BL) testing, 28 days of daily supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists of five visits, of which, the first visit will consist of maximal strength testing. The remaining visits will consist of performance testing and muscle evaluation.

Phase two of this study will consist of six weeks of supervised resistance training along with supplementation of XSurge. Following the six weeks of training, subjects will complete a second acute exercise protocol. Measures to be evaluated will consist of performance testing and muscle evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally active.
* Subject is judged by the Investigator to be healthy and free of any physical limitations
* Subject is male 18-35 y of age, inclusive
* Subject has a body mass index of 18.0-34.9 kg/m2
* Subject is willing to maintain habitual diet
* Subject is willing to abstain from dietary supplementation
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators

Exclusion Criteria:

* Subject is currently or will be enrolled in another clinical trial.
* Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
* Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Subject is unable to perform physical exercise
* Subject is a current smoker or has quit within the last 6 months
* Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.
* Subject is allergic to the study product or placebo
* Subject is taking any other nutritional supplement or performance enhancing drug
* Subjects that have donated blood or plasma within the previous week
* Subject has any chronic illness that causes continuous medical care
* Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.
Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome

The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration improves fatigue and general well-being in patients with systemic lupus erythematosus or primary Sjögren's syndrome

Fatigue and reduced general well-being are frequent complaints in patients with the chronic autoimmune disorder systemic lupus erythematosus (SLE) or primary Sjögren's syndrome (pSS). Uncontrolled studies suggested that the administration of dehydroepiandrosterone (DHEA) may improve such complaints. The aim of our randomized double-blind placebo-controlled study is to examine the effect of daily oral 200 mg DHEA on fatigue, well-being, and functioning in women with SLE or pSS.

Eligibility Criteria:
Inclusion Criteria:

* pSS with a focus score \>= 1 on minor salivary gland biopsy and fulfilling European classification criteria (Ann Rheum Dis 1996;55:116-21)
* SLE according to ACR classification criteria (Arthritis Rheum 1982;25:1271-7)
* Willingness to apply effective contraception (premenopausal women)
* Written informed consent.

Exclusion Criteria:

* Pregnancy
* Pregnancy wish
* Serum creatinine \> 150 µmol/L
* Glucocorticoid use at a daily dose \> 10 mg prednisone (or equivalent)
* Cyclophosphamide treatment in the preceding year
* Hyper- or hypothyroidism
* History of malignancy within the previous 5 years with exception of squamous or basal cell carcinoma of the skin
Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients

The aim of the study is to investigate the Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors.

Prior to start of rTMS sessions, Clinical evaluation and scaling of tremors using the ET rating scale (Fahn, Tolosa, Marin Tremor Rating Scale) will be employed on the participants in both groups.

rTMS frequency of 1Hz will be delivered to each of the participants in both groups. Each session will be administered once daily for 3 days a week for 4 weeks. 1200 pulses (30 pulses per train with total 40 trains having inter-train delay of 3 seconds) per session will be provided with the coil placed on both cerebellar hemispheres. rTMS frequency of 1Hz was kept constant based on previous studies.

rTMS sessions will be administered by trained professionals who was kept blinded to the research protocols used in the study. After completion of therapeutic programs (after 4 weeks), the participants will be asked to undergo post assessment of Fahn, Tolosa, Marin Tremor Rating Scale at the end of last rTMS session, 1 month, 3 months later.

Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1)
2. Patient should have significant residual tremors despite of using appropriate medical treatment.
3. Age: patient should be above 18 years old.
4. Gender: males and females.

Exclusion Criteria:

1. Patients with history of seizures.
2. Patient receiving tremor active drugs including:

   * Central cholinergic drugs (acetylcholine chloride, muscarinic and nicotinic agonists, anticholinesterases, and aminopropranolols)
   * Central monoaminergic drugs (neuroleptics, phenylethylamines, and indoles)
   * Peripheral adrenergic drugs (lithium carbonate, amphetamine sulfate, adrenocorticosteroids, and thyroid hormone supplements)
   * Anticonvulsants (valproic acid), bronchodilators (theophylline and terbutaline sulfate)
   * Antidepressants (amitriptyline hydrochloride).
3. patients who have metal or electronic device implanted in their body such as :

   * cardiac peace maker
   * Aneurysm clips or coils
   * Stents in the neck or brain
   * Deep brain stimulators
   * Spinal cord stimulators
   * Electrodes to monitor brain activity
   * Metallic implants in ears and eyes
   * Bullet fragments in or near the head
   * Baclofen pumps
   * Other metal devices or object implanted in or near the head
Effectiveness of Messages to Mobile Phone in Smoke Cessation

Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking.

Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients.

Methods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale.

Sample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients.

Control group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test).

Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years.
* Current smoker (25): Current smoker is defined as the person who at the time of the study beginning declares that smoked daily or occasionally.
* Possessing mobile phone.
* Able to receive and send messages through mobile phone.
* Score greater than 5 or equal to 5 on the Richmond scale

Exclusion criteria:

* People with a history of mental and behavioral disorders.
* Patients with a diagnosis of depression using the depression subscale of Goldberg (two or more positive responses).
* Patients who with pharmacological therapy for smoking cessation or who require it throughout the study.
* Pregnant women.
Patients With Non-ST-segment Elevation Acute Coronary Syndrome

There are two types of acute coronary syndrome (ACS): ACS with persistent ST segment elevation (ACS ST +) and ACS without ST segment elevation (non-ST + ACS). The incidence of non-ST + ACS is increasing and currently accounts for the majority of myocardial infarction (MI) hospitalizations, while that of ST + ACS is declining. Complications of MI, which include rhythm and conduction disturbances, are mainly associated with ACS ST +. It is recognized that these complications can occur during non-ST + ACS, but with less frequency. This frequency is not clearly established, and has been the subject of few studies. Recent studies in this direction suggest that the frequency of rhythmic complications is low during non-ST + ACS. However, the data collected concerns inter-hospital transport.

The aim of the study is to estimate the frequency of occurrence of potentially fatal rhythmic complications in patients admitted to the emergency room and to the cardiology department for non-ST + ACS.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥ 18 years old)
* Man or woman
* Patient admitted to the Emergency Department (SU) or to the Cardiology Department at the NHC between January 1, 2019 and December 31, 2020
* Patient whose main diagnosis retained at the end of hospitalization is a non-ST + ACS
* Patient who did not express his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice