cyrilzakka/clinical-trials huggingface dataset:
Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT1806 Injection vs Actemra® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).

The study has a screening period of 7 days. PK blood samples will be collected from subjects to determine the serum concentration of tocilizumab, thus to evaluate the change and similarity of the pharmacokinetics of the three study drugs.

The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Signed the Inform Consent Form and fully understood the trial conduction, procedure and potential adverse reactions before entering the trial;
* Willing and able to follow the visits, treatments specified in this study;
* Subjects (including their partners) who are willing to refrain from pregnancy, sperm donation and take effective contraceptive method in the future 6 months (i.e. 6 months after study medication), see Appendix 4 for specific contraceptive methods;
* Healthy male subjects at age of 18-55 years (inclusive for both);
* BMI between 18-28 kg/m2 (inclusive for both) and body weight between 55-85 kg (inclusive for both);
* Normal physical examinations results or abnormality without clinical significance.

Exclusion Criteria:

* Daily smoking amount of \>5 cigarettes within 3 months prior to the trial;
* Any current or history of severe allergic reaction to foods or drugs and History of allergy to tocilizumab or severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
* Having a history of alcoholism (14 units of alcohol per week: 1 unit= 285 mL beer, or 25 mL spirit, or 125 mL wine);
* Having donated blood or loss of massive blood (\> 450 mL) within 3 months prior to screening, or planning to donate blood or to receive surgery during the study;
* Prior use of prescription medication, over-the-counter drugs, any vitamin products or herbs within 28 days before screening;
* Having significant changes in diet and exercise habits within 2 weeks before screening or from screening to dose;
* Having any diseases that increase the risk of bleeding, such as hemorrhoids with bleeding symptoms, acute gastritis or gastric and duodenal ulcers;
* Color Doppler echocardiography abnormalities with clinical significance;
* Having clinically significant laboratory abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases);
* Ineligible subjects based on investigator's judgement.
Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)


Eligibility Criteria:
Inclusion Criteria:

* Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
* Patients who are refractory to cytokine therapy as 1st line.
* Patients who experienced nephrectomy.
* Patients with at least 1 target lesion, as defined by RECIST.
* Patients with no uncontrolled hypertension.

Exclusion Criteria:

* Gastrointestinal abnormalities
* Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
* Active seizure disorder or evidence of brain metastases.
* Patients with hemoptysis.
Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

Treatment of primary hyperhidrosis through a comparative study between oxybutynin hydrochloride and placebo.

Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of life.

Clinical Trial phase III, randomized, national, prospective, double-blind, multicenter, comparative between oxybutynin hydrochloride and placebo, to be held in participants aged over 18 years to evaluate the therapeutic efficacy and safety of oxybutynin chloride to systemic treatment of primary hyperhidrosis.

Primary hyperhidrosis is a relatively common disorder, affecting approximately 3% of the population. It affects both sexes similarly and in all age groups, varying only the starting age of symptoms according to the most affected part of the body:

childhood - plantar and palmar hyperhidrosis adolescence - axillary hyperhidrosis adult - craniofacial hyperhidrosis

There is a family history associated with between 12.5% and 56.5% of the participants, according to epidemiological studies.

Initially the subjects will be evaluated on the inclusion and exclusion criteria through screening and safety tests such as blood tests , ECG and tonometry, to confirm enrollment.

When included will be randomized into the corresponding study arm to start study treatment.

During the period of the study it will evaluate the efficacy parameters of the drug.

The treatment for each subject will be about 8 weeks. The inclusion period is foreseen for 6 months and may be extended or decreased according to the pace of inclusion.

The data are summarized according to the study group (per dose and per visit, if applicable) through appropriate descriptive statistics to the variable type. Frequency and percentage will be used for the variables.

The Adverse Events (AE) will be analyzed based on questioning by the investigators in relation to the AE experienced by the subjects. The orientation will be to the subject to note the symptom, the date and time that the event appeared.

Eligibility Criteria:
Inclusion Criteria:

* Understanding, agreement and consent form signed;
* Literate;
* Confirmed diagnosis for primary hyperhidrosis;
* Screening tests at normal standards;
* Absence of pregnancy by Beta-human chorionic gonadotropin test;

Exclusion Criteria:

* Secondary Hyperhidrosis;
* Myasthenia gravis;
* Lactation;
* Hypersensitivity to oxybutynin;
* Use more than 500mg of caffeine;
* Alcoholism;
* Use of illicit drug;
* Changes in ECG (echocardiogram) or tonometry;
* Any clinical condition that the investigator considers clinically significant.
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

The morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI. The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms.

Twelve RYGB candidates who were successfully treated with an SRI for primary mood or anxiety disorders were studied prospectively. Blood samples for SRI plasma levels were drawn immediately after dose for pharmacokinetic studies (PK) preoperatively. Maximum concentration (CMAX), time to CMAX (TMAX), and Area Under Concentration/Time curve (AUC) were determined. PK studies were repeated at one, six, and twelve months post-operatively. PK data were corrected for dose at each study time point. The Structured Interview Guide for the Hamilton Depression Rating Scale- Atypical Depression Symptom Version was used to quantify depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Able to tolerate general anesthesia
* Able to document prior unsuccessful attempts at weight loss under medical supervision during the last 6 months
* Able to provide informed consent
* Cleared for surgery by primary care MD, dietician, and psychiatrist
* SRI treatment specifically for depression for ≥6 wks at constant dose for last 2 out of 6 wks

Exclusion Criteria:

* pregnancy
* Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup
Bladder Cancer Screening Trial

There is currently no accepted screening strategy for patients at high risk of developing bladder cancer. This study will ask patients to complete a urine test every 6 months for 2 years to help assess if routine screening helps finding bladder cancer at an earlier stage.

Bladder cancer is the 4th most common cancer in men and 6th most common cancer overall with over 80,000 new cases in the US per year. The most common causes of bladder cancer are smoking and it is usually found in patients over the age of 50. By the time it is diagnosed, the disease is often advanced since there are few warning signs other than seeing blood in the urine.

Screening is currently accepted practice for colon, cervical, and breast cancer. However, there is not an accepted screening methodology for bladder cancer. Bladder cancer is currently detected in 2-5% of patients who have microhematuria on routine urinalysis, a cheap, non-invasive test obtained by many primary care physicians. Bladder cancer diagnosed by microscopic blood on urinalysis is often lower stage than patients diagnosed with visible blood. Urine testing, therefore, offers a simple screening mechanism that can be tailored to patients at higher risk for bladder cancer based on age, tobacco exposure and other risk factors. In conjunction with routine traditional urinalysis testing, there are advances in urine molecular markers which utilize protein and genetic alterations resulting in a higher sensitivity and specificity for the detection of bladder cancer. Markers have not been evaluated for screening in high-risk populations, and there is a gap in knowledge of the most accurate screening method.

Early detection of bladder cancer has the potential to identify disease at an earlier stage resulting in a lower burden of treatment, improved quality of life, and improved survival.

This study will prospectively screen patients at high risk for the development of bladder cancer at bi-annual intervals with a commonly available urinalysis test that assess for microhematuria and urine based molecular markers.

This is a single arm study. The outcomes from the experimental arm will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50
* Smoking: ≥15 pack-year smoking history
* Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners

Exclusion Criteria:

* Prior history of bladder, kidney, or prostate cancer
* Prior evaluation of micro or gross hematuria within the last 2 years
* Do not provide informed consent
Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help patients to accept their problem and to cope it. In consequence, the present study is aimed to evaluate the efficacy of a mindfulness therapy program in management of chronic orofacial pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria:

* Pain with oncologic origin
* Severe mental disorder
Pilot Study to Evaluate A Novel Gastric Space Occupying Device

This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 21-64 years
2. BMI 27-40 Kg/m2
3. No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion Criteria:

1. Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
5. History or symptoms of thyroid disease which is not controlled by medication;
6. Have severe renal, hepatic, pulmonary disease or cancer;
7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
8. Have a history of adhesive peritonitis;
9. History or symptoms of esophageal and/or gastric varices;
10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
11. History or symptoms of inflammatory bowel disease, such as Chron's disease;
12. History of/ signs and /or symptoms of duodenal or gastric ulcer;
13. Have gastroparesis;
14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
15. Currently using pharmaceutical agents for weight loss;
Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease

The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.

Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register the duration, pattern and symptom correlation of distal esophageal acid exposure. This can be accomplished via a catheter probe connected from outside the body and placed through a nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH detector temporarily implanted in the distal esophagus during endoscopy can record reflux events. However, despite available technologies, there has long been a deficiency in detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus, and non-cardiac chest pain. Until now, there has not been a device sensitive enough for accurately detecting extra-esophageal reflux (EERD) and clinicians have relied upon subjective response to empiric treatment with acid reducing medications to determine whether acid reflux was at the root of the symptoms. There are currently no well designed published studies with this device to assess its role in this group of difficult to treat patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female volunteers aged 18 to 65 years old.
2. Control group: No known history of GERD or EERD or prior PPI use.
3. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
4. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

Exclusion Criteria:

1. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
2. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
3. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
4. Expected non-compliance.
5. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
6. Recent nasal surgery or nasal obstruction.
7. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)
8. Pregnancy
Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population

The goal of this clinical trial is to evaluate the efficacy and safety of a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy in the Bangladeshi population.

Researchers will compare atorvastatin (10 mg) and ezetimibe (10 mg) to atorvastatin (20 mg) monotherapy to see if atorvastatin (10 mg) and ezetimibe (10 mg) FDC works to treat dyslipidemia.

Participants will:

* Take a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy for 3 months
* Follow-up visits at 6 weeks and 12 weeks for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>18 years.
* Patients with a confirmed diagnosis of elevated LDL-C levels necessitating medical management.
* Patients in the low to moderate cardiovascular disease (CVD) risk category according to ESC guidelines (2019)

  * Low-risk: Increased LDL-C level without any co-morbidities
  * Moderate-risk: Young patients (T1DM \<35 years; T2DM \<50 years) with DM duration \<10 years, without other risk factors.

Exclusion Criteria:

* History of hypersensitivity to any study drugs.
* Clinically significant hepatic impairment (ALT, AST level \> 2xULN) and/or renal impairment (Serum creatinine level ≥2xULN).
* Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, cancer, psychiatric instability, HIV + status, intestinal malabsorption.
* Pregnant or lactating females.
* The presence of a condition that, in the opinion of the investigator, would place the subject at increased risk from study participation.
Therapeutic Fasting and Immune Aging

Immunosenescence is the age-related decline of the immune system, involving a state of chronic inflammation and a decrease in the diversity/adaptability of the lymphocyte repertoire. The consequences of immunosenescence are multiple, including increased susceptibility to infections and poorer vaccine responses.

In order to fight against immunosenescence, many therapeutics are envisaged, with the aim of restoring, renewing and/or reprogramming the immune system. Among these leads, therapeutic fasting, and in particular the "fasting mimicking diet" (FMD), seems to modify the reprogramming and renewal of the immune system with, on the one hand, the elimination of inefficient "overactivated" cells and, on the other hand, the activation of hematopoietic stem cells. FMD consists of a significant reduction in food intake, limited to 3-5 days/month. The FMD seems to be the best compromise between efficacy and tolerance (already evaluated in humans, including oncology).

Eligibility Criteria:
Inclusion Criteria :

* Patient affiliated or entitled to a social security scheme
* Residing in a Long-Term Care Unit (LTCU) or a Facility for the Elderly Dependent (EHPAD)
* A person deemed a priori, by the geriatrician member of the monitoring committee, to be capable of following the dietary recommendations required for the study.
* A person deemed a priori, by the clinician in charge, to be able to follow the dietary recommendations required by the study.
* Patient who has received informed information about the study and has co-signed a consent to participate in the study with the investigator.

Exclusion Criteria :

* Inability and/or unwillingness to follow dietary recommendations and/or perform follow-up examinations required for the study
* Iso-resource group 1 or 2 according to the AGGIR grid
* BMI \< 18.5 kg/m2 or recent weight loss \> 5% in 1 month or recent weight loss \> 10% in 6 months from previous weight
* Albuminemia \< 30g/l
* All swallowing disorders requiring a specific diet.
* Influenza vaccination received prior to inclusion
* Episode of influenza or suspected influenza during the 2020-2021 season and prior to inclusion
* Any acute medical or surgical event less than 2 weeks prior to inclusion
* Presence of systemic inflammatory or autoimmune disease
* Presence of an innate or acquired immune deficiency (including taking immunosuppressive treatment)
* Presence of a chronic disease which, according to the physician, makes the follow-up of a "fasting diet" and/or the consumption of large amounts of liquids (cf. fasting diet modalities) risky (e.g. insulin-dependent or insulin-requiring diabetes, severe heart failure, severe kidney failure, active cancer, significant undernutrition...) or impossible (e.g. advanced neurodegenerative pathology).
Determination of the Optimum Cut-off Value of Type 2 Diabetes Diagnosis Among Chinese Population(SENSIBLE STUDY II)

Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence: determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China

To find the cut-off point of AGEsP and HbA1c for diagnosis of diabetes by drawing the logistic regression model between prevalence of retinopathy and AGEsP level and HbA1c level,and find the point where the prevalence of retinopathy changes most rapidly.

Eligibility Criteria:
Inclusion Criteria:

* 20\~70 years old;
* Volunteer to participate in this study and signed informed consent.

Exclusion Criteria:

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