cyrilzakka/clinical-trials huggingface dataset:
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225

The main objectives of the SRD part of this trial are to investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects following oral administration of single rising doses. The main objective of the BA part of this trial will be to explore the influence of food on the bioavailability of tablet fasted versus tablet fed


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
Viaskin Pertussis Vaccine Trial

The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or 50 mcg PT protein compared to Viaskin placebo.

Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be assessed throughout the 10-week study and its immunogenicity will be assessed at regular intervals with collection of blood samples for immunological analyses.

Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis.


Eligibility Criteria:
Inclusion Criteria:

* Has provided written informed consent before enrollment;
* Adult male or female, ages 18 to 40 years (inclusive) at the time of enrollment;
* Non-pregnant, non-lactating female;
* Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening;
* With documented history of pertussis immunization (at least 4 doses);
* Women of childbearing potential with a negative pregnancy test at entry;
* Females of childbearing potential who are willing to use an effective method of contraception.

Exclusion Criteria:

* Prior dTpa immunization within the last 10 years or prior dT immunization within the last 2 years, or any other investigational vaccine likely to impact on interpretation of the trial data;
* Suspected or confirmed pertussis infection within the last 10 years or documented pertussis infection in a household member within the last 10 years;
* Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines) or ongoing participation in another clinical interventional trial.
Transnasal Induction of Normothermia for Neurogenic Fever

The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
2. Ages 18-85 years, inclusive.
3. Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
4. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
5. Glasgow Coma Scale score of 3-11, inclusive.
6. Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.

Exclusion Criteria:

1. Intubation is contraindicated.
2. Weight of ≤ 100lb or ≥ 250lb.
3. Active/ongoing epistaxis.
4. Known or suspected pregnancy.
5. Participation in another ongoing investigational study.
6. Prisoners and/or patients for whom no LAR is available.
7. Patient is in airborne/droplet disease isolation protocol.
8. Patient is or suspected to be immunocompromised.
9. Nasal septal deviations (per standard of care CT scan; any degree).
10. Chronic rhinosinusitis.
11. Traumatic brain injury.
12. Prior skull-base surgery.
13. Penetrating cranial trauma.
14. Recent nasal trauma or anterior base skull fracture.
15. Any condition for which transnasal air flow would be contraindicated.
16. Refractory hypoxemia (partial pressure of oxygen in arterial blood (paO2) below 60 torr or oxyhemoglobin saturation below 90% despite endotracheal intubation, mechanical ventilation, and provision of supplemental oxygen of up to 0.60).
17. Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe

This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male patients, 18 to 45 years of age, inclusive
* No history of hypersensitivity or allergic reactions following drug administration
* No history of clinically significant or clinically relevant cardiac condition
* No history of previous anticancer treatment
* Body mass index (BMI) between 18-32 kg/m2, inclusive

Exclusion Criteria:

* Positive test result for drugs of abuse
* Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2
* Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG
* Clinically significant abnormal laboratory values
Randomized Controlled Trial of Conventional vs Theta Burst rTMS

This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.


Eligibility Criteria:
Inclusion Criteria:

* outpatients
* voluntary and competent to consent
* Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single, recurrent
* between ages 18-65
* failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
* have a score of ≥ 18 on the HAMD-17 item
* have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
* able to adhere to the treatment schedule
* Pass the TMS adult safety screening (TASS) questionnaire
* have normal thyroid functioning based on pre-study blood work

Exclusion Criteria:

* have a history of substance dependence or abuse within the last 3 months
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
* have active suicidal intent
* are pregnant
* have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
* have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
A Study in Participants With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) Who Are New to Conventional, Targeted and Biological DMARDs

The purpose of this Italian multicenter study is to collect prospective clinical data in participants with first diagnosis or confirmation diagnosis of Spondyloarthritis (SpA), according to Assessment of Spondyloarthritis classification (ASAS) criteria, in order to describe SpA characteristics and pattern of clinical presentation.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a first or confirmed diagnosis of Spondyloarthritis (SpA) according to Assessment of Spondyloarthritis classification (ASAS) criteria
* Participants must be naïve to conventional, targeted and biological Disease modifying anti-rheumatic drugs (DMARDs) treatment
* Participants must understand the purpose of the study
* Participants must sign a participation agreement/ Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

* Participants who already started conventional, targeted and biological DMARDs treatment for SpA
* Participants who participate to an investigational study in the last 30 days
* Participants unwilling or unable to participate in long-term, 24 months, data collection
* Participants unwilling or unable to fill in the Participant-reported outcome (PRO) foreseen by the protocol
* Participants unwilling or unable to sign the informed consent to the study
Changes of Cardiopulmonary Function After Thrombolysis in Patients With Pulmonary Embolism

The investigators expect to enroll about 80-100 acute pulmonary embolism patients treated with thrombolysis in two hospitals. Dynamic changes of cardiopulmonary function after thrombolysis are detected to evaluate which indicators can quickly reflect the effectiveness of thrombolysis.

About 80-100 acute pulmonary embolism(APE) patients treated with thrombolysis are enrolled in the First Affiliated Hospital with Nanjing Medical University and Nanjing Drum Town Hospital from January 1, 2020, to June 30, 2024. According to the 2019 ESC guideline, the standards for thrombolysis in APE patients are as follows: within 2 weeks of onset; high-risk pulmonary embolism; medium-high-risk pulmonary embolism with symptoms of aggravation.

Investigators dynamically monitor cardiopulmonary function of participants after thrombolysis, including blood pressure, heart rate, respiratory rate, blood gas analysis, 2-dimensional echocardiography (left and right ventricular diameter, pulmonary artery pressure, interventricular septum) and laboratory tests (cTnT,pro-BNP).participants are divided into two groups: thrombolytic success group and thrombolytic failure group according the previously reported criterion which is evaluated 48h after thrombolysis.

Cardiopulmonary characteristics are analyzed to seek accurate and rapid index to reflect success of thrombolysis.

Eligibility Criteria:
Inclusion Criteria:

* medium-high risk or high risk pulmonary embolism and treated with thrombolysis

Exclusion Criteria:

* lack of radiologic evidence to diagnose APE
* death within 48 hours after thrombolytic therapy
* unable to partner treatment and leaving hospitals
* missing other necessary data
* pregnancy
Study of Arterial Recanalization of the Central Retinal Artery Occlusions

Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at the retinal level. They share the same risk factors and common pathology. Their incidence is lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual acuity (VA) \<1/10. The diagnosis of an CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. There is no data on early retinal arterial recanalization after CRAO, nor on the relationship between early recanalization (spontaneous or post-thrombolysis) and visual prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Central Retinal Artery Occlusion ≤ 24 hours

Exclusion Criteria:

* Retinal Dynamic angiography not performed within 48 hours of onset of symptoms
* Occlusion of a branch of the central retinal artery
Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 to 30.0 kg/m2.
* Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
* Non-pregnant woman (negative pregnancy test) and not currently breast feeding
* Female subjects abstain from either hormonal methods of contraception
* Male subjects who are willing or able to use effective contraceptive
* Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.

Exclusion Criteria:

* History serious hypersensitivity reactions
* History or evidence of clinically significant diseases or any significant ongoing chronic medical illness
* History or evidence of family diabetes
* History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
* History or evidence of shock or severe dehydrate or severe infection
* History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period
* History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
* History of problems with swallowing tablet or capsule
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* Any condition possibly affecting drug absorption
* Have renal creatinine clearance (Clcr) \< 45 mL/min based on serum creatinine results at the screening laboratory test
* 12-lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening
Rice Germ Supplementation on Swimmers

In order to enhance the effects of training and improve performance, athletes often turn to nutritional supplements. According to the American College of Sports Medicine (ACSM), adequate selection of nutrients and supplements, adjusting intake according to the exercise performed, is necessary for optimal performance in athletes. The most recent consensus from the International Society for Sport Nutrition (ISSN), The American Dietetic Association (ADA) and ACSM on sport nutrition have been reviewed by Potgieter, stating that a single guideline is not sufficient to elaborate an individualized and focused nutritional management of athletes. Moreover, apart from the abovementioned guidelines, sport-specific nutritional strategies, including quantity, structure and timing of food (or supplement) intake should also be followed in order to maximize sports performance and recovery. The importance of dietary supplementation is of particular interest in swimming, where athletes usually undertake a training approach characterized by a high volume of training during aerobic development and high intensity training during the competition phase, coupled with strength training.

The size and market value of the sports supplement industry is continuing to grow, with health, safety and contamination concerns becoming more pressing. Therefore, it is important to identify dietary supplements that are safe and effective in supporting swimmers. Rice germ could be a safe and effective dietary supplement for swimmers. In the last few years, scientific research is trying to use waste rice products in the pharmaceutical and nutraceutical fields, considering the potential value of nutrients they contain. In particular, rice germ has a high protein and essential amino acids, such as lysine, histidine and valine content, a good lipid content (with prevalence of mono- unsaturated and polyunsaturated fatty acids - in particular linoleic and linolenic essential fatty acids and oleic acid), an high fiber presence; regarding water-soluble vitamins, rice germ has high content if thiamine (B1) and pyridoxine (B6), while vitamin E prevails for liposoluble vitamins. About minerals, are most present iron and magnesium. All these nutrients play important roles in maintaining the health of athletes. Currently, despite these characteristics, no study has evaluated the potential beneficial effect of RG supplementation on athletes. Given this background, the purpose of this investigation was to ascertain whether performance in swimmers could be improved by a 5-weeks of RG supplementation.


Eligibility Criteria:
Inclusion Criteria:

* moderately trained athletes
* regularly involved in regional and national competitions

Exclusion Criteria:

* No history of cardiac or respiratory disease
* no medication at the time of the study
* no abnormalities on physical examination or on resting electrocardiogram
Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function.

The aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.

The use of probiotics and prebiotics has become popular in human nutrition and food product development. The most common probiotics are Lactobacillus and Bifidobacterium species. Bifidobacteria spp are dominant in the intestinal microflora and are considered to be beneficial to the host, for this reason research efforts have focused on increasing their proportion in the intestinal microflora through oral administration of mixtures containing bifidobacteria or oral supplementation with prebiotics. An important limitation for the effectiveness of oral probiotics is that they might be destroyed during digestion in the gastrointestinal tract therefore and adequate vehicle could improve its potential benefits. Yogurt is a suitable vehicle for the administration of bifidobacteria, due to its physicochemical properties, such as pH and nutrients content, as well as the organoleptic properties that contribute to its increasing consumption. Thus simultaneous administration of probiotics and prebiotics in a suitable vehicle could act synergistically and may have potential for improving gut health. Few clinical trials have been performed using prebiotics and probiotics. The aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 55 years,
* be free of known gastrointestinal diseases,
* desist of consuming prebiotic and/or probiotic-containing foods or dietary supplements during the entire duration of the study,
* agree to avoid any medication that produced changes in gastrointestinal function, diarrhea or constipation until completion of the study,
* be willing to complete all necessary study questionnaires,
* accept voluntary participation and sign a written informed consent before inclusion in the study.

Exclusion Criteria:

* subjects receiving any kind of treatment that may had altered bowel function;
* intake of laxatives,
* a concomitant sever gastrointestinal disease;
* that were consuming probiotics and/or prebiotics-containing foods or dietary supplements within the two previous weeks;
* subjects were also excluded if they had received any antimicrobial medication during the previous 2 months.
Brief Intervention to Reduce Fear of Public Speaking

The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking.

Twenty subjects with Performance-Only type of Social Anxiety Disorder will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance of public speaking. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear activation procedure. Primary outcome assessment will be self-reported fear of public speaking and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age at the time of consent
* Principal Diagnosis of Social Anxiety Disorder, Performance only type
* Has clinically significant fear of public speaking
* Physically healthy
* If female, non-pregnant and not nursing
* Off all psychotropic drug for at least 4 weeks
* A level of understanding sufficient to provide written informed consent to all required study tests and procedures.

Exclusion Criteria:

* History of other serious psychiatric disorder
* Current Major Depressive Disorder
* Presence of developmental disorder or intellectual disability
* SAD patients with SAD not of the performance only type
* Women who are pregnant or nursing
* Current use of psychiatric medication
* Current substance use disorder
* Persons planning to start another treatment during the study period.
* Any significant medical condition that might increase the risk or participation (e.g., seizure disorder, respiratory disorders \[e.g., bronchial asthma\], cardiovascular disease \[e.g., congestive heart failure, heart arrhythmias, sinus bradycardia and greater than first degree block \], low blood pressure \[ \< 90/60\], diabetes, liver or kidney disorders)
* Use of medications that might negatively interact with propranolol (e.g., ACE inhibitors; catecholamine depleting drugs, such as reserpine; calcium channel blockers; digitalis glycosides; haloperidol; chlorpromazine; aluminum hydroxide gel; phenytoin; phenobarbitone; rifampin; antipyrine; lidocaine; cimetidine; theophylline)