cyrilzakka/clinical-trials huggingface dataset:
A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazolam in the Blood

The trial will be performed to assess the influence of BI 730357 on the pharmacokinetics of caffeine, warfarin, omeprazole and midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (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
* Either male subject, or female subject who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Use of non-hormonal intrauterine device plus condom for birth control
  * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
  * Surgically sterilised (including hysterectomy or bilateral tubal occlusion)
  * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 45 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 (except appendectomy or simple hernia repair) that could interfere with the pharmacokinetics (PK) of the trial medication
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further inclusion exclusion criteria apply
Deprexil in Subjects With Signs and Symptoms of Depression

The purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of persons to be recruited and randomized for the study is 200.


Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration.
* Signed informed consent

Exclusion Criteria:

* Severe symptoms and signs of depression or Suicide proneness.
* Pregnancy or breastfeeding
* Receiving other experimental drug
* Use of anti-depressive medication within 15 days
Isometric Training on Blood Pressure and on the Autonomic Modulation of Hypertensive Patients

Objective: analyze the effects of isometric handgrip exercise on arterial pressure and on the autonomic cardiac modulation of hypertensive individuals treated in the Unified Health System (UHS).

Intervention: Patients were randomized into Supervised group (SG) and control group (CG). SG will perform supervised isometric handgrip exercise for three weekly sessions in four sets with two minutes of isometric contraction with 30% of maximal voluntary contraction (MVC), In CG, individuals will be encouraged to increase their level of physical activity.

Measurements: Blood pressure, autonomic modulation

The objective of this study is to analyze the effects of isometric handgrip exercise on arterial pressure and on the autonomic cardiac modulation of hypertensive individuals treated in the Unified Health System (UHS). Two prospective, randomized, controlled trials will be conducted with hypertensive patients in the public health network of Petrolina (PE) and São Paulo (SP). Included in the study will be individuals with an age group over 18 years of both genders, with systemic arterial hypertension (SAH) controlled with the use of antihypertensive medication, non-smokers and without the presence of diabetes or other cardiovascular diseases that will be allocated randomly in two groups: supervised group (SG) and control group (CG). SG will be instructed to perform supervised isometric handgrip exercise for three weekly sessions in four sets with two minutes of isometric contraction with 30% of maximal voluntary contraction (MVC) of the subjects and interval between two-minute series. In CG, individuals will be encouraged to increase their level of physical activity. Prior to initiation and after 12 weeks of intervention, blood pressure, autonomic cardiac modulation and level of physical activity will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* It will include individuals with age range over 18 years of both genders and with controlled hypertension using antihypertensive medication and without the presence of diabetes or other cardiovascular diseases and who do not present high cardiovascular risk.

Exclusion Criteria:

* Those individuals who: a) are diagnosed of diseases such as dyslipidemia, diabetes mellitus, cardiovascular or pulmonary diseases; B) adhere to another program of physical activities besides the training offered by the present study; C) change the class and dose of medication during the study; and d) aggravate the disease.
Novel Epidermal Recording and Detection of Seizures

For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity. The experimental aspect of this study will be the application of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a continuous bedside recording of brain activity in the same manner as an EEG recording, while ideally producing less irritation of newborn skin than conventional EEG electrodes.

Infants admitted to our NICU that require a standard EEG for clinical diagnosis will be approached for consent to test one of two new methods of EEG recording. Patients will be randomized to the new epidermal electronic system (EES) or the a hydrogel EKG electrode. All patients will continue to receive the standard of care EEG monitoring.

EES is slim new temporary tattoo technology that can easily be applied to the skin without requiring a technician or scrubbing and preparation as with standard EEG lead. The hydrogel EKG are FDA approved leads normally used to detect cardiac rhythm.

Specific Aims:

1. To compare the rate of detection of neonatal seizures between a new method of recording electrical brain rhythms (EES or EKG) and the current standard of care (EEG, or electroencephalography.)
2. To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized neonates who already require continuous EEG recording for clinical care
* Parents signed informed consent
* CGA 44 weeks or less

Exclusion Criteria:

* Patient is moribund
Evaluation of Thioldisulfide Balance in Cervical Preinvasive Lesions

The purpose of this study is to investigate Thiol-disulfide balance in patients with cervical preinvasive lesions

To date various oxidative stress paramaters were studied in patients with cervical preinvasive lesions, however dynamic thiol disulfide hemostasis has not been previously investigated. The thiol-disulfide balance in the circulation will be measured by the automated system created by Erel \& Neselioglu(1).

References 1- Erel O, Neselioglu S. A novel and automated assay for thiol/ disulphide homeostasis. Clin Biochem 2014;47:326-32. doi:10.1016/ j.clinbiochem.2014.09.026.

Eligibility Criteria:
Inclusion Criteria:

• Histopathologically confirmed diagnosis of LGSIL or HGSIL

Exclusion Criteria:

* pulmonary disease
* pulmonary hypertension
* cardiac dysfunction
* renal dysfunction
* liver disease
* chronic ishemia
* systemic inflammation
* other cervical biopy results than LGSIL or HGSIL
* concomitant malignancy
* patients who use vitamin A,C or E (antioxidant vitamins)
* patients who use smoke • patients who use drink alcohol
* patients who use addictive for any drug
Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms.

This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. This is a single dose study and three different dose concentrations will be compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy, positive for COVID-19 by an EUA-approved rapid antigen or PCR test, has ongoing "mild to moderate illness or symptoms" with symptom onset starting \< 5 days prior to screening visits
* Must provide written informed consent/assent if a minor which includes signing the institutional review board/independent ethics committee approved consent form prior to participating in any study related activity
* Willing and able to comply with study procedures and follow-up visits
* Willing to follow all contraception guidelines

Exclusion Criteria:

* In the Investigator's opinion, has progressive symptoms with likely imminent (24-48 hours) hospitalization or severe COVID-19 illness/symptoms
* Any medical condition that, in the Investigator's or designee's opinion, could adversely impact participant safety or key objectives of the study
* Has a prior history of long COVID
* Has a clinically documents acute infection other than COVID-19
* Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding
* Has participated, or is participating in a clinical reserach study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or IV immunoglobulin within 2 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment

New therapies for cancer increased patient survival, but led to the recognition of adverse effects associated with cancer treatment, such as the use of chemotherapy. Cardiotoxicity is the most significant adverse effect, which affect the functional capacity and quality of life and is associated with high morbidity and mortality, regardless of the oncological prognosis. One of the manifestations of cardiotoxicity is ventricular dysfunction that can lead to heart failure. Neuro humoral hyperactivation with increased sympathetic nerve activity is a typical manifestation of heart failure and is associated with worse prognosis. Studies have shown that physical training significantly reduces sympathetic nerve activity in addition to improving muscle blood flow, reversing effects on skeletal muscle and improving quality of life. The hypothesis is that physical training may reduce sympathetic nerve activity and vasoconstrictor status in patients with heart failure caused by anthracyclines, as well as improving baroreflex and chemoreflex sensibility, mechanoreflex and metaborreflex control and skeletal myopathy.

The investigators included patients\> 18 years, left ventricular ejection fraction \<= 0.55, functional class (NYHA) I-III, under medical treatment for heart failure. Patients with coronary artery disease, moderate to severe valve disease, positive Chagas serology, inability to participate in an exercise program are excluded.

Primary outcome: Muscle sympathetic nerve activity Secondary outcome: arterial baroreflex sensitivity, peripheral chemorreflex sensitivity, mecanic and muscuclar metaborreflex control, ubiquitin proteasome system activity.

Patients were divided into 2 groups-trained (n = 10) and non-trained (n = 10). Patients in the trained group will complete 16 weeks of aerobic training. Evaluation of cardiac function, functional capacity, quality of life and biochemical evaluation (troponin, hs-CRP and BNP). For muscle evaluation will be performed biopsy of the vastus lateralis muscle

Eligibility Criteria:
Inclusion Criteria:

* age 18 years old
* Funcional Class I-III (NYHA)
* Ejection fraction \< o,55
* treated for heart failure

Exclusion Criteria:

* Coronary artery disease
* Moderate to major valve disease
* Positive serology for Chagas
* Inability to perform physical exercises
Abatacept for Patients With COVID-19 and Respiratory Distress

This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus). The primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level \</= 93% on room air. The primary endpoint analysis will be performed using all enrolled patients.

Patients with COVID-19 who are admitted with respiratory distress will be considered for enrollment on this study. Patients will be screened and then if they meet eligibility criteria will be enrolled. Abatacept will be administered on Day 1 at a dose of 10 mg/kg. Patients will then be followed closely through 90 days post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old.
* Confirmed SARS-CoV-2 infection, confirmed by polymerase chain reaction (PCR) \</=4 days prior to enrollment
* Evidence of respiratory distress including SpO2 \</=93% on room air.
* Radiographic evidence of pulmonary infiltrates.
* Ability to understand and the willingness to provide informed consent.

Exclusion Criteria:

* Patients already intubated/mechanically ventilated at screening will not be eligible.
* Patients with uncontrolled severe bacterial or fungal infections at the time of enrollment.
* Patients with previously diagnosed autoimmune disorders or who were on immunosuppressive medications prior to developing COVID-19 are not eligible
* Pregnant or breastfeeding
The Investigation of Acute Effects of Action Observation Training on Upper Extremity Functionality, Reaction Time and Cognitive Functions in Right-handed Healthy Subjects

The aim of the study is to investigate the acute effects of action observation training on upper extremity functionality, reaction times, and cognitive functions in right-handed healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* willingness

Exclusion Criteria:

* any kind of neurological or musculoskeletal problems
* sight problems
* pain in the upper limb
* left handedness
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety, Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults with COVID-19.

This is a randomized, double-blinded, placebo-controlled, dose-climbing Phase Ib clinical trial, designed to evaluate the safety, pharmacodynamics, and pharmacokinetics of SSD8432/ ritonavir versus placebo in asymptomatic, mild, and common type adult COVID-19 subjects.

This clinical trial is planned to enroll 32 asymptomatic infected, mild or common type adult COVID-19 subjects, divided into 2 cohorts according to different doses of SSD8432:

Cohort 1: 16 subjects, 12 subjects will receive low-dose SSD8432/ ritonavir, and 4 subjects received placebo; Cohort 2: 16 subjects, 12 subjects will receive high-dose SSD8432/ ritonavir, and 4 subjects received placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤75, male or female.
2. Asymptomatic Infection, Mild, or Common Type of COVID-19.
3. Initial positive test of SARS-Cov-2 within 5 days of randomization.
4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
5. The Ct value of SARS-COV-2 nucleic acid test before randomization is ≤ 25, or the Ct value is \>25 and sarS-COV-2 serum IgG and IgM are negative.

Exclusion Criteria:

1. Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required.
2. Prior to current disease episode, any confirmed SARS-CoV-2 infection.
3. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis).
4. Receiving dialysis or have known moderate to severe renal impairment.
5. Known human immunodeficiency virus (HIV) infection.
6. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.s.
7. Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization..
8. Treatment with antivirals against SARS-CoV-2 within 14 days.
9. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance.
10. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days.
11. Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication.
12. Females who are pregnant or breastfeeding.
Evaluation of the "Eat Less Meat" One-month Challenge

In a context where meat consumption should be dramatically reduced in western countries to improve both population and planet health, the "Eat Less Meat" one-month challenge is a new behavioural intervention that aims (i) to weaken meat consumption habit and (ii) to enhance intrinsic motivation to eat less meat to trigger long-term reduction in meat consumption. The present study focusses on the quantitative evaluation of the effect of this challenge on French university student's meat consumption.

Parallel two-arm randomized controlled trial with repeated measures (online questionnaires) pre-, during- and post-intervention. All the participants will be recruited to take part in the "Eat Less Meat" challenge for one month. Participants in the control group will take part in the challenge 4 months after the participants in the intervention group. Participants in both groups will complete the online questionnaires at the exact same time, i.e., pre-, during- and post-intervention measures will take place before the control group starts the challenge.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 18.5
* University student in 'Bourgogne Franche-Comté'
* Fluent in French
* Available email address
* Available Instagram profile

Exclusion Criteria:

* Vegetarian or vegan or pescetarian
* Pregnant/breastfeeding
* Iron deficiency
7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).
2. Subject:

   * Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) \<0.7 at screening; and
   * Has a post-bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of the predicted normal value.
3. Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of receiving 500 µg of ipratropium bromide from a PARI LC Sprint® nebulizer.
4. Females of non-childbearing potential. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.
5. Subject (or care giver) is able to properly prepare and administer study medication.
6. Subject is willing and able to give written informed consent to participate.

Exclusion Criteria:

1. Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.
2. Subject has had an initiation of treatment, or a change in dose, of an inhaled or oral corticosteroid, or long-acting beta2 agonist (LABA), or long-acting muscarinic antagonist (LAMA) within 4 weeks before the qualifying ipratropium bromide response test.
3. Subject is taking daily maintenance inhaled/systemic corticosteroids (\>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
4. Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study.
5. Subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. Subject has a history (or family history) of congenital prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB (QT interval corrected for heart rate using Bazett's formula) value \>450 msec (males) or \>470 msec (females); or shows evidence of clinically significant rhythm abnormality.
6. Subject has a known hypersensitivity to TD-4208 or similar drug class.
7. Subject has a history of alcoholism or drug abuse within 2 years prior to screening.
Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients

This is multi-center prospective, longitudinal case series with comparison to historical controls.

The primary objective to this study is to determine the effectiveness of CelluTome™ epidermal harvesting system as an outpatient skin grafting system for selected patients versus inpatient skin graft harvest. This is multi-center prospective, longitudinal case series with comparison to historical controls. In this study, all subjects will receive the same treatment protocol regardless of institution. This will include routine wound photography. Ongoing healing process will be recorded and reviewed. The secondary objectives of this study are to establish an ideal donor site size, recipient site size and ideal patient population (especially high operative risk patients) that would benefit from the use of CelluTome™ Epidermal Harvesting System.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Patients requiring split-thickness skin grafting with non-infected wounds
* Age of participants: 18 years and above at the time of informed consent
* Gender: Male or Female
* Subjects who will be locally available for the next 6 months.

Exclusion Criteria:

* Infected chronic wound
* Patients who are unable to adhere to scheduled study visits
* Patients who have severe arterial insufficiency requiring vascular intervention to restore adequate blood flow
* Patients who have an active drug/alcohol dependence or abuse history
* Use of Investigational Agents/Devices on study or within 30 days prior to informed consent or within 30 days prior to use of device.