cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian males
* Age 30 to 65 years
* BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg.
* Must be willing and able to communicate and participate in the whole study
* Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
* Must provide written informed consent
* Regular alcohol consumption of 4-14 units of alcohol per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
* Must agree to adhere to the contraception

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1
* any drug or alcohol abuse
* Current smokers and those who have smoked within the last 12 months.
* Radiation exposure, including that from the present study, excluding background adiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* No occupationally exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study
* Clinically significant abnormal biochemistry, hematology, coagulation or urinalysis as judged by the investigator
* Positive test for HIV, HBV, HBC
* eGFR \<80 mL/min
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
* Known sensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions)
* History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome
* Mental handicap
Study of Epratuzumab in Systemic Lupus Erythematosus

Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments


Eligibility Criteria:
Inclusion Criteria:

* Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria:

* Development of toxicity to Epratuzumab
* Significant protocol deviations from SL0003 Study.
SB17170 Phase 1 Clinical Trial in Solid Tumors

Phase 1 Open-label, multicenter, dose escalation, dose expansion study

This is an open-label, multicenter, Phase 1 clinical trial to evaluate the maximum tolerated dose, safety, pharmacokinetic/pharmacodynamic characteristics and preliminary anti-tumor activity of SB17170 when administered alone(1a) and co-administered with standard of care(1b) to patients with locally advanced or metastatic solid tumors who have failed standard of care.

1 cycle of treatment of this clinical trial is 21 days, and tumors are assessed every 2 cycles.

Eligibility Criteria:
Inclusion Criteria:

* A patient with a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors.
* A person who has failed the known standard of care or has developed resistance to the standard of care and no longer has applicable standard of care
* A patient with at least one measurable lesion according to the RECIST v1.1 criteria.
* A person with Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
* Those with an expected survival period of 3 months or more at the discretion of of the investigator.

Exclusion Criteria:

* A patient who has received drugs targeting High Mobility Group Box 1 (HMGB1).
* A patient who has received or is undergoing chemotherapy (including chemotherapy, radiation therapy, immunotherapy, hormone therapy, targeted therapy, biological products, and tumor embolization) within 28 days from the first administration date of the investigational drug.
* A person who needs to take contraindicated drugs or is expected to take them during the study period.
Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient

Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang Gung Memorial Hospital. The objective of this study is to compare the number of clinical visits, total prices, complications and nasal symmetry between these two NAM reconstruction methods.

Grayson's NAM reconstruction starts with alveolar molding first. The alveolar molding is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. After the alveolar cleft gap is less than 5 mm (usually at the end of second months), nasal molding was added to the alveolar molding plate.

Figueroa's NAM reconstruction use labial tapes and acrylic relief to the palatal plate to approximate alveolar gap. The device starts with nasal and alveolar molding simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* Complete unilateral cleft lip infant
* Signed informed consent

Exclusion Criteria:

* Incomplete unilateral cleft lip infant
* Association of other craniofacial anomalies
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in HIV-infected adults. The study will enroll 150 adults (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 days.

During the first wave of the H1N12009 pandemic in Canada, adults with immune deficiency were more likely to die with severe infections than were other Canadians. Of 76 deaths attributed to date to this new virus, 37% occurred in persons with immune system compromise. Adults with human immunodeficiency virus (HIV) infection constitute a significant proportion of the at-risk population with over 56,000 affected individuals. Most such individuals retain some capacity to respond to influenza vaccination. The dosing regimen for the pandemic vaccine will be based on limited studies in the general population, leaving open the question of whether HIV-infected persons can respond satisfactorily to the recommended dosing. Availability of an adjuvanted formulation of the pandemic vaccine may improve responsiveness but two doses may be required for the best possible response. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest HIV-infected persons to receive it, to inform the subsequent vaccination of others.

The objectives of this study are three-fold:

1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults with HIV infection.
2. To compare immune responses of subjects randomized to receive either one or two doses of adjuvanted vaccine to identify the optimal regimen.
3. To complete this evaluation soon after the pandemic vaccine becomes available so as to inform the subsequent use of the vaccine in HIV-infected persons.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed HIV
* Written informed consent
* Adults 20-59 years of age

Exclusion Criteria:

* Allergies to eggs, thimerosal or gentamicin sulphate
* Life-threatening reaction to previous Flu vaccine
* Bleeding disorder
* Pregnancy
* Receipt of blood or blood products in past 3 months
* Chronic illness
* Previous lab-confirmed H1N12009 infection
* Receipt of any non-study H1N12009 or Seasonal Influenza vaccine for 2009/10
A Study to Collect Information of People With Narcolepsy in Spain

This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly. Study doctors will review the medical records of the participants from sleep clinics in Spain. They will do this from 1 year before the participant was diagnosed with narcolepsy up to the start of this study.

Participants will visit the sleep clinic once. During this visit, the study doctors will carry out a short medical exam. Participants will also complete a few questionnaires during this visit. If participants cannot visit the clinic for any reason, the clinic staff will arrange a phone call instead.

This is a non-interventional, cross-sectional study with retrospective medical chart review conducted in public and private Spanish sleep clinics, to describe the management of adult participants diagnosed with narcolepsy defined by ICDS-3 in real world practice.

This study will enroll approximately 196 participants (137 with NT1 and 59 with NT2). Participants will be enrolled in 2 cohorts:

* Cohort A: NT1 Participants
* Cohort B: NT2 Participants

The data will be collected retrospectively through clinical records and at study visit (clinical and demographic data, and participant related outcomes \[PRO\]) in an electronic case report form (eCRF).

This multi-center study will be conducted in Spain. The overall duration of this study is approximately 24 months. Participants will attend a single visit in the participating centers. In the event of a possible outbreak of coronavirus disease 2019 (COVID-19) participants will have a telepathic visits, the invitation to participate, the obtention of participant's informed consent and the collection of participant's questionnaires will be carried out remotely (by phone or via email).

Eligibility Criteria:
Inclusion Criteria:

1. With confirmed diagnosis of narcolepsy defined by ICDS-3.
2. With at least 1-year follow-up with data available at the participating site after initial narcolepsy diagnosis and before study inclusion.
3. With data available at the participant site at least 1-year before first narcolepsy diagnosis.
4. Capable to fulfill the study questionnaires.

Exclusion Criteria:

1. Participating in a clinical trial (less than or equal to \[\<=\] 12 months).
2. With any serious degenerative disease (Alzheimer, Parkinson or epilepsy) or psychiatric condition.
Effects of Gynecological Age on LH Sensitivity to Energy Availability

The purpose of this experiment is to investigate whether the dependence of luteinizing hormone pulsatility on energy availability declines during adolescence.

The incidence of menstrual disorders declines during adolescence. This has long been attributed to the gradual "maturation" of the hypothalamic-pituitary-ovarian axis, but the mechanism of this "maturation" is not known. Ovarian function critically depends on the pulsatile secretion of gonadotropin-releasing hormone (GnRH) by the hypothalamus and on the consequent and more readily assessed pulsatility of luteinizing hormone (LH) secretion by the pituitary. LH pulsatility has been shown to depend on energy availability, operationally defined as dietary energy intake minus exercise energy expenditure. The effects of energy availability on LH pulsatility are thought to be mediated by certain metabolic substrates and hormones.

Comparison: By manipulating diet and exercise regimens, contrasting energy availability treatments of 10 and 45 kilocalories per kilogram of fat-free mass per day are being administered to adolescents with 5-8 years of gynecological age and to adults with 14-18 years of gynecological age for five days in the early follicular phase of separate menstrual cycles. Effects of low energy availability on LH pulsatility and on selected metabolic substrates and hormones are being measured.

Eligibility Criteria:
Inclusion Criteria:

* 5-8 or 14-18 years of gynecological age
* menstrual cycles of 26 to 32 days for the previous 3 months
* luteal phase length \>11 days
* 18-32% body fat

Exclusion Criteria:

* smoking
* oral contraceptives
* hematocrit \<35%
* diet with \<35 or \>55 kcal/kgFFM/day of energy
* habitually performing more than 60 minutes/week of aerobic exercise
* histories or evidence of heart, liver, or kidney disease, diabetes, menstrual or thyroid disorders, pregnancy, lactation, and congenital or acquired orthopedic abnormalities
AST-120 Used to Treat Mild Hepatic Encephalopathy

The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed cirrhosis of any cause
2. Abnormal RBANS global summary score
3. Grade 0 or 1 hepatic encephalopathy by West-Haven Scale
4. MELD score \< or = 25
5. Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control

Exclusion Criteria:

1. Previous participation in any trial involving AST-120
2. History of TIPS or surgically created portocaval shunt
3. Treatment for overt HE within the past 3 months
4. Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days
5. Active alcohol abuse
6. Psychosis or organic brain syndromes due to alcohol or other causes
7. Use of interferon and sedating or cognition-altering drugs
8. Undergoing chemotherapy or radiotherapy for the treatment of cancer
9. Active GI bleeding within the past 3 months
10. Presence of an active infection
11. Presence of signs and symptoms of severe dehydration
12. Other major physical or major psychiatric illness within the past 6 months
13. Pregnant, breast feeding, or planning to become pregnant during the study
14. Using hormonal contraception as the only method of birth control
Circulating Stem Cells, SDF-1, HIF-1 and Sepsis's Indices in Emergency Abdominal Surgical Patients

Septic shock is a systemic inflammatory response syndrome with acute circulatory failure secondary to a documented infection. It is the most feared complication in ICU patients, with a 50% mortality rate.

The study of stem cells and their experimental use in sepsis treatment is particularly relevant in the international scientific research, where Italy plays an important role. In the vast and complex field of stem cell research, the primary aim of the current proposal is to evaluate the time course level of circulating endothelial progenitor stem cells CD34 + / CD133 + (EPCs), and some factors EPCs-related, such as hypoxia- inducible factor (HIF- 1) and stromal derived factor-1 (SDF-1) in septic patients undergoing major abdominal surgery.

Secondary objective 2: to investigate the relationship between CD133/CD34, HIF-1, SDF-1a and outcome of septic/septic shock patients treated with standard conventional therapy alone (CT) or with extracorporeal hemoperfusion therapy (HCT).

Primary objective: to determine the time course level of the circulating EPC (CD133/CD34), SDF-1a, and HIF-1 in septic patients undergoing major abdominal surgery.

Secondary objective 1: to investigate the relationship between these factors: CD133/CD34, HIF-1 and SDF-1a.

Secondary objective 2: to investigate the relationship between CD133/CD34, HIF-1, SDF-1° and outcomeof septic/septic shock patients treated with standard conventional therapy alone (CT) or with extracorporeal hemoperfusion therapy (HCT).

In this trial, we hypothesize that CD133/CD34, HIF1 and SDF1a will increase in septic surgical patients as consequence of impaired tissue perfusion and cellular hypoxia. Our hypothesis is based on the fact that the stimulation of factors hypoxia-related, as SDF-1a and HIF-1 could be the primary step for bone marrow stem cells stimulation. Furthermore, we assume that survivors septic patients will show higher levels of EPC, HIF-1 and SDF-1a.

Each day, the anesthesiologist of the operating room and the on-call anesthesiologist will alerts the principal investigator to a potential eligible patient. Participants included in the trial will be divided into two groups:

* C group: postoperative non septic patients in emergency surgical ward (ES) (control group)
* S group: postoperative septic shock patients in intensive care unit (ICU) Healthy volunteers (H group) will be recruited from among staff members of the University Hospital of Foggia

The research study can provide useful parameters for early diagnostic and therapeutic interventions in sepsis which is the leading cause of death from infection, with an incidence of approximately 10% in ICU postoperative patients according to recent epidemiologic studies.

Eligibility Criteria:
Inclusion criteria:

Caucasian, Over 18 years of age

Exclusion criteria:

when it is impossible to collect blood samples (organizational reasons or because of emergencies regarding the health of the patients),Pregnant patients,Organ transplantation, Palliative care,Metastatic cancer patients
Antidepressant Treatment of Mexican-Americans: UCLA Pharmacogenetics and Pharmacogenomics Research Group

Our goal is to study pharmacogenetics in Mexican-Americans, using depression treatments as a proof of the concept that pharmacogenetic approaches can be used to optimize treatment strategies for common and complex disorders in this population.

This is a single site, 8-week, double-blinded, placebo lead-in trial with fluoxetine or desipramine. All subjects have a comprehensive psychiatric and medical assessment, and if enrolled, continued with two consecutive phases of the study: 1) A one-week, single-blind placebo lead-in phase to eliminate placebo responders. 2) Subsequent random assignment to one of two treatment groups: fluoxetine 10-40 mg/day or desipramine 50-200 mg/day. Given the proven efficacy of these antidepressant medications, a placebo lead-in period followed by active treatment for all patients has been utilized in order to minimize human subjects at risk.

Eligibility Criteria:
Inclusion Criteria: 1) At least 3 out of 4 grandparents born in Mexico \[12\]. 2) DSM-IV diagnosis of current, unipolar major depressive episode \[13\]. 3) 21-Item Hamilton Depression Rating Scale (HAM-D) \[14\] score of 18 or greater with item #1 (depressed mood) rated 2 or greater. 4) Age between 18-70 years.

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Exclusion Criteria: 1) Any axis I disorder other than major depressive disorder (e.g. dementia, psychotic illness, bipolar disorder, adjustment disorder) or primary anxiety disorders. 2) Active medical illnesses that could be related to the ongoing depression (e.g. untreated hypothyroidism, recent myocardial infarction or cerebrovascular accident within the past six months, uncontrolled hypertension or diabetes). 3) Current suicidal ideation with a plan and strong intent, or recent serious suicide attempt. 4) Pregnant or lactating women, or women of childbearing age not using contraception. 5) History of electroconvulsive therapy in the last six months. 6) Current use of medications with central nervous system activity which interfere with EEG activity (e.g. benzodiazepines) or any other antidepressant treatment within the 2 weeks prior to enrollment. 7) History of poor response to therapeutic treatment with desipramine or fluoxetine. 8) Illicit drug use and/or alcohol abuse in the last three months. 9) Current enrollment in counseling or psychotherapies.

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Effect of Symbicort on HAT and HDAC in Sputum Macrophages of COPD

The purpose of the study is to compare histone acetyltransferase (HAT) and histone deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from patients with moderate to severe COPD and age-matched normal non-smokers


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria-Healthy non-smokers

* Non-smoking volunteer
* aged 40 -75 years (age matched to COPD patients)
* Normal spirometry (normal FEV1/FVC ratio \>70% and FEV1\>80% predicted)
* Subjects are able to give informed consent

Inclusion Criteria-COPD patients (stage II-III according to the GOLD guidelines)

* Current and/or ex-smokers with no less than 10 pack-year smoking history
* aged 40 -75 years
* FEV1 greater than or equal to 30% and less than 80% of predicted (the upper value is a prostbronchodilator value)
* FEV1/FVC \< 70%
* Patients with stable COPD
* Inhaled Corticosteroid (ICS) treatment, if exists, must be stopped for 2 weeks prior the study treatment
* Long-acting beta2-agonists and theophylline need to be stopped at least 3 days before run-in , but anti-cholinergics will be allowed throughout the study
* The subjects are able to give informed consent

Exclusion Criteria:

Exclusion Criteria-Healthy non-smokers

* Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
* Upper respiratory infection within the last 4 weeks
* Subjects who have received research medication within the previous one month
* Subjects unable to give informed consent
* Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.

Exclusion Criteria-COPD patients

* Evidence of asthma
* Bronchodilator reversibility \> 12%
* Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
* Patients who have had oral steroids within 8 weeks prior to the screening visit.
* Patients who are already on ICS and in which it is considered unsafe (as judged by the Investigator) to stop this treatment for the study period.
* Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the screening visit.
* Upper respiratory infection within the last 4 weeks
* Subjects who have received research medication within the previous one month
* Subjects unable to give informed consent
* Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patients with significant co-morbidities as judged by the investigator
* Any other respiratory disease, which is considered by the investigator to be clinically significant
Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

This clinical study has been planned to determine the effectiveness of a special laser treatment intended to correct both near and distance vision in patients who have undergone previous cataract surgery.

This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACOR presbyopic excimer laser treatment algorithm for near myopic and near hyperopic indications, with or without astigmatism, when performed on the cornea of pseudophakic eyes implanted with a monofocal IOL.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 45 years old
* Subjects must read, understand, and sign an Informed Consent Form (ICF).
* Subjects must be willing and able to return for scheduled follow-up examinations through 6 months after surgery.
* Subjects must have undergone previous uncomplicated cataract surgery with monofocal IOL implant in the study eye at least 3 months prior to study enrollment.
* Subjects must have up to +/- 2.0 (D) of absolute spherical myopia or hyperopia (not spherical equivalent), with up to +/- 2.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent must be no more than +/- 2.0 D.
* Subjects who have be screened successfully for acceptance of the SUPRACOR simulation

Exclusion Criteria:

* Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining corneal thickness below the flap postoperatively.
* Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan (e.G. Keratoconus).