cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin.

There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with 15 or more clinically typical, visible and discrete AKs on either:

   * Full face (corresponding to a treatment area of at least 250 cm2). If subjects have a beard they must shave no later than the day before the first drug application.
   * A contiguous area of approximately 250 cm2 on the arm between wrist and shoulder.
   * Balding scalp (corresponding to a treatment area of approximately 250 cm2). Subjects with sparse hair on the scalp can be enrolled as long as LSR and AK assessments are not compromised.
2. Subject at least 18 years of age.
3. Female subjects of childbearing potential\* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
4. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

Exclusion Criteria:

1. Location of the treatment area (full face, full balding scalp, chest, trunk or extremities)

   * within 5 cm of an incompletely healed wound.
   * within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
2. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
3. Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns)and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy

RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.

OBJECTIVES:

Primary

* To assess the therapeutic activity of trabectedin, in terms of progression-free survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy.

Secondary

* To assess the safety profile of this drug.
* To assess the response rate and response duration.
* To assess the overall survival of these patients.
* To assess the PFS rate at 9 and 18 weeks.
* To perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies.

OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Blood samples and tumor tissue are analyzed for identifying biological markers predictive for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor activity in translational research studies.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas
* Metastatic disease progressed after 1 prior gemcitabine-contained chemotherapy

  * May be given with neoadjuvant, adjuvant, or palliative therapy
* Measurable disease according to RECIST criteria
* No symptomatic brain metastasis

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Bone marrow, liver, and kidney function normal
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe comorbidities, including any of the following:

  * Cardiac disease
  * History of psychiatric disability
* No other prior or concurrent malignancy except surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, and other neoplasms without evidence of disease for ≥ 5 years
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior second-line chemotherapy
* No other concurrent chemotherapy or target therapy
* No concurrent treatment with other experimental drugs
The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation

While the use of herbals is increasing considerably, their efficacy and safety in the humans remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary data demonstrates that KRG can affect vascular function and our research group has previously shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive individuals. However, it is unknown which dose is the most effective in producing a desired effect. To address this issue, we will test escalating doses of a single Korean red ginseng batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most efficacious dose. The most promising dose will be extracted and will advance to next level to be tested again on BP control. The findings of the study may result in better ginseng standardization.

Individuals will arrive at the Risk Factor Modification Centre, St. Michael's Hospital between the hours of 8:00 and 10:00am after a 10 to 12-hour fast on seven separate mornings. They will not have consumed any antihypertensive medications on the study mornings. Each visit will be separated by a minimum of a week. Since the half-life of ginsenosides in humans is less than 24-hours, to allow for a washout of approximately seven half-lives.

In each of the four studies, when individuals arrive at our clinic on a test day they will first have their weight measured and subsequently rest in the seated position. They will then have a catheter inserted into a forearm vein, which will be kept patent by saline. From this device, a registered intravenous nurse will obtain a series of 7ml blood samples. Blood will be taken at 30-min intervals. Subsequently, individuals will fill out forms detailing their pharmacological regimen for the previous 24-hours and their diet (dinner) and activity (sleep, urination, morning routine) regimen for the previous 12-hours. As well, they will detail any adverse events that they experienced since their previous visit. Individuals will then have their office BP measured with a mercury sphygmomanometer until three consecutive measurements of both SBP and DBP \<5 mmHg different are obtained. At this point, BP should be steady and subjects will be fitted with an ABPM. Measurements will be taken every 5-min for 30-min, for a total of seven measurements. After the seventh measurement (time 0-min), measurements will be taken automatically every 10-min for 180-min. At time 0-min, treatment or placebo capsules will be consumed. At time 60-min a 360-calorie Ensure® breakfast will be consumed within 5-min. Blood samples will be drawn at 30-min intervals, starting at time 0-min. For 24-hours after the ingestion of treatment, a record of any side effects will be detailed by the participants and then provided to us.

Eligibility Criteria:
Inclusion Criteria:

* Essential Hypertension

Exclusion Criteria:

* Secondary Hypertension
* Diabetes
* Chronic Kidney Disease
* Liver Disease
* Unstable Angina
* Coronary / Cerebrovascular event in the previous 6 months
Reducing Breast Cancer Risk in Korean American Women

The goals of the study are to develop a culturally and linguistically appropriate intervention to reduce SHS exposure for LEP Korean women using a family-focused intervention approach targeting Korean Americans ages 18 and above in the greater San Francisco Bay Area, CA, and to evaluate efficacy of the proposed intervention. The study is a single group feasibility trial targeting a total of 4 lay health workers (LHW) and 24 dyads of LEP Korean women with self-reported SHS exposure at home and a male household smoker. The hypothesis is:

H. Can a family-based intervention approach reduce SHS exposure among Korean American women who live with a current smoker?


Eligibility Criteria:
Inclusion Criteria:

* self-identified as Korean or Korean American;
* Korean speaking;
* reside in the San Francisco Bay Area
* plan to stay in the area for the next 3 months
* for women participants, the participant must report having SHS exposure at home at least 1 day in the past 7 days and live in the same household as the smoker participant to form a dyad.
* for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
* provide a valid contact telephone number for pre- and post-intervention assessments
Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects

The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.

The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.

Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.

Eligibility Criteria:
Inclusion Criteria:

* Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
* Must agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria:

* Subjects have received or are receiving off-protocol immunosuppressive medications
* Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.
Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype

The objective of this study is to estimate the effect of CYP3A4\*22 on the clearance and area under the plasma concentration-time curve of Palbociclib, Ribociclib, and Abemaciclib


Eligibility Criteria:
Inclusion Criteria:

1. MGI participant with genotype of interest (e.g., CYP3A4\*1/\*1, CYP3A4\*1/\*22, or CYP3A4\*22/\*22) and consented to recontact for future research
2. Age≥18
3. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Concurrent use of a moderate or strong inhibitor or inducer of CYP3A4, based on the current version of the Drug Interactions Flockhart Table™, available at this link or by google search: https://drug-interactions.medicine.iu.edu/MainTable.aspx
2. Carriers another variant known to affect CYP3A4 activity, particularly CYP3A4\*20.
3. Active malignancy or other disease state that would affect the pharmacokinetics of CDK4/6 inhibitors or place the participant at particular risk of toxicity from a single dose of a CDK4/6 inhibitor, in the opinion of the study team
4. History of allergic reaction to CDK4/6 inhibitor
5. Pregnancy or nursing female
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration

Evaluation of patch as specific immunotherapy in allergic patients


Eligibility Criteria:
Inclusion criteria:

* Written informed consent
* History of grass pollen allergic rhinitis
* Male and female between 18 years to 65 years
* Positive skin-prick test to grass pollen
* Positive conjunctival provocation test

Exclusion criteria:

* Eczematous skin lesions on the upper arms
* Perennial allergic rhinitis
* Symptoms of infectious disease with rhinitis in between the last 2 weeks
* Surgical intervention in between the last 30 days
* Pregnancy or nursing
* History of HIV or AIDS
* History of mastocytosis (cutaneous or systemic)
* History of significant cardiovascular disease
* Hypertension (blood pressure \> 160 / 95)
* History of significant pulmonary, renal and/or hepatic disease
* History of significant hematological disorder
* Moderate or severe asthma
* History of malignancy
* History of neurological or psychiatric disease
* History of autoimmune disease
* Antihistamines with longed half-lives in the last week
* Systemic or topical steroids for 5 days
* Active infectious disease
* Contraindicated medications:

  * immunosuppressive agents
  * Betablockers
  * ACE-inhibitors, AT 2 Antagonists
  * tricyclic antidepressants
  * daily use of Beta-agonists or steroid inhalers
* Participation in another clinical trial /study at the moment or within the last 60 days
MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years.

All eligible patients (STEMI \< 12 hours from onset of chest pain) will be randomized to

* Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or
* Biotronik ORSIRO Sirolimus Eluting Coronary Stent System

Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months angiographic follow-up (Primary endpoint).

In a subgroup of 40 patients Optical Coherence Tomography will be performed after the procedure and at 12 months follow-up.

Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months follow-up) will be analyzed off-line by an independent core lab.


Eligibility Criteria:
Inclusion Criteria:

Clinical:

1. At least 18 years of age.
2. ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab, with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab \<12 hours after the onset of symptoms lasting ≥20 min requiring primary PCI.
3. Target lesion must be a de-novo lesion located in a native vessel.
4. The patient accepts Informed Consent
5. The patient understands and accepts clinical follow-up and angiographic control.

   Angiographic:
6. Vessel size should match available M-BRS scaffold sizes (≥2.75 mm, and ≤3.7 mm by visual assessment).
7. Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and TIMI ≥2 and residual stenosis \<20%.

Exclusion Criteria:

1. Pregnancy.
2. Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material.
3. Distal vessel occlusion after recanalization
4. STEMI due to stent/scaffold thrombosis
5. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal m-BRS placement.
6. Fibrinolysis prior to PCI
7. Known thrombocytopenia (PLT\< 100,000/mm3)
8. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
9. Cardiogenic Shock
10. Significant comorbidities precluding clinical/angiographic FU (as judged by investigators)
11. Major planned surgery that requires discontinuation of dual antiplatelet therapy.
12. Diffuse coronary artery disease that will require CABG
13. Chronic kidney disease with GFR\<30 ml/min
Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective Randomized Trial

Morbid obesity has become a major global health problem, and the use of bariatric surgery is increasing. One common complication seen following bariatric surgery is the formation of gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder and supersaturation of bile due to rapid weight loss and mobilization of cholesterol. Previous studies revealed oral probiotics could reduce the cholesterol level by as much as 22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and physiological actions of the end products of short chain fatty acid fermentation. Therefore, the aim of this study was to determine the ability of probiotics to prevent gallstones formation after bariatric surgery and to evaluate the impact of oral administration of probiotics on the post bariatric surgery patients 's quality of life.

Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the quality of life for patients receiving bariatric surgery. It consists of five domains: digestive symptoms; physical function; emotional condition; social condition and effect of medical treatment, which could access the quality of life of bariatric patient effectively and completely.


Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving bariatric surgery for morbid obesity
2. Patiets at ages between 20 to 65 y/o
3. Patients willing to follow up regulary after bariatric surgery.

Exclusion Criteria:

1. Patients having gallstones before bariatric surgery
2. Patients refusing taking probiotics or refusing regular follow up after bariatric surgery
Study Evaluating Multiple Ascending Dose in Schizophrenia Patients

This is a randomized, inpatient, ascending multiple dose study to assess safety and tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men, aged 18-50 years old
* Women, aged 18-50 years old

Exclusion Criteria:

* Non-lactating women, aged 18-50 years old
* Non-pregnant women, aged 18-50 years old
Minimum Local Anesthetic Volume of Bupivacaine in Labour Epidurals

Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the most commonly used drugs for that purpose. The efficacy of a certain medication injected epidurally depends on the dose that is given. A certain dose can be administered in different concentrations, which will consequently mean different volumes. Our hypothesis is that for each concentration of a certain drug, there has to be a minimum effective volume that will be associated with the best possible performance of the drug. This study is being conducted to find the minimum volume of bupivacaine (a local anesthetic) that produces successful analgesia in 95% of patients in labor.

Epidural administration of local anesthetics during labor produces analgesia, sympathetic block and motor block. The characteristics of the block depend on the volume and concentration of the local anesthetic that is used as well as the potential use of adjuncts. Although many researchers have investigated the efficacy of different drugs at different concentrations, the volumes used have been arbitrary. There is limited data regarding the minimum volume that is necessary for a successful anesthetic for a given concentration of bupivacaine.

This study is conducted as a prospective, randomized, up-down sequential allocation trial. The aim is to determine the minimum volume of 0.125% bupivacaine that will provide effective analgesia for 95% of parturients in the first stage of labor. The verbal numeric rating scale (VNRS) is used to rate the pain felt over the first 20 minutes, where 0 is no pain and 10 is the worst pain imaginable. After 20 minutes, if the VNRS was greater than 2, the volume of bupivacaine was considered inadequate and additional medication was given.

The volume of bupivacaine for the first patient was arbitrarily chosen as 8 ml, and the dose for each subsequent patient depends on the outcome of the previous injection. Doses will be increased or decreased in increments of 1 ml. If the previous response was ineffective, the next patient will receive 1 ml more than the last patient. If the response of the previous patient is effective, the Narayana rule, which is used to cluster doses around EV95, will be applied to determine if the dose remains the same or decreases.

50 patients will be included in the study. An estimate of EV95 will be calculated based on a logistic model with non-log-transformed doses, fit using Firth's penalized maximum likelihood approach for small sample bias correction. Confidence intervals will be calculated based on the profile likelihood approach.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* Full term (more than 37 weeks gestation)
* Singleton pregnancy, vertex presentation
* Regular painful contractions occurring at least every 5 minutes
* Cervical dilatation \< 5 cm

Exclusion Criteria:

* Any contraindication to epidural anesthesia
* Accidental dural puncture
* Allergy or hypersensitivity to bupivacaine
* Women who have received opioids or sedative medications within the last 4 hours
Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.

Investigator seeks to determine wether integrating an addiction team into a liver transplantation unit improves the prognosis of patients with alcohol-related liver disease requiring liver transplantation. Our hypothesis is that patients managed by an addiction team before and after liver transplantation have less frequent alcohol relapses, thus decreasing the risk of cardiovascular complications, de novo cancer, recurrence of alcohol-related cirrhosis, and consequently increasing their overall survival.

In this observational, retrospective and multicentre study, investigator seek to determine the effect of integrating an addiction team into liver transplantation unit on prognosis of patients with alcohol-related liver disease requiring liver transplantation. Investigatore plan to compare patients in 2 groups, depending on whether they have received or not specific addiction care before and after transplantation. This study was conducted over a period of 15 years in three French liver transplant units.

Eligibility Criteria:
Inclusion criteria:

* adult patients
* who received a liver transplant between January 2000 and December 2015 for alcohol-related liver disease as a primary or secondary indication (hepatocellular carcinoma)
* who survived for more than 6 months after their liver transplant.

Exclusion criteria:

* association of other causes of hepatopathy: viral hepatitis B or C, hereditary hemochromatosis.
* death before discharge from hospital after liver transplantation.
* patient unwilling to participate to the study