cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer

The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who aged 18 years or older
2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

Exclusion Criteria:

1. Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
2. Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
3. Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit
Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

PURPOSE: To determine the prognostic properties of a comprehensive evaluation of body composition and physical function in patients with GI-HEP cancer from point of diagnosis and throughout the treatment trajectory.

GI-HEP: Patients with tumors of the upper gastrointestinal or hepatobiliary tract, specifically tumors of the esophagus, gastro-esophageal junction, stomach, primary tumors of the liver or biliary tract, as well as colorectal liver metastasis or tumors of the pancreas.

RATIONAL: Patients diagnosed with GI-HEP cancer are faced with poor prognosis. The treatment is demanding and associated with severe deconditioning potentially leading to worse prognostic outcomes. To what extend patients body composition at the point of diagnoses, as well as changes in body composition throughout the cancer continuum is associated with cancer outcomes is currently not well-described, specifically if this should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with histologically verified GI-HEP cancer

Exclusion Criteria:

* Age: \<18
* Pregnancy
* Physical or mental disabilities precluding physical testing
* Inability to read and understand Danish
SX ELLA Esophageal Degradable BD Stent System

The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)

Exclusion Criteria:

* Patient \< 18 years old
* Patient is unwilling or unable to sign and date the informed consent
* Patient is unwilling or unable to comply with the follow-up schedule
* Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months
* Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
* Patient with a life expectancy \< 12 months
Effects of Cocoa Products on Cardiovascular Disease Risk Factors

The purpose of this study is to evaluate the effects of optimized composition chocolates that include natural ingredients with demonstrated biological activity are observed cardioprotectores effects in the human.

Studies carried out during the last decades have demonstrated of conclusive form that foods like nuts, products like cocoa or other ingredients, to be consumed of isolated form or when taking several from integrated them in a same diet can contribute to the prevention or the treatment of the cardiovascular diseases.

The study was a randomized, controlled, double-blind, parallel multi-center study in which the 4 different types of cocoa products \[1)cocoa and other ingredients (sugar and vegetal oils), 2)cocoa plus hazelnuts and other ingredients, 3)the same as 2 plus other ingredient and 4) cocoa, hazelnuts and other ingredients called (LMN)\], introduced into a calorie-balanced diet for 4 weeks with a prior stabilization period of 2 weeks in which all participants received the cocoa product type 1. Cocoa product type 1 is a control of type 2, and types 1 and 2 were controls of types 3 and 4.

Cocoa products type 4 is registered as patent. The trial was conducted in Reus and 3 other cities in Catalonia (Alcover, Centelles and Vic) (Spain).

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants had systolic blood pressure (BP) of 120 to 159 mm Hg or a diastolic blood pressure of 80 to 99 mm Hg. This range includes participants with prehypertension (systolic, 120-139 mm Hg or diastolic, 80-89 mm Hg) and stage 1 hypertension (systolic, 140-159 mm Hg or diastolic, 90-99 mm Hg).
* Moreover, participants' plasma LDL-cholesterol concentrations were ≥ 3.35 mmol/L (≥ 130 and ≤ 189 mg/dL) and triglyceride concentrations \< 4 mmol/L (350 mg/dL) in the fasting state and at least one CVD risk factor such as age (men ≥45 years; women ≥55 years), cigarette smoking, low high density lipoprotein cholesterol concentration (\<1.0 mmol/L (40 mg/dL) and \<1,18 mmol/L (46 mg/dL), men and women, respectively), family history of premature CVD (in male first-degree relative \<55 years of age, in female first-degree relative \<65 years of age.

Exclusion Criteria:

* Assessed from the medical history and a complete physical examination, were plasma triglyceride concentrations ≥4 mmol/L (350 mg/dL), BMI \>35 kg/m2, CVD clinical events, use of lipid-lowering drugs at least 2 months prior to the start of study, diabetes mellitus (at least 2 fasting glucose ≥7.0 mmol/L (≥ 126 mg/dL), renal insufficiency, thyroid or other endocrine disease.
Calibration and Validation of the STISIM Driving Simulator

The aim of this study is to calibrate the STISIM driving simulator under influence of three different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance decrement for the three blood alcohol concentrations will serve as a standard for comparing the effects that will be observed with psychoactive drugs in future trials. This will make the results of these future studies more easily to interpret and will provide health care providers and policy makers who read our scientific work with an easy-to-understand and clinically relevant comparison.


Eligibility Criteria:
Inclusion Criteria:

* 21-50 years old
* Written informed consent
* Normal static binocular acuity, corrected or uncorrected
* Normal hearing
* Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)
* No current or past drug use
* Possession of a driver's license for at least 3 years
* Be considered as reliable and mentally capable of adhering to the protocol

Exclusion Criteria:

* Current and past drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
* Positive urine pregnancy screen in women
* Present use of psychoactive medication
* Positive alcohol breath test
* Prior enrollment in the same study
* Physical or mental illness
* Excessive alcohol use ( \> 21 alcoholic drinks per week)
* Excessive smoking (more than 10 cigarettes per day)
* Intake of caffeine-containing beverages over 5 glasses per day
* Simulator sickness, as determined during the training session
Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients

To compare the efficacy and safety of different adjuvant chemotherapy regimens for low-risk triple-negative breast cancer patients predicted by mRNA-lncRNA model


Eligibility Criteria:
Inclusion Criteria:

1. Female participants aged ≥18 and ≤70 years.
2. ECOG performance status of 0 to 1.
3. Histologically confirmed invasive triple-negative breast cancer (TNBC), defined as breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all determined to be negative by pathological testing. Specifically, ER-negative: IHC \&lt;1%, PR-negative: IHC \&lt;1%, HER2-negative: IHC -/+ or IHC++ but FISH/CISH negative. Tissue samples must be verified by the central lead institution as low-risk according to the mRNA-lncRNA model.
4. Postoperative early-stage breast cancer patients who have undergone radical surgery, with pathological TNM staging of pT1c-3N0-3M0.
5. Normal major organ function, meeting the following criteria: ① Hematological examination standards: HB ≥ 90g/L (no blood transfusion within the last 14 days); ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; ② Biochemical examination standards: TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN; Serum Cr ≤ 1×ULN, and creatinine clearance rate \&gt; 50ml/min (Cockcroft-Gault formula).
6. Women of childbearing potential must use medically approved contraception during the study treatment period and for at least 3 months after the last dose of the study drug.
7. Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up procedures.

Exclusion Criteria:

1. Patients who have received neoadjuvant treatment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
2. Bilateral breast cancer.
3. Metastasis at any site.
4. Any \&gt;T4 lesions (UICC1987) (involving skin invasion, tumor fixation, or inflammatory breast cancer).
5. History of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmias.
6. History of other malignancies within the past 5 years, except for cured in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma of the skin.
7. Pregnant or breastfeeding women, or women of childbearing potential who are unable to use effective contraception.
8. Patients concurrently participating in other clinical trials.
9. Severe or uncontrolled infections.
10. Known active HBV or HCV infection, or HBV DNA ≥ 500, or chronic infection with abnormal liver function.
11. History of substance abuse that cannot be quit or any psychiatric disorders.
12. Patients deemed unsuitable for the study by the investigator.
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

The study included:

* A screening visit of up to 21 days prior to randomization
* Randomization at baseline (Treatment was initiated with 3 days of randomization)
* A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment
* A post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)

Eligibility Criteria:
Inclusion Criteria:

* Histological/cytological proven locally advanced or metastatic non-small cell lung cancer
* Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Adequate renal, liver and bone marrow functions

Exclusion Criteria:

* Squamous histology/cytology
* Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
* Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to \> 25% of bone marrow
* Prior docetaxel treatment
* Uncontrolled hypertension

The above information was not intended to contain all considerations relevant to participation in a clinical trial.
MRI FDG PET Imaging Cervix

The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI.

The main purpose of this study is to determine whether the following imaging tests can visualize the tumor better for planning the brachytherapy treatment:

1. special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
2. an x-ray test called positron emission test (PET) performed with a sugar dye called FDG. MRI-guided brachytherapy is resource-intensive and not widely available.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
3. FIGO Stage IB - IVA
4. Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
5. Intention to treat with MR-guided brachytherapy as part of standard radiotherapy according to the current treatment policies of the PMH Gynecology Group
6. No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
7. A negative urine or serum pregnancy test within the two week interval immediately prior to the first PET-CT imaging, in women of child-bearing age
8. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

1. Prior complete or partial hysterectomy
2. Carcinoma of the cervical stump
3. Inability to lie supine for more than 30 minutes
4. Insulin-dependent diabetes mellitus
5. Impaired kidney function with glomerular filtration rate \< 30
6. Previous anaphylactic reaction to gadolinium or other contraindications to MR.
RCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021

This study will explore the potential of probiotic based, novel cosmetic active ingredient to rebuild the collagen based skin barrier with the overall aim to rejuvenate ageing or damaged skin, improve skin integrity, appearance, beauty, and support personal well-being and vitality.


Eligibility Criteria:
Inclusion Criteria:

1. Male and/or female subjects aged 18 to 69 years
2. Subjects who have given and signed written informed consent
3. Subjects who are willing to comply with the study requirements

Exclusion Criteria:

1. Subjects with any systemic disorder or face dermatoses including acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
2. Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
3. Subjects with a history of skin cancer
4. Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid ...) in the 3 months prior the study inclusion
5. Subjects who are sensitive to any compound in the base cream
6. Subjects who are sensitive to any active cosmetic compound including Sphingomielinaze, Hylauronic Acid, Lactic Acid or Lipothecoic acid
7. Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
8. Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
9. Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion
10. Subjects having applied any topical products on face (including make- up) the day of the study inclusion
11. Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
12. Subjects belonging to the staff of the study center
13. Subjects in an exclusion period or participating in another biomedical research study
RDEA3170 Tablet and Capsule Bioavailability Study

The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the study procedures and the risks involved, and is willing to provide written informed consent before the first study-related activity.
* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* Subject has a Screening serum urate level of 4 to 7 mg/dL.
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Subject has a history or suspicion of kidney stones.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
* Subject has clinically unacceptable physical examination, per the Investigator's judgment.
* Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
* Subject has Screening clinical safety laboratory parameters (serum chemistry \[other than serum creatinine and serum urate\], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
* Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
* Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
* Subject has a history of cardiac abnormalities
* Subject cannot swallow multiple tablets or capsules.
* Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.

We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* SAH from ruptured cerebral aneurysm within 48 hours of admission.
* Modified Fisher grade 2,3,or 4
* Planned surgical or endovascular aneurysm repair

Exclusion Criteria:

* Pregnancy
* SAH secondary to traumatic or mycotic aneurysms
* Pre-ictal statin therapy
* Contraindication to stain therapy
* WFNS grade 5
* Contraindications to MAP elevation on day 7-10
N-acetylcysteine in Alcohol Dependence

The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.

The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.

Eligibility Criteria:
Inclusion Criteria:

* age 18 - 65
* alcohol dependence by DSM-IV
* heavy drinking at least 4 times in the past month
* able to provide informed consent

Exclusion Criteria:

* current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis)
* current psychotic disorders, bipolar disorders, or cognitive disorders
* current suicidal or homicidal ideation
* positive illicit drug screen (except cannabis)
* Clinical Institute Withdrawal Assessment for Alcohol, Revised \>15
* initiation of individual therapy or counseling in the past 3 months
* changes in doses of psychiatric medications in the past 3 months
* clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease
* current use of naltrexone, disulfiram or acamprosate
* pregnant or nursing women, or inadequate birth control methods in women of childbearing potential
Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC

This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,


Eligibility Criteria:
Inclusion Criteria:

1. Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
2. Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
3. ECOG performance status 0 or 1
4. Adequate hematologic function
5. Adequate liver and renal function
6. Able to swallow and retain oral medication.
7. Patients enrolled into Cohort B must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising PSA, progression of disease per RECIST, or \>2 new lesions on bone scan.
8. Patients enrolled into Cohort B must have received at least two cycles of docetaxel. Minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
9. At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.

Exclusion Criteria:

1. Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
2. Known history of or clinical evidence of central nervous system (CNS) metastases.
3. Active secondary malignancy or history of other malignancy within the last 5 years.
4. Prior history of radiation therapy to \> 25% of the bone marrow
5. Peripheral neuropathy of \> Grade 2
6. Uncontrolled concurrent illness
7. Failure to recover fully, as judged by the investigator, from prior surgical procedures.
8. Concurrent anti-cancer therapy other than docetaxel and prednisone.
9. Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)