cyrilzakka/clinical-trials huggingface dataset:
Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.

The purposes of the study are to assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage.

To assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage. Variation factors assessed are:

* Fasting condition
* Sampling time
* Sampling season
* Physical activity
* Duration and temperature of total blood treatment
* Type of blood collection tube.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged above 18 years.
* Sign an informed consent after being informed
* Able to follow the instructions of the study

Exclusion Criteria:

* Serious associated diseases:

  * Severe liver disease
  * Renal failure
  * HIV
  * hepatitis B or C
* Patient who are the subject of a judicial protection measure or under guardianship
A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria

1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
2. Presence of advanced/metastatic solid tumor not amenable to curative treatment

   1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
   2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
3. Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
4. Disease measurable as defined by RECIST v1.1
5. Adequate organ function as defined in the protocol.
6. Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.

Exclusion Criteria

1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
3. Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
4. Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)
5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
6. Prior irradiation to \> 25% of the bone marrow
7. Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.
Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. II. Determine the tolerablility and clinical benefit of this regimen in these patients. III. Evaluate the progression free survival and the overall survival of these patients when treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5 hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or locally advanced unresectable adenocarcinoma of the pancreas Measurable disease At least 2 cm in diameter No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: Adequate cardiac function Pulmonary: Adequate respiratory function Other: Not pregnant or nursing Fertile patients must use effective contraception No sensitive neuropathy No other active malignancy No uncontrolled hypercalcemia No significant medical or psychiatric condition that would preclude study No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroid use except as antiemetic Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs
The Efficacy of Patients With Moderate to Severe Atopic Dermatitis Treated With Chinese Herbal Medicine

Conduct a clinical trial of integration of Chinese and Western medicine to evaluate whether the association of traditional Chinese medicine therapy has a remission effect on atopic dermatitis, and to explore the remission of lesions after an association of Chinese herbal medicine, and the correlation of syndrome differentiation types before and after treatment with Chinese and Western medicine, with a view to better understand the efficacy of atopic dermatitis in the treatment of the same disease in Traditional Chinese Medicine, and provide another option for patients with atopic dermatitis.

This examination will be posted at Taipei Veterans General Hospital to recruit 24 participants who meet the inclusion criteria of atopic dermatitis to do the study. After participants agreeing to the clinical study and signing the consent form, the investigators are going to separate them into the A group (12 participants) and the B group (12 participants). The tests are going to take a total of 14 weeks.

Participants need to pass the international diagnostic criteria Hannifin and Rajka to be determined as patients with atopic dermatitis. After, participants need test by scoring Atopic Dermatitis Index (SCORAD) to be determined as mild to moderate atopic dermatitis and accept the Wang Qi Traditional Chinese Medical Constitutional Scale (TCMCS), dermatological quality of life index (DLQI) score or children's skin disease quality of life index (CDLQI) score, routine blood tests, liver and kidney function tests, immunological markers associated with atopic dermatitis Diagnosis of (eosinophils count, ECP, and IgE), tongue diagnosis, and pulse diagnosis. After the collection of data is completed, the investigators will be analyzing the data by SPSS version 21 as a two-paired t-test, ANOVA statistical method, and P \<0.05 as a significant result.

Eligibility Criteria:
Inclusion Criteria:

* 6 years old to 30 years old.
* Diagnosis as an atopic dermatitis patient.
* The score of the SCORAD is over 20. (moderate to severe atopic dermatitis)

Exclusion Criteria:

* Secondary bacterial infections
* Received oral or intravenous steroid treatment, anti-biotics, phototherapy, or other immunosuppressive therapies in the previous 2 months.
* Received Chinese herbal medicine treatment or acupuncture.
* Pregnant woman or current breastfeeding.
* Who had catastrophes illness now or in the past must be avoided.
* Can not sign informed consent or can not communicate with the researcher.
* Abnormal liver enzymes.
* Abnormal kidney function tests (1.5 times higher than the upper normal limit)
Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)

The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.

Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.

Eligibility Criteria:
Inclusion Criteria:

* age 21+,
* current smoker
* regular use of email OR capacity to receive SMS text and internet access
* additional smoking and health criteria determined at screening
Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies

The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.

For objectives 1 and 2, a retrospective study of the microbiology database will be carried out and the medical records will be consulted to collect the variables included in Annex 2. The other prediction rules to be compared are those of Cobo et al., Reigadas et al and Gerding et al.

We will review a total of 215 patients according to the calculation of the sample size (see section) A prospective study will also be carried out in which the positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón will be included. The medical records of the selected cases will be reviewed. All patients included in the prospective study (Objective 3) will receive the information sheet and consent sheet that they must sign for this study (Annex 1). These patients will be followed and the variables included in Annex 2 will be collected.

Eligibility Criteria:
Inclusion Criteria:

* For the retrospective cohort, those patients with a positive sample for ICD will be randomly selected from the microbiology database.
* For the prospective cohort: after the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.

Exclusion Criteria:

* Children under 18 years or patients with \<3 faeces not trained in the last 24 hours will not be included.
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.

The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Registry study after 2 years.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years
* able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
* evidence of myocardial ischemia
* acceptable candidate for coronary artery bypass graft (CABG) surgery
* undergo all CIP-required follow-up examinations
* artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
* target lesions must be de novo lesions
* target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
* target lesion ≤ 28 mm in length by visual estimate

Exclusion Criteria:

Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
AVAI: Atrial Ventricular Arrythmia Incidence

The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
* Patient has signed the study specific Informed consent document.
* Patient is older than 18 years of age

Exclusion Criteria:

* Patient has a permanent Atrial Fibrillation
* Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
* Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
* Patient requires cardiac resynchronization
* Patient has Brugada Syndrome
* Patient has long QT Syndrome
* Patient has a device replacement;
* Patient is pregnant or nursing
* Patient is unable to attend the follow-up visits
Portal Vein Flow Velocity as a Screening Tool for Oesophageal Varices in Cirrhotic Patients

Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy

Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy with its high cost \& complications Using portal vein flow velocity and the relation between it \& presence of oesophageal varices in cirrhotic patient \& its efficacy as a primary tool for these cases

Eligibility Criteria:
Inclusion Criteria:

* cirrhotic patients with oesophageal varices
* cirrhotic patients without oesophageal varices

Exclusion Criteria:

* Patients with hepato-cellular carcinomas \[HCCs\], portal vein thrombosis, hepatic encephalopathy.
* Patients with positive HCV antibody, but without liver cirrhosis diagnostic criteria
Role of FCI in the Detection of Proctosigmoiditis Caused by IBD

The goal of this pilot study is to explore the ability of field-cycling imaging, a new scanning technology being developed at the University of Aberdeen, to detect active disease in patients with proctosigmoiditis caused by inflammatory bowel disease.

Field-cycling imaging (FCI) is an emerging technology that is being developed at the University of Aberdeen. It combines the use of a moderately high magnetic field (200mT) with the ability to probe low magnetic fields (0.2mT) so that image resolution can be preserved while also exploiting the high contrast present at low magnetic fields. This non-invasively provides quantitative data on the molecular dynamics in the tissues.

FCI represents a potentially new, non-invasive, way of assessing the extent and activity of inflammatory bowel disease (IBD). IBD can affect the rectum and distal sigmoid colon, this condition is called Proctosigmoiditis (PS). Currently, diagnosis of IBD depends on endoscopy for direct visualisation of the upper and lower gut, using CT scanning, with its attendant use of ionising radiation, and conventional MRI, particularly for the small bowel. Determining the activity of IBD remains a continuing challenge.

In this proof-of-concept study, the investigators will explore the ability of FCI to detect active disease in patients with PS.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of proctosigmoiditis, on the basis of a compatible history and previous flexible sigmoidoscopy
* Participants who are already under follow up in the NHS Grampian IBD clinic
* Participants must be between 16 and 80 years old
* Participants who meet the safety criteria for undergoing an MRI scan
* Participants who are able to fit inside the scanner
* Participants must be able to give fully informed consent
* Participants must be mobile enough to be positioned onto the FCI scanner couch

Exclusion Criteria:

* MRI-incompatible conditions, as detected in the MRI safety screening sheet
* Participants under 16 years old
* Participants who are unable to communicate in English
* Participants who are unable to give fully informed consent
* Women who are pregnant
* Restrictions to mobility that would prevent the correct positioning in the scanner
* Previous major abdominal surgery
* Any known significant comorbid disease that might interfere with treatment
* Malignancy or other conditions that would significantly reduce life expectancy
* Participants who suffer from claustrophobia
Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers

Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage. NMP may allow these livers to be evaluated before transplantation. NMP has already been used in a clinical setting with promising results. The advantage to utilizing NMP is that it would attenuate the incidence and clinical impact of classical preservation injury, allow liver function assessment before implantation and thus improve donor pool and outcomes for high risk ECD liver transplants performed at our center.

This will be a single center prospective cohort pilot study. 30 livers that have been declined for clinical use by all centers due to their marginality will be preserved with NMP in 1-18 hours after cross clamp and cold flush. The liver grafts at NMP will be at Physiological temperature and have oxygen and nutrient supply with continuous perfusion. Once the liver grafts have been evaluated and determined to be transplantable, the transplantation and post-transplant care will follow the standard of care. The follow-up period is 12 months after transplantation. The primary end point will be the rate of patient survival and primary non function (PNF) within 30 days after transplantation, while the secondary end points will be: Early Allograft Dysfunction (EAD), 6 months patient and graft survival, peak liver function tests in the first 7 days after transplantation, surgical outcomes (operative time, transfusion requirement etc.), rate of post-transplant kidney failure, assessment of histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate of biliary complications, hospital and ICU length of stay, rejection rate, infection rate, the ability to predict function based on "on-pump" viability markers, and the incidence of adverse effect (AE).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary liver transplantation
* Age 18-75 years at the time of transplantation
* Willingness and ability to comply with the study procedures
* Signed Informed Consent Form
* For patients with hepatocellular carcinoma as indication for Orthoptic Liver Transplantation (OLT), tumor must be within Milan Criteria or down-staged to Milan Criteria.

Exclusion Criteria:

Recipient Exclusion Criteria:

* History of prior solid organ transplantation
* Patient on a respiratory and/or cardiocirculatory support at the time of transplant
* MELD score \>35
* HIV positive patient
* Patient with current severe systemic infection
* Multiorgan transplant