cyrilzakka/clinical-trials huggingface dataset:
Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma

The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up of patients previously included in the AVANT trial from December 2004 to June 2007.

Clinical data of the AVANT trial will be updated. Neither additional examination nor administration of any treatment will be performed on the patients.

330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium, Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece, Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).

The AVANT study aiming at demonstrating superiority of bevacizumab in combination with FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when adding bevacizumab to chemotherapy in resected stage III colon cancer.

Adverse events were consistent with the known safety profile of bevacizumab. However, more relapses and deaths due to disease progression have been observed in both bevacizumab arms.

A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term results and safety.

Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median follow-up (expected to be reached around Q2 2016).

All analyses will be performed on an exploratory purpose only. An analysis at 8 years median follow-up and a final analysis at 10 years median follow-up will be performed in the main population (all randomized patients in the AVANT trial including patients lost to follow up or died).


Eligibility Criteria:
Inclusion Criteria:

* All patients randomized in the AVANT trial.

Exclusion Criteria:

* Written opposition from alive patients
Blueberry Intervention Study for Brain Aging

The purpose of this study is to determine if increased blueberry intake helps increase brain antioxidant (glutathione) and cerebral blood flow in older adults.

Consuming blueberries may improve brain health of older adults by increasing the antioxidant levels in the brain to protect nerve cells in the aging brain. Researchers think that there may be a relationship between the brain's antioxidant defense system and blueberry intake due to the high antioxidant content in blueberries.

This study will investigate if blueberry intake may aid in enhancing glutathione levels and cerebral blood flow using special Magnetic Resonance Imaging (MRI) scans.

Participants will be asked to make a total of up to 4 visits to the research site. Participation will last about 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Speak English as the primary language and be able to read and write.
* Good general health with no concomitant diseases
* Low berry consumption (≤1 serving/week)
* Cognitively normal (Mini-Mental State Exam Score ≥24)
* BMI range=18.5-35 kg/m2.

Exclusion Criteria:

* Presence of any central neurological diseases or prior major head trauma with loss of consciousness
* Presence of an active unstable and life-threatening systemic illness
* Presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol or drug abuse
* Presence of diabetes mellitus; metabolic syndrome or uncontrolled hypertension
* Use of psychoactive and investigational medications
* MRI contraindications (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia)
* Blueberry or salicylate allergy
* Pregnancy
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with Ulcerative Colitis.

This study is a Phase 1 randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers, followed by a cohort of three repeating doses in healthy volunteers. The third part of this study will be a Phase 2, randomized, placebo controlled, double blind evaluation of participants with Ulcerative Colitis with a dose determined from Parts A and B.

This study consists of 3 parts, as follows:

Part A: SAD in healthy participants, will entail administration of XmAb942 or matching placebo.

Part B: Repeat Dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo.

Part C: Participants with UC to receive XmAb942 or placebo with dose determined from Part A and Part B.

Eligibility Criteria:
Inclusion Criteria:

Parts A and B

* Age 18-55
* Must be in good health with no significant medical history
* Clinical laboratory values within normal range
* BMI 18-35 (inclusive)
* Contraceptive use by men or women consistent with local regulations
* Able and willing to provide written informed consent

Part C

* Age 18-55
* Must be in good health with no significant medical history
* UC diagnosis
* Clinical laboratory values within normal range
* BMI 18-35 (inclusive)
* Contraceptive use by men or women consistent with local regulations
* Able and willing to provide written informed consent

Exclusion Criteria:

Parts A and B

* Any physical or psychological condition that prohibits study completion
* History of suicidal behavior or suicidal ideation
* Heavy use of nicotine containing products
* HIV, hepatitis B and hepatitis C positive
* Cardiac arrhythmia, or clinically significant abnormal ECG
* Active use of prescription medications within 14 days of Day -1
* Active use of over-the-counter, or herbal medication within 7 days of Screening
* Other investigational products within 30 days
* Blood or plasma donation within 60 days
* Pregnant or breastfeeding

Part C

* Any physical or psychological condition that prohibits study completion
* Diagnosis of Crohn disease, pouchitis, or indeterminate colitis
* Positive screen for Clostridium difficile (C. Difficile)
* History of suicidal behavior or suicidal ideation
* Heavy use of nicotine containing products
* HIV, hepatitis B and hepatitis C positive
* Cardiac arrhythmia, or clinically significant abnormal ECG
* Other investigational products within 30 days
* Blood or plasma donation within 60 days
* Pregnant or breastfeeding
a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication

To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP

To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP based on machine learning

Eligibility Criteria:
Inclusion Criteria:

* Routine ERCP patients

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Pregnant women or breastfeeding
* current acute pancreatitis
A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults

This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared to a reference formulation of vadadustat (B)

This is a randomized, open-label, single-dose, two-period crossover study in healthy adults to assess the bioequivalence of a test formulation of vadadustat compared to the reference formulation of vadadustat. Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 55 years of age, inclusive, at time of informed consent.
* Healthy subjects per Investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
* Minimum weight of 45 kg with Body mass index (BMI) between 18 and 29.5 kg/m2, inclusive.
* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
* Willing and able to comply with the requirements of the study protocol.

Exclusion Criteria:

* Current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, history of cancer (except non-melanoma skin cancer) or history of chemotherapy use.
* Any surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or gastric or duodenal ulcers.
* History of severe allergic or anaphylactic reactions.
* Chronic daily medication use.
* History of drug abuse
* Excessive alcohol consumption
* Smoking and the use of nicotine-containing products
* Consumption of grapefruit or grapefruit juice, pomelo, star fruit, Seville or Moro (blood) orange, or their associated products
* Participation in another clinical trial or exposure to any investigational agent.
* Donation of blood or significant blood loss or plasma donation.
* Any condition that would interfere with the ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
Social Determinants of Health in Hepatobiliary Cancer Patients

This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer.

PRIMARY OBJECTIVE:

I. To characterize the social determinants of health - and specifically travel-limiting access to cancer care but also other issues, such as trouble in finding childcare, joblessness, and limited education - among SEA Americans with hepatobiliary cancers, exposure risk including aflatoxin and viral hepatitis among other exposures.

OUTLINE: This is an observational study.

Patients complete a questionnaire, undergo blood, urine, and buccal swab sample collection and have their medical records reviewed on study. Patients also undergo collection of clinically archived tissue samples on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18+ year of age with hepatobiliary cancers

Exclusion Criteria:

* Patients under 18 years of age
Extended Treatment for Smoking Cessation

Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.

During open label treatment, all receive CBT and bupropion and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)

Exclusion Criteria:

1. Currently pregnant
2. Currently breastfeeding
3. Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus
4. History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
5. Family history of seizures
6. Currently using intravenous drugs
7. Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
8. Currently using any over-the-counter stimulants and anorectics (diet pills)
9. Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
10. Currently on NRT or bupropion (Zyban)
11. Current or past diagnosis of anorexia nervosa or bulimia nervosa
12. Previous allergic response to bupropion or NRT
Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients

In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed Multiple Sclerosis (McDonald criteria),
* an EDSS score of less than or equal to 4.0,
* not less than 4 weeks of clinical stability prior to inclusion in the study,
* access to the internet.
* the taking of immunotherapeutic agents was not relevant and not monitored

Exclusion Criteria:

* primary progressive multiple sclerosis
* clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
PNF Exercises on Treatment of Temporomandibular Dysfunction

Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of TMJD. Although that, there is no previous studies about the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture. So, the purpose of the present double-blind, randomized, controlled trial is to investigate the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture.


Eligibility Criteria:
Inclusion criteria:

* Patients of both genders of age between 20-40 years
* having symptoms of TMD for at least six weeks duration established by an expert physician or orthopaedician
* having forward head posture with CVA \< 53
* pain over TMJ between 3 to 6 on NPRS
* mouth opening \< 25mm.

Exclusion criteria:

Patients will be excluded if they exhibited any of the following criteria:

* TMJ fracture undergone any surgical procedure for TMJ
* Fracture surrounding TMJ
* Dislocation or subluxation of TMJ
* systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases, or facial paralysis
* recently any dental treatment is taken or surgery over TMJ
* hematological cervical disorders which may affect the jaw
* Neurological deficits e.g. Bells palsy, Trigeminal neuralgia.
* Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection
* Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study
* DDwR, DDwoR
* Patients were excluded from the study if they were receiving any other form of treatment for their TMJ dysfunction.
Improving Outcomes of Necrotising Otitis Externa

A UK multi-centre prospective observational study of clinically possible cases of NOE.

Patients with clinically possible NOE for whom CT imaging is requested will be recruited to the study by hospital staff at 20-25 UK sites.

NOE remains a relatively uncommon condition with UK - ENT surgeons report seeing between 1 and 10 cases per year. We plan to recruit 350 patients consented prior to or after CT imaging for a diagnosis of clinically possible NOE. After providing consent, patients will be asked to complete an EQ-5D-3L questionnaire. For patients consented remotely, this questionnaire will be completed via an interview. Local study staff will complete an online case report form hosted on Redcap™ for each patient including data on demographics, co-morbidities, clinical presentation, investigations and surgical and antibiotic management. Local study staff will review patients' hospital notes and contact patients' GPs by telephone 1-year post recruitment to assess clinical outcomes and mortality rates. Patients will then be contacted 12 months (+/- 1 month) post-recruitment by telephone by local study staff in order to confirm clinical outcomes (e.g. relapse) and gain information to complete the EQ-5D-3L questionnaire a second time.

All CT scans performed at recruitment and any other CT and/or MRI scans performed in the 12-month follow-up period will be de-identified and uploaded by local sites to an online, web-based secure repository for radiological images. Subspecialised radiologists blinded to clinical details will assess the images according to pre-agreed, standardised criteria.

Selected sites will be asked to freeze any P. aeruginosa isolates routinely collected via ear swabs as part of clinical care from enrolled participants within 14 days of CT imaging. These de-identified samples may be sent from sites to undergo genotypic and phenotypic analysis at the University of Oxford for virulence factors to assess the relationship between these and disease severity. Of note, no samples beyond those routinely collected as part of the patients' care will be collected and no patient tissue samples will be stored. These samples will not contain any biological or genetic material from the patient.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old).
* Clinical diagnosis of possible NOE for whom CT imaging is requested or has been done as part of routine clinical care.

Exclusion Criteria:

* Any previous clinical diagnosis of NOE.
* CT performed or due to be performed at hospital other than recruiting study site.
Amnesia After Surgery for Anterior Communicating Aneurysm： High Resolution Magnetic Resonance (MR) Imaging Findings

To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with amnesia following treatment of ACoA aneurysm.

Cohort register is made by experienced neuropsychologists in our institute.

MR imaging and data storage is in the department of diagnostic radiology of our institute.

MR images are evaluated by two neuroradiologists using a work station.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Amnesia

Exclusion Criteria:

Severe decreased intellectual function
Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy

AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy.

METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth were included. The patients were assigned randomly into two groups of 20 patients each. The teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Healthy patients without any medical conditions

Exclusion Criteria:

* root canal retreatment
* pregnancy
* teeth with open apices
* a history of intolerance to nonsteroidal anti-inflammatory drugs
* immunosuppressed patients
* those under 18 years old
* patients requiring antibiotic prophylaxis
* patients with pacemakers.
Effect of Topical CBD Cream for Degenerative Hallux Disorders

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. While operative interventions exist, nonoperative modalities are the mainstay of treatment for most patients. Options include shoe wear modification, manual and physical therapy, intraarticular injection of corticosteroids or sodium hyaluronate, oral nonsteroidal anti-inflammatories, and foot orthoses. Oral anti-inflammatories are the most effective non-operative strategy, but unfortunately, are associated with major adverse side effects and are contraindicated in many patients. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. This prospective randomized trial will compare topical CBD cream vs placebo cream for the treatment of pain secondary to hallux valgus and hallux rigidus. The primary outcome of interest in the change in pre and post-treatment Visual Analog System (VAS) pain scores. VAS pain score is a measurement on a continuum of values of pain intensity. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a new diagnosis of hallux rigidus or hallux valgus
* VAS pain score of 4 or higher
* Age \> 18 years
* The patient provides informed consent

Exclusion Criteria:

* A previous operative procedure to the first metatarsal for treatment of hallux valgus or hallux rigidus
* VAS pain score at presentation less than 4
* Concomitant hallux valgus and hallux rigidus on the ipsilateral side
* Allergy to CBD, Cannabidiolic acid (CBDa) or any other ingredient contained in the topical cream
* Pregnant patients
Study of the Impact on the Evolution of the Disease in the Medium Term of the Implementation of a System of Extended Follow-up by Telephone Interview of Patients With an Eating Disorder Organized by the Nurses of the Eating Disorder Referral Center

The referral center for eating disorders provides for a systematic many years follow-up of patients under care with an annual assessment at the center. The investigators have recently shown the frequency of relapse in the first 7 years after diagnosis, but the literature remains poor on this epidemiology and on the risk factors for relapse. The investigators would therefore like to extend this follow-up for an additional 3 years after remission with an annual telephone nursing interview for all cured patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with an eating disorder confirmed at the multidisciplinary consultation meeting of the referring center and considered cured (in remission). For patients with Oral Disorders, inclusion is within one year of recovery
* Patient affiliated or entitled to a social security plan
* Oral participation agreement
* Pregnant women

Exclusion Criteria:

* Persons deprived of liberty
* Patients under guardianship or curatorship
* refusal to participate