cyrilzakka/clinical-trials huggingface dataset:
Erlotinib Combined With Chemotherapy in TKI Resistant Non-Small Cell Lung Cancers

Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or secondary resistance will be developed after TKI treatment, doctors do plenty of researches to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive mutations, several study shows that sensitive mutations still exist after TKI resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese patients could not support. Thus, the investigators hypothesis that, after first line TKI treatment, the patients who developed TKI resistance could still benefit from second line TKI combined with chemotherapy.

The investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with EGFR TKI sensitive mutations and developed TKI resistance in first line treatment. After enrollment, the investigators will do biopsy again before second line treatment to find out the potential mechanism of TKI resistance, do EGFR mutation test for both sensitive and resistant mutation in exon 18, 19, 20 and 21; do KRAS, BRAF and PI3K mutation test, do FISH for MET and HER-2, the investigators do all these test to evaluated both primary and secondary resistance, the investigators do all these tests to get an overview for EGFR mutation status of each patient who develop TKI resistance. For second line treatment, patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease. For the patients who have stable brain metastases, combined chemotherapy should begin after local treatment, such as whole brain radiotherapy or sterotactic radiosurgery.

the main endpoint of this study is mean PFS, second endpoints of this study consist of mean OS, 8 week ORR.

Eligibility Criteria:
Inclusion Criteria:

* advanced non-small cell lung cancer, stage IIIB/IV
* non-squamous
* EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R
* received first line TKIs treatment and developed TKI resistance
* ECOG 0-2

Exclusion Criteria:

* squamous non-small cell lung cancer
* patients have unstable brain metastasis, predict survival less than 8 weeks
* spinal-cord compression without evidence of stabilisation or treatment
* women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline
* patients have any unstable illness that could not receive further treatment
Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis

This was an open-label long-term study that was completed following study drug approval in Japan for the treatment of JRA. Data are presented through Week 144 and for the final visit.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) according to the criteria of the American College on Rheumatology (ACR)
* Disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (NSAIDs) or methotrexate (MTX)
* Presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness)
* Stable dosage of MTX for at least 12 weeks prior to the screening visit or discontinuation of MTX at least 14 days prior to baseline visit (Day 1)
* Discontinuation of disease-modifying antirheumatic drugs (DMARDs) other than MTX at least 28 days before screening visit

Exclusion Criteria

* History of inflammatory joint disease other than JRA
* Functional class IV JRA by ACR criteria
* Clinically significant cardiac disease or laboratory abnormalities
* Any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Interest of the Donor-specific Antibodies After Liver Transplantation

The study is a prospective observational mono center study

Primary objective :

Study the anti-HLA antibodies frequency preformed before liver transplantation and the kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver transplantation.

Secondary objective :

* Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)
* Impact of DSA on:

  * Graft and patients survivals
  * Onset of allograft rejection (acute, late-onset, chronic)
  * Unexplained liver graft dysfunction
  * Unexplained liver enzymes abnormalities
  * Liver fibrosis development (liver stiffness study using fibroscan©)


Eligibility Criteria:
Inclusion Criteria:

* Liver transplanted patients older than 18, transplanted in Lille University Hospital.
* Written consent by the patient or his/her legal representative (especially patient with hepatic encephalopathy).
* Patients with health insurance

Exclusion Criteria:

* Minor patients.
* Pregnant women or during lactation.
* Patient under curatorship.
Biological Age in Worksite Health Promotion

This cohort study investigates how implementation of Biological Age technology in worksite health promotion, affects health behavior in the general Danish working population.

This cohort study is designed on the basis of Body Age tests, executed by a private Danish health care company in the period from 2010 to 2013.

The dataset comprises pre- and post Body Age tests from \>4000 individuals. They used a standardised protocol and educated staff ( physiotherapists or with a degree in sports science) to carry out the tests. Body Age tests apply biometrics, fitness level and health status data of the employee. The test results are characterized by a Body Age score, which defines the employee's biological age (in years).

This design categorises as a register study why The Danish National Committee is not applied for.

Eligibility Criteria:
Inclusion Criteria:

* Males and females interested in their personal health status
* Participants who perform both baseline and follow up test.

Exclusion Criteria:

* Use of beta blockers
Role of Nutrition in Patients Over 75 Years of Age With Stroke

Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. Patients older than 75 years also show excess mortality. One of the hypotheses to explain this situation is the high level of frailty in this population. Many tools to measure the concept of frailty have been developed. One important dimension of these tools is the nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent situation, is also a complex phenomenon.

The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects older than 75 years hospitalized in Dijon CHU.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic stroke defined according to WHO criteria (including cerebral infarction and intracerebral haemorrhage) managed at the stroke ICU, Neurology 1, Neurology 2, Internal Medicine 2 or Geriatrics at Dijon CHU during the period from 1st November 2015 to 30th September 2016.
* Patients aged 75 years and older.
* Patients who have provided informed consent to take part in the study.

Exclusion Criteria:

* Patients with meningeal haemorrhage or TIA.
* Patients who refuse to take part in the study.
* Patients with hypo-albuminemia not related to malnutrition: chronic infectious or inflammatory syndrome, nephrotic syndrome, exudative enteropathy, hydration disorders.
* Subjects in custody.
* Patients (or person of trust) who cannot be contacted by telephone during the follow-up.
Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women

The purpose of this study was to determine the effect of diaphragmatic training on urgency urinary incontinence in postmenopausal women.

Urgency urinary incontinence affects 9-13% of women, increasing with age and impacting daily activities, quality of life, depression, and social isolation. It is a significant source of dependency among the elderly and a factor in nursing home admissions. Untreated incontinence can lead to falls, infections, and loss of independence. Conservative management is the first-line therapy, but pelvic floor muscle training is a potential treatment method. This study aims to evaluate the effectiveness of diaphragmatic training on urinary incontinence in postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women suffer from UUI.
* They will be multipara more than 1.
* Their age will range from 55-65 years old.
* Their body mass index (BMI) will range from 25-29.9 kg/m2..
* They will experience menopause at least for 3 years.

Exclusion Criteria:

* Urinary tract infection
* Previous surgery for urinary incontinence
* Upper motor neuron diseases
* History of genito-urinary cancer
* Previous pelvic irradiation
* Pure stress urinary incontinence
* Genital prolapse
* Diabetes mellitus
* Pace maker
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.

In the 4-year Base Study (V501-015) (NCT00092534), participants were randomized in a 1:1 order to receive 3 doses of GARDASIL™ or matching placebo at Day 1, Month 2, and Month 6 and were assessed for efficacy, immunogenicity, and safety.

In the Base Study Extension (EXT) \[V501-015-10\], participants who received placebo or only 1 dose of GARDASIL™ in the Base Study, were given 3 doses of open-label GARDASIL™ at EXT Day 1, EXT Month 2, and EXT Month 6, and were followed to EXT Month 7. Participants who who received 2 doses of GARDASIL™ in the Base Study were given 1 dose of GARDASIL™ at EXT Day 1 and were followed for 15 days (day of vaccination plus 14 days).

In the 10-year Base Study Long-Term Follow-Up (LTFU) \[V501-015-21\] the effectiveness, immunogenicity and safety of GARDASIL™ was assessed during a period of 10 years following completion of the Base Study (V501-015) \[14 years after the first dose of GARDASIL™\] and, for some measures, the Base Study EXT (V501-015-10) \[10 years after the first dose of GARDASIL™\]. Participants from Denmark, Iceland, Norway and Sweden who participated in the Base Study were eligible to enroll in the LTFU. Effectiveness and safety was assessed by registry-based follow-up, and immunogenicity was assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-21 LTFU.

An 8-year extension was added to the LTFU (V501-015-22\] to continue the evaluation of the long-term effectiveness and immunogenicity of GARDASIL™. Effectiveness and safety will be assessed by registry-based follow-up, and immunogenicity will be assessed by serological testing at approximately Year 4 and Year 8 of the extension of the LTFU.

Eligibility Criteria:
Inclusion Criteria for the Base Study:

* Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

  --For Extension Phase:
* Participant received placebo or an incomplete vaccination series in the original study

  --For LTFU:
* Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
* Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

* Prior Human Papilloma Virus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts

  --For Extension Phase:
* Prior complete HPV vaccination series
* Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil

  --For LTFU Study:
* There were no exclusion criteria that did not overlap the inclusion criteria for this study.
Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD

To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.

Patients using adalimumab for Crohn's disease or ulcerative colitis who are in clinical remission will be followed with fecal calprotectin monitoring every 3 months. Patients with a sustained rise in calprotectin who maintain clinical remission will be offered an opportunity to have an increase in adalimumab for three months. Patients who use the three months of increased adalimumab dosing will be compared to patients who do not use increased dosing to determine if relapse rates differ between these two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ages 18 and older with Crohn's disease and ulcerative colitis
2. Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score \< 2 or Harvey-Bradshaw Index \< 4)
3. Patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly).

Exclusion Criteria:

1. Pregnant women or plans for pregnancy within 3 months of study inclusion
2. Abdominal abscess
3. Inability or unwillingness to provide informed consent
4. Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease

The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.

We conducted a randomized placebo controlled trial of topiramate in PD dyskinetic subjects already on amantadine but with continuing dyskinesia. Topiramate or placebo was introduced in blinded fashion with a gradual titration (topiramate 25-150 mg/d) over 6 weeks and then a maintenance period of 8 weeks. The primary outcome of interest was change from baseline to end of study in total Unified Dyskinesia Rating Scale (UDysRS) score using Intention to Treat analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
2. Current age between 30-90
3. Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity (CGI-s) score (see attachment) \> 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. \*
4. Stable doses of all antiparkinsonian medications for at least 4 weeks
5. Stable treatment with at least 200 mg amantadine for at least 4 weeks.
6. Presence of a caregiver willing to participate in the study
7. In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
8. Subjects must be free of dementia, depression and psychosis as determined by clinical examination.
9. The subject must be willing to participate in all study related activities and visits.

Exclusion criteria:

1. Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
2. Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
3. Any subject who, in the opinion of the Principal Investigator, will be unable to maintain current stable dosing of their anti-parkinsonian medications for the duration of the trial,
4. Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
5. Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.
A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy

This pilot study will include up to 25 patients with cancer experiencing chemotherapy-induced peripheral neuropathy. Patients enrolled in the study will participate in a 10-week QiGong for Chemotherapy-Induced Neuropathy program. Patients will be evaluated before and after their program participation. Within 2 weeks before the program start date, patients will be administered an objective neuropathy assessment by a physician or nurse, and will complete questionnaires assessing chemotherapy-induced peripheral neuropathy, perceived cognitive functioning, quality of life, and cancer-related symptoms. Patients will repeat these assessments at the end of the last QiGong class and will be asked to provide feedback on the QiGong program as a whole. Self-report questionnaires will also be repeated one week after the last class.

Total duration of subject participation will be 11-13 weeks. Total duration of the study is expected to be approximately 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer, stage 1-4.
* Completed taxane- or platinum-based chemotherapy at least three months (90 days) ago but within 24 months of signing consent. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay.
* Experiencing at least grade 1 peripheral sensory neuropathy, peripheral motor neuropathy, or dysesthesias based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 (NCI CTCAE v4.0).
* Age ≥ 18 years.
* Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to study enrollment).
* Reasonable functional stability as assessed by the evaluating physician.
* Must be able to understand and communicate proficiently in English.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician.
* Medical history of neuropathy from any type of nerve compression (e.g., carpal tunnel or tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy, leptomeningeal carcinomatosis), as assessed by the treating physician.
* Neuropathy related to abnormal TSH or B12 levels as assessed by treating physician
* Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician.
* Severe personality disorder or psychiatric disorder that would interfere with participation in a QiGong program, as assessed by the evaluating physician.
* Currently participating in another QiGong or Tai Chi program.
Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by destruction of normal epithelial structure, proliferation of fibroblasts, and deposition of connective-tissue matrix proteins. There are currently no effective therapies for IPF. Over the past two decades, preclinical studies of inhaled low dose carbon monoxide (CO) have shown that this biologically active diatomic gas possesses properties that would make it a viable novel therapy for IPF. CO therapy has been well tolerated in Phase I and Phase II human trials to date. This phase II study is designed to investigate whether IPF patients show evidence of decreased peripheral blood levels of matrix metalloproteinase-7 (MMP7) and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adults above the age of 18 and equal to or below the age of 85
* Diagnosis of IPF by biopsy or
* American Thoracic Society (ATS)/European Respiratory Society (ERS)/ Latin American Thoracic Association (ALAT) Guidelines (Am J Respir Crit Care Med Vol 183. pp 788-824,2011)
* Forced vital capacity (FVC) greater than or equal to 50% predicted, greater than or equal to one month off all medications prescribed for IPF

Exclusion Criteria:

* Evidence of active infection within the last month
* Significant obstructive respiratory defect
* Supplemental oxygen required to maintain an oxygen saturation over 88% at rest
* History of myocardial infarction within the last year, heart failure within the last 3 years or cardiac arrhythmia requiring drug therapy
* History of smoking within 4 weeks of screening
* Pregnancy or lactation
* Participation in another therapeutic clinical trial
Protein Ingestion and Muscle Carnitine Uptake

The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and carbohydrate-only controls, and to determine whether increasing plasma carnitine availability can impact upon insulin-stimulated muscle carnitine uptake.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Body mass index of 18-25 kg/cm2

Exclusion Criteria:

* Unhealthy
* Smoker
* Taking any medication that interferes with skeletal muscle metabolism