cyrilzakka/clinical-trials huggingface dataset:
Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy (RT) in locally advanced rectal carcinoma

Total neoadjuvant treatment (TNT) is currently the standard of care in the management of locally advanced rectal cancer since recent studies have shown improved pathological complete response and disease-free survival with this approach. However, survival benefits remain unproven.

Two strategies of TNT are validated so far : induction chemotherapy with FOLFIRINOX followed by long course radio-chemotherapy (RCT) or short course RT (5x5 Gy) followed by consolidation chemotherapy with CAPOX (capecitabine and oxaliplatin) or FOLFOX (5 FU and oxaliplatin) .

The objective of investigators is to evaluate pathological complete response with a new strategy of TNT consisting in induction chemotherapy with FOLFIRINOXm followed by short course RT and a delayed surgery.

Eligibility Criteria:
Inclusion Criteria:

* World Health Organization (WHO) performance status : 0 or 1
* Histologically proven rectal adenocarcinoma \< 10 cm from anal margin on rectoscopy
* clinically T3 (cT3) or clinically T4 (cT4) and/ or N+ non metastatic rectal cancer
* Neutrophil count \> 1500 e/mm3
* Platelet count \>100000
* Hemoglobin \> 10 g/dl ( transfusion allowed)
* Normal bilirubin level
* Creatinine clearance \> 50 ml/mn

Exclusion Criteria:

* Distant metastases
* History of chemotherapy or radiotherapy
* Grade 1 neuropathy
* Patient undergoing treatment for another cancer
* Active infection or severe comorbidities contraindicating chemotherapy
Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

Age-related cognitive decline is unavoidable. However, recent results of neuroplasticity-based research show that neuroplasticity-based training and physical activity might have the potential to decelerate or even reverse effects of aging and age-related cognitive impairments. Little is known whether these results also apply to pathological processes of aging such as mild cognitive impairment (MCI) and dementia.

This multi-center study aims at investigating efficiency and feasibility of a neuroplasticity-based auditory discrimination training and a physical fitness training for patients suffering from mild cognitive impairment or mild Alzheimer's disease (Mini Mental State Examination, MMSE \> 19). Evaluation will include neuropsychological testing, electroencephalography (EEG) and magnetic resonance imaging (MRI) measurements as well as blood and liquor analyses.


Eligibility Criteria:
Inclusion Criteria:

* focus: subjective and/or objective memory complaints with MMSE \> 19 (MCI or mild Alzheimer's Disease, with stable medication for at least 3 months)
* mild to moderate depression
* corrected-to-normal hearing and vision
* for MRI: non-magnetic metals inside the body
* right handedness preferred

Exclusion Criteria:

* cognitive impairment/ dementia with MMSE \< 20, severe psychiatric or neurological disease (current and lifetime)
* physical health that does not allow physical fitness tests and trainings
* benzodiazepin, tricyclic antidepressants
* for MRI: magnetic metal inside the body, cardiac pacemaker etc.
* for liquor: insufficient blood coagulation, insufficient brain pressure
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma

The purpose of the study is to determine the efficacy and safety of enzastaurin in participants with Cutaneous T-Cell Lymphoma (CTCL) who failed prior therapies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed mycosis fungoides or Sezary Syndrome.
* Stage IB to IVB disease at screening.
* Recurrent or refractory disease after at least 1 prior systemic therapy.
* Have adequate organ function defined as:

  * Hepatic: total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine transaminase/aspartate transaminase (ALT/AST) ≤2.5 times the ULN.
  * Renal: serum creatinine ≤1.5 times the ULN.
  * Adequate bone marrow reserve: platelets ≥75 \* 10\^9/Liters (L); absolute neutrophil count (ANC) ≥1.0 \* 10\^9/L.
* At least 30 days must have passed since other treatment for CTCL.

Exclusion Criteria:

* Receiving concurrent treatment for CTCL.
* Unable to swallow tablets.
* Receiving high potency oral or topical steroids. Low potency oral steroid may be permitted in participants who have been on a stable dose for at least 4 weeks prior to screening. Oral or topical antihistamine is allowed.
* Unable to discontinue use of carbamazepine, phenobarbital, or phenytoin.
* Have a serious concomitant systemic disorder or Human Immunodeficiency Virus (HIV).
* Have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the New York Heart Association (NYHA) Class III or IV.
* Have electrocardiogram (ECG) abnormalities.
* Are pregnant or breastfeeding.
Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

To test the efﬁcacy of 14 day levoﬂoxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.


Eligibility Criteria:
Inclusion Criteria:

* all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.

Exclusion Criteria:

* patients less than 18 years old,
* previous gastric surgery,
* pregnancy,
* lactation,
* major systemic diseases,
* administration of antibiotics,
* bismuth,
* antisecretory drugs in the preceding 8 weeks, or
* allergy to any one of the medication used in the quadruple regimens.
Study on the Effect of Filters on Discomfort Glare on Healthy Adults

The goal of this clinical trial is to evaluate the glare protection provided by two filters compared to no filter. Using the Lumiz 100™ device (a headset with gradually increasing light), participants will measure their discomfort thresholds under three different conditions (one per filter). Each measurement will be repeated three times. The study requires a single visit of 2 hours for each participant. Glare protection will be quantified by comparing discomfort thresholds across the no-filter condition and the two studied filters.


Eligibility Criteria:
Inclusion Criteria:

* A willing person, fluent in French, inclined to follow protocol, capable of reading and understanding the information form, and able to give their free and informed consent.
* Beneficiary of the French Social Security system
* Aged 18 to 65 years
* No or moderate ocular correction (Spherical prescription for distance vision: in the range \[-8.00 to +6.00 D\]\* (negative cylinder) for each eye; Cylindrical prescription for distance vision: in the range \[0 to -4.00 D\] for each eye; Anisometropia ≤ 2.00 D on the equivalent sphere)
* Correct vision with prescription glasses (Corrected visual acuity +0.10 logMAR or better (distance vision / high contrast / photopic luminance)
* Regular user of sunglasses at least in bright light conditions

Exclusion Criteria:

* Age \< 18 years (i.e., no minors in accordance with Article L1121-7 of the Public Health Code of "Code de Santé Publique")
* Pregnant, parturient, or breastfeeding women (Article L1121-5 of the Public Health Code of "Code de Santé Publique")
* Persons deprived of liberty by judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, and persons admitted to a health or social institution for purposes other than research
* Adults incapable or unable to express their consent (Article L1121-8 of the Public Health Code of "Code de Santé Publique")
* Participant in the exclusion period of another biomedical research study
* Participant who cannot be contacted in case of emergency
* All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code)
* Employees at the Institut des Sciences de la Vision or EssilorLuxottica
* Ocular pathology that may affect vision (e.g., glaucoma involving visual field loss, maculopathy involving visual acuity loss, or retinitis pigmentosa causing significant discomfort in poorly or overly lit environments)
* Neurological deficit, including a history of epileptic pathology or regular or severe migraines
* Ocular surgery affecting vision (e.g., refractive surgery, cataract surgery, or iridectomy)
* Ocular or head trauma
Safety Study of GNbAC1 in Multiple Sclerosis Patients

The purpose of this study is to assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.

Scientific research has shown that the expression of genes of a virus which is integrated in the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a critical role in the causation of multiple sclerosis.

GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV that might contribute to the development or deterioration of multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients (if female, neither pregnant nor breast-feeding, should be post-menopausal or surgically sterile, or should use two highly effective method of contraception such as oral contraception plus mechanical barrier); Male subjects with partners of childbearing potential have to use adequate contraception during the study. Contraception methods should be followed during the study and up to 3 months after the last study drug administration. Female subjects who are women of childbearing potential (WOCBP) will have to be tested negative with a pregnancy test (serum or urine) at screening and Day 1 and before each repeated administrations of GNbAC1.
* Between 18 and 65 years of age;
* Patients with Primary Progressive MS (PPMS) according to the Revised McDonald criteria 2010 or patients with Secondary Progressive MS (SPMS) or patients with Relapsing-Remitting MS(RRMS)according to the Revised McDonald criteria 2010 who cannot be treated with available treatments for MS due to intolerance, non response or refusal of treatment;
* Score ≤ 6.5 on the Expanded Disability Status Scale (EDSS);
* Body weight between 40 and 100kg.

Exclusion Criteria:

* Positive serology for viral hepatitis and HIV;
* Disease other than MS that could better explain his/her signs and symptoms;
* Previously treated with cladribine, lymphoid irradiation or depleting antibodies;
* Usage in the last 3 months of interferon beta or glatiramer acetate;
* Any usage in the last 6 months of mitoxantrone, cytotoxic immunosuppressive therapy, natalizumab, fingolimod or immunoglobulin;
* Usage within 30 days prior to baseline of oral or systemic corticosteroids or ACTH;
* Inadequate liver function;
* Severe renal impairment;
* Severe psychiatric disorder;
* Known inability to undergo an MRI scan;
* Having participated in another clinical study within 6 months prior to study baseline except for patients who have participated or who are currently participating in an interventional study without any study drug intake.
* Pregnancy or breastfeeding
* Female subjects considering becoming pregnant during the study
Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis

The primary goals of this investigation are to provide guidance on how to dose Argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in hemodialysis patients. The secondary goal of the study will be to assess the adequacy of anticoagulation during hemodialysis.


Eligibility Criteria:
Basic Inclusion Criteria:

1. Patients, adult men or women who are between 21 and 75 years of age who are on maintenance hemodialysis regimen for at least three (3) months prior to the study start.
2. Patients who can tolerate a hemodialysis session lasting up to 9 hours.
3. Patients who can tolerate a hemodialysis treatment with blood flow rates of 300 ml per minute.
4. Female volunteers who are not documented to be surgically sterile must be willing to abstain from sexual intercourse during the study or be willing to use intrauterine devices or 2 forms of barrier contraception for at least 7 days prior to the initial dose of study medication and continuing through the completion of the study.

Basic Exclusion Criteria:

1. Any clinically relevant abnormality identified per the investigator on the screening medical assessment or laboratory examination.
2. History of regular alcohol abuse.
3. Treatment with an investigational drug within 30 days.
4. History of drug allergy of clinical significance in the opinion of the investigator.
5. Currently taking warfarin or other anticoagulants.
6. Currently taking NSAIDs (with the exception of aspirin).
7. Individuals who are obese.
8. Any history of bleeding disorder.
9. Any subject with a screening resting systolic blood pressure \>180 mmHg and/or resting diastolic blood pressure of \>100 mmHg unless, in the opinion of the principal investigator, the blood pressures would not endanger the subject while participating in this trial.
10. Concurrent uncontrolled cardiovascular, hematologic, respiratory, CNS, gastrointestinal disease or chronic alcoholism.
11. Anemia defined as a hematocrit of \< 30 and hemoglobin \< 10g/dL.
12. Concurrently taking (within the past 30 days) phenytoin, cimetidine, rifampin, cyclosporin or tacrolimus.
13. Known hypersensitivity to Argatroban or related compounds.
14. Significant hepatic insufficiency as defined by total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range.
Comparison of Three Different Puncture Techniques in EBUS-TBNA

The purpose of this study was to compare the accuracy and sensitivity of slow-pull capillary technique, traditional suction aspiration and non negative pressure puncture in the diagnosis of mediastinal and/or hilar lymph node enlargement by ultrasound bronchoscopic lymph node biopsy.

EBUS-TBNA has been widely used in the diagnosis of diseases involving lung hilar and mediastinal lymph node enlargement.But different puncture methods are still controversial. Research shows that there was no significant difference in sample adequacy, diagnostic specificity and accuracy between the no negative pressure aspiration and traditional negative pressure aspiration technique.Slow-pull capillary technique is a relatively new operating method of endoscopic ultrasound guided fine needle biopsy in recent years. At present, this technology is widely used in pancreatic space occupying lesions. Compared with the traditional negative pressure aspiration method, our previous retrospective study found that the slow-pull capillary technique can improve the diagnostic accuracy of patients. Therefore, the purpose of this study is to prospectively and randomly compare the advantages and disadvantages of three puncture methods in EBUS-TBNA.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80years
* Chest computed tomography showing hilar or mediastinal lymph node enlargement
* No contraindications for bronchoscopy
* Signed informed consent provided by the patient
* Disease needs to be diagnosed through the EBUS-TBNA

Exclusion Criteria:

* Severe coagulation dysfunction
* Severe cardiopulmonary dysfunction
* Acute asthma attack or massive haemoptysis
* Poor general condition
* Physical weakness without tolerance for anaesthesia or allergy to narcotic drug
* Disease can be diagnosed by other less invasive methods (such as skin or peripheral superficial lymph node biopsy)
Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A: Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks; Arm B: Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks;


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic breast cancer;
2. All patients were required to give written informed consent;
3. To have received a previous treatment with anthracyclines and taxanes;
4. Previous radiotherapy is allowed, whenever the radiated area is not the only disease location;
5. At least 4 weeks since the last previous antineoplastic treatment;
6. Patients must have recovered from all previous toxicities;
7. Karnofsky Performance status \>= 70%;
8. Adequate hematological, renal, cardiac and hepatic function;
9. Life expectancy of at least 12 weeks;
10. Patients able to comply and to receive an adequate follow-up;

Exclusion Criteria:

1. Only bone metastases;
2. Active infection;
3. Previous treatment with one of the study drugs;
4. Application of other cytotoxic chemotherapy;
5. Insufficient renal function (creatinine clearance \< 60ml/min);
6. Clinically unstable brain metastasis;
7. Pregnancy or lactation;
8. Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin);
9. Abnormal liver function (bilirubin \> 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase \>2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted;
10. Males;
11. Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma;
Improving Quality Based on the Joint Registry

Test whether an intervention, consisting of frequently feedback of performance outcomes and education will improve patient care, expressed in better functional outcomes, fewer complications and more quality improving interventions.

A randomized controlled trial will be conducted where hospitals will be randomized to an early versus late group, stratified by teaching status as this might influence the time available for quality improvement. Randomization will be done using a computer generated randomization table in a 1:1 ratio. During the study only orthopedic surgeons performing THA and TKA will receive monthly feedback by email.

The intervention will consist of the following components:

* Monthly feedback of performance outcomes;
* Education on how to use joint registry data for quality improvement;
* Create awareness by sending monthly feedback about performance; education and by asking what improvement activities have been introduced;
* Hospitals will be linked to hospital with opposite performance outcomes to exchange information and find areas for improvement.

During the trial, the investigators will conduct monthly measurement on intermediate outcomes showing whether the intervention reaches the target group (process evaluation). The following measurements will take place:

* Knowledge among orthopaedic surgeons on their recent performance and how that relates to others;
* Number of quality improvement activities undertaken with the aim to improve the quality of care;
* Planned improvement activities (e.g. record review to figure out why performance is not as good as in other centers) together with who is responsible and by which time;
* Number of people attending the meetings, number of times a specific account has accessed the LROI site to ensure that information has reached the target group;
* Survey among orthopaedic surgeons at the end of the intervention period on knowledge learned and the extent to which they think this is sustainable in daily practice.

In addition, the investigators will compare the outcomes between the early and the late group to test the effectiveness of the intervention, using the appropriate regression techniques. In the second period the investigators will test the sustainability of this approach in daily practice by comparing the outcomes within the early group with the first period, and compare with the late group to test whether outcomes in the sustainability phase are similar as when actively supported.

Eligibility Criteria:
Inclusion Criteria:

* All Dutch orthopedic clinics where hip- and knee replacement surgery is performed who agree to participate will be randomized.

Exclusion Criteria:

* None
Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status 1 or 2
* Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
* Vomiting or retching in the 24 h preceding surgery
* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
* Ongoing vomiting from gastrointestinal disease
A Pharmaceutical Intervention to Reduce Drug-Related Problems in a Home Healthcare Program

The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of patients in a home healthcare program will be effective in improving the quality and safety of treatments. This study aims to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients (catalan home healthcare program at primary care level), compared to the usual management.

ATDOM is the catalan home healthcare program at primary care level. Patients in home care program are frequently polymedicated, which entails a high risk of drug-related problems (DRPs). The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of ATDOM patients will be effective in improving the quality and safety of treatments, reducing DRPs in terms of indication, adequacy, effectiveness, and safety.

The main objective of this study is therefore to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients, compared to the usual management.

Specifically, the investigators want to determine, through a six-month intervention, the effectiveness in reducing DRPs per patient and polypharmacy. Additionally, the investigators will evaluate in the intervention group the implementation of the proposals for change or improvement by the responsible physician.

This is a pragmatic randomized clinical trial with a comparable control group, with prospective follow-up of an intervention for the adequacy of the pharmacological treatment of patients in the ATDOM program assigned to primary care teams of the Camp de Tarragona Primary Care Directorate. PRMs, proposals and implementation will be determined.

A descriptive statistical analysis will be carried out using multivariate adjustments.

If the evaluation results are favorable, widespread implementation of the program would be possible. It could be extended to all ATDOM patients or outpatients in general. Thus, interdisciplinary teamwork would be strengthened to favor the health care continuum.

Eligibility Criteria:
Inclusion Criteria:

* Patient in the home care program
* Sixty-five years of age or older
* Active pharmacological treatment plan with at least one drug

Exclusion Criteria:

* The responsible physician considers that participation may harm the patient