cyrilzakka/clinical-trials huggingface dataset:
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed infiltrating breast cancer.
* Stage II or stage III breast cancer.28 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of \>2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is \>3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
* Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:

  * \>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
  * \>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of \>2.2. or as \>5 HER2 gene copies per nucleus in CISH analysis.

Patients with a negative or equivocal overall result (FISH test ratio of \<2.2, \<6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.

* Age ≥18
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)
* Adequate bone marrow function (ANC \>1.0 x 109/l, platelets \>100 x 109/l)
* Adequate hepatic function (ALAT, ASAT and bilirubin \<2 times upper limit of normal)
* Adequate renal function (creatinine clearance \>60 ml/min)
* LVEF ≥50% measured by echocardiography or MUGA
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Signed written informed consent

Exclusion Criteria:

* No previous radiation therapy or chemotherapy
* No other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
* No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
* No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
* No concurrent anti-cancer treatment or another investigational drug
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.

This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15) or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice daily.

The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300 mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in the 36-week open-label study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years old with HIV-1 RNA ≥ 2,000 copies/mL and currently failing therapy.
* Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening.
* Agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy.

Exclusion Criteria:

* Current or recent (last 30 days of study entry) AIDS defining diseases.
* Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation.
* Prior exposure to lopinavir/ritonavir or amdoxovir.
* Impaired hepatic function (ALT \> 5 x ULN).
* Women who are pregnant or breast feeding.
Tramadol Versus Lidocaine Infiltration for Tonsillectomy

The investigators postulate that the use of pre-incisional peritonsillar infiltration of tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic consumption, without harmful effects. Therefore, the present study is designed to evaluate the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum protein, C-reactive protein, and analgesic consumption after tonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I \& II preschool children aged 2-6 years, undergoing elective tonsillectomy with or without adenoidectomy, under general anaesthesia. Indications for tonsillectomy will be chronic recurrent tonsillitis or tonsillar hypertrophy

Exclusion Criteria:

* Patients with a history of allergy to tramadol or amide local anaesthetics, epilepsy, or taking cardiovascular, antihypertensive, steroids, or anti-inflammatory medications, those with cardiac, liver, or kidney diseases, or any underlying systemic diseases or acute infectious processes will be excluded from the study. All operations will be performed, using an electro-dissection technique, by the same surgeon.
Mobile Outreach Screening of High-Risk Human Papillomavirus Infection in Women with Limited Access to Health Services in Seine-Saint-Denis (greater Paris Area, France)

The study is a prospective cervical cancer screening intervention in the nonclinical setting of a mobile testing unit in a vehicle, using point-of-care HPV PCR tests with self-collected vaginal swabs.

It is designed for women with limited access to healthcare and prevention in underprivileged municipalities in the greater Paris area (Seine-Saint-Denis department, detailed in Annexe 3).

HPV positive participants will receive counseiling and guidance to help them find a healthcare professional to take care of their needs


Eligibility Criteria:
Inclusion Criteria:

* - Women from 30 to 65 years of age presenting to the " Bus Santé " nonclinical testing unit, eligible to cervical cancer screening by an HPV-HR test
* Women affiliated to the French social security or immigrants benefiting from the state medical aid program for undocumented immigrants (Aide Médicale d'Etat). The inclusion of people not affiliated to a social security system is an exception and depends on the decision of the Personal Protection Committee, if it is based on an expected benefit for these people of a nature to justify the foreseeable risk incurred.
* The intervention is designed for vulnerable women with limited access to healthcare, including but not limited to:

  * Women living in shelters and hostels, women living in the streets, in squats, hot-bedding arrangements, emergency social housing;
  * Recent immigrants, documented or undocumented;
  * Young adults from priority neighbourhoods,
  * Isolated or marginalized women
* Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any sampling carried out as part of the trial (article L1122-1-1 of the Public Health Code)

The Bus will operate in underprivileged neighbourhoods in the greater Paris area (eastern Seine-Saint-Denis department.

Exclusion Criteria:

* Screened for cervical cancer by a PAP smear in the last 3 years or by an HPV test in the last 5 years,
* Women on their period (haemoglobin inhibits PCRs)
* Pregnancy in the 2nd and 3rd trimesters
* Total hysterectomy; absence of a vagina
* Women under guardianship/tutelage
Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery

The purpose of the research is to prove the analgesic efficacy of a novel technique in regional anaesthesia, i.e. the catheter under the erector spinae muscle (ESC). Investigators will evaluate the use of the ESC for analgesia after video-assisted thoracoscopic lung surgeries in comparison to the standard method of post-operative analgesia, which is the multiple level intercostal block given at the end of surgery by the surgeon. Investigators will compare the amount of opioid analgesics required by the patient using the patient controlled pump, the pain status in 48-hours after surgery and compare the differences between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* ASA (American Society of Anesthesiologists status) I-III
* Elective video-assisted thoracic surgery - lobectomy with 3 ports technique
* No contraindications for regional anesthesia

Exclusion Criteria:

* Allergy to local anesthetic
* Pregnancy, breastfeeding
* BMI\>35
* Inflammation in the area of ES catheter insertion
* Inability to use the PCA pump
* Inability to execute the main inspiratory and expiratory pressure measurements
Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty

This is a single center, randomized, double-blinded, controlled clinical trial. The purpose of this study is to to determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative complications in patients undergoing artificial joint replacement surgery.

The complications from patients accepted artificial joint replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. It has been proved that the electroacupuncture application during perioperative period can reduce the dosage of anesthetic drugs, and has a good effect on the protection of the heart and brain. At the same time, the electroacupuncture can also regulate the body's immune function, reduce allergy, reduce postoperative pain and so on.Compared with acupuncture, transcutaneous electric acupoint stimulation (TEAS) is a noninvasive technique that has similar effects to acupuncture. The investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after artificial joint replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

1. ASAⅡ-Ⅲ,elective operation patients
2. No other severe complications history
3. Able to give informed consent

Exclusion Criteria:

1. Having severe comorbidity resulting in estimated life expectancy \<1 year.
2. Infection at the electroacupuncture site.
3. Suffered from neurologic disorder or impaired mental state
4. Participate in the other clinical trial 3 months before the enrollment
5. No suitable to participate in this experiment
Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus

* To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint.
* To compare the safety of HMR1964 with insulin lispro.

* To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28; consecutive change in HbA1C by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total).
* To collect 6-month safety data of HMR1964.

Eligibility Criteria:
Inclusion Criteria:

* Men or women with type 1 diabetes mellitus, an HbA1C range of \>=6.0 - =\<11.0%, and on a basal-bolus insulin regimen. They must have had at least 1 year of continuous insulin treatment at the date of informed consent.

Exclusion Criteria:

* Subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
* Subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
* Subjects who were treated with another investigational product within 12 weeks prior to informed consent
* Subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
* Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or systemic disease making implementation of the protocol or interpretation of the study results difficult
* Subjects who have undergone pancreatectomy or pancreas/islet cell transplant
* Night shift workers
* Subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study
* Subjects who have previously been treated with HMR1964
* Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
* Female subjects who are possibly pregnant \[female subjects of reproductive potential who have serum human chorionic gonadotropin (hCG) level \> 0.7 mIU/mL as determined by central laboratory, SRL Medisearch Inc., during screening phase\]
* Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period
* Subjects with history of alcohol abuse
* Subjects with hypersensitivity to insulin preparations
* Subjects with impaired hepatic function (SGOT or SGPT ³=\<80 IU/L determined by central laboratory, SRL Medisearch Inc., during screening phase) or impaired renal function (serum creatinine =\<2.0 mg/dL determined by central laboratory, SRL Medisearch Inc., during screening phase)
* Subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason
Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Short-axis and Long-axis Techniques

This study compares the long-axis and short-axis technique of continues adductor canal block for total knee replacement surgery. Half participants will receive long-axis catheterization, while the other half will receive short-axis catheterization.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* Knee-arthroscopy
* Written consent
* ASA I-III
* BMI 19-35

Exclusion Criteria:

* Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).
* coagulopathy or on anticoagulant medication
* Allergic reactions toward drugs used in the trial
* History of substance abuse
* Infection at injection site
* Can not be mobilised to 5 meters of walk pre-surgery
A Retrospective Real World Analysis Of Sutent In Patients With Metastatic Renal Cell Carcinoma In Community And Academic Centers To Assess The Impact Of Dose Variation On Duration Of Response And Overall Survival

This is a retrospective, non-interventional study which looks at the cohort of Renal Cell Carcinoma patients in a real life clinical setting and analyses into factors why these patients have been surviving for as long as 3-5 years unlike Clinical study where the survival is around 2 years.

The factors which will be analysed include patient characteristics, dosage and adverse event management and tries to correlate these factors with survival.

A single cohort of 200 patients who are diagnosed with metastatic renal cell carcinoma prior to 1st Jan 2012, and are seen by the medical oncologist at the centers involved with BIOGRID and its affiliated registries. Patients will be identified from the first date of their consultation with the medical oncologist and captured in the electronic database. Consent to use datasets has already been obtained from participating research institutes and hospitals IRB/Ethics Committees

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Male or female
* Metastatic renal cell cancer
* First presentation with metastatic disease prior to 1st Jan 2012 since 2006, i.e. between 1st Jan 2006 to 31st Dec 2011

Exclusion Criteria:

* No referral to medical oncologist
* No record available in electronic database
Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring

The purpose of this study is to develop and validate the accuracy and reliability of an artificial intelligence(AI) system for bowel preparation quality scoring based of Boston Bowel preparation Scoring(BBPS). Then evaluate whether this AI system can help endoscopists to improve the quality of colonoscopy in clinical practice.

Bowel preparation is one of the most important factors which decide the quality of colonoscopy. Adequate bowel preparation is essential to guarantee a clear vision of colonic mucosa, complete inspection of entire colon and improves the adenoma detection rates(ADRs). Therefore, the quality of bowel preparation should be evaluated accurately and objectively. However, current bowel preparation quality scales depend on memories and subjective decision of endoscopists. Recently, articifial intelligence system based on deep learning algorithm has been used widely in medical fields. But, few studies have been reported to evaluate the performance of AI system based on deep learning in bowel preparation quality scoring. This study aims to develop and train an AI system to assess bowel preparation quality using the BBPS, and validate the AI system to improve the quality of colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-80 years undergoing elective colonoscopy

Exclusion Criteria:

* Patients received colon or rectal surgery
Cancer Patients Treated With Immunotherapy in Intensive Care Unit

This work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

The place of checkpoint inhibitors (anti-PD-1 and PD-L-1) is currently validated in the management of melanoma and metastatic non-small cell lung cancer. The toxicity profile is specific with adverse effects related to immunity. Some side effects (myocarditis, colitis, interstitial lung disease, etc.) can be severe and patient could be hospitalized in intensive care unit.

The question of immunotherapy's imputability in the acute disease is becoming more frequent.

Eligibility Criteria:
Inclusion Criteria:

* \> or = 18 years old;
* with a solid tumor;
* Treatment with anti-CTLA4 and / or anti-PD-1 / PDL-1 still in progress or up to 6 months after stopping;
* Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason.

Exclusion Criteria:

* Minors;
* Pregnant or lactating woman;
* Admission after surgery of a scheduled surgery or for the security of procedure;
* Anti-CTLA4 and / or anti-PD-1 / PDL-1 treatment stopped for more than 6 months;
* Subject under guardianship or deprivation of liberty;
* Refusal of consent;
* No affiliation to a health insurance scheme.
Efficacy of an Smartphone App Intervention Based on Self-compassion for Mental Health Among University Students

Since the beginning of Covid-19, there has been an increase in the incidence of mental disorders and psychopathological symptoms, such as depression, anxiety and stress, among university students. Even with the end of social distancing, many students still have losses in emotional well-being, so psychotherapeutic interventions are important for the recovery and promotion of the mental health of this public. Interventions based on self-compassion have been associated with improving the mental health of different audiences, either by reducing psychopathological symptoms (such as anxiety) or improving positive constructs associated with mental health, such as hope and optimism. One way to administer interventions based on self-compassion is through mHealth technologies, which have been consolidating since the pandemic. Some studies sought to assess the benefits of self-compassion-based interventions administered in the mHealth format among university students suggest that they have acceptability and are effective regarding indicators of emotional well-being. However, in Brazil, there is still no digital intervention for the cultivation of self-compassion among university students, which could help to mitigate the deleterious effects of the pandemic on mental health. Considering this gap, an intervention based on self-compassion administered via a smartphone app called "Eu + Compassivo" was developed. The present study seeks to evaluate its efficacy in mental health indicators, both psychopathological symptoms and Positive Psychology constructs.


Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled in a course that originally works in the face-to-face format
* Having basic knowledge of the use of smartphones
* Owning a smartphone with internet access and the Android or IOS system
* At least mild depressive, anxiety or stress symptoms

Exclusion Criteria

• Diagnosed with any serious and persistent mental disorder
Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques

The purpose of this research study is to determine if a very sensitive chemistry lab analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs.

Types of skin cancer, like melanoma, are likely to spread and are becoming increasingly common. At this time, healthcare providers look at patient's skin and remove a sample of suspicious areas of the skin (biopsy) to test for cancer.

This research study will inspect cotton and cloth swabs of normal skin and suspicious areas of the skin that are going to be biopsied just before the biopsy. The swabs will be looked at with a very sensitive chemistry lab analyzer to see if the lab analyzer can confirm conventional lab test findings.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Seen at the dermatology clinic \& determined to need a skin biopsy of a suspicious lesion

Exclusion Criteria:

* \< 18 years of age