cyrilzakka/clinical-trials huggingface dataset:
Deciphering Mechanisms Underlying Cancer Immunogenicity

This trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.

The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.

Patients with any of the following tumor types may be enrolled in the trial:

* Head and neck cancer,
* Ovarian cancer,
* Cervical cancer,
* Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
* Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)

Each tumor type will be considered as an independent cohort.

For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.

Study participation of each patient will be 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)
2. Age ≥ 18 years at the time of study entry
3. Patient followed within a standard of care procedure or clinical trial
4. ECOG Performance status 0-2
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
6. Patient affiliated to a Social Health Insurance in France
7. Patient may participate to other clinical trials

Exclusion Criteria:

1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
2. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin \< 8g/dl)
3. Patient pregnant, or breast-feeding
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship
Analysis of Atropine and Propranolol Induced Changes

The purpose of this study is to learn the effects of genetic make up on response to the drugs atropine and propranolol, to examine how changes in heart rate and blood pressure can be measured, and to test a new statistical analysis method.

Healthy volunteers will be recruited and screened for eligibility. Participants will be placed into three possible groups based on genetic information obtained during screening. Rolling admissions will continue until at least 10 participants have been recruited for each genetic group. Participants will be randomly assigned to receive either the control (propranolol and saline) or combined drug (propranolol and atropine) treatment in a non-blinded fashion. The participant will return over one week later to receive the alternate treatment. Continuous heart rate/blood pressure data will be recorded until the end of the study period. Respiratory rate will be maintained at a fixed rate. Participants will undergo an orthostasis task, receive the drug or control infusions, and blood samples will then be obtained to determine drug concentrations at specific time intervals. Several relatively new mathematical techniques will be applied to the data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Ages 21-40
* Body Mass Index \>18.0 and \<27.0

Exclusion Criteria:

* History of any chronic illnesses including cardiac diseases and bleeding problems
* Drug use of any kind
* Participation in any clinical trial within the last month
* Tobacco use and/or alcohol abuse
* Use of dietary supplements and unwillingness to refrain
Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome

The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.


Eligibility Criteria:
Inclusion Criteria:

* Patient has to be ≥ 18 years of age of either gender
* Nuclear sclerotic cataract graded by LOCS III to be \< 5
* Diagnosis of Plateau Iris Configuration or Syndrome
* No contraindication for cataract or ECPL operation
* Written informed consent on IRB approved Informed Consent Form

Exclusion Criteria:

* Hard cataracts, LOCS III 5 and 6
* Ciliary body cysts
* Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.)
* Congenital anomaly of the irido-trabecular angle
* Previous intraocular surgery
* Previous laser gonioplasty to either eye
* Placement of the intraocular lens in any place other than the capsular bag
* Pupilloplasty
* Rubeosis
* Peripheral anterior synechiae (PAS) nasal angle and/or \>180 degrees of PAS
* Neovascular glaucoma; or glaucoma associated with vascular ischemic disorders
* Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
* Corneal opacities or disorders that would inhibit visualization of the nasal angle
* Chronic ocular inflammatory disease or presence of active ocular inflammation with risk for synechial/proliferative changes
* Inability to attend regular follow-up assessment or to give informed written consent.
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion

The aim of the sudy is to evaluate, through clinical, biological and transthoracic echocardiography follow up, the evolution of post operative (cardiac surgery) pericardial effusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory (NSAID) drug (diclofenac)for this indication.

Following cardiac surgery, the incidence of Pericardial effusion (PE) is high (50-85%) . The risk of tamponade is well acknowledged : about 2%. We published in 2004 in CHEST a study which allows us to know the natural history of post-operative PE and to validate, for the first time the use of an echocardiographic classification for predicting the occurrence of a tamponade. NSAID are widely used in this setting, but no study has ever been conducted trying to assess their efficiency. The aim of the study is therefore obvious : must we use NSAID in order to prevent post operative cardiac tamponades ?.

In order to answer this question, we are going to conduct a double-blind randomized study comparing diclofenac to a placebo.

Every patient hospitalized in a post operative cardiac rehabilitation center less than 30 days after cardiac surgery and presenting at the first TTE (Trans Thoracic cardiac Echography) a PE of severity \> 2 (that is to say about 10 % of the totality of the patients having undergone a cardiac operation) will be included.: after randomisation, patients will receive a placebo or diclofenac (50 mg ) bid, in a double blind way, during 14 days.

Trans thoracic cardiac echography, creatininemia, haemoglobinemia, International Normalized Ratio (for patients receiving a vitamin K antagonist) will be performed once a week during 2 weeks.

Clinical assessment will be done every day (there will be no outpatient

Primary end point : evolution of the mean echocardiographic score in each group

-Secondary end-points :

Number of tamponades Number of patients in whom the individual echographic grade is decreasing of at least one point Number of pericardiotomy Creatininemia Haemoglobinemia PE evolution in patients having an inflammatory syndrome (C reactive Protein \>30) PE evolution in patients receiving a vitamin K antagonist

86 patients per group are necessary; therefore we will include a total of 200 patients

Eligibility Criteria:
Inclusion Criteria:

* -Every patient hospitalized in a post operative cardiac rehabilitation center less than 30 days after cardiac surgery and presenting at the first TTE (Trans Thoracic cardiac Echography) a PE of severity \> or equal to 2 (that is to say loculated effusion \>10 millimeters or circumferential effusion \> 1 mm ) will be included

Exclusion Criteria:

* Cardiac transplantation
* Age \<18 and \> 80
* Pregnancy
* Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure...)
Header Burden in Football (Soccer)

To assess the realistic magnitude of the header burden in children's and youth' football in eight European countries. In a cross-sectional observational design, one match of 60 different teams in each of the eight European countries were monitored via video recording throughout the second half of the regular season 2017/18 and the first half of the regular season 2018/19. Clubs with (female, male, or mixed) Under-10, Under-12 and female and male Under-16 teams were invited to participate. Header frequencies and types were analysed using standardized heading registration forms. Additionally, head injuries were recorded using standardized head injury registration forms.


Eligibility Criteria:
Inclusion Criteria:

* 1) officially registered in the football association
* 2) regular training participation
* 3) regular participation in official matches
Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are the most frequent symptoms with an incident of 50% to 70% in patients.

Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia. TMS is capable of inducing changes in the electrical activities of the brain in humans.

The purpose of this trial is to study the use of TMS to decrease auditory hallucinations in schizophrenia.

We hypothesize that: True treatment with rTMS will have significant decrease in auditory hallucinations versus sham treatment over the temporoparietal cortex.

FMRI will highlight areas of activation with auditory hallucinations distinct from the area identified by Hoffman's scalp based method.

Cortical inhibition as measured by paired pulse TMS will be increased after true TMS but not sham TMS.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia
* Auditory hallucinations occuring more than 5 times per day
* Adequate (6 weeks) trial of antipsychotic medication
* Including at least 1 atypical antipsychotic medication
* Medication stable for 4 weeks prior to commencement of the study
* Competent to consent

Exclusion Criteria:

* history of seizure disorder in patient or first degree relative
* recent head injury
* Acute suicidality
* Alcohol or substance abuse
* Implanted pacemaker or metal in head or neck
* Pregnancy
Faecal Microbiota Transplantation as Means of Preventing Recurrent Urinary Tract Infections

This study investigates Faecal microbiota transplantation (FMT) in prevention of recurrent urinary tract infections (UTIs) caused either by sensitive E. coli or ESBL-E. coli.


Eligibility Criteria:
Inclusion criteria:

* Female subjects aged ≥18
* History of recurrent UTI: at least two episodes of UTI over the past 6 months or at least three episodes over the past year, most recent episode within the past three months
* Written informed consent

Exclusion criteria:

* Suspected non-compliance
* Diagnosis of a gastrointestinal disease
* Pregnancy
* Immunosuppression
* Any kind of permanent urinary catheter or intermittent urinary catheterization
* Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib

This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥ 18 years
* Histological or cytological documentation of adenocarcinoma of the colon or rectum
* Suitable to receive mFOLFOX6 regimen as first line metastatic treatment
* At least 1 measurable lesion as per RECIST version 1.1
* Unresectable or unlikely becoming resectable metastatic disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 3 months
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Prior systemic anticancer therapy for metastatic colorectal cancer (CRC). Adjuvant chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended \> 6 months before screening and recurrent disease was documented.
* Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and any signal transduction inhibitors (STIs)
* Uncontrolled hypertension
* Subjects with symptoms, signs, or history of brain metastases
* Any hemorrhage or bleeding event ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks of start of study treatment
* Sensory neuropathy (\> CTCAE Grade 1), unresolved toxicity \> CTCAE Grade 1 attributed to any prior therapy/procedure excluding alopecia
Sanctuary Youth Series Randomized Control Trial

Sanctuary Mental Health Ministries designed an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. The program is intended to be conducted by an experienced facilitator, although there is no specific training provided for facilitators outside of the facilitation guide. The facilitator would lead groups of 11-15 year olds by leading games, showing the films, and facilitating discussion. The series is freely available on Sanctuary's website; individuals can access the material by creating an account, logging in, and downloading the course content. This RCT is to evaluate the effectiveness of the Youth Series course on improving youth's mental health literacy, knowledge, and attitudes towards help-seeking.

Churches will be recruited to the study based on social media sites and through Sanctuary's newsletter distribution lists. Churches who agree to participate in the study will be randomized to one of two groups, the Pilot Group that receives the 8-week series, and the Comparison Group, that does not receive the series. Both groups will be asked to complete a baseline survey and then a follow-up (end line) survey 8-weeks later. The results will be scored and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Youth between the ages of 11-18 attending a youth group that has been recruited to the study.

Exclusion Criteria:

* Youth outside of the age range that are not attending a youth group recruited to the study.
Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period

patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.

in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.

Eligibility Criteria:
Inclusion Criteria:

female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection

Exclusion Criteria:

1. Male patients
2. Bilateral breast cancer.
3. Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
4. Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
5. Patients with known psychological or mental problems.
6. Patients who were not exposed to axillary dissection
Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer

This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.


Eligibility Criteria:
Key inclusion criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.)
2. Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
3. ECOG performance status 0 or 1
4. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.)
5. Disease progression after the start of the 1 prior regimen based on computed tomography
6. Adequate bone marrow, hepatic, and renal function
7. Ability to swallow an oral solid-dosage form of medication

Key exclusion criteria:

1. Squamous cell gastric carcinoma
2. Bone-only metastatic disease
3. History or presence of brain metastasis or leptomeningeal disease
4. Operable gastric or gastroesophageal-junction cancer
5. HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent
6. Uncontrolled diarrhea, nausea, or vomiting
7. Known malabsorptive disorder
8. Significant medical disease other than gastric cancer
9. Presence of neuropathy \> Grade 1 (NCI Common Toxicity Criteria)
10. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.)
11. Prior radiation therapy to more than 25% of the bone marrow
12. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
13. Pregnancy or lactation
Arestin - Use in Subjects With Peri-Implantitis

The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.

The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.


Eligibility Criteria:
Inclusion Criteria:

* A minimum of one osseointegrated implant with a diagnosis of peri-implantitis
* Absence of any significant oral soft tissue pathology
* At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing
* Confirmed evidence of pathologic bone loss
* At least 1mm of keratinized gingiva present around the implant

Exclusion Criteria:

* Pregnancy
* Allergy to tetracycline-class drug(s)
* Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures
* Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis
* Diagnosis of clinically significant or unstable organic disease, or compromised healing potential
* Signs of untreated advanced periodontal disease and/or poor oral hygiene
* Subjects having a probing depth greater than 8mm at time of enrollment
* Subjects presenting with mobility of any dental implant
* Subjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)
Frontier Registry II Bifurcation Stent System Registry

To assess the procedural success, performance, 30-day and 6 month clinical outcome of bifurcation stenting, and the six month incidence of clinically indicated target lesion revascularization with the use of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System in patients with de novo or restenotic bifurcation lesions.

The purpose of this study is to assess the performance of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System (CBSS) with one and six months clinical outcomes, when used for bifurcation de novo or restenotic lesion treatment. The device allows for a stent to be implanted in the main branch and simultaneous preservation and access of the side branch for balloon dilatation or stenting when indicated.

Eligibility Criteria:
Inclusion Criteria:

* Other lesions in different epicardial vessels must be successfully treated prior to bifurcation procedure.
* Native parent vessel suitable to receive at least a 2.5mm x 18mm FRONTIER stent (\>2.5mm and \<4.0mm diameter with a side branch of \>2.0mm) with a lesion length \<15mm determined by visual assessment .
* Target main branch vessel must be a major epicardial native vessel.
* Appropriate lesion morphology.
* Target lesion is restenosis following original treatment by PTCA only (no in-stent restenosis).

Exclusion Criteria:

* Estimated artery reference diameter \<2.5mm
* Patients with diffuse disease defined as long segments of abnormal vessel without interposed areas of normal vessel
* Target lesion contains thrombus.
* Target lesion is aorto-ostial or left main stem location.
* Untreated lesion \>50% diameter stenosis proximal or distal to target lesion after the planned target lesion intervention.
* Patients with a contraindication for anti-platelet / anti-coagulation therapy.
* Target lesion distal to previously placed stents.
* Fibrotic or calcified lesions that cannot be pre-dilated.