cyrilzakka/clinical-trials huggingface dataset:
Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).

This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.

The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

The study data (immune-related adverse events) will be collected during each administration of the treatment.

A questionnaire will be completed by the patient before the treatment administrations.

Patients will be followed until disease progression or up to 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = 18 years old
2. Patient with a solid tumor whatever the organ
3. Patient receiving an Immune Checkpoint Inhibitor treatment
4. Patient starting first cycle of Immune Checkpoint Inhibitor treatment whatever the treatment line
5. Patient affiliated to the french social security system
6. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure

Exclusion Criteria:

1. Patient who must receive a treatment other than Immune Checkpoint Inhibitor
2. Patient with contraindication to the use of a checkpoint inhibitor (e.g., auto immune disorders requiring an immunosuppressive therapy)
3. Pregnant or breastfeeding women
4. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
5. Patient protected by law
Infection and Adverse Pregnancy Outcome

Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse out-come of pregnancy and a significant proportion is caused by infection. The investigators aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously. Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV) subclasses, to vaginal fluid inflammation markers, and to the presence of novel Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on selected specimens with the aim to identify markers allowing for a personalised treatment approach.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* None
Intrauterine Injection of HCG and Implantation Rate

The study aims to examine the effect of intrauterine injection of HCG on pregnany rate in women undergoing IVF treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF treatment

Exclusion Criteria:

* \> 40 years
Local Anesthesia Impact on Dental Sedation

The goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures.

The main questions it aims to answer are:

* Impact of local anesthesia on sedation depth and hemodynamic parameters
* Impact of presence of local anesthesia on the requirement of propofol to maintain deep sedation.

Participants were deeply sedated and one group received local anesthesia at the anesthesia induction, while other group of patients received local anesthesia after the maintenance anesthesia was discontinued.

If there is a comparison group:

Local anaesthesia (LA) is often preferred for stabilization of vital signs, depth of anaesthesia in dental restorations but the optimal timing of LA administration during sedation is varies according to personal preferences of dentists. Aim of this retrospective study is to investigate the effects of the timing of LA on hemodynamic parameters, depth of anaesthesia and total dose of anaesthetic drugs given in paediatric patients sedated for dental procedures.

Records of healthy children who were sedated for dental restorations will be divided into two groups. Patients who received LA at the beginning of sedation or who received LA at the end of sedation after completion of restorations. It is planned to compare the patient groups in terms of demographic data, hemodynamic data, BIS scores, Ramsey Sedation Scale scores, total propofol dose administered.

Eligibility Criteria:
Inclusion Criteria:

Paediatric dental patients who were previously sedated and fulfilled the following inclusion criteria were included in this investigation. Patients with an American Society of Anesthesiologist (ASA) physical status classification of I-II and aged between 2 and 8 years were included in the study.

Exclusion Criteria:

Exclusion criteria were ASA status III-V, age older than 8 years, having any history of allergy to anaesthetic drugs and renal disease interfering with drug metabolism.
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients with Ischemic Stroke

The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.

Atrial fibrillation (AF) and hypertension are among the main treatable risk factors for ischemic stroke and transient ischemic attack (TIA). Detecting paroxysmal atrial fibrillation in stroke patients is challenging, but highly relevant since anticoagulation can effectively reduce the risk of recurrent strokes. Furthermore, hypertension remains poorly controlled even after stroke despite multiple available treatment options. In the CARDIOSTROKE trial, the investigators aim to randomize 405 patients with recent ischemic stroke or TIA into (1) standard diagnostic work-up, follow-up and treatment (control group) and (2) 3-week ECG monitoring to detect occult AF and self-monitoring of blood pressure with mobile-device-assisted self-titration of antihypertensive medication (intervention group). Randomization will occur 2:1 into control and intervention groups. The co-primary outcomes include (1) incidence of new-onset AF and (2) difference in the mean blood pressure at 12-months.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke or transient ischemic attack (ABCD2 score ≥3)
* Age ≥40 years
* Pre-existing or newly diagnosed hypertension
* Informed consent from the patient or legal representative

Exclusion Criteria:

* Known high-risk source of cardioembolism
* Known indication for anticoagulation
* Contraindication for anticoagulation
* Pacemaker
* Non-compliance to study interventions as judged by the investigator
* Serious condition hampering the study conduct
Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery

OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin 0.3% ophthalmic solution).

DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical trial.

PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned, according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n = 31).

INTERVENTION Cataract surgery by means of phacoemulsification and implantation of posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.

Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).

Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after surgery. Standard post-operative topical antibiotic and steroid will be also given concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).

Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks from cataract extraction.


Eligibility Criteria:
Inclusion Criteria:

* cataract
* pseudoexfoliation syndrome

Exclusion Criteria:

* history of ocular inflammation or trauma
* previous intraocular surgery
* corneal haze
* retinal vascular disease
* diabetic retinopathy
* variation of the foveal profile at OCT (macular edema, epiretinal membrane)
* moderate to severe age related macular degeneration
Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.

Most patients with mCRC are treated with palliative chemotherapy and only a small number of patients with limited metastatic disease achieve long-term remission following metastasectomy. There is a growing need for more effective treatment in patients with liver-only mCRC to improve the rate of curative resection without compromising QOL.The current study is informed by our patient's needs. It aims to evaluate the rate of conversion therapy in patients with unresectable liver-only mCRC using the combination of FOLFOXIRI and bevacizumab and to assess the association between an early FDG-PT/CT response and other clinical and pathological biomarkers and hepatic metastasectomy.

Colorectal cancer is the second leading cause of cancer-related death in North America. Patients with metastatic colorectal cancer generally have limited life expectancy, however, a small number of patients with liver-only metastases could potentially be cured following surgical resection of metastases. Patients and their family strongly feel that there is an unmet need for a more effective treatment in metastatic colorectal cancer to improve disease response rate and thereby curative surgery. Recent evidence suggest that a triplet chemotherapy regimen, FOLFOXIRI plus bevacizumab has been associated with higher response rates. The CONVERSION trial will evaluate the rate of conversion from unresectable to resectable liver metastases in patients with liver-only metastatic colorectal cancer treated with FOLFOXIRI-bevacizumab. Furthermore, this study will assess disease control rate, survival, quality of life and association between various biomarkers including an early FDG-PET/CT response and curative surgery. Thirty-two eligible patients will be recruited at the two major cancer centers in Saskatchewan. Patients will receive FOLFOXIRI-bevacizumab every two weeks for a total of 12 cycles and will undergo periodic imaging studies. The resectability of liver metastases will be assessed by a multidisciplinary team comprised of surgeons, radiologists, and oncologists. This study will be helpful to establish a standard chemotherapy regimen for patients with liver-only metastatic colorectal cancer and to determine the role of FDG-PET/CT scan and other biomarkers in predicting curative surgery. Complete resection of metastases will allow such patients to discontinue chemotherapy and live a normal life.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, aged between 18 and 70 years with histologically proven adenocarcinoma or poorly differentiated carcinoma of the colon and rectum with unresectable liver-only metastases and no extra-hepatic disease.
* World Health Organization (WHO) performance status of 0-1.
* No previous chemotherapy for advanced disease.
* Adequate functioning of the bone marrow, liver, and kidneys.

Exclusion Criteria:

* Breastfeeding or pregnancy.
* An active second primary cancer with the exception of squamous cell carcinoma of the skin or an in situ cancer.
* Severe or uncompensated concomitant medical conditions.
Novel Rapid POC Diagnostics for COVID-19

This is a prospective, multicentre study in which the diagnostic accuracy of multiple Covid-19 Antigen rapid diagnostic tests will be assessed for COVID-19 case detection using prospectively collected nasal swabs and saliva samples from participants suspected to have Covid-19 infection (with or without symptoms). The study will last approximately 9 months.

Adult individuals with presumptive Covid-19, either symptomatic or asymptomatic, will be screened for inclusion at 4 different study sites located in Georgia and South Africa.

Enrolled participants will be asked to provide 2 samples: one nasopharyngeal swab that will be utilized for Covid-19 diagnosis by standard PCR and one sample (either nasal swab or saliva) to be used for the new antigen rapid diagnostic test under evaluation. At least 2 different antigen tests will be evaluated to determine sensitivity and specificity: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Jiangsu Bioperfectus Technologies) and GeneFinder COVID-19 Ag Rapid test (Osang Healthcare).

The data gathered from this study, could be used as part of the dossier to be submitted to WHO (world health organization) for review.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Presenting to testing locations linked to the clinical sites
* Suspected to have COVID-19 (as per WHO or national guidelines). These include the following groups:

  * Individuals with acute onset of any of the following signs or symptoms: fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting, diarrhoea, altered mental status (for SYMPTOMATIC group);
  * Contacts of confirmed cases of COVID-19
  * Individuals residing or working in an area with high risk of transmission of virus
  * Individuals residing or travelling to an area with community transmission
  * Individuals working in any health care setting, including within health facilities or within the community
* Provided voluntary written consent to participate in this study
* Provided a specimen suitable for testing

Exclusion Criteria:

* Individuals unable to cooperate with respiratory sample collection
* Individuals on oxygen therapy
* Recent history of excessive nose bleeds
* Individuals unable to give informed consent
* Hemodynamic instability as determined by the treating physician
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients

In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.

In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, which will be determined by efficacy and safety profiles of the patients; afterward, the optimal dosage of chidamide will be combined with VRD regimen, patients will be randomly assigned to chidamide+VRD group or VRD group, and their efficacy and safety will be compared.

Eligibility Criteria:
Inclusion Criteria:

* 1.Diagnosed as multiple myeloma, and has one of the above:

  1. high risk karyotype, such as 17p-，t（4；14），t（14；16），t（14；20）或1q gain,1p-, double hit myeloma, triple hit myeloma, etc;
  2. RISS-3;
  3. IgD/IgE MM;
  4. with measurable extra-medullary plasmacytoma;
  5. flowcytometry showed peripheral blood plasma cell ≥0.165%；
* 2.Secretory MM should have measurable markers, including:

  1. specific M protein value (≥5g/L)；
  2. and/or involved flc ≥100mg/L；
  3. and/or measurable extramedullary foci (diameter\>1cm on CT);
* 3.Age≥18 years, male or female;
* 4.ECOG 0-2 points, with life expectance ≥3 months; GA score \<2;
* 5.ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of normal maximum；
* 6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L;
* 7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy;
* 8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1;
* 9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
* 10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.

Exclusion Criteria:

* 1.With ≥2 degree of peripheral neuropath or with pain;
* 2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
* 3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
* 4.Patients in pregnancy or lactation;
* 5.Allergic constitution or being allergic to any drug within the regimen of the trial;
* 6.With uncontrolled mental diseases;
* 7.With active infection;
* 8.With non-myeloma-associated acute renal dysfunction;
* 9.With active hepatitis;
* 10.HIV positive;
* 11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
* 12.With other conditions that the investigators think unfit for the trial.
A Trial Investigating NN1218 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for more than 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
* Body mass index (BMI) between 18.0-28.0 kg/m2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

The investigators propose to develop a novel intervention that targets the system (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain management alternatives.

The investigators will develop and test the acceptability, feasibility, and preliminary efficacy of a Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain. Specifically, after honing the intervention, the investigators will conduct a pilot randomized controlled trial of Collaborative Care/Motivational Interviewing in 100 veterans (ages 18 and older) with chronic pain in primary care who are prescribed opioid pain medications and exhibit at least one "high-risk" opioid use behavior (e.g. obtaining early opioid refills, etc.). Using ATHENA-OT decision support, PCPs will make guideline-concordant recommendations to all enrolled study patients and initiate a Pain Care Plan. Veterans randomized to Collaborative Care, will have one MI session with their assigned study Care Manager followed by 3 Care Manager-delivered telephone MI/monitoring sessions; patients randomized to the Attention Control arm will have one brief session with their assigned Care Manager, followed by 3 Care Manager-delivered neutral telephone sessions

Eligibility Criteria:
Inclusion Criteria:

* Current Male or Female patient at San Francisco VA Medical Center or affiliated VA clinics
* Must be older than 18 years
* Chronic musculoskeletal pain of at least 6 months duration and
* Prescribed one or more opioid pain medication for more than three months and
* Evidence of being a high-risk opioid user as determined by PI, electronic medical record, and study measures

Exclusion Criteria:

* Non-English speakers
* Plans to relocate within 6 months; not able to come to San Francisco VA Medical Center for three in-person visits
* Cancer or other terminal illness involving palliative care with opioid medications
* Serious or untreated mental illness
Comparison of Exercise Therapies for Patellofemoral Pain

Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young adults. PFP is characterised by significant retropatellar and/or peripatellar pain and impairment of function and quality of daily life. Exercise therapy is unequivocally recommended as a core component of the management of PFP. Different exercise types (e.g. quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been investigated, with knee and hip strengthening exercises as the most common and recommended types. These exercises approaches produce similar small to moderate effects on pain and physical function. However, the PFP population is very heterogeneous and "one-size-fits-all"-approaches presumably are sub-optimal because the heterogeneity is ignored. The heterogeneity probably explains the overall limited beneficial effects of exercise, and the lack of differences in direct comparisons of different exercise types. In that sense, it is not unlikely that certain patient characteristics may predict outcome success of either a hip training program or a training program that focus on the quadriceps but this remains to be shown.

This study has two aims:

1. To assess the comparative effectiveness of two different exercise programs (Quadricep Exercise \[QE\] vs. Hip Exercise \[HE\]) on self-reported pain and function in individuals with PFP.
2. To explore candidate patient characteristics that predict differential responses to the two exercise programs (QE vs HE) on self-reported pain and physical function in individuals with PFP.

According to the study aims we pursue the following hypothesis:

- QE and HE have equivalent efficacy on self-reported pain after 12 weeks of treatment in patients with PFP.

The second study aim is to explore possible candidate patient characteristics that may associate with differential outcomes. As this is exploratory, the pursuit of this aim is hypothesis-free.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of PFP in at least one knee
* Visual analogue score rating of pain during activities of daily living during the previous week at a minimum of 3 on a 10 cm scale.
* Insidious onset of symptoms unrelated to trauma and persistent for at least 4 weeks.
* Pain in the anterior knee associated with at least 3 of the following:

  * During or after activity
  * Prolonged sitting
  * Stair ascent or descent
  * Squatting

Exclusion Criteria:

* Meniscal or other intra-articular injury
* Cruciate or collateral ligament laxity or tenderness
* Patellar tendon, iliotibial band, or pes anserine tenderness
* Osgood-Schlatter or Sinding-Larsen-Johansson syndrome
* History of recurrent patellar subluxation or dislocation
* History of surgery to the knee joint
* History of head injury or vestibular disorder within the last 6 months