cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Vaccine Efficacy in Patients With Malignant Pathologies

In the context of malignant disease, it is likely that vaccine efficacy and immunogenicity depends on the type of pathology, stage of the disease, immunosuppression induced by the treatments, in addition to more classic factors such as age, general condition and possibly the type of vaccine used.

There are very little data on the efficacy and immunogenicity of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with malignant disease in the active phase of treatment.

This multicenter observational study aims to assess the efficacy and the immunogenicity of anti-Sars-CoV-2 vaccines in the cohort of patients treated for malignant pathology (solid or hematological tumors) at Saint Louis Hospital and in thoracic oncology patients at Bichat Hospital.

During the visit carried out as part of the follow-up, participation in this study will be proposed to any patient who is treated for a malignant disease (solid or hematological tumors) within the university hospitals of AP-HP.Nord.

The patients participating in this prospective cohort will benefit from all standard care his/her condition requires.

Clinical and biological data will be collected as part of the usual follow-up. Clinical data: pathology, stage, treatment line, type of current treatment and date of the last treatment administered, previous treatments, radiotherapy, concept of radiation lung disease, history of pneumonectomy, comorbidities, performance status, history of coronavirus disease 2019 (COVID-19).

Laboratory data: pre-vaccination polynuclear neutrophil count, lymphocyte counts, plasma protein electrophoresis or Ig weight dosage (routine care in hematology), lactate dehydrogenase (LDH), C-reactive protein (CRP), albuminemia in the previous month.

Vaccination data: type of vaccine, date of the 1st injection, date of the 2nd injection, pre-vaccination antibody levels

* Seroconversion with anti-S IgG after anti-Sars-CoV-2 vaccination
* Anti-S and / or anti-N Sars-CoV-2 IgG seroprevalence before vaccination
* Adverse effects related to vaccines
* Levels of the anti-S IgG antibodies in AU / ml

During visits between D21 and D28 (before the 2nd injection), at month 3, month 6 and month 12, the following data will be collected:

* Antibody levels
* Adverse effects related to vaccines
* Levels of the anti-S IgG antibodies in AU / ml
* Associated side effects
* Occurrence of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant disease undergoing treatment at Saint Louis Hospital or Bichat Hospital (for chest cancer)
* with chemotherapy
* with chemotherapy + Immunotherapy
* with immunotherapy
* with targeted therapies
* with radiotherapy
* in the event of radiation pneumonitis after radiotherapy for lung cancers
* after pneumonectomy for lung cancer
* Patient informed and having expressed their non-opposition to participating in this research

Exclusion Criteria:

* Patient with a contraindication to Sars-Cov2 vaccination
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.

Cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. The principal pathogen is Pseudomonas aeruginosa which is present in the airways of 70% of adult patients with CF. Of particular concern is the increasing resistance observed to existing agents.

While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF based on positive sweat chloride or know CF mutation
* Age \> 17 years
* Able to spontaneously expectorate sputum

Exclusion Criteria:

* Any clinically significant laboratory abnormality
* Presence of an ongoing acute pulmonary exacerbation
* Pregnancy
* Serious past allergy to a beta-lactam antibiotic
Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage

This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . Misoprostol is a synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age less than 70 days gestation (\<10 wks).
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 30 kg/m2.
* Missed abortion
* previous one or more cesarean deliveries

Exclusion Criteria:

* Molar pregnancy
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or INH.
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.


Eligibility Criteria:
Inclusion criteria

* Participants who qualified and entered the core study.
* Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2.

Exclusion criteria

* Participants who did not complete Period 1 of the core study.
* Participants who were re-randomized in Period 2 of core study but did not continue for =\> 3 days in Period 2 of the core study.
* Participants who experienced any adverse events considered serious or drug related in the core study.
* Participants excluded from the core study.
Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome

The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.

The study will include overweight infertile women with PCOS seeking fertility who will receive induction of ovulation by clomiphene citrate will be recruited and randomized into two groups:

Group A (study group): 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement

Group B (control group): 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement

Eligibility Criteria:
Inclusion Criteria:

* polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
* infertility is the cause for seeking treatment.
* overweight females with BMI more than 25 but less than 30.

Exclusion Criteria:

* causes of infertility other than PCOS.
* causes of anovulation other than PCOS.
* current or in last six months use of hormonal treatment.
* contraindication to any drug used in the study.
Parent Education and Choice About Newborn Screening and Bloodspot Retention

To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.

It is widely recognized that new parents receive insufficient information about newborn screening (NBS) and little or no information regarding the retention of residual newborn screening samples. Our current research (R01 HD058854) clearly demonstrates that parents are supportive of NBS and the research use of residual specimens, but they want information before the child is born and want an informed choice regarding the retention and use of residual samples. Previous research has outlined the basic elements of what parents want to know about NBS generally. However, given that many states are adopting an "opt-out" approach for residual samples, it is unclear what basic information parents want to know to enable an informed choice about this practice. While it is recognized that retention and use of residual NBS samples is a valuable research resource, there are prevalent concerns in the NBS community that discussion of this will lead some parents to decline NBS altogether. Some authorities have suggested that discussions of NBS and residual sample retention be conducted separately to reduce the risk that parents will confuse the issues and decline NBS altogether.

To address this the project has the following specific aims:

Specific Aim 1) To determine what pregnant women, young mothers, and their partners want to know regarding the retention and use of residual bloodspot samples

Specific Aim 2) To create multimedia educational tools to be used in the prenatal care environment that will provide basic information about NBS and the core information determined through Specific Aim 1 about residual sample retention and use.

Specific Aim 3) To determine the impact of the prenatal education intervention on parental knowledge, attitudes, and decisions regarding NBS services and the retention and use of residual samples in diverse populations of English and Spanish speaking pregnant women.

Specific Aim 4) To examine the normative/ethical implications of the results of SA3 for the conduct of state NBS programs. Recommendations on the content and timing of parental NBS education will be developed.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years) women
* Uncomplicated pregnancy
* English and Spanish speaking
* Partners of pregnant women who have give birth.

Exclusion Criteria:

* Women younger than 18 years
* Complicated pregnancy
Melatonin for Migraine Prevention

The circadian system with its centre in the hypothalamus is involved in migraine pathophysiology. Whether it plays a pivotal role is not clarified. The investigators postulate that a destabilized circadian system may increase migraine attack susceptibility, and that stabilization by supplying melatonin a migraine preventive effect will be achieved.

A previous open label study has shown effects that certainly warrant a placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 65 years, both male and females.
* Migraine present for at least 1 year and fulfilling diagnostic criteria that conform to those of the International Headache Society (HIS) \[2\] but otherwise healthy.
* Attacks of migraine should occur 4-6 times per month, there should be no regular use of other drugs, and the patient has to be able to differentiate between migraine headache and non-migrainous headache.
* Preventive drugs for migraine should not have been used the last three months.
* Conventional acute attack treatment is accepted, but not sporadic use of other drugs like hypnotics and anxiolytics.
* Residence of North-Norway.

Exclusion Criteria:

* Medication overuse headache, chronic migraine.
* Pregnant and breast feeding women.
* Patient with either serious co-morbidity or conditions requiring medical treatment or caution.
* Psychiatric disease.
Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy

Anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. It is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. Blocking these checkpoints, such as PD-1, unleashes the action of anti-cancer T cells that can then destroy the tumor. The efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.Immune checkpoint inhibitors (ICIs) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers Since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.Most side effects of ICIs occur within the first few months after initiation of treatment. The toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected.

Cardiac autoimmune involvement in ICIs can involve the myocardium, pericardium, and/or vascular endothelium. These entities may be interrelated or, on the contrary, isolated.

In the last 5 years, the number of described cases of myocarditis associated with ICIstreatment has increased. Their incidence remains low, estimated between 0.5 and 2%. This probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%.

In recent years MRI has become very important in the noninvasive diagnosis of acute myocarditis. The latest update of the Lake Louise criteria in 2018 has thus confirmed cardiac MRI in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or other cardiovascular complications
* Patient over 18 years of age
* Patient affiliated to a health insurance plan
* Patient who has given free, informed and oral consent

Exclusion Criteria:

* Contraindication to immunotherapy
* Pregnant or breastfeeding patient (if applicable)
* Contraindication to cardiac MRI
Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism

Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (HOA). HOA's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. Specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing HOA's and improving vision. In many patients the resultant vision, though improved, still has some level of residual HOA's affecting the quality of vision. Custom scleral lenses with customized wavefront guided optics can be used to reduce residual HOA's and improve vision further. These lenses have been referred to as higher order aberration correcting scleral lenses or HOA correcting sclerals and wavefront guided scleral lenses or WFG sclerals.

The purpose of this study is to investigate the effect of an advanced technique for designing custom scleral contact lenses to further improve vision in keratoconus or irregular astigmatism by reducing residual aberrations. The derived custom scleral lenses will include customized aberration correcting optics, guided by a wavefront aberrometer measurements. These lenses are custom made based on the individual measurements from an eye.The primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. In particular, the investigators will compare efficacy in reducing aberrations and improvement in vision.

Eligibility Criteria:
Inclusion Criteria:

-A diagnosis of keratoconus or irregular astigmatism

Exclusion Criteria:

* Patients with other visually significant ocular pathology.
* Inability to apply or remove a scleral lens.
Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model

Aim of the study:

Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model.

Clinical relevance:

* Accelerated healing of uncomplicated wounds
* Enhanced healing of complicated (chronic, non-healing) wounds

Study design:

* Prospective controlled phase I/II study
* Cohort of 5 patients in pilot study, then reevaluation

Patients:

- Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the classification of Daniel and Seiler

Methods:

1. First surgical intervention:

* Radical debridement of pressure sore
* Bone marrow harvest from the iliac crest
* Isolation of hematopoietic stem cells, aiming to gain \> 1 mio. CD 34+ cells per patient under GMP conditions

  3. Stem cell therapy (after 2 days)
* Injection of stem cells in suspension (50'000 CD 34+ cells in 100 microliter saline per cm2 of wound surface) on one half of the total wound surface and cell-free saline on the other half as a control

  4. Second surgical intervention (after 3-4 weeks):
* Complete excision of the wound
* Closure of the defect by fasciocutaneous flap

  5. Evaluation of wound healing:
* Clinical
* 3D laser imaging
* Histology
* Growth factor assay


Eligibility Criteria:
Inclusion Criteria:

* Para- or tetraplegic
* Sacral pressure sores
* Grade III-IV according to classification of Daniel and Seiler

Exclusion Criteria:

* Diabetes mellitus
* Peripheral vascular disease
* Coronary artery disease
* Smoking
* Steroids and other immunosuppressive drugs
* Systemic autoimmune or rheumatoid diseases
* HIV
* Hepatitis B/C
The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

The incident of epilepsy still very high in Indonesia, thus many patients become drug resistant epilepsy. As vitamin D has some anticonvulsant effect, the investigators want to study if an additional dose of vitamin D can help with the therapy responses.

Specifically the investigators want to study about :

1. Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
2. Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
3. Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
4. Responder rate. Percentage of patients change of at least 50% of the seizure frequency
5. Remission rate after vitamin D treatment. Percentage of patients without any seizure (seizure freedom)
6. Effect of vitamin D according to epilepsy type. Responder rate in focal and generalized epilepsy.
7. Effect on Global Assesment of the Severity of Epilepsy (GASE)
8. Effect on Hague Seizure Severity scale (HASS)
9. Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)

Eligibility Criteria:
Inclusion Criteria:

1. Age 1 - 18 years
2. Drug-resistant epilepsy
3. Having at least 6 unprovoked seizures in the previous 3 months
4. No vitamin D treatment in the previous 6 months
5. Medication compliance
6. Agreeing to participate in the study
7. Having a social insurance
8. Parental agreement

Exclusion Criteria:

1. Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)
2. Known hypersensitivity to vitamin D
3. Lost to follow up
A Mobile App to Improve Participation in Following-up Cohorts

The main objective is to test the superiority of a newly developed mobile application - RECAP_MyLife - for data collection in cohort studies in order to increase participation in follow-up evaluations. We hypothesize that data collection through a mobile app will contribute to improvements in participation.

An accurate assessment of the potential benefits and drawbacks of using this mobile technology tool for data collection in cohort studies will be conducted. For such, the study will be conducted in three cohorts developed in different temporal, cultural, and geographic contexts, increasing the generalization of the results found. This evaluation is intended to contribute to the development of more appropriate tools for data collection and consequently to increase participation in epidemiological studies.

This is a multicenter, two-arm, parallel unmasked pragmatic randomized controlled trial with baseline and post-intervention (4 weeks from baseline) assessments. A convenience sample of participants of three population-based cohorts of individuals born very preterm and/or very low birth weight will be randomized and allocated 1:1 to either a mobile app intervention group or into the control arm (usual data collection methods).

Secondary aims of this study are:

1. To evaluate the usability and acceptability of the mobile app among cohort participants.
2. To investigate the potential Hawthorne effect on the results on physical activity behavior and mood status.
3. To measure the agreement between passively tracked physical activity by the mobile app and physical activity measured weekly with a self-reported questionnaire.
4. To measure the agreement between mood status collected by the mobile app through Ecological Momentary Assessment and mood status measured weekly with a self-reported questionnaire.
5. To survey participant's preferences about the different data collection methods.

Intention-to-treat approach will be applied in the data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 16 years or over
* Individuals with no evidence of visual impairment, physical condition that may affect the ability to walk, or major cognitive or motor disabilities until the enrollment of the study
* Individuals owning a smartphone with an Android software version 7 or newer.

Exclusion Criteria:

-
Verapamil and Catamenial Epilepsy

One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting MDRs and thus may help patients with refractory seizures. If the study shows improved seizure control, the results will help establish the role of MDRs in refractory epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* females
* at least 2 seizures per month
* more than 50% of the seizures occur 7 days before or 7 days after the onset of menses
* patient of the Toronto Western Hospital Epilepsy Clinic

Exclusion Criteria:

* cardiovascular history
An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years with rheumatoid arthritis (RA)
* Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide \[CCP\])
* Active disease despite receiving one or more TNF inhibitors
* Absence of serious or active infection

Exclusion Criteria:

* Participants with serious history of heart failure (class New York Heart Association \[NYHA\] IV) or severe uncontrolled heart disease
* Participants pregnant or lactating
* Prior treatment with Mabthera®
* Participants receiving any other investigational product in the context of other clinical study
* Participants with known hypersensitivity to rituximab or to any of the excipients