cyrilzakka/clinical-trials huggingface dataset:
Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto

Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth and sixth decades of life, with fertility and childbearing becoming important issues. Data regarding this important topic remain limited, without clear data regarding iron control including serial assessment of hepatic iron concentration, the need for assistance in becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy increases and overall health improves in thalassemia, clear data on fertility, pregnancy complications, and the effect of pregnancy on maternal health in thalassemia patients are necessary since these will have a direct impact on patient care, quality of life, and patient expectations.


Eligibility Criteria:
Inclusion Criteria:

* Thalassemia, thalassemia intermedia or E-thalassemia patients in Toronto
* Subject has attempted conception

Exclusion Criteria:

* Subject has any other form of blood disease
* Subject has not attempted conception
Phase II Iressa + Irradiation Followed by Chemo in NSCLC

The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* 18 to 75 years inclusive.
* At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
* WHO performance status of 0 to 2 inclusive.
* Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
* Life expectancy of at least 6 months.
* Using secure contraceptives precautions.

Exclusion Criteria:

* Any previous anti cancer therapy for NSCLC.
* Known severe hypersensitivity to these products
* Any evidence of clinically active interstitial lung disease
* Other co-existing malignancies, symptomatic metastases.
* Abnormal blood test
* Weight loss of over 15% in the 3 months before the start of the study.
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Budesonide for Induction of Remission in Incomplete Microscopic Colitis

The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.


Eligibility Criteria:
Inclusion Criteria:

* Histologically established diagnosis of incomplete microscopic colitis (MCi)
* History of chronic non-bloody, watery diarrhoea
* Clinically active disease

Exclusion Criteria:

* Other significant abnormalities in colonoscopy
* Infectious cause of diarrhoea
* Clinical suspicion of drug-induced diarrhoea
* Prior and present MC
* History of bowel resection
* Radiation therapy of the abdominal or pelvic region
* Positive antibody titres for celiac disease
* Untreated active thyroid dysfunction
* Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
* Abnormal hepatic function
* Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
* History of colorectal cancer
* History of cancer (other than colorectal) in the last 5 years
* Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
* Current or intended pregnancy or breast-feeding
* Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures

The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.

The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

Eligibility Criteria:
Inclusion Criteria:

* The subject must be 18 years of age or older at the time of consent
* Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureForm™Staplers are utilized for transection and/or creation of anastomosis

Exclusion Criteria:

* Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy
* Subject with active bacterial or fungal infection
* Subject is contraindicated for general anesthesia or surgery
* Subject is undergoing an emergency procedure
* Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure.
* Subject has metastatic disease and/or subject has life expectancy of less than 1 year
* Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgical procedure
* Subject has history of coagulation or hematologic disorder
* Pregnant or suspect pregnancy
* The subject is unable to comply with the follow-up visit schedule
* Subject has perforated, obstructing or locally invasive neoplasm (T4b)
* Subject with inflammatory bowel disease
* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
* Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

Intra-Operative Exclusion Criteria:

* Subjects who require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler.
* Inadequate visualization making an endoscopic approach not feasible
* Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
Talent Aortic Cuff Stent Graft System Compassionate Use Registry

An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff.

The primary purpose of this registry is to provide an endovascular means of treatment for those patients experiencing a sub-optimal outcome related to the implanted AneuRx bifurcated stent graft and who are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff. A sub-optimal outcome is defined as either a Type I or Type III endoleak and/or an inadequate seal zone (\< 1 cm). For Registry purposes, a Type III endoleak will be defined as a proximal modular endoleak.

Eligibility Criteria:
Inclusion Criteria:

* Patient \>= 18 years of age
* Patient has a serious disease or condition
* No generally acceptable alternative for treating patient is available
* Patient has had the AneuRx stent graft system implanted \>= 30 days
* Patient has suboptimal outcome with the AneuRx stent graft system as evidenced by one or more of the following:
* Type I endoleak
* Type III endoleak (Proximal, modular)
* Loss of seal zone
* Proximal aortic neck diameter \>= 14mm and \<= 30mm
* Angle between axis of the suprarenal aorta and aneurysm neck is \<= 60 degrees
* Patient is able and willing to be available for 12,24,26,48 and 60 months post-procedure

Exclusion Criteria:

* Patient is pregnant of lactating
* Arterial access cannot be crossed with a delivery system
* Excessive vessel tortuosity
* Excessive aortic calcification
* AneuRx stent graft system implanted within the last 30 days
Real World CCH Study in Adult Females With Cellulite

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).

Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.


Eligibility Criteria:
Inclusion Criteria:

1. Have both buttocks or both posterolateral thighs with:

   1. A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
   2. A Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 0 (absence of laxity, flaccidity, or sagging skin), or 1 (slightly draped appearance) at the Screening Visit only.
2. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
3. Be judged to be in good health.
4. Have a negative pregnancy test.
5. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
3. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
6. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
7. Requires anticoagulant or antiplatelet medication during the study.
8. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
9. Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.
10. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
11. Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant and/or to provide breast milk during the course of the study.
12. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
Correlation Study Between Socio-economical Deprivation and Oral Health in Children of 9 Years of Age

Retrospective, observational cohort study.

Objectives :

To search for correlations between socio-economical deprivation and oral health in french children of 9 years of age.

To study the annual use of oral and dental care of children from 6 to 9 years of age depending on their geographical and socio-economical environment, and the medical demography ; To identify and study the share of the cohort not using oral and dental care, and the socio-economical and geographical factors implicated in this non-use of care.

The study will use data from the french nationwide healthcare systems database (SNDS) and data from the french national institute of statistics and economic studies (INSEE).


Eligibility Criteria:
Inclusion criteria:

* Being born in 2008
* Being covered by the mandatory french national health insurance plan without discontinuity between 2014 and 2017
* Living in France without discontinuity between 2014 and 2017

Exclusion criteria:

- None
ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.

Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.

Endoscopic resection of large colonic polyps is preferred over Surgical resections due to lower morbidity and preservation of the colon and its functions.

The use of submucosal injection is essential for a successful resection (EMR/ ESD). Injection of fluid into the submucosa cushions and isolates the tissue just before capture of the target lesion with a snare, thereby reducing thermal injury and the risk of perforation during EMR. ESD requires a long period of submucosal dissection and that involves multiple injections to maintain the submucosal cushion; without which the risk of perforation increases.

A mixture of normal saline solution + epinephrine and blue dye like indigo carmine is the commonly used injecting solution. However, Saline dissipates very quickly leading to frequent and multiple injections. This leads to longer procedure time.

Studies have demonstrated long-lasting effects of colloids when injected in the submucosal space. ORISE gel is a newly licensed injecting solution which contains a poloxamer agent leading to longer lasting submucosal cushion effect.

Multicentre prospective observational cohort study

Primary Objective : Primary Objective To evaluate the technical feasibility, effectiveness \& safety of the ORISE gel as an injecting solution on its own during endoscopic resection of colorectal polyps (ability to start and finish the resection with ORISE).

Secondary Objective : To identify Polyp Resection Time (PRT) and the amount of ORISE gel used during resection of large colorectal polyps.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old at the date of consent
* Subjects referred for EMR for the excision of:

Treatment naïve, laterally spreading sessile, flat polyps or adenomas of the colon equal to or greater than 20 mm in largest dimension, assessed by the investigator to be suitable for EMR or ESD.

Exclusion Criteria:

* Lesions less than 20 mm in largest dimension
* Subjects with ulcerated depressed lesions (Paris type III-excavated) or biopsy proven invasive carcinoma
* Scarred polyps
* Endoscopic appearance of deep invasive malignancy
* Previous partial resection or attempted resection
Medical Follow-up and Self-medication Among Medical Students

As health actors, medical students educate patients to have regular medical follow-up and give them justified medical prescriptions. Regarding their own health, medical students do not seem to apply these same principles.

The medical follow-up of medical students seems insufficient, which can be explained by the lack of medical follow-up by occupational medicine, a consequent work time, but also the fear of judgment by colleagues Moreover, medical student have an easy access to all types of prescriptions and therefore the ease of self-prescription and self-medication. Medical students may also overestimate their medical knowledge and may not be objective about their symptomatology.

The aim of the study will be to describe medical follow-up and self-medication among medical students

Eligibility Criteria:
Inclusion Criteria:

* medical student in general practice or in specialty medicine
* agreeing to participate in the study

Exclusion Criteria:

* none
tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

The purpose of this study is to assess the effects on pain of transcranial direct current stimulation combined with therapeutic exercise in fibromyalgia patients.

Fibromyalgia is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated. Perhaps this is why its therapeutic approach is refractory to current treatments.

Based on the theory that fibromyalgia is characterized by a sensitization at the level of the central nervous system that leads to an increase in the perception of pain, any therapeutic approach aimed at modulating the central nervous system may be beneficial. Electrical stimulation with transcranial direct current (tDCS) is among these techniques.

In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect on pain in different chronic pathologies.

The present study aims to investigate the effect on pain of a combination therapy of tDCS and therapeutic exercise in patients with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
* Normal pain intensity of 4 or more points on a visual analog scale.
* Able to participated in a therapeutic exercise program.
* Understanding of spoken and written Spanish.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Metallic implants in the head.
* Tumor, trauma or surgery in the brain.
* Epilepsy or stroke.
* History of substance abuse in the last 6 months.
* Use of carbamazepine in the last 6 months.
* Severe depression (Beck Depression Index II of 29 or more).
* Diagnosed psychiatric pathology.
* Rheumatic pathology not medically controlled.
* Coexisting autoimmune pathology.
* Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs

Several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in France. The oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. It is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. It shows why resistant mechanisms to treatment need to be elucidated. MicroRNA (miR) are short RNA, implicated in messenger ribonucleic acid (mRNA) regulation. Evidence is emerging that miR is implicated in prostate cancer response to treatment. It would be interesting to determine if a miR profile can predict treatment response to chemotherapy and/or to novel hormonal agents.

Several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in France. The oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. It is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. It shows why resistant mechanisms to treatment need to be elucidated. MicroRNA (miR) are short RNA, implicated in messenger ribonucleic acid (mRNA) regulation. Evidence is emerging that miR is implicated in prostate cancer response to treatment. It would be interesting to determine if a miR profile can predict treatment response to chemotherapy and/or to novel hormonal agents.

Eligibility Criteria:
Inclusion Criteria:

* prostate adenocarcinoma
* metastatic disease, proven (CT or bone scintigraphy or MRI or positron emission tomography(PET)-CT or X ray)
* castration resistance, proven with biology or radiologic progression
* affiliated to a french social security regimen

Exclusion Criteria:

* other cancer within five years
* any judiciary protection measure
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)

The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.

The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 3 months post-transplant of a cadaveric or living donor kidney
* Patient has been on a cyclosporine-based immunosuppression regimen since the transplant
* Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:

  * Serum creatinine: Male: \>=2.0mg/dL (176.8 umol/L); Female: \>= 1.7mg/dL (150.28 umol/L) 3 months or later post-transplant
  * Serum creatinine \> 30% increased over post-discharge nadir
* Patient has had a renal biopsy \> 3 months after transplant and within 6 months prior to enrollment
* Patient or legal guardian has signed and dated an IRB approved informed consent document
* Female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF)

Exclusion Criteria:

* Patient is dialysis dependent and has recurrence of primary or de novo renal disease
* Patient has an estimated creatinine clearance \<25mL/min
* Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization
* Baseline biopsy shows acute rejection Grade \>=IIB using Banff 95 criteria or \>= Grade IIA using Banff 97 criteria
* Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy
* Patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug
* Patient is a known carrier of any of the HIV viruses