cyrilzakka/clinical-trials huggingface dataset:
Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France

Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers.

The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.

Results will help identify long-term complications, respond to patients' expectations, and evaluate the feasibility of conducting such a follow-up in all patients. They should guide the choice of the most appropriate tools for care, help assess needs in terms of collaboration with adult care staff, and identify potential partners.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with cancer between 01/01/1987 and 31/12/1992, before age 15, and living in Auvergne or Rhône-Alpes (France)
* Being a beneficiary of health insurance
* Having signed the informed consent form

Exclusion Criteria:

* Having been diagnosed with leukemia as a primary cancer
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
* Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
* Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous left atrium (LA) ablation or surgery
* Participant known to require ablation outside the PV region (example. cavotricuspid isthmus \[CTI\] region, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
* Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
* Severe dilatation of the LA (LAD \>50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))
TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I)

Part I of the TaPaS trial forms part of a twofold clinical RCT:

Part 1) A prospective RCT comparing the efficacy of transcutaneous tibial nerve stimulation (TTNS) with TTNS sham therapy for children with idiopathic overactive bladder on clinical and patient reported outcomes (PROMS).

Part 2) A prospective RCT comparing TTNS versus Percutaneous tibial nerve stimulation (PTNS) on clinical outcomes and PROMS.

Non invasive neuromodulation therapy for children with the overactive bladder syndrome is a highly under investigated topic in medical literature.

Only 2 studies ( Patidar et al. and Boudaouid et al.) investigated the use of tibial nerve stimulation with adhesive electrodes.

1) In the first trial the superiority of TTNS vs.Sham therapy for the therapeutic management of children with OAB naive to any pharmacological treatment will be examined.

Clinical outcomes will be assessed by the use of daytime and nighttime bladder diaries.

Assessment of outcomes at baseline, after 6 weeks and 12 weeks of treatment, and investigation of mean time to partial or complete relapse following 6 weeks observation.

After a wash-out period of 6 weeks, patients from the part I Sham group will be able to be included for TaPaS part II.

Eligibility Criteria:
Inclusion Criteria:

* Children between 5 and 12 years old, clinically diagnosed with the idiopathic overactive bladder syndrome with urinary incontinence (daytime and/or nighttime)
* Untreated, except from urotherapy.

Exclusion Criteria:

* Enuresis nocturna due to nocturnal polyuria
* Dysfunctional voiding
* Neurogenic bladder
* Psychiatric disorders, behavioural disturbances or mental disabilities
* Treated before with pharmacotherapy or invasive therapies for OAB
* Children with parents unable to record reliably micturition diaries.
IDEA-033 Open Label Study

The main aim of the study is to evaluate safety, efficacy, compliance, and usage of epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.

Multi-centre, one arm, multiple dose, open-label, at home usage study. Adult volunteers experiencing joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation will be screened for study participation.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years or older
* agree to refrain from chronic usage of NSAIDs or any other analgesics or anti-inflammatory drugs other than those provided during the course of the study or documented sporadic concomitant analgesics
* joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation in designated target area(s) that are appropriate for self-treatment with a topical analgesic or where availability of a second person can be guaranteed in case self-treatment is not possible
* healthy skin in the target area(s)

Exclusion Criteria:

* known hypersensitivity to IDEA-033 or other NSAIDs
* history of coagulation disorders
* history of peptic ulcers or gastric intolerance with NSAIDs
* urinary tract infection
* clinically significant renal, hepatic, or gastric disease
* acute or chronic coexisting illness qualifying for exclusion according to clinical judgement of the investigator
* clinical laboratory values outside normal range deemed clinically significant by the investigator
* Narcotics-containing products within 7 days of administering IMP
* Malignancy within the past 2 years
A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)

The main goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate with warfarin or lisinopril. Researchers want to learn if the amount of warfarin in a person's blood is similar when warfarin is taken alone or with enlicitide decanoate.

Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Warfarin is a drug that reduces risk of blood clotting, and lisinopril is a drug that lowers blood pressure.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to:

* Is in good health
* Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to:

* History of gastrointestinal disease which may affect food or drug absorption, or has had a gastric bypass or similar surgery
* History of cancer
Identification of Genetic and Cellular Markers Associated With Vascular Endothelial Modifications in Cutaneous Arteriovenous Malformations

Cutaneous Arteriovenous malformations (AVM's) rare congenital high-flow vascular malformations in which arteries and veins are directly connected through a complex web of abnormal arteries and veins instead of a normal capillary network. Arterial feeders and enlarged draining veins directly connect through arteriovenous fistulas that create the "nidus". The natural history of AVMs is organized into a clinical staging system: during the first phase of quiescence, the arteriovenous malformation mimics a capillary malformation. After many years, the AVM may enlarge with loco-regional expansion and tissular destruction. At the ultimate stage, AVM may impact the heart function. They are considered non malignant but can expand and become a significant clinical risk when extensive. The management of these high flow AVM remains often problematic. Complete and large surgical excision of the nidus after hyperselective embolization is the only potential therapeutic solution but this, is often difficult if not impossible. There is no pathogenetic hypothesis for the development of these malformations. Histopathological examination (performed only on surgical resection specimen) is poor and does not provide sufficient evidence to assess the evolutivity or the severity of the MAV. Recent data hypothesize that these vascular malformations are associated with alterations of the vascular endothelium caused by genetic abnormalities involved in the control of angiogenesis and vascular homeostasis. The detection of these anomalies allows the search for cellular and genetic markers that might be useful to optimize the clinical classification, staging, predicting the evolution of these defects and some understanding of its pathophysiological mechanisms. To our knowledge, no studies to identify cellular markers / genetic and endothelial associated with the development of cutaneous AVMs have been published to date.


Eligibility Criteria:
Inclusion Criteria:

* Male or feminine Subject
* Subject of 10 and more years old,
* Subject weighing more than 55 kg. patients:
* Subject presenting a cutaneous artério-venous deformation there outside of any other deformation or known vascular tumor.
* Subject presenting no other susceptible pathology to influence endothéliaux markers (Renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular, diabetes, evolutionary tumoral pathology).

volunteers:

* Unhurt Subject of deformation or vascular tumor.
* Subject presenting no other susceptible pathology to influence endothéliaux markers(scorers) (Renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular).

Exclusion Criteria:

* Subject of less than 10 years old
* Subject weighing less than 55 kg
* Subject presenting another type(chap) of vascular vascular deformation or tumor
The Effect of Wii Fit Rehabilitation in Patients With Chronic Ankle Instability a Randomized Control Study

The goal of this clinical trial is to investigate the effect of Wii Fit rehabilitation on risk of fall, balance, and functional limitation, in patients with chronic ankle instability ,The main question it aims to answer is:

Are there any effect of Wii Fit rehabilitation training on balance, functional limitation, and risk of falls in patients with chronic ankle instability? Participants will be asked to sign a written informed consent form before the study according to guidelines of ethical committee The first group control group: 30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.

The second group experimental group: 30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training.

Wii Fit is an effective virtual reality approach for balance training. This intervention requires less time per session compared to traditional physical therapy treatment. Moreover, it is user-friendly, engaging, cost-effective and can be delivered at home without the need for supervision by a trained rehabilitation professional. Given the growing popularity of the technological approach as Wii Fit intervention, it would be important for the rehabilitation field to replicate these findings as high quality randomized clinical trials with large sample size and equal distribution of males and females.Further researches are needed to assess the long term effect of Wii training in patients with functional ankle instability. A variety of exercise programs were used as an intervention for chronic ankle instability, and conservative treatment interventions including balance, proprioceptive, and muscle strengthening exercises are effective for patients with chronic ankle instability

Eligibility Criteria:
Inclusion Criteria:

* Sixty patients, their age ranges between 18 to 60 years old.
* Patients of both gender (men and women)
* A history of at least one ankle sprain, with the initial sprain occurring more than 1-year before the study
* A feeling of ''giving way'' at least 2 episodes in the last 6 months before the study
* Experiencing a recurring sprain, which is defined as two or more sprains on the same ankle
* No history of ankle injury within the three months prior to participation, and no cognitive deficit
* Capability to perform the intervention or daily activities without an increase in pain
* Currently they are not participating in any other rehabilitation exercise programs
* No history of ankle surgery

Exclusion Criteria:

* Subjects had balance deficits due to vestibular disorders, such as vertebro-basilar insufficiency and/or visual disorders
* Tumors in the area to be treated for the study
* pregnancy
* Any injury or surgery done in ankle joint, deformity at lower extremity
* Musculoskeletal condition like fracture, osteoporosis
* Neurological condition like parkinsonism disease, ataxia, stroke, muscular dystrophy, myasthenia gravis
* Cardiopulmonary conditions
Neoadjuvant Therapy With Trastuzumab and Chemotherapy and the Resultant Pathologic Complete Response Observed in HER2 Positive Breast Cancer;a Systematic Review

The goal of this systematic review is to assess the effectiveness of neoadjuvant chemotherapy and Trastuzumab in achieving pathological complete response (pCR) in patients with HER2-positive breast cancer. The main questions it aims to answer are:

* What is the overall rate of pathological complete response (pCR) in HER2-positive breast cancer patients treated with neoadjuvant chemotherapy and Trastuzumab?
* Are there any variations in the definition of pCR among the included trials?

Participants in the selected clinical trials were HER2-positive breast cancer patients with non-metastatic operable, locally advanced, or inflammatory breast cancer. The main tasks participants were asked to do and the treatments they received are as follows:

* Undergo neoadjuvant chemotherapy: Participants received chemotherapy treatment before their primary surgery.
* Receive Trastuzumab: Participants were administered Trastuzumab, a targeted therapy for HER2-positive breast cancer.

Researchers would compare the group of participants receiving neoadjuvant chemotherapy and Trastuzumab to other groups, if present, to see if there are differences in the rates of pathological complete response (pCR) or other effects.

This systematic review aimed to assess the effectiveness of neoadjuvant chemotherapy and Trastuzumab in achieving pathological complete response (pCR) in patients with HER2-positive breast cancer. The researchers identified nine clinical trials that met the inclusion criteria. These trials included patients with non-metastatic operable, locally advanced, or inflammatory breast cancer, and they evaluated the pCR as the primary or secondary endpoint.

The trials utilized different chemotherapy and targeted therapy regimens, along with varying dosages of Trastuzumab. The primary outcome of interest was the pCR rate, while other survival outcomes were not analyzed. Among the 1,209 patients who received neoadjuvant chemotherapy and Trastuzumab, the overall pCR rate was found to be 42%.

The review provided detailed information about the design of the selected trials, patient characteristics, disease staging, HER2 status, administered treatment regimens, and primary/secondary endpoints. It also mentioned slight variations in the definition of pCR across the trials.

Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer that was found to be HER2 positive were included
* Only patients who underwent neoadjuvant therapy were included
* All cytotoxic chemotherapy regimens were considered eligible for this systematic review given that the same drugs were given at the same dose in every trial.

Exclusion Criteria:

* Patients with metastatic breast cancer were not included in the systematic review
* Results from adjuvant therapy were excluded from this study.
* Only the most recent publication (and the most informative) was included if numerous publications of the same trial were retrieved or if there was a case mix between publications.
Follow up of High Myopic Eyes

In this non-interventional retrospective and prospective observational study, the long-term evolution of clinical and iconographic characteristics of patients with pathological myopia will be considered Changes of some specific clinical, tomographic and angiographic variables evaluated on the baseline and after a minimum of 5 years follow-up will be studied.


Eligibility Criteria:
Inclusion Criteria:

- high myopia

Exclusion Criteria:

* acute ischemic optic neuropathy
* macular and peripapillary atrophy
* other forms of maculopathy
Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

When a bilateral nerve-sparing radical prostatectomy (RP) is performed, recovery of erectile function (rigid erections) is reported for up to 80% of patients, who are less than 60 years old. Erectile function recovery is also impacted by patient age, erectile function before surgery, and the length of time after surgery.

Current evidence from studies suggests that developing erections is important, however, these studies have been small, and the evidence is not definite. Animal studies suggest that erection medication (Viagra, Levitra, Cialis) may protect erection tissue, even in the absence of erections. However, the correct treatment plan is unknown. For example, how often does a man need to take sildenafil (Viagra®) to protect his erectile function or to maximize his erectile function recovery? Is only using erection medication enough for erectile function recovery? Would penile injections, which almost ensure production of an erection, be better than using sildenafil (Viagra®), or might a combination be even better at helping recovery of erections? These are types of questions this study might answer.


Eligibility Criteria:
Inclusion Criteria:

* Male, must be ≥ 18 years of age, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland
* Stable sexual relationship for ≥ 6 months
* Open or laparoscopic bilateral nerve-sparing radical prostatectomy
* Baseline score of ≥ 22 on the International Index of Erectile Function Domain (Appendix A)
* Able to speak, read and write in the English language
* Calculated creatinine clearance using the 4 variable MDRD equation based on serum creatinine, age, race, and gender of \> 60 cc/min
* Patient is able to walk up two flights of stairs briskly without chest pain
* Patient needs to have their baseline sitting AND standing blood pressure and pulse done at the time of consent

Exclusion Criteria:

* Preoperative or planned postoperative pelvic radiation therapy
* Preoperative or planned postoperative androgen deprivation
* Presence of Peyronie's disease at baseline
* Presence of a penile prosthesis at baseline
* Resection of one or both nerve bundles at surgery
* Any contraindications to sildenafil:

  * Patient is currently using nitrates;
  * Presence of retinitis pigmentosa;
  * Presence macular degeneration;
  * MI or CVA within 3 months;
  * Patient is currently using MAOI medications
* Patient is currently using penile self injection medication (Trimix, Bimix, or PGE-1)
* Patient requiring sildenafil for penetration
* Use of sildenafil within 30 days of consent